,i #aafth ,,congress #b;d ,session ,h4 ,r4 #ad ,,in ,,the ,,house ,,of ,,representatives ,october #cj1 #bjbj ,mr4 ,hudson 7for himself1 ,mr4 ,mc,carthy1 ,mr4 ,walden1 ,mr4 ,brady1 and ,ms4 ,granger7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce1 and in addition to the ,committees on ,homeland ,security1 ,transportation and ,infrastructure1 the ,judiciary1 ,ways and ,means1 the ,budget1 and ,science1 ,space1 and ,technology1 for a period to be subsequently determined by the ,speaker1 in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned ,a ,,bill ,to increase the ,federal commitment to defeating the virus that causes ,,covid-#ai and prepare for future pandemics1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,commitment to ,defeat the ,virus and ,keep ,america ,healthy ,act4 #b4 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title4 ,sec4 #b4 ,table of contents4 ,title ,i--,pandemic ,preparedness and ,response ,subtitle ,a--,clarifying the ,role of the ,department of ,health and ,human ,services ,during ,public ,health ,emergencies ,sec4 #ajja4 ,lead agency for ,federal public health and medical response to public health emergencies4 ,sec4 #ajjb4 ,deployment by the ,secretary of ,health and ,human ,services of ,national ,strategic ,stockpile4 ,sec4 #ajjc4 ,authority and responsibilities of the ,federal ,emergency ,management ,agency regarding the ,strategic ,national ,stockpile4 ,subtitle ,b--,reagan-,udall ,foundation and ,foundation for the ,national ,institutes of ,health ,sec4 #ajaa4 ,reagan-,udall ,foundation and ,foundation for the ,national ,institutes of ,health4 ,subtitle ,c--,protections for ,good ,samaritan ,health ,professionals ,sec4 #ajba4 ,limitation on liability for volunteer health care professionals4 ,sec4 #ajbb4 ,sense of the ,congress4 ,subtitle ,d--,medical ,sheltering ,sec4 #ajca4 ,reducing the spread of ,,covid-#ai through payments to ,states to lease hotels to temporarily house eligible individuals4 ,subtitle ,e--,,cdc campaign on ,,covid-#ai awareness ,sec4 #ajda4 ,,covid-#ai public awareness campaign4 ,subtitle ,f--,protecting ,children from ,,covid-#ai ,sec4 #ajea4 ,study on children's role in transmitting ,,sars-,co,v-#b4 ,subtitle ,g--,ensuring ,understanding of ,,covid-#ai ,sec4 #ajfa4 ,study on the impact of ,,covid-#ai4 ,subtitle ,h--,safeguarding ,therapeutics ,sec4 #ajga4 ,authority to destroy counterfeit devices4 ,sec4 #ajgb4 ,determination of budgetary effects4 ,subtitle ,i--,advisory ,committee on ,immunization ,practices ,sec4 #ajha4 ,expedited meeting of ,,acip for ,,covid-#ai vaccines4 ,subtitle ,j--,improvements to ,transparency of the ,pricing of ,diagnostic ,testing for ,,covid-#ai ,sec4 #ajia4 ,improvements to transparency of the pricing of diagnostic testing for ,,covid-#ai4 ,title ,,ii--,domestic ,manufacturing and ,supply ,chain ,subtitle ,a--,sustained ,on-,shore ,manufacturing ,capacity for ,public ,health ,emergencies ,sec4 #bjja4 ,sustained on-shore manufacturing capacity for public health emergencies4 ,subtitle ,b--,manufacturing ,,api1 ,drugs1 and ,excipients in ,america ,sec4 #bjaa4 ,report to ,congress on barriers to domestic manufacturing of medical products and supplies4 ,sec4 #bjab4 ,enhancing intra-agency coordination and public health assessment with regard to compliance activities4 ,sec4 #bjac4 ,encouraging international harmonization4 ,sec4 #bjad4 ,mutual recognition agreements for inspections and review activities4 ,sec4 #bjae4 ,enhancing transparency of drug facility inspection timelines4 ,sec4 #bjaf4 ,advanced manufacturing technologies program4 ,subtitle ,c--,improving the ,american ,drug ,supply ,chain ,sec4 #bjba4 ,study and reporting on domestic and foreign production4 ,subtitle ,d--,essential ,medicines ,strategic ,stockpile ,sec4 #bjca4 ,pilot program on ensuring medication supply stability4 ,subtitle ,e--,national ,centers of ,excellence in ,continuous ,pharmaceutical ,manufacturing ,sec4 #bjda4 ,national ,centers of ,excellence in ,continuous ,pharmaceutical ,manufacturing4 ,title ,,iii--,strategic ,national ,stockpile ,improvements ,subtitle ,a--,stockpiling for ,america's ,future ,endeavors ,sec4 #cjja4 ,strategic ,national ,stockpile4 ,subtitle ,b--,stockpile ,inventory ,modernization ,sec4 #cjaa4 ,reimbursable transfers4 ,subtitle ,c--,equipment ,maintenance ,sec4 #cjba4 ,equipment maintenance4 ,subtitle ,d--,medical ,supplies for ,pandemics ,sec4 #cjca4 ,supply chain flexibility manufacturing pilot4 ,subtitle ,e--,state ,stockpile ,readiness ,sec4 #cjda4 ,grants for ,state strategic stockpiles4 ,subtitle ,f--,process ,improvements and ,reports ,sec4 #cjea4 ,,gao study on the feasibility and benefits of user fee agreements4 ,sec4 #cjeb4 ,action reporting4 ,sec4 #cjec4 ,improved1 transparent processes4 ,subtitle ,g--,strategic ,national ,stockpile ,funding ,sec4 #cjfa4 ,authorization of appropriations4 ,title ,,iv--,public ,health ,infrastructure ,improvements ,subtitle ,a--,public ,health ,infrastructure ,modernization ,sec4 #djja4 ,public health data system transformation4 ,subtitle ,b--,modernizing infectious disease data collection ,sec4 #djaa4 ,modernizing infectious disease data collection4 ,subtitle ,c--,diagnostic ,testing for ,public ,health ,labs ,sec4 #djba4 ,grants for public health laboratories to acquire high-throughput diagnostic equipment4 ,subtitle ,d--,rapid ,testing for ,communities ,sec4 #djca4 ,grants for same-day point-of-care clinical laboratory diagnostic testing in communities4 ,subtitle ,e--,public ,health ,workforce ,loan ,repayment ,sec4 #djda4 ,public ,health ,workforce ,loan ,repayment ,program4 ,subtitle ,f--,vaccine ,awareness and ,disease ,prevention ,sec4 #djea4 ,improving awareness of disease prevention4 ,subtitle ,g--,protecting the ,health of ,america's ,older ,adults ,during ,,covid-#ai ,beyond ,sec4 #djfa4 ,national ,,covid-#ai ,resource ,center for ,older ,adults4 ,sec4 #djfb4 ,healthy ,aging ,program4 ,sec4 #djfc4 ,authorization of appropriations4 ,subtitle ,h--,expanding ,capacity for ,health ,outcomes ,sec4 #djga4 ,expanding capacity for health outcomes4 ,subtitle ,i--,community ,readiness ,sec4 #djha4 ,grants for research on1 or establishing1 wastewater surveillance and other early warning systems4 ,title ,v--,addressing ,,covid-#ai ,health ,disparities ,subtitle ,a--,tribal ,health ,data ,improvement ,sec4 #ejja4 ,collection and availability of health data with respect to ,indian ,tribes4 ,sec4 #ejjb4 ,improving health statistics reporting with respect to ,indian ,tribes4 ,subtitle ,b--,tribal ,medical ,supplies ,stockpile ,access ,sec4 #ejaa4 ,provision of items to ,indian programs and facilities4 ,subtitle ,c--,native ,american ,suicide ,prevention ,sec4 #ejba4 ,native ,american suicide prevention4 ,subtitle ,d--,pursuing ,equity in ,mental ,health ,part #a--;,health ,equity and ,accountability ,sec4 #ejca4 ,integrated ,health ,care ,demonstration ,program4 ,sec4 #ejcb4 ,addressing racial and ethnic minority mental health disparities research gaps4 ,sec4 #ejcc4 ,health professions competencies to address racial and ethnic minority mental health disparities4 ,sec4 #ejcd4 ,racial and ethnic minority behavioral and mental health outreach and education strategy4 ,sec4 #ejce4 ,additional funds for ,national ,institutes of ,health4 ,sec4 #ejcf4 ,additional funds for ,national ,institute on ,minority ,health and ,health ,disparities4 ,part #b--,other provisions ,sec4 #ejcg4 ,reauthorization of ,minority ,fellowship ,program4 ,sec4 #ejch4 ,study on the ,effects of ,smartphone and ,social ,media ,use on ,adolescents4 ,sec4 #ejci4 ,technical correction4 ,subtitle ,e--,maternal ,health ,quality ,improvement ,sec4 #ejda4 ,innovation for maternal health4 ,sec4 #ejdb4 ,training for health care providers4 ,sec4 #ejdc4 ,study on training to reduce and prevent discrimination4 ,sec4 #ejdd4 ,perinatal quality collaboratives4 ,sec4 #ejde4 ,integrated services for pregnant and postpartum women4 ,sec4 #ejdf4 ,improving rural maternal and obstetric care data4 ,sec4 #ejdg4 ,rural obstetric network grants4 ,sec4 #ejdh4 ,telehealth network and telehealth resource centers grant programs4 ,sec4 #ejdi4 ,rural maternal and obstetric care training demonstration4 ,title ,,vi--,addressing the ,impacts of ,,covid-#ai on ,mental ,health ,subtitle ,a--,creating ,resources ,to ,improve ,situations of ,inherent ,severity ,sec4 #fjja4 ,set-aside for evidence-based crisis care services4 ,subtitle ,b--,emergency ,mental ,health and ,substance ,use ,training and ,technical ,assistance ,center ,sec4 #fjaa4 ,emergency mental health and substance use training and technical assistance center4 ,subtitle ,c--,suicide ,prevention ,grants ,sec4 #fjba4 ,syndromic surveillance of self-harm behaviors program4 ,sec4 #fjbb4 ,grants to provide self-harm and suicide prevention services4 ,subtitle ,d--,effective ,suicide ,screening in the ,emergency ,department ,sec4 #fjca4 ,program to improve the care provided to patients in the emergency department who are at risk of suicide4 ,subtitle ,e--,suicide ,prevention ,lifeline ,improvement ,sec4 #fjda4 ,suicide ,prevention ,lifeline4 ,sec4 #fjdb4 ,pilot program on innovative technologies4 ,sec4 #fjdc4 ,,hhs study and report4 ,sec4 #fjdd4 ,,gao study and report4 ,sec4 #fjde4 ,definition4 ,subtitle ,f--,campaign ,to ,prevent ,suicide ,sec4 #fjea4 ,national ,suicide ,prevention ,lifeline4 ,sec4 #fjeb4 ,national suicide prevention media campaign4 ,subtitle ,g--,helping ,emergency ,responders ,overcome ,sec4 #fjfa4 ,data system to capture national public safety officer suicide incidence4 ,sec4 #fjfb4 ,peer-support behavioral health and wellness programs within fire departments and emergency medical service agencies4 ,sec4 #fjfc4 ,health care provider behavioral health and wellness programs4 ,sec4 #fjfd4 ,development of resources for educating mental health professionals about treating fire fighters and emergency medical services personnel4 ,sec4 #fjfe4 ,best practices and other resources for addressing posttraumatic stress disorder in public safety officers4 ,subtitle ,h--,behavioral ,health ,intervention ,guidelines ,sec4 #fjga4 ,best practices for behavioral intervention teams4 ,subtitle ,i--,suicide ,training and ,awareness ,nationally ,delivered for ,universal ,prevention ,sec4 #fjha4 ,student suicide awareness and prevention training4 ,sec4 #fjhb4 ,effective date4 ,title ,,vii--,addressing the ,impacts of ,,covid-#ai on ,substance ,use ,disorders ,subtitle ,a--,easy ,medication ,access and ,treatment for ,opioid ,addiction ,sec4 #gjja4 ,dispensation of narcotic drugs for the purpose of relieving acute withdrawal symptoms from opioid use disorder4 ,subtitle ,b--,access to ,remote ,behavioral ,health ,treatment ,sec4 #gjaa4 ,registration of qualified community mental health centers4 ,subtitle ,c--,,pdmp ,pilot ,program ,sec4 #gjba4 ,pilot program for integrating substance use disorder and behavioral health treatment locator tool into ,state prescription drug monitoring programs4 ,subtitle ,d--,family ,support ,services for ,addiction ,sec4 #gjca4 ,family support services for individuals struggling with substance use disorder4 ,subtitle ,e--,block1 ,report1 ,and ,suspend ,suspicious ,shipments ,sec4 #gjda4 ,clarification of process for registrants to exercise due diligence upon discovering a suspicious order4 ,subtitle ,f--,debarment ,enforcement of ,bad ,actor ,registrants ,sec4 #gjea4 ,debarment of certain registrants4 ,subtitle ,g--,ensuring ,compliance ,against ,opioid ,diversion ,sec4 #gjfa4 ,modification1 transfer1 and termination of registration to manufacture1 distribute1 or dispense controlled substances4 ,subtitle ,h--,opioid ,prescription ,verification ,sec4 #gjga4 ,materials for training pharmacists on certain circumstances under which a pharmacist may decline to fill a prescription4 ,sec4 #gjgb4 ,incentivizing ,states to facilitate responsible1 informed dispensing of controlled substances4 ,subtitle ,i--,suspicious ,order ,identification ,sec4 #gjha4 ,strengthening ,,arcos4 ,sec4 #gjhb4 ,suspicious ,orders ,task ,force4 ,subtitle ,j--,stop the ,importation and ,manufacturing of ,synthetic ,analogues ,sec4 #gjia4 ,establishment of schedule ,a4 ,sec4 #gjib4 ,temporary and permanent scheduling of schedule ,a substances4 ,sec4 #gjic4 ,penalties4 ,sec4 #gjid4 ,false labeling of schedule ,a controlled substances4 ,sec4 #gjie4 ,registration requirements for importers and exporters of schedule ,a substances4 ,sec4 #gjif4 ,additional conforming amendments4 ,sec4 #gjig4 ,sentencing review4 ,sec4 #gjih4 ,rules of construction4 ,sec4 #gjii4 ,clarification of certain registration requirements related to research4 ,sec4 #gajj4 ,review of research registration process4 ,title ,,viii--,tax ,incentives to ,improve ,health ,care ,sec4 #hjja4 ,domestic medical and drug manufacturing credit4 ,sec4 #hjjb4 ,qualifying advanced medical manufacturing equipment credit4 ,sec4 #hjjc4 ,new medical research expenditure component of credit for increasing research activities4 ,sec4 #hjjd4 ,refundable portion of research credit for small businesses engaging in specified medical research4 ,sec4 #hjje4 ,exception from passive loss rules for investments in specified medical research small business pass-thru entities4 ,sec4 #hjjf4 ,temporary carryover for health and dependent care flexible spending arrangements4 ,sec4 #hjjg4 ,increase in exclusion for employer-provided dependent care assistance4 ,sec4 #hjjh4 ,temporary increase in contribution limits for health savings accounts4 ,sec4 #hjji4 ,temporary allowance of payments for employment-related expenses under health savings accounts4 ,sec4 #hjaj4 ,treatment of direct primary care service arrangements4 ,sec4 #hjaa4 ,allow both spouses to make catch-up contributions to the same ,,hsa account4 ,sec4 #hjab4 ,repeal of ceiling on deductible and out-of-pocket expenses under a high deductible health plan4 ,sec4 #hjac4 ,on-site employee clinics4 ,sec4 #hjad4 ,adjustment of medical expense deduction4 ,sec4 #hjae4 ,healthy workplace tax credit4 ,title ,,ix--,medicare ,provisions ,subtitle ,a--,telehealth ,sec4 #ijja4 ,removing certain geographic and originating site restrictions on the furnishing of telehealth services under the ,medicare program4 ,sec4 #ijjb4 ,making permanent ,,fqhc and ,,rhc telehealth payments4 ,sec4 #ijjc4 ,expanding the list of practitioners eligible to furnish telehealth services4 ,sec4 #ijjd4 ,allowing for the provision of telehealth services via audio-only telecommunications systems4 ,sec4 #ijje4 ,making permanent the safe harbor for absence of deductible for telehealth4 ,sec4 #ijjf4 ,removing requirement for face-to-face visits between home dialysis patients and physicians4 ,sec4 #ijjg4 ,report on telehealth payment integrity4 ,sec4 #ijjh4 ,increasing funding for review of telehealth claims4 ,sec4 #ijji4 ,telehealth resources4 ,subtitle ,b--,protecting ,access to ,innovation ,during ,,covid-#ai ,sec4 #ijaa4 ,authorizing the extension of pass-through status under the ,medicare program for certain drugs and devices impacted by ,,covid-#ai4 ,subtitle ,c--,reducing ,unnecessary ,senior ,hospitalizations ,sec4 #ijba4 ,,snf-based provision of preventive acute care and hospitalization reduction program4 ,title ,x--,appropriations ,sec4 #ajjja4 ,appropriations4 ,subtitle ,a--,health programs ,subtitle ,b--,general provisions-,this ,title ,i ,pandemic ,preparedness and ,response ,a ,clarifying the ,role of the ,department of ,health and ,human ,services ,during ,public ,health ,emergencies #ajja4 ,lead agency for ,federal public health and medical response to public health emergencies ,section #bhja of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh7 is amended-- 7#a7 in subsection 7a71 by inserting after shall lead all ,federal public health and medical response to public health emergencies and incidents the following3 7including emergencies and disasters declared by the ,president pursuant to the ,national ,emergencies ,act or the ,robert ,t4 ,stafford ,disaster ,relief and ,emergency ,assistance ,act72 and 7#b7 in subsection 7b71 by inserting after shall assume operational control of emergency public health and medical response assets1 as necessary1 in the event of a public health emergency the following3 or in the event of an emergency or disaster declared by the ,president under the ,national ,emergencies ,act or the ,robert ,t4 ,stafford ,disaster ,relief and ,emergency ,assistance ,act4 #ajjb4 ,deployment by the ,secretary of ,health and ,human ,services of ,national ,strategic ,stockpile ,section #cai;,f-#b7;a77#c77;,f7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7a77#c77;,f77 is amended by striking as required by and inserting in consultation with4 #ajjc4 ,authority and responsibilities of the ,federal ,emergency ,management ,agency regarding the ,strategic ,national ,stockpile ,the ,homeland ,security ,act of #bjjb is amended-- 7#a7 in subparagraph 7,a7 of section #ejc7;b77#b7 7#f ,u4,s4,c4 #cac7;b77#b771 by inserting 1 in coordination with relevant ,federal agencies1 after lead2 and 7#b7 in subparagraph 7,d7 of section #ejd7;a77#c7 7#f ,u4,s4,c4 #cad7;a77#c771 by striking requiring and inserting 1 at the direction of the ,secretary of ,health and ,human ,services1 assisting in4 ,b ,reagan-,udall ,foundation and ,foundation for the ,national ,institutes of ,health #ajaa4 ,reagan-,udall ,foundation and ,foundation for the ,national ,institutes of ,health 7a7 ,reagan-,udall ,foundation for the ,food and ,drug ,administration ,section #ggj7n7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;dd7n77 is amended by striking #ejj1jjj and not more than #a1bej1jjj and inserting #a1bej1jjj and not more than #e1jjj1jjj4 7b7 ,foundation for the ,national ,institutes of ,health ,section #dii7l7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;b7l77 is amended by striking #ejj1jjj and not more than #a1bej1jjj and inserting #a1bej1jjj and not more than #e1jjj1jjj4 ,c ,protections for ,good ,samaritan ,health ,professionals #ajba4 ,limitation on liability for volunteer health care professionals 7a7 ,in general ,title ,,ii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bjb et seq47 is amended by inserting after section #bbd the following3 #bbd;,a4 ,limitation on liability for volunteer health care professionals 7a7 ,limitation on liability ,except as provided in subsection 7b71 a health care professional shall not be liable under ,federal or ,state law for any harm caused by an act or omission of the professional in the provision of health care services if-- 7#a7 the professional is serving1 for purposes of responding to a disaster1 as a volunteer2 and 7#b7 the act or omission occurs-- 7,a7 during the period of the disaster1 as determined under the laws listed in subsection 7d77#a72 7,b7 in the ,state or ,states for which the disaster is declared2 7,c7 in the health care professional's capacity as a volunteer2 7,d7 in the course of providing services that are within the scope of the license1 registration1 or certification of the volunteer1 as defined by the ,state of licensure1 registration1 or certification2 and 7,e7 in a good faith belief that the individual being treated is in need of health care services4 7b7 ,exceptions ,subsection 7a7 does not apply if-- 7#a7 the harm was caused by an act or omission constituting willful or criminal misconduct1 gross negligence1 reckless misconduct1 or a conscious flagrant indifference to the rights or safety of the individual harmed by the health care professional2 or 7#b7 the health care professional rendered the health care services under the influence 7as determined pursuant to applicable ,state law7 of alcohol or an intoxicating drug4 7c7 ,preemption 7#a7 ,in general ,this section preempts the laws of a ,state or any political subdivision of a ,state to the extent that such laws are inconsistent with this section1 unless such laws provide greater protection from liability4 7#b7 ,volunteer ,protection ,act ,protections afforded by this section are in addition to those provided by the ,volunteer ,protection ,act of #aiig4 7d7 ,definitions ,in this section3 7#a7 ,the term disaster means-- 7,a7 a national emergency declared by the ,president under the ,national ,emergencies ,act2 7,b7 an emergency or major disaster declared by the ,president under the ,robert ,t4 ,stafford ,disaster ,relief and ,emergency ,assistance ,act2 or 7,c7 a public health emergency that is determined by the ,secretary under section #cai of this ,act with respect to one or more ,states specified in such determination-- 7i7 during only the initial period covered by such determination2 and 7ii7 excluding any period covered by a renewal of such determination4 7#b7 ,the term harm includes physical1 nonphysical1 economic1 and noneconomic losses4 7#c7 ,the term health care professional means an individual who is licensed1 registered1 or certified under ,federal or ,state law to provide health care services4 7#d7 ,the term health care services means any services provided by a health care professional1 or by any individual working under the supervision of a health care professional1 that relate to-- 7,a7 the diagnosis1 prevention1 or treatment of any human disease or impairment2 or 7,b7 the assessment or care of the health of a human being4 7#e7 ,the term ,state includes each of the several ,states1 the ,district of ,columbia1 the ,commonwealth of ,puerto ,rico1 the ,virgin ,islands1 ,guam1 ,american ,samoa1 the ,northern ,mariana ,islands1 and any other territory or possession of the ,united ,states4 7#f7 7,a7 ,the term volunteer means a health care professional who1 with respect to the health care services rendered1 does not receive-- 7i7 compensation2 or 7ii7 any other thing of value in lieu of compensation1 in excess of #ejj per year4 7,b7 ,for purposes of subparagraph 7,a71 the term compensation-- 7i7 includes payment under any insurance policy or health plan1 or under any ,federal or ,state health benefits program2 and 7ii7 excludes-- 7,i7 reasonable reimbursement or allowance for expenses actually incurred2 7,,ii7 receipt of paid leave2 and 7,,iii7 receipt of items to be used exclusively for rendering the health services in the health care professional's capacity as a volunteer described in subsection 7a77#a74 4 7b7 ,effective date 7#a7 ,in general ,section #bbd;,a of the ,public ,health ,service ,act1 as added by subsection 7a71 shall take effect #ij days after the date of the enactment of this ,act4 7#b7 ,application ,section #bbd;,a of the ,public ,health ,service ,act1 as added by subsection 7a71 applies to a claim for harm only if the act or omission that caused such harm occurred on or after the effective date described in paragraph 7#a74 #ajbb4 ,sense of the ,congress ,it is the sense of ,congress that-- 7#a7 health care professionals should be encouraged to register with the ,emergency ,system for ,advance ,registration of ,volunteer ,health ,professionals 7,,esar-,,vhp71 and ,states should employ online registration with the promptest processing possible of such registrations to foster the rapid deployment and utilization of volunteer health care professionals following a disaster2 7#b7 ,federal and ,state agencies and licensing boards should cooperate to facilitate the timely movement of properly licensed volunteer health care professionals to areas affected by a disaster2 and 7#c7 the appropriate licensing entities should verify the licenses of volunteer health care professionals serving disaster victims as soon as is reasonably practical following a disaster4 ,d ,medical ,sheltering #ajca4 ,reducing the spread of ,,covid-#ai through payments to ,states to lease hotels to temporarily house eligible individuals 7a7 ,in general ,the ,secretary of ,health and ,human ,services may make payments to ,states to lease hotels to temporarily house1 on a voluntary basis1 eligible individuals4 7b7 ,formula ,the ,secretary shall allocate the amount appropriated to carry out this section pursuant to a formula developed by the ,secretary that-- 7#a7 distributes the amount among the ,states that-- 7,a7 submit applications in accordance with subsection 7c72 and 7,b7 are determined by the ,secretary to need such payments2 and 7#b7 takes into consideration-- 7,a7 the number of active cases of individuals infected with ,,covid-#ai in the applying ,state relative to the overall population of the ,state2 and 7,b7 the average income of individuals in the applying ,state relative to the average income of individuals in the ,united ,states4 7c7 ,applications 7#a7 ,in general ,to seek a payment under this section1 a ,state shall submit an application to the ,secretary at such time1 in such manner1 and containing such information and assurances as the ,secretary may require4 7#b7 ,process ,the ,secretary shall-- 7,a7 not later than #ae days after the date of enactment of this ,act1 publish the process for ,states to apply for payments under this section2 and 7,b7 not later than #ae days after the submission of an application in accordance with such process1 approve or disapprove the application4 7#c7 ,contents ,the ,secretary shall require the application of a ,state under this section to include-- 7,a7 a plan for leasing hotels as described in subsection 7a72 7,b7 health guidelines which the ,state will require to be implemented to protect the staff of the hotels2 7,c7 the rates to be paid to lease the hotels2 7,d7 a plan to ensure that the hotels each have-- 7i7 workplace safety standards for their staff2 7ii7 proper personal protective equipment and sanitation supplies2 7iii7 a cleaning protocol for rooms and facilities2 and 7iv7 at least one qualified health care professional onsite or on call to monitor the health of individuals being housed at the hotels2 7,e7 a plan to feed and provide other necessary materials to individuals described in subsection 7a7 at the hotels1 including medications and hygiene products1 without letting such individuals leave their rooms or accept visitors2 7,f7 a plan to assist the hotels in removing individuals who attempt to continue their stay after the allotted time2 7,g7 a plan for hospital networks1 local health departments1 and the hotels to coordinate on the exchange and protection of patient information in accordance with other applicable law2 7,h7 a plan to effectively communicate the ,state's program funded through this section to racial and ethnic minority groups and low-income communities2 and 7,i7 each funding assurance listed in subsection 7e74 7d7 ,no responsibility for diet or administration of medicine ,notwithstanding subsection 7c77#c77;,e71 a contract between a ,state and a hotel pursuant to this section shall not make the hotel responsible for the diet of1 or the administration of medications to1 individuals described in subsection 7a74 7e7 ,funding assurances ,as a condition on receipt of a payment of this section1 a ,state shall give such assurances as the ,secretary may require that-- 7#a7 each contract between the ,state and a hotel pursuant to this section will be entered into on a voluntary basis1 and no hotel will be required by the ,state to participate in the program under this section2 7#b7 individuals described in subsection 7a7 will not be charged for their lodging at a hotel pursuant to this section1 except that such individuals may be required to reimburse the costs of receiving food and beverages2 7#c7 individuals described in subsection 7a7 will retain the option of self-isolating at home 7including the option of checking out early and returning to their homes7 rather than being required to stay at a hotel funded pursuant to this section2 7#d7 before an individual is allowed to stay at a hotel pursuant to this section1 the individual will be required to present1 in such form and manner as may be required by the local department of health1 documentation from a physician that the individual meets the criteria described in subsection 7a72 7#e7 any non-transient homeless population residing at a hotel will not be displaced for purposes of entering into or carrying out a contract between the ,state and the hotel under this section2 and 7#f7 the ,state will pay 7from funds provided to the ,state under this section or from other ,state funds7-- 7,a7 at least #dj percent of the costs of the personal protective equipment and sanitation supplies needed by individuals staying at a hotel pursuant to this section and the staff of such hotel2 and 7,b7 all of the costs of having one or more qualified health care professionals described in subsection 7c77#c77;,d77iii7 for the provision of monitoring described in such subsection 7whether by being onsite or on call74 7f7 ,review ,at the conclusion of the program under this section1 the ,inspector ,general of the ,department of ,health and ,human ,services shall-- 7#a7 review the program and activities of each ,state funded pursuant to this section2 and 7#b7 submit a report on the results of the review to-- 7,a7 the ,committee on ,energy and ,commerce and the ,committee on ,ways and ,means of the ,house of ,representatives2 and 7,b7 the ,committee on ,finance and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate4 7g7 ,liability protection 7#a7 ,in general ,except as provided under paragraph 7#b71 a hotel or member of the staff shall not be liable under ,federal or ,state law for-- 7,a7 any harm caused by an act or omission in the provision of hotel services pursuant to this section2 or 7,b7 failing to keep an individual who is staying at a hotel pursuant to this section isolated from people other than the staff of the hotel and any qualified health care professional described in subsection 7c77#c77;,d77iii74 7#b7 ,exception ,paragraph 7#a7 does not apply in the case that the harm was caused by an act or omission constituting willful or criminal misconduct1 gross negligence1 reckless misconduct1 or a conscious flagrant indifference to the rights or safety of the individual harmed4 7h7 ,definitions ,in this section3 7#a7 ,the term eligible individual means an individual who is unable to self-isolate at home1 does not require inpatient or outpatient health care treatment1 and-- 7,a7 has a laboratory-confirmed case of ,,covid-#ai2 7,b7 has a presumptive positive case of ,,covid-#ai2 or 7,c7 is a person under investigation who is displaying symptoms of ,,covid-#ai4 7#b7 ,the terms ,indian tribe and tribal organization have the meanings given to those terms in section #d of the ,indian ,self-,determination and ,education ,assistance ,act 7#be ,u4,s4,c4 #ecjd74 7#c7 ,the term ,secretary means the ,secretary of ,health and ,human ,services4 7#d7 ,the term ,state includes each of #ej ,states1 the ,district of ,columbia1 each ,indian ,tribe and tribal organization1 ,guam1 ,american ,samoa1 the ,united ,states ,virgin ,islands1 the ,commonwealth of ,puerto ,rico1 and the ,commonwealth of the ,northern ,mariana ,islands4 7i7 ,funding ,to carry out this section1 there is authorized to be appropriated #a1jjj1jjj1jjj1 to remain available through the earlier of-- 7#a7 the end of calendar year #bjba2 or 7#b7 the end of the emergency period 7as defined in section #aace7;g77#a77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;b-#e7;g77#a77;,b7774 ,e ,,cdc campaign on ,,covid-#ai awareness #ajda4 ,,covid-#ai public awareness campaign ,the ,secretary of ,health and ,human ,services1 acting through the ,director of the ,centers for ,disease ,control and ,prevention and in coordination with other offices and agencies1 as appropriate1 shall award competitive grants or contracts to one or more public or private entities to carry out a national campaign that is multilingual and culturally competent and based on available scientific evidence to increase awareness and knowledge of ,,covid-#ai1 including reducing stigma associated with ,,covid-#ai and improving information on the availability of diagnostic testing and other related services at community health centers4 ,f ,protecting ,children from ,,covid-#ai #ajea4 ,study on children's role in transmitting ,,sars-,co,v-#b 7a7 ,study 7#a7 ,in general ,the ,secretary of ,health and ,human ,services 7in this section referred to as the ,secretary71 in coordination with the heads of agencies of the ,department of ,health and ,human ,services and experts from outside of the ,department1 as appropriate1 shall complete a study on children's role in transmitting ,,sars-,co,v-#b4 7#b7 ,issues to be studied ,the study under paragraph 7#a7 shall address-- 7,a7 the transmissibility of ,,covid-#ai from child to child1 child to adult1 and adult to child2 7,b7 the vulnerability of children1 especially those with underlying health conditions1 to severe illness as such vulnerability relates to ,,covid-#ai2 7,c7 the vulnerability of adults1 especially those with underlying health conditions1 who send their children back to school2 and 7,d7 the vulnerability of adults1 especially those with underlying health conditions1 who interact with children who may be asymptomatic but infectious4 7#c7 ,considerations ,in carrying out the study under paragraph 7#a71 the ,secretary shall-- 7,a7 take into consideration the best available science1 including as provided by the ,national ,academy of ,sciences2 and 7,b7 ensure that such study includes consideration of children who are members of racial or ethnic minority groups4 7b7 ,reporting ,the ,secretary shall submit a report to the ,congress on children's role in transmitting ,,sars-,co,v-#b4 ,the report shall include the results of the study under subsection 7a74 7c7 ,dissemination of best practices ,the ,secretary shall disseminate to stakeholders best practices for protecting children and adults in educational settings4 ,the first best practices disseminated pursuant to the preceding sentence shall include any best practices for protecting children and adults in educational settings identified through the study under subsection 7a74 7d7 ,definition ,in this section1 the term emergency period has the meaning given to such term in section #aace7;g77#a77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;b-#e7;g77#a77;,b774 ,g ,ensuring ,understanding of ,,covid-#ai #ajfa4 ,study on the impact of ,,covid-#ai ,part ,a of title ,,iv of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bha et seq47 is amended by adding at the end the following3 #djd,o4 ,study on the impact of ,,covid-#ai 7a7 ,in general ,the ,secretary shall conduct a longitudinal study1 over not less than #aj years1 on the full impact of ,,covid-#ai on infected individuals1 including both short-term and long-term health impacts4 7b7 ,timing ,the ,secretary shall begin enrolling patients in the study under this section not later than #f months after the date of enactment of this section4 7c7 ,requirements ,the study under this section shall-- 7#a7 be nationwide2 7#b7 include diversity of enrollees to account for gender1 age1 race1 ethnicity1 geography1 comorbidities1 and underrepresented populations1 including pregnant and lactating women2 7#c7 study individuals who were infected with ,,covid-#ai who experienced mild symptoms1 such individuals who experienced moderate symptoms1 and such individuals who experienced severe symptoms2 7#d7 monitor the health outcomes and symptoms of individuals who were infected with ,,covid-#ai1 or had prenatal exposure to ,,covid-#ai1 including lung capacity and function1 and immune response1 taking into account any pharmaceutical interventions such individuals may have received2 7#e7 monitor the mental health outcomes of individuals infected with ,,covid-#ai1 taking into account any interventions that affected mental health2 and 7#f7 monitor individuals enrolled in the study not less frequently that twice per year after the first year of the individual's infection with ,,covid-#ai4 7d7 ,public-,private research network ,for purposes of carrying out the study under this section1 the ,director of ,,nih may develop a network of public-private research partners1 provided that all research1 including the research carried out through any such partner1 is available publicly4 7e7 ,summaries of findings ,the ,director of ,,nih shall make public a summary of findings under this section not less frequently than once every #c months for the first #b years of the study1 and not less frequently than every #f months thereafter4 ,such summaries may include information about how the findings of the study under this section compare with findings from research conducted abroad4 7f7 ,authorization of appropriations ,there are authorized to be appropriated such sums as may be necessary to carry out this section4 4 ,h ,safeguarding ,therapeutics #ajga4 ,authority to destroy counterfeit devices 7a7 ,in general ,section #hja7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;a77 is amended-- 7#a7 in the fourth sentence1 by inserting or counterfeit device after counterfeit drug2 and 7#b7 by striking ,the ,secretary of the ,treasury shall cause the destruction of and all that follows through liable for costs pursuant to subsection 7c74 and inserting the following3 ,the ,secretary of the ,treasury shall cause the destruction of any such article refused admission unless such article is exported1 under regulations prescribed by the ,secretary of the ,treasury1 within #ij days of the date of notice of such refusal or within such additional time as may be permitted pursuant to such regulations1 except that the ,secretary of ,health and ,human ,services may destroy1 without the opportunity for export1 any drug or device refused admission under this section1 if such drug or device is valued at an amount that is #b1ejj or less 7or such higher amount as the ,secretary of the ,treasury may set by regulation pursuant to section #dih7;a77#a7 of the ,tariff ,act of #aicj 7#ai ,u4,s4,c4 #adih7;a77#a777 and was not brought into compliance as described under subsection 7b74 ,the ,secretary of ,health and ,human ,services shall issue regulations providing for notice and an opportunity to appear before the ,secretary of ,health and ,human ,services and introduce testimony1 as described in the first sentence of this subsection1 on destruction of a drug or device under the seventh sentence of this subsection4 ,the regulations shall provide that prior to destruction1 appropriate due process is available to the owner or consignee seeking to challenge the decision to destroy the drug or device4 ,where the ,secretary of ,health and ,human ,services provides notice and an opportunity to appear and introduce testimony on the destruction of a drug or device1 the ,secretary of ,health and ,human ,services shall store and1 as applicable1 dispose of the drug or device after the issuance of the notice1 except that the owner and consignee shall remain liable for costs pursuant to subsection 7c744 7b7 ,definition ,section #bja7;h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;h77 is amended-- 7#a7 by redesignating subparagraphs 7#a71 7#b71 and 7#c7 as clauses 7,a71 7,b71 and 7,c71 respectively2 and 7#b7 after making such redesignations-- 7,a7 by striking 7h7 ,the term and inserting 7h77#a7 ,the term2 and 7,b7 by adding at the end the following3 7#b7 ,the term counterfeit device means a device which1 or the container1 packaging1 or labeling of which1 without authorization1 bears a trademark1 trade name1 or other identifying mark1 imprint1 or symbol1 or any likeness thereof1 or is manufactured using a design1 of a device manufacturer1 packer1 or distributor other than the person or persons who in fact manufactured1 packed1 or distributed such device and which thereby falsely purports or is represented to be the product of1 or to have been packed or distributed by1 such other device manufacturer1 packer1 or distributor4 7#c7 ,for purposes of subparagraph 7#b7-- 7,a7 the term manufactured refers to any of the following activities3 manufacture1 preparation1 propagation1 compounding1 assembly1 or processing2 and 7,b7 the term manufacturer means a person who is engaged in any of the activities listed in clause 7,a74 4 #ajgb4 ,determination of budgetary effects ,the budgetary effects of this subtitle1 for the purpose of complying with the ,statutory ,pay-,as-,you-,go ,act of #bjaj1 shall be determined by reference to the latest statement titled ,budgetary ,effects of ,,paygo ,legislation for this subtitle1 submitted for printing in the ,congressional ,record by the ,chairman of the ,house ,budget ,committee1 provided that such statement has been submitted prior to the vote on passage4 ,i ,advisory ,committee on ,immunization ,practices #ajha4 ,expedited meeting of ,,acip for ,,covid-#ai vaccines 7a7 ,in general ,notwithstanding section #cjia of the #bast ,century ,cures ,act 7#ba ,u4,s4,c4 #cfj;bbb-#d note71 the ,advisory ,committee on ,immunization ,practices shall meet and issue a recommendation with respect to a vaccine that is intended to prevent or treat ,,covid-#ai not later than #ae business days after the date on which such vaccine is licensed under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 or authorized under section #efd of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c74 7b7 ,definition ,in this section1 the term ,advisory ,committee on ,immunization ,practices means the ,advisory ,committee on ,immunization ,practices established by the ,secretary of ,health and ,human ,services pursuant to section #bbb of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bag;a71 acting through the ,director of the ,centers for ,disease ,control and ,prevention4 ,j ,improvements to ,transparency of the ,pricing of ,diagnostic ,testing for ,,covid-#ai #ajia4 ,improvements to transparency of the pricing of diagnostic testing for ,,covid-#ai 7a7 ,in general ,section #cbjb of the ,,cares ,act 7,public ,law #aaf-acf7 is amended-- 7#a7 in subsection 7b7-- 7,a7 in the heading1 by inserting and ,related ,items and ,services after ,diagnostic ,testing for ,,covid-#ai2 7,b7 in paragraph 7#a7-- 7i7 by striking a diagnostic test for ,,covid-#ai and inserting a test1 item1 or service described in section #fjja7;a7 of division ,f of the ,families ,first ,coronavirus ,response ,act 7,public ,law #aaf-abg72 and 7ii7 by striking such test and inserting such test1 item1 or service2 and 7,c7 in paragraph 7#b71 by striking a diagnostic test for ,,covid-#ai and inserting a test1 item1 or service described in section #fjja7;a7 of division ,f of the ,families ,first ,coronavirus ,response ,act 7,public ,law #aaf-abg72 and 7#b7 by adding at the end the following new subsections3 7c7 ,improvements to transparency policy 7#a7 ,in general ,not later than #cj days after the date of the enactment of this subsection1 the ,secretary of ,health and ,human ,services shall survey providers subject to the requirement under subsection 7b7 regarding the cash prices referred to in such subsection4 7#b7 ,representative sample ,in carrying out paragraph 7#a71 the ,secretary shall survey a sample of providers that is representative of the diversity of sizes1 geographic locations1 and care settings 7such as hospitals1 laboratories1 and independent freestanding emergency departments7 in which diagnostic testing for ,,covid-#ai is performed4 7#c7 ,consumer complaints ,the ,secretary shall ensure that consumers have a method to submit complaints to the ,department of ,health and ,human ,services that identify providers that-- 7,a7 may be in violation of subsection 7b72 and 7,b7 have not made public a cash price in accordance with such subsection4 7d7 ,public report ,not later than #fj days after the date of the enactment of this subsection1 the ,secretary of ,health and ,human ,services shall publish on the internet website of the ,department of ,health and ,human ,services a report on cash prices for items and services published under subsection 7b77#a7 during the period beginning on the date of the enactment of this ,act and ending on the date of the enactment of this subsection1 which shall include-- 7#a7 the percentage of providers that comply with the requirement under such subsection2 7#b7 the average cash price for each such item and service published under such subsection2 and 7#c7 any providers identified pursuant to paragraph 7#b7 or 7#c7 of subsection 7c7 and found to be in violation of such requirement4 4 ,,ii ,domestic ,manufacturing and ,supply ,chain ,a ,sustained ,on-,shore ,manufacturing ,capacity for ,public ,health ,emergencies #bjja4 ,sustained on-shore manufacturing capacity for public health emergencies 7a7 ,in general ,section #cai,l of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#g;e7 is amended-- 7#a7 in subsection 7a77#f77;,b7-- 7,a7 by redesignating clauses 7iv7 and 7v7 as clauses 7v7 and 7vi71 respectively2 7,b7 by inserting after clause 7iii71 the following3 7iv7 activities to support domestic manufacturing surge capacity of products or platform technologies1 including manufacturing capacity and capabilities to utilize platform technologies to provide for flexible manufacturing initiatives2 2 and 7,c7 in clause 7vi7 7as so redesignated71 by inserting manufacture1 after improvement12 7#b7 in subsection 7b7-- 7,a7 in the first sentence of paragraph 7#a71 by inserting support for domestic manufacturing surge capacity1 after initiatives for innovation12 and 7,b7 in paragraph 7#b7-- 7i7 in subparagraph 7,b71 by striking and at the end2 7ii7 by redesignating subparagraph 7,c7 as subparagraph 7,d72 and 7iii7 by inserting after subparagraph 7,b71 the following3 7,c7 activities to support manufacturing surge capacities and capabilities to increase the availability of existing medical countermeasures and utilize existing novel platforms to manufacture new medical countermeasures to meet manufacturing demands to address threats that pose a significant level of risk to national security2 and 2 7#c7 in subsection 7c7-- 7,a7 in paragraph 7#b7-- 7i7 in subparagraph 7,c71 by striking and at the end2 7ii7 in subparagraph 7,d71 by striking the period and inserting 2 and2 and 7iii7 by adding at the end the following3 7,e7 promoting domestic manufacturing surge capacity and capabilities for countermeasure advanced research and development1 including facilitating contracts to support flexible or surge manufacturing4 2 7,b7 in paragraph 7#d7-- 7i7 in subparagraph 7,b7-- 7,i7 in clause 7iii71 by striking and at the end2 7,,ii7 in clause 7iv71 by striking the period and inserting 2 and2 and 7,,iii7 by adding at the end the following3 7v7 support and maintain domestic manufacturing surge capacity and capabilities1 including through contracts to support flexible or surge manufacturing1 to ensure that additional production of countermeasures is available in the event that the ,secretary determines there is such a need for additional production4 2 7ii7 in subparagraph 7,d7-- 7,i7 in clause 7ii71 by striking and at the end2 7,,ii7 by redesignating clause 7iii7 as clause 7iv72 and 7,,iii7 by inserting after clause 7ii7 the following3 7iii7 research to advance manufacturing capacities and capabilities for medical countermeasures and platform technologies that may be utilized for medical countermeasures2 and 2 and 7iii7 in subparagraph 7,e71 by striking clause 7ix72 and 7,c7 in paragraph 7#g77;,c77i71 by striking up to #ajj highly qualified individuals1 or up to #ej percent of the total number of employees1 whichever is less1 and inserting #ge percent of the total number of employees2 7#d7 in subsection 7e77#a7-- 7,a7 by redesignating subparagraphs 7,b7 through 7,d7 as subparagraphs 7,c7 through 7,e71 respectively2 and 7,b7 by inserting after subparagraph 7,a71 the following3 7,b7 ,temporary flexibility ,during a public health emergency under section #cai1 the ,secretary shall be provided with an additional #fj business days to comply with information requests for the disclosure of information under section #eeb of title #e1 ,united ,states ,code1 related to the activities under this section 7unless such activities are otherwise exempt under subparagraph 7,a774 2 and 7#e7 in subsection 7f7-- 7,a7 in paragraph 7#a71 by striking ,not later than #ahj days after the date of enactment of this subsection and inserting ,not later than #ahj days after the date of enactment of the ,commitment to ,defeat the ,virus and ,keep ,america ,healthy ,act2 and 7,b7 in paragraph 7#b71 by striking ,not later than #a year after the date of enactment of this subsection and inserting ,not later than #a year after the date of enactment of the ,commitment to ,defeat the ,virus and ,keep ,america ,healthy ,act4 7b7 ,medical ,countermeasure ,innovation ,partner ,the restrictions under section #bjb of division ,a of the ,further ,consolidated ,appropriations ,act1 #bjbj 7,public ,law #aaf-id71 or any other provision of law imposing a restriction on salaries of individuals related to a previous appropriation to the ,department of ,health and ,human ,services1 shall not apply with respect to salaries paid pursuant to an agreement under the medical countermeasure innovation partner program under section #cai,l7c77#d77;,e7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#g;e7c77#d77;,e774 ,b ,manufacturing ,,api1 ,drugs1 and ,excipients in ,america #bjaa4 ,report to ,congress on barriers to domestic manufacturing of medical products and supplies 7a7 ,report ,not later than ,january #a1 #bjba1 the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall submit to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate a report on barriers to domestic manufacturing of active pharmaceutical ingredients1 drugs1 and devices that are manufactured outside of the ,united ,states4 7b7 ,contents ,such report shall-- 7#a7 identify factors that limit or otherwise discourage the domestic manufacturing of active pharmaceutical ingredients1 drugs1 and devices that are currently manufactured outside of the ,united ,states1 including any ,federal1 ,state1 local1 or ,tribal laws and regulations that hinder domestic manufacturing opportunities2 and 7#b7 recommend specific strategies to overcome the challenges identified under paragraph 7#a71 including strategies-- 7,a7 to develop effective incentives for domestic manufacturing2 and 7,b7 to make changes to laws or regulations that hinder domestic manufacturing opportunities4 7c7 ,consultation ,in carrying out the report under subsection 7a71 the ,secretary shall consult with-- 7#a7 the ,food and ,drug ,administration1 the ,centers for ,medicare ,medicaid ,services1 the ,department of ,defense1 the ,department of ,commerce1 the ,department of ,state1 the ,department of ,veterans ,affairs1 the ,department of ,justice1 and any other ,federal agencies as appropriate2 and 7#b7 relevant stakeholders1 including drug1 device1 and active pharmaceutical ingredient manufacturers1 and other entities1 as appropriate4 7d7 ,definition ,in this section1 the term active pharmaceutical ingredient has the meaning given to such term in section #bjg4a of title #ba1 ,code of ,federal ,regulations 7and any successor regulations74 7e7 ,publication ,the ,secretary shall make the report under subsection 7a7 available on the public website of the ,department of ,health and ,human ,services4 #bjab4 ,enhancing intra-agency coordination and public health assessment with regard to compliance activities 7a7 ,benefit_/,risk framework 7#a7 ,in general ,paragraph 7#b7 of section #gjd7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7;b77 is amended by adding at the end the following3 ,the ,secretary shall ensure timely and effective coordination among such offices regarding the reviews of such report and the alignment of any feedback regarding such report1 and any corrective or preventive actions in response to such report1 after consideration of the benefits and risks to the public health1 patient