,i #aahth ,,congress #ast ,session ,h4 ,r4 #dfig ,,in ,,the ,,house ,,of ,,representatives ,july #ah1 #bjbc ,ms4 ,schrier 7for herself1 ,ms4 ,eshoo1 ,mr4 ,pallone1 ,ms4 ,de,gette1 ,ms4 ,schakowsky1 ,ms4 ,matsui1 ,ms4 ,castor of ,florida1 ,mr4 ,sarbanes1 ,mr4 ,tonko1 ,ms4 ,clarke of ,new ,york1 ,mr4 ,crdenas1 ,mr4 ,ruiz1 ,mr4 ,peters1 ,mrs4 ,dingell1 ,mr4 ,veasey1 ,ms4 ,kuster1 ,ms4 ,kelly of ,illinois1 ,ms4 ,barragn1 ,ms4 ,blunt ,rochester1 ,mr4 ,soto1 ,ms4 ,craig1 ,mrs4 ,trahan1 and ,mrs4 ,fletcher7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to amend the ,public ,health ,service ,act to reauthorize certain programs with respect to public health security and all-hazards preparedness and response related to the ,administration for ,strategic ,preparedness and ,response and certain programs with respect to public health security and all-hazards preparedness and response related to the ,centers for ,disease ,control and ,prevention1 and for other purposes4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,protecting ,pandemic and ,all-,hazards ,preparedness ,act of #bjbc or the ,protecting ,,pahpa ,act of #bjbc4 7b7 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4 ,title ,i--,preparing for and responding to public health security threats ,sec4 #aja4 ,national health security strategy4 ,sec4 #ajb4 ,protection of national security from threats4 ,sec4 #ajc4 ,partnerships for ,state and regional hospital preparedness to improve surge capacity4 ,sec4 #ajd4 ,guidelines for regional health care emergency preparedness and response systems4 ,sec4 #aje4 ,strategic ,national ,stockpile4 ,sec4 #ajf4 ,diagnostic testing preparedness plan4 ,sec4 #ajg4 ,biomedical ,advanced ,research and ,development ,authority4 ,sec4 #ajh4 ,ensuring collaboration and coordination in medical countermeasure development4 ,sec4 #aji4 ,review of ,,aspr efforts to ensure supply chain resiliency and accountability4 ,sec4 #aaj4 ,review of ,,hhs efforts ,to ensure rapid production and domestic manufacturing capacity of medical countermeasures4 ,sec4 #aaa4 ,crisis standards of care4 ,title ,,ii--,ensuring workforce to prepare for and respond to public health security threats ,sec4 #bja4 ,emergency system for advance registration of volunteer health professional4 ,sec4 #bjb4 ,military and civilian partnership for trauma readiness4 ,sec4 #bjc4 ,national advisory committees on disasters4 ,sec4 #bjd4 ,national ,disaster ,medical ,system4 ,sec4 #bje4 ,volunteer ,medical ,reserve ,corps4 ,title ,,iii--,preparing for and responding to public health security threats ,sec4 #cja4 ,improving ,state and local public health security4 ,sec4 #cjb4 ,facilities and capacities of the ,centers for ,disease ,control and ,prevention to combat public health security threats4 ,sec4 #cjc4 ,monitoring and distribution of certain medical countermeasures4 ,sec4 #cjd4 ,enhanced control of dangerous biological agents and toxins4 ,sec4 #cje4 ,mosquito-borne diseases4 ,sec4 #cjf4 ,epidemiology-laboratory capacity4 ,sec4 #cjg4 ,supporting public health data availability and access4 ,title ,,iv--,ensuring workforce to prepare for and respond to public health security threats ,sec4 #dja4 ,temporary reassignment of ,state and local personnel during a public health emergency4 ,sec4 #djb4 ,epidemic ,intelligence ,service4 ,title ,v--,addressing drug and supply chain shortages ,subtitle ,a--,ensuring access to lifesaving drugs ,sec4 #eja4 ,extended expiration dates for life-saving drugs4 ,subtitle ,b--,drug origin transparency ,sec4 #eaa4 ,enhanced drug manufacturing amount information reporting4 ,sec4 #eab4 ,require drug labeling to include original manufacturer and supply chain information4 ,subtitle ,c--,medical device shortage reduction ,sec4 #eba4 ,clarifying device shortage notifications4 ,sec4 #ebb4 ,supply chain risk management4 ,sec4 #ebc4 ,clarifying voluntary notifications4 ,subtitle ,d--,drug shortage prevention ,sec4 #eca4 ,improving notification procedures in case of increased demand for critical essential medicines4 ,subtitle ,e--,protecting ,americans from unsafe drugs ,sec4 #eda4 ,notification1 nondistribution1 and recall of drugs4 ,i ,preparing for and responding to public health security threats #aja4 ,national health security strategy 7a7 ,public health workforce ,section #bhjb7;a77#c7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#a7;a77#c77 is amended by striking ,in #bjbb1 the and inserting ,the4 7b7 ,medical and public health community preparedness goal ,section #bhjb7;b77#h77;,a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#a7;b77#h77;,a77 is amended by inserting before the semicolon the following3 1 including by protecting against cybersecurity threats4 7c7 ,cybersecurity resiliency of health care delivery systems ,section #bhjb7;b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#a7;b77 is amended by adding at the end the following3 7#aa7 ,cybersecurity resiliency of health care delivery systems ,strengthening the ability of ,states1 local communities1 ,tribal communities1 and territorial entities to protect against1 mitigate1 or otherwise address the impact of cybersecurity risks or cybersecurity attacks that affect public health through mechanisms 7including awards of grants or cooperative agreements under section #cai;,c-#b7 that encourage hospitals and other facilities involved in the delivery of health care items and services to use recognized security practices meeting or exceeding the approaches promulgated under section #dje7;d7 of the ,cybersecurity ,act of #bjae4 4 #ajb4 ,protection of national security from threats ,section #bhaa7;f77#b77;,a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#aj7;f77#b77;,a77 is amended by striking #bej1jjj1jjj for each of fiscal years #bjai through #bjbc and inserting #cbg1iia1jjj for each of fiscal years #bjbd through #bjbh4 #ajc4 ,partnerships for ,state and regional hospital preparedness to improve surge capacity 7a7 ,authorization of appropriations ,section #cai;,c-#b7;j77#a77;,a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#c;b7j77#a77;,a77 is amended-- 7#a7 by striking is authorized to be appropriated and inserting are authorized to be appropriated2 and 7#b7 by inserting and #ejj1jjj1jjj for each of fiscal years #bjbd through #bjbh before the period at the end4 7b7 ,sunset ,section #cai;,c-#b7;j77#a77;,b77iii7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#c;b7j77#a77;,b77iii77 is amended by striking #bjbc and inserting #bjbh4 #ajd4 ,guidelines for regional health care emergency preparedness and response systems 7a7 ,guidelines ,section #cai;,c-#c7;b77#c7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#c;c7b77#c77 is amended by striking the ,pandemic and ,all-,hazards ,preparedness and ,advancing ,innovation ,act of #bjai 7including any amendments made by such ,act7 and inserting the ,pandemic and ,all-,hazards ,preparedness and ,advancing ,innovation ,act of #bjai1 the ,,prevent ,pandemics ,act 7title ,,ii of division ,,ff of ,public ,law #aag-cbh71 and the ,protecting ,pandemic and ,all-,hazards ,preparedness ,act of #bjbc4 7b7 ,demonstration project for regional health care preparedness and response systems ,section #cai;,c-#c7;e77#b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#c;c7e77#b77 is amended by striking #bjbc and inserting #bjbh4 #aje4 ,strategic ,national ,stockpile 7a7 ,vendor-,managed inventory and warm-,based surge capacity contracts and cooperative agreements with clinical laboratories ,section #cai;,f-#b7;a77#e77;,a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7a77#e77;,a77 is amended-- 7#a7 by inserting after contracts or cooperative agreements with vendors1 which may