safety1 the drug supply and drug supply chain1 and timely patient access to drugs44 7#b7 ,annual reporting ,subsection 7b7 of section #gjd of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7 is amended by adding at the end the following new paragraph3 7#c7 ,on an annual basis1 the ,secretary shall prepare a report on the utilization of the framework described in paragraph 7#b7 and post such report on the public website of the ,food and ,drug ,administration4 4 7#c7 ,applicability ,the amendments made by paragraphs 7#a7 and 7#b7 shall take effect on the effective date described in section #caab of the ,,cares ,act 7,public ,law #aaf-acf71 after executing the amendments made by such section #caab1 and shall apply beginning on the date that is #a year after the date of enactment of this ,act4 7b7 ,public meeting ,the ,secretary of ,health and ,human ,services shall publish in the ,federal ,register a notice of a public meeting to be held no later than six months after the date of enactment of this ,act to discuss and obtain input and recommendations from public stakeholders1 including patient advocates1 consumers1 regulated industry1 and health care providers1 regarding the contents of a benefit_/risk framework described in section #gjd7;b77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as amended by subsection 7a71 that supports a safe1 stable1 redundant drug supply chain4 7c7 ,guidance ,the ,secretary of ,health and ,human ,services shall-- 7#a7 not later than one year after the date on which the public meeting described in subsection 7b7 is held1 issue draft guidance regarding the goals and implementation of a benefit_/risk framework described in subsection 7b72 and 7#b7 not later than two years after such date of enactment1 issue final guidance with respect to the implementation of such a framework4 #bjac4 ,encouraging international harmonization 7a7 ,,gao study ,not later than one year after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall issue a report evaluating-- 7#a7 the consistency with which the ,international ,conference on ,harmonisation 7in this section referred to as ,,ich7 guidelines on good manufacturing practices1 including ,,ich ,guidelines ,q#h-aa1 are being implemented by drug regulatory authorities across countries and international regions2 7#b7 whether domestic active pharmaceutical ingredient manufacturers 7including any such contract manufacturers7 are provided sufficient opportunity to participate with regulatory authorities in the development of guidelines prior to implementation2 7#c7 whether divergence from ,,ich guidelines or differing regulatory standards or requirements by drug regulatory authorities across countries and international regions creates-- 7,a7 inefficiencies in drug manufacturing2 7,b7 incompatible requirements that can contribute to or exacerbate drug shortages2 and 7,c7 the most common areas of divergence between ,,ich guidelines and regulatory standards and requirements by drug regulatory authorities across countries and international regions that1 if rectified1 may reduce the inefficiencies and incompatibilities identified pursuant to subparagraphs 7,a7 and 7,b74 7b7 ,international training program ,not later than two years after the date of enactment of this ,act1 informed by the needs identified in the report issued pursuant to subsection 7a71 the ,secretary of ,health and ,human ,services1 in conjunction with drug regulatory authorities across countries and international regions and the ,,ich1 shall develop and implement a training program for drug regulatory authorities across countries and international regions to promote consistent application of and reduce divergence from ,,ich guidelines on good manufacturing practices4 #bjad4 ,mutual recognition agreements for inspections and review activities 7a7 ,mutual ,recognition of ,inspections ,pursuant to section #hji of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #chd;e71 the ,secretary of ,health and ,human ,services 7in this section referred to as the ,secretary7 shall establish or expand initiatives for mutual sharing of review and inspection findings between drug regulatory authorities across countries and international regions1 such as through the ,pharmaceutical ,cooperation ,inspection ,scheme1 the ,mutual ,recognition ,agreement with the ,european ,union1 and the ,australia-,canada-,singapore-,switzerla nd ,consortium1 to-- 7#a7 reduce the potential for duplicative regulatory evaluation of medical products regulated by the ,food and ,drug ,administration2 and 7#b7 more constructively allocate appropriations to the ,food and ,drug ,administration1 including those attributable to user fees1 to harmonized regulatory processes4 7b7 ,additional countries1 regions1 and evaluation ,in carrying out subsection 7a71 the ,secretary may expand the initiatives to include-- 7#a7 additional countries and geographic regions with established and competent regulatory frameworks2 and 7#b7 additional types of regulatory evaluation1 including with respect to-- 7,a7 good manufacturing practice inspections2 and 7,b7 approval of changes to the manufacturing of drugs for which an approval or licensure is in effect under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb74 7c7 ,implementation framework 7#a7 ,publication ,not later than one year after the date of enactment of this ,act1 the ,secretary shall publish an implementation framework for the agreements to share review and inspection findings under subsection 7a7 on the public website of the ,food and ,drug ,administration4 7#b7 ,contents ,the implementation framework under this subsection shall-- 7,a7 include the timeline for establishing or expanding initiatives described in subsection 7a72 7,b7 describe additional types of regulatory processes that will become subject to such initiatives2 7,c7 specify the countries and geographic regions where such initiatives will be established or expanded2 and 7,d7 identify additional opportunities and challenges for expanding mutual recognition agreements in drug and biologic regulation4 7d7 ,annual reporting 7#a7 ,in general ,not later than the end of calendar year #bjbj and annually thereafter1 the ,secretary shall publish a report on the public website of the ,food and ,drug ,administration on the utilization of agreements described in subsection 7c77#a7 in the previous fiscal year4 7#b7 ,contents ,the report under paragraph 7#a7 shall include each of the following3 7,a7 ,the total number of establishments that are registered under section #eaj7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7 and located outside of the ,united ,states1 and of these establishments1 the number in each region of interest4 7,b7 ,the total number of inspections conducted at establishments described in subparagraph 7,a74 7,c7 ,of the inspections described in subparagraph 7,b71 the total number of inspections in each of region of interest4 7,d7 ,of the inspections in each region of interest reported pursuant to subparagraph 7,c71 the number of inspections in each ,,fda inspection category4 7,e7 ,of the number of inspections reported under each of subparagraphs 7,b71 7,c71 and 7,d7-- 7i7 the number of inspections which have been conducted pursuant to an agreement described in subsection 7c77#a72 and 7ii7 the number of inspections which have been conducted by employees or other agents of the ,food and ,drug ,administration4 7#c7 ,definitions ,in this subsection3 7,a7 ,the term region of interest refers to ,china1 ,india1 the ,european ,union1 and any other geographic region as determined appropriate by the ,secretary4 7,b7 ,the term ,,fda inspection category means refers to the following inspection categories3 7i7 ,inspections to support an approval of a drug under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb74 7ii7 ,good manufacturing practice inspections4 7iii7 ,for-cause inspections4 #bjae4 ,enhancing transparency of drug facility inspection timelines ,section #ijb of the ,,fda ,reauthorization ,act of #bjag 7#ba ,u4,s4,c4 #cee note7 is amended to read as follows3 #ijb4 ,annual report on inspections ,not later than ,march #a of each year1 the ,secretary of ,health and ,human ,services shall post on the public website of the ,food and ,drug ,administration information related to inspections of facilities necessary for approval of a drug under subsection 7c7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 approval of a device under section #eae of such ,act 7#ba ,u4,s4,c4 #cfj;e71 or clearance of a device under section #eaj7k7 of such ,act 7#ba ,u4,s4,c4 #cfj7k77 that were conducted during the previous calendar year4 ,such information shall include the following3 7#a7 ,the median time following a request from staff of the ,food and ,drug ,administration reviewing an application or report to the beginning of the inspection1 and the median time from the beginning of an inspection to the issuance of a report pursuant to section #gjd7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7;b771 including-- 7,a7 the median time for drugs described in #eje7;j77#aa77;,a77i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#aa77;,a77i772 7,b7 the median time for drugs described in section #ejf;,c7a7 of such ,act 7#ba ,u4,s4,c4 #cef;c7a77 only2 and 7,c7 the median time for drugs on the drug shortage list in effect under section #ejf;,e of such ,act 7#ba ,u4,s4,c4 #cef;f74 7#b7 ,the median time from the issuance of a report pursuant to such section #gjd7;b7 to the sending of a warning letter1 issuance of an import alert1 or holding of a regulatory meeting for inspections for which the ,secretary concluded that regulatory or enforcement action was indicated1 including the median time for each category of drugs listed in subparagraphs 7,a7 through 7,c7 of paragraph 7#a74 7#c7 ,the median time from the sending of a warning letter1 issuance of an import alert1 or holding of a regulatory meeting to resolution of the regulatory or enforcement action indicated for inspections for which the ,secretary concluded that such action was indicated4 7#d7 ,the number of times that a facility was issued a report pursuant to such section #gjd7;b7 and approval of an application was delayed due to the issuance of a withhold recommendation1 including the number of such times for each category of drugs listed in subparagraphs 7,a7 through 7,c7 of paragraph 7#a74 4 #bjaf4 ,advanced manufacturing technologies program ,subchapter ,a of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is amended by adding at the end the following3 #ebd;,b4 ,advanced manufacturing technologies program 7a7 ,in general ,not later than #a year after the date of enactment of the ,commitment to ,defeat the ,virus and ,keep ,america ,healthy ,act1 the ,secretary shall continue in effect the program to evaluate new drug manufacturing technologies that are included in an application1 or supplement to an application1 for a drug under subsection 7b7 or 7j7 of section #eje of this ,act or for a biological product submitted under subsection 7a7 or 7k7 of section #cea of the ,public ,health ,service ,act4 7b7 ,designation ,the ,secretary shall designate a method of manufacturing a drug as an advanced manufacturing technology under this section if the drug manufacturer demonstrates that such technology is likely to-- 7#a7 prevent or resolve a drug shortage2 7#b7 maintain an adequate supply of critical medications for national emergencies2 or 7#c7 promote the adoption of innovative approaches to drug product design and manufacturing4 7c7 ,consultation ,if the ,secretary designates a method of manufacturing as an advanced manufacturing technology under this section1 the ,secretary shall take actions to expedite the development and implementation of such method of manufacture for purposes of approval of the application under subsection 7c7 or 7j7 of section #eje of this ,act or subsection 7a7 or 7k7 of section #cea of the ,public ,health ,service ,act1 which may include1 as appropriate-- 7#a7 holding meetings between the sponsor of the application and appropriate ,food and ,drug ,administration staff throughout the development of the technology2 7#b7 providing timely advice to1 and interactive communication with1 the sponsor regarding the development of the technology2 and 7#c7 involving senior managers and experienced staff of the ,food and ,drug ,administration1 as appropriate1 in a collaborative1 cross-disciplinary review of the method of manufacturing4 7d7 ,evaluation of an ,advanced ,manufacturing ,technology 7#a7 ,package ,a sponsor who receives designation of an advanced manufacturing technology under this section shall provide the ,secretary with a package of scientific evidence supporting the implementation of the advanced manufacturing technology in a particular context-of-use4 7#b7 ,evaluation ,within #ij days of receiving the package1 the ,secretary shall determine whether a designated advanced manufacturing technology is validated for the proposed context of use based on the scientific merit the supporting evidence provided by the sponsor4 7#c7 ,effect of ,approval ,upon approval1 the same sponsor may rely upon the advanced manufacturing technology for use across multiple manufacturing product lines within the same context-of-use without having to re-submit data to the ,secretary validating the underlying technology4 7e7 ,implementation and ,reporting 7#a7 ,public meeting ,the ,secretary shall publish in the ,federal ,register a notice of a public meeting to be held no later than #a year after the date of enactment of the ,commitment to ,defeat the ,virus and ,keep ,america ,healthy ,act to discuss and obtain input and recommendations from stakeholders regarding the goals and scope of1 and a suitable framework and procedures and requirements for1 the program under this section4 7#b7 ,program guidance ,the ,secretary shall-- 7,a7 not later than #a year after the date of enactment of the ,commitment to ,defeat the ,virus and ,keep ,america ,healthy ,act1 issue draft guidance regarding the goals and implementation of the program under this section2 and 7,b7 not later than #b years after the date of enactment of the ,commitment to ,defeat the ,virus and ,keep ,america ,healthy ,act1 issue final guidance with respect to the implementation of such program4 7#c7 ,report ,the ,secretary shall make available on the public website of the ,food and ,drug ,administration an annual report on the progress of the program under this section4 4 ,c ,improving the ,american ,drug ,supply ,chain #bjba4 ,study and reporting on domestic and foreign production 7a7 ,in general ,the ,secretary of ,health and ,human ,services shall enter into an agreement with the ,national ,academies of ,sciences1 ,engineering1 and ,medicine 7referred to in this section as the ,national ,academies7 under which1 not later than #bd months after the date of enactment of this ,act1 the ,national ,academies will-- 7#a7 study the current and historical production of drugs and key ingredients thereof 7including active pharmaceutical ingredients7 in the ,united ,states and in foreign countries2 7#b7 formulate recommendations for promoting increased production of drugs and key ingredients thereof 7including active pharmaceutical ingredients7 in the ,united ,states2 and 7#c7 in a manner that does not compromise national security or disclose trade secrets or other confidential commercial information that is subject to section #eeb7;b77#d7 of title #e1 ,united ,states ,code1 or section #aije of title #ah1 ,united ,states ,code1 submit a report to the ,congress on-- 7,a7 the findings and conclusions of the study under paragraph 7#a72 and 7,b7 the recommendations under paragraph 7#b74 7b7 ,study topics ,the study pursuant to subsection 7a77#a7 shall include-- 7#a7 evaluation of-- 7,a7 the extent to which production of drugs for use in the ,united ,states and key ingredients thereof 7including active pharmaceutical ingredients7 takes place in the ,united ,states2 and 7,b7 the extent to which such production takes place in foreign countries2 7#b7 identification of the foreign countries in which such production takes place2 7#c7 evaluation of historical changes in the countries in which such production takes place2 7#d7 determination of the reasons why such production takes place in foreign countries1 including why such production takes place in particular foreign countries1 including consideration of-- 7,a7 the reasons for historical migration of such production to foreign countries1 or from foreign countries to other foreign countries or the ,united ,states2 7,b7 economic factors1 including economic impediments to domestic production and incentives for foreign production2 and 7,c7 regulatory1 intellectual property1 international trade1 and other legal and policy factors2 and 7#e7 evaluation of the benefits of redundancies in the supply chain of drugs in the ,united ,states in the event of a public health emergency4 7c7 ,recommendations ,the agreement under subsection 7a7 shall-- 7#a7 provide for inclusion in the recommendations under subsection 7a77#b7 of measures 7which may include statutory1 regulatory1 and other policy changes7 that should be taken-- 7,a7 to encourage the domestic production of drugs for use in the ,united ,states and key ingredients thereof 7including active pharmaceutical ingredients72 or 7,b7 to otherwise reduce the risks to the availability of drugs in the ,united ,states in the event of a public health emergency2 and 7#b7 require consideration1 in developing such recommendations1 of-- 7,a7 factors affecting the production of drugs1 including-- 7i7 access to skilled labor2 7ii7 the cost of raw materials1 the cost of energy1 and related costs2 7iii7 taxes and other incentives2 and 7iv7 the effects of regulations2 and 7,b7 the costs and consequences of implementing1 or failing to implement1 each such recommendation4 7d7 ,input ,the agreement under subsection 7a7 shall require-- 7#a7 consideration of input from the ,department of ,health and ,human ,services1 the ,department of ,commerce1 and1 as appropriate1 other ,federal agencies2 and 7#b7 consultation with relevant stakeholders1 which-- 7,a7 may include conducting public meetings and other forms of engagement1 as appropriate2 7,b7 shall include consultation with experts in-- 7i7 the manufacturing of drugs2 7ii7 pharmaceutical industry business and economics2 7iii7 drug purchasing1 pricing1 and reimbursement2 7iv7 regulatory and intellectual property issues affecting drug manufacturing2 7v7 economics2 7vi7 international trade policy2 and 7vii7 emergency planning2 and 7,c7 may include consultation with other entities with experience in drug manufacturing and pricing1 as appropriate4 7e7 ,definitions ,in this section1 the term drug has the meaning given such term in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba74 ,d ,essential ,medicines ,strategic ,stockpile #bjca4 ,pilot program on ensuring medication supply stability ,part ,d of title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bed;b et seq47 is amended by adding at the end the following new subpart3 ,,xiii ,ensuring ,medication ,supply ,stability #cdj;,j4 ,ensuring medication supply stability 7a7 ,award of contracts ,beginning not later than ,january #a1 #bjba1 the ,secretary shall award contracts to eligible entities to each implement and test the effectiveness of acquiring1 maintaining1 managing1 and distributing a stockpile that-- 7#a7 consists of generic drugs at risk of shortage2 and 7#b7 is of sufficient quantity to ensure that customers in the ,united ,states of the respective eligible entity have access to such drugs for at least #f months 7as specified by the ,secretary based on the historic demand for those drugs74 7b7 ,selection of drugs 7#a7 ,in general ,the ,secretary shall-- 7,a7 select not more than #ej types of drugs that may be included by eligible entities in a stockpile pursuant to a contract under this section2 7,b7 maintain an up-to-date list of such drugs2 and 7,c7 make such list publicly available4 7#b7 ,choice of eligible entities ,a contract awarded to an eligible entity under this section need not require the stockpile of the eligible entity to include all #ej types of drugs listed pursuant to paragraph 7#a74 7c7 ,sufficient quantity ,for each generic drug in a stockpile maintained pursuant to subsection 7a71 the ,secretary shall specify the quantity of such drug that is sufficient for purposes of such subsection to ensure that consumers in the ,united ,states of the respective eligible entity have access to such drug for at least #f months4 7d7 ,duration2 liquidation of inventory 7#a7 ,duration ,a contract awarded under this section shall be for a term of no more than #c years4 7#b7 ,liquidation of inventory ,a drug held in a stockpile pursuant to a contract under this section may be liquidated by the eligible entity at the end of the period of the contract4 7e7 ,stockpile requirements 7#a7 ,ensuring availability of unexpired products ,each eligible entity with a contract under this section for a stockpile of generic drugs at risk of shortage shall-- 7,a7 ensure that each drug maintained in the stockpile has an expiration date at least #a year beyond the current date2 and 7,b7 to comply with subparagraph 7,a7-- 7i7 sell drugs in the stockpile through normal commercial channels and replace those drugs2 or 7ii7 if there is no commercial market for a drug in the stockpile1 dispose of the drug1 report such disposal to the ,secretary1 and replace the drug4 7#b7 ,management of stockpile 7,a7 ,in general ,each eligible entity with a contract under this section for a stockpile of generic drugs at risk of shortage shall-- 7i7 acquire not later than #f months following the date the contract is awarded1 and maintain thereafter1 a #f-month supply of each type of drug the eligible entity has contracted to stockpile1 which #f-month supply shall be in addition to the average levels of inventory held by such eligible entity over the previous year for such drug2 and 7ii7 if it is not possible to comply with clause 7i71 notify the ,secretary1 citing the reason why it is not possible and the expected time of acquisition of the drug4 7,b7 ,inventory management ,each eligible entity with a contract under this section for a stockpile of generic drugs at risk of shortage shall manage inventory to ensure that drugs in the stockpile are efficiently cycled to the commercial market and-- 7i7 may stockpile inventory at the eligible entity's distribution center with specified inventory amounts virtually reserved for the ,federal ,government with constant cycling to reduce product expiration2 or 7ii7 may store stockpiled inventory separately in a different location and replace drugs in the stockpile inventory with the same drug with newer dating4 7,c7 ,insufficient funds ,if amounts available to an eligible entity through contracts under this section are not sufficient to acquire or maintain a #f-month supply of any drug in the stockpile of the eligible entity funded under this section1 the eligible entity-- 7i7 may acquire and maintain less than a #f-month supply1 but in no case less than a #c-month supply2 and 7ii7 shall submit a report to the ,secretary identifying-- 7,i7 each such drug2 and 7,,ii7 the reasons why such amounts are not sufficient to acquire or maintain a #f-month supply4 7,d7 ,annual audits ,not more than annually1 the ,secretary may request a physical audit count of the inventories of all eligible entities with a contract under this section to validate that each such entity is maintaining the appropriate amount of stockpiled inventory4 7#c7 ,periodic product review 7,a7 ,use of proceeds ,an eligible entity with a contract under this section for a stockpile of generic drugs at risk of shortage shall use the proceeds of the sale of any drugs in the stockpile to purchase drugs for the stockpile in accordance with this section4 7,b7 ,market inflation or deflation ,in the case of market inflation or deflation affecting the price of a drug in the stockpile of an eligible entity maintained pursuant to a contract under this section1 the contract shall ensure that the ,federal ,government does not profit or suffer loss on items of such drug as a result of such inflation or deflation4 7#d7 ,reporting ,each eligible entity with a contract under this section shall submit reports at such time and in such manner as the ,secretary may require regarding-- 7,a7 current inventory levels of stockpiled drugs at a drug level2 7,b7 indicators of current inventory levels of stockpiled drugs relative to acceptable minimums2 and 7,c7 such other matters as the ,secretary determines appropriate4 7f7 ,contract terms 7#a7 ,payment of monthly fees for management ,subject to paragraph 7#b71 the ,secretary shall pay to each eligible entity with a contract under this section for a stockpile of generic drugs at risk of shortage appropriate monthly fees for the management of the stockpile4 7#b7 ,payment conditioned on stockpile adequacy 7,a7 ,in general ,except as provided in subparagraph 7,b71 each contract with an eligible entity under this section shall provide that no payment under the contract may be made until the entity demonstrates to the ,secretary that the entity has stockpiled such portion of the total quantity of drugs to be stockpiled under the contract as the ,secretary determines to be acceptable for payment4 7,b7 ,exceptions for advance payments 7i7 ,in general ,a contract under this section may provide that1 if the ,secretary determines 7in the ,secretary's discretion7 that an advance payment1 partial payment for significant milestones1 or payment to increase capacity is necessary to ensure success of the terms of the contract1 the ,secretary shall pay1 in advance of delivery1 an amount not to exceed #aj percent of the total contract amount to be paid to the eligible entity by the ,secretary pursuant to the contract over the full period of the contract4 7ii7 ,cost of capital ,a contract under this section may provide for payments to compensate the contracting eligible entity for additional capital requirements related to the additional inventory to be maintained4 7iii7 ,timing ,the ,secretary shall1 to the extent practicable1 make any determination under clause 7i7 to make an advance payment at the same time as the issuance of a solicitation4 7iv7 ,repayment ,if the ,secretary makes an advance payment pursuant to clause 7i71 the ,secretary shall require the eligible entity receiving such advance payment to repay it if there is a failure to perform by the eligible entity4 7#c7 ,termination 7,a7 ,in general ,subject to subparagraph 7,b71 nothing in this section shall be construed as affecting the rights of eligible entities under provisions of statute or regulation 7including the ,federal ,acquisition ,regulation7 relating to the termination of contracts for the convenience of the ,government4 7,b7 ,liquidation of stockpile ,if a contract under this section is terminated1 the eligible entity with the contract shall liquidate the drugs comprising the stockpile funded through the contract and return to the ,government any amounts owed in relation to such drugs1 but shall collect the management fees associated with such liquidation4 7g7 ,congressional oversight 7#a7 ,independent evaluation and report ,not later than #a year after the date of enactment of this section and annually thereafter1 the ,comptroller ,general of the ,united ,states shall conduct an independent evaluation1 and submit to the appropriate congressional committees a report1 concerning the program under this section4 7#b7 ,contents of report ,the report under paragraph 7#a7 shall review1 assess1 and provide recommendations1 as appropriate1 on the following3 7,a7 ,details on likely costs and resultant savings as compared to a stockpiling method that does not incorporate perpetual inventory cycling4 7,b7 ,identification of drawdowns from the stockpile1 as evidence of market shortage avoidance4 7,c7 ,the allocation of drugs included in the stockpiles funded pursuant to this section to the customers of the eligible entities with contracts under this section4 7,d7 ,the degree to which eligible entities with contracts under this section fulfilled their obligations under such contracts4 7h7 ,definitions ,in this section3 7#a7 ,the term eligible entity means an entity that meets each of the following criteria3 7,a7 ,the entity is licensed or registered in accordance with applicable ,federal and ,state law and in good standing with respect to such licensure or registration4 7,b7 ,the entity agrees-- 7i7 to purchase all drugs to be maintained in its stockpile funded under this section directly from the manufacturers of the drugs or the exclusive distributors of such manufacturers2 or 7ii7 in the case of an entity that is a co-op or chain pharmacy warehouse-- 7,i7 to purchase drugs to be maintained in its stockpile funded under this section from an authorized distributor2 and 7,,ii7 distribute those drugs only to its member pharmacies4 7,c7 ,the entity holds a verified authorized wholesale distributor certification issued by the ,national ,association of ,boards of ,pharmacy4 7,d7 ,the entity sells more than #ij percent of its drugs to dispensers4 7,e7 ,the entity agrees to distribute inventory from its stockpile funded under this section only to dispensers that are customers of the entity4 7#b7 ,the term generic drug at risk of shortage means a drug 7as defined in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act7 that-- 7,a7 is approved pursuant to section #eje7;j7 of such ,act2 7,b7 is included in the ,world ,health ,organization's most recent ,model ,list of ,essential ,medicines2 7,c7 is included1 at any point during the preceding #cf months1 on the drug shortage list in effect under section #ejf;,e of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 and 7,d7 is manufactured by #c or fewer persons that are registered under section #eaj of the ,federal ,food1 ,drug1 and ,cosmetic ,act for purposes of such manufacture4 7i7 ,authorization of appropriations ,to carry out this section1 there is authorized to be appropriated #abj1jjj1jjj for fiscal years #bjba through #bjbc1 to remain available until expended4 4 ,e ,national ,centers of ,excellence in ,continuous ,pharmaceutical ,manufacturing #bjda4 ,national ,centers of ,excellence in ,continuous ,pharmaceutical ,manufacturing 7a7 ,in general ,section #cjaf of the #bast ,century ,cures ,act 7#ba ,u4,s4,c4 #cii;h7 is amended to read as follows3 #cjaf4 ,national ,centers of ,excellence in ,continuous ,pharmaceutical ,manufacturing 7a7 ,in general ,the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs-- 7#a7 shall solicit and1 beginning not later than one year after the date of enactment of the ,commitment to ,defeat the ,virus and ,keep ,america ,healthy ,act1 receive requests from institutions of higher education to be designated as a ,national ,center of ,excellence in ,continuous ,pharmaceutical ,manufacturing 7in this section referred to as a ,national ,center of ,excellence7 to support the advancement and development of continuous manufacturing2 and 7#b7 shall so designate any institution of higher education that-- 7,a7 requests such designation2 and 7,b7 meets the criteria specified in subsection 7c74 7b7 ,request for designation ,a request for designation under subsection 7a7 shall be made to the ,secretary at such time1 in such manner1 and containing such information as the ,secretary may require4 ,any such request shall include a description of how the institution of higher education meets or plans to meet each of the criteria specified in subsection 7c74 7c7 ,criteria for designation described ,the criteria specified in this subsection with respect to an institution of higher education are that the institution has1 as of the date of the submission of a request under subsection 7a7 by such institution-- 7#a7 physical and technical capacity for research and development of continuous manufacturing2 7#b7 manufacturing knowledge-sharing networks with other institutions of higher education1 large and small pharmaceutical manufacturers1 generic and nonprescription manufacturers1 contract manufacturers1 and other entities2 7#c7 proven capacity to design and demonstrate new1 highly effective technology for use in continuous manufacturing2 7#d7 a track record for creating and transferring knowledge with respect to continuous manufacturing2 7#e7 the potential to train a future workforce for research on and implementation of advanced manufacturing and continuous manufacturing2 and 7#f7 experience in participating in and leading a continuous manufacturing technology partnership with other institutions of higher education1 large and small pharmaceutical manufacturers1 generic and nonprescription manufacturers1 contract manufacturers1 and other entities-- 7,a7 to support companies with continuous manufacturing in the ,united ,states2 7,b7 to support ,federal agencies with technical assistance1 which may include regulatory and quality metric guidance as applicable1 for advanced manufacturing and continuous manufacturing2 7,c7 with respect to continuous manufacturing1 to organize and conduct research and development activities needed to create new and more effective technology1 capture and disseminate expertise1 create intellectual property1 and maintain technological leadership2 7,d7 to develop best practices for designing continuous manufacturing2 and 7,e7 to assess and respond to the workforce needs for continuous manufacturing1 including the development of training programs if needed4 7d7 ,termination of designation ,the ,secretary may terminate the designation of any ,national ,center of ,excellence designated under this section if the ,secretary determines such ,national ,center of ,excellence no longer meets the criteria specified in subsection 7c74 ,not later than #fj days before the effective date of such a termination1 the ,secretary shall provide written notice to the ,national ,center of ,excellence1 including the rationale for such termination4 7e7 ,conditions for designation ,as a condition of designation as a ,national ,center of ,excellence under this section1 the ,secretary shall require that an institution of higher education enter into an agreement with the ,secretary under which the institution agrees-- 7#a7 to collaborate directly with the ,food and ,drug ,administration to publish the reports required by subsection 7g72 7#b7 to share data with the ,food and ,drug ,administration regarding best practices and research generated through the funding under subsection 7f72 7#c7 to develop1 along with industry partners 7which may include large and small biopharmaceutical manufacturers1 generic and nonprescription manufacturers1 and contract manufacturers7 and another institution or institutions designated under this section1 if any1 a roadmap for developing a continuous manufacturing workforce2 7#d7 to develop1 along with industry partners and other institutions designated under this section1 a roadmap for strengthening existing1 and developing new1 relationships with other institutions2 and 7#e7 to provide an annual report to the ,food and ,drug ,administration regarding the institution's activities under this section1 including a description of how the institution continues to meet and make progress on the criteria listed in subsection 7c74 7f7 ,funding 7#a7 ,in general ,the ,secretary shall award funding1 through grants1 contracts1 or cooperative agreements1 to the ,national ,centers of ,excellence designated under this section for the purpose of studying and recommending improvements to continuous manufacturing1 including such improvements as may enable the ,centers-- 7,a7 to continue to meet the conditions specified in subsection 7e72 and 7,b7 to expand capacity for research on1 and development of1 continuing manufacturing4 7#b7 ,consistency with ,,fda mission ,as a condition on receipt of funding under this subsection1 a ,national ,center of ,excellence shall agree to consider any input from the ,secretary regarding the use of funding that would-- 7,a7 help to further the advancement of continuous manufacturing through the ,national ,center of ,excellence2 and 7,b7 be relevant to the mission of the ,food and ,drug ,administration4 7#c7 ,authorization of appropriations ,there is authorized to be appropriated to carry out this subsection #hj1jjj1jjj for the period of fiscal years #bjba through #bjbe4 7#d7 ,rule of construction ,nothing in this section shall be construed as precluding a ,national ,center for ,excellence designated under this section from receiving funds under any other provision of this ,act or any other ,federal law4 7g7 ,annual review and reports 7#a7 ,annual report ,beginning not later than one year after the date on which the first designation is made under subsection 7a71 and annually thereafter1 the ,secretary shall-- 7,a7 submit to ,congress a report describing the activities1 partnerships and collaborations1 ,federal policy recommendations1 previous and continuing funding1 and findings of1 and any other applicable information from1 the ,national ,centers of ,excellence designated under this section2 and 7,b7 make such report available to the public in an easily accessible electronic format on the website of the ,food and ,drug ,administration4 7#b7 ,review of national centers of excellence and potential designees ,the ,secretary shall periodically review the ,national ,centers of ,excellence designated under this section to ensure that such ,national ,centers of ,excellence continue to meet the criteria for designation under this section4 7#c7 ,report on long-term vision of ,,fda role ,not later than #b years after the date on which the first designation is made under subsection 7a71 the ,secretary1 in consultation with the ,national ,centers of ,excellence designated under this section1 shall submit a report to the ,congress on the long-term vision of the ,department of ,health and ,human ,services on the role of the ,food and ,drug ,administration in supporting continuous manufacturing1 including-- 7,a7 a national framework of principles related to the implementation and regulation of continuous manufacturing2 7,b7 a plan for the development of ,federal regulations and guidance for how advanced manufacturing and continuous manufacturing can be incorporated into the development of pharmaceuticals and regulatory responsibilities of the ,food and ,drug ,administration2 and 7,c7 appropriate feedback solicited from the public1 which may include other institutions1 large and small biopharmaceutical manufacturers1 generic and nonprescription manufacturers1 and contract manufacturers4 7h7 ,definitions ,in this section3 7#a7 ,advanced manufacturing ,the term advanced manufacturing means an approach for the manufacturing of pharmaceuticals that incorporates novel technology1 or uses an established technique or technology in a new or innovative way 7such as continuous manufacturing where the input materials are continuously transformed within the process by two or more unit operations7 that enhances drug quality or improves the manufacturing process4 7#b7 ,continuous manufacturing ,the term continuous manufacturing-- 7,a7 means a process where the input materials are continuously fed into and transformed within the process1 and the processed output materials are continuously removed from the system2 and 7,b7 consists of an integrated process that consists of a series of two or more unit operations4 7#c7 ,institution of higher education ,the term institution of higher education has the meaning given such term in section #aja7;a7 of the ,higher ,education ,act of #aife 7#bj ,u4,s4,c4 #ajja7;a774 7#d7 ,secretary ,the term ,secretary means the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs4 4 7b7 ,transition rule ,section #cjaf of the #bast ,century ,cures ,act 7#ba ,u4,s4,c4 #cii;h71 as in effect on the day before the date of the enactment of this section1 shall apply with respect to grants awarded under such section before such date of enactment4 ,,iii ,strategic ,national ,stockpile ,improvements ,a ,stockpiling for ,america's ,future ,endeavors #cjja4 ,strategic ,national ,stockpile ,section #cai;,f-#b7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7a77 is amended by adding at the end the following3 7#f7 ,acceptance of gifts 7,a7 ,in general ,the ,secretary may1 without further appropriation and without fiscal year limitation1 accept1 use1 and dispose of gifts1 bequests1 or devises of money1 services1 or property1 both real and personal1 for the purpose of carrying out this subsection4 ,any such gift1 bequest1 or devise of money and proceeds from sales of other property received as a gift1 bequest1 or devise shall be deposited in the ,treasury and shall be available for obligation and expenditure upon order of the ,secretary4 7,b7 ,limitations 7i7 ,compromising integrity ,the ,secretary may not accept a gift1 bequest1 or devise under this paragraph if the ,secretary determines that the use of the property or services would compromise the integrity or appearance of integrity of-- 7,i7 a program of the ,department of ,health and ,human ,services2 or 7,,ii7 an individual involved in a program of the ,department4 7ii7 ,unapproved products ,the ,secretary may accept a drug or device 7as those terms are defined in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act7 as part of a gift1 bequest1 or devise under this paragraph only if such drug or device is-- 7,i7 a drug that is approved under section #eje of such ,act1 that meets the requirements for marketing under section #eje;,g of such ,act1 or that is licensed under section #cea of this ,act2 7,,ii7 a device that is approved under section #eae of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 that is classified under section #eac7;f77#b7 of such ,act1 that is licensed under section #cea of this ,act1 that is cleared under section #eaj7k7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 or for which a report is not required under such section #eaj7k72 7,,iii7 authorized for emergency use in accordance with section #efd or #efd;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act or prepositioned for use in accordance with section #efd;,b of such ,act2 7,,iv7 authorized for investigational use under section #eje1 #eab1 or #ebj of the ,federal ,food1 ,drug1 and ,cosmetic ,act or section #cea of this ,act2 7,v7 determined by the ,commissioner of ,food and ,drugs to be appropriate for use1 without approval1 licensure1 authorization1 or clearance1 to respond to a shortage or potential shortage situation2 or 7,,vi7 a respiratory protective device approved and determined to be a priority1 as described in section #cai;,f-#c7;i77#a77;,d7 of this ,act4 7,c7 ,report 7i7 ,in general ,the ,secretary shall submit to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate an annual report disclosing-- 7,i7 any gift1 bequest1 or devise that was accepted under this paragraph during the year covered by the report2 7,,ii7 how the gifts1 bequests1 and devises contribute to the mission of the stockpile2 and 7,,iii7 the amount of ,federal savings that were generated from the acceptance of the gifts1 bequests1 and devises4 7ii7 ,publication ,each report required under clause 7i7 shall be made publicly available4 4 ,b ,stockpile ,inventory ,modernization #cjaa4 ,reimbursable transfers ,section #cai;,f-#b7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7a771 as amended by section #cjja1 is further amended by adding at the end the following3 7#g7 ,transfers and reimbursements 7,a7 ,in general ,without regard to chapter #e of title #dj1 ,united ,states ,code1 the ,secretary may transfer to any ,federal department or agency1 on a reimbursable basis1 any drugs1 vaccines and other biological products1 medical devices1 and other supplies in the stockpile if-- 7i7 the transferred supplies are less than one year from expiry2 7ii7 the stockpile is able to replenish the supplies1 as appropriate2 and 7iii7 the ,secretary decides the transfer is in the best interest of the ,united ,states ,government4 7,b7 ,use of reimbursement ,reimbursement derived from the transfer of supplies pursuant to subparagraph 7,a7 may1 to the extent and in the amounts made available in advance in appropriations ,acts1 be used by the ,secretary to carry out this section4 ,funds made available pursuant to the preceding sentence are in addition to any other funds that may be made available for such purpose4 7,c7 ,rule of construction ,this paragraph shall not be construed to preclude transfers of products in the stockpile under other authorities4 7,d7 ,report ,not later than ,september #cj1 #bjbb1 the ,secretary shall submit to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate a report on each transfer made under this paragraph and the amount received by the ,secretary in exchange for that transfer4 7,e7 ,sunset ,the authority to make transfers under this paragraph shall cease to be effective on ,september #cj1 #bjbc4 4 ,c ,equipment ,maintenance #cjba4 ,equipment maintenance ,section #cai;,f-#b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7 is amended-- 7#a7 in subsection 7a77#c7-- 7,a7 in subparagraph 7,i71 by striking 2 and and inserting a semicolon2 7,b7 in subparagraph 7,j71 by striking the period at the end and inserting a semicolon2 and 7,c7 by inserting the following new subparagraph at the end3 7,k7 ensure contents of the stockpile remain in good working order and1 as appropriate1 conduct maintenance services on contents of the stockpile2 and 2 and 7#b7 in subsection 7c77#g77;,b71 by adding at the end the following new clause3 7ix7 ,equipment maintenance service ,in carrying out this section1 the ,secretary may enter into contracts for the procurement of equipment maintenance services4 4 ,d ,medical ,supplies for ,pandemics #cjca4 ,supply chain flexibility manufacturing pilot 7a7 ,in general ,section #cai;,f-#b7;a77#c7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7a77#c771 as amended by section #cjab1 is further amended by adding at the end the following new subparagraph3 7,l7 enhance medical supply chain elasticity and establish and maintain domestic reserves of critical medical supplies 7including personal protective equipment1 ancillary medical supplies1 and other applicable supplies required for the administration of drugs1 vaccines and other biological products1 and other medical devices 7including diagnostic tests77 by-- 7i7 increasing emergency stock of critical medical supplies2 7ii7 geographically diversifying domestic production of such medical supplies1 as appropriate2 7iii7 entering into cooperative agreements or partnerships with respect to manufacturing lines1 facilities1 and equipment for the domestic production of such medical supplies2 and 7iv7 managing1 either directly or through cooperative agreements with manufacturers and distributors1 domestic reserves established under this subparagraph by refreshing and replenishing stock of such medical supplies4 4 7b7 ,reporting2 sunset ,section #cai;,f-#b7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7a771 as amended by section #cjaa1 is further amended by adding at the end the following3 7#h7 ,reporting ,not later than ,september #cj1 #bjbb1 the ,secretary shall submit to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate a report on the details of each cooperative agreement or partnership entered into under paragraph 7#c77,l71 including the amount expended by the ,secretary on each such cooperative agreement or partnership4 7#i7 ,sunset ,the authority to enter into cooperative agreements or partnerships pursuant to paragraph 7#c77,l7 shall cease to be effective on ,september #cj1 #bjbc4 4 7c7 ,funding ,section #cai;,f-#b7;f7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7f77 is amended by adding at the end the following3 7#c7 ,supply chain elasticity 7,a7 ,in general ,for the purpose of carrying out subsection 7a77#c77,l71 there is authorized to be appropriated #ejj1jjj1jjj for each of fiscal years #bjba through #bjbc1 to remain available until expended4 7,b7 ,relation to other amounts ,the amount authorized to be appropriated by subparagraph 7,a7 for the purpose of carrying out subsection 7a77#c77,l7 is in addition to any other amounts available for such purpose4 4 ,e ,state ,stockpile ,readiness #cjda4 ,grants for ,state strategic stockpiles ,title ,,iii of the ,public ,health ,service ,act is amended by inserting after section #cai;,f-#d of such ,act 7#db ,u4,s4,c4 #bdg;d-#f;e7 the following new section3 #cai;,f-#e4 ,grants for ,state strategic stockpiles 7a7 ,in general ,the ,secretary may establish a pilot program consisting of awarding grants to ,states to expand or maintain a strategic stockpile of commercially available drugs1 devices1 personal protective equipment1 and other products deemed by the ,state to be essential in the event of a public health emergency4 7b7 ,allowable use of funds 7#a7 ,uses ,a ,state receiving a grant under this section may use the grant funds to-- 7,a7 acquire commercially available products listed pursuant to paragraph 7#b7 for inclusion in the ,state's strategic stockpile2 7,b7 store1 maintain1 and distribute products in such stockpile2 and 7,c7 conduct planning in connection with such activities4 7#b7 ,list ,the ,secretary shall develop and publish a list of the products that are eligible1 as described in subsection 7a71 for inclusion in a ,state's strategic stockpile using funds received under this section4 7#c7 ,consultation ,in developing the list under paragraph 7#b7 and otherwise determining the allowable uses of grant funds under this section1 the ,secretary shall consult with ,states and relevant stakeholders1 including public health organizations4 7c7 ,funding requirement ,the ,secretary may not obligate or expend any funds to award grants or fund any previously awarded grants under this section for a fiscal year unless the total amount made available to carry out section #cai;,f-#b for such fiscal year is equal to or greater than the total amount of funds made available to carry out section #cai;,f-#b for fiscal year #bjbj4 7d7 ,matching funds 7#a7 ,in general ,with respect to the costs of expanding and maintaining a strategic stockpile through a grant under this section1 as a condition on receipt of the grant1 a ,state shall make available 7directly7 non-,federal contributions in cash toward such costs in an amount that is equal to not less than the amount of ,federal funds provided through the grant4 7#b7 ,waiver ,the ,secretary may waive the requirement of paragraph 7#a7 with respect to a ,state for the first two years of the ,state receiving a grant under this section if the ,secretary determines that such waiver is needed for the ,state to establish a strategic stockpile described in subsection 7a74 7e7 ,technical assistance ,the ,secretary shall provide technical assistance to ,states in establishing1 expanding1 and maintaining a stockpile described in subsection 7a74 7f7 ,definition ,in this section1 the term drug has the meaning given to that term in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act4 7g7 ,authorization of appropriations ,to carry out this section1 there is authorized to be appropriated #c1ejj1jjj1jjj for each of fiscal years #bjba through #bjbc1 to remain available until expended4 7h7 ,sunset ,the authority vested by this section terminates at the end of fiscal year #bjbc4 4 ,f ,process ,improvements and ,reports #cjea4 ,,gao study on the feasibility and benefits of user fee agreements 7a7 ,in general ,the ,comptroller ,general of the ,united ,states shall conduct a study to investigate the feasibility of establishing user fees to offset certain ,federal costs attributable to the procurement of single-source materials for the ,strategic ,national ,stockpile under section #cai;,f-#b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7 and distributions of such materials from the ,stockpile4 ,in conducting this study1 the ,comptroller ,general shall consider1 to the extent information is available-- 7#a7 whether entities receiving such distributions generate profits from those distributions2 7#b7 any ,federal costs attributable to such distributions2 7#c7 whether such user fees would provide the ,secretary with funding to potentially offset procurement costs of such materials for the ,strategic ,national ,stockpile2 and 7#d7 any other issues the ,comptroller ,general identifies as relevant4 7b7 ,report ,not later than ,february #a1 #bjbc1 the ,comptroller ,general of the ,united ,states shall submit to the ,congress a report on the findings and conclusions of the study under subsection 7a74 #cjeb4 ,action reporting 7a7 ,in general ,the ,secretary of ,health and ,human ,services or the ,assistant ,secretary for ,preparedness and ,response1 in consultation with the ,administrator of the ,federal ,emergency ,management ,agency1 shall-- 7#a7 not later than #cj days after the date of enactment of this ,act1 issue a report to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate regarding all ,state1 local1 ,tribal1 and territorial requests for supplies from the ,strategic ,national ,stockpile related to ,,covid-#ai2 and 7#b7 not less than every #cj days thereafter through the end of the emergency period 7as such term is defined in section #aace7;g77#a77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;b-#e7;g77#a77;,b7771 submit to such committees an updated version of such report4 7b7 ,reporting period 7#a7 ,initial report ,the initial report under subsection 7a7 shall address all requests described in such subsection made during the period-- 7,a7 beginning on ,january #ca1 #bjbj2 and 7,b7 ending on the date that is #cj days before the date of submission of the report4 7#b7 ,updates ,each update to the report under subsection 7a7 shall address all requests described in such subsection made during the period-- 7,a7 beginning at the end of the previous reporting period under this section2 and 7,b7 ending on the date that is #cj days before the date of submission of the updated report4 7c7 ,contents of report ,the report under subsection 7a7 7and updates thereto7 shall include-- 7#a7 the details of each request described in such subsection1 including-- 7,a7 the specific medical countermeasures1 devices1 personal protective equipment1 and other materials requested2 and 7,b7 the amount of such materials requested2 and 7#b7 the outcomes of each request described in subsection 7a71 including-- 7,a7 whether the request was wholly fulfilled1 partially fulfilled1 or denied2 7,b7 if the request was wholly or partially fulfilled1 the fulfillment amount2 and 7,c7 if the request was partially fulfilled or denied1 a rationale for such outcome4 #cjec4 ,improved1 transparent processes 7a7 ,in general ,not later than ,january #a1 #bjba1 the ,secretary of ,health and ,human ,services shall develop and implement improved1 transparent processes for the use and distribution of drugs1 vaccines and other biological products1 medical devices1 and other supplies 7including personal protective equipment1 ancillary medical supplies1 and other applicable supplies required for the administration of drugs1 vaccines and other biological products1 medical devices1 and diagnostic tests7 in the ,strategic ,national ,stockpile under section #cai;,f-#b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7 7in this section referred to as the ,stockpile74 7b7 ,processes ,the processes developed under subsection 7a7 shall include-- 7#a7 the form and manner in which ,states1 localities1 ,tribes1 and territories are required to submit requests for supplies from the ,stockpile2 7#b7 the criteria used by the ,secretary of ,health and ,human ,services in responding to such requests1 including the reasons for fulfilling or denying such requests2 7#c7 what circumstances result in prioritization of distribution of supplies from the ,stockpile to ,states1 localities1 ,tribes1 or territories2 7#d7 clear plans for future1 urgent communication between the ,secretary and ,states1 localities1 ,tribes1 and territories regarding the outcome of such requests2 and 7#e7 any differences in the processes developed under subsection 7a7 for geographically related emergencies1 such as weather events1 and national emergencies1 such as pandemics4 7c7 ,classification ,the processes developed under subsection 7a7 shall be unclassified to the greatest extent possible consistent with national security4 ,the ,secretary of ,health and ,human ,services may classify portions of such processes as necessary to protect national security4 7d7 ,report to ,congress ,not later than ,january #a1 #bjba1 the ,secretary of ,health and ,human ,services shall-- 7#a7 submit a report to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate regarding the improved1 transparent processes developed under this section2 7#b7 include in such report recommendations for opportunities for communication 7by telebriefing1 phone calls1 or in-person meetings7 between the ,secretary and ,states1 localities1 ,tribes1 and territories regarding such improved1 transparent processes2 and 7#c7 submit such report in unclassified form to the greatest extent possible1 except that the ,secretary may include a classified appendix if necessary to protect national security4 ,g ,strategic ,national ,stockpile ,funding #cjfa4 ,authorization of appropriations ,section #cai;,f-#b7;f77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7f77#a77 is amended by striking #faj1jjj1jjj for each of fiscal years #bjai through #bjbc and inserting #gje1jjj1jjj for each of fiscal years #bjba through #bjbc4 ,,iv ,public ,health ,infrastructure ,improvements ,a ,public ,health ,infrastructure ,modernization #djja4 ,public health data system transformation ,subtitle ,c of title ,,xxviii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#ca et seq47 is amended by adding at the end the following3 #bhbb4 ,public health data system transformation 7a7 ,expanding ,,cdc and public health department capabilities 7#a7 ,in general ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall-- 7,a7 conduct activities to expand1 enhance1 and improve public health data systems used by the ,centers for ,disease ,control and ,prevention1 related to the interoperability and improvement of such systems 7including with respect to preparedness for1 prevention and detection of1 and response to public health emergencies72 and 7,b7 award grants or cooperative agreements to ,state1 local1 ,tribal1 or territorial public health departments for the expansion and modernization of public health data systems1 to assist public health departments in-- 7i7 assessing current data infrastructure capabilities and gaps to improve consistency in data collection1 storage1 and analysis1 and as appropriate to improve dissemination of public health-related information2 7ii7 improving secure public health data collection1 transmission1 exchange1 maintenance1 and analysis2 7iii7 improving the secure exchange of data between the ,centers for ,disease ,control and ,prevention1 ,state1 local1 ,tribal1 and territorial public health departments1 public health organizations1 and health care providers1 including-- 7,i7 between public health officials in multiple jurisdictions within a ,state2 and 7,,ii7 by simplifying and supporting reporting by health care providers pursuant to ,state law1 including through the use of health information technology2 7iv7 enhancing the interoperability of public health data systems 7including systems created or accessed by public health departments7 with health information technology1 including with health information technology certified under section #cjja7;c77#e72 7v7 supporting and training public health data systems1 data science1 and informatics personnel2 7vi7 supporting earlier disease and health condition detection1 such as through near real-time data monitoring1 to support rapid public health responses2 7vii7 supporting activities within the applicable jurisdiction related to the expansion and modernization of electronic case reporting2 and 7viii7 developing and disseminating information related to the use and importance of public health data4 7#b7 ,data standards ,in carrying out paragraph 7#a71 the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall1 as appropriate and in coordination with the ,office of the ,national ,coordinator for ,health ,information ,technology1 designate data and technology standards 7including standards for interoperability7 for public health data systems1 with deference given to standards published by consensus-based standards development organizations with public input and voluntary consensus-based standards bodies4 7#c7 ,public-private partnerships ,the ,secretary may develop and utilize public-private partnerships for technical assistance1 training1 and related implementation support for ,state1 local1 ,tribal1 and territorial public health departments1 and the ,centers for ,disease ,control and ,prevention1 on the expansion and modernization of electronic case reporting and public health data systems1 as applicable4 7b7 ,requirements 7#a7 ,health information technology standards ,the ,secretary may not award a grant or cooperative agreement under subsection 7a77#a77;,b7 unless the applicant uses or agrees to use standards endorsed by the ,national ,coordinator for ,health ,information ,technology pursuant to section #cjja7;c77#a7 or adopted by the ,secretary under section #cjjd4 7#b7 ,waiver ,the ,secretary may waive the requirement under paragraph 7#a7 with respect to an applicant if the ,secretary determines that the activities under subsection 7a77#a77;,b7 cannot otherwise be carried out within the applicable jurisdiction4 7#c7 ,application ,a ,state1 local1 ,tribal1 or territorial health department applying for a grant or cooperative agreement under this section shall submit an application to the ,secretary at such time and in such manner as the ,secretary may require4 ,such application shall include information describing-- 7,a7 the activities that will be supported by the grant or cooperative agreement2 and 7,b7 how the modernization of the public health data systems involved will support or impact the public health infrastructure of the health department1 including a description of remaining gaps1 if any1 and the actions needed to address such gaps4 7c7 ,strategy and implementation plan ,not later than #ahj days after the date of enactment of this section1 the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a coordinated strategy and an accompanying implementation plan that identifies and describes the measures the ,secretary will utilize to-- 7#a7 update and improve public health data systems used by the ,centers for ,disease ,control and ,prevention2 and 7#b7 carry out the activities described in this section to support the improvement of ,state1 local1 ,tribal1 and territorial public health data systems4 7d7 ,consultation ,in carrying out this section1 the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall consult with ,state1 local1 ,tribal1 and territorial public health departments1 professional medical and public health associations1 associations representing hospitals or other health care entities1 health information technology experts1 and other appropriate public or private entities4 7e7 ,report to ,congress ,not later than #a year after the date of enactment of this section1 the ,secretary shall submit a report to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives that includes-- 7#a7 a description of any barriers to-- 7,a7 public health authorities implementing interoperable public health data systems and electronic case reporting2 7,b7 the exchange of information pursuant to electronic case reporting2 or 7,c7 reporting by health care providers using such public health data systems1 as appropriate1 and pursuant to ,state law2 7#b7 an assessment of the potential public health impact of implementing electronic case reporting and interoperable public health data systems2 and 7#c7 a description of the activities carried out pursuant to this section4 7f7 ,electronic case reporting ,in this section1 the term electronic case reporting means the automated identification1 generation1 and bilateral exchange of reports of health events among electronic health record or health information technology systems and public health authorities4 7g7 ,authorization of appropriations ,to carry out this section1 there is authorized to be appropriated #ajj1jjj1jjj for each of fiscal years #bjba through #bjbe4 4 ,b ,modernizing infectious disease data collection #djaa4 ,modernizing infectious disease data collection 7a7 ,improving infectious disease data collection ,section #cai;,d of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#d7 is amended-- 7#a7 in subsection 7c7-- 7,a7 in paragraph 7#c77;,a77iv71 by inserting 7such as commercial1 academic1 and other hospital laboratories7 after clinical laboratories2 7,b7 in paragraph 7#e7-- 7i7 in subparagraph 7,a7-- 7,i7 in the matter preceding clause 7i71 by striking and operating and inserting 1 operating1 and updating2 7,,ii7 in clause 7iv71 by striking and at the end2 7,,iii7 in clause 7v71 by striking the period and inserting 2 and2 and 7,,iv7 by adding at the end the following3 7vi7 integrate and update applicable existing ,centers for ,disease ,control and ,prevention data systems and networks in collaboration with ,state1 local1 tribal1 and territorial public health officials1 including public health surveillance and disease detection systems4 2 and 7ii7 in subparagraph 7,b7-- 7,i7 in clause 7i71 by inserting and #fj days after the date of enactment of the ,commitment to ,defeat the ,virus and ,keep ,america ,healthy ,act after ,innovation ,act of #bjai2 7,,ii7 in clause 7ii71 by inserting epidemiologists1 clinical microbiologists1 pathologists and laboratory experts1 experts in health information technology1 privacy1 and data security after forecasting722 and 7,,iii7 in clause 7iii7-- 7aa7 in subclause 7,v71 by striking and at the end2 7bb7 in subclause 7,,vi71 by striking the period2 and 7cc7 by adding at the end the following3 7,,vii7 strategies to integrate laboratory and epidemiology systems and capabilities to conduct rapid and accurate laboratory tests2 7,,viii7 strategies to improve the collection and reporting of appropriate1 aggregated1 deidentified demographic data to inform responses to public health emergencies1 including identification of at-risk populations and to address health disparities2 and 7,,ix7 strategies to improve the electronic exchange of health information between ,state and local health departments and health care providers and facilities to improve public health surveillance4 2 and 7,c7 in paragraph 7#f7-- 7i7 in subparagraph 7,a7-- 7,i7 in clause 7iii7-- 7aa7 in subclause 7,,iii71 by striking and at the end2 7bb7 in subclause 7,,iv71 by inserting 1 including the ability to conduct and report on rapid and accurate laboratory testing during a public health emergency before the semicolon2 and 7cc7 by adding at the end the following3 7,v7 improve coordination and collaboration1 as appropriate1 with other ,federal departments2 and 7,,vi7 implement applicable lessons learned from recent public health emergencies to address gaps in situational awareness and biosurveillance capabilities1 including an evaluation of ways to improve the collection and reporting of aggregated1 deidentified demographic data to inform public health preparedness and response 2 7,,ii7 in clause 7iv71 by striking and at the end2 7,,iii7 in clause 7v71 by striking the period and inserting including a description of how such steps will further the goal of improving awareness of and timely responses to emerging infectious disease threats2 and2 and 7,,iv7 by adding at the end the following3 7vi7 identifies and demonstrates measurable steps the ,secretary will take to further develop and integrate infectious disease detection1 including expanding capabilities to conduct rapid and accurate diagnostic laboratory testing during a public health emergency1 and improve coordination and collaboration with ,state1 local1 ,tribal1 and territorial public health officials1 clinical laboratories 7including commercial1 hospital and academic laboratories71 and other entities with expertise in public health surveillance4 2 and 7ii7 by redesignating subparagraph 7,b7 as subparagraph 7,c72 and 7iii7 by inserting after subparagraph 7,a71 the following3 7,b7 ,reports 7i7 ,in general ,not later than #a month after date of enactment of the ,commitment to ,defeat the ,virus and ,keep ,america ,healthy ,act1 and as provided for in clause 7ii71 the ,secretary shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 a report on the status of the ,department of ,health and ,human ,services' biosurveillance modernization and assessment progress with respect to emerging infectious disease threats4 7ii7 ,additional reports ,during the #b-year period beginning on the date of enactment of the ,commitment to ,defeat the ,virus and ,keep ,america ,healthy ,act1 the ,secretary shall provide additional reports under clause 7i7 every #ij days after the submission of the initial report under such clause4 ,the ,secretary shall provide such reports annually thereafter4 ,the ,secretary may provide such additional reports less frequently1 but not less frequently than every #ahj days1 during an ongoing public health emergency or another significant infectious disease outbreak4 2 7#b7 in subsection 7d7-- 7,a7 in paragraph 7#b77;,c71 by inserting 1 including any public-private partnerships entered into to improve such capacity before the semicolon2 and 7,b7 in paragraph 7#c7-- 7i7 in subparagraph 7,b71 by striking and at the end2 7ii7 in subparagraph 7,c71 by striking the period and inserting 2 and2 and 7iii7 by adding at the end the following3 7,d7 may establish1 enhance1 or maintain a system or network for the collection of data to provide for early detection of infectious disease outbreaks1 near real-time access to relevant electronic data and integration of electronic data and information from public health and other appropriate sources1 such as laboratories1 hospitals1 and epidemiology systems1 to enhance the capability to conduct rapid and accurate diagnostic laboratory tests to provide for disease detection4 2 7#c7 in subsection 7f77#a77;,a71 by inserting pathologists1 clinical microbiologists1 laboratory professionals1 epidemiologists1 after forecasting712 and 7#d7 in subsection 7h71 by adding at the end the following3 ,such evaluation shall include identification of any gaps in biosurveillance and situational awareness capabilities identified related to recent public health emergencies1 any immediate steps taken to address such gaps1 and any long-term plans to address such gaps1 including steps related to activities authorized under this section44 7b7 ,national health security strategy ,section #bhjb7;b77#b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#a7;b77#b77 is amended-- 7#a7 in subparagraph 7,a71 by inserting such as by integrating laboratory and epidemiology systems and capability to conduct rapid and accurate laboratory tests1 after detection1 identification12 and 7#b7 in subparagraph 7,b71 by inserting laboratory testing1 after services and supplies14 7c7 ,epidemiology-,laboratory capacity grants ,section #bhba7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#ca7;a77 is amended-- 7#a7 in paragraph 7#c71 by striking and2 7#b7 in paragraph 7#d71 by striking the period and inserting 2 and2 and 7#c7 by adding at the end the following3 7#e7 supporting activities of ,state and local public health departments related to biosurveillance and disease detection1 which may include activities related to section #cai;,d1 as appropriate4 4 ,c ,diagnostic ,testing for ,public ,health ,labs #djba4 ,grants for public health laboratories to acquire high-throughput diagnostic equipment ,section #bhba of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#ca7 is amended-- 7#a7 by redesignating subsection 7b7 as subsection 7c72 7#b7 by inserting after subsection 7a7 the following new subsection3 7b7 ,grants for public health laboratories ,to acquire high-,throughput diagnostic equipment 7#a7 ,grants ,the ,secretary shall award grants to eligible entities to assist such entities in purchasing high-throughput diagnostic equipment and related supplies and in hiring and training staff to use such equipment4 7#b7 ,eligibility ,to be eligible for a grant under paragraph 7#a71 an entity shall-- 7,a7 be-- 7i7 a ,state1 local1 or ,tribal public health laboratory2 7ii7 a laboratory within a public health laboratory network coordinated or managed by the ,centers for ,disease ,control and ,prevention2 7iii7 a laboratory not described in clause 7i7 or 7ii7 that the ,secretary determines 7at the ,secretary's discretion7 provides population-based testing for the prevention and control of infectious1 communicable1 genetic1 or chronic diseases2 or 7iv7 a consortium of #b or more entities described in any of clauses 7i7 through 7iii72 and 7,b7 submit to the ,secretary an application at such time1 in such manner1 and containing such information as the ,secretary may reasonably require4 7#c7 ,use of funds ,amounts received through a grant under this subsection shall be used-- 7,a7 to purchase high-throughput diagnostic equipment and such materials as are necessary to administer1 store1 and process applicable tests1 including diagnostic and serological tests2 and 7,b7 to hire and train staff to use such equipment4 7#d7 ,amount of grant ,the amount of a grant under paragraph 7#a7 may not exceed #b1jjj1jjj1 except in the case of eligible entity described in paragraph 7#b77;,a77iv74 7#e7 ,high-throughput diagnostic equipment defined ,in this subsection1 the term high-throughput diagnostic equipment means legally marketed equipment and supplies capable of performing multichannel analysis for use in clinical laboratory diagnostic testing4 2 and 7#c7 in subsection 7c71 as so redesignated-- 7,a7 by redesignating paragraphs 7#a71 7#b71 and 7#c7 as subparagraphs 7,a71 7,b71 and 7,c71 respectively1 and moving the margin of each such redesignated subparagraph #b ems to the right2 7,b7 by striking ,there are authorized to be appropriated to carry out this section and inserting the following3 7#a7 ,in general ,there are authorized to be appropriated to carry out subsection 7a7 2 and 7,c7 by adding at the end the following new paragraph3 7#b7 ,authorization of appropriations 7,a7 ,in general ,for the purpose of carrying out subsection 7b71 there is authorized to be appropriated #bej1jjj1jjj for fiscal year #bjba1 to remain available until expended4 7,b7 ,administrative expenses ,of the amount made available to carry out subsection 7b7 for any fiscal year1 the ,secretary may not use more than #e percent of such amount for the expenses of administering subsection 7b74 4 ,d ,rapid ,testing for ,communities #djca4 ,grants for same-day point-of-care clinical laboratory diagnostic testing in communities ,section #bhba of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#ca7 is amended-- 7#a7 by redesignating subsection 7c71 as redesignated by section #djba1 as subsection 7d72 7#b7 by inserting after subsection 7b71 as added by section #djba1 the following new subsection3 7c7 ,grants for same-,day point-of-,care clinical laboratory diagnostic testing in communities 7#a7 ,grants ,the ,secretary shall award grants to eligible entities to assist such entities in acquiring legally marketed equipment and supplies capable of performing same-day clinical laboratory diagnostic testing in a point-of-care setting4 7#b7 ,eligibility ,to be eligible for a grant under paragraph 7#a71 an entity shall-- 7,a7 be-- 7i7 a hospital2 7ii7 a primary care facility2 7iii7 a clinic2 7iv7 a physician2 or 7v7 another type of health care provider as the ,secretary may define2 and 7,b7 submit to the ,secretary an application at such time1 in such manner1 and containing such information as the ,secretary may reasonably require4 7#c7 ,use of funds ,amounts received through a grant under this subsection shall be used to purchase legally marketed rapid diagnostic equipment and such materials as are necessary to administer1 store1 and process same-day clinical laboratory diagnostic testing in a point-of-care setting1 including diagnostic and serological tests4 7#d7 ,amount of grant ,the amount of a grant under paragraph 7#a7 may not exceed #bj1jjj4 7#e7 ,priority in making awards ,in awarding grants under paragraph 7#a71 the ,secretary shall give priority to eligible entities providing services to-- 7,a7 medically underserved populations 7as defined in section #ccj7;b77#c77 in rural areas2 and 7,b7 all other areas4 2 and 7#c7 by adding at the end of subsection 7d71 as redesignated1 the following new paragraph3 7#c7 ,authorization of ,appropriations 7,a7 ,in general ,for the purpose of carrying out subsection 7c71 there is authorized to be appropriated #ejj1jjj1jjj for fiscal year #bjba1 to remain available until expended4 7,b7 ,administrative expenses ,of the amount made available to carry out subsection 7c7 for any fiscal year1 the ,secretary may not use more than #e percent of such amount for the expenses of administering this section4 4 ,e ,public ,health ,workforce ,loan ,repayment #djda4 ,public ,health ,workforce ,loan ,repayment ,program ,part ,d of title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bed;b et seq471 as amended by section #bjca1 is further amended by adding at the end the following new subpart3 ,,xiv ,public ,health ,workforce #cdj,k4 ,loan ,repayment ,program 7a7 ,establishment ,the ,secretary of ,health and ,human ,services shall establish a program to be known as the ,public ,health ,workforce ,loan ,repayment ,program 7referred to in this section as the ,program7 to assure an adequate supply of and encourage recruitment of public health professionals to eliminate critical public health workforce shortages in local1 ,state1 and ,tribal public health agencies4 7b7 ,eligibility ,to be eligible to participate in the ,program1 an individual shall-- 7#a7 7,a7 be accepted for enrollment1 or be enrolled1 as a student in an accredited academic educational institution in a ,state or territory in the final year of a course of study or program leading to a public health or health professions degree or certificate and have accepted employment with a local1 ,state1 or ,tribal public health agency1 or a related training fellowship1 as recognized by the ,secretary1 to commence upon graduation2 or 7,b7 7i7 have graduated1 during the preceding #aj-year period1 from an accredited educational institution in a ,state or territory and received a public health or health professions degree or certificate2 and 7ii7 be employed by1 or have accepted employment with1 a local1 ,state1 or ,tribal public health agency or a related training fellowship1 as recognized by the ,secretary2 7#b7 be a ,united ,states citizen2 7#c7 7,a7 submit an application to the ,secretary to participate in the ,program2 and 7,b7 execute a written contract as required in subsection 7c72 and 7#d7 not have received1 for the same service1 a reduction of loan obligations under section #dbh;,j1 #dbh,k1 #dbh,l1 #dee7m71 or #dfj of the ,higher ,education ,act of #aife 7#bj ,u4,s4,c4 #ajgh-aj1 #ajgh-aa1 #ajgh-ab1 #ajhg;e7m71 and #ajhg;j74 7c7 ,contract ,the written contract referred to in subsection 7b77#c77;,b7 between the ,secretary and an individual shall contain-- 7#a7 an agreement on the part of the ,secretary that the ,secretary will repay1 on behalf of the individual1 loans incurred by the individual in the pursuit of the relevant degree or certificate in accordance with the terms of the contract2 7#b7 an agreement on the part of the individual that the individual will serve in the full-time employment of a local1 ,state1 or ,tribal public health agency or a related fellowship program in a position related to the course of study or program for which the contract was awarded for a period of time equal to the greater of-- 7,a7 #c years2 or 7,b7 such longer period of time as determined appropriate by the ,secretary and the individual2 7#c7 an agreement1 as appropriate1 on the part of the individual to relocate to a priority service area 7as determined by the ,secretary7 in exchange for an additional loan repayment incentive amount to be determined by the ,secretary2 7#d7 a provision that any financial obligation of the ,united ,states arising out of a contract entered into under this section and any obligation of the individual that is conditioned thereon1 is contingent on funds being appropriated for loan repayments under this section2 7#e7 a statement of the damages to which the ,united ,states is entitled1 under this section for the individual's breach of the contract2 and 7#f7 such other statements of the rights and liabilities of the ,secretary and of the individual as the ,secretary determines appropriate1 not inconsistent with this section4 7d7 ,payments 7#a7 ,in general ,a loan repayment provided for an individual under a written contract referred to in subsection 7b77#c77;,b7 shall consist of payment1 in accordance with paragraph 7#b71 on behalf of the individual of the principal1 interest1 and related expenses on government and commercial loans received by the individual regarding the undergraduate or graduate education of the individual 7or both71 which loans were made for tuition expenses incurred by the individual4 7#b7 ,payments for years served ,for each year of service that an individual contracts to serve pursuant to subsection 7c77#b71 the ,secretary may pay not more than #ce1jjj on behalf of the individual for loans described in paragraph 7#a74 ,with respect to participants under the ,program whose total eligible loans are less than #aje1jjj1 the ,secretary shall pay an amount that does not exceed of the eligible loan balance for each year of such service of such individual4 7#c7 ,tax liability ,for the purpose of providing reimbursements for tax liability resulting from payments under paragraph 7#b7 on behalf of an individual1 the ,secretary shall1 in addition to such payments1 make payments to the individual in an amount not to exceed #ci percent of the total amount of loan repayments made for the taxable year involved4 7e7 ,postponing obligated service ,with respect to an individual receiving a degree or certificate from a health professions or other related school1 the date of the initiation of the period of obligated service may be postponed as approved by the ,secretary4 7f7 ,breach of contract ,an individual who fails to comply with the contract entered into under subsection 7c7 shall be subject to the same financial penalties as provided for under section #cch;,e of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bedo7 for breaches of loan repayment contracts under section #cch;,b of such ,act 7#db ,u4,s4,c4 section #bedl-#a74 7g7 ,authorization of appropriations ,there is authorized to be appropriated to carry out this section-- 7#a7 #ajj1jjj1jjj for fiscal year #bjba2 and 7#b7 #ge1jjj1jjj for each of fiscal years #bjbb through #bjbf4 4 ,f ,vaccine ,awareness and ,disease ,prevention #djea4 ,improving awareness of disease prevention 7a7 ,in general ,the ,public ,health ,service ,act is amended by striking section #cac of such ,act 7#db ,u4,s4,c4 #bde7 and inserting the following3 #cac4 ,public awareness campaign on the importance of vaccinations 7a7 ,in general ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention and in coordination with other offices and agencies1 as appropriate1 shall award competitive grants or contracts to one or more public or private entities to carry out a national1 evidence-based campaign to increase awareness and knowledge of the safety and effectiveness of vaccines for the prevention and control of diseases1 combat misinformation about vaccines1 and disseminate scientific and evidence-based vaccine-related information1 with the goal of increasing rates of vaccination across all ages1 as applicable1 particularly in communities with low rates of vaccination1 to reduce and eliminate vaccine-preventable diseases4 7b7 ,consultation ,in carrying out the campaign under this section1 the ,secretary shall consult with appropriate public health and medical experts1 including the ,national ,academy of ,medicine and medical and public health associations and nonprofit organizations1 in the development1 implementation1 and evaluation of the evidence-based public awareness campaign4 7c7 ,requirements ,the campaign under this section shall-- 7#a7 be a nationwide1 evidence-based media and public engagement initiative2 7#b7 include the development of resources for communities with low rates of vaccination1 including culturally and linguistically appropriate resources1 as applicable2 7#c7 include the dissemination of vaccine information and communication resources to public health departments1 health care providers1 and health care facilities1 including such providers and facilities that provide prenatal and pediatric care2 7#d7 be complementary to1 and coordinated with1 any other ,federal1 ,state1 local1 or ,tribal efforts1 as appropriate2 and 7#e7 assess the effectiveness of communication strategies to increase rates of vaccination4 7d7 ,additional activities ,the campaign under this section may-- 7#a7 include the use of television1 radio1 the internet1 and other media and telecommunications technologies2 7#b7 include the use of in-person activities2 7#c7 be focused to address specific needs of communities and populations with low rates of vaccination2 and 7#d7 include the dissemination of scientific and evidence-based vaccine-related information1 such as-- 7,a7 advancements in evidence-based research related to diseases that may be prevented by vaccines and vaccine development2 7,b7 information on vaccinations for individuals and communities1 including individuals for whom vaccines are not recommended by the ,advisory ,committee for ,immunization ,practices1 and the effects of low vaccination rates within a community on such individuals2 7,c7 information on diseases that may be prevented by vaccines2 and 7,d7 information on vaccine safety and the systems in place to monitor vaccine safety4 7e7 ,evaluation ,the ,secretary shall-- 7#a7 establish benchmarks and metrics to quantitatively measure and evaluate the awareness campaign under this section2 7#b7 conduct qualitative assessments regarding the awareness campaign under this section2 and 7#c7 prepare and submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and ,committee on ,energy and ,commerce of the ,house of ,representatives an evaluation of the awareness campaign under this section4 7f7 ,supplement not supplant ,funds appropriated under this section shall be used to supplement and not supplant other ,federal1 ,state1 and local public funds provided for activities described in this section4 7g7 ,authorization of appropriations ,there are authorized to be appropriated to carry out this section and subsections 7k7 and 7n7 of section #cag #aj1jjj1jjj for each of fiscal years #bjba through #bjbe4 4 7b7 ,grants ,to address vaccine-,preventable diseases ,section #cag of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;b7 is amended-- 7#a7 in subsection 7k77#a7-- 7,a7 in subparagraph 7,c71 by striking 2 and and inserting a semicolon2 7,b7 in subparagraph 7,d71 by striking the period and inserting a semicolon2 and 7,c7 by adding at the end the following3 7,e7 planning1 implementation1 and evaluation of activities to address vaccine-preventable diseases1 including activities to-- 7i7 identify communities at high risk of outbreaks related to vaccine-preventable diseases1 including through improved data collection and analysis2 7ii7 pilot innovative approaches to improve vaccination rates in communities and among populations with low rates of vaccination2 7iii7 reduce barriers to accessing vaccines and evidence-based information about the health effects of vaccines2 7iv7 partner with community organizations and health care providers to develop and deliver evidence-based interventions1 including culturally and linguistically appropriate interventions1 to increase vaccination rates2 7v7 improve delivery of evidence-based1 vaccine-related information to parents and others2 and 7vi7 improve the ability of ,state1 local1 ,tribal1 and territorial public health departments to engage communities at high risk for outbreaks related to vaccine-preventable diseases1 in coordination1 as appropriate1 with local educational agencies1 as defined in section #haja of the ,elementary and ,secondary ,education ,act of #aife2 and 7,f7 research related to strategies for improving awareness of scientific and evidence-based1 vaccine-related information1 including for communities with low rates of vaccination1 in order to understand barriers to vaccination1 improve vaccination rates1 and assess the public health outcomes of such strategies4 2 and 7#b7 by adding at the end the following3 7n7 ,vaccination data ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall expand and enhance1 and1 as appropriate1 establish and improve1 programs and conduct activities to collect1 monitor1 and analyze vaccination coverage data to assess levels of protection from vaccine-preventable diseases1 including by assessing factors contributing to underutilization of vaccines and variations of such factors1 and identifying communities at high risk of outbreaks associated with vaccine-preventable diseases4 4 7c7 ,supplemental grant funds ,section #ccj7;d77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bed;b7 is amended-- 7#a7 in subparagraph 7,f71 by striking and at the end2 7#b7 in subparagraph 7,g71 by striking the period and inserting 2 and2 and 7#c7 by adding at the end the following3 7,h7 improving access to recommended immunizations4 4 7d7 ,update of #bjae ,,nvac report ,the ,national ,vaccine ,advisory ,committee established under section #baje of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;aa-#e7 shall1 as appropriate1 update the report entitled1 ,assessing the ,state of ,vaccine ,confidence in the ,united ,states3 ,recommendations from the ,national ,vaccine ,advisory ,committee1 approved by the ,national ,vaccine ,advisory ,committee on ,june #aj1 #bjae1 with respect to factors affecting childhood vaccination4 ,g ,protecting the ,health of ,america's ,older ,adults ,during ,,covid-#ai ,beyond #djfa4 ,national ,,covid-#ai ,resource ,center for ,older ,adults 7a7 ,in general ,the ,secretary of ,health and ,human ,services 7in this subtitle referred to as the ,secretary7 shall establish within the ,office of the ,assistant ,secretary for ,health a ,national ,,covid-#ai ,resource ,center for ,older ,adults 7in this section referred to as the ,center7 to identify1 curate1 and disseminate1 promising and proven practices and tools for the care of older adults in their homes1 community-based care settings1 hospitals1 and nursing and acute care facilities4 7b7 ,involvement by ,federal departments and all levels of government ,the ,center shall-- 7#a7 be advised by a team of senior officials from-- 7,a7 agencies across the ,department of ,health and ,human ,services1 including the ,administration for ,community ,living 7including the ,administration on ,aging71 the ,centers for ,disease ,control and ,prevention1 the ,centers for ,medicare ,medicaid ,services1 the ,health ,resources and ,services ,administration1 the ,indian ,health ,service1 and the ,office of ,minority ,health in the ,office of the ,secretary2 and 7,b7 other ,federal departments1 including the ,department of ,housing and ,urban ,development and the ,department of ,veterans ,affairs2 and 7#b7 collaborate with ,state and local governments1 ,indian tribes and ,tribal organizations1 and nonprofit organizations4 7c7 ,activities ,the ,center shall perform the following activities3 7#a7 ,develop a set of best practices for older adult health and well-being during and beyond the period of the ,,covid-#ai pandemic1 including such best practices with respect to the following focus areas3 7,a7 ,providing specialized services to overcome the risks associated with social isolation1 such as additional resources for home-delivered meals and other nutrition programs to provide not only food but also face-to-face interactions4 7,b7 ,streamlining and improving access to screening1 testing1 and health care services and resources1 and prioritizing venues older adults can reach4 7,c7 ,expanding the use of telemedicine1 including the provision of technology to execute televisits that safely and comprehensively address older adults' health care needs4 7,d7 ,supporting family caregivers1 including those with additional responsibilities for homebound individuals4 7,e7 ,reducing disparities among underserved populations4 7,f7 ,developing cross-sector collaborative efforts4 7#b7 ,create and disseminate tools1 technical assistance1 training1 and funding to ,state1 local1 ,tribal1 and territorial governments to adopt best practices developed under subparagraphs 7,e7 and 7,f7 of paragraph 7#a74 7#c7 ,establish mechanisms for providing training and technical assistance to ,state1 local1 ,tribal1 and territorial governments to ensure that complementary cross-sector activities are replicated at the ,state1 local1 ,tribal1 and territorial levels4 7#d7 ,facilitate the development of learning networks of practitioners at the hospital1 nursing facility1 and community levels to disseminate the best practices developed under paragraph 7#a7 and ensure implementation of such best practices to reduce morbidity and mortality of older adults affected by ,,covid-#ai4 7#e7 ,identify and disseminate approaches that strengthen public health and health care system capacity to serve older ,americans with regard to health issues during and beyond the ,,covid-#ai pandemic4 #djfb4 ,healthy ,aging ,program 7a7 ,in general ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall establish a ,healthy ,aging ,program for the purpose of promoting the health and well-being of older adults by-- 7#a7 improving the coordination of public health interventions that promote the health and well-being of older adults2 7#b7 disseminating and implementing evidence-based best practices and programs with respect to promoting the health and well-being of older adults2 and 7#c7 coordinating multisectoral efforts to promote the health and well-being of older adults across governmental and nongovernmental health and related agencies4 7b7 ,activities ,for the purpose described in subsection 7a71 the ,secretary shall design the ,healthy ,aging ,program to carry out the following activities3 7#a7 ,regularly assess the health-related needs of older adults and promote policies addressing those needs through evidence-based public health interventions to promote overall health and well-being among older adults and reduce health care costs4 7#b7 ,identify disparities in health among vulnerable populations of older adults4 7#c7 ,identify gaps in existing public health programs and policies that focus on older adults4 7#d7 ,promote public health partnerships with aging and other sector stakeholders to ensure nonduplication of efforts and increase efficiency by working collaboratively across sectors4 7#e7 ,work with multisectoral agencies to improve emergency preparedness plans and activities for vulnerable older adult populations4 7#f7 ,coordinate efforts to promote the health of older adults with the ,administration for ,community ,living1 other ,federal departments and agencies1 and nonprofit organizations4 7#g7 ,identify resources and evidence-based programs available to local and ,state health departments1 including resources and programs that could be coordinated across sectors1 to address the health and well-being of older adults4 7c7 ,grants to health departments ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall award grants or cooperative agreements to eligible health departments to carry out any of the following activities3 7#a7 ,improving availability of data on the older adult population1 including through data-sharing with elder affairs agencies4 7#b7 ,linking the health care sector with the community services sector 7including aging services and supports7 to coordinate and promote community-based prevention services4 7#c7 ,ensuring that ,state and local emergency preparedness plans and activities address the special needs of older adults1 particularly the most vulnerable populations4 7#d7 ,training ,state and local public health personnel to implement or adapt evidence-based and innovative health promotion and disease prevention programs and policies4 7#e7 ,improving community conditions and addressing social determinants to promote health and well-being and foster independence among older adults1 such as efforts to advance age-friendly communities and dementia-friendly communities4 7d7 ,technical assistance ,the ,secretary shall 7directly or through grants1 cooperative agreements1 or contracts7 provide technical assistance to eligible health departments in carrying out activities described in subsection 7c74 7e7 ,evaluations ,the ,secretary shall 7directly or through grants1 cooperative agreements1 or contracts7 provide for the evaluation of activities carried out under subsections 7a71 7b71 and 7c7 in order to determine the extent to which such activities have been effective in carrying out the purpose described in subsection 7a71 including the effects of such activities on addressing health disparities4 7f7 ,definition ,in this section1 the term eligible health department means a health department of a ,state1 the ,district of ,columbia1 the ,commonwealth of ,puerto ,rico1 the ,united ,states ,virgin ,islands1 ,guam1 ,american ,samoa1 the ,commonwealth of the ,northern ,mariana ,islands1 a ,tribe 7as defined in section #d of the ,indian ,self-,determination and ,education ,assistance ,act 7#be ,u4,s4,c4 #ecjd771 or a large city 7as defined by the ,director of the ,centers for ,disease ,control and ,prevention for purposes of this section74 #djfc4 ,authorization of appropriations ,there is authorized to be appropriated-- 7#a7 #aj1jjj1jjj for the period of fiscal years #bjba through #bjbe to carry out section #djfa1 to remain available until ,september #cj1 #bjbe2 and 7#b7 #bj1jjj1jjj for each of fiscal years #bjba through #bjbe to carry out section #djfb1 including for grants under section #djfb7;c71 to remain available until ,september #cj1 #bjbe4 ,h ,expanding ,capacity for ,health ,outcomes #djga4 ,expanding capacity for health outcomes ,title ,,iii of the ,public ,health ,service ,act is amended by inserting after section #ccj,m 7#db ,u4,s4,c4 #bed;c-#ai7 the following3 #ccj,n4 ,expanding capacity for health outcomes 7a7 ,definitions ,in this section3 7#a7 ,eligible entity ,the term eligible entity-- 7,a7 means an entity that provides1 or supports the provision of1 health care services-- 7i7 in rural areas1 frontier areas1 health professional shortage areas1 or medically underserved areas2 or 7ii7 to medically underserved populations or ,native ,americans1 including ,indian ,tribes1 ,tribal organizations1 or urban ,indian organizations2 and 7,b7 may include entities leading1 or capable of leading1 a technology-enabled collaborative learning and capacity building model or engaging in technology-enabled collaborative training of participants in such model4 7#b7 ,health professional shortage area ,the term health professional shortage area means a health professional shortage area designated under section #ccb4 7#c7 ,indian tribe ,the terms ,indian ,tribe and ,tribal organization have the meanings given the terms ,indian tribe and tribal organization in section #d of the ,indian ,self-,determination and ,education ,assistance ,act4 7#d7 ,medically underserved population ,the term medically underserved population has the meaning given the term in section #ccj7;b77#c74 7#e7 ,native ,americans ,the term ,native ,americans has the meaning given such term in section #gcf and includes ,indian ,tribes and ,tribal organizations4 7#f7 ,technology-enabled collaborative learning and capacity building model ,the term technology-enabled collaborative learning and capacity building model means a distance health education model that connects health care professionals1 and particularly specialists1 with multiple other health care professionals through simultaneous interactive videoconferencing for the purpose of facilitating case-based learning1 disseminating best practices1 and evaluating outcomes4 7#g7 ,urban ,indian organization ,the urban ,indian organization has the meaning given the term ,urban ,indian organization in section #d of the ,indian ,health ,care ,improvement ,act4 7b7 ,program established ,the ,secretary shall1 as appropriate1 award grants to evaluate1 develop1 and1 as appropriate1 expand the use of technology-enabled collaborative learning and capacity building models1 to improve retention of health care providers and increase access to health care services1 such as those to address chronic diseases and conditions1 infectious diseases1 mental health1 substance use disorders1 prenatal and maternal health1 pediatric care1 pain management1 palliative care1 and other specialty care in rural areas1 frontier areas1 health professional shortage areas1 or medically underserved areas and for medically underserved populations or ,native ,americans1 including ,indian ,tribes and ,tribal organizations4 7c7 ,use of funds 7#a7 ,in general ,grants awarded under subsection 7b7 shall be used for-- 7,a7 the development and acquisition of instructional programming1 and the training of health care providers and other professionals that provide or assist in the provision of services through models described in subsection 7b71 such as training on best practices for data collection and leading or participating in such technology-enabled activities consistent with technology-enabled collaborative learning and capacity building models2 7,b7 information collection and evaluation activities to study the impact of such models on patient outcomes and health care providers1 and to identify best practices for the expansion and use of such models2 or 7,c7 other activities consistent with achieving the objectives of the grants awarded under this section1 as determined by the ,secretary4 7#b7 ,other uses ,in addition to any of the uses under paragraph 7#a71 grants awarded under subsection 7b7 may be used for-- 7,a7 equipment to support the use and expansion of technology-enabled collaborative learning and capacity building models1 including for hardware and software that enables distance learning1 health care provider support1 and the secure exchange of electronic health information2 or 7,b7 support for health care providers and other professionals that provide or assist in the provision of services through such models4 7d7 ,length of grants ,grants awarded under subsection 7b7 shall be for a period of up to #e years4 7e7 ,grant requirements ,the ,secretary may require entities awarded a grant under this section to collect information on the effect of the use of technology-enabled collaborative