include manufacturers or distributors of medical products1 the following3 as well as clinical laboratories12 and 7#b7 in clause 7ii71 by striking domestic manufacturing capacity and inserting domestic manufacturing and laboratory capacity4 7b7 ,authorization of appropriations 7#a7 ,in general ,section #cai;,f-#b7;f7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7f77 is amended-- 7,a7 in paragraph 7#a71 by striking #faj1jjj1jjj for each of fiscal years #bjai through #bjba1 and #gej1jjj1jjj for each of fiscal years #bjbb and #bjbc and inserting #a1ifc1jjj1jjj for each of fiscal years #bjbd through #bjbh2 7,b7 by striking paragraph 7#b72 and 7,c7 by striking ,authorization of appropriations and all that follows through ,for the purpose of carrying out subsection 7a71 there are authorized to be appropriated and inserting ,authorization of appropriations4--,for the purpose of carrying out subsection 7a71 there is authorized to be appropriated4 7#b7 ,pilot program to support ,state medical stockpiles ,section #cai;,f-#b7;i77#i7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7i77#i77 is amended by striking #bjbd and inserting #bjbh4 #ajf4 ,diagnostic testing preparedness plan ,the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bja et seq47 is amended by inserting after section #cai;,f-#e of such ,act 7#db ,u4,s4,c4 #bdg;d-#f;f7 the following3 #cai;,f-#f4 ,diagnostic testing preparedness plan 7a7 ,in general ,the ,secretary1 acting through the ,assistant ,secretary for ,preparedness and ,response1 and in consultation with the heads of relevant ,federal agencies1 shall develop not later than #a year after the date of enactment of this section and update not less than every #c years thereafter a plan for rapid development1 authorization1 scaling1 procurement1 and distribution of diagnostics and clinical and diagnostic laboratory testing capacity during a public health emergency declared under section #cai4 7b7 ,purposes ,the purposes of the plan under subsection 7a7 shall be-- 7#a7 to facilitate the development and utilization of diagnostics for use with respect to a novel chemical1 biological1 radiological1 or nuclear threat or an emerging infectious disease1 including any such high-throughput laboratory diagnostic1 point-of-care diagnostic1 or rapid at-home or point-of-use diagnostic2 and 7#b7 to describe the processes for rapid development1 authorization1 scaling1 procurement1 and distribution of diagnostics and clinical and diagnostic laboratory testing capacity4 7c7 ,public-,private coordination 7#a7 ,in general ,the ,secretary1 acting through the ,assistant ,secretary for ,preparedness and ,response1 shall include within the plan under subsection 7a7 a plan for public-private coordination on national diagnostic testing during a public health emergency4 7#b7 ,contents ,the plan under paragraph 7#a7 shall be designed to facilitate coordination and collaboration among-- 7,a7 government agencies2 and 7,b7 critical private-sector diagnostic testing stakeholders1 including private-sector clinical and diagnostic laboratories1 diagnostic manufacturers1 health care product distributors1 and research laboratories4 7d7 ,public availability ,the ,secretary1 acting through the ,assistant ,secretary for ,preparedness and ,response1 shall make the plan under subsection 7a7 publicly available4 7e7 ,reports to ,congress ,not later than #a year after commencing implementation of the plan under subsection 7a7 for a public health emergency1 the ,secretary1 acting through the ,assistant ,secretary for ,preparedness and ,response1 shall submit to the ,congress a report evaluating the effectiveness of activities implemented under the plan4 4 #ajg4 ,biomedical ,advanced ,research and ,development ,authority 7a7 ,medical countermeasures for viral threats with pandemic potential ,section #cai,l7c77#d7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#g;e7c77#d77 is amended-- 7#a7 in subparagraph 7,d7-- 7,a7 in clause 7ii71 by striking 2 and and inserting a semicolon2 7,b7 by redesignating clause 7iii7 as clause 7v72 and 7,c7 by inserting after clause 7ii7 the following3 7iii7 the identification and development of platform manufacturing technologies needed for advanced development and manufacturing of medical countermeasures for viral families which have significant potential to cause a pandemic2 7iv7 advanced research and development of flexible medical countermeasures against priority respiratory virus families and other respiratory viral pathogens with a significant potential to cause a pandemic1 with both pathogen-specific and pathogen-agnostic approaches2 and 2 and 7#b7 in subparagraph 7,f7-- 7,a7 in clause 7ii71 by striking 2 and at the end and inserting a semicolon2 7,b7 in clause 7iii71 by striking the period and inserting 2 and2 and 7,c7 by adding at the end the following3 7iv7 priority virus families and other viral pathogens with a significant potential to cause a pandemic4 4 7b7 ,authorization of appropriations ,section #cai,l7d77#b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#g;e7d77#b77 is amended by striking #faa1gjj1jjj for each of fiscal years #bjai through #bjbc and inserting #iej1jjj1jjj for each of fiscal years #bjbd through #bjbh4 7c7 ,inapplicability of certain provisions sunset ,section #cai,l7e77#a77;,d7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#g;e7e77#a77;,d77 is amended by striking on the date that is #ag years after the date of enactment of the ,pandemic and ,all-,hazards ,preparedness ,act and inserting on ,october #a1 #bjbh4 #ajh4 ,ensuring collaboration and coordination in medical countermeasure development ,section #cai,l-#a7;b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bgd;d-#g;f7b77 is amended by striking at the end of the #ag-year period that begins on the date of enactment of this ,act and inserting on ,october #a1 #bjbh4 #aji4 ,review of ,,aspr efforts to ensure supply chain resiliency and accountability 7a7 ,in general ,not later than #ah months after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall complete a review of-- 7#a7 the ,supply ,chain ,control ,tower ,program 7in this section referred to as the ,,scct ,program7 under the ,administration for ,strategic ,preparedness and ,response of the ,department of ,health and ,human ,services2 and 7#b7 any related efforts of the ,administration for ,strategic ,preparedness and ,response-- 7,a7 to create supply chain visibility into inventory1 capacity1 and distribution flow of certain products critical to preparedness and response efforts2 7,b7 to provide insights into demand forecasting and modeling of certain products critical to preparedness and response efforts2 or 7,c7 to inform preparedness and response efforts by targeting distribution and coordinating supply with demand for certain products critical to preparedness and response efforts4 7b7 ,issues ,the review under this section shall include examination of-- 7#a7 the data being collected and maintained pursuant to the ,,scct ,program2 7#b7 how the ,department of ,health and ,human ,services1 acting through the ,administration for ,strategic ,preparedness and ,response1 uses such data to provide supply chain visibility and address actual or potential supply gaps2 7#c7 the extent to which such data is provided and shared with end users1 including ,states1 localities1 ,territories1 ,tribes1 and industry partners2 7#d7 the frequency and cadence of data reporting and sharing by and among ,states1 localities1 ,territories1 ,tribes1 and industry partners2 7#e7 information related to the type and number of ,states1 localities1 ,territories1 ,tribes1 and industry partners participating in