learning and capacity building models1 such as on health outcomes1 access to health care services1 quality of care1 and provider retention in areas and populations described in subsection 7b74 ,the ,secretary may award a grant or contract to assist in the coordination of such models1 including to assess outcomes associated with the use of such models in grants awarded under subsection 7b71 including for the purpose described in subsection 7c77#a77;,b74 7f7 ,application ,an eligible entity that seeks to receive a grant under subsection 7b7 shall submit to the ,secretary an application1 at such time1 in such manner1 and containing such information as the ,secretary may require4 ,such application shall include plans to assess the effect of technology-enabled collaborative learning and capacity building models on patient outcomes and health care providers4 7g7 ,access to broadband ,in administering grants under this section1 the ,secretary may coordinate with other agencies to ensure that funding opportunities are available to support access to reliable1 high-speed internet for grantees4 7h7 ,technical assistance ,the ,secretary shall provide 7either directly through the ,department of ,health and ,human ,services or by contract7 technical assistance to eligible entities1 including recipients of grants under subsection 7b71 on the development1 use1 and evaluation of technology-enabled collaborative learning and capacity building models in order to expand access to health care services provided by such entities1 including for medically underserved areas and to medically underserved populations or ,native ,americans1 including ,indian ,tribes and ,tribal organizations4 7i7 ,research and evaluation ,the ,secretary1 in consultation with stakeholders with appropriate expertise in such models1 shall develop a strategic plan to research and evaluate the evidence for such models4 ,the ,secretary shall use such plan to inform the activities carried out under this section4 7j7 ,report by ,secretary ,not later than #d years after the date of enactment of this section1 the ,secretary shall prepare and submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 and post on the internet website of the ,department of ,health and ,human ,services1 a report including1 at minimum-- 7#a7 a description of any new and continuing grants awarded to entities under subsection 7b7 and the specific purpose and amounts of such grants2 7#b7 an overview of-- 7,a7 the evaluations conducted under subsection 7b72 7,b7 technical assistance provided under subsection 7h72 and 7,c7 activities conducted by entities awarded grants under subsection 7b72 and 7#c7 a description of any significant findings or developments related to patient outcomes or health care providers and best practices for eligible entities expanding1 using1 or evaluating technology-enabled collaborative learning and capacity building models1 including through the activities described in subsection 7h74 7k7 ,authorization of appropriations ,there is authorized to be appropriated to carry out this section1 #bj1jjj1jjj for each of fiscal years #bjba through #bjbe4 4 ,i ,community ,readiness #djha4 ,grants for research on1 or establishing1 wastewater surveillance and other early warning systems ,subtitle ,c of title ,,xxviii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#ca et seq47 is amended by adding at the end the following3 #bhbc4 ,grants for research on1 or establishing1 wastewater surveillance and other early warning systems 7a7 ,in general ,the ,secretary1 in consultation with the ,administrator of the ,environmental ,protection ,agency1 may award grants to eligible entities to conduct research on1 or to establish1 a wastewater surveillance or other early warning system through-- 7#a7 wastewater testing2 7#b7 temperature tracking to monitor axillary body temperature2 and 7#c7 other methods deemed permissible by the ,secretary and ,administrator4 7b7 ,permissible uses of funds ,a grant recipient under this section may use grant funds to support the activities described in subsection 7a71 including by-- 7#a7 paying for data-centric services that can detect infectious diseases before positive cases or hospitalizations2 7#b7 entering into contracts with private companies to implement early warning detection methods2 or 7#c7 funding research to study early warning detection methods4 7c7 ,priority ,in selecting grant recipients under this section1 the ,secretary shall give priority to eligible entities proposing to conduct research on1 or to establish1 wastewater surveillance or other early warning system in one or more areas that-- 7#a7 are 7or include one or more areas that are7 a hot spot2 or 7#b7 a higher percentage of vulnerable populations than the national average4 7d7 ,federal privacy requirements ,nothing in this section shall be construed to supersede any ,federal privacy or confidentiality requirement1 including the regulations promulgated under section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif and section #edc of this ,act4 7e7 ,definitions ,in this section3 7#a7 ,the term ,administrator means the ,administrator of the ,environmental ,protection ,agency4 7#b7 ,the term eligible entity means-- 7,a7 a ,state government2 7,b7 a local government2 7,c7 a ,tribal government2 7,d7 an entity that conducts health research2 and 7,e7 an academic institution4 7#c7 ,the term emergency period has the meaning given to that term in section #aace7;g77#a77;,b7 of the ,social ,security ,act4 7#d7 ,the term hot spot means a geographic area where the rate of infection with a particular pathogen exceeds the national average4 7#e7 ,the term local government means a county1 municipality1 town1 township1 village1 parish1 borough1 or other unit of general local government4 7#f7 ,the term ,secretary means the ,secretary of ,health and ,human ,services4 7#g7 ,the term ,state means each of the several ,states1 the ,district of ,columbia1 the ,commonwealth of ,puerto ,rico1 ,american ,samoa1 ,guam1 the ,commonwealth of the ,northern ,mariana ,islands1 the ,virgin ,islands1 and the ,trust ,territory of the ,pacific ,islands4 7#h7 ,the term vulnerable population means people at increased risk of severe illness4 7f7 ,authorization of appropriations ,to carry out this section1 there are authorized to be appropriated #ah1jjj1jjj for each of fiscal years #bjba through #bjbe4 4 ,v ,addressing ,,covid-#ai ,health ,disparities ,a ,tribal ,health ,data ,improvement #ejja4 ,collection and availability of health data with respect to ,indian ,tribes 7a7 ,data collection ,section #caja7;a77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjjkk7a77#a77 is amended-- 7#a7 by striking 1 by not later than #b years after the date of enactment of this title12 and 7#b7 in subparagraph 7,b71 by inserting ,tribal1 after ,state14 7b7 ,data reporting and dissemination ,section #caja7;c7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjjkk7c77 is amended-- 7#a7 by amending subparagraph 7,f7 of paragraph 7#a7 to read as follows3 7,f7 the ,indian ,health ,service1 ,indian ,tribes1 ,tribal organizations1 and epidemiology centers authorized under the ,indian ,health ,care ,improvement ,act2 2 and 7#b7 in paragraph 7#c71 by inserting ,indian ,tribes1 ,tribal organizations1 and epidemiology centers1 after ,federal agencies14 7c7 ,protection and sharing of data ,section #caja7;e7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjjkk7e77 is amended by adding at the end the following new paragraphs3 7#c7 ,data sharing strategy ,with respect to data access for ,tribal epidemiology centers and ,tribes1 the ,secretary shall create a data sharing strategy that takes into consideration recommendations by the ,secretary's ,tribal ,advisory ,committee for-- 7,a7 ensuring that ,tribal epidemiology centers and ,indian ,tribes have access to the data sources necessary to accomplish their public health responsibilities2 and 7,b7 protecting the privacy and security of such data4 7#d7 ,tribal public health authority 7,a7 ,availability ,beginning not later than #ahj days after the date of the enactment of the ,commitment to ,defeat the ,virus and ,keep ,america ,healthy ,act1 the ,secretary shall make available to the entities listed in subparagraph 7,b7 all data that is collected pursuant to this title with respect to health care and public health surveillance programs and activities1 including such programs and activities that are federally supported or conducted1 so long as-- 7i7 such entities request the data pursuant to statute2 and 7ii7 the data is requested for use-- 7,i7 consistent with ,federal law and obligations2 and 7,,ii7 to satisfy a particular purpose or carry out a specific function consistent with the purpose for which the data was collected4 7,b7 ,entities ,the entities listed in this subparagraph are-- 7i7 the ,indian ,health ,service2 7ii7 ,indian ,tribes and ,tribal organizations2 and 7iii7 epidemiology centers4 4 7d7 ,technical updates ,section #caja of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjjkk7 is amended-- 7#a7 by striking subsections 7g7 and 7h72 and 7#b7 by redesignating subsection 7i7 as subsection 7h74 7e7 ,definitions ,after executing the amendments made by subsection 7d71 section #caja of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjjkk7 is amended by inserting after subsection 7f7 the following new subsection3 7g7 ,definitions ,in this section3 7#a7 ,the term epidemiology center means an epidemiology center established under section #bad of the ,indian ,health ,care ,improvement ,act1 including such ,tribal epidemiology centers serving ,indian ,tribes regionally and any ,tribal epidemiology center serving ,urban ,indian organizations nationally4 7#b7 ,the term ,indian ,tribe has the meaning given to the term ,indian tribe in section #d of the ,indian ,self-,determination and ,education ,assistance ,act4 7#c7 ,the term ,tribal organization has the meaning given to the term tribal organization in section #d of the of the ,indian ,self-,determination and ,education ,assistance ,act4 7#d7 ,the term ,urban ,indian organization has the meaning given to that term in section #d of the ,indian ,health ,care ,improvement ,act4 4 7f7 ,technical correction ,section #caja7;b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjjkk7b77 is amended by striking ,data analysis4-- and all that follows through ,for each federally and inserting ,data analysis4--,for each federally4 #ejjb4 ,improving health statistics reporting with respect to ,indian ,tribes 7a7 ,technical aid to ,states and localities ,section #cjf7;d7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdbk7d77 is amended by inserting 1 ,indian ,tribes1 ,tribal organizations1 and epidemiology centers after jurisdictions4 7b7 ,cooperative health statistics system ,section #cjf7;e77#c7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdbk7e77#c77 is amended by inserting 1 ,indian ,tribes1 ,tribal organizations1 and epidemiology centers after health agencies4 7c7 ,federal-,state-,tribal cooperation ,section #cjf7;f7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdbk7f77 is amended-- 7#a7 by inserting the ,indian ,health ,service1 before the ,departments of ,commerce2 7#b7 by inserting a comma after the ,departments of ,commerce and ,labor2 7#c7 by inserting 1 ,indian ,tribes1 ,tribal organizations1 and epidemiology centers after ,state and local health departments and agencies2 and 7#d7 by striking he shall and inserting the ,secretary shall4 7d7 ,registration area records ,section #cjf7;h77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdbk7h77#a77 is amended-- 7#a7 by striking in his discretion and inserting in the discretion of the ,secretary2 and 7#b7 by striking ,hispanics1 ,asian ,americans1 and ,pacific ,islanders and inserting ,american ,indians and ,alaska ,natives1 ,hispanics1 ,asian ,americans1 and ,native ,hawaiian and other ,pacific ,islanders4 7e7 ,national ,committee on ,vital and ,health ,statistics ,section #cjf7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdbk7k77 is amended-- 7#a7 in paragraph 7#c71 by striking 1 not later than #fj days after the date of the enactment of the ,health ,insurance ,portability and ,accountability ,act of #aiif1 each place it appears2 and 7#b7 in paragraph 7#g71 by striking ,not later than #a year after the date of the enactment of the ,health ,insurance ,portability and ,accountability ,act of #aiif1 and annually thereafter1 the ,committee shall and inserting ,the ,committee shall1 on an biennial basis14 7f7 ,grants for assembly and analysis of data on ethnic and racial populations ,section #cjf7m77#d7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdbk7m77#d77 is amended-- 7#a7 in subparagraph 7,a7-- 7,a7 by striking ,subject to subparagraph 7,b71 the and inserting ,the2 and 7,b7 by striking and major ,hispanic subpopulation groups and ,american ,indians and inserting 1 major ,hispanic subgroups1 and ,american ,indians and ,alaska ,natives2 and 7#b7 by amending subparagraph 7,b7 to read as follows3 7,b7 ,in carrying out subparagraph 7,a71 with respect to ,american ,indians and ,alaska ,natives1 the ,secretary shall-- 7i7 consult with ,indian ,tribes1 ,tribal organizations1 the ,tribal ,technical ,advisory ,group of the ,centers for ,medicare ,medicaid ,services maintained under section #ejjf7;e7 of the ,american ,recovery and ,reinvestment ,act of #bjji1 and the ,tribal ,advisory ,committee established by the ,centers for ,disease ,control and ,prevention1 in coordination with epidemiology centers1 to develop guidelines for ,state and local health agencies to improve the quality and accuracy of data with respect to the birth and death records of ,american ,indians and ,alaska ,natives2 7ii7 confer with ,urban ,indian organizations to develop guidelines for ,state and local health agencies to improve the quality and accuracy of data with respect to the birth and death records of ,american ,indians and ,alaska ,natives2 7iii7 enter into cooperative agreements with ,indian ,tribes1 ,tribal organizations1 ,urban ,indian organizations1 and epidemiology centers to address misclassification and undersampling of ,american ,indians and ,alaska ,natives with respect to-- 7,i7 birth and death records2 and 7,,ii7 health care and public health surveillance systems1 including1 but not limited to1 data with respect to chronic and infectious diseases1 unintentional injuries1 environmental health1 child and adolescent health1 maternal health and mortality1 foodborne and waterborne illness1 reproductive health1 and any other notifiable disease or condition2 7iv7 encourage ,states to enter into data sharing agreements with ,indian ,tribes1 ,tribal organizations1 and epidemiology centers to improve the quality and accuracy of public health data2 and 7v7 not later than #ahj days after the date of enactment of the ,commitment to ,defeat the ,virus and ,keep ,america ,healthy ,act1 and biennially thereafter1 issue a report on the following3 7,i7 ,which ,states have data sharing agreements with ,indian ,tribes1 ,tribal organizations1 ,urban ,indian organizations1 and ,tribal epidemiology centers to improve the quality and accuracy of health data4 7,,ii7 ,what the ,centers for ,disease ,control and ,prevention is doing to encourage ,states to enter into data sharing agreements with ,indian ,tribes1 ,tribal organizations1 ,urban ,indian organizations1 and ,tribal epidemiology centers to improve the quality and accuracy of health data4 7,,iii7 ,best practices and guidance for ,states1 ,indian ,tribes1 ,tribal organizations1 ,urban ,indian organizations1 and ,tribal epidemiology centers that wish to enter into data sharing agreements4 7,,iv7 ,best practices and guidance for local1 ,state1 ,tribal1 and ,federal uniform standards for the collection of data on race and ethnicity4 4 7g7 ,definitions ,section #cjf of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdbk7 is amended-- 7#a7 by redesignating subsection 7n7 as subsection 7o72 and 7#b7 by inserting after subsection 7m7 the following3 7n7 ,in this section3 7#a7 ,the term epidemiology center means an epidemiology center established under section #bad of the ,indian ,health ,care ,improvement ,act1 including such ,tribal epidemiology centers serving ,indian ,tribes regionally and any ,tribal epidemiology center serving ,urban ,indian organizations nationally4 7#b7 ,the term ,indian ,tribe has the meaning given to the term ,indian tribe in section #d of the ,indian ,self-,determination and ,education ,assistance ,act4 7#c7 ,the term ,tribal organization has the meaning given to the term tribal organization in section #d of the ,indian ,self-,determination and ,education ,assistance ,act4 7#d7 ,the term ,urban ,indian organization has the meaning given to that term in section #d of the ,indian ,health ,care ,improvement ,act4 4 7h7 ,authorization of appropriations ,section #cjf7o7 of the ,public ,health ,service ,act1 as redesignated by subsection 7g71 is amended to read as follows3 7o7 7#a7 ,to carry out this section1 there is authorized to be appropriated #ahe1jjj1jjj for each of the fiscal years #bjba through #bjbe4 7#b7 ,of the amount authorized to be appropriated to carry out this section for a fiscal year1 the ,secretary shall not use more than #aj percent for the combined costs of-- 7,a7 administration of this section2 and 7,b7 carrying out subsection 7m77#b74 4 ,b ,tribal ,medical ,supplies ,stockpile ,access #ejaa4 ,provision of items to ,indian programs and facilities 7a7 ,strategic national stockpile ,section #cai;,f-#b7;a77#c77;,g7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7a77#c77;,g77 is amended by inserting 1 and1 in the case that the ,secretary deploys the stockpile under this subparagraph1 ensure that appropriate drugs1 vaccines and other biological products1 medical devices1 and other supplies are deployed by the ,secretary directly to health programs or facilities operated by the ,indian ,health ,service1 an ,indian tribe1 a tribal organization 7as those terms are defined in section #d of the ,indian ,self-,determination and ,education ,assistance ,act 7#be ,u4,s4,c4 #ecjd771 or an inter-tribal consortium 7as defined in section #eja of the ,indian ,self-,determination and ,education ,assistance ,act 7#be ,u4,s4,c4 #echa77 or through an urban ,indian organization 7as defined in section #d of the ,indian ,health ,care ,improvement ,act71 while avoiding duplicative distributions to such programs or facilities before the semicolon4 7b7 ,distribution of qualified pandemic or epidemic products to ,,ihs facilities ,title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bda et seq471 as amended by section #cjae1 is further amended by inserting after section #cai;,f-#e the following3 #cai;,f-#f4 ,distribution of qualified pandemic or epidemic products to ,indian programs and facilities ,in the case that the ,secretary distributes qualified pandemic or epidemic products 7as defined in section #cai;,f-#c7;i77#g77 to ,states or other entities1 the ,secretary shall ensure that1 as appropriate1 such products are distributed directly to health programs or facilities operated by the ,indian ,health ,service1 an ,indian tribe1 a tribal organization 7as those terms are defined in section #d of the ,indian ,self-,determination and ,education ,assistance ,act 7#be ,u4,s4,c4 #ecjd771 or an inter-tribal consortium 7as defined in section #eja of the ,indian ,self-,determination and ,education ,assistance ,act 7#be ,u4,s4,c4 #echa77 or through an urban ,indian organization 7as defined in section #d of the ,indian ,health ,care ,improvement ,act71 while avoiding duplicative distributions to such programs or facilities4 4 ,c ,native ,american ,suicide ,prevention #ejba4 ,native ,american suicide prevention ,section #ebj;,e7b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;bb-#cf7;b77 is amended by inserting after paragraph 7#c7 the following3 7#d7 ,consultation ,a ,state applying for a grant or cooperative agreement under this section shall1 in the development and implementation of a statewide early intervention strategy1 consult or confer with entities described in paragraph 7#a77;,c7 in such ,state4 4 ,d ,pursuing ,equity in ,mental ,health #a ,health ,equity and ,accountability #ejca4 ,integrated ,health ,care ,demonstration ,program ,part ,d of title ,v of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;dd et seq47 is amended by adding at the end the following3 #eed4 ,interprofessional health care teams for provision of behavioral health care in primary care settings 7a7 ,grants ,the ,secretary shall award grants to eligible entities for the purpose of establishing interprofessional health care teams that provide behavioral health care4 7b7 ,eligible entities ,to be eligible to receive a grant under this section1 an entity shall be a federally qualified health center 7as defined in section #ahfa7;aa7 of the ,social ,security ,act71 rural health clinic1 or behavioral health program1 serving a high proportion of individuals from racial and ethnic minority groups 7as defined in section #agjg7;g774 7c7 ,scientifically based ,integrated health care funded through this section shall be scientifically based1 taking into consideration the results of the most recent peer-reviewed research available4 7d7 ,authorization of appropriations ,to carry out this section1 there is authorized to be appropriated #bj1jjj1jjj for each of the first #e fiscal years following the date of enactment of the ,commitment to ,defeat the ,virus and ,keep ,america ,healthy ,act4 4 #ejcb4 ,addressing racial and ethnic minority mental health disparities research gaps ,not later than #f months after the date of the enactment of this ,act1 the ,director of the ,national ,institutes of ,health shall enter into an arrangement with the ,national ,academies of ,sciences1 ,engineering1 and ,medicine 7or1 if the ,national ,academies of ,sciences1 ,engineering1 and ,medicine decline to enter into such an arrangement1 the ,patient-,centered ,outcomes ,research ,institute1 the ,agency for ,healthcare ,research and ,quality1 or another appropriate entity7-- 7#a7 to conduct a study with respect to mental health disparities in racial and ethnic minority groups 7as defined in section #agjg7;g7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjju-#f7;g7772 and 7#b7 to submit to the ,congress a report on the results of such study1 including-- 7,a7 a compilation of information on the dynamics of mental disorders in such racial and ethnic minority groups2 and 7,b7 a compilation of information on the impact of exposure to community violence1 adverse childhood experiences1 structural racism1 and other psychological traumas on mental disorders in such racial and minority groups4 #ejcc4 ,health professions competencies to address racial and ethnic minority mental health disparities 7a7 ,in general ,the ,secretary of ,health and ,human ,services shall award grants to qualified national organizations for the purposes of-- 7#a7 developing1 and disseminating to health professional educational programs best practices or core competencies addressing mental health disparities among racial and ethnic minority groups for use in the training of students in the professions of social work1 psychology1 psychiatry1 marriage and family therapy1 mental health counseling1 and substance misuse counseling2 and 7#b7 certifying community health workers and peer wellness specialists with respect to such best practices and core competencies and integrating and expanding the use of such workers and specialists into health care to address mental health disparities among racial and ethnic minority groups4 7b7 ,best practices2 core competencies ,organizations receiving funds under subsection 7a7 may use the funds to engage in the following activities related to the development and dissemination of best practices or core competencies described in subsection 7a77#a73 7#a7 ,formation of committees or working groups comprised of experts from accredited health professions schools to identify best practices and core competencies relating to mental health disparities among racial and ethnic minority groups4 7#b7 ,planning of workshops in national fora to allow for public input into the educational needs associated with mental health disparities among racial and ethnic minority groups4 7#c7 ,dissemination and promotion of the use of best practices or core competencies in undergraduate and graduate health professions training programs nationwide4 7#d7 ,establishing external stakeholder advisory boards to provide meaningful input into policy and program development and best practices to reduce mental health disparities among racial and ethnic minority groups4 7c7 ,definitions ,in this section3 7#a7 ,qualified national organization ,the term qualified national organization means a national organization that focuses on the education of students in one or more of the professions of social work1 psychology1 psychiatry1 marriage and family therapy1 mental health counseling1 and substance misuse counseling4 7#b7 ,racial and ethnic minority group ,the term racial and ethnic minority group has the meaning given to such term in section #agjg7;g7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjju-#f7;g774 #ejcd4 ,racial and ethnic minority behavioral and mental health outreach and education strategy ,part ,d of title ,v of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;dd et seq471 as amended by section #ejca1 is further amended by adding at the end the following new section3 #eee4 ,behavioral and mental health outreach and education strategy 7a7 ,in general ,the ,secretary shall1 in consultation with advocacy and behavioral and mental health organizations serving racial and ethnic minority groups1 develop and implement an outreach and education strategy to promote behavioral and mental health and reduce stigma associated with mental health conditions and substance abuse among racial and ethnic minority groups4 ,such strategy shall-- 7#a7 be designed to-- 7,a7 meet the diverse cultural and language needs of the various racial and ethnic minority groups2 and 7,b7 be developmentally and age-appropriate2 7#b7 increase awareness of symptoms of mental illnesses common among such groups1 taking into account differences within at-risk subgroups2 7#c7 provide information on evidence-based1 culturally and linguistically appropriate and adapted interventions and treatments2 7#d7 ensure full participation of1 and engage1 both consumers and community members in the development and implementation of materials2 and 7#e7 seek to broaden the perspective among both individuals in these groups and stakeholders serving these groups to use a comprehensive public health approach to promoting behavioral health that addresses a holistic view of health by focusing on the intersection between behavioral and physical health4 7b7 ,reports ,beginning not later than #a year after the date of the enactment of this section and annually thereafter1 the ,secretary shall submit to ,congress1 and make publicly available1 a report on the extent to which the strategy developed and implemented under subsection 7a7 increased behavioral and mental health outcomes associated with mental health conditions and substance abuse among racial and ethnic minority groups4 7c7 ,definition ,in this section1 the term racial and ethnic minority group has the meaning given to that term in section #agjg7;g74 7d7 ,authorization of appropriations ,there is authorized to be appropriated to carry out this section #aj1jjj1jjj for each of fiscal years #bjba through #bjbe4 4 #ejce4 ,additional funds for ,national ,institutes of ,health 7a7 ,in general ,in addition to amounts otherwise authorized to be appropriated to the ,national ,institutes of ,health1 there is authorized to be appropriated to such ,institutes #ajj1jjj1jjj for each of fiscal years #bjba through #bjbe to build relations with communities and conduct or support clinical research1 including clinical research on racial or ethnic disparities in physical and mental health4 7b7 ,definition ,in this section1 the term clinical research has the meaning given to such term in section #dji of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhd;d74 #ejcf4 ,additional funds for ,national ,institute on ,minority ,health and ,health ,disparities ,in addition to amounts otherwise authorized to be appropriated to the ,national ,institute on ,minority ,health and ,health ,disparities1 there is authorized to be appropriated to such ,institute #fej1jjj1jjj for each of fiscal years #bjba through #bjbe4 #b ,other provisions #ejcg4 ,reauthorization of ,minority ,fellowship ,program ,section #eig7;c7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bigll7c77 is amended by striking #ab1ffi1jjj for each of fiscal years #bjah through #bjbb and inserting #be1jjj1jjj for each of fiscal years #bjba through #bjbe4 #ejch4 ,study on the ,effects of ,smartphone and ,social ,media ,use on ,adolescents 7a7 ,in general ,not later than #a year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall conduct or support research on-- 7#a7 smartphone and social media use by adolescents2 and 7#b7 the effects of such use on-- 7,a7 emotional1 behavioral1 and physical health and development2 and 7,b7 disparities in minority and underserved populations4 7b7 ,report ,not later than #e years after the date of the enactment of this ,act1 the ,secretary shall submit to the ,congress1 and make publicly available1 a report on the findings of research described in this section4 #ejci4 ,technical correction ,title ,v of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;aa et seq47 is amended-- 7#a7 by redesignating the second section #eej of such ,act 7#db ,u4,s4,c4 #bij;ee-#aj7 7relating to ,sobriety ,treatment ,and ,recovery ,teams7 as section #eec2 and 7#b7 by moving such section #eec1 as so redesignated1 so as to appear after section #eeb of such ,act 7#db ,u4,s4,c4 #bij;ee-#g74 ,e ,maternal ,health ,quality ,improvement #ejda4 ,innovation for maternal health ,part ,d of title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bed;b et seq471 as amended by section #djga1 is further amended-- 7#a7 in the section designation of section #ccj,m of such ,act 7#db ,u4,s4,c4 #bed;c-#ai7 by inserting a period after #ccj,m2 and 7#b7 by inserting after section #ccj,n of such ,act1 as inserted by section #djga1 the following3 #ccj,o4 ,innovation for maternal health 7a7 ,in general ,the ,secretary1 in consultation with experts representing a variety of clinical specialties1 ,state1 ,tribal1 or local public health officials1 researchers1 epidemiologists1 statisticians1 and community organizations1 shall establish or continue a program to award competitive grants to eligible entities for the purposes of-- 7#a7 identifying1 developing1 or disseminating best practices to improve maternal health care quality and outcomes1 eliminate preventable maternal mortality and severe maternal morbidity1 and improve infant health outcomes1 which may include-- 7,a7 information on evidence-based practices to improve the quality and safety of maternal health care in hospitals and other health care settings of a ,state or health care system1 including by addressing topics commonly associated with health complications or risks related to prenatal care1 labor care1 birthing1 and postpartum care2 7,b7 best practices for improving maternal health care based on data findings and reviews conducted by a ,state maternal mortality review committee that address topics of relevance to common complications or health risks related to prenatal care1 labor care1 birthing1 and postpartum care2 and 7,c7 information on addressing determinants of health that impact maternal health outcomes for women before1 during1 and after pregnancy2 7#b7 collaborating with ,state maternal mortality review committees to identify issues for the development and implementation of evidence-based practices to improve maternal health outcomes and reduce preventable maternal mortality and severe maternal morbidity2 7#c7 providing technical assistance and supporting the implementation of best practices identified pursuant to paragraph 7#a7 to entities providing health care services to pregnant and postpartum women2 and 7#d7 identifying1 developing1 and evaluating new models of care that improve maternal and infant health outcomes1 which may include the integration of community-based services and clinical care4 7b7 ,eligible entities ,to be eligible for a grant under subsection 7a71 an entity shall-- 7#a7 submit to the ,secretary an application at such time1 in such manner1 and containing such information as the ,secretary may require2 and 7#b7 demonstrate in such application that the entity is capable of carrying out data-driven maternal safety and quality improvement initiatives in the areas of obstetrics and gynecology or maternal health4 7c7 ,authorization of appropriations ,to carry out this section1 there are authorized to be appropriated #e1jjj1jjj for each of fiscal years #bjba through #bjbe4 4 #ejdb4 ,training for health care providers ,title ,,vii of the ,public ,health ,service ,act is amended by striking section #gfc 7#db ,u4,s4,c4 #bidp7 and inserting the following3 #gfc4 ,training for health care providers 7a7 ,grant program ,the ,secretary shall establish a program to award grants to accredited schools of allopathic medicine1 osteopathic medicine1 and nursing1 and other health professional training programs for the training of health care professionals to reduce and prevent discrimination 7including training related to implicit and explicit biases7 in the provision of health care services related to prenatal care1 labor care1 birthing1 and postpartum care4 7b7 ,eligibility ,to be eligible for a grant under subsection 7a71 an entity described in such subsection shall submit to the ,secretary an application at such time1 in such manner1 and containing such information as the ,secretary may require4 7c7 ,reporting requirement ,each entity awarded a grant under this section shall periodically submit to the ,secretary a report on the status of activities conducted using the grant1 including a description of the impact of such training on patient outcomes1 as applicable4 7d7 ,best practices ,the ,secretary may identify and disseminate best practices for the training of health care professionals to reduce and prevent discrimination 7including training related to implicit and explicit biases7 in the provision of health care services related to prenatal care1 labor care1 birthing1 and postpartum care4 7e7 ,authorization of appropriations ,to carry out this section1 there are authorized to be appropriated #e1jjj1jjj for each of fiscal years #bjba through #bjbe4 4 #ejdc4 ,study on training to reduce and prevent discrimination ,not later than #b years after date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall1 through a contract with an independent research organization1 conduct a study and make recommendations for accredited schools of allopathic medicine1 osteopathic medicine1 and nursing1 and other health professional training programs1 on best practices related to training to reduce and prevent discrimination1 including training related to implicit and explicit biases1 in the provision of health care services related to prenatal care1 labor care1 birthing1 and postpartum care4 #ejdd4 ,perinatal quality collaboratives ,section #cag,k7a77#b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;b-#ab7;a77#b77 is amended by adding at the end the following3 7,e7 7i7 ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention and in coordination with other offices and agencies1 as appropriate1 shall establish or continue a competitive grant program for the establishment or support of perinatal quality collaboratives to improve perinatal care and perinatal health outcomes for pregnant and postpartum women and their infants4 ,a ,state1 ,indian ,tribe1 or ,tribal organization may use funds received through such grant to-- 7,i7 support the use of evidence-based or evidence-informed practices to improve outcomes for maternal and infant health2 7,,ii7 work with clinical teams2 experts2 ,state1 local1 and1 as appropriate1 ,tribal public health officials2 and stakeholders1 including patients and families1 to identify1 develop1 or disseminate best practices to improve perinatal care and outcomes2 and 7,,iii7 employ strategies that provide opportunities for health care professionals and clinical teams to collaborate across health care settings and disciplines1 including primary care and mental health1 as appropriate1 to improve maternal and infant health outcomes1 which may include the use of data to provide timely feedback across hospital and clinical teams to inform responses1 and to provide support and training to hospital and clinical teams for quality improvement1 as appropriate4 7ii7 ,to be eligible for a grant under clause 7i71 an entity shall submit to the ,secretary an application in such form and manner and containing such information as the ,secretary may require4 4 #ejde4 ,integrated services for pregnant and postpartum women 7a7 ,grants ,title ,,iii of the ,public ,health ,service ,act is amended by inserting after section #ccj,o of such ,act1 as added by section #ejda1 the following3 #ccj,p4 ,integrated services for pregnant and postpartum women 7a7 ,in general ,the ,secretary may award grants to ,states1 ,indian ,tribes1 and ,tribal organizations for the purpose of establishing or operating evidence-based or innovative1 evidence-informed programs to deliver integrated health care services to pregnant and postpartum women to optimize the health of women and their infants1 including to reduce adverse maternal health outcomes1 pregnancy-related deaths1 and related health disparities 7including such disparities associated with racial and ethnic minority populations71 and1 as appropriate1 by addressing issues researched under subsection 7b77#b7 of section #cag,k4 7b7 ,integrated services for pregnant and postpartum women 7#a7 ,eligibility ,to be eligible to receive a grant under subsection 7a71 a ,state1 ,indian ,tribe1 or ,tribal organization shall work with relevant stakeholders that coordinate care 7including coordinating resources and referrals for health care and social services7 to develop and carry out the program1 including-- 7,a7 ,state1 ,tribal1 and local agencies responsible for ,medicaid1 public health1 social services1 mental health1 and substance use disorder treatment and services2 7,b7 health care providers who serve pregnant and postpartum women2 and 7,c7 community-based health organizations and health workers1 including providers of home visiting services and individuals representing communities with disproportionately high rates of maternal mortality and severe maternal morbidity1 and including individuals representing racial and ethnic minority populations4 7#b7 ,terms 7,a7 ,period ,a grant awarded under subsection 7a7 shall be made for a period of #e years4 ,any supplemental award made to a grantee under subsection 7a7 may be made for a period of less than #e years4 7,b7 ,preference ,in awarding grants under subsection 7a71 the ,secretary shall-- 7i7 give preference to ,states1 ,indian ,tribes1 and ,tribal organizations that have the highest rates of maternal mortality and severe maternal morbidity relative to other such ,states1 ,indian ,tribes1 or ,tribal organizations1 respectively2 and 7ii7 shall consider health disparities related to maternal mortality and severe maternal morbidity1 including such disparities associated with racial and ethnic minority populations4 7,c7 ,priority ,in awarding grants under subsection 7a71 the ,secretary shall give priority to applications from up to #ae entities described in subparagraph 7,b77i74 7,d7 ,evaluation ,the ,secretary shall require grantees to evaluate the outcomes of the programs supported under the grant4 7c7 ,definitions ,in this section1 the terms ,indian ,tribe and ,tribal organization have the meanings given the terms ,indian tribe and tribal organization1 respectively1 in section #d of the ,indian ,self-,determination and ,education ,assistance ,act4 7d7 ,authorization of appropriations ,there are authorized to be appropriated to carry out this section #aj1jjj1jjj for each of fiscal years #bjba through #bjbe4 4 7b7 ,report on grant outcomes and dissemination of best practices 7#a7 ,report ,not later than ,february #a1 #bjbf1 the ,secretary of ,health and ,human ,services shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report that describes-- 7,a7 the outcomes of the activities supported by the grants awarded under the amendment made by this section on maternal and child health2 7,b7 best practices and models of care used by recipients of grants under such amendment2 and 7,c7 obstacles identified by recipients of grants under such amendment1 and strategies used by such recipients to deliver care1 improve maternal and child health1 and reduce health disparities4 7#b7 ,dissemination of best practices ,not later than ,august #a1 #bjbf1 the ,secretary of ,health and ,human ,services shall disseminate information on best practices and models of care used by recipients of grants under the amendment made by this section 7including best practices and models of care relating to the reduction of health disparities1 including such disparities associated with racial and ethnic minority populations1 in rates of maternal mortality and severe maternal morbidity7 to relevant stakeholders1 which may include health providers1 medical schools1 nursing schools1 relevant ,state1 ,tribal1 and local agencies1 and the general public4 #ejdf4 ,improving rural maternal and obstetric care data 7a7 ,maternal mortality and morbidity activities ,section #cja7;e7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bda7;e77 is amended by inserting 1 preventable maternal mortality and severe maternal morbidity1 after delivery4 7b7 ,office of women's health ,section #caj;,a7b77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdbs7b77#a77 is amended by striking and sociocultural contexts1 and inserting sociocultural 7including among ,american ,indians1 ,native ,hawaiians1 and ,alaska ,natives71 and geographical contexts4 7c7 ,safe motherhood ,section #cag,k of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;b-#ab7 is amended-- 7#a7 in subsection 7a77#b77;,a71 by inserting 1 including improving collection of data on race1 ethnicity1 and other demographic information before the period2 and 7#b7 in subsection 7b77#b7-- 7,a7 in subparagraph 7,l71 by striking and at the end2 7,b7 by redesignating subparagraph 7,m7 as subparagraph 7,n72 and 7,c7 by inserting after subparagraph 7,l7 the following3 7,m7 an examination of the relationship between maternal health and obstetric services in rural areas and outcomes in delivery and postpartum care2 and 4 7d7 ,office of research on women's health ,section #dhf of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhg;d7 is amended-- 7#a7 in subsection 7b71 by amending paragraph 7#c7 to read as follows3 7#c7 carry out paragraphs 7#a7 and 7#b7 with respect to-- 7,a7 the aging process in women1 with priority given to menopause2 and 7,b7 pregnancy1 with priority given to deaths related to preventable maternal mortality and severe maternal morbidity2 2 and 7#b7 in subsection 7d77#d77;,a77iv71 by inserting 1 including preventable maternal morbidity and severe maternal morbidity before the semicolon4 #ejdg4 ,rural obstetric network grants ,the ,public ,health ,service ,act is amended by inserting after section #ccj;,a-#a 7#db ,u4,s4,c4 #bed;c-#a;a7 the following3 #ccj;,a-#b4 ,rural obstetric network grants 7a7 ,program established ,the ,secretary shall award grants or cooperative agreements to eligible entities to establish collaborative improvement and innovation networks 7referred to in this section as rural obstetric networks7 to improve maternal and infant health outcomes and reduce preventable maternal mortality and severe maternal morbidity by improving maternity care and access to care in rural areas1 frontier areas1 maternity care health professional target areas1 or jurisdictions of ,indian ,tribes and ,tribal organizations4 7b7 ,use of funds ,grants or cooperative agreements awarded pursuant to this section shall be used for the establishment or continuation of collaborative improvement and innovation networks to improve maternal health in rural areas by improving infant health and maternal outcomes and reducing preventable maternal mortality and severe maternal morbidity4 ,rural obstetric networks established in accordance with this section may-- 7#a7 develop a network to improve coordination and increase access to maternal health care and assist pregnant women in the areas described in subsection 7a7 with accessing and utilizing maternal and obstetric care1 including health care services related to prenatal care1 labor care1 birthing1 and postpartum care to improve outcomes in birth and maternal mortality and morbidity2 7#b7 identify and implement evidence-based and sustainable delivery models for maternal and obstetric care 7including health care services related to prenatal care1 labor care1 birthing1 and postpartum care for women in the areas described in subsection 7a771 including home visiting programs and culturally appropriate care models that reduce health disparities2 7#c7 develop a model for maternal health care collaboration between health care settings to improve access to care in areas described in subsection 7a71 which may include the use of telehealth2 7#d7 provide training for professionals in health care settings that do not have specialty maternity care2 7#e7 collaborate with academic institutions that can provide regional expertise and help identify barriers to providing maternal health care1 including strategies for addressing such barriers2 and 7#f7 assess and address disparities in infant and maternal health outcomes1 including among racial and ethnic minority populations and underserved populations in areas described in subsection 7a74 7c7 ,definitions ,in this section3 7#a7 ,eligible entities ,the term eligible entities means entities providing maternal health care services in rural areas1 frontier areas1 or medically underserved areas1 or to medically underserved populations or ,indian ,tribes or ,tribal organizations4 7#b7 ,frontier area ,the term frontier area means a frontier county1 as defined in section #ahhf7;d77#c77;,e77iii77,,iii7 of the ,social ,security ,act4 7#c7 ,indian ,tribes2 ,tribal organization ,the terms ,indian ,tribe and ,tribal organization have the meanings given the terms ,indian tribe and tribal organization1 respectively1 in section #d of the ,indian ,self-,determination and ,education ,assistance ,act4 7#d7 ,maternity care health professional target area ,the term maternity care health professional target area has the meaning described in section #ccb7k77#b74 7d7 ,authorization of appropriations ,there are authorized to be appropriated to carry out this section #c1jjj1jjj for each of fiscal years #bjba through #bjbe4 4 #ejdh4 ,telehealth network and telehealth resource centers grant programs ,section #ccj;,i of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bed;c-#ad7 is amended-- 7#a7 in subsection 7f77#c71 by adding at the end the following3 7,m7 ,providers of maternal care1 including prenatal1 labor care1 birthing1 and postpartum care services and entities operating obstetric care units4 2 and 7#b7 in subsection 7h77#a77;,b71 by inserting labor care1 birthing care1 postpartum care1 before or prenatal4 #ejdi4 ,rural maternal and obstetric care training demonstration ,subpart #a of part ,e of title ,,vii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bidn et seq47 is amended by adding at the end the following3 #gfd4 ,rural maternal and obstetric care training demonstration 7a7 ,in general ,the ,secretary shall award grants to accredited schools of allopathic medicine1 osteopathic medicine1 and nursing1 and other appropriate health professional training programs1 to establish a training demonstration program to support-- 7#a7 training for physicians1 medical residents1 fellows1 nurse practitioners1 physician assistants1 nurses1 certified nurse midwives1 relevant home visiting workforce professionals and paraprofessionals1 or other professionals who meet relevant ,state training and licensing requirements1 as applicable1 to provide maternal health care services in rural community-based settings2 and 7#b7 developing recommendations for such training programs4 7b7 ,application ,to be eligible to receive a grant under subsection 7a71 an entity shall submit to the ,secretary an application at such time1 in such manner1 and containing such information as the ,secretary may require4 7c7 ,activities 7#a7 ,training for health care professionals ,a recipient of a grant under subsection 7a7-- 7,a7 shall use the grant funds to plan1 develop1 and operate a training program to provide maternal health care in rural areas2 and 7,b7 may use the grant funds to provide additional support for the administration of the program or to meet the costs of projects to establish1 maintain1 or improve faculty development1 or departments1 divisions1 or other units necessary to implement such training4 7#b7 ,training program requirements ,the recipient of a grant under subsection 7a7 shall ensure that training programs carried out under the grant are evidence-based and address improving maternal health care in rural areas1 and such programs may include training on topics such as-- 7,a7 maternal mental health1 including perinatal depression and anxiety2 7,b7 substance use disorders2 7,c7 social determinants of health that affect individuals living in rural areas2 and 7,d7 implicit and explicit bias4 7d7 ,evaluation and report 7#a7 ,evaluation 7,a7 ,in general ,the ,secretary shall evaluate the outcomes of the demonstration program under this section4 7,b7 ,data submission ,recipients of a grant under subsection 7a7 shall submit to the ,secretary performance metrics and other related data in order to evaluate the program for the report described in paragraph 7#b74 7#b7 ,report to ,congress ,not later than ,january #a1 #bjbe1 the ,secretary shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report that includes-- 7,a7 an analysis of the effects of the demonstration program under this section on the quality1 quantity1 and distribution of maternal health care services1 including health care services related to prenatal care1 labor care1 birthing1 and postpartum care1 and the demographics of the recipients of those services2 7,b7 an analysis of maternal and infant health outcomes 7including quality of care1 morbidity1 and mortality7 before and after implementation of the program in the communities served by entities participating in the demonstration program2 and 7,c7 recommendations on whether the demonstration program should be continued4 7e7 ,authorization of appropriations ,there are authorized to be appropriated to carry out this section #e1jjj1jjj for each of fiscal years #bjba through #bjbe4 4 ,,vi ,addressing the ,impacts of ,,covid-#ai on ,mental ,health ,a ,creating ,resources ,to ,improve ,situations of ,inherent ,severity #fjja4 ,set-aside for evidence-based crisis care services ,section #aibj of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjjx-#i7 is amended-- 7#a7 in subsection 7a71 by striking #ecb1ega1jjj for each of fiscal years #bjah through #bjbb and inserting #ecb1ega1jjj for each of fiscal years #bjah through #bjbj1 and #geh1jjj1jjj for each of fiscal years #bjba