the ,,scct ,program2 7#f7 the process by which ,states1 localities1 ,territories1 ,tribes1 and industry partners voluntarily choose to participate in the ,,scct ,program2 and 7#g7 any inefficiencies1 deficiencies1 or challenges related to the application or operation of the ,,scct ,program4 7c7 ,report to ,congress ,not later than the deadline described in subsection 7a7 for the completion of the review under this section1 the ,comptroller ,general 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 results of such review4 #aaj4 ,review of ,,hhs efforts to ensure rapid production and domestic manufacturing capacity of medical countermeasures 7a7 ,in general ,not later than #a year after the date of the enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall conduct and complete a review examining the efforts of the ,secretary of ,health and ,human ,services to ensure that the ,united ,states is prepared to rapidly produce qualified countermeasures 7as defined in section #cai;,f-#a of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;a77 in the event of a public health emergency declared under section #cai of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bgd;d74 7b7 ,contents ,the review conducted under subsection 7a7 shall include a review of-- 7#a7 the efforts described in such subsection1 including the ,secretary's efforts to transition from the ,centers for ,innovation and ,advanced ,drug ,manufacturing program to any new efforts1 including the ,national ,biopharmaceutical ,manufacturing ,partnership and ,industrial ,base ,expansion ,connect2 7#b7 the progress made toward the implementation of such efforts2 and 7#c7 the planning within the ,department of ,health and ,human ,services to assess risks and challenges associated with advanced development and manufacturing of qualified countermeasures4 7c7 ,report to ,congress ,not later than #a year after completing the review under subsection 7a71 the ,comptroller ,general of the ,united ,states shall submit to the ,congress a report containing-- 7#a7 the results of the review2 and 7#b7 the ,comptroller ,general's recommendations for ensuring that the ,united ,states is prepared to rapidly produce qualified countermeasures in the event of a public health emergency4 #aaa4 ,crisis standards of care ,not later than #b years after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services1 acting through the ,director of the ,office for ,civil ,rights of the ,department of ,health and ,human ,services1 shall issue guidance on how to develop or modify ,state and local crisis standards of care for use during an emergency period 7as defined in section #aace7;g77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;b-#e7;g77#a77 so as to bring such standards of care into compliance with the nondiscrimination requirements of section #ejd of the ,rehabilitation ,act of #aigc 7#bi ,u4,s4,c4 #gid74 ,,ii ,ensuring workforce to prepare for and respond to public health security threats #bja4 ,emergency system for advance registration of volunteer health professional 7a7 ,in general ,section #cai;,i7a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#g;b7 is amended by striking ,not later than #ab months after the date of enactment of the ,pandemic and ,all-,hazards ,preparedness ,act1 the ,secretary shall link existing ,state verification systems to maintain and inserting ,the ,secretary shall continue to maintain4 7b7 ,authorization of appropriations ,section #cai;,i7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#g;b7k77 is amended by striking #bjai through #bjbc and inserting #bjbd through #bjbh4 #bjb4 ,military and civilian partnership for trauma readiness ,section #abia7;g7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;d-#ia7;g77 is amended by striking #bjai through #bjbc and inserting #bjbd through #bjbh4 #bjc4 ,national advisory committees on disasters 7a7 ,national ,advisory ,committee on ,children and ,disasters ,subsection 7g7 of section #bhaa;,a of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#aj;b7 is amended to read as follows3 7g7 ,sunset 7#a7 ,in general ,the ,advisory ,committee shall terminate on ,september #cj1 #bjbh4 7#b7 ,extension of committee ,not later than ,october #a1 #bjbg1 the ,secretary shall submit to ,congress a recommendation on whether the ,advisory ,committee should be extended4 4 7b7 ,national ,advisory ,committee on ,seniors and ,disasters ,section #bhaa;,b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#aj;c7 is amended-- 7#a7 in subsection 7d7-- 7,a7 in paragraph 7#a71 by striking in consultation with such other heads of agencies as appropriate1 shall appoint not more than #ag members and inserting in consultation with such other ,secretaries as may be appropriate1 shall appoint not more than #bc members2 7,b7 by redesignating paragraph 7#b7 as paragraph 7#c72 7,c7 by amending paragraph 7#c71 as so redesignated-- 7i7 in the paragraph heading1 by striking ,required members and inserting ,required ,federal members2 7ii7 in the matter preceding subparagraph 7,a71 by striking and non-,federal members12 7iii7 by striking subparagraphs 7,j7 and 7,k72 and 7iv7 by redesignating subparagraph 7,l7 as subparagraph 7,j72 7,d7 by inserting after paragraph 7#a7 the following new paragraph3 7#b7 ,required non-,federal members ,the ,secretary1 in consultation with such other heads of ,federal agencies as may be appropriate1 shall appoint to the ,advisory ,committee under paragraph 7#a7 at least #ac individuals1 including-- 7,a7 at least #d non-,federal health care providers with expertise in geriatric medical disaster planning1 preparedness1 response1 or recovery2 7,b7 at least #c representatives of ,state1 local1 ,tribal1 or territorial agencies with expertise in geriatric disaster planning1 preparedness1 response1 or recovery2 and 7,c7 at least #d non-,federal professionals with training in gerontology1 including social workers1 scientists1 human services specialists1 or other non-medical professionals1 with experience in disaster planning1 preparedness1 response1 or recovery among other adults4 2 and 7,e7 by adding at the end the following new paragraphs3 7#d7 ,term of appointment ,each member of the ,advisory ,committee appointed under paragraph 7#b7 shall serve for a term of #c years1 except that the ,secretary may adjust the terms of the ,advisory ,committee appointees serving on the date of enactment of the ,preparing for ,all ,hazards and ,pathogens ,reauthorization ,act1 or appointees who are initially appointed after such date of enactment1 in order to provide for a staggered term of appointment for all members4 7#e7 ,consecutive appointments2 maximum terms ,a member appointed under paragraph 7#b7 may serve not more than #c terms on the ,advisory ,committee1 and not more than #b of such terms may be served consecutively4 2 and 7#b7 in subsection 7g7-- 7,a7 in paragraph 7#a71 by striking #bjbc and inserting #bjbh2 and 7,b7 in paragraph 7#b71 by striking #bjbb and inserting #bjbg4 7c7 ,national ,advisory ,committee on ,individuals with ,disabilities ,section #bhaa;,c of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#aj;d7 is amended-- 7#a7 by redesignating subsections 7c7 through 7g7 as subsections 7d7 through 7h71 respectively2 7#b7 by inserting after subsection 7b7 the following new subsection3 7c7 ,additional duties ,the ,advisory ,committee may provide advice and recommendations to the ,secretary with respect to individuals with disabilities1 and medical and public health grants and cooperative agreements1 as applicable to preparedness and response activities under this title and title ,,iii4 2 7#c7 in subsection 7d71 as so redesignated-- 