through #bjbb2 and 7#b7 by adding at the end the following3 7d7 ,crisis care 7#a7 ,in general ,except as provided in paragraph 7#c71 a ,state shall expend at least #e percent of the amount the ,state receives pursuant to section #aiaa for each fiscal year to support evidenced-based programs that address the crisis care needs of individuals with serious mental disorders1 and children with serious mental and emotional disturbances4 7#b7 ,core elements ,at the discretion of the single ,state agency responsible for the administration of the program of the ,state under a grant under section #aiaa1 funds expended pursuant to paragraph 7#a7 may be used to fund some or all of the core crisis care service components1 delivered according to evidence-based principles1 including the following3 7,a7 ,crisis call centers4 7,b7 #bd_/g mobile crisis services4 7,c7 ,crisis stabilization programs offering acute care or subacute care in a hospital or appropriately licensed facility1 as determined by the ,substance ,abuse and ,mental ,health ,services ,administration1 with referrals to inpatient or outpatient care4 7#c7 ,state flexibility ,in lieu of expending #e percent of the amount the ,state receives pursuant to section #aiaa for a fiscal year to support evidence-based programs as required by paragraph 7#a71 a ,state may elect to expend not less than #aj percent of such amount to support such programs by the end of two consecutive fiscal years4 4 ,b ,emergency ,mental ,health and ,substance ,use ,training and ,technical ,assistance ,center #fjaa4 ,emergency mental health and substance use training and technical assistance center ,subpart #c of part ,b of title ,v of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;bb-#ca et seq47 is amended by inserting after section #ebj;,a 7#db ,u4,s4,c4 #bij;bb-#cb7 the following3 #ebj;,b4 ,emergency mental health and substance use training and technical assistance center 7a7 ,establishment ,the ,secretary1 acting through the ,assistant ,secretary1 shall establish or operate a center to be known as the ,emergency ,mental ,health and ,substance ,use ,training and ,technical ,assistance ,center 7referred to in this section as the ,center7 to provide technical assistance and support-- 7#a7 to public or nonprofit entities seeking to establish or expand access to mental health and substance use prevention1 treatment1 and recovery support services1 and increase awareness of such services2 and 7#b7 to public health professionals1 health care professionals and support staff1 essential workers 7as defined by a ,state1 ,tribe1 locality1 or territory71 and members of the public to address the trauma1 stress1 and mental health needs associated with an emergency period4 7b7 ,assistance and support ,the assistance and support provided under subsection 7a7 shall include assistance and support with respect to-- 7#a7 training on identifying signs of trauma1 stress1 and mental health needs2 7#b7 providing accessible resources to assist individuals and families experiencing trauma1 stress1 or other mental health needs during and after an emergency period2 7#c7 providing resources for substance use disorder prevention1 treatment1 and recovery designed to assist individuals and families during and after an emergency period2 7#d7 the provision of language access services1 including translation services1 interpretation1 or other such services for individuals with limited ,english speaking proficiency or individuals with disabilities2 and 7#e7 evaluation and improvement1 as necessary1 of the effectiveness of such services provided by public or nonprofit entities4 7c7 ,best practices ,the ,center shall periodically issue best practices for use by organizations seeking to provide mental health services or substance use disorder prevention1 treatment1 or recovery services1 including best practices for the following special populations3 7#a7 ,incarcerated individuals4 7#b7 ,children4 7#c7 ,pregnant women4 7#d7 ,underserved populations4 7#e7 ,communities of color4 7#f7 ,health care providers and essential workers4 7d7 ,emergency period ,in this section1 the term emergency period has the meaning given such term in section #aace7;g77#a77;,a7 of the ,social ,security ,act4 7e7 ,authorization of appropriations ,there is authorized to be appropriated to carry out this section #bj1jjj1jjj for each of fiscal years #bjba and #bjbb4 4 ,c ,suicide ,prevention ,grants #fjba4 ,syndromic surveillance of self-harm behaviors program ,title ,,iii of the ,public ,health ,service ,act is amended by inserting after section #cag,u of such ,act 7#db ,u4,s4,c4 #bdg;b-#bc7 the following3 #cag,v4 ,syndromic surveillance of self-harm behaviors program 7a7 ,in general ,the ,secretary shall award grants to ,state1 local1 ,tribal1 and territorial public health departments for the expansion of surveillance of self-harm4 7b7 ,data sharing by grantees ,as a condition of receipt of such grant under subsection 7a71 each grantee shall agree to share with the ,centers for ,disease ,control and ,prevention in real time1 to the extent feasible and as specified in the grant agreement1 data on suicides and self-harm for purposes of-- 7#a7 tracking and monitoring self-harm to inform response activities to suicide clusters2 7#b7 informing prevention programming for identified at-risk populations2 and 7#c7 conducting or supporting research4 7c7 ,disaggregation of data ,the ,secretary shall provide for the data collected through surveillance of self-harm under subsection 7b7 to be disaggregated by the following categories3 7#a7 ,nonfatal self-harm data of any intent4 7#b7 ,data on suicidal ideation4 7#c7 ,data on self-harm where there is no evidence1 whether implicit or explicit1 of suicidal intent4 7#d7 ,data on self-harm where there is evidence1 whether implicit or explicit1 of suicidal intent4 7#e7 ,data on self-harm where suicidal intent is unclear based on the available evidence4 7d7 ,priority ,in making awards under subsection 7a71 the ,secretary shall give priority to eligible entities that are-- 7#a7 located in a ,state with an age-adjusted rate of nonfatal suicidal behavior that is above the national rate of nonfatal suicidal behavior1 as determined by the ,director of the ,centers for ,disease ,control and ,prevention2 7#b7 serving an ,indian ,tribe 7as defined in section #d of the ,indian ,self-,determination and ,education ,assistance ,act7 with an age-adjusted rate of nonfatal suicidal behavior that is above the national rate of nonfatal suicidal behavior1 as determined through appropriate mechanisms determined by the ,secretary in consultation with ,indian ,tribes2 or 7#c7 located in a ,state with a high rate of coverage of statewide 7or ,tribal7 emergency department visits1 as determined by the ,director of the ,centers for ,disease ,control and ,prevention4 7e7 ,geographic distribution ,in making grants under this section1 the ,secretary shall make an effort to ensure geographic distribution1 taking into account the unique needs of rural communities1 including-- 7#a7 communities with an incidence of individuals with serious mental illness1 demonstrated suicidal ideation or behavior1 or suicide rates that are above the national average1 as determined by the ,assistant ,secretary for ,mental ,health and ,substance ,use2 7#b7 communities with a shortage of prevention and treatment services1 as determined by the ,assistant ,secretary for ,mental ,health and ,substance ,use and the ,administrator of the ,health ,resources and ,services ,administration2 and 7#c7 other appropriate community-level factors and social determinants of health such as income1 employment1 and education4 7f7 ,period of participation ,to be selected as a grant recipient under this section1 a ,state1 local1 ,tribal1 or territorial public health department shall agree to participate in the program for a period of not less than #d years4 7g7 ,technical assistance ,the ,secretary shall provide technical assistance and training to grantees for collecting and sharing the data under subsection 7b74 7h7 ,data sharing by ,,hhs ,subject to subsection 7b71 the ,secretary shall1 with respect to data on self-harm that is collected pursuant to this section1 share and integrate such data through-- 7#a7 the ,national ,syndromic ,surveillance ,program's ,early ,notification of ,community ,epidemics 7,,essence7 platform 7or any successor platform72 7#b7 the ,national ,violent ,death ,reporting ,system1 as appropriate2 or 7#c7 another appropriate surveillance program1 including such a program that collects data on suicides and self-harm among special populations1 such as members of the military and veterans4 7i7 ,rule of construction regarding applicability of privacy protections ,nothing in this section shall be construed to limit or alter the application of ,federal or ,state law relating to the privacy of information to data or information that is collected or created under this section4 7j7 ,report 7#a7 ,submission ,not later than #c years after the date of enactment of this ,act1 the ,secretary shall evaluate the suicide and self-harm syndromic surveillance systems at the ,federal1 ,state1 and local levels and submit a report to ,congress on the data collected under subsections 7b7 and 7c7 in a manner that prevents the disclosure of individually identifiable information1 at a minimum1 consistent with all applicable privacy laws and regulations4 7#b7 ,contents ,in addition to the data collected under subsections 7b7 and 7c71 the report under paragraph 7#a7 shall include-- 7,a7 challenges and gaps in data collection and reporting2 7,b7 recommendations to address such gaps and challenges2 and 7,c7 a description of any public health responses initiated at the ,federal1 ,state1 or local level in response to the data collected4 7k7 ,authorization of appropriations ,to carry out this section1 there are authorized to be appropriated #bj1jjj1jjj for each of fiscal years #bjba through #bjbe4 4 #fjbb4 ,grants to provide self-harm and suicide prevention services ,part ,b of title ,v of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;aa et seq47 is amended by adding at the end the following3 #ebj,n4 ,grants to provide self-harm and suicide prevention services 7a7 ,in general ,the ,secretary of ,health and ,human ,services shall award grants to hospital emergency departments to provide self-harm and suicide prevention services4 7b7 ,activities supported 7#a7 ,in general ,a hospital emergency department awarded a grant under subsection 7a7 shall use amounts under the grant to implement a program or protocol to better prevent suicide attempts among hospital patients after discharge1 which may include-- 7,a7 screening patients for self-harm and suicide in accordance with the standards of practice described in subsection 7e77#a7 and standards of care established by appropriate medical and advocacy organizations2 7,b7 providing patients short-term self-harm and suicide prevention services in accordance with the results of the screenings described in subparagraph 7,a72 and 7,c7 referring patients1 as appropriate1 to a health care facility or provider for purposes of receiving long-term self-harm and suicide prevention services1 and providing any additional follow up services and care identified as appropriate as a result of the screenings and short-term self-harm and suicide prevention services described in subparagraphs 7,a7 and 7,b74 7#b7 ,use of funds to hire and train staff ,amounts awarded under subsection 7a7 may be used to hire clinical social workers1 mental and behavioral health care professionals1 and support staff as appropriate1 and to train existing staff and newly hired staff to carry out the activities described in paragraph 7#a74 7c7 ,grant terms ,a grant awarded under subsection 7a7-- 7#a7 shall be for a period of #c years2 and 7#b7 may be renewed subject to the requirements of this section4 7d7 ,applications ,a hospital emergency department seeking a grant under subsection 7a7 shall submit an application to the ,secretary at such time1 in such manner1 and accompanied by such information as the ,secretary may require4 7e7 ,standards of ,practice 7#a7 ,in general ,not later than #ahj days after the date of the enactment of this section1 the ,secretary shall develop standards of practice for screening patients for self-harm and suicide for purposes of carrying out subsection 7b77#a77;,c74 7#b7 ,consultation ,the ,secretary shall develop the standards of practice described in paragraph 7#a7 in consultation with individuals and entities with expertise in self-harm and suicide prevention1 including public1 private1 and non-profit entities4 7f7 ,reporting 7#a7 ,reports to the ,secretary 7,a7 ,in general ,a hospital emergency department awarded a grant under subsection 7a7 shall1 at least quarterly for the duration of the grant1 submit to the ,secretary a report evaluating the activities supported by the grant4 7,b7 ,matters to be included ,the report required under subparagraph 7,a7 shall include-- 7i7 the number of patients receiving-- 7,i7 screenings carried out at the hospital emergency department2 7,,ii7 short-term self-harm and suicide prevention services at the hospital emergency department2 and 7,,iii7 referrals to health care facilities for the purposes of receiving long-term self-harm and suicide prevention2 7ii7 information on the adherence of the hospital emergency department to the standards of practice described in subsection 7f77#a72 and 7iii7 other information as the ,secretary determines appropriate to evaluate the use of grant funds4 7#b7 ,reports to ,congress ,not later than #b years after the date of the enactment of the ,commitment to ,defeat the ,virus and ,keep ,america ,healthy ,act1 and biennially thereafter1 the ,secretary shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report on the grant program under this section1 including-- 7,a7 a summary of reports received by the ,secretary under paragraph 7#a72 and 7,b7 an evaluation of the program by the ,secretary4 7g7 ,authorization of appropriations ,to carry out this section1 there are authorized to be appropriated #cj1jjj1jjj for each of fiscal years #bjba through #bjbe4 4 ,d ,effective ,suicide ,screening in the ,emergency ,department #fjca4 ,program to improve the care provided to patients in the emergency department who are at risk of suicide ,part ,p of title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhj;g et seq47 is amended by adding at the end the following new section3 #cii,v-#g4 ,program to improve the care provided to patients in the emergency department who are at risk of suicide 7a7 ,in general ,the ,secretary shall establish a program 7in this section referred to as the ,program7 to improve the identification1 assessment1 and treatment of patients in emergency departments who are at risk for suicide1 including by-- 7#a7 developing policies and procedures for identifying and assessing individuals who are at risk of suicide2 and 7#b7 enhancing the coordination of care for such individuals after discharge4 7b7 ,grant establishment and participation 7#a7 ,in general ,in carrying out the ,program1 the ,secretary shall award grants on a competitive basis to not more than #dj eligible health care sites described in paragraph 7#b74 7#b7 ,eligibility ,to be eligible for a grant under this section1 a health care site shall-- 7,a7 submit an application to the ,secretary at such time1 in such manner1 and containing such information as the ,secretary may specify2 7,b7 be a hospital 7as defined in section #ahfa7;e7 of the ,social ,security ,act72 7,c7 have an emergency department2 and 7,d7 deploy onsite health care or social service professionals to help connect and integrate patients who are at risk of suicide with treatment and mental health support services4 7#c7 ,preference ,in awarding grants under this section1 the ,secretary may give preference to eligible health care sites described in paragraph 7#b7 that meet at least one of the following criteria3 7,a7 ,the eligible health care site is a critical access hospital 7as defined in section #ahfa7mm77#a7 of the ,social ,security ,act74 7,b7 ,the eligible health care site is a sole community hospital 7as defined in section #ahhf7;d77#e77;,d77iii7 of the ,social ,security ,act74 7,c7 ,the eligible health care site is operated by the ,indian ,health ,service1 by an ,indian tribe or tribal organization 7as such terms are defined in section #d of the ,indian ,self-,determination and ,education ,assistance ,act71 or by an urban ,indian organization 7as defined in section #d of the ,indian ,health ,care ,improvement ,act74 7,d7 ,the eligible health care site is located in a geographic area with a suicide rate that is higher than the national rate1 as determined by the ,secretary based on the most recent data from the ,centers for ,disease ,control and ,prevention4 7c7 ,period of grant ,a grant awarded to an eligible health care site under this section shall be for a period of at least #b years4 7d7 ,grant uses 7#a7 ,required uses ,a grant awarded under this section to an eligible health care site shall be used for the following purposes3 7,a7 ,to train emergency department health care professionals to identify1 assess1 and treat patients who are at risk of suicide4 7,b7 ,to establish and implement policies and procedures for emergency departments to improve the identification1 assessment and treatment of individuals who are at risk of suicide4 7,c7 ,to establish and implement policies and procedures with respect to care coordination1 integrated care models1 or referral to evidence-based treatment to be used upon the discharge from the emergency department of patients who are at risk of suicide4 7#b7 ,additional permissible uses ,in addition to the required uses listed in paragraph 7#a71 a grant awarded under this section to an eligible health care site may be used for any of the following purposes3 7,a7 ,to hire emergency department psychiatrists1 psychologists1 nurse practitioners1 counselors1 therapists1 or other licensed health care and behavioral health professionals specializing in the treatment of individuals at risk of suicide4 7,b7 ,to develop and implement best practices for the follow-up care and long-term treatment of individuals who are at risk of suicide4 7,c7 ,to increase the availability of and access to evidence-based treatment for individuals who are at risk of suicide1 including through telehealth services and strategies to reduce the boarding of these patients in emergency departments4 7,d7 ,to offer consultation with and referral to other supportive services that provide evidence-based treatment and recovery for individuals who are at risk of suicide4 7e7 ,reporting requirements 7#a7 ,reports by grantees ,each eligible health care site receiving a grant under this section shall submit to the ,secretary an annual report for each year for which the grant is received on the progress of the program funded through the grant4 ,each such report shall include information on-- 7,a7 the number of individuals screened in the site's emergency department for being at risk of suicide2 7,b7 the number of individuals identified in the site's emergency department as being-- 7i7 survivors of an attempted suicide2 or 7ii7 are at risk of suicide2 7,c7 the number of individuals who are identified in the site's emergency department as being at risk of suicide by a health care or behavioral health professional hired pursuant to subsection 7d77#b77;,a72 7,d7 the number of individuals referred by the site's emergency department to other treatment facilities1 the types of such other facilities1 and the number of such individuals admitted to such other facilities pursuant to such referrals2 7,e7 the effectiveness of programs and activities funded through the grant in preventing suicides and suicide attempts2 and 7,f7 any other relevant additional data regarding the programs and activities funded through the grant4 7#b7 ,report by ,secretary ,not later than one year after the end of fiscal year #bjbe1 the ,secretary shall submit to ,congress a report that includes-- 7,a7 findings on the ,program2 7,b7 overall patient outcomes achieved through the ,program2 7,c7 an evaluation of the effectiveness of having a trained health care or behavioral health professional onsite to identify1 assess1 and treat patients who are at risk of suicide2 and 7,d7 a compilation of policies1 procedures1 and best practices established1 developed1 or implemented by grantees under this section4 7f7 ,authorization of appropriations ,there is authorized to be appropriated to carry out this section #bj1jjj1jjj for the period of fiscal years #bjba through #bjbe4 4 ,e ,suicide ,prevention ,lifeline ,improvement #fjda4 ,suicide ,prevention ,lifeline 7a7 ,plan ,section #ebj;,e-#c of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;bb-#cf;c7 is amended-- 7#a7 by redesignating subsection 7c7 as subsection 7e72 and 7#b7 by inserting after subsection 7b7 the following3 7c7 ,plan 7#a7 ,in general ,for purposes of maintaining the suicide prevention hotline under subsection 7b77#b71 the ,secretary shall develop and implement a plan to ensure the provision of high-quality service4 7#b7 ,contents ,the plan required by paragraph 7#a7 shall include the following3 7,a7 ,quality assurance provisions1 including-- 7i7 clearly defined and measurable performance indicators and objectives to improve the responsiveness and performance of the hotline1 including at backup call centers2 and 7ii7 quantifiable timeframes to track the progress of the hotline in meeting such performance indicators and objectives4 7,b7 ,standards that crisis centers and backup centers must meet-- 7i7 to participate in the network under subsection 7b77#a72 and 7ii7 to ensure that each telephone call1 online chat message1 and other communication received by the hotline1 including at backup call centers1 is answered in a timely manner by a person1 consistent with the guidance established by the ,american ,association of ,suicidology or other guidance determined by the ,secretary to be appropriate4 7,c7 ,guidelines for crisis centers and backup centers to implement evidence-based practices including with respect to followup and referral to other health and social services resources4 7,d7 ,guidelines to ensure that resources are available and distributed to individuals using the hotline who are not personally in a time of crisis but know of someone who is4 7,e7 ,guidelines to carry out periodic testing of the hotline1 including at crisis centers and backup centers1 during each fiscal year to identify and correct any problems in a timely manner4 7,f7 ,guidelines to operate in consultation with the ,state department of health1 local governments1 ,indian tribes1 and tribal organizations4 7#c7 ,initial plan2 updates ,the ,secretary shall-- 7,a7 not later than #f months after the date of enactment of the ,commitment to ,defeat the ,virus and ,keep ,america ,healthy ,act1 complete development of the initial version of the plan required by paragraph 7#a71 begin implementation of such plan1 and make such plan publicly available2 and 7,b7 periodically thereafter1 update such plan and make the updated plan publicly available4 4 7b7 ,transmission of data to ,,cdc ,section #ebj;,e-#c of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;bb-#cf;c7 is amended by inserting after subsection 7c7 of such section1 as added by subsection 7a7 of this section1 the following3 7d7 ,transmission of data to ,,cdc ,the ,secretary shall formalize and strengthen agreements between the ,national ,suicide ,prevention ,lifeline program and the ,centers for ,disease ,control and ,prevention to transmit any necessary epidemiological data from the program to the ,centers1 including local call center data1 to assist the ,centers in suicide prevention efforts4 4 7c7 ,authorization of appropriations ,subsection 7e7 of section #ebj;,e-#c of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;bb-#cf;c7 is amended to read as follows3 7e7 ,authorization of appropriations 7#a7 ,in general ,to carry out this section1 there are authorized to be appropriated #ej1jjj1jjj for each of fiscal years #bjba through #bjbc4 7#b7 ,allocation ,of the amount authorized to be appropriated by paragraph 7#a7 for each of fiscal years #bjba through #bjbc1 at least #hj percent shall be made available to crisis centers4 4 #fjdb4 ,pilot program on innovative technologies 7a7 ,pilot program 7#a7 ,in general ,the ,secretary of ,health and ,human ,services1 acting through the ,assistant ,secretary for ,mental ,health and ,substance ,use1 shall carry out a pilot program to research1 analyze1 and employ various technologies and platforms of communication 7including social media platforms1 texting platforms1 and email platforms7 for suicide prevention in addition to the telephone and online chat service provided by the ,suicide ,prevention ,lifeline4 7#b7 ,authorization of appropriations ,to carry out paragraph 7#a71 there is authorized to be appropriated #e1jjj1jjj for the period of fiscal years #bjba and #bjbb4 7b7 ,report ,not later than #bd months after the date on which the pilot program under subsection 7a7 commences1 the ,secretary of ,health and ,human ,services1 acting through the ,assistant ,secretary for ,mental ,health and ,substance ,use1 shall submit to the ,congress a report on the pilot program4 ,with respect to each platform of communication employed pursuant to the pilot program1 the report shall include-- 7#a7 a full description of the program2 7#b7 the number of individuals served by the program2 7#c7 the average wait time for each individual to receive a response2 7#d7 the cost of the program1 including the cost per individual served2 and 7#e7 any other information the ,secretary determines appropriate4 #fjdc4 ,,hhs study and report ,not later than #bd months after the ,secretary of ,health and ,human ,services begins implementation of the plan required by section #ebj;,e-#c7;c7 of the ,public ,health ,service ,act1 as added by section #fjda7;a77#b7 of this subtitle1 the ,secretary shall-- 7#a7 complete a study on-- 7,a7 the implementation of such plan1 including the progress towards meeting the objectives identified pursuant to paragraph 7#b77;,a77i7 of such section #ebj;,e-#c7;c7 by the timeframes identified pursuant to paragraph 7#b77;,a77ii7 of such section #ebj;,e-#c7;c72 and 7,b7 in consultation with the ,director of the ,centers for ,disease ,control and ,prevention1 options to expand data gathering from calls to the ,suicide ,prevention ,lifeline in order to better track aspects of usage such as repeat calls1 consistent with applicable ,federal and ,state privacy laws2 and 7#b7 submit a report to the ,congress on the results of such study1 including recommendations on whether additional legislation or appropriations are needed4 #fjdd4 ,,gao study and report 7a7 ,in general ,not later than #bd months after the ,secretary of ,health and ,human ,services begins implementation of the plan required by section #ebj;,e-#c7;c7 of the ,public ,health ,service ,act1 as added by section #fjda7;a77#b7 of this subtitle1 the ,comptroller ,general of the ,united ,states shall-- 7#a7 complete a study on the ,suicide ,prevention ,lifeline2 and 7#b7 submit a report to the ,congress on the results of such study4 7b7 ,issues ,to be studied ,the study required by subsection 7a7 shall address-- 7#a7 the feasibility of geolocating callers to direct calls to the nearest crisis center2 7#b7 operation shortcomings of the ,suicide ,prevention ,lifeline2 7#c7 geographic coverage of each crisis call center2 7#d7 the call answer rate of each crisis call center2 7#e7 the call wait time of each crisis call center2 7#f7 the hours of operation of each crisis call center2 7#g7 funding avenues of each crisis call center2 7#h7 the implementation of the plan under section #ebj;,e-#c7;c7 of the ,public ,health ,service ,act1 as added by section #fjda7;a7 of this subtitle1 including the progress towards meeting the objectives identified pursuant to paragraph 7#b77;,a77i7 of such section #ebj;,e-#c7;c7 by the timeframes identified pursuant to paragraph 7#b77;,a77ii7 of such section #ebj;,e-#c7;c72 and 7#i7 service to individuals requesting a foreign language speaker1 including-- 7,a7 the number of calls or chats the ,lifeline receives from individuals speaking a foreign language2 7,b7 the capacity of the ,lifeline to handle these calls or chats2 and 7,c7 the number of crisis centers with the capacity to serve foreign language speakers1 in house4 7c7 ,recommendations ,the report required by subsection 7a7 shall include recommendations for improving the ,suicide ,prevention ,lifeline1 including recommendations for legislative and administrative actions4 #fjde4 ,definition ,in this subtitle1 the term ,suicide ,prevention ,lifeline means the suicide prevention hotline maintained pursuant to section #ebj;,e-#c of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;bb-#cf;c74 ,f ,campaign ,to ,prevent ,suicide #fjea4 ,national ,suicide ,prevention ,lifeline ,section #ebj;,e-#c7;b77#b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;bb-#cf;c7b77#b77 is amended by inserting after suicide prevention hotline the following3 1 which1 beginning not later than one year after the date of the enactment of the ,commitment to ,defeat the ,virus and ,keep ,america ,healthy ,act1 shall be a #c-;digit nationwide toll-free telephone number14 #fjeb4 ,national suicide prevention media campaign 7a7 ,national suicide prevention media campaign 7#a7 ,in general ,not later than the date that is three years after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary71 in coordination with the ,assistant ,secretary for ,mental ,health and ,substance ,use 7referred to in this section as the ,assistant ,secretary7 and the ,director of the ,centers for ,disease ,control and ,prevention 7referred to in this section as the ,director71 shall conduct a national suicide prevention media campaign 7referred to in this section as the national media campaign71 in accordance with the requirements of this section1 for purposes of-- 7,a7 preventing suicide in the ,united ,states2 7,b7 educating families1 friends1 and communities on how to address suicide and suicidal thoughts1 including when to encourage individuals with suicidal risk to seek help2 and 7,c7 increasing awareness of suicide prevention resources of the ,centers for ,disease ,control and ,prevention and the ,substance ,abuse and ,mental ,health ,services ,administration 7including the suicide prevention hotline maintained under section #ebj;,e-#c of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;bb-#cf;c771 any suicide prevention mobile application of the ,centers for ,disease ,control and ,prevention or the ,substance ,abuse ,mental ,health ,services ,administration1 and other support resources determined appropriate by the ,secretary4 7#b7 ,additional consultation ,in addition to coordinating with the ,assistant ,secretary and the ,director under this section1 the ,secretary shall consult with1 as appropriate1 ,state1 local1 ,tribal1 and territorial health departments1 primary health care providers1 hospitals with emergency departments1 mental and behavioral health services providers1 crisis response services providers1 first responders1 suicide prevention and mental health professionals1 patient advocacy groups1 survivors of suicide attempts1 and representatives of television and social media platforms in planning the national media campaign to be conducted under paragraph 7#a74 7b7 ,target audiences 7#a7 ,tailoring advertisements and other communications ,in conducting the national media campaign under subsection 7a77#a71 the ,secretary may tailor culturally competent advertisements and other communications of the campaign across all available media for a target audience 7such as a particular geographic location or demographic7 across the lifespan4 7#b7 ,targeting certain local areas ,the ,secretary shall1 to the maximum extent practicable1 use amounts made available under subsection 7f7 for media that targets individuals in local areas with higher suicide rates4 7c7 ,use of funds 7#a7 ,required uses 7,a7 ,in general ,the ,secretary shall1 to the extent reasonably feasible with the funds made available under subsection 7f71 carry out the following1 with respect to the national media campaign3 7i7 ,the purchase of advertising time and space1 including the strategic planning for1 and accounting of1 any such purchase4 7ii7 ,creative services and talent costs4 7iii7 ,advertising production costs4 7iv7 ,testing and evaluation of advertising4 7v7 ,evaluation of the effectiveness of the national media campaign4 7vi7 ,operational and management expenses4 7vii7 ,the creation of an educational toolkit for television and social media platforms to use in discussing suicide and raising awareness about how to prevent suicide4 7,b7 ,specific requirements 7i7 ,testing and evaluation of advertising ,in testing and evaluating advertising under subparagraph 7,a77iv71 the ,secretary shall test all advertisements after use in the national media campaign to evaluate the extent to which such advertisements have been effective in carrying out the purposes of the national media campaign4 7ii7 ,evaluation of effectiveness of national media campaign ,in evaluating the effectiveness of the national media campaign under subparagraph 7,a77v71 the ,secretary shall take into account-- 7,i7 the number of unique calls that are made to the suicide prevention hotline maintained under section #ebj;,e-#c of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;bb-#cf;c7 and assess whether there are any ,state and regional variations with respect to the capacity to answer such calls2 7,,ii7 the number of unique encounters with suicide prevention and support resources of the ,centers for ,disease ,control and ,prevention and the ,substance ,abuse and ,mental ,health ,services ,administration and assess engagement with such suicide prevention and support resources2 7,,iii7 whether the national media campaign has contributed to increased awareness that suicidal individuals should be engaged1 rather than ignored2 and 7,,iv7 such other measures of evaluation as the ,secretary determines are appropriate4 7#b7 ,optional uses ,the ,secretary may use amounts made available under subsection 7f7 for the following1 with respect to the national media campaign3 7,a7 ,partnerships with professional and civic groups1 community-based organizations1 including faith-based organizations1 and ,government or ,tribal organizations that the ,secretary determines have experience in suicide prevention1 including the ,substance ,abuse and ,mental ,health ,services ,administration and the ,centers for ,disease ,control and ,prevention4 7,b7 ,entertainment industry outreach1 interactive outreach1 media projects and activities1 public information1 news media outreach1 outreach through television programs1 and corporate sponsorship and participation4 7d7 ,prohibitions ,none of the amounts made available under subsection 7f7 may be obligated or expended for any of the following3 7#a7 ,to supplant current suicide prevention campaigns4 7#b7 ,for partisan political purposes1 or to express advocacy in support of or to defeat any clearly identified candidate1 clearly identified ballot initiative1 or clearly identified legislative or regulatory proposal4 7e7 ,report to ,congress ,not later than #ah months after implementation of the national media campaign has begun1 the ,secretary1 in coordination with the ,assistant ,secretary and the ,director1 shall1 with respect to the first year of the national media campaign1 submit to ,congress a report that describes-- 7#a7 the strategy of the national media campaign and whether specific objectives of such campaign were accomplished1 including whether such campaign impacted the number of calls made to lifeline crisis centers and the capacity of such centers to manage such calls2 7#b7 steps taken to ensure that the national media campaign operates in an effective and efficient manner consistent with the overall strategy and focus of the national media campaign2 7#c7 plans to purchase advertising time and space2 7#d7 policies and practices implemented to ensure that ,federal funds are used responsibly to purchase advertising time and space and eliminate the potential for waste1 fraud1 and abuse2 and 7#e7 all contracts entered into with a corporation1 a partnership1 or an individual working on behalf of the national media campaign4 7f7 ,authorization of appropriations ,for purposes of carrying out this section1 there is authorized to be appropriated #aj1jjj1jjj for each of fiscal years #bjba through #bjbe4 ,g ,helping ,emergency ,responders ,overcome #fjfa4 ,data system to capture national public safety officer suicide incidence ,the ,public ,health ,service ,act is amended by inserting before section #cah of such ,act 7#db ,u4,s4,c4 #bdg;c7 the following3 #cag,w4 ,data system to capture national public safety officer suicide incidence 7a7 ,in general ,the ,secretary1 in coordination with the ,director of the ,centers for ,disease ,control and ,prevention and other agencies as the ,secretary determines appropriate1 shall-- 7#a7 develop and maintain a data system1 to be known as the ,public ,safety ,officer ,suicide ,reporting ,system1 for the purposes of-- 7,a7 collecting data on the suicide incidence among public safety officers2 and 7,b7 facilitating the study of successful interventions to reduce suicide among public safety officers2 and 7#b7 integrate such system into the ,national ,violent ,death ,reporting ,system1 so long as the ,secretary determines such integration to be consistent with the purposes described in paragraph 7#a74 7b7 ,data collection ,in collecting data for the ,public ,safety ,officer ,suicide ,reporting ,system1 the ,secretary shall1 at a minimum1 collect the following information3 7#a7 ,the total number of suicides in the ,united ,states among all public safety officers in a given calendar year4 7#b7 ,suicide rates for public safety officers in a given calendar year1 disaggregated by-- 7,a7 age and gender of the public safety officer2 7,b7 ,state2 7,c7 occupation2 including both the individual's role in their public safety agency and their primary occupation in the case of volunteer public safety officers2 7,d7 where available1 the status of the public safety officer as volunteer1 paid-on-call1 or career2 and 7,e7 status of the public safety officer as active or retired4 7c7 ,consultation during development ,in developing the ,public ,safety ,officer ,suicide ,reporting ,system1 the ,secretary shall consult with non-,federal experts to determine the best means to collect data regarding suicide incidence in a safe1 sensitive1 anonymous1 and effective manner4 ,such non-,federal experts shall include1 as appropriate1 the following3 7#a7 ,public health experts with experience in developing and maintaining suicide registries4 7#b7 ,organizations that track suicide among public safety officers4 7#c7 ,mental health experts with experience in studying suicide and other profession-related traumatic stress4 7#d7 ,clinicians with experience in diagnosing and treating mental health issues4 7#e7 ,active and retired volunteer1 paid-on-call1 and career public safety officers4 7#f7 ,relevant national police1 and fire and emergency medical services1 organizations4 7d7 ,data privacy and security ,in developing and maintaining the ,public ,safety ,officer ,suicide ,reporting ,system1 the ,secretary shall ensure that all applicable ,federal privacy and security protections are followed to ensure that-- 7#a7 the confidentiality and anonymity of suicide victims and their families are protected1 including so as to ensure that data cannot be used to deny benefits2 and 7#b7 data is sufficiently secure to prevent unauthorized access4 7e7 ,reporting 7#a7 ,annual report ,not later than #b years after the date of enactment of the ,commitment to ,defeat the ,virus and ,keep ,america ,healthy ,act1 and biannually thereafter1 the ,secretary shall submit a report to the ,congress on the suicide incidence among public safety officers4 ,each such report shall-- 7,a7 include the number and rate of such suicide incidence1 disaggregated by age1 gender1 and ,state of employment2 7,b7 identify characteristics and contributing circumstances for suicide among public safety officers2 7,c7 disaggregate rates of suicide by-- 7i7 occupation2 7ii7 status as volunteer1 paid-on-call1 or career2 and 7iii7 status as active or retired2 7,d7 include recommendations for further study regarding the suicide incidence among public safety officers2 7,e7 specify in detail1 if found1 any obstacles in collecting suicide rates for volunteers and include recommended improvements to overcome such obstacles2 7,f7 identify options for interventions to reduce suicide among public safety officers2 and 7,g7 describe procedures to ensure the confidentiality and anonymity of suicide victims and their families1 as described in subsection 7d77#a74 7#b7 ,public availability ,upon the submission of each report to the ,congress under paragraph 7#a71 the ,secretary shall make the full report publicly available on the website of the ,centers for ,disease ,control and ,prevention4 7f7 ,definition ,in this section1 the term public safety officer means-- 7#a7 a public safety officer as defined in section #abjd of the ,omnibus ,crime ,control and ,safe ,streets ,act of #aifh2 or 7#b7 a public safety telecommunicator as described in detailed occupation #dc-ejca in the ,standard ,occupational ,classification ,manual of the ,office of ,management and ,budget 7#bjah74 7g7 ,prohibited use of information ,notwithstanding any other provision of law1 if an individual is identified as deceased based on information contained in the ,public ,safety ,officer ,suicide ,reporting ,system1 such information may not be used to deny or rescind life insurance payments or other benefits to a survivor of the deceased individual4 4 #fjfb4 ,peer-support behavioral health and wellness programs within fire departments and emergency medical service agencies 7a7 ,in general ,part ,b of title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdc et seq47 is amended by adding at the end the following3 #cbj;,b4 ,peer-support behavioral health and wellness programs within fire departments and emergency medical service agencies 7a7 ,in general ,the ,secretary shall award grants to eligible entities for the purpose of establishing or enhancing peer-support behavioral health and wellness programs within fire departments and emergency medical services agencies4 7b7 ,program description ,a peer-support behavioral health and wellness program funded under this section shall-- 7#a7 use career and volunteer members of fire departments or emergency medical services agencies to serve as peer counselors2 7#b7 provide training to members of career1 volunteer1 and combination fire departments or emergency medical service agencies to serve as such peer counselors2 7#c7 purchase materials to be used exclusively to provide such training2 and 7#d7 disseminate such information and materials as are necessary to conduct the program4 7c7 ,definition ,in this section3 7#a7 ,the term eligible entity means a nonprofit organization with expertise and experience with respect to the health and life safety of members of fire and emergency medical services agencies4 7#b7 ,the term member-- 7,a7 with respect to an emergency medical services agency1 means an employee1 regardless of rank or whether the employee receives compensation 7as defined in section #abjd7g7 of the ,omnibus ,crime ,control and ,safe ,streets ,act of #aifh72 and 7,b7 with respect to a fire department1 means any employee1 regardless of rank or whether the employee receives compensation1 of a ,federal1 ,state1 ,tribal1 or local fire department who is responsible for responding to calls for emergency service4 4 7b7 ,technical correction ,effective as if included in the enactment of the ,children's ,health ,act of #bjjj 7,public ,law #ajf-caj71 the amendment instruction in section #afjc of such ,act is amended by striking ,part ,b of the ,public ,health ,service ,act and inserting ,part ,b of title ,,iii of the ,public ,health ,service ,act4 #fjfc4 ,health care provider behavioral health and wellness programs ,part ,b of title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdc et seq471 as amended by section #fjfb1 is further amended by adding at the end the following3 #cbj;,c4 ,health care provider behavioral health and wellness programs 7a7 ,in general ,the ,secretary shall award grants to eligible entities for the purpose of establishing or enhancing behavioral health and wellness programs for health care providers4 7b7 ,program description ,a behavioral health and wellness program funded under this section shall-- 7#a7 provide confidential support services for health care providers to help handle stressful or traumatic patient-related events1 including counseling services and wellness seminars2 7#b7 provide training to health care providers to serve as peer counselors to other health care providers2 7#c7 purchase materials to be used exclusively to provide such training2 and 7#d7 disseminate such information and materials as are necessary to conduct such training and provide such peer counseling4 7c7 ,definitions ,in this section1 the term eligible entity means a hospital1 including a critical access hospital 7as defined in section #ahfa7mm77#a7 of the ,social ,security ,act7 or a disproportionate share hospital 7as defined under section #aibc7;a77#a77;,a7 of such ,act71 a federally qualified health center 7as defined in section #aije7a77b77;,b7 of such ,act71 or any other health care facility4 4 #fjfd4 ,development of resources for educating mental health professionals about treating fire fighters and emergency medical services personnel 7a7 ,in general ,the ,administrator of the ,united ,states ,fire ,administration1 in consultation with the ,secretary of ,health and ,human ,services1 shall develop and make publicly available resources that may be used by the ,federal ,government and other entities to educate mental health professionals about-- 7#a7 the culture of ,federal1 ,state1 ,tribal1 and local career1 volunteer1 and combination fire departments and emergency medical services agencies2 7#b7 the different stressors experienced by firefighters and emergency medical services personnel1 supervisory firefighters and emergency medical services personnel1 and chief officers of fire departments and emergency medical services agencies2 7#c7 challenges encountered by retired firefighters and emergency medical services personnel2 and 7#d7 evidence-based therapies for mental health issues common to firefighters and emergency medical services personnel within such departments and agencies4 7b7 ,consultation ,in developing resources under subsection 7a71 the ,administrator of the ,united ,states ,fire ,administration and the ,secretary of ,health and ,human ,services shall consult with national fire and emergency medical services organizations4 7c7 ,definitions ,in this section3 7#a7 ,the term firefighter means any employee1 regardless of rank or whether the employee receives compensation1 of a ,federal1 ,state1 ,tribal1 or local fire department who is responsible for responding to calls for emergency service4 7#b7 ,the term emergency medical services personnel means any employee1 regardless of rank or whether the employee receives compensation1 as defined in section #abjd7g7 of the ,omnibus ,crime ,control and ,safe ,streets ,act of #aifh 7#cd ,u4,s4,c4 #ajbhd7g774 7#c7 ,the term chief officer means any individual who is responsible for the overall operation of a fire department or an emergency medical services agency1 irrespective of whether such individual also serves as a firefighter or emergency medical services personnel4 #fjfe4 ,best practices and other resources for addressing posttraumatic stress disorder in public safety officers 7a7 ,development2 updates ,the ,secretary of ,health and ,human ,services shall-- 7#a7 develop and assemble evidence-based best practices and other resources to identify1 prevent1 and treat posttraumatic stress disorder and co-occurring disorders in public safety officers2 and 7#b7 reassess and update1 as the ,secretary determines necessary1 such best practices and resources1 including based upon the options for interventions to reduce suicide among public safety officers identified in the annual reports required by section #cag,w7e77#a77;,f7 of the ,public ,health ,service ,act1 as added by section #fjfa of this subtitle4 7b7 ,consultation ,in developing1 assembling1 and updating the best practices and resources under subsection 7a71 the ,secretary of ,health and ,human ,services shall consult with1 at a minimum1 the following3 7#a7 ,public health experts4 7#b7 ,mental health experts with experience in studying suicide and other profession-related traumatic stress4 7#c7 ,clinicians with experience in diagnosing and treating mental health issues4 7#d7 ,relevant national police1 fire1 and emergency medical services organizations4 7c7 ,availability ,the ,secretary of ,health and ,human ,services shall make the best practices and resources under subsection 7a7 available to ,federal1 ,state1 and local fire1 law enforcement1 and emergency medical services agencies4 7d7 ,federal training and development programs ,the ,secretary of ,health and ,human ,services shall work with ,federal departments and agencies1 including the ,united ,states ,fire ,administration1 to incorporate education and training on the best practices and resources under subsection 7a7 into ,federal training and development programs for public safety officers4 7e7 ,definition ,in this section1 the term public safety officer means-- 7#a7 a public safety officer as defined in section #abjd of the ,omnibus ,crime ,control and ,safe ,streets ,act of #aifh 7#cd ,u4,s4,c4 #ajbhd72 or 7#b7 a public safety telecommunicator as described in detailed occupation #dc-ejca in the ,standard ,occupational ,classification ,manual of the ,office of ,management and ,budget 7#bjah74 ,h ,behavioral ,health ,intervention ,guidelines #fjga4 ,best practices for behavioral intervention teams ,the ,public ,health ,service ,act is amended by inserting after section #ebj;,g of such ,act 7#db ,u4,s4,c4 #bij;bb-#ch7 the following new section3 #ebj;,h4 ,best practices for behavioral intervention teams 7a7 ,in general ,the ,secretary1 acting through the ,assistant ,secretary1 shall develop and periodically update-- 7#a7 best practices to assist elementary schools1 secondary schools1 and institutions of higher education in establishing and using behavioral intervention teams2 and 7#b7 a list of evidence-based threat assessment training providers to assist personnel in elementary schools1 secondary schools1 and institutions of higher education in implementing such best practices1 including with respect to training behavioral intervention teams4 7b7 ,elements ,the best practices under subsection 7a77#a7 shall include guidance on the following3 7#a7 ,how behavioral intervention teams can operate effectively from an evidence-based1 objective perspective while protecting the constitutional and civil rights of individuals1 including any individual of concern4 7#b7 ,the use of behavioral intervention teams to identify individuals of concern1 implement interventions1 and manage risk through the framework of the school's or institution's rules or code of conduct1 as applicable4 7#c7 ,how behavioral intervention teams can1 when