7,a7 in paragraph 7#a71 by striking in consultation with such other heads of agencies and departments as appropriate1 shall appoint not more than #ag members and inserting in consultation with such other ,secretaries as may be appropriate1 shall appoint not more than #bc members2 7,b7 by redesignating paragraph 7#b7 as paragraph 7#c72 7,c7 by amending paragraph 7#c71 as redesignated-- 7i7 in the paragraph heading1 by striking ,required members and inserting ,required ,federal members2 7ii7 in the matter preceding subparagraph 7,a71 by striking and non-,federal members12 7iii7 by striking subparagraph 7,k7 and inserting the following3 7,k7 ,representatives of such other ,federal agencies as the ,secretary determines necessary to fulfill the duties of the ,advisory ,committee4 2 and 7iv7 by striking subparagraphs 7,l7 and 7,m72 7,d7 by inserting after paragraph 7#a7 the following new paragraph3 7#b7 ,required non-,federal members ,the ,secretary1 in consultation with such other heads of ,federal agencies as may be appropriate1 shall appoint to the ,advisory ,committee under paragraph 7#a7 at least #ac individuals1 including-- 7,a7 at least #d non-,federal health care professionals with expertise in disability accessibility before1 during1 and after disasters1 medical and mass care disaster planning1 preparedness1 response1 or recovery2 7,b7 at least #c representatives from ,state1 local1 ,tribal1 or territorial agencies with expertise in disaster planning1 preparedness1 response1 or recovery for individuals with disabilities2 and 7,c7 at least #d individuals with a disability with expertise in disaster planning1 preparedness1 response1 or recovery for individuals with disabilities4 2 and 7,e7 by adding at the end the following new paragraphs3 7#d7 ,term of appointment ,each member of the ,advisory ,committee appointed under paragraph 7#b7 shall serve for a term of #c years1 except that the ,secretary may adjust the terms of the ,advisory ,committee appointees serving on the date of enactment of the ,preparing for ,all ,hazards and ,pathogens ,reauthorization ,act1 or appointees who are initially appointed after such date of enactment1 in order to provide for a staggered term of appointment for all members4 7#e7 ,consecutive appointments2 maximum terms ,a member appointed under paragraph 7#b7 may serve not more than #c terms on the ,advisory ,committee1 and not more than #b of such terms may be served consecutively4 2 and 7#d7 in subsection 7g7-- 7,a7 in paragraph 7#a71 by striking #bjbc and inserting #bjbh2 and 7,b7 in paragraph 7#b71 by striking #bjbb and inserting #bjbg4 #bjd4 ,national ,disaster ,medical ,system 7a7 ,elimination of sunset of authority ,to make certain appointments for ,national ,disaster ,medical ,system ,section #bhab7;c77#d7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#aa7;c77#d77 is amended-- 7#a7 by striking 7,a7 ,in general4--,if the ,secretary determines and inserting ,if the ,secretary determines2 and 7#b7 by striking subparagraph 7,b74 7b7 ,authorization of appropriations ,section #bhab7;g7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#aa7;g77 is amended by striking #eg1djj1jjj for each of fiscal years #bjai through #bjbc and inserting #if1ijd1jjj for each of fiscal years #bjbd through #bjbh4 #bje4 ,volunteer ,medical ,reserve ,corps ,section #bhac7;i7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#ae7;i77 is amended by striking #bjai through #bjbc and inserting #bjbd through #bjbh4 ,,iii ,preparing for and responding to public health security threats #cja4 ,improving ,state and local public health security 7a7 ,authorization of appropriations ,section #cai;,c-#a7;h77#a77;,a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#c;a7h77#a77;,a77 is amended by striking #fhe1jjj1jjj for each of fiscal years #bjai through #bjbc and inserting #a1jjj1jjj1jjj for each of fiscal years #bjbd through #bjbh4 7b7 ,elimination of deadwood ,section #cai;,c-#a7;h7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#c;a7h77 is amended-- 7#a7 by striking paragraphs 7#d7 and 7#e72 and 7#b7 by redesignating paragraphs 7#f7 and 7#g7 as paragraphs 7#d7 and 7#e74 #cjb4 ,facilities and capacities of the ,centers for ,disease ,control and ,prevention to combat public health security threats 7a7 ,study ,section #cai;,d7a77#d7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#d7;a77#d77 is amended by striking ,not later than ,june #a1 #bjbb1 the ,comptroller ,general of the ,united ,states shall conduct a study on ,federal spending in fiscal years #bjac through #bjah and inserting ,not later than ,june #a1 #bjbg1 the ,comptroller ,general of the ,united ,states shall conduct a study on ,federal spending in fiscal years #bjba through #bjbf4 7b7 ,authorization of appropriations ,section #cai;,d7h7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#d7;h77 is amended-- 7#a7 in paragraph 7#a71 by striking #be1jjj1jjj for each of fiscal years #bjbb and #bjbc and inserting #dj1jjj1jjj for each of fiscal years #bjbd through #bjbh2 and 7#b7 in paragraph 7#b71 by striking #bjbb and #bjbc and inserting #bjbd through #bjbh4 #cjc4 ,monitoring and distribution of certain medical countermeasures ,section #cai;,a7e7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#a7;e77 is amended by striking #bjai through #bjbc and inserting #bjbd through #bjbh4 #cjd4 ,enhanced control of dangerous biological agents and toxins ,section #cea;,a7m7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb;a7m77 is amended by striking #bjbg and inserting #bjbh4 #cje4 ,mosquito-borne diseases ,section #cag,s7f7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;b-#ba7;f77 is amended-- 7#a7 in paragraph 7#a71 by striking #bjai through #bjbc and inserting #bjbd through #bjbh2 and 7#b7 by striking paragraph 7#c74 #cjf4 ,epidemiology-laboratory capacity ,section #bhba7;b7 7#db ,u4,s4,c4 #cjj;hh-#ca7;b77 is amended by striking #bjai through #bjbc and inserting #bjbd through #bjbh4 #cjg4 ,supporting public health data availability and access 7a7 ,designation of public health data standards ,section #bhbc7;a77#b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#cc7;a77#b77 is amended by adding at the end the following3 7,d7 ,selection of data and technology standards ,the standards designated as described in subparagraph 7,a7 may include standards to improve-- 7i7 the exchange of electronic health information for-- 7,i7 electronic case reporting2 7,,ii7 syndromic surveillance2 7,,iii7 reporting of vital statistics2 and 7,,iv7 reporting test orders and results electronically1 including from laboratories2 7ii7 automated electronic reporting to relevant public health data systems of the ,centers for ,disease ,control and ,prevention2 and 7iii7 such other uses as the ,secretary determines appropriate4 7,e7 ,considerations ,standards designated under this paragraph shall include standards and implementation specifications necessary to ensure the appropriate capture1 exchange1 access1 and use of information regarding race1 ethnicity1 sex 7including sexual orientation and gender identity71 disability status1 veteran status1 housing status1 age1 functional status1 and other elements4 4 7b7 ,improving information sharing and availability of public health data ,section #caj;,b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdbu7 is amended to read as follows3 #caj;,b4 ,improving information sharing and availability of public health data 7a7 ,in general ,the ,secretary acting through the ,director of the ,centers for ,disease ,control and ,prevention 7in this section referred to as the ,secretary7 may require the reporting of public health and health care data and information to the ,centers for ,disease ,control and ,prevention by-- 7#a7 health care providers and facilities1 including pharmacies2 7#b7 public health1 clinical1 and other laboratories and diagnostic testing entities2 7#c7 ,state1 local1 and ,tribal health departments2 and 7#d7 other entities1 as determined appropriate by the ,secretary4 7b7 ,content1 form1 manner1 and frequency 7#a7 ,collaboration ,the ,secretary shall collaborate with representatives of ,state1 local1 and ,tribal health departments and other entities on determining the content1 form1 manner1 and frequency of the reporting of public health and health care data and information required pursuant to subsection 7a74 7#b7 ,simultaneous reporting ,in determining the content1 form1 manner1 and frequency of the reporting of public health and health care data and information pursuant to subsection 7a71 where a disease1 condition1 or related event is reportable under applicable ,state or local law1 the ,secretary shall require the data and information to be reported first or simultaneously to the appropriate ,state or local jurisdiction4 7#c7 ,alignment with standards and implementation specifications ,the content1 form1 manner1 and frequency requirements required pursuant to this section shall align with the standards and implementation specifications adopted by the ,secretary under section #cjjd1 where applicable4 7#d7 ,reasonable efforts to limit reporting ,the ,secretary shall make reasonable efforts to limit the public health and health care data and information required to be reported under this section to the minimum necessary to accomplish the intended public health purpose4 7#e7 ,implementation and regulations ,the ,secretary-- 7,a7 may promulgate by regulation the content1 form1 manner1 and frequency in which public health and health care data and information is required to be reported under this section2 and 7,b7 in the event of a public health emergency declared under section #cai1 or where the ,secretary determines there is a significant potential for such an emergency to exist1 may issue such requirements-- 7i7 by guidance in accordance with this section2 and 7ii7 without regard to the procedures otherwise required by section #eec of title #e1 ,united ,states ,code4 7c7 ,ensuring that data is accessible in a timely manner to ,state1 local1 and ,tribal health authorities 7#a7 ,collaboration ,the ,secretary shall collaborate with representatives of ,state1 local1 and ,tribal health departments1 and entities representing such departments1 to ensure that data and information that is collected by the ,centers for ,disease ,control and ,prevention pursuant to this section are accessible1 as appropriate1 in a timely manner1 to ,state1 local1 and ,tribal health authorities4 7#b7 ,rules of construction ,nothing in this section shall be construed-- 7,a7 to prevent any ,federal agency1 ,state1 local1 or ,tribal health department1 or other entity from collecting data or information under other applicable law2 or 7,b7 to limit the authority of the ,centers for ,disease ,control and ,prevention to share public health surveillance data with ,state1 local1 or ,tribal health authorities4 7#c7 ,reasonable efforts to reduce reporting burdens and potential duplication ,the ,secretary shall make reasonable efforts to collaborate with representatives of ,federal agencies and ,state1 local1 and ,tribal health departments to reduce reporting burdens and potential duplication of reporting requirements4 ,such efforts may include ensuring simultaneous sharing of data and information described in subsection 7b7 with ,state1 local1 and ,tribal public health authorities4 7d7 ,confidentiality and protection of data ,any identifiable1 sensitive information reported to the ,centers for ,disease ,control and ,prevention pursuant to this section shall not be further disclosed or provided to any other individual or party1 including any party involved in civil1 criminal1 or administrative litigation1 except-- 7#a7 as necessary for public health purposes1 including with relevant ,federal1 ,state1 local1 or tribal public health authorities2 7#b7 as required under section #eeb;a7d77#a7 of title #e1 ,united ,states ,code2 7#c7 as required by applicable ,federal laws1 excluding instances of disclosure in any ,federal1 ,state1 or local civil1 criminal1 administrative1 legislative1 or other proceeding2 or 7#d7 with the consent of each individual to whom the information pertains4 7e7 ,exemption of certain public health data from disclosure ,the ,secretary may exempt from disclosure under section #eeb7;b77#c7 of title #e1 ,united ,states ,code1 public health and health care data and information collected by the ,centers for ,disease ,control and ,prevention pursuant to this section or any other authority under which the ,centers collects public health or health care data and information if-- 7#a7 an individual is identified through such data or information2 or 7#b7 there is at least a very small risk1 as determined by current scientific practices or statistical methods1 that some combination of the data or information1 the request for disclosure under such section #eeb7;b77#c71 and other available data sources or the application of technology could be used to deduce the identity of the individuals to which such data or information pertains4 4 7c7 ,public ,health ,information ,sharing and ,availability ,advisory ,committee ,part ,a of title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bda et seq47 is amended by adding at the end the following3 #caj;,c4 ,public ,health ,information ,sharing and ,availability ,advisory ,committee 7a7 ,establishment ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall establish an advisory committee1 to be known as the ,public ,health ,information ,sharing and ,availability ,advisory ,committee1 to advise1 and make recommendations to1 the ,director with respect to the implementation of public health and health care data and information reporting and sharing under section #caj;,b4 7b7 ,membership ,the membership of the advisory committee established pursuant to this section shall include-- 7#a7 individuals with subject matter expertise or experience in the following areas of public health and health care data and information1 including-- 7,a7 ,state1 territorial1 local1 and ,tribal health department data systems or practices2 and 7,b7 health care data2 7#b7 ex officio members1 including from relevant ,federal agencies such as the ,office of the ,national ,coordinator for ,health ,information ,technology1 the ,centers for ,medicare ,medicaid ,services1 the ,centers for ,disease ,control and ,prevention1 and the ,office of the ,assistant ,secretary for ,health2 7#c7 representatives of national organizations1 including the ,council of ,state and ,territorial ,epidemiologists1 the ,association of ,public ,health ,laboratories1 the ,association of ,state and ,territorial ,health ,officials1 the ,national ,association of ,county and ,city ,health ,officials1 and the ,big ,cities ,health ,coalition2 and 7#d7 such additional members as the ,secretary determines appropriate4 7c7 ,,faca applicability ,the advisory committee established pursuant to this section is deemed to be an advisory committee subject to the ,federal ,advisory ,committee ,act4 4 7d7 ,improving public health data collection 7#a7 ,in general ,the ,secretary of ,health and ,human ,services 7referred to in this subsection as the ,secretary7 shall award grants1 contracts1 or cooperative agreements to eligible entities for purposes of identifying1 developing1 or disseminating best practices in the collection of electronic