assessing an individual of concern-- 7,a7 seek training on evidence-based1 threat-assessment rubrics2 7,b7 ensure that such teams-- 7i7 have adequately trained1 diverse stakeholders with varied expertise2 and 7ii7 use cross validation by a wide-range of individual perspectives on the team2 and 7,c7 use violence risk assessment4 7#d7 ,how behavioral intervention teams can avoid-- 7,a7 attempting to predict future behavior by the concept of pre-crime2 7,b7 inappropriately using a mental health assessment2 7,c7 inappropriately limiting or restricting law enforcement's jurisdiction over criminal matters2 7,d7 attempting to substitute the behavioral intervention process in place of a criminal process1 or impede a criminal process1 when an individual of concern's behavior has potential criminal implications2 7,e7 endangering an individual's privacy by failing to ensure that all applicable ,federal and ,state privacy laws are fully complied with2 or 7,f7 creating school-to-prison pipelines4 7c7 ,consultation ,in carrying out subsection 7a77#a71 the ,secretary shall consult with-- 7#a7 the ,secretary of ,education2 7#b7 the ,director of the ,national ,threat ,assessment ,center of the ,department of ,homeland ,security2 7#c7 the ,attorney ,general of the ,united ,states2 and 7#d7 as appropriate1 relevant stakeholders including-- 7,a7 teachers and other educators1 principals1 school administrators1 school board members1 school psychologists1 mental health professionals1 and parents of elementary school and secondary school students2 7,b7 local law enforcement agencies and campus law enforcement administrators2 7,c7 mental health mobile crisis providers2 7,d7 child and adolescent psychiatrists2 and 7,e7 other education and mental health professionals4 7d7 ,publication ,not later than #b years after the date of enactment of this section1 the ,secretary shall publish the best practices under subsection 7a77#a7 and the list under subsection 7a77#b7 on a publicly accessible website of the ,department of ,health and ,human ,services4 7e7 ,technical assistance ,the ,secretary shall provide technical assistance to institutions of higher education1 elementary schools1 and secondary schools to assist such institutions and schools in implementing the best practices under subsection 7a74 7f7 ,definitions ,in this section3 7#a7 ,the term behavioral intervention team means a team of qualified individuals who-- 7,a7 are responsible for identifying and assessing individuals of concern2 and 7,b7 develop and facilitate implementation of evidence-based interventions to mitigate the threat of harm to self or others posed by individuals of concern and address the mental and behavioral health needs of individuals of concern to reduce such threat4 7#b7 ,the terms elementary school1 parent1 and secondary school have the meanings given to such terms in section #haja of the ,elementary and ,secondary ,education ,act of #aife 7#bj ,u4,s4,c4 #ghja74 7#c7 ,the term individual of concern means an individual whose behavior indicates a potential threat to self or others4 7#d7 ,the term institution of higher education has the meaning given to such term in section #ajb of the ,higher ,education ,act of #aife 7#bj ,u4,s4,c4 #ajjb74 7#e7 ,the term mental health assessment means an evaluation1 primarily focused on diagnosis1 determining the need for involuntary commitment1 medication management1 and on-going treatment recommendations4 7#f7 ,the term pre-crime means law-enforcement efforts and strategies to deter crime by predicting when and where criminal activity will occur4 7#g7 ,the term violence risk assessment refers to a broad determination of the potential risk of violence based on evidence-based literature4 4 ,i ,suicide ,training and ,awareness ,nationally ,delivered for ,universal ,prevention #fjha4 ,student suicide awareness and prevention training 7a7 ,in general ,title ,v of the ,public ,health ,service ,act is amended by inserting after section #ebj;,a of such ,act 7#db ,u4,s4,c4 #bij;bb-#cb7 the following3 #ebj;,b4 ,student suicide awareness and prevention training policies 7a7 ,in general ,as a condition on receipt of funds under section #ebj;,a1 each ,state educational agency1 local educational agency1 and ,tribal educational agency that receives such funds1 directly or through a ,state or ,indian ,tribe1 for activities to be performed within secondary schools1 including the ,project ,,aware ,state ,education ,agency ,grant ,program1 shall-- 7#a7 establish and implement a school-based student suicide awareness and prevention training policy2 7#b7 consult with stakeholders 7including principals1 teachers1 parents1 local ,tribal officials1 and other school leaders7 in the development of the policy under subsection 7a77#a72 and 7#c7 collect and report information in accordance with subsection 7c74 7b7 ,school-,based student suicide awareness and prevention training policy ,a school-based student suicide awareness and prevention training policy implemented pursuant to subsection 7a7-- 7#a7 shall be evidence-based2 7#b7 shall be culturally and linguistically appropriate2 7#c7 shall provide evidence-based training to students in grades #f through #ab1 in coordination with school-based mental health service providers as defined in section #dajb7f7 of the ,elementary and ,secondary ,education ,act of #aife1 if applicable1 regarding-- 7,a7 suicide education and awareness1 including warning signs of self-harm or suicidal ideation2 7,b7 methods that students can use to seek help for themselves and others2 and 7,c7 student resources for suicide awareness and prevention2 7#d7 shall provide for retraining of such students every school year2 7#e7 may last for such period as the ,state educational agency1 local educational agency1 or ,tribal educational agency involved determines to be appropriate2 7#f7 may be implemented through any delivery method1 including in-person trainings1 digital trainings1 or train-the-trainer models2 and 7#g7 may include discussion of comorbidities or risk factors for suicidal ideation or self-harm1 including substance misuse1 sexual or physical abuse1 mental illness1 or other evidence-based comorbidities and risk factors4 7c7 ,collection of information and reporting ,each ,state educational agency1 local educational agency1 and ,tribal educational agency that receives funds under section #ebj;,a shall1 with respect to each school served by the agency1 collect and report to the ,secretary the following information3 7#a7 ,the number of student trainings conducted4 7#b7 ,the number of students trained1 disaggregated by age and grade level4 7#c7 ,the number of help-seeking reports made by students after implementation of such policy4 7d7 ,evidence-,based program listing ,the ,secretary of ,health and ,human ,services shall coordinate with the ,secretary of ,education to make publicly available the policies established by ,state educational agencies1 local educational agencies1 and ,tribal educational agencies pursuant to this section and the training that is available to students and teams pursuant to such policies1 including identification of whether such training is available to trainees at no cost4 7e7 ,implementation timeline ,a ,state educational agency1 local educational agency1 or ,tribal educational agency shall establish and begin implementation of the policies required by subsection 7a77#a7 not later than the beginning of the third fiscal year following the date of enactment of this section for which the agency receives funds under section #ebj;,a4 7f7 ,definitions ,in this section and section #ebj;,b-#a3 7#a7 ,the term evidence-based has the meaning given to such term in section #haja of the ,elementary and ,secondary ,education ,act of #aife4 7#b7 ,the term local educational agency has the meaning given to such term in section #haja of the ,elementary and ,secondary ,education ,act of #aife4 7#c7 ,the term ,state educational agency has the meaning given to such term in section #haja of the ,elementary and ,secondary ,education ,act of #aife4 7#d7 ,the term ,tribal educational agency has the meaning given to the term tribal educational agency in section #facb of the ,elementary and ,secondary ,education ,act of #aife4 #ebj;,b-#a4 ,best practices for student suicide awareness and prevention training ,the ,secretary of ,health and ,human ,services1 in consultation with the ,secretary of ,education and the ,bureau of ,indian ,education1 shall-- 7#a7 publish best practices for school-based student suicide awareness and prevention training1 pursuant to section #ebj;,b1 that are based on-- 7,a7 evidence-based practices2 and 7,b7 input from relevant ,federal agencies1 national organizations1 ,indian ,tribes and ,tribal organizations1 and related stakeholders2 7#b7 publish guidance1 based on the best practices under paragraph 7#a71 to provide ,state educational agencies1 local educational agencies1 and ,tribal educational agencies with information on student suicide awareness and prevention best practices2 7#c7 disseminate such best practices to ,state educational agencies1 local educational agencies1 and ,tribal educational agencies2 and 7#d7 provide technical assistance to ,state educational agencies1 local educational agencies1 and ,tribal educational agencies4 4 #fjhb4 ,effective date ,the amendments made by this subtitle shall only apply with respect to applications for assistance under section #ebj;,a of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;bb-#cb7 that are submitted after the date of enactment of this ,act4 ,,vii ,addressing the ,impacts of ,,covid-#ai on ,substance ,use ,disorders ,a ,easy ,medication ,access and ,treatment for ,opioid ,addiction #gjja4 ,dispensation of narcotic drugs for the purpose of relieving acute withdrawal symptoms from opioid use disorder ,not later than #ahj days after the date of enactment of this ,act1 the ,attorney ,general shall revise section #acjf4jg7;b7 of title #ba1 ,code of ,federal ,regulations1 so that practitioners1 in accordance with applicable ,state1 ,federal1 or local laws relating to controlled substances1 are allowed to dispense not more than a three-day supply of narcotic drugs to one person or for one person's use at one time for the purpose of initiating maintenance treatment or detoxification treatment 7or both74 ,b ,access to ,remote ,behavioral ,health ,treatment #gjaa4 ,registration of qualified community mental health centers 7a7 ,definitions ,section #ajb of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hjb7 is amended-- 7#a7 by striking paragraph 7#ed77;,a77i7 and inserting the following3 7i7 while the patient is being treated by1 and physically located in-- 7,i7 a hospital or clinic registered under section #cjc7;f72 or 7,,ii7 a qualified community mental health center registered under section #cjc7l72 and 2 7#b7 by redesignating paragraph 7#eh7 as paragraph 7#ei72 7#c7 by redesignating the second paragraph 7#eg7 7as added by section #dja7;a7 of the ,first ,step ,act of #bjah 7,public ,law #aae-cia77 as paragraph 7#eh72 and 7#d7 by adding at the end the following3 7#fj7 ,the term qualified community mental health center means a facility that-- 7,a7 7i7 meets the criteria specified in section #aiac7;c7 of the ,public ,health ,service ,act to be considered a community mental health center2 or 7ii7 meets the criteria specified pursuant to section #bbc of the ,protecting ,access to ,medicare ,act of #bjad to be considered a certified community behavioral health clinic2 and 7,b7 is licensed1 operated1 authorized1 certified1 or otherwise recognized by a ,state government4 4 7b7 ,registration ,section #cjc of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc7 is amended by adding at the end the following3 7l7 ,qualified community mental health centers 7#a7 ,registration ,the ,attorney ,general shall register qualified community mental health centers to administer controlled substances through the practice of telemedicine4 7#b7 ,denial of applications ,the ,attorney ,general may deny an application for registration under paragraph 7#a7 if the ,attorney ,general determines that the registration would be inconsistent with the public interest after considering-- 7,a7 any recommendation by the licensing board or professional disciplinary authority of the ,state in which the applicant is located2 7,b7 the experience of the applicant in treating patients2 7,c7 any conviction of an employee of the applicant under ,federal or ,state law relating to treatment of patients2 7,d7 the compliance of the applicant with applicable ,federal1 ,state1 or local laws relating to treatment of patients2 and 7,e7 any other conduct by the applicant that may threaten the public's health and safety4 4 7c7 ,report to ,congress ,not later than #fj days after the date of enactment of this ,act1 the ,attorney ,general of the ,united ,states shall submit to the ,congress a plan for implementation of the amendments made by subsections 7a7 and 7b74 7d7 ,delayed applicability ,the amendments made by subsections 7a7 and 7b7 apply beginning on the date that is #abj days after the date of enactment of this ,act4 ,c ,,pdmp ,pilot ,program #gjba4 ,pilot program for integrating substance use disorder and behavioral health treatment locator tool into ,state prescription drug monitoring programs 7a7 ,in general ,the ,secretary of ,health and ,human ,services1 in consultation with the ,assistant ,secretary for ,mental ,health and ,substance ,use1 shall establish and implement a pilot program in which the ,secretary awards grants to1 or enters into cooperative agreements with1 not more than #e eligible ,states to test the feasibility and outcomes of integrating a substance use disorder and behavioral health treatment locator tool into the ,state's prescription drug monitoring program4 7b7 ,grant establishment and participation 7#a7 ,in general ,in carrying out the pilot program under this section1 the ,secretary shall1 on a competitive basis1 award grants to1 or enter into cooperative agreements with1 not more than #e eligible ,states4 7#b7 ,eligibility ,to be eligible for a grant under this section1 a ,state shall demonstrate to the ,secretary's satisfaction that the ,state is making progress in integrating the ,state's ,,pdmp with electronic health records and health information technology infrastructure4 7#c7 ,preference ,in awarding grants under this section1 the ,secretary shall give preference to eligible ,states described in paragraph 7#b7 whose rates of death due to drug overdose per population of #ajj1jjj are in the top quartile according to the most recent data of the ,centers for ,disease ,control and ,prevention4 7c7 ,period of grant ,a grant awarded to an eligible entity under this section shall be for a period of #b years4 7d7 ,grant uses 7#a7 ,required uses ,a grant awarded under this section to an eligible ,state shall be used for both of the following purposes3 7,a7 ,to integrate a substance use disorder and behavioral health treatment locator tool into the ,,pdmp4 7,b7 ,to develop and disseminate guidance for health care providers on how to consult and share information obtained through the substance use disorder and behavioral health treatment locator tool when a patient's ,,pdmp information indicates possible misuse of a controlled substance4 7#b7 ,additional permissible uses ,a grant awarded under this section to an eligible ,state may be used for any of the following additional purposes3 7,a7 ,to integrate a substance use disorder and behavioral health treatment locator tool into the ,,pdmp that incorporates direct referral capabilities that enable the health care provider-- 7i7 to refer a patient to treatment or for an assessment2 and 7ii7 consistent with the protection of information by ,federal and ,state privacy laws and security rules1 receive feedback about the patient's engagement with such treatment or assessment4 7,b7 ,to integrate a substance use disorder and behavioral health treatment locator tool into the ,,pdmp that provides information regarding the current capacity of inpatient or outpatient treatment resources of a health care provider4 7e7 ,reporting requirements 7#a7 ,reports by ,states ,each eligible ,state that participates in the pilot program under this section shall submit to the ,secretary an annual report for each year of the pilot program that includes information on-- 7,a7 the number of health care providers and health facilities with access to the substance use disorder and behavioral health treatment locator tool2 7,b7 the number of individuals referred to treatment with the assistance of the locator tool2 7,c7 aggregate1 de-identified patient data related to the type of treatment located by the locator tool1 how often patients followed through on seeking such treatment1 and the average duration of such treatment1 to the extent collected by the ,state2 7,d7 feedback from providers with access to the locator tool on usability and any impact on outcomes2 7,e7 recommendations to improve the usability and efficacy of a substance use disorder and behavioral health treatment locator tool within the ,,pdmp2 and 7,f7 additional information and reporting metrics as determined by the ,secretary4 7#b7 ,report by ,secretary ,not less than #ahj days after the conclusion of the pilot program under this section1 the ,secretary shall submit to the ,congress a report on the findings of the program1 including-- 7,a7 outcomes reported by the participating ,states2 7,b7 findings on the suitability of including a substance use disorder and behavioral health treatment locator tool within ,state ,p,d,m,ps2 and 7,c7 recommendations on best practices for integrating a substance use disorder and behavioral health treatment locator tool within ,state ,p,d,m,ps4 7f7 ,definitions ,in this section3 7#a7 ,the term prescription drug monitoring program or ,,pdmp has the meaning given to the term ,,pdmp in section #cii,o of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhj;g-#c74 7#b7 ,the term ,secretary means the ,secretary of ,health and ,human ,services4 7g7 ,authorization of appropriations ,to carry out this section1 there are authorized to be appropriated #b1ejj1jjj for each of fiscal years #bjba and #bjbb4 ,d ,family ,support ,services for ,addiction #gjca4 ,family support services for individuals struggling with substance use disorder ,part ,d of title ,v of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;dd et seq47 is amended by adding at the end the following3 #eec4 ,family support services for individuals struggling with substance use disorder 7a7 ,definitions ,in this section-- 7#a7 the term family community organization means an independent nonprofit organization that-- 7,a7 mobilizes resources within and outside of the community of families with individuals living with addiction1 to provide a support network1 education1 and evidence-informed tools for families and loved ones of individuals struggling with substance use disorders2 and 7,b7 is governed by experts in the field of addiction1 which may include-- 7i7 experts in evidence-informed interventions for family members2 7ii7 experts in the impact of addiction on family systems2 7iii7 families who have experience with substance use disorders and addiction2 and 7iv7 other experts in the field of addiction2 and 7#b7 the term family support services means resources or programs that support families that include an individual with substance use disorder4 7b7 ,grants authorized ,the ,secretary shall award grants to family community organizations to enable such organizations to develop1 expand1 and enhance evidence-informed family support services4 7c7 ,federal share ,the ,federal share of the costs of a program funded by a grant under this section may not exceed #he percent4 7d7 ,use of funds ,grants awarded under subsection 7b7-- 7#a7 shall be used to develop1 expand1 and enhance community and statewide evidence-informed family support services2 and 7#b7 may be used to-- 7,a7 build connections between family support networks1 including providing technical assistance between family community organizations and peer support networks1 and with other family support services1 focused on enhancing knowledge of evidence-informed interventions for family members and loved ones of individuals living with substance use disorders and reducing harm by educating service providers on current evidence regarding addiction and the family1 including-- 7i7 behavioral health providers1 including such providers focused specifically on family and couples therapy in the context of addiction2 7ii7 primary care providers2 7iii7 providers of foster care services or support services for grandparents1 guardians1 and other extended family impacted by addiction2 and 7iv7 other family support services that connect to community resources for individuals with substance use disorders1 including non-clinical community services2 7,b7 reduce stigma associated with the family of individuals with substance use disorders by improving knowledge about addiction and its treatment1 providing compassionate support1 and dispelling myths that perpetuate such stigma2 7,c7 conduct outreach on issues relating to substance use disorders and family support1 which may include education1 training1 and resources with respect to-- 7i7 building a resilience- and strengths-based approach to prevention of1 and living with1 addiction in the family2 7ii7 identifying the signs of substance use disorder2 7iii7 adopting an approach that minimizes harm to all family members2 and 7iv7 families of individuals with a substance use disorder1 including with respect to-- 7,i7 navigating the treatment and recovery systems2 7,,ii7 paying for addiction treatment2 7,,iii7 education about substance use disorder2 and 7,,iv7 avoiding predatory treatment programs2 and 7,d7 connect families to evidence-informed peer support programs4 7e7 ,data reporting and program oversight ,with respect to a grant awarded under subsection 7a71 not later than #ij days after the end of the first year of the grant period1 and annually thereafter for the duration of the grant period1 the entity shall submit data1 as appropriate and to the extent practicable1 to the ,secretary regarding-- 7#a7 the programs and activities funded by the grant2 7#b7 health outcomes of the population of individuals with a substance use disorder who received services through programs supported by the grant1 as evaluated by an independent program evaluator through the use of outcomes measures1 as determined by the ,secretary2 and 7#c7 any other information that the secretary may require for the purpose of ensuring that the grant recipient is complying with all the requirements of the grant4 7f7 ,authorization of appropriations ,there is authorized to be appropriated to carry out this section #e1jjj1jjj for each of fiscal years #bjba through #bjbe4 4 ,e ,block1 ,report1 ,and ,suspend ,suspicious ,shipments #gjda4 ,clarification of process for registrants to exercise due diligence upon discovering a suspicious order 7a7 ,in general ,paragraph 7#c7 of section #cab7;a7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hcb7;a77 is amended to read as follows3 7#c7 upon discovering a suspicious order or series of orders-- 7,a7 exercise due diligence2 7,b7 establish and maintain 7for not less than a period to be determined by the ,administrator of the ,drug ,enforcement ,administration7 a record of the due diligence that was performed2 7,c7 decline to fill the order or series of orders if the due diligence fails to resolve all of the indicators that gave rise to the suspicion that filling the order or series of orders would cause a violation of this title by the registrant or the prospective purchaser2 and 7,d7 notify the ,administrator of the ,drug ,enforcement ,administration and the ,special ,agent in ,charge of the ,division ,office of the ,drug ,enforcement ,administration for the area in which the registrant is located or conducts business of-- 7i7 each suspicious order or series of orders discovered by the registrant2 and 7ii7 the indicators giving rise to the suspicion that filling the order or series of orders would cause a violation of this title by the registrant or the prospective purchaser4 4 7b7 ,applicability ,section #cab7;a77#c7 of the ,controlled ,substances ,act1 as amended by subsection 7a71 shall apply beginning on the day that is #f months after the date of enactment of this ,act4 ,until such day1 section #cab7;a77#c7 of the ,controlled ,substances ,act shall apply as such section #cab7;a77#c7 was in effect on the day before the date of enactment of this ,act4 7c7 ,regulations ,the ,attorney ,general shall1 issue regulations specifying1 for purposes of paragraph 7#c7 of section #cab7;a7 of the ,controlled ,substances ,act1 as added by subsection 7a71 the indicators that give rise to a suspicion that filling an order or series of orders would cause a violation of title ,,iii of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hja et seq47 by a registrant or a prospective purchaser4 ,f ,debarment ,enforcement of ,bad ,actor ,registrants #gjea4 ,debarment of certain registrants ,section #cjd of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbd7 is amended by adding at the end the following3 7h7 ,the ,attorney ,general may issue an order to prohibit1 conditionally or unconditionally1 and permanently or for such period as the ,attorney ,general may determine1 any person from being registered under this title to manufacture1 distribute1 or dispense a controlled substance or a list ,i chemical1 if the ,attorney ,general finds that-- 7#a7 such person meets or has met any of the conditions for suspension or revocation of registration under subsection 7a72 and 7#b7 such person has a history of prior suspensions or revocations of registration4 4 ,g ,ensuring ,compliance ,against ,opioid ,diversion #gjfa4 ,modification1 transfer1 and termination of registration to manufacture1 distribute1 or dispense controlled substances ,subsection 7a7 of section #cjb of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbb7 is amended by adding at the end the following new paragraph3 7#c7 7,a7 ,except as provided in subparagraph 7,c71 the registration of any registrant under this title to manufacture1 distribute1 or dispense controlled substances or list ,i chemicals terminates if and when such registrant-- 7i7 dies2 7ii7 ceases legal existence2 7iii7 discontinues business or professional practice2 or 7iv7 surrenders such registration4 7,b7 ,in the case of such a registrant who ceases legal existence or discontinues business or professional practice1 such registrant shall promptly notify the ,attorney ,general in writing of such fact4 7,c7 ,no registration under this title to manufacture1 distribute1 or dispense controlled substances or list ,i chemicals1 and no authority conferred thereby1 may be assigned or otherwise transferred except upon such conditions as the ,attorney ,general may specify and then only pursuant to written consent4 ,a registrant to whom a registration is assigned or transferred pursuant to the preceding sentence may not manufacture1 distribute1 or dispense controlled substances or list ,i chemicals pursuant to such registration until the ,attorney ,general receives such written consent4 7,d7 ,in the case of a registrant under this title to manufacture1 distribute1 or dispense controlled substances or list ,i chemicals desiring to discontinue business or professional practice altogether or with respect to controlled substances and list ,i chemicals 7without assigning or transferring such business or professional practice to another entity71 such registrant shall return to the ,attorney ,general for cancellation-- 7i7 the registrant's certificate of registration2 7ii7 any unexecuted order forms in the registrant's possession2 and 7iii7 any other documentation that the ,attorney ,general may require4 4 ,h ,opioid ,prescription ,verification #gjga4 ,materials for training pharmacists on certain circumstances under which a pharmacist may decline to fill a prescription 7a7 ,updates to materials ,section #cbab7;a7 of the ,,support for ,patients and ,communities ,act 7,public ,law #aae-bga7 is amended by striking ,not later than #a year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services1 in consultation with the ,administrator of the ,drug ,enforcement ,administration1 ,commissioner of ,food and ,drugs1 ,director of the ,centers for ,disease ,control and ,prevention1 and ,assistant ,secretary for ,mental ,health and ,substance ,use1 shall develop and disseminate and inserting ,the ,secretary of ,health and ,human ,services1 in consultation with the ,administrator of the ,drug ,enforcement ,administration1 ,commissioner of ,food and ,drugs1 ,director of the ,centers for ,disease ,control and ,prevention1 and ,assistant ,secretary for ,mental ,health and ,substance ,use1 shall develop and disseminate not later than #a year after the date of enactment of this ,act1 and update periodically thereafter4 7b7 ,materials included ,section #cbab7;b7 of the ,,support for ,patients and ,communities ,act 7,public ,law #aae-bga7 is amended-- 7#a7 by redesignating paragraphs 7#a7 and 7#b7 as paragraphs 7#b7 and 7#c71 respectively2 and 7#b7 by inserting before paragraph 7#b71 as so redesignated1 the following new paragraph3 7#a7 pharmacists on how to verify the identity of individuals picking up prescriptions2 4 7c7 ,materials for training on verification of identity ,section #cbab of the ,,support for ,patients and ,communities ,act 7,public ,law #aae-bga7 is amended by adding at the end the following new subsection3 7d7 ,materials for training on verification of identity of individuals picking up prescribed medications ,not later than #f months after the date of enactment of this subsection1 the ,secretary of ,health and ,human ,services1 after seeking stakeholder input in accordance with subsection 7c71 shall-- 7#a7 update the materials developed under subsection 7a7 to include information for pharmacists on how to verify the identity of individuals picking up prescribed medications2 and 7#b7 disseminate1 as appropriate1 the updated materials4 4 #gjgb4 ,incentivizing ,states to facilitate responsible1 informed dispensing of controlled substances 7a7 ,in general ,section #cib;,a of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhj;b-#a7 is amended-- 7#a7 by redesignating subsections 7c7 and 7d7 as subsections 7d7 and 7e71 respectively2 and 7#b7 by inserting after subsection 7b7 the following new subsection3 7c7 ,preference ,in determining the amounts of grants awarded to ,states under subsections 7a7 and 7b71 the ,director of the ,centers for ,disease ,control and ,prevention may give preference to ,states in accordance with such criteria as the ,director may specify and may choose to give preference to ,states that-- 7#a7 maintain a prescription drug monitoring program2 7#b7 require dispensers of controlled substances in schedule ,,ii1 ,,iii1 or ,,iv to verify the identity of the person who picks up a prescribed medication by requiring such person to present a photo identification card that is valid as determined by the respective ,state2 and 7#c7 require dispensers of such controlled substances to enter certain information about the purchase of such controlled substances into the respective ,state's prescription drug monitoring program1 including-- 7,a7 the ,national ,drug ,code or1 in the case of compounded medications1 compound identifier2 7,b7 the quantity dispensed2 7,c7 the name of the patient2 7,d7 the name of the ultimate user2 7,e7 the name of the person who picks up the controlled substance1 if different from the patient and ultimate user2 and 7,f7 the date filled4 4 7b7 ,definitions ,subsection 7d7 of section #cib;,a of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhj;b-#a71 as redesignated by subsection 7a77#a71 is amended to read as follows3 7d7 ,definitions ,in this section3 7#a7 ,controlled substance ,the term controlled substance has the meaning given that term in section #ajb of the ,controlled ,substances4 7#b7 ,dispenser ,the term dispenser means a physician1 pharmacist1 or other person that dispenses a controlled substance to an ultimate user4 7#c7 ,indian tribe ,the term ,indian tribe has the meaning given that term in section #d of the ,indian ,self-,determination and ,education ,assistance ,act4 7#d7 ,state ,the term ,state means each of the #ej ,states1 the ,district of ,columbia1 and any commonwealth or territory of the ,united ,states4 7#e7 ,ultimate user ,the term ultimate user means a person who has obtained from a dispenser1 and who possesses1 a controlled substance for the person's own use1 for the use of a member of the person's household1 or for the use of an animal4 4 ,i ,suspicious ,order ,identification #gjha4 ,strengthening ,,arcos ,section #cjg7;d7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbg7;d77 is amended to read as follows3 7#a7 7,a7 ,every registrant under section #cjc shall and in such form as the ,attorney ,general may require1 make reports in electronic format to the ,attorney ,general of every sale1 delivery1 or other disposal 7other than by dispensing by a practitioner7 by the registrant of any controlled substance1 identifying by the registration number assigned under this title the person or establishment 7unless exempt from registration under section #cjb7;d77 to whom such sale1 delivery1 or other disposal was made4 7,b7 ,every registrant shall make each report required under subparagraph 7,a7-- 7i7 not later than #cj days after the sale1 delivery1 or other disposal2 or 7ii7 after the date on which the real-time reporting system is established under section #gjhb7;e77#c7 of the ,commitment to ,defeat the ,virus and ,keep ,america ,healthy ,act is implemented1 in real time4 4 #gjhb4 ,suspicious ,orders ,task ,force 7a7 ,definitions ,in this section3 7#a7 ,administrator ,the term ,administrator means the ,administrator of the ,drug ,enforcement ,administration4 7#b7 ,controlled substance2 distributor2 manufacturer ,the terms controlled substance1 distributor1 and manufacturer have the meanings given those terms in section #ajb of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hjb74 7#c7 ,real time ,the term real time means with as little delay as technically and economically feasible1 as determined by the ,attorney ,general following the program designed under subsection 7e77#a71 but not to exceed #bd hours4 7#d7 ,registrant ,the term registrant-- 7,a7 means a person registered under section #cjc of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc72 and 7,b7 does not include practitioner4 7b7 ,establishment ,the ,attorney ,general1 in consultation with the ,director of the ,office of ,national ,drug ,control ,policy and the ,secretary of ,health and ,human ,services1 shall establish a ,suspicious ,order ,monitoring ,task ,force 7referred to in this section as the ,task ,force74 7c7 ,composition 7#a7 ,in general ,the ,task ,force shall be composed of appropriate personnel from-- 7,a7 the ,department of ,justice2 7,b7 the ,drug ,enforcement ,administration2 7,c7 the ,office of ,national ,drug ,control ,policy2 7,d7 the ,national ,institute of ,standards and ,technology2 and 7,e7 other appropriate ,federal1 ,state1 and local law enforcement and regulatory agencies with experience in investigating and prosecuting illegal transactions of controlled substances as determined by the ,attorney ,general1 in consultation with the ,secretary of ,health and ,human ,services4 7#b7 ,consultants ,the ,task ,force shall consult with-- 7,a7 industry members1 including-- 7i7 data analytic professionals2 7ii7 community pharmacies that dispense controlled substances2 7iii7 chain pharmacies that dispense controlled substances2 7iv7 distributors of controlled substances2 7v7 manufacturers of controlled substances2 7vi7 ,state and local public health officials2 and 7vii7 other relevant industry professionals2 and 7,b7 relevant industry regulators and entities that utilize real-time reporting of transactions1 orders1 or other activities with the goal of identifying suspicious activity1 such as appropriate personnel from the ,financial ,crimes ,enforcement ,network and money transfer industry professionals4 7d7 ,meetings 7#a7 ,in general ,the ,task ,force shall meet not less frequently than #d times per year and at such other times as may be determined necessary by the ,task ,force4 7#b7 ,initial meeting ,not later than #fj days after the date of enactment of this ,act1 the ,task ,force shall hold the initial meeting of the ,task ,force4 7e7 ,preliminary order evaluation program 7#a7 ,in general 7,a7 ,design ,not later than #fj days after the date on which the ,task ,force holds the initial meeting required under subsection 7d77#b71 the ,task ,force shall begin to design a program in accordance with paragraph 7#b74 7,b7 ,purpose ,the program described in subparagraph 7,a7 shall be designed to share necessary data1 in a limited capacity1 with registrants in order to provide registrants with information to identify suspicious ordering in real time4 7,c7 ,deadline for completion ,not later than #h months after the date of enactment of this ,act1 the ,task ,force shall complete the design required under subparagraph 7,a74 7#b7 ,requirements 7,a7 ,in general ,the program required under paragraph 7#a7 shall establish a process for-- 7i7 transitioning to a requirement to report in real time to the ,attorney ,general under section #cjg7;d7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbg7;d77 every sale1 delivery1 or other disposal by a registrant of any controlled substance2 7ii7 limited sharing in real time of ,automation of ,reports and ,consolidated ,orders ,system 7commonly known as ,,arcos7 data with registrants to share necessary data1 in a limited capacity1 with registrants in order to provide registrants with information to identify suspicious ordering in real time2 and 7iii7 ensuring data privacy1 data de-identification1 protection of trade secrets and purchasing history4 7,b7 ,other considerations ,in designing the program under paragraph 7#a71 the ,task ,force shall take into consideration-- 7i7 the inclusion of a waiver process for pharmacies and other registrants unable to transmit orders electronically on the date of enactment of this ,act2 7ii7 a mechanism to ensure that the costs of running the program are not passed through to customers of registrants1 unless the registrants are customers of other registrants2 7iii7 technical requirements for ensuring that registrants may access all relevant de-identified data1 with output provided in a standard database file format2 and 7iv7 a mechanism to ensure that the program required to be designed under subparagraph 7,a7 is updated based on feedback from industry members and other relevant entities4 7#c7 ,implementation ,not later than #a year after the date of enactment of this ,act1 the ,attorney ,general shall-- 7,a7 implement the program designed under paragraph 7#a7 to collect and share in real time data for registrants to evaluate the orders of controlled substances from distributors to manufacturers and from pharmacies to distributors2 or 7,b7 otherwise implement a program to collect and share in real time data for drug manufacturers and distributors1 by providing access to anonymized information to help drug manufacturers and distributors identify1 report1 and stop suspicious orders of controlled substances and reduce diversion rates4 7#d7 ,recommended statutory and regulatory changes ,in designing the program required under paragraph 7#a71 the ,task ,force-- 7,a7 shall submit to the ,attorney ,general any recommendations for necessary amendments to regulations of the ,department of ,justice relating to the requirements for ordering schedule ,,ii controlled substances1 so as to allow uniform electronic ordering of controlled substances in schedules ,,ii1 ,,iii1 ,,iv1 and ,v electronically through the program2 and 7,b7 may submit to ,congress any recommendations for necessary legislative changes so that a real-time data analytics solution can be used across the ,united ,states4 7#e7 ,responsibility of registrants ,all registered drug manufacturers and distributors shall be responsible for reviewing any information made available by the ,attorney ,general and complying with any regulations regarding the program designed under paragraph 7#a7 and implemented under paragraph 7#c74 7f7 ,funding 7#a7 ,in general ,the ,attorney ,general1 acting through the ,administrator1 shall use amounts collected as fees for distributors and registrants under section #cjc of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc7 and section #ajjg of the ,controlled ,substances ,import and ,export ,act 7#ba ,u4,s4,c4 #ieg7 to carry out this section4 7#b7 ,offset 7,a7 ,in general ,the ,administrator may1 on an equal basis and in accordance with subparagraph 7,b71 increase the fees described in paragraph 7#a7 for distributors and registrants to the extent necessary to defray the costs of this section4 7,b7 ,tiered fee ,the ,administrator shall establish a tiered user fee for distributors and registrants in proportion to the volume of sales and purchases4 7g7 ,applicability of ,,faca 7#a7 ,in general ,except as provided in paragraph 7#b71 the ,federal ,advisory ,committee ,act 7#e ,u4,s4,c4 ,app47 shall apply to the ,task ,force4 7#b7 ,termination ,the ,task ,force shall terminate on the date on which the program is fully implemented under subsection 7e77#c74 7h7 ,rules of construction ,nothing in this subtitle shall be construed as relieving any manufacturer1 distributor1 or other registrant from the responsibilities of the manufacturer1 distributor1 or other registrant1 as the case may be1 to-- 7#a7 identify1 stop1 and report suspicious orders2 7#b7 maintain effective controls against diversion in accordance with section #cjc of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc72 and 7#c7 comply with the requirements established in section #acja4gd7;b7 of title #ba1 ,code of ,federal ,regulations1 or any successor regulation thereto1 with respect to suspicious orders4 ,j ,stop the ,importation and ,manufacturing of ,synthetic ,analogues #gjia4 ,establishment of schedule ,a ,section #bjb of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hab7 is amended-- 7#a7 in subsection 7a71 by striking five schedules of controlled substances1 to be known as schedules ,i1 ,,ii1 ,,iii1 ,,iv1 and ,v and inserting six schedules of controlled substances1 to be known as schedules ,i1 ,,ii1 ,,iii1 ,,iv1 ,v1 and ,a2 7#b7 in subsection 7b71 by adding at the end the following3 7#f7 ,schedule ,a 7,a7 ,in general ,the drug or substance-- 7i7 is or has been imported1 or is offered for import1 into the ,united ,states2 7ii7 has-- 7,i7 a chemical structure that is substantially similar to the chemical structure of a controlled substance in schedule ,i1 ,,ii1 ,,iii1 ,,iv1 or ,v2 and 7,,ii7 an actual or predicted stimulant1 depressant1 or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the stimulant1 depressant1 or hallucinogenic effect on the central nervous system of a controlled substance in schedule ,i1 ,,ii1 ,,iii1 ,,iv1 or ,v2 and 7iii7 is not-- 7,i7 listed or otherwise included in any other schedule in this section or by regulation of the ,attorney ,general2 and 7,,ii7 with respect to a particular person1 subject to an exemption that is in effect for investigational use1 for that person1 under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 to the extent conduct with respect to such substance is pursuant to such exemption4 7,b7 ,predicted stimulant1 depressant1 or hallucinogenic effect ,for purposes of this paragraph1 a predicted stimulant1 depressant1 or hallucinogenic effect on the central nervous system may be based on-- 7i7 7,i7 the chemical structure2 and 7,,ii7 7aa7 the structure activity relationships2 or 7bb7 binding receptor assays and other relevant scientific information about the substance2 7ii7 7,i7 the current or relative potential for abuse of the substance2 and 7,,ii7 the clandestine importation1 manufacture1 or distribution1 or diversion from legitimate channels1 of the substance2 or 7iii7 the capacity of the substance to cause a state of dependence1 including physical or psychological dependence that is similar to or greater than that of a controlled substance in schedule ,i1 ,,ii1 ,,iii1 ,,iv1 or ,v4 2 and 7#c7 in subsection 7c7-- 7,a7 in the matter preceding schedule ,i1 by striking ,,iv1 and ,v and inserting ,,iv1 ,v1 and ,a2 and 7,b7 by adding at the end the following3 ,schedule ,a ,any substance temporarily or permanently scheduled by the ,attorney ,general in accordance with section #bja7k74 4 #gjib4 ,temporary and permanent scheduling of schedule ,a substances ,section #bja of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #haa7 is amended by adding at the end the following3 7k7 ,temporary and permanent scheduling of schedule ,a substances 7#a7 ,in general ,the ,attorney ,general may issue a temporary order adding a drug or substance to schedule ,a if the ,attorney ,general finds that-- 7,a7 the drug or other substance satisfies the criteria for being considered a schedule ,a substance2 and 7,b7 adding such drug or substance to schedule ,a will assist in preventing abuse of the drug or other substance4 7#b7 ,duration of temporary scheduling order ,a temporary scheduling order issued under paragraph 7#a7 shall-- 7,a7 not take effect until #cj days after the date of the publication by the ,attorney ,general of a notice in the ,federal ,register of the intention to issue such order and the grounds upon which such order is to be issued2 and 7,b7 expire not later than #e years after the date on which the order becomes effective1 except that the ,attorney ,general may1 during the pendency of proceedings under paragraph 7#e71 extend the temporary scheduling order for up to #ahj days4 7#c7 ,effect of issuance of permanent scheduling order ,a temporary scheduling order issued under paragraph 7#a7 shall be vacated upon the issuance of a permanent order issued under paragraph 7#e7 with regard to the same substance1 or upon the subsequent issuance of any scheduling order under this section4 7#d7 ,limitation on judicial review ,a temporary scheduling order issued under paragraph 7#a7 shall not be subject to judicial review4 7#e7 ,permanent scheduling order 7,a7 ,in general ,except as provided in subparagraph 7,b71 not earlier than #c years after the date on which the ,attorney ,general issues an order temporarily scheduling a drug or substance under this subsection1 the ,attorney ,general may1 by rule1 issue a permanent order adding the drug or other substance to schedule ,a if such drug or substance satisfies the criteria for being considered a schedule ,a substance4 7,b7 ,limitation ,if the ,secretary of ,health and ,human ,services has determined1 based on relevant scientific studies and necessary data requested by the ,secretary of ,health and ,human ,services and gathered by the ,attorney ,general1 that a drug or other substance that has been temporarily placed in schedule ,a does not have sufficient potential for abuse to warrant control in any schedule1 and provides written notice of such determination to the ,attorney ,general1 the ,attorney ,general-- 7i7 may not issue a permanent scheduling order under subparagraph 7,a72 and 7ii7 not later than #cj days after the date on which the ,attorney ,general receives such notice1 shall issue an order immediately terminating the temporary scheduling order for the drug or other substance4 7#f7 ,notice to ,,hhs ,before initiating proceedings under paragraph 7#a71 the ,attorney ,general shall transmit notice of a temporary order proposed to be issued to the ,secretary of ,health and ,human ,services4 ,in issuing an order under paragraph 7#a71 the ,attorney ,general shall take into consideration any comments submitted by the ,secretary of ,health and ,human ,services in response to a notice transmitted pursuant to this paragraph4 4 #gjic4 ,penalties ,section #ajaj of the ,controlled ,substances ,import and ,export ,act 7#ba ,u4,s4,c4 #ifj7 is amended-- 7#a7 in subsection 7a71 by inserting or a drug or substance in schedule ,a after controlled substance each place it appears2 and 7#b7 in subsection 7b71 by adding at the end the following3 7#h7 ,in the case of a violation under subsection 7a7 involving a controlled substance in schedule ,a1 the person committing such violation shall be sentenced to a term of imprisonment of not more than #bj years and if death or serious bodily injury results from the use of such substance shall be sentenced to a term of imprisonment for any term of years or for life1 a fine not to exceed the greater of that authorized in accordance with the provisions of title #ah1 ,united ,states ,code1 or #a1jjj1jjj if the defendant is an individual or #e1jjj1jjj if the defendant is other than an individual1 or both4 ,if any person commits such a violation after a prior conviction for a felony drug offense has become final1 such person shall be sentenced to a term of imprisonment of not more than #cj years and if death or serious bodily injury results from the use of such substance shall be sentenced to a term of imprisonment for any term of years or for life1 a fine not to exceed the greater of twice that authorized in accordance with the provisions of title #ah1 ,united ,states ,code1 or #b1jjj1jjj if the defendant is an individual or #aj1jjj1jjj if the defendant is other than an individual1 or both4 ,notwithstanding section #cehc of title #ah1 ,united ,states ,code1 any sentence imposing a term of imprisonment under this paragraph shall1 in the absence of such a prior conviction1 impose a term of supervised release of not less than #c years in addition to such term of imprisonment and shall1 if there was such a prior conviction1 impose a term of supervised release of not less than #f years in addition to such term of imprisonment4 ,notwithstanding the prior sentence1 and notwithstanding any other provision of law1 the court shall not place on probation or suspend the sentence of any person sentenced under the provisions of this paragraph which provide for a mandatory term of imprisonment if death or serious bodily injury results4 4 #gjid4 ,false labeling of schedule ,a controlled substances 7a7 ,in general ,section #cje of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbe7 is amended by adding at the end the following3 7f7 ,false labeling of schedule ,a controlled substances 7#a7 ,it shall be unlawful to import or export1 with intent to manufacture1 distribute1 or dispense1 a schedule ,a substance or product containing a schedule ,a substance1 unless the substance or product bears a label clearly identifying a schedule ,a substance or product containing a schedule ,a substance by the nomenclature used by the ,international ,union of ,pure and ,applied ,chemistry 7,,iupac74 7#b7 7,a7 ,a product described in subparagraph 7,b7 is exempt from the ,international ,union of ,pure and ,applied ,chemistry nomenclature requirement of this subsection if such product is labeled in the manner required under the ,federal ,food1 ,drug1 and ,cosmetic ,act4 7,b7 ,a product is described in this subparagraph if the product-- 7i7 is the subject of an approved application as described in section #eje7;b7 or 7j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 or 7ii7 is exempt from the provisions of section #eje of such ,act relating to new drugs because-- 7,i7 it is intended solely for investigational use as described in section #eje7;i7 of such ,act2 and 7,,ii7 such product is being used exclusively for purposes of a clinical trial that is the subject of an effective investigational new drug application4 4 7b7 ,penalties ,section #djb of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hdb7 is amended-- 7#a7 in subsection 7a7-- 7,a7 in paragraph 7#af71 by striking or at the end2 7,b7 by redesignating paragraph 7#ag7 as paragraph 7#ah72 and 7,c7 by inserting after paragraph 7#af7 the following3 7#ag7 to violate section #cje7;f72 or 2 and 7#b7 in subsection 7c7-- 7,a7 in paragraph 7#a7-- 7i7 in subparagraph 7,b77i71 by striking 7#ag7 and inserting 7#ah72 and 7ii7 in subparagraph 7,c71 by inserting or 7#ag7 after paragraph 7#af7 each place it appears2 and 7,b7 in paragraph 7#b77;,d71 by striking 7#ag7 and inserting 7#ah74 #gjie4 ,registration requirements for importers and exporters of schedule ,a substances ,section #ajjh of the ,controlled ,substances ,import and ,export ,act 7#ba ,u4,s4,c4 #ieh7 is amended by adding at the end the following3 7j7 7#a7 ,the ,attorney ,general shall register an applicant to import or export a schedule ,a substance if-- 7,a7 the applicant demonstrates that the schedule ,a substance will be used for research1 analytical1 or industrial purposes approved by the ,attorney ,general2 and 7,b7 the ,attorney ,general determines that such registration is consistent with the public interest and with the ,united ,states obligations under international treaties1 conventions1 or protocols in effect on the date of enactment of this subsection4 7#b7 ,in determining the public interest under paragraph 7#a77;,b71 the ,attorney ,general shall consider-- 7,a7 maintenance of effective controls against diversion of particular controlled substances and any controlled substance in schedule ,a compounded therefrom into other than legitimate medical1 scientific1 research1 or industrial channels1 by limiting the importation and bulk manufacture of such controlled substances to a number of establishments which can produce an adequate and uninterrupted supply of these substances under adequately competitive conditions for legitimate medical1 scientific1 research1 and industrial purposes2 7,b7 compliance with applicable ,state and local law2 7,c7 promotion of technical advances in the art of manufacturing substances described in subparagraph 7,a7 and the development of new substances2 7,d7 prior conviction record of applicant under ,federal and ,state laws relating to the importation1 manufacture1 distribution1 or dispensing of substances described in subparagraph 7,a72 7,e7 past experience in the importation and manufacture of controlled substances1 and the existence in the establishment of effective control against diversion2 and 7,f7 such other factors as may be relevant to and consistent with the public health and safety4 7#c7 ,if an applicant is registered to import or export a controlled substance in schedule ,i or ,,ii under subsection 7a71 the applicant shall not be required to apply for a separate registration under this subsection4 4 #gjif4 ,additional conforming amendments ,the ,controlled ,substances ,import and ,export ,act 7#ba ,u4,s4,c4 #iea et seq47 is amended-- 7#a7 in section #ajjb7;a7 7#ba ,u4,s4,c4 #ieb7;a77-- 7,a7 in the matter preceding paragraph 7#a71 by inserting or drug or substance in schedule ,a after schedule ,i or ,,ii2 and 7,b7 in paragraph 7#b71 by inserting or drug or substances in schedule ,a after schedule ,i or ,,ii2 7#b7 in section #ajjc 7#ba ,u4,s4,c4 #iec7-- 7,a7 in subsection 7c71 in the matter preceding paragraph 7#a71 by inserting or drug or substance in schedule ,a after schedule ,i or ,,ii2 and 7,b7 in subsection 7d71 by inserting or drug or substance in schedule ,a after schedule ,i or ,,ii2 7#c7 in section #ajjd7a7 7#ba ,u4,s4,c4 #ied7a771 in the matter preceding subparagraph 7,a71 by inserting or drug or substance in schedule ,a after schedule ,i2 7#d7 in section #ajje 7#ba ,u4,s4,c4 #iee71 by inserting or drug or substance in schedule ,a after schedule ,i or ,,ii2 and 7#e7 in section #ajji7;a7 7#ba ,u4,s4,c4 #iei7;a771 by inserting or drug or substance in schedule ,a after schedule ,i or ,,ii4 #gjig4 ,sentencing review 7a7 ,covered offense defined ,in this section1 the term covered offense means an offense involving a schedule ,a substance for which the penalty was established under section #gjic or #gjid of this subtitle4 7b7 ,sentencing review 7#a7 ,petition for review ,if a schedule ,a substance that is temporarily or permanently scheduled under section #bja7k7 of the ,controlled ,substances ,act1 as added by this subtitle1 is subsequently descheduled or rescheduled on a schedule with lower penalties1 any individual convicted of a covered offense involving such schedule ,a substance who is awaiting sentencing or is still serving a term of imprisonment for such covered offense on the date of the descheduling or rescheduling may petition the court that imposed the sentence for a sentencing reduction hearing for such covered offense4 7#b7 ,sentencing review ,not later than #cj days after the date on which a petition is filed under paragraph 7#a71 the court shall conduct a sentencing reduction hearing and may modify the sentence of the petitioner as if the descheduling or rescheduling described in paragraph 7#a7 had been in effect on the date the covered offense was committed4 #gjih4 ,rules of construction ,nothing in this subtitle1 or the amendments made by this subtitle1 may be construed to limit-- 7#a7 the prosecution of offenses involving controlled substance analogues under the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hja et seq472 or 7#b7 the authority of the ,attorney ,general to temporarily or permanently schedule1 reschedule1 or decontrol controlled substances under provisions of section #bja of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #haa7 that are in effect on the day before the date of enactment of this ,act4 #gjii4 ,clarification of certain registration requirements related to research 7a7 ,exception for agents or employees of registered researchers ,section #cjb7;c7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbb7;c77 is amended in paragraph 7#a7 by striking or dispenser and inserting dispenser1 or researcher4 7b7 ,conforming amendment ,section #ajb7c7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hjb7c77 is amended by striking or dispenser and inserting dispenser1 or researcher4 7c7 ,single registration for contiguous research sites ,section #cjb7;e7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbb7;e77 is amended by adding at the end the following new paragraph3 7#c7 ,notwithstanding paragraph 7#a71 a person registered to conduct research with a controlled substance under section #cjc7;f7 may conduct such research under a single registration if such research occurs exclusively on a single1 contiguous campus and the registrant notifies the ,attorney ,general in writing of all sites on the campus where the research will be conducted or where the controlled substance will be stored or administered4 ,the registrant must so notify the ,attorney ,general prior to conducting research at such additional sites4 4 7d7 ,new inspection not required in certain situations ,section #cjc7;f7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc7;f77 is amended-- 7#a7 by redesignating paragraphs 7#a7 through 7#e7 as subparagraphs 7,a7 through 7,e71 respectively1 and by moving the margins of such subparagraphs two ems to the right2 7#b7 by striking 7f7 ,the and inserting 7f77#a7 ,the2 and 7#c7 by adding at the end1 after the matter following subparagraph 7,e71 as so redesignated1 the following new paragraph3 7#b7 7,a7 ,if a person is registered to conduct research with a controlled substance and applies for a registration1 or a modification of a registration to conduct research with a second controlled substance that is in the same schedule or in a schedule with a higher numerical designation1 a new inspection by the ,attorney ,general of the registered location is not required4 7,b7 ,nothing in this paragraph shall prohibit the ,attorney ,general from conducting any inspection if the ,attorney ,general deems it necessary4 4 7e7 ,continuation of research on substances newly added to schedule ,i2 authority ,to conduct research with other substances in schedule ,i ,section #cjb of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbb7 is amended by adding at the end the following new subsection3 7h7 ,continuation of research on substances newly added to schedule ,i2 authority ,to conduct research with other substances in schedule ,i 7#a7 ,if a person is conducting research on a substance at the time the substance is added to schedule ,i1 and such person is already registered to conduct research with a controlled substance in schedule ,i or ,,ii then-- 7,a7 the person shall1 within #cj days of the scheduling of the newly scheduled substance1 submit a completed application for registration or modification of existing registration1 to conduct research on such substance1 in accordance with the regulations issued by the ,attorney ,general2 7,b7 the person may1 notwithstanding subsections 7a7 and 7b71 continue to conduct the research on such substance until the application referred to in subparagraph 7,a7 is withdrawn by the applicant or until the ,attorney ,general serves on the applicant an order to show cause proposing the denial of the application pursuant to section #cjd7;c72 and 7,c7 if the ,attorney ,general serves such an order to show cause and the applicant requests a hearing1 such hearing shall be held on an expedited basis and not later than #de days after the request is made1 except that the hearing may be held at a later time if so requested by the applicant4 7#b7 7,a7 ,a person who is registered to conduct research with a controlled substance in schedule ,i may1 notwithstanding subsections 7a7 and 7b71 conduct research with another controlled substance in schedule ,i1 provided the following conditions are met3 7i7 ,the person has applied for a modification of the person's registration to authorize research with such other controlled substance in accordance with the regulations issued by the ,attorney ,general4 7ii7 ,the ,attorney ,general has obtained verification from the ,secretary that the research protocol submitted with the application is meritorious4 7iii7 ,the ,attorney ,general has determined that such activity is consistent with ,united ,states obligations under the ,single ,convention on ,narcotic ,drugs1 #aifa4 ,the ,attorney ,general shall make such determination not later than #cj days after receiving the application referred to in clause 7i74 7,b7 ,nothing in this section shall be construed to alter the authority of the ,attorney ,general to initiate proceedings to deny1 suspend1 or revoke any registration in accordance with sections #cjc and #cjd4 4 7f7 ,treatment of certain activities as coincident to research ,section #cjb of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbb71 as amended by subsection 7d71 is further amended by adding at the end the following new subsection3 7i7 ,treatment of certain activities as coincident to research 7#a7 ,in general ,except as specified in paragraph 7#b71 a person who is registered to perform research with a controlled substance may perform the following activities with small quantities of that substance1 as set forth in the relevant statement or protocol filed with the application for registration approved by the ,attorney ,general without being required to obtain a manufacturing registration3 7,a7 ,processing the substance to create extracts1 tinctures1 oils1 solutions1 derivatives1 or other forms of the substance consistent with the approved research protocol4 7,b7 ,dosage form development for the purpose of satisfying regulatory requirements implemented by the ,food and ,drug ,administration for submitting an investigational new drug application4 7#b7 ,exception regarding marihuana ,the authority under paragraph 7#a7 does not include authority to grow marihuana4 4 #gajj4 ,review of research registration process 7a7 ,review ,not later than one year after the date of the enactment of this section1 the ,attorney ,general and the ,secretary of ,health and ,human ,services shall conduct a review of the processes used to obtain or modify ,federal authorization to conduct research with controlled substances1 including-- 7#a7 an evaluation of the impacts of the amendments made by section #gjii on the risk of the diversion of controlled substances used in research and related public safety considerations2 and 7#b7 identification of opportunities to reduce any unnecessary burden on persons seeking registration1 potential redundancies1 and inefficiencies in the process to obtain or modify ,federal authorization to conduct research with controlled substances1 including the process for obtaining a registration under section #cjc of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc7 and the process by which the ,secretary of ,health and ,human ,services reviews research protocols4 7b7 ,guidance ,following the review described in subsection 7a71 the ,attorney ,general and the ,secretary of ,health and ,human ,services shall1 as appropriate1 jointly issue guidance to registrants and potential registrants clarifying the process for registration under section #cjc of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc74 ,,viii ,tax ,incentives to ,improve ,health ,care #hjja4 ,domestic medical and drug manufacturing credit 7a7 ,in general ,subpart ,d of part ,,iv of subchapter ,a of chapter #a of the ,internal ,revenue ,code of #aihf is amended by adding at the end the following new section3 #de,u4 ,domestic medical and drug manufacturing credit 7a7 ,in general ,for purposes of section #ch1 the domestic medical and drug manufacturing credit determined under this section for any taxable year is an amount equal to #aj4e percent of the lesser of-- 7#a7 the qualified medical and drug manufacturing income of the taxpayer for the taxable year1 or 7#b7 taxable income of the taxpayer for the taxable year4 7b7 ,credit limited to wages paid 7#a7 ,in general ,the amount of the credit allowable under subsection 7a7 for any taxable year shall not exceed #ej percent of the ,w-#b wages of the taxpayer for the taxable year4 7#b7 ,w-#b wages ,for purposes of this section-- 7,a7 ,in general ,the term ,w-#b wages means1 with respect to any person for any taxable year of such person1 the sum of the amounts described in paragraphs 7#c7 and 7#h7 of section #fjea7;a7 paid by such person with respect to employment of employees by such person during the calendar year ending during such taxable year4 7,b7 ,limitation to wages attributable to domestic production ,such term shall not include any amount which is not properly allocable to domestic medical and drug manufacturing gross receipts for purposes of subsection 7c77#a74 7,c7 ,return requirement ,such term shall not include any amount which is not properly included in a return filed with the ,social ,security ,administration on or before the #fjth day after the due date 7including extensions7 for such return4 7#c7 ,acquisitions1 dispositions1 and short taxable years ,the ,secretary shall provide for the application of this subsection in cases of a short taxable year or where the taxpayer acquires1 or disposes of1 the major portion of a trade or business or the major portion of a separate unit of a trade or business during the taxable year4 7c7 ,qualified medical and drug manufacturing income ,for purposes of this section-- 7#a7 ,in general ,the term qualified medical and drug manufacturing income for any taxable year means an amount equal to the excess 7if any7 of-- 7,a7 the taxpayer's domestic medical and drug manufacturing gross receipts for the taxable year1 over 7,b7 the sum of-- 7i7 the cost of goods sold that are allocable to such receipts1 and 7ii7 other expenses1 losses1 or deductions which are properly allocable to such receipts4 7#b7 ,allocation method ,the ,secretary shall prescribe rules for the proper allocation of items described in paragraph 7#a77;,b7 for purposes of determining qualified medical and drug manufacturing income4 ,such rules shall provide for the proper allocation of items whether or not such items are directly allocable to domestic medical and drug manufacturing gross receipts4 7#c7 ,special rules for determining costs 7,a7 ,in general ,for purposes of determining costs under clause 7i7 of paragraph 7#a77;,b71 any item or service brought into the ,united ,states shall be treated as acquired by purchase1 and its cost shall be treated as not less than its value immediately after it entered the ,united ,states4 7,b7 ,exports for further manufacture ,in the case of any property described in subparagraph 7,a7 that had been exported by the taxpayer for further manufacture1 the increase in cost or adjusted basis under subparagraph 7,a7 shall not exceed the difference between the value of the property when exported and the value of the property when brought back into the ,united ,states after the further manufacture4 7#d7 ,domestic medical and drug manufacturing gross receipts 7,a7 ,in general ,the term domestic medical and drug manufacturing gross receipts means the gross receipts of the taxpayer which are derived from any sale1 exchange1 or other disposition of-- 7i7 any active pharmaceutical ingredient1 or 7ii7 any qualified countermeasure1 which was manufactured or produced by the taxpayer in whole or in significant part within the ,united ,states4 7,b7 ,active pharmaceutical ingredient ,the term active pharmaceutical ingredient means any substance or mixture of substances intended to be used in the manufacture of a drug product and 7when so used7 becomes an active ingredient in the drug product4 7,c7 ,qualified countermeasure ,the term qualified countermeasure has the meaning given such term in section #cai;,f-#a7;a77#b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;a7a77#b7740 7,d7 ,partnerships owned by expanded affiliated groups ,for purposes of this paragraph1 if all of the interests in the capital and profits of a partnership are owned by members of a single expanded affiliated group at all times during the taxable year of such partnership1 the partnership and all members of such group shall be treated as a single taxpayer during such period4 7d7 ,definitions and ,special ,rules ,for purposes of this section-- 7#a7 ,application of section to pass-thru entities 7,a7 ,partnerships and s corporations ,in the case of a partnership or ,s corporation-- 7i7 this section shall be applied at the partner or shareholder level1 7ii7 each partner or shareholder shall take into account such person's allocable share of each item described in subparagraph 7,a7 or 7,b7 of subsection 7c77#a7 7determined without regard to whether the items described in such subparagraph 7,a7 exceed the items described in such subparagraph 7,b771 and 7iii7 each partner or shareholder shall be treated for purposes of subsection 7b7 as having ,w-#b wages for the taxable year in an amount equal to such person's allocable share of the ,w-#b wages of the partnership or ,s corporation for the taxable year 7as determined under regulations prescribed by the ,secretary74 7,b7 ,trusts and estates ,in the case of a trust or estate-- 7i7 the items referred to in subparagraph 7,a77ii7 7as determined therein7 and the ,w-#b wages of the trust or estate for the taxable year1 shall be apportioned between the beneficiaries and the fiduciary 7and among the beneficiaries7 under regulations prescribed by the ,secretary1 and 7ii7 for purposes of paragraph 7#b71 adjusted gross income of the trust or estate shall be determined as provided in section #fg7;e7 with the adjustments described in such paragraph4 7,c7 ,regulations ,the ,secretary may prescribe rules requiring or restricting the allocation of items and wages under this paragraph and may prescribe such reporting requirements as the ,secretary determines appropriate4 7#b7 ,application to individuals ,in the case of an individual1 subsection 7a77#b7 shall be applied by substituting adjusted gross income for taxable income4 ,for purposes of the preceding sentence1 adjusted gross income shall be determined after application of sections #hf1 #ace1 #acg1 #bai1 #bba1 #bbb1 and #dfi4 7#c7 ,special rule for affiliated groups 7,a7 ,in general ,all members of an expanded affiliated group shall be treated as a single corporation for purposes of this section4 7,b7 ,expanded affiliated group ,for purposes of this section1 the term expanded affiliated group means an affiliated group as defined in section #aejd7;a71 determined-- 7i7 by substituting more than #ej percent for at least #hj percent each place it appears1 and 7ii7 without regard to paragraphs 7#b7 and 7#d7 of section #aejd7;b74 7,c7 ,allocation of credit ,except as provided in regulations1 the credit under subsection 7a7 shall be allocated among the members of the expanded affiliated group in proportion to each member's respective amount 7if any7 of qualified medical and drug manufacturing income4 7#d7 ,trade or business requirement ,this section shall be applied by only taking into account items which are attributable to the actual conduct of a trade or business4 7#e7 ,coordination with minimum tax ,for purposes of determining alternative minimum taxable income under section #ee1 qualified medical and drug manufacturing income shall be determined without regard to any adjustments under sections #ef through #ei4 7#f7 ,unrelated business taxable income ,for purposes of determining the tax imposed by section #eaa1 subsection 7a77#a77;,b7 shall be applied by substituting unrelated business taxable income for taxable income4 7#g7 ,regulations ,the ,secretary shall prescribe such regulations as are necessary to carry out the purposes of this section1 including regulations which prevent more than #a taxpayer from being allowed a credit under this section with respect to any activity described in subsection 7c77#d77;,a74 4 7b7 ,treatment under base erosion tax ,section #ei;,a7b77#a77;,b77ii7 of such ,code is amended by striking plus at the end of subclause 7,i71 by redesignating subclause 7,,ii7 as subclause 7,,iii71 and by inserting after subclause 7,i7 the following new subclause3 7,,ii7 the credit allowed under section #ch for the taxable year which is properly allocable to the domestic medical and drug manufacturing credit determined under section #de,u7a71 plus 4 7c7 ,part of general business credit ,section #ch7;b7 of such ,code is amended by striking plus at the end of paragraph 7#cb71 by striking the period at the end of paragraph 7#cc7 and inserting 1 plus1 and by adding at the end the following new paragraph3 7#cd7 the domestic medical and drug manufacturing credit determined under section #de,u7a74 4 7d7 ,credit allowed against alternative minimum tax ,section #ch7;c77#d77;,b7 of such ,code is amended by redesignating clauses 7x7 through 7xii7 as clauses 7xi7 through 7xiii71 respectively1 and by inserting after clause 7ix7 the following new clause3 7x7 the credit determined under section #de,u1 4 7e7 ,clerical amendment ,the table of sections for subpart ,d of part ,,iv of subchapter ,a of chapter #a of such ,code is amended by adding at the end the following new item3 ,sec4 #de,u4 ,domestic medical and drug manufacturing credit4 4 7f7 ,effective date ,the amendments made by this section shall apply to taxable years beginning after ,december #ca1 #bjbj4 #hjjb4 ,qualifying advanced medical manufacturing equipment credit 7a7 ,in general ,subpart ,e of part ,,iv of subchapter ,a of chapter #a of the ,internal ,revenue ,code of #aihf is amended by adding at the end the following new section3 #dh;,d4 ,qualifying advanced medical manufacturing equipment credit 7a7 ,in general ,for purposes of section #df1 the qualifying advanced medical manufacturing equipment credit determined under this section for any taxable year is the applicable percentage of the basis of any qualifying advanced medical manufacturing equipment placed in service during such taxable year4 7b7 ,applicable percentage ,for purposes of subsection 7a71 the applicable percentage is-- 7#a7 #cj percent in the case of equipment which is placed in service before ,january #a1 #bjbh1 7#b7 #bj percent in the case of equipment which is placed in service during calendar year #bjbh1 7#c7 #aj percent in the case of equipment which is placed in service during calendar year #bjbi1 and 7#d7 #j percent in the case of equipment which is placed in service after ,december #ca1 #bjbi4 7c7 ,qualifying advanced medical manufacturing equipment ,for purposes of this section1 the term qualifying advanced medical manufacturing equipment means property of a character subject to the allowance for depreciation-- 7#a7 which is machinery or equipment that is designed and used to manufacture a-- 7,a7 drug 7as such term is defined in section #bja7;g77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act71 7,b7 device 7as such term is defined in section #bja7;h7 of such ,act71 or 7,c7 biological product 7as such term is defined in section #cea7;i7 of the ,public ,health ,service ,act71 7#b7 which has been identified by the ,secretary 7after consultation with the ,secretary of ,health and ,human ,services7 as machinery or equipment that-- 7,a7 incorporates novel technology or uses an established technique or technology in a new or innovative way1 or 7,b7 that can improve medical product quality1 address shortages of medicines1 and speed time-to-market1 7#c7 which is placed in service in the ,united ,states by the taxpayer1 and 7#d7 with respect to which depreciation is allowable4 7d7 ,certain qualified progress expenditures rules made applicable ,rules similar to the rules of subsections 7c77#d7 and 7d7 of section #df 7as in effect on the day before the enactment of the ,revenue ,reconciliation ,act of #aiij7 shall apply for purposes of this section4 7e7 ,regulations ,the ,secretary shall prescribe such regulations or other guidance as may be necessary to carry out the purposes of this section1 including regulations which prevent abuse or fraud4 4 7b7 ,treatment under base erosion tax ,section #ei;,a7b77#a77;,b77ii7 of such ,code1 as amended by section #hjja of this ,act1 is further amended by striking plus at the end of subclause 7,,ii71 by redesignating subclause 7,,iii7 as subclause 7,,iv71 and by inserting after subclause 7,,ii7 the following new subclause3 7,,iii7 the credit allowed under section #df for the taxable year which is properly allocable to the qualifying advanced medical manufacturing equipment credit determined under section #dh;,d7a71 plus 4 7c7 ,part of investment credit ,section #df of such ,code is amended by striking and at the end of paragraph 7#e71 by striking the period at the end of paragraph 7#f7 and inserting 1 and1 and by adding at the end the following new paragraph3 7#g7 the qualifying advanced medical manufacturing equipment credit4 4 7d7 ,clerical amendment ,the table of sections for subpart ,d of part ,,iv of subchapter ,a of chapter #a of such ,code is amended by adding at the end the following new item3 ,sec4 #dh;,d4 ,qualifying advanced medical manufacturing equipment credit4 4 7e7 ,effective date ,the amendments made by this section shall apply to periods after the date of the enactment of this section under rules similar to the rules of section #dh7m7 of the ,internal ,revenue ,code of #aihf 7as in effect on the date of the enactment fo the ,revenue ,reconciliation ,act of #aiij74 #hjjc4 ,new medical research expenditure component of credit for increasing research activities 7a7 ,in general ,section #da7;a7 of the ,internal ,revenue ,code of #aihf is amended by striking and at the end of paragraph 7#b71 by striking the period at the end of paragraph 7#c7 and inserting 1 and1 and by adding at the end the following new paragraph3 7#d7 #ad percent of specified medical research expenditures4 4 7b7 ,specified medical research expenditures ,section #da7;f7 of such ,code is amended by adding at the end the following new paragraph3 7#g7 ,specified medical research expenditures 7,a7 ,in general ,the term specified medical research expenditures means amounts paid or incurred for qualified research with respect to any qualified countermeasure4 7,b7 ,qualified countermeasure ,the term qualified countermeasure has the meaning given to such term in section #cai;,f-#a7;a77#b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;a7a77#b774 4 7c7 ,denial of double benefit 7#a7 ,taxable years beginning before ,january #a1 #bjba ,in the case of specified medical research expenditures 7as defined in section #da7;f77#g7 of such ,code 7as added by this section77 paid or incurred in taxable years beginning before ,january #a1 #bjba-- 7,a7 such expenditures shall be treated in the same manner as qualified research expenses and basic research expenses under section #bhj;,c7c77#a7 of such ,code 7as in effect on the day before the enactment of the ,tax ,cuts and ,jobs ,act71 and 7,b7 the amount determined under section #bhj;,c7c77#b77;,a7 7as in effect on such day7 for the taxable year shall be increased by the amount of credit determined for the taxable year under section #da7;a77#d7 7as added by this section74 7#b7 ,taxable years beginning after ,december #ca1 #bjbj ,section #bhj;,c7c77#a7 of such ,code is amended by striking section #da7;a77#a7 and inserting paragraphs 7#a7 and 7#d7 of section #da7;a74 7d7 ,conforming amendment ,section #da7;f77#a7 of such ,code is amended by striking and amounts paid or incurred to energy research consortiums each place it appears and inserting 1 amounts paid or incurred to energy research consortiums1 and specified medical research expenditures4 7e7 ,effective date ,the amendments made by this section shall apply to amounts paid or incurred after the date of the enactment of this ,act1 in taxable years ending after such date4 #hjjd4 ,refundable portion of research credit for small businesses engaging in specified medical research 7a7 ,in general ,section #da of the ,internal ,revenue ,code of #aihf is amended by adding at the end the following new subsection3 7i7 ,refundable portion for small businesses engaging in specified medical research 7#a7 ,in general ,at the election of a medical research small business1 the portion of the credit determined under this section for the taxable year which is properly allocable to specified medical research shall be treated 7other than for purposes of section #bhj;,c7 as a credit allowed under subpart ,c 7and not this subpart74 7#b7 ,medical research small business ,for purposes of this subsection1 the term medical research small business means any domestic ,c corporation-- 7,a7 which conducts any specified medical research during the taxable year1 and 7,b7 the gross receipts of which 7determined under the rules of subsection 7c77 for the taxable year do not exceed #a1jjj1jjj4 7#c7 ,specified medical research ,for purposes of this subsection1 the term specified medical research means any qualified research with respect to qualified countermeasures 7as defined in section #cai;,f-#a7;a77#b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;a7a77#b7774 7#d7 ,election ,any election under this subsection for any taxable year-- 7,a7 shall specify the amount of the credit to which such election applies1 7,b7 shall be made on or before the due date 7including extensions7 of the return of tax for the taxable year1 7,c7 may not be made for any taxable year with respect to any portion of the credit determined under this section with respect to which an election is made under subsection 7h71 and 7,d7 may be revoked only with the consent of the ,secretary4 7#e7 ,regulations ,the ,secretary shall prescribe such regulations for purposes of this subsection as may be necessary or appropriate for determining proper allocation to specified medical research of the portion of any credit allowed to a taxpayer for a taxable year under this section4 4 7b7 ,conforming amendment ,section #acbd7;b7 of title #ca1 ,united ,states ,code1 is amended by inserting #da7;i71 after #fdbh14 7c7 ,effective date ,the amendments made by this section shall apply to taxable years beginning after ,december #ca1 #bjbj4 #hjje4 ,exception from passive loss rules for investments in specified medical research small business pass-thru entities 7a7 ,in general ,subsection 7c7 of section #dfi of the ,internal ,revenue ,code of #aihf is amended by redesignating paragraphs 7#d7 through 7#g7 as paragraphs 7#e7 through 7#h71 respectively1 and by inserting after paragraph 7#c7 the following new paragraph3 7#d7 ,specified medical research activities 7,a7 ,in general ,the term passive activity shall not include any qualified medical research activity of the taxpayer carried on by a specified medical research small business pass-thru entity4 7,b7 ,treatment of losses and deductions 7i7 ,in general ,losses or deductions of a taxpayer in connection with qualified medical research activities carried on by a specified medical research small business pass-thru entity shall not be treated as losses or deductions1 respectively1 from a passive activity except as provided in clause 7ii7 and subparagraph 7,c74 7ii7 ,limitation ,clause 7i7 shall apply to losses and deductions of a taxpayer in connection with a specified medical small business pass-thru entity for a taxable year only to the extent that the aggregate losses and deductions of the taxpayer in connection with qualified medical research activities of such entity for such taxable year do not exceed the portion of the taxpayer's adjusted basis in the taxpayer's ownership interest in such entity that is attributable to money or other property contributed-- 7,i7 in exchange for such ownership interest1 and 7,,ii7 specifically for use in connection with qualified medical research activities4 ,for purposes of the preceding sentence1 the taxpayer's basis shall not include any portion of such basis which is attributable to an increase in a partner's share of the liabilities of a partnership that is considered under section #geb7;a7 as a contribution of money4 7,c7 ,treatment of carryovers ,subparagraph 7,b77i7 shall not apply to the portion of any loss or deduction that is carried over under subsection 7b7 into a taxable year other than the taxable year in which such loss or deduction arose4 7,d7 ,qualified medical research activity ,for purposes of this paragraph1 the term qualified medical research activity means any qualified research 7within the meaning of section #da7;d77 with respect to qualified countermeasures 7as defined in section #cai;,f-#a7;a77#b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;a7a77#b7774 7,e7 ,specified medical research small business pass-thru entity ,for purposes of this paragraph1 the term specified medical research small business pass-thru entity means any domestic pass-thru entity for any taxable year if-- 7i7 more than #hj percent of such entity's expenditures on qualified research for such taxable year are paid or incurred in connection with qualified medical research activities1 and 7ii7 the gross receipts 7as determined under the rules of section #da7;h77#c77 of such entity for the taxable year 7and each preceding taxable year7 is less than #a1jjj1jjj4 7,f7 ,capital expenditures taken into account for expenditures test ,an expenditure shall not fail to be taken into account under subparagraph 7,e77i7 merely because such expenditure is chargeable to capital account4 7,g7 ,pass-thru entity ,for purposes of this paragraph1 the term pass-thru entity means any partnership1 ,s corporation1 or other entity identified by the ,secretary as a pass-thru entity for purposes of this paragraph4 7,h7 ,aggregation rules 7i7 ,in general ,all persons treated as a single employer under subsection 7a7 or 7b7 of section #eb1 or subsection 7m7 or 7o7 of section #dad1 shall be treated as a single entity for purposes of subparagraphs 7,e7 and 7,f77iii74 7ii7 ,limitation where entity would not qualify ,no entity shall be treated as a specified medical research small business pass-thru entity unless such entity qualifies as such both with and without the application of clause 7i74 4 7b7 ,material participation not required ,paragraph 7#e7 of section #dfi7;c7 of the ,internal ,revenue ,code of #aihf1 as redesignated by subsection 7a71 is amended by striking and 7#c7 in the heading and text and inserting 1 7#c71 and 7#d74 7c7 ,certain research-,related deductions and credits of specified medical research small business pass-,thru entities allowed for purposes of determining alternative minimum tax 7#a7 ,deduction for research and experimental expenditures ,paragraph 7#b7 of section #ef7;b7 of the ,internal ,revenue ,code of #aihf is amended by adding at the end the following new subparagraph3 7,e7 ,exception for specified medical research small business pass-thru entities ,in the case of a specified medical research small business pass-thru entity 7as defined in section #dfi7;c77#d771 this paragraph shall not apply to any amount allowable as a deduction under section #agd7;a74 4 7#b7 ,allowance of certain research-related credits ,subparagraph 7,b7 of section #ch7;c77#d7 of such ,code is amended by redesignating clauses 7ii7 through 7ix7 as clauses 7iii7 through 7x71 respectively1 and by inserting after clause 7i7 the following new clause3 7ii7 the credit of an individual taxpayer determined under section #da to the extent attributable to a specified medical research small business pass-thru entity 7as defined in section #dfi7;c77#d771 4 7d7 ,exception to limitation on pass-,thru of research credit ,subsection 7g7 of section #da of such ,code is amended by adding at the end the following3 ,paragraphs 7#b7 and 7#d7 shall not apply with respect to any specified medical research small business pass-thru entity 7as defined in section #dfi7;c77#d7744 7e7 ,effective date ,the amendments made by this section shall apply to losses and credits arising in taxable years beginning after ,december #ca1 #bjbj4 #hjjf4 ,temporary carryover for health and dependent care flexible spending arrangements 7a7 ,in general ,with respect to the #bjbj plan year for any health flexible spending arrangement or any dependent care flexible spending arrangement1 an employer may elect to amend its cafeteria plan to permit any unused amounts remaining in such flexible spending arrangement at the end of such plan year to be carried over to the #bjba plan year1 pursuant to rules similar to the rules established for health flexible spending arrangements under ,internal ,revenue ,service ,notice #bjac-ga4 7b7 ,retroactive application ,an employer shall be permitted to amend its cafeteria plan to effectuate the rule described in subsection 7a71 provided that such amendment-- 7#a7 is adopted before ,january #a1 #bjba2 and 7#b7 provides that the rule described in such subsection shall be in effect as of the first day of the #bjbj plan year4 7c7 ,definitions ,any term used in this section which is also used in section #abe of the ,internal ,revenue ,code of #aihf or the regulations thereunder shall have the same meaning as when used in such section or regulations4 #hjjg4 ,increase in exclusion for employer-provided dependent care assistance 7a7 ,in general ,section #abi7;a77#b7 of the ,internal ,revenue ,code of #aihf is amended by adding at the end the following new subparagraph3 7,d7 ,special rule for #bjbj and #bjba ,in the case of any taxable year beginning during #bjbj or #bjba1 subparagraph 7,a7 shall be applied by substituting #aj1ejj 7#e1bej for #e1jjj 7#b1ejj4 4 7b7 ,effective date ,the amendment made by this section shall apply to taxable years beginning after ,december #ca1 #bjai4 7c7 ,retroactive plan amendments ,a plan or other arrangement that otherwise satisfies all applicable requirements of sections #ajf1 #abe1 and #abi of the ,internal ,revenue ,code of #aihf 7including any rules or regulations thereunder7 shall not fail to be treated as a cafeteria plan or dependent care flexible spending arrangement merely because such plan or arrangement is amended pursuant to a provision under this section and such amendment is retroactive1 if-- 7#a7 such amendment is adopted no later than the last day of the plan year in which the amendment is effective1 and 7#b7 the plan or arrangement is operated consistent with the terms of such amendment during the period beginning on the effective date of the amendment and ending on the date the amendment is adopted4 #hjjh4 ,temporary increase in contribution limits for health savings accounts 7a7 ,in general ,section #bbc7;b7 of the ,internal ,revenue ,code of #aihf is amended by adding at the end the following new paragraph3 7#i7 ,increase in monthly limitations for taxable years #bjbj and #bjba ,in the case of any month during a taxable year which begins after ,december #ca1 #bjai1 and before ,january #a1 #bjbb1 the dollar amount in effect under subparagraph 7,a7 or 7,b7 of paragraph 7#b7 for such month shall be twice the amount otherwise applicable under such subparagraph1 as determined-- 7,a7 before application of paragraph 7#c71 7,b7 after application of subsection 7g71 and 7,c7 without regard to this paragraph4 4 7b7 ,effective date ,the amendment made by this section shall apply with respect to taxable years beginning after ,december #ca1 #bjai4 #hjji4 ,temporary allowance of payments for employment-related expenses under health savings accounts 7a7 ,in general ,section #bbc7;d77#b7 of the ,internal ,revenue ,code of #aihf is amended by adding at the end the following new subparagraph3 7,e7 ,inclusion of employment-related expenses for taxable years #bjbj and #bjba ,in the case of any taxable year which begins after ,december #ca1 #bjai1 and before ,january #a1 #bjbb1 the term qualified medical expenses includes1 with respect to an account beneficiary1 any amounts paid by such beneficiary for employment-related expenses 7as defined in section #ba7;b77#b77 which are incurred during such taxable year4 4 7b7 ,conforming amendment ,section #ba7;c7 of the ,internal ,revenue ,code of #aihf is amended by inserting and any amounts paid or distributed out of a health savings account which are used exclusively to pay expenses described in section #bbc7;d77#b77;,e7 which are incurred by the taxpayer during such taxable year before the period at the end of the second sentence4 7c7 ,effective date ,the amendments made by this section shall apply with respect to taxable years beginning after ,december #ca1 #bjai4 #hjaj4 ,treatment of direct primary care service arrangements 7a7 ,in general ,section #bbc7;c77#a7 of the ,internal ,revenue ,code of #aihf is amended by adding at the end the following new subparagraph3 7,d7 ,treatment of direct primary care service arrangements 7i7 ,in general ,a direct primary care service arrangement shall not be treated as a health plan for purposes of subparagraph 7,a77ii74 7ii7 ,direct primary care service arrangement ,for purposes of this paragraph-- 7,i7 ,in general ,the term direct primary care service arrangement means1 with respect to any individual1 an arrangement under which such individual is provided medical care 7as defined in section #bac7;d77 consisting solely of primary care services provided by primary care practitioners 7as defined in section #ahcc7x77#b77;,a7 of the ,social ,security ,act1 determined without regard to clause 7ii7 thereof71 if the sole compensation for such care is a fixed periodic fee4 7,,ii7 ,limitation ,with respect to any individual for any month1 such term shall not include any arrangement if the aggregate fees for all direct primary care service arrangements 7determined without regard to this subclause7 with respect to such individual for such month exceed #aej 7twice such dollar amount in the case of an individual with any direct primary care service arrangement 7as so determined7 that covers more than one individual74 7iii7 ,certain services specifically excluded from treatment as primary care services ,for purposes of this subparagraph1 the term primary care services shall not include-- 7,i7 procedures that require the use of general anesthesia1 and 7,,ii7 laboratory services not typically administered in an ambulatory primary care setting4 ,the ,secretary1 after consultation with the ,secretary of ,health and ,human ,services1 shall issue regulations or other guidance regarding the application of this clause4 4 7b7 ,direct primary care service arrangement fees treated as medical expenses ,section #bbc7;d77#b77;,c7 of the ,internal ,revenue ,code of #aihf is amended by striking or at the end of clause 7iii71 by striking the period at the end of clause 7iv7 and inserting 1 or1 and by adding at the end the following new clause3 7v7 any direct primary care service arrangement4 4 7c7 ,inflation adjustment ,section #bbc7;g77#a7 of the ,internal ,revenue ,code of #aihf is amended-- 7#a7 by inserting 1 7c77#a77;,d77ii77,,ii71 after 7b77#b71 each place such term appears1 and 7#b7 in subparagraph 7,b71 by inserting and 7iii7 after clause 7ii7 in clause 7i71 by striking and at the end of clause 7i71 by striking the period at the end of clause 7ii7 and inserting 1 and1 and by inserting after clause 7ii7 the following new clause3 7iii7 in the case of the dollar amount in subsection 7c77#a77;,d77ii77,,ii7 for taxable years beginning in calendar years after #bjbj1 calendar year #bjai4 4 7d7 ,reporting of direct primary care service arrangement fees on ,w-#b ,section #fjea7;a7 of the ,internal ,revenue ,code of #aihf is amended by striking and at the end of paragraph 7#af71 by striking the period at the end of paragraph 7#ag7 and inserting 1 and1 and by inserting after paragraph 7#ag7 the following new paragraph3 7#ah7 in the case of a direct primary care service arrangement 7as defined in section #bbc7;c77#a77;,d77ii77 which is provided in connection with employment1 the aggregate fees for such arrangement for such employee4 4 7e7 ,effective date 7#a7 ,in general ,except as provided under paragraph 7#b71 the amendments made by this section shall apply to months beginning after ,december #ca1 #bjai1 in taxable years ending after such date4 7#b7 ,inflation adjustment ,the amendments made by subsection 7c7 shall apply to taxable years beginning in calendar years beginning after ,december #ca1 #bjbj4 #hjaa4 ,allow both spouses to make catch-up contributions to the same ,,hsa account 7a7 ,in general ,paragraph 7#e7 of section #bbc7;b7 of the ,internal ,revenue ,code of #aihf is amended to read as follows3 7#e7 ,special rule for married individuals with family coverage 7,a7 ,in general ,in the case of individuals who are married to each other1 if both spouses are eligible individuals and either spouse has family coverage under a high deductible health plan as of the first day of any month-- 7i7 the limitation under paragraph 7#a7 shall be applied by not taking into account any other high deductible health plan coverage of either spouse 7and if such spouses both have family coverage under separate high deductible health plans1 only one such coverage shall be taken into account71 7ii7 such limitation 7after application of clause 7i77 shall be reduced by the aggregate amount paid to ,archer ,m,s,as of such spouses for the taxable year1 and 7iii7 such limitation 7after application of clauses 7i7 and 7ii77 shall be divided equally between such spouses unless they agree on a different division4 7,b7 ,treatment of additional contribution amounts ,if both spouses referred to in subparagraph 7,a7 have attained age #ee before the close of the taxable year1 the limitation referred to in subparagraph 7,a77iii7 which is subject to division between the spouses shall include the additional contribution amounts determined under paragraph 7#c7 for both spouses4 ,in any other case1 any additional contribution amount determined under paragraph 7#c7 shall not be taken into account under subparagraph 7,a77iii7 and shall not be subject to division between the spouses4 4 7b7 ,effective date ,the amendment made by this section shall apply to taxable years beginning after ,december #ca1 #bjai4 #hjab4 ,repeal of ceiling on deductible and out-of-pocket expenses under a high deductible health plan 7a7 ,in general ,subparagraph 7,a7 of section #bbc7;c77#b7 of the ,internal ,revenue ,code of #aihf is amended to read as follows3 7,a7 ,high deductible health plan ,the term high deductible health plan means a health plan which has an annual deductible which is not less than-- 7i7 #a1jjj for self-only coverage1 and 7ii7 twice the dollar amount in clause 7i7 for family coverage4 4 7b7 ,conforming amendments 7#a7 ,subparagraph 7,d7 of section #bbc7;c77#b7 of the ,internal ,revenue ,code of #aihf is amended to read as follows3 7,d7 ,special rule for network plans ,in the case of a plan using a network of providers1 such plan's annual deductible for services provided outside of such network shall not be taken into account for purposes of subsection 7b77#b74 4 7#b7 ,clause 7ii7 of section #bbc7;g77#a77;,b7 of such ,code is amended by striking each dollar amount in subsection 7c77#b77;,a7 and inserting the dollar amount in subsection 7c77#b77;,a77i74 7c7 ,effective date ,the amendments made by this section shall apply with respect to taxable years beginning after ,december #ca1 #bjai4 #hjac4 ,on-site employee clinics 7a7 ,in general ,paragraph 7#a7 of section #bbc7;c7 of the ,internal ,revenue ,code of #aihf1 as amended by section #hjaj of this ,act1 is amended by adding at the end the following new subparagraph3 7,e7 ,special rule for qualified items and services 7i7 ,in general ,for purposes of subparagraph 7,a77ii71 an individual shall not be treated as covered under a health plan described in subclauses 7,i7 and 7,,ii7 of such subparagraph merely because the individual is eligible to receive1 or receives1 qualified items and services-- 7,i7 at a healthcare facility located at a facility owned or leased by the employer of the individual 7or of the individual's spouse71 or 7,,ii7 at a healthcare facility operated primarily for the benefit of employees of the employer of the individual 7or of the individual's spouse74 7ii7 ,qualified items and services defined ,for purposes of this subparagraph1 the term qualified items and services means the following3 7,i7 ,physical examination4 7,,ii7 ,immunizations1 including injections of antigens provided by employees4 7,,iii7 ,drugs or biologicals other than a prescribed drug 7as such term is defined in section #bac7;d77#c774 7,,iv7 ,treatment for injuries occurring in the course of employment4 7,v7 ,preventive care for chronic conditions 7as defined in clause 7iv774 7,,vi7 ,drug testing4 7,,vii7 ,hearing or vision screenings and related services4 7iii7 ,aggregation ,for purposes of clause 7i71 all persons treated as a single employer under subsection 7b71 7c71 7m71 or 7o7 of section #dad shall be treated as a single employer4 7iv7 ,preventive care for chronic conditions ,for purposes of this subparagraph1 the term preventive care for chronic conditions means any item or service specified in the ,appendix of ,internal ,revenue ,service ,notice #bjai-de which is prescribed to treat an individual diagnosed with the associated chronic condition specified in such ,appendix for the purpose of preventing the exacerbation of such chronic condition or the development of a secondary condition1 including any amendment1 addition1 removal1 or other modification made by the ,secretary 7pursuant to the authority granted to the ,secretary under paragraph 7#b77;,c77 to the items or services specified in such ,appendix subsequent to the date of enactment of this subparagraph4 