health information and the use of designated data standards and implementation specifications-- 7,a7 to improve the quality and completeness of data1 including demographic data1 collected1 accessed1 or used for public health purposes2 and 7,b7 to address health disparities and related health outcomes4 7#b7 ,eligible entities ,to be eligible to receive an award under this subsection an entity shall-- 7,a7 be a health care provider1 academic medical center1 community-based organization1 ,state1 local governmental entity1 ,indian ,tribe or ,tribal organization 7as such terms are defined in section #d of the ,indian ,self ,determination and ,education ,assistance ,act 7#be ,u4,s4,c4 #ecjd771 ,urban ,indian organization 7as defined in section #d of the ,indian ,health ,care ,improvement ,act 7#be ,u4,s4,c4 #afjc771 or other appropriate public or private nonprofit entity1 or a consortia of any such entities2 and 7,b7 submit an application to the ,secretary at such time1 in such manner1 and containing such information as the ,secretary may require4 7#c7 ,activities ,entities receiving awards under this subsection shall use such award to develop and test best practices for training health care providers to use standards and implementation specifications that assist in the capture1 access1 exchange1 and use of electronic health information1 including demographic information1 disability status1 veteran status1 housing status1 functional status1 and other data elements4 ,such activities shall1 at a minimum1 include-- 7,a7 improving1 understanding1 and using data standards and implementation specifications2 7,b7 developing or identifying methods to improve communication with patients in a culturally and linguistically appropriate manner1 including to better capture information related to demographics of such individuals2 7,c7 developing methods for accurately categorizing and recording patient responses using available data standards2 7,d7 educating providers regarding the utility of such information for public health purposes and the importance of accurate collection and recording of such data2 and 7,e7 other activities1 as the ,secretary determines appropriate4 7#d7 ,reporting 7,a7 ,reporting by award recipients ,each recipient of an award under this subsection shall submit to the ,secretary a report on the results of best practices identified1 developed1 or disseminated through such award4 7,b7 ,report to congress ,not later than #a year after the completion of the program under this subsection1 the ,secretary shall submit a report to ,congress on the success of the best practices developed under such program1 opportunities for further dissemination of such best practices1 and recommendations for improving the capture1 access1 exchange1 and use of information to improve public health and reduce health disparities4 7#e7 ,nonduplication of efforts ,the ,secretary shall ensure that the activities and programs carried out under this subsection are free of unnecessary duplication of effort4 7#f7 ,authorization of appropriations ,there is authorized to be appropriated #aj1jjj1jjj for each of fiscal years #bjbd through #bjbf to carry out this subsection4 7e7 ,information collection ,section #cai;,d7a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#d7;a77 is amended by adding at the end the following3 7#e7 ,information collection ,subchapter ,i of chapter #ce of title #dd1 ,united ,states ,code1 shall not apply to information collection by the ,centers for ,disease ,control and ,prevention1 including the ,agency for ,toxic ,substances and ,disease ,registry1 that are part of investigations1 research1 surveillance1 or evaluations undertaken for public health purposes under any available authority4 4 ,,iv ,ensuring workforce to prepare for and respond to public health security threats #dja4 ,temporary reassignment of ,state and local personnel during a public health emergency 7a7 ,report to ,congress ,section #cai7;e77#f7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d7e77#f77 is amended by striking ,not later than #d years after the date of enactment of the ,pandemic and ,all-,hazards ,preparedness ,reauthorization ,act of #bjac1 the ,comptroller ,general of the ,united ,states shall and inserting ,not later than #d years after the date of enactment of the ,protecting ,,pahpa ,act of #bjbc1 the ,comptroller ,general of the ,united ,states shall4 7b7 ,sunset ,section #cai7;e77#h7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d7e77#h77 is amended by striking #bjbc and inserting #bjbh4 #djb4 ,epidemic ,intelligence ,service ,section #cag;,f7c77#b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;b-#g7;c77#b77 is amended by striking #bjai through #bjbc and inserting #bjbd through #bjbh4 ,v ,addressing drug and supply chain shortages ,a ,ensuring access to lifesaving drugs #eja4 ,extended expiration dates for life-saving drugs 7a7 ,in general ,the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq47 is amended by inserting after section #ejf,l of such ,act 7#ba ,u4,s4,c4 #cefl7 the following new section3 #ejf,m4 ,extended expiration dates for life-saving drugs 7a7 ,in general ,a manufacturer of a life-saving drug shall-- 7#a7 submit to the ,secretary data and information as required by subsection 7b77#a72 7#b7 conduct and submit the results1 data1 and information generated by any studies required under subsection 7b77#b72 and 7#c7 make any labeling change described in subsection 7c7 by the date specified by the ,secretary pursuant to such subsection4 7b7 ,data and information 7#a7 ,in general ,the ,secretary may issue an order requiring the manufacturer of a life-saving drug to submit1 in such manner as the ,secretary may prescribe1 data and information from any stage of development of the drug that are adequate to assess the stability of the drug to determine the longest supported expiration date4 7#b7 ,lack of data and information ,if the data and information required pursuant to an order issued under paragraph 7#a7 are not available or are insufficient1 as determined by the ,secretary1 the ,secretary may issue an order requiring the manufacturer of the drug-- 7,a7 to conduct studies1 which may be a continuation of ongoing studies1 to provide data and information adequate to assess the stability of the drug and to determine the longest supported expiration date2 and 7,b7 to submit such data and information to the ,secretary in such manner as the ,secretary may prescribe in the order4 7c7 ,labeling ,the ,secretary may issue an order requiring the manufacturer of a life-saving drug1 by a date determined by the ,secretary in consultation with the sponsor of the drug1 to make any labeling change regarding the expiration date or storage and handling of the drug that the ,secretary determines to be appropriate based on the data and information required to be submitted under this section or any other data and information available to the ,secretary4 7d7 ,definitions ,in this section3 7#a7 ,life-saving drug ,the term life-saving drug means a drug1 that is-- 7,a7 7i7 a medical countermeasure2 or 7ii7 on the drug shortage list under section #ejf;,e or determined by the ,secretary to be at risk of shortage2 and 7,b7 7i7 life-supporting2 7ii7 life-sustaining2 or 7iii7 intended for use in the prevention or treatment of a debilitating disease or condition in humans or animals1 including any such drug used in emergency medical care or during surgery or any such drug that is critical to the public health during a public health emergency declared by the ,secretary under section #cai of the ,public ,health ,service ,act4 7#b7 ,medical countermeasure ,the term medical countermeasure means a countermeasure as defined in section #efe7;a74 7e7 ,confidentiality ,nothing in this section shall be construed as authorizing the ,secretary to disclose any information that is a trade secret or confidential information subject to section #eeb7;b77#d7 of title #e1 ,united ,states ,code1 or section #aije of title #ah1 ,united ,states ,code4 4 7b7 ,prohibited act ,section #cja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cca71 as amended by section #cejc7;a77#a77;,a7 of division ,,ff of ,public ,law #aag-cbh1 is amended by inserting at the end the following new subsection3 7jjj7 ,the failure to comply with any order issued under section #ejf,m4 4 7c7 ,penalties ,subsection 7b7 of section #cjc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7 is amended by inserting at the end the following3 7#i7 ,if a manufacturer of a life-saving drug fails to submit data and information as required under section #ejf,m7b77#a71 fails to conduct or submit the data and information generated by studies as required under section #ejf,m7b77#b71 or fails to make a labeling change as required under section #ejf,m7c71 such manufacturer shall be subject to a civil penalty of not more than #aj1jjj for the first day on which the violation occurs and not more than #aj1jjj for each subsequent day on which the violation is not corrected4 4 ,b ,drug origin transparency #eaa4 ,enhanced drug manufacturing amount information reporting 7a7 ,in general ,section #eaj7;j77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7;j77#c77 is amended-- 7#a7 in subparagraph 7,a71 by adding or 7#b7 after paragraph 7#a72 and 7#b7 by adding at the end the following3 7,c7 ,each report submitted pursuant to subparagraph 7,a7 with respect to a drug shall-- 7i7 include additional information as may be specified by the ,secretary in regulation or guidance regarding the supply chain for such drug1 such as-- 7,i7 the identity of the respective suppliers of each active pharmaceutical ingredient1 active pharmaceutical ingredient intermediate1 and in-process material used in such manufacture1 preparation1 propagation1 compounding1 or processing of the drug2 and 7,,ii7 the respective amounts of such drug that were manufactured1 prepared1 propagated1 compounded1 or processed using an active pharmaceutical ingredient1 active pharmaceutical ingredient intermediate1 and in-process material from each such identified supplier2 and 7ii7 be submitted more frequently than annually1 in accordance with a reporting schedule as may be specified by the ,secretary in such regulation or guidance1 but not more frequently than #d times per year4 7,d7 ,any additional information specified in regulation or guidance pursuant to subparagraph 7,c7 shall be a required element of reports under this paragraph not earlier than #f months after the date on which such regulation or guidance is issued in final form 7and in no event shall the absence of any regulation or guidance issued under subparagraph 7,c7 affect the requirement to report as described in subparagraph 7,a774 4 7b7 ,conforming amendment ,section #eaj7;j77#c77;,b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #eaj7;j77#c77;,b77 is amended by striking subparagraph 7,a7 and inserting this paragraph4 #eab4 ,require drug labeling to include original manufacturer and supply chain information ,section #ejb of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7 is amended-- 7#a7 in paragraph 7b7-- 7,a7 by striking 7b7 ,if in a package and inserting 7b77#a7 ,if in a package2 7,b7 by striking a label containing 7#a7 the name and place and inserting a label containing-- 7,a7 the name and place 2 7,c7 by striking or distributor2 and 7#b7 an accurate statement and inserting or distributor2 and 7,b7 an accurate statement 2 7,d7 by striking under clause 7#b7 of this paragraph and inserting under this clause2 and 7,e7 by inserting at the end the following3 7#b7 7,a7 ,subject to clause 7,c71 if it is a drug1 including an active pharmaceutical ingredient1 unless it bears a label containing the name and place of business1 and unique facility identifier of the original manufacturer of such drug or active pharmaceutical ingredient1 except that the ,secretary may provide1 by regulation1 for reasonable variations in the implementation of such labeling requirements4 7,b7 ,subject to clause 7,c71 if it is a drug that is an active pharmaceutical ingredient1 unless any accompanying certificate of analysis contains the name and place of business1 and unique facility identifier of the original manufacturer of the active pharmaceutical ingredient4 7,c7 ,the ,secretary may provide1 by regulation1 for reasonable variations in the implementation of labeling requirements specified in this subparagraph4 2 and 7#b7 by inserting after paragraph 7c7 the following3 7d7 7#a7 ,subject to subparagraph 7#b71 if it is a drug1 including an active pharmaceutical ingredient1 unless it bears labeling containing the name and place of business of-- 7,a7 the original manufacturer of each active pharmaceutical ingredient2 7,b7 each manufacturer1 if different from the original manufacturer2 and 7,c7 the packer or distributor1 if any4 7#b7 ,the ,secretary may provide1 by regulation1 for reasonable variations or an alternative placement for the labeling requirements specified in subparagraph 7#a71 including by electronic means4 4 ,c ,medical device shortage reduction #eba4 ,clarifying device shortage notifications ,section #ejf;,j7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;j7a77 is amended-- 7#a7 in paragraph 7#b71 by striking during1 or in advance of1 a public health emergency2 and 7#b7 in the matter following paragraph 7#b71 by striking 1 during1 or in advance of1 a public health emergency declared by the ,secretary under section #cai of the ,public ,health ,service ,act14 #ebb4 ,supply chain risk management 7a7 ,section #ejf;,j of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;j7 is amended by striking subsection 7h7 and inserting the following3 7h7 ,risk management plans ,each manufacturer of a device described in subsection 7a7 shall develop1 maintain1 and1 as appropriate1 implement a risk management plan that identifies and evaluates risks to the supply of the device1 as applicable1 for each establishment in which such device is manufactured4 ,such risk management plan-- 7#a7 may identify and evaluate risks to the supply of more than #a device1 or device category1 manufactured at the same establishment2 and 7#b7 shall be subject to inspection and copying by the ,secretary pursuant to section #gjd or at the request of the ,secretary4 4 7b7 ,conforming amendment ,section #ejf;,j7f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;j7f77 is amended by striking or 7h7 after subsection 7a74 #ebc4 ,clarifying voluntary notifications ,section #ejf;,j7i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;j7i77 is amended by adding at the end the following3 ,nothing in this section shall be construed to limit the authority of the ,secretary to request that a manufacturer 7or other person involved in the device supply chain7 provide1 on a voluntary basis1 information to the ,secretary or the authority of the ,secretary to receive such information44 ,d ,drug shortage prevention #eca4 ,improving notification procedures in case of increased demand for critical essential medicines 7a7 ,in general ,section #ejf;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;c7 is amended-- 7#a7 in the section heading1 by striking ,discontinuance or interruption in the production of life-saving drugs and inserting ,notification of issues affecting domestic supply of critical essential