4 7b7 ,effective date ,the amendments made by this section shall apply to months in taxable years beginning after the date of enactment of this ,act4 #hjad4 ,adjustment of medical expense deduction 7a7 ,in general ,section #bac of the ,internal ,revenue ,code of #aihf is amended-- 7#a7 in subsection 7a71 by striking #aj percent and inserting #g4e percent1 and 7#b7 by striking subsection 7f7 and inserting the following3 7f7 ,temporary special rule ,in the case of any taxable year beginning after ,december #ca1 #bjai1 and ending before ,january #a1 #bjbb1 subsection 7a7 shall be applied with respect to a taxpayer by substituting #e percent for #g4e percent4 4 7b7 ,effective date ,the amendments made by this section shall apply to taxable years beginning after ,december #ca1 #bjai4 #hjae4 ,healthy workplace tax credit 7a7 ,in general ,in the case of an employer1 there shall be allowed as a credit against applicable employment taxes for each calendar quarter an amount equal to #ej percent of the sum of-- 7#a7 the qualified employee protection expenses paid or incurred by the employer during such calendar quarter1 7#b7 the qualified workplace reconfiguration expenses paid or incurred by the employer during such calendar quarter1 7#c7 the qualified workplace technology expenses paid or incurred by the employer during such calendar quarter1 and 7#d7 the qualified workplace training expenses paid or incurred by the employer during such calendar quarter4 7b7 ,limitations and refundability 7#a7 ,overall dollar limitation on credit 7,a7 ,in general ,the amount of the credit allowed under subsection 7a7 with respect to any employer for any calendar quarter shall not exceed the excess 7if any7 of-- 7i7 the applicable dollar limit with respect to such employer for such calendar quarter1 over 7ii7 the aggregate credits allowed under subsection 7a7 with respect to such employer for all preceding calendar quarters4 7,b7 ,applicable dollar limit ,the term applicable dollar limit means1 with respect to any employer for any calendar quarter1 the sum of-- 7i7 #a1jjj1 multiplied so much of the average number of employees employed by such employer during such calendar quarter as does not exceed #ejj1 plus 7ii7 #gej1 multiplied by so much of such average number of employees as exceeds #ejj but does not exceed #a1jjj1 plus 7iii7 #ejj1 multiplied by so much of such average number of employees as exceeds #a1jjj4 7#b7 ,credit limited to employment taxes ,the credit allowed by subsection 7a7 with respect to any calendar quarter shall not exceed the applicable employment taxes 7reduced by any credits allowed under subsections 7e7 and 7f7 of section #caaa of the ,internal ,revenue ,code of #aihf1 sections #gjja and #gjjc of the ,families ,first ,coronavirus ,response ,act1 and section #bcja of the ,,cares ,act7 on the wages paid with respect to the employment of all the employees of the eligible employer for such calendar quarter4 7#c7 ,refundability of excess credit 7,a7 ,in general ,if the amount of the credit under subsection 7a7 exceeds the limitation of paragraph 7#b7 for any calendar quarter1 such excess shall be treated as an overpayment that shall be refunded under sections #fdjb7;a7 and #fdac7;b7 of the ,internal ,revenue ,code of #aihf4 7,b7 ,treatment of payments ,for purposes of section #acbd of title #ca1 ,united ,states ,code1 any amounts due to the employer under this paragraph shall be treated in the same manner as a refund due from a credit provision referred to in subsection 7b77#b7 of such section4 7c7 ,qualified employee protection expenses ,for purposes of this section1 the term qualified employee protection expenses means amounts paid or incurred by the employer for-- 7#a7 testing employees of the employer for ,,covid-#ai 7including on a periodic basis71 7#b7 equipment to protect employees of the employer from contracting ,,covid-#ai1 including masks1 gloves1 and disinfectants1 and 7#c7 cleaning products or services 7whether provided by an employee of the taxpayer or a cleaning service provider7 related to preventing the spread of ,,covid-#ai4 7d7 ,qualified workplace reconfiguration expenses ,for purposes of this section-- 7#a7 ,in general ,the term qualified workplace reconfiguration expenses means amounts paid or incurred by the employer to design and reconfigure retail space1 work areas1 break areas1 or other areas that employees or customers regularly use in the ordinary course of the employer's trade or business if such design and reconfiguration-- 7,a7 has a primary purpose of preventing the spread of ,,covid-#ai1 7,b7 is with respect to an area that is located in the ,united ,states and that is leased or owned by the employer1 7,c7 is consistent with the purpose of the property immediately before the reconfiguration1 7,d7 is commensurate with the risks faced by the employees or customers or is consistent with recommendations made by the ,centers for ,disease ,control and ,prevention or the ,occupational ,safety and ,health ,administration1 7,e7 is completed pursuant to a reconfiguration plan and no comparable reconfiguration plan was in place before ,march #ac1 #bjbj1 and 7,f7 is completed before ,january #a1 #bjba4 7#b7 ,regulations ,the ,secretary shall prescribe such regulations and other guidance as may be necessary or appropriate to carry out the purposes of this subsection1 including guidance defining primary purpose and reconfiguration plan4 7e7 ,qualified workplace technology expenses ,for purposes of this section-- 7#a7 ,in general ,the term qualified workplace technology expenses means amounts paid or incurred by the employer for technology systems that employees or customers use in the ordinary course of the employer's trade or business if such technology system-- 7,a7 has a primary purpose of preventing the spread of ,,covid-#ai1 7,b7 is used for limiting physical contact between customers and employees in the ,united ,states1 7,c7 is commensurate with the risks faced by the employees or customers or is consistent with recommendations made by the ,centers for ,disease ,control and ,prevention or the ,occupational ,safety and ,health ,administration1 7,d7 is acquired by the taxpayer after ,march #ab1 #bjbj1 and is not acquired pursuant to a written binding contract entered into before such date1 and 7,e7 is placed in service by the taxpayer before ,january #a1 #bjba4 7#b7 ,technology systems ,the term technology systems means computer software 7as defined in section #afg7;f77#a77 and qualified technological equipment 7as defined in section #afh7;i77#b774 7#c7 ,regulations ,the ,secretary shall prescribe such regulations and other guidance as may be necessary or appropriate to carry out the purposes of this subsection1 including guidance defining primary purpose4 7f7 ,qualified workplace training expenses ,for purposes of this section1 the term qualified workplace training expenses means amounts paid or incurred by the employer for education and training with respect to industry best practices that ensure-- 7#a7 the health and safety of employees in the workplace with respect to ,,covid-#ai1 and 7#b7 the prevention of the spread of ,,covid-#ai in the workplace4 7g7 ,other definitions ,for purposes of this section-- 7#a7 ,applicable employment taxes ,the term applicable employment taxes means the following3 7,a7 ,the taxes imposed under section #caaa7;a7 of the ,internal ,revenue ,code of #aihf4 7,b7 ,so much of the taxes imposed under section #cbba7;a7 of such ,code as are attributable to the rate in effect under section #caaa7;a7 of such ,code4 7#b7 ,,covid-#ai ,except where the context clearly indicates otherwise1 any reference in this section to ,,covid-#ai shall be treated as including a reference to the virus which causes ,,covid-#ai4 7#c7 ,secretary ,the term ,secretary means the ,secretary of the ,treasury or the ,secretary's delegate4 7#d7 ,other terms ,any term used in this section 7other than subsection 7b77#a77;,b77 which is also used in chapter #ba or #bb of the ,internal ,revenue ,code of #aihf shall have the same meaning as when used in such chapter4 7h7 ,certain governmental employers ,this credit shall not apply to the ,government of the ,united ,states1 the government of any ,state or political subdivision thereof1 or any agency or instrumentality of any of the foregoing4 7i7 ,special rules 7#a7 ,aggregation rule ,all persons treated as a single employer under subsection 7a7 or 7b7 of section #eb of the ,internal ,revenue ,code of #aihf1 or subsection 7m7 or 7o7 of section #dad of such ,code1 shall be treated as one employer for purposes of this section4 7#b7 ,denial of double benefit 7,a7 ,in general ,rules similar to the rules of paragraphs 7#a7 and 7#b7 of section #bhj;,c7b7 shall apply for purposes of this section4 7,b7 ,expenses not taken into account more than once ,any qualified workplace reconfiguration expense or qualified workplace technology expense shall not be treated as a qualified employee protection expense and any qualified workplace technology expense shall not be treated as a qualified workplace reconfiguration expense4 7#c7 ,third-party payors ,any credit allowed under this section shall be treated as a credit described in section #ceaa7;d77#b7 of such ,code4 7#d7 ,election not to have section apply ,this section shall not apply with respect to any eligible employer for any calendar quarter if such employer elects 7at such time and in such manner as the ,secretary may prescribe7 not to have this section apply4 7j7 ,transfers to certain trust funds ,there are hereby appropriated to the ,federal ,old-,age and ,survivors ,insurance ,trust ,fund and the ,federal ,disability ,insurance ,trust ,fund established under section #bja of the ,social ,security ,act 7#db ,u4,s4,c4 #dja7 and the ,social ,security ,equivalent ,benefit ,account established under section #ae;,a7a7 of the ,railroad ,retirement ,act of #aigd 7#de ,u4,s4,c4 #bcan-#a7;a77 amounts equal to the reduction in revenues to the ,treasury by reason of this section 7without regard to this subsection74 ,amounts appropriated by the preceding sentence shall be transferred from the general fund at such times and in such manner as to replicate to the extent possible the transfers which would have occurred to such ,trust ,fund or ,account had this section not been enacted4 7k7 ,treatment of deposits ,the ,secretary shall waive any penalty under section #ffef of the ,internal ,revenue ,code of #aihf for any failure to make a deposit of any applicable employment taxes if the ,secretary determines that such failure was due to the reasonable anticipation of the credit allowed under this section4 7l7 ,regulations and guidance ,the ,secretary shall prescribe such regulations and other guidance as may be necessary or appropriate to carry out the purposes of this section1 including-- 7#a7 with respect to the application of the credit under subsection 7a7 to third-party payors 7including professional employer organizations1 certified professional employer organizations1 or agents under section #cejd of the ,internal ,revenue ,code of #aihf71 regulations or other guidance allowing such payors to submit documentation necessary to substantiate the amount of the credit allowed under subsection 7a71 and 7#b7 regulations or other guidance to prevent abusive transactions4 7m7 ,application ,this section shall only apply to amounts paid or incurred after ,march #ab1 #bjbj1 and before ,january #a1 #bjba4 ,,ix ,medicare ,provisions ,a ,telehealth #ijja4 ,removing certain geographic and originating site restrictions on the furnishing of telehealth services under the ,medicare program ,section #ahcd7m77#d77;,c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77#d77;,c77 is amended-- 7#a7 in clause 7i71 by inserting 1 with respect to services furnished on or after ,january #a1 #bjbd1 after telecommunications system and2 and 7#b7 in clause 7ii77,x71 by inserting 1 with respect to services furnished on or after ,january #a1 #bjbd1 after but4 #ijjb4 ,making permanent ,,fqhc and ,,rhc telehealth payments ,section #ahcd7m77#f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77#h771 as so redesignated by section #b7g71 is amended-- 7#a7 in the header1 by striking during emergency period2 7#b7 in subparagraph 7,a71 in the matter preceding clause 7i71 by striking ,during and inserting ,with respect to services furnished on or after the first day of2 and 7#c7 in subparagraph 7,b77i71 by striking during such emergency period4 #ijjc4 ,expanding the list of practitioners eligible to furnish telehealth services ,section #ahcd7m7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77 is amended-- 7#a7 in paragraph 7#a71 by striking described in section #ahdb7;b77#ah77;,c7 and inserting as defined in paragraph 7#d77;,e72 7#b7 in paragraph 7#c77;,b71 by inserting described in subparagraph 7,c7 of such section after practitioners2 and 7#c7 in paragraph 7#d71 by amending subparagraph 7,e7 to read as follows3 7,e7 ,practitioner ,the term practitioner means a practitioner described in section #ahdb7;b77#ah77;,c7 and includes1 with respect to services furnished before ,january #a1 #bjbd1 any supplier 7other than a physician7 permitted to receive payment for a telehealth service under this section as of the date of the enactment of this subparagraph pursuant to a waiver in effect as of such date under section #aace4 4 #ijjd4 ,allowing for the provision of telehealth services via audio-only telecommunications systems ,section #ahcd7m77#d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77#d77 is amended by adding at the end the following new subparagraph3 7,g7 ,telecommunications system 7i7 ,in general ,the term telecommunications system includes1 in the case of a telehealth service furnished by a qualified provider 7as defined in clause 7ii77 to an individual located at an originating site before ,january #a1 #bjbd1 a communications system consisting of only audio capabilities1 but only if such individual does not have access to a communications system with audio-visual capabilities at such site4 7ii7 ,qualified provider ,for purposes of clause 7i71 the term qualified provider means1 with respect a telehealth service furnished to an individual1 a physician or practitioner who-- 7,i7 furnished to such individual an item or service 7other than such telehealth service7 for which payment was made under any group health plan 7as defined in section #bgia of the ,public ,health ,service ,act71 health insurance coverage 7as so defined71 ,federal health care program 7as defined in section #aabh;,b7f771 or the health care program under chapter #hi of title #e1 ,united ,states ,code1 during the #c-year period ending on the date such telehealth service was furnished2 or 7,,ii7 is in the same practice 7as determined by tax identification number7 of a physician or practitioner who furnished such an item or service to such individual during such period4 4 #ijje4 ,making permanent the safe harbor for absence of deductible for telehealth 7a7 ,in general ,section #bbc7;c77#b77;,e7 of the ,internal ,revenue ,code of #aihf is amended by striking ,in the case of plan years beginning on or before ,december #ca1 #bjba1 a and inserting ,a4 7b7 ,certain coverage disregarded ,section #bbc7;c77#a77;,b77ii7 of the ,internal ,revenue ,code of #aihf is amended by striking 7in the case of plan years beginning on or before ,december #ca1 #bjba74 #ijjf4 ,removing requirement for face-to-face visits between home dialysis patients and physicians 7a7 ,in general ,section #ahha7;b77#c77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acierr7b77#c77;,b77 is amended-- 7#a7 in clause 7i71 by striking clauses 7ii7 and 7iii7 and inserting clause 7ii72 7#b7 in clause 7ii71 by inserting or 7iv7 after clause 7iii72 7#c7 by moving clause 7iii7 #f ems to the left2 and 7#d7 by adding at the end the following new clause3 7iv7 ,clause 7ii7 shall not apply to monthly end stage renal disease-related clinical assessments furnished before ,january #a1 #bjbd1 in the case of an individual who has received in-person training with respect to home dialysis4 4 7b7 ,waiver authority 7#a7 ,in general ,notwithstanding any provision of section #aace of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;b-#e71 the ,secretary of ,health and ,human ,services may1 with respect to a specified waiver 7as defined in paragraph 7#b771 continue such waiver in effect for any period of time before ,january #a1 #bjbd4 7#b7 ,definition ,in this subsection1 the term specified waiver means a waiver in effect on the date of the enactment of this ,act that1 with respect to any provision of title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq47 that requires an in-person visit with a provider of services or supplier 7as such terms are defined in section #ahfa of such ,act 7#db ,u4,s4,c4 #aciex77 as a prerequisite for payment of any item or service under such title or for any other purpose1 modifies such provision to allow such visit to be conducted through the use of telehealth4 #ijjg4 ,report on telehealth payment integrity ,not later than #a year after the date of the enactment of this ,act1 the ,inspector ,general of the ,department of ,health and ,human ,services shall review claims for payment for telehealth services furnished under the ,medicare program during the emergency period described in section #aace7;g77#a77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;b-#e7;g77#a77;,b77 and submit to ,congress a report on any instances of waste1 fraud1 or abuse identified through such review4 #ijjh4 ,increasing funding for review of telehealth claims ,there are authorized to be appropriated to the ,inspector ,general of the ,department of ,health and ,human ,services #aj1jjj1jjj for fiscal years #bjba through #bjbc for purposes of conducting audits and other oversight activities with respect to payments made under section #ahcd7m7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m774 #ijji4 ,telehealth resources ,not later than #f months after the last day of the emergency period described in section #aace7;g77#a77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;b-#e7;g77#a77;,b771 the ,secretary of ,health and ,human ,services shall develop and make available to physicians 7as defined in section #ahfa7r7 of such ,act 7#db ,u4,s4,c4 #aciex7r777 and practitioners 7as defined in section #ahcd7m77#d77;,e7 of such ,act 7#db ,u4,s4,c4 #aciem7m77#d77;,e777 educational resources and training sessions on requirements relating to the furnishing of telehealth services under section #ahcd7m7 of such ,act 7#db ,u4,s4,c4 #aciem7m774 ,b ,protecting ,access to ,innovation ,during ,,covid-#ai #ijaa4 ,authorizing the extension of pass-through status under the ,medicare program for certain drugs and devices impacted by ,,covid-#ai ,section #ahcc7t77#f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7t77#f77 is amended by adding at the end the following new subparagraph3 7,k7 ,authority to extend pass-through status for certain drugs and devices impacted by ,,covid-#ai 7i7 ,in general ,notwithstanding the preceding provisions of this paragraph1 in the case of an eligible drug or device 7as defined in clause 7iv771 if the ,secretary determines1 prior to or on the date of the expiration of pass-through status for such drug or device 7or1 in the case of such a drug or device whose pass-through status expired before the date of the enactment of this subparagraph1 not later than #cj days after such date71 that the cost of such drug or device is unable to be accurately calculated due to the effects of ,,covid-#ai1 the ,secretary may extend the pass-through status of such eligible drug or device in accordance with clause 7ii74 7ii7 ,extension ,the ,secretary may extend the pass-through status of an eligible drug or device described in clause 7i7 with respect to which a determination has been made under such clause-- 7,i7 in the case of a drug or device whose period of pass-through status expired during the emergency period described in section #aace7;g77#a77;,b7 before the date of the enactment of this subparagraph1 for a period beginning on the first day after such period of up to the number of days occurring during such period during which such drug or device had pass-through status2 7,,ii7 in the case of a drug or device whose period of pass-through status would otherwise expire during such emergency period on or after such date of enactment-- 7aa7 for the remainder of such period2 and 7bb7 for a period beginning on the first day after such period of up to the number of days occurring during such period during which such drug or device had pass-through status 7not taking into account any extension of such status pursuant to this subclause72 and 7,,iii7 in the case of a drug or device not described in subclause 7,i7 or 7,,ii71 by the number of days occurring during such emergency period during which such drug or device had pass-through status4 7iii7 ,special rules for already-expired drugs and devices ,in the case of an eligible drug or device described in clause 7ii77,i7 for which payment under this subsection was packaged into a payment for a covered ,,opd service 7or group of services7 and whose period of pass-through status is extended in accordance with such clause1 the ,secretary-- 7,i7 shall1 for the period during which such extension is in effect for such drug or device-- 7aa7 remove1 during such period1 the packaged costs of such drug or device 7as determined by the ,secretary7 from the payment amount under this subsection for the covered ,,opd service 7or group of services7 with which it is packaged2 and 7bb7 not make any adjustments to payment amounts under this subsection for a covered ,,opd service 7or group of services7 for which no costs were removed under subclause 7,i72 and 7,,ii7 may not1 when calculating the cost of such drug or device at the end of such extension1 take into account claims for such drug or device made while such drug or device was so packaged4 7iv7 ,eligible drug or device defined ,for purposes of this subparagraph1 the term eligible drug or device means a drug1 biological1 or device with pass-through status in effect during any portion of the emergency period described in section #aace7;g77#a77;,b7 that will not be 7or was not7 separately payable upon the expiration of such status1 but only if1 in the case of a drug or biological1 such drug or biological-- 7,i7 was payable based upon the wholesale acquisition cost of such drug or biological in lieu of the average sales price of such drug or biological on the first date of such emergency period2 and 7,,ii7 will be 7or was7 packaged into a payment for a covered ,,opd service 7or group of services7 upon expiration of such status4 4 ,c ,reducing ,unnecessary ,senior ,hospitalizations #ijba4 ,,snf-based provision of preventive acute care and hospitalization reduction program ,title ,,xviii of the ,social ,security ,act is amended by adding at the end the following new section3 #ahii;,c4 ,,snf-based provision of preventive acute care and hospitalization reduction program 7a7 ,establishment ,there is established a program to be known as the ,,snf-based ,provision of ,preventive ,acute ,care and ,hospitalization ,reduction ,program 7in this section referred to as the ,program71 to be administered by the ,secretary1 for purposes of reducing unnecessary hospitalizations and emergency department visits by allowing qualified group practices 7as defined in section #ahgg7;h77#d77 on or after ,january #a1 #bjbb1 to furnish items and services identified under subsection 7b77#c7 to individuals entitled to benefits under part ,a and enrolled under part ,b residing in qualified skilled nursing facilities4 7b7 ,operation of ,program ,under the ,program1 the ,secretary shall provide for the following3 7#a7 ,certification of skilled nursing facilities as qualified skilled nursing facilities under subsection 7c77#a74 7#b7 ,certification of group practices as qualified group practices under subsection 7c77#b74 7#c7 ,identification of minimum required nonsurgical items and services furnished at a hospital emergency department that may be safely furnished by a qualified group practice at a qualified skilled nursing facility under the ,program1 as determined as clinically appropriate by the ,secretary1 and that such qualified group practice shall offer to furnish under the ,program4 7#d7 ,annual identification of additional items and services furnished at a hospital emergency department that may be safely furnished by a qualified group practice at a qualified skilled nursing facility under the ,program during a year and that such qualified group practice may offer to furnish under the ,program during such year4 7#e7 ,establishment of qualifications for nonphysician employees who may furnish such items and services at a qualified skilled nursing facility4 ,such qualifications shall include the requirement that such an employee-- 7,a7 be certified in basic life support by a nationally recognized specialty board of certification or equivalent certification board2 and 7,b7 have-- 7i7 clinical experience furnishing medical care-- 7,i7 in a skilled nursing facility2 7,,ii7 in a hospital emergency department setting2 or 7,,iii7 as an employee of a provider or supplier of ambulance services2 or 7ii7 a certification in paramedicine4 7#f7 ,payment under this title for items and services identified under paragraph 7#c7 or 7#d7 furnished by such qualified group practices at such a facility in amounts determined under subsection 7d74 7c7 ,certifications 7#a7 ,qualified skilled nursing facilities ,for purposes of this section1 the ,secretary shall certify a skilled nursing facility as a qualified skilled nursing facility if the facility submits an application in a time and manner specified by the ,secretary and meets the following requirements3 7,a7 ,the facility has on-site diagnostic equipment necessary for a qualified group practice to furnish items and services under the ,program and real-time audio and visual capabilities4 7,b7 ,the facility has at least one individual who meets the qualifications described in paragraph 7#e7 or a physician present #bd hours a day and #g days a week to work with the qualified group practice4 ,such individual may be a member of the staff of the qualified skilled nursing facility or of the qualified group practice4 7,c7 ,the facility ensures that residents of such facility1 upon entering such facility1 are allowed to specify in an advanced care directive whether the resident wishes to receive items and services furnished at the facility under the ,program in a case where communication with the resident is not possible4 7,d7 ,the facility ensures that individuals to be furnished such items and services under the ,program at such facility have the opportunity1 at their request1 to instead be transported to a hospital emergency department4 7,e7 ,the facility is not part of the ,special ,focus ,facility program of the ,centers for ,medicare ,medicaid ,services 7although the facility may1 at the discretion of the ,secretary1 be a candidate for selection under such program74 ,nothing in this paragraph shall affect the requirements under section #ahai7;b77#d74 7#b7 ,qualified group practices ,for purposes of this section1 the ,secretary shall certify a group practice as a qualified group practice for a period of #c years if the group practice submits an application in a time and manner specified by the ,secretary and meets the following requirements3 7,a7 ,the group practice offers to furnish all minimum required items and services identified under subsection 7b77#c7 under the ,program4 7,b7 ,the group practice submits a notification to the ,secretary annually specifying which 7if any7 additional items and services identified under subsection 7b77#d7 for a year the group practice will offer to furnish for such year under the ,program4 7,c7 ,the group practice ensures that only individuals who meet the qualifications established under subsection 7b77#e7 or a physician who is part of such group practice may furnish such minimum required items and services and such additional items and services4 7,d7 ,the group practice ensures that1 in the case where such minimum required items and services or such additional items and services are furnished by such an individual1 such individual furnishes such minimum required items and services or additional items and services under the supervision1 either in-person or through the use of telehealth 7not including store-and-forward technologies71 of-- 7i7 a physician-- 7,i7 who is board certified or board eligible in emergency medicine1 family medicine1 geriatrics1 or internal medicine2 or 7,,ii7 who has been certified by a nationally recognized specialty board of certification or equivalent certification board in basic life support2 7ii7 a nurse practitioner who has been certified by a nationally recognized specialty board of certification or equivalent certification board in basic life support2 or 7iii7 a physician assistant who has been certified by a nationally recognized specialty board of certification or equivalent certification board in basic life support4 7,e7 ,with respect to any year in which the qualified group practice would participate in the ,program1 the ,chief ,actuary for the ,centers for ,medicare ,medicaid ,services determines that such participation during such year will not result in total estimated expenditures under this title for such year being greater than total estimated expenditures under such title for such year without such participation4 7d7 ,payments 7#a7 ,in general ,for #bjbb and each subsequent year1 the ,secretary shall develop a schedule of payments to apply for items and services identified under paragraph 7#c7 or paragraph 7#d7 of subsection 7b7 furnished during such year under the ,program4 ,such payments shall be in lieu of any other payments that may be made under this title for such items and services4 7#b7 ,shared savings ,in the case of a year for which the ,secretary determines that participation in the ,program resulted in a reduction in expenditures under this title compared to what such expenditures would have been without such participation1 the ,secretary shall-- 7,a7 pay to such qualified group practice an amount equal to #cg4e percent of the estimated amount of such reduction2 and 7,b7 in the case of each qualified skilled nursing facility where such qualified group practice furnished items and services under the ,program during such year-- 7i7 if the qualified skilled nursing facility has at least a three-star rating under the ,five ,star ,quality ,rating ,system 7or a successor system71 pay to the facility an amount that bears the same ratio to #ab4e percent of the estimated amount of such reduction as the amount of expenditures under the ,program for such items and services furnished with respect to individuals at such facility by such qualified group practice during such year bears to the total amount of expenditures under the ,program for such items and services furnished with respect to all individuals by such qualified group practice during such year2 and 7ii7 in the case of a qualified skilled nursing facility that is not described in clause 7i71 retain in the ,federal ,hospital ,insurance ,trust ,fund under section #ahag the amount that the facility would have been paid pursuant to clause 7i7 if the facility were described in such clause until such time as the facility has at least a three-star rating under the ,five ,star ,quality ,rating ,system 7or a successor system71 at which point the ,secretary shall pay such amount to the facility4 7#c7 ,advanced alternative payment models ,paragraph 7#b7 shall not apply to items and services furnished to an individual entitled to benefits under part ,a and enrolled under part ,b for whom shared savings would otherwise be attributed through an advanced alternative payment model as authorized under section #aaae;,a or section #ahii4 7e7 ,evaluation 7#a7 ,in general ,with respect to a qualified group practice and a qualified skilled nursing facility1 not later than #f months after such group practice begins furnishing items and services under the ,program 7or1 in the case of a qualified skilled nursing facility1 not less than #f months after a qualified group practice first furnishes such items and services at such facility71 and not less than once every #b years thereafter1 the ,secretary shall evaluate such qualified group practice and such qualified facility using information received under paragraph 7#b7 on such criteria as determined appropriate by the ,secretary4 7#b7 ,reporting of information ,in a time and manner specified by the ,secretary1 a qualified group practice and a qualified skilled nursing facility shall submit to the ,secretary a report containing the following information with respect to items and services furnished under the ,program during a reporting period 7as specified by the ,secretary73 7,a7 ,the number of individuals with respect to whom such group practice furnished such items and services in such period 7or1 in the case of a qualified skilled nursing facility1 the number of individuals with respect to whom such a group practice furnished such items and services at such facility in such period74 7,b7 ,the number of such individuals who were admitted to a hospital or treated in the emergency department of a hospital within #bd hours of being furnished such items and services4 7,c7 ,other information determined appropriate by the ,secretary4 7#c7 ,loss of qualified certification 7,a7 ,in general ,not later than #c months after a determination described in this sentence is made1 the ,secretary may revoke the certification of a qualified skilled nursing facility or a qualified group practice made under subsection 7c7 if-- 7i7 the ,chief ,actuary of the ,centers for ,medicare ,medicaid ,services determines that the participation of such skilled nursing facility or such group practice in the ,program during a year resulted in total expenditures under this title for such period being greater than total expenditures under such title would have been during such period without such participation2 or 7ii7 a facility is selected for the ,special ,focus ,facility program or1 if the facility is a candidate for the ,special ,focus ,facility program1 the ,secretary determines that the participation of such facility in the ,program should be terminated4 7,b7 ,exclusion from certification 7i7 ,in general ,in the case that the ,secretary revokes the certification of a qualified skilled nursing facility or a qualified group practice under subparagraph 7,a71 such skilled nursing facility or such group practice shall be ineligible for certification as a qualified skilled nursing facility or a qualified group practice 7as applicable7 under subsection 7c7 for the applicable period 7as defined under clause 7ii774 7ii7 ,applicable period defined ,in this subparagraph1 the term applicable period means-- 7,i7 if the revocation of a facility or group practice under subparagraph 7,a7 is due to the application of clause 7i7 of such subparagraph1 a #a-year period beginning on the date of such revocation2 and 7,,ii7 in the revocation of a facility under subparagraph 7,a7 is due to the application of clause 7ii7 of such subparagraph1 the period beginning on the date of such revocation and ending on the date on which the facility graduates from the ,special ,focus ,facility program 7or1 in the case of a facility that is a candidate for such program1 the date on which the facility is no longer such a candidate1 as determined by the ,secretary74 7f7 ,determination of budget neutrality2 termination of program 7#a7 ,determination ,not later than ,july #a1 #bjbg1 the ,chief ,actuary of the ,centers for ,medicare ,medicaid ,services shall determine whether the ,program has resulted in an increase in total expenditures under this title with respect to the period beginning on ,january #a1 #bjbb1 and ending on ,december #ca1 #bjbf1 compared to what such expenditures would have been during such period had the ,program not been in operation4 7#b7 ,termination ,if the ,chief ,actuary makes a determination under paragraph 7#a7 that the ,program has resulted in an increase in total expenditures under this title1 the ,secretary shall terminate the ,program as of ,january #a of the first year beginning after such determination4 4 ,x ,appropriations #ajjja4 ,appropriations ,the following sums are hereby appropriated1 out of any money in the ,treasury not otherwise appropriated1 for the fiscal year ending ,september #cj1 #bjba1 and for other purposes1 namely3 ,a ,health programs ,department of ,health and ,human ,services ,office of the ,secretary ,public ,health and ,social ,services ,emergency ,fund 7,including ,transfer of ,funds7 ,for an additional amount for ,public ,health and ,social ,services ,emergency ,fund1 #ca1jjj1jjj1jjj1 to remain available until ,september #cj1 #bjbe1 to prevent1 prepare for1 and respond to coronavirus1 domestically or internationally1 including the development of necessary countermeasures and vaccines1 prioritizing platform-based technologies with ,united ,states-based manufacturing capabilities1 the purchase of vaccines1 therapeutics1 diagnostics1 necessary medical supplies1 as well as medical surge capacity1 addressing blood supply chain1 workforce modernization1 telehealth access and infrastructure1 initial advanced manufacturing1 novel dispensing1 enhancements to the ,united ,states ,commissioned ,corps1 and other preparedness and response activities3 ,provided1 ,that funds appropriated under this paragraph in this title may be used to develop and demonstrate innovations and enhancements to manufacturing platforms to support such capabilities3 ,provided further1 ,that the ,secretary of ,health and ,human ,services shall purchase vaccines developed using funds made available under this paragraph in this title to respond to an outbreak or pandemic related to coronavirus in quantities determined by the ,secretary to be adequate to address the public health need3 ,provided further1 ,that products purchased by the ,federal ,government with funds made available under this paragraph in this title1 including vaccines1 therapeutics1 and diagnostics1 shall be purchased in accordance with ,federal ,acquisition ,regulation guidance on fair and reasonable pricing3 ,provided further1 ,that the ,secretary may take such measures authorized under current law to ensure that vaccines1 therapeutics1 and diagnostics developed from funds provided in this title will be affordable in the commercial market3 ,provided further1 ,that in carrying out the previous proviso1 the ,secretary shall not take actions that delay the development of such products3 ,provided further1 ,that the ,secretary shall ensure that protections remain for individuals enrolled in group or individual health care coverage with pre-existing conditions1 including those linked to coronavirus3 ,provided further1 ,that products purchased with funds appropriated under this paragraph in this title may1 at the discretion of the ,secretary of ,health and ,human ,services1 be deposited in the ,strategic ,national ,stockpile under section #cai;,f-#b of the ,public ,health ,service ,act3 ,provided further1 ,that of the amount appropriated under this paragraph in this title1 not more than #b1jjj1jjj1jjj shall be for the ,strategic ,national ,stockpile under section #cai;,f-#b7;a7 of such ,act3 ,provided further1 ,that funds appropriated under this paragraph in this title may be transferred to1 and merged with1 the fund authorized by section #cai;,f-#d1 the ,covered ,counter measure ,process ,fund1 of the ,public ,health ,service ,act3 ,provided further1 ,that of the amount appropriated under this paragraph in this title1 not more than #b1jjj1jjj1jjj1 to remain available until ,september #cj1 #bjbc1 shall be for activities to improve and sustain ,state medical stockpiles3 ,provided further1 ,that of the amount appropriated under this paragraph in this title1 #bj1jjj1jjj1jjj shall be available to the ,biomedical ,advanced ,research and ,development ,authority for necessary expenses of manufacturing1 production1 and purchase1 at the discretion of the ,secretary1 of vaccines1 therapeutics1 diagnostics1 and small molecule active pharmaceutical ingredients1 including the development1 translation1 and demonstration at scale of innovations in manufacturing platforms3 ,provided further1 ,that funds in the previous proviso may be used for the construction or renovation of ,united ,states-based next generation manufacturing facilities1 other than facilities owned by the ,united ,states ,government3 ,provided further1 ,that amounts provided in the eleventh proviso may be for necessary expenses related to the sustained on-shore manufacturing capacity for public health emergencies3 ,provided further1 ,that of the amount appropriated under this paragraph in this title1 #f1jjj1jjj1jjj shall be for activities to plan1 prepare for1 promote1 distribute1 administer1 monitor1 and track coronavirus vaccines to ensure broad-based distribution1 access1 and vaccine coverage3 ,provided further1 ,that the ,secretary shall coordinate funding and activities outlined in the previous proviso through the ,director of the ,centers for ,disease ,control and ,prevention3 ,provided further1 ,that the ,secretary1 through the ,director of the ,centers for ,disease ,control and ,prevention1 shall report to the ,committees on ,appropriations of the ,house of ,representatives and the ,senate within #fj days of the date of enactment of this title on a comprehensive coronavirus vaccine distribution strategy and spend plan that includes how existing infrastructure will be leveraged1 enhancements or new infrastructure that may be built1 considerations for moving and storing vaccines1 guidance for how ,states and health care providers should prepare for1 store1 and administer vaccines1 nationwide vaccination targets1 funding that will be distributed to ,states1 how an informational campaign to both the public and health care providers will be executed1 and how the vaccine distribution plan will focus efforts on high risk1 underserved1 and minority populations3 ,provided further1 ,that such plan shall be updated and provided to the ,committees on ,appropriations of the ,house of ,representatives and the ,senate #ij days after submission of the first plan3 ,provided further1 ,that the ,secretary shall notify the ,committees on ,appropriations of the ,house of ,representatives and the ,senate #b days in advance of any obligation in excess of #ej1jjj1jjj1 including contracts and interagency agreements1 from funds provided in this paragraph in this title3 ,provided further1 ,that funds appropriated under this paragraph in this title may be used for the construction1 alteration1 or renovation of nonfederally owned facilities for the production of vaccines1 therapeutics1 diagnostics1 and medical supplies where the ,secretary determines that such a contract is necessary to secure sufficient amounts of such supplies3 ,provided further1 ,that not later than #cj days after enactment of this title1 and every #cj days thereafter until funds are expended1 the ,secretary shall report to the ,committees on ,appropriations of the ,house of ,representatives and the ,senate on uses of funding for ,operation ,warp ,speed1 detailing current obligations by ,department or ,agency1 or component thereof broken out by the coronavirus supplemental appropriations ,act that provided the source of funds3 ,provided further1 ,that the plan outlined in the previous proviso shall include funding by contract1 grant1 or other transaction in excess of #bj1jjj1jjj with a notation of which ,department or ,agency1 and component thereof is managing the contract3 ,provided further1 ,that such amount is designated by the ,congress as being for an emergency requirement pursuant to section #bea7;b77#b77;,a77i7 of the ,balanced ,budget and ,emergency ,deficit ,control ,act of #aihe4 ,for an additional amount for ,public ,health and ,social ,services ,emergency ,fund1 #af1jjj1jjj1jjj1 to remain available until ,september #cj1 #bjbc1 to prevent1 prepare for1 and respond to coronavirus1 domestically or internationally1 which shall be for necessary expenses for testing1 contact tracing1 surveillance1 containment1 and mitigation to monitor and suppress ,,covid-#ai1 including tests for both active infection and prior exposure1 including molecular1 antigen1 and serological tests1 the manufacturing1 procurement and distribution of tests1 testing equipment and testing supplies1 including personal protective equipment needed for administering tests1 the development and validation of rapid1 molecular point-of-care tests1 and other tests1 support for workforce1 epidemiology1 to scale up academic1 commercial1 public health1 and hospital laboratories1 to conduct surveillance and contact tracing1 support development of ,,covid-#ai testing plans1 and other related activities related to ,,covid-#ai testing3 ,provided1 ,that of the amount appropriated under this paragraph in this title1 not less than #ae1jjj1jjj1jjj shall be for ,states1 localities1 territories1 ,tribes1 ,tribal organizations1 urban ,indian health organizations1 or health service providers to ,tribes for necessary expenses for testing1 contact tracing1 surveillance1 containment1 and mitigation1 including support for workforce1 epidemiology1 use by employers1 elementary and secondary schools1 child care facilities1 institutions of higher education1 long-term care facilities1 or in other settings1 scale up of testing by public health1 academic1 commercial1 and hospital laboratories1 and community-based testing sites1 health care facilities1 and other entities engaged in ,,covid-#ai testing1 and other related activities related to ,,covid-#ai testing1 contact tracing1 surveillance1 containment1 and mitigation3 ,provided further1 ,that the amount provided in the preceding proviso shall be made available within #cj days of the date of enactment of this title3 ,provided further1 ,that the amount identified in the first proviso under this paragraph in this title shall be allocated to ,states1 localities1 and territories according to the formula that applied to the ,public ,health ,emergency ,preparedness cooperative agreement in fiscal year #bjai3 ,provided further1 ,that not less than #ejj1jjj1jjj shall be allocated in coordination with the ,director of the ,indian ,health ,service1 to ,tribes1 ,tribal organizations1 urban ,indian health organizations1 or health service providers to ,tribes3 ,provided further1 ,that the ,secretary of ,health and ,human ,services 7referred to in this paragraph as the ,secretary7 may satisfy the funding thresholds outlined in the first and fourth provisos under this paragraph in this title by making awards through other grant or cooperative agreement mechanisms3 ,provided further1 ,that the ,governor or designee of each ,state1 locality1 territory1 ,tribe1 or ,tribal organization receiving funds pursuant to this title shall update their plans1 as applicable1 for ,,covid-#ai testing and contact tracing submitted to the ,secretary pursuant to the ,paycheck ,protection ,program and ,health ,care ,enhancement ,act 7,public ,law #aaf-aci7 and submit such updates to the ,secretary not later than #fj days after funds appropriated in this paragraph in this title have been awarded to such recipient3 ,provided further1 ,that not later than #fj days after the date of enactment1 and every quarter thereafter until funds are expended1 the ,governor or designee of each ,state1 locality1 territory1 ,tribe1 or ,tribal organization receiving funds shall report to the ,secretary on uses of funding1 detailing current commitments and obligations broken out by the coronavirus supplemental appropriations ,act that provided the source of funds3 ,provided further1 ,that not later than #ae days after receipt of such reports1 the ,secretary shall summarize and report to the ,committees on ,appropriations of the ,house of ,representatives and the ,senate on ,states' commitments and obligations of funding3 ,provided further1 ,that funds an entity receives from amounts described in the first proviso in this paragraph may also be used for the rent1 lease1 purchase1 acquisition1 construction1 alteration1 renovation1 or equipping of nonfederally owned facilities to improve coronavirus preparedness and response capability at the ,state and local level3 ,provided further1 ,that such amount is designated by the ,congress as being for an emergency requirement pursuant to section #bea7;b77#b77;,a77i7 of the ,balanced ,budget and ,emergency ,deficit ,control ,act of #aihe4 ,b ,general provisions-,this ,title #ajaja4 ,each amount appropriated or made available by this title is in addition to amounts otherwise appropriated for the fiscal year involved4 #ajajb4 ,no part of any appropriation contained in this title shall remain available for obligation beyond the current fiscal year unless expressly so provided herein4 #ajajc4 ,unless otherwise provided for by this title1 the additional amounts appropriated by this title to appropriations accounts shall be available under the authorities and conditions applicable to such appropriations accounts for fiscal year #bjbj4 #ajajd4 ,in this title1 the term coronavirus means ,,sars-,co,v-#b or another coronavirus with pandemic potential4 #ajaje4 ,each amount designated in this title by the ,congress as being for an emergency requirement pursuant to section #bea7;b77#b77;,a77i7 of the ,balanced ,budget and ,emergency ,deficit ,control ,act of #aihe shall be available 7or rescinded or transferred1 if applicable7 only if the ,president subsequently so designates all such amounts and transmits such designations to the ,congress4 #ajajf4 ,any amount appropriated by this title1 designated by the ,congress as an emergency requirement pursuant to section #bea7;b77#b77;,a77i7 of the ,balanced ,budget and ,emergency ,deficit ,control ,act of #aihe and subsequently so designated by the ,president1 and transferred pursuant to transfer authorities provided by this title shall retain such designation4 #ajajg4 7a7 ,statutory paygo scorecards ,the budgetary effects of this title shall not be entered on either ,,paygo scorecard maintained pursuant to section #d7;d7 of the ,statutory ,pay ,as-,you-,go ,act of #bjaj4 7b7 ,senate paygo scorecards ,the budgetary effects of this title shall not be entered on any ,,paygo scorecard maintained for purposes of section #dajf of ,h4 ,con4 ,res4 #ga 7#aaeth ,congress74 7c7 ,classification of budgetary effects ,notwithstanding ,rule #c of the ,budget ,scorekeeping ,guidelines set forth in the joint explanatory statement of the committee of conference accompanying ,conference ,report #aje-bag and section #bej7;c77#g7 and 7c77#h7 of the ,balanced ,budget and ,emergency ,deficit ,control ,act of #aihe1 the budgetary effects of this title shall be estimated for purposes of section #bea of such ,act4 7d7 ,ensuring no within-,session sequestration ,solely for the purpose of calculating a breach within a category for fiscal year #bjbj pursuant to section #bea7;a77#f7 or section #bed7;g7 of the ,balanced ,budget and ,emergency ,deficit ,control ,act of #aihe1 and notwithstanding any other provision of this title1 the budgetary effects from this title shall be counted as amounts designated as being for an emergency requirement pursuant to section #bea7;b77#b77;,a7 of such ,act4 ,this title may be cited as the ,coronavirus ,response ,additional ,supplemental ,appropriations ,act1 #bjbj4