medicines2 7#b7 by striking subsections 7a71 7b71 and 7c71 and inserting the following3 7a7 ,notification required 7#a7 ,in general ,a manufacturer of a critical essential medicine shall notify the ,secretary1 in accordance with subsection 7b71 of-- 7,a7 7i7 a permanent discontinuance in the manufacture of the drug or an interruption of the manufacture of the drug that is likely to lead to a meaningful disruption in the supply of such drug in the ,united ,states2 7ii7 a permanent discontinuance in the manufacture of an active pharmaceutical ingredient1 an excipient1 or any other input in the final dosage form of such drug or an interruption in the manufacture of the active pharmaceutical ingredient1 an excipient1 or any other input in the final dosage form of such drug of such drug that is likely to lead to a meaningful disruption in the supply of the active pharmaceutical ingredient of such drug2 7iii7 an increased demand 7other than an anticipated seasonal surge7 for such drug or an active pharmaceutical ingredient1 an excipient1 or any other input in the final dosage form of such drug that is likely to lead to a shortage of the drug or the active pharmaceutical ingredient1 an excipient1 or any other input in the final dosage form of such drug2 and 7,b7 the reasons for such discontinuance1 interruption1 or increased demand4 7#b7 ,contents ,notification under this subsection with respect to a critical essential medicine shall include-- 7,a7 with respect to the reasons for the discontinuation1 interruption1 or increased demand referred to in paragraph 7#a77;,c71 if an active pharmaceutical ingredient1 an excipient1 or any other input in the final dosage form of such drug is a reason for1 or risk factor in1 such discontinuation1 interruption1 or increased demand1 the source of the active pharmaceutical ingredient1 excipient1 or other input and any alternative sources for the an active pharmaceutical ingredient1 an excipient1 or any other input by the manufacturer2 7,b7 whether any associated device used for preparation or administration included in the drug is a reason for1 or a risk factor in1 such discontinuation1 interruption1 or increased demand2 7,c7 the expected duration of the interruption or increased demand2 and 7,d7 such other information as the ,secretary may require4 7b7 ,timing 7#a7 ,in general ,a notice required under subsection 7a7 shall be submitted to the ,secretary-- 7,a7 at least #f months prior to the date of the discontinuance or interruption2 7,b7 in the case of such a notice with respect to increased demand for a critical essential medicine1 not later than #cj days after the submission of the initial notification under paragraph 7#b72 or 7,c7 if compliance with subparagraph 7,a7 or 7,b7 is not possible1 as soon as practicable4 7#b7 ,initial notification with respect to increased demand ,in the case a notification required under subsection 7a7 with respect to increased demand for a critical essential medicine1 the manufacturer of the drug involved shall submit to the ,secretary an initial notification not later than #dh hours after the date on which there has been increased demand for the critical essential medicine for a period of at least #f consecutive weeks4 7c7 ,distribution ,to the maximum extent practicable1 the ,secretary shall distribute1 through such means as the ,secretary deems appropriate1 information on the discontinuance or interruption of the manufacture of1 or the increased demand for1 critical essential medicines to appropriate organizations1 including physician1 health provider1 and patient organizations1 as described in section #ejf;,e4 2 7#c7 in subsection 7g71 in the matter preceding paragraph 7#a71 by striking drug described in subsection 7a7 and inserting critical essential medicine2 and 7#d7 in subsection 7j71 by striking drug described in subsection 7a7 and inserting critical essential medicine4 7b7 ,application to nonprescription drugs ,section #ejf;,c7h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;c7h77 is amended-- 7#a7 by redesignating paragraphs 7#a71 7#b71 and 7#c7 as paragraphs 7#b71 7#c71 and 7#d71 respectively2 7#b7 in paragraph 7#b77;,a7 7as so redesignated71 by striking and that is subject to section #ejc7;b77#a7 and inserting 1 including a drug that is not subject to section #ejc7;b77#a72 and 7#c7 by inserting before paragraph 7#b7 7as so redesignated7 the following3 7#a7 the term critical essential medicine means a drug that-- 7,a7 is-- 7i7 life-supporting2 7ii7 life-sustaining2 or 7iii7 intended for use in the prevention or treatment of a debilitating disease or condition1 including any such drug used in emergency medical care or during surgery or any such drug that is critical to the public health during a public health emergency declared by the ,secretary under section #cai of the ,public ,health ,service ,act2 and 7,b7 is not a radio pharmaceutical drug product or any other product as designated by the ,secretary2 4 7c7 ,regulations ,not later than #ah months after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall issue final regulations to implement the amendments made by subsections 7a7 and 7b74 7d7 ,guidance 7#a7 ,in general ,the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall issue guidance on the requirements for notifications required to be submitted under section #ejf;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;c71 as amended by subsections 7a7 and 7b71 with respect to increased demand for critical essential medicines 7as defined in such section #ejf;,c74 ,such guidance shall specifically address-- 7,a7 the ways in which manufacturers of critical essential medicines can improve demand predictability2 7,b7 what information manufacturers of critical essential medicines should send to the ,secretary2 and 7,c7 what communications from the manufacturer the ,secretary would request with respect to increases in demand following such notifications4 7#b7 ,consultation ,in developing such guidance1 the ,secretary shall consult with relevant stakeholders1 including manufacturers of critical essential medicines and local1 ,state1 or ,federal public health officials4 7#c7 ,timing ,the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall issue-- 7,a7 draft guidance under paragraph 7#a7 not later than #abj days after the date of the enactment of this ,act2 and 7,b7 final guidance under such paragraph not later than #ahj days after the date of the enactment of this ,act4 ,e ,protecting ,americans from unsafe drugs #eda4 ,notification1 nondistribution1 and recall of drugs 7a7 ,order ,to cease distribution and recall ,section #efi;,d of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#h;d7 is amended-- 7#a7 in the section heading1 by striking controlled substances and inserting drugs2 7#b7 by striking controlled substance each place such term appears and inserting drug2 7#c7 in subsection 7b7-- 7,a7 by striking controlled substances and inserting drugs2 and 7,b7 by inserting of subsection 7a7 after an order pursuant to paragraph 7#a7 or an amended order pursuant to subparagraph 7,b7 or 7,c7 of paragraph 7#c72 and 7#d7 in subsection 7c71 by striking or an official senior to such ,director and inserting or the ,director of the ,center for ,biologics ,evaluation and ,research 7or an official senior to either such ,director74 7b7 ,imports and exports ,section #hja7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;a771 as amended by section #cejc7;a77#d77;,c7 of division ,,ff of ,public ,law #aag-cbh1 is amended by striking is a controlled substance subject to an order under section #efi;,d and inserting is a drug subject to an order under section #efi;,d4