#aadth ,,congress #ast ,session ,h4 ,r4 #f ,,an ,,act ,to accelerate the discovery1 development1 and delivery of #bast century cures1 and for other purposes4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the #bast ,century ,cures ,act4 7b7 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4 ,sec4 #b4 ,,nih and ,cures ,innovation ,fund4 ,title ,i--,discovery ,subtitle ,a--,national ,institutes of ,health ,funding ,sec4 #ajja4 ,national ,institutes of ,health reauthorization4 ,sec4 #ajjb4 ,prize competitions4 ,subtitle ,b--,national ,institutes of ,health ,planning and ,administration ,sec4 #ajba4 ,,nih research strategic plan4 ,sec4 #ajbb4 ,increasing accountability at the ,national ,institutes of ,health4 ,sec4 #ajbc4 ,reducing administrative burdens of researchers4 ,sec4 #ajbd4 ,exemption for the ,national ,institutes of ,health from the ,paperwork ,reduction ,act requirements4 ,sec4 #ajbe4 ,,nih travel4 ,sec4 #ajbf4 ,other transactions authority4 ,sec4 #ajbg4 ,,ncats phase ,,iib restriction4 ,sec4 #ajbh4 ,high-risk1 high-reward research4 ,sec4 #ajbi4 ,sense of ,congress on increased inclusion of underrepresented communities in clinical trials4 ,subtitle ,c--,supporting ,young ,emerging ,scientists ,sec4 #ajda4 ,improvement of loan repayment programs of the ,national ,institutes of ,health4 ,sec4 #ajdb4 ,report4 ,subtitle ,d--,capstone ,grant ,program ,sec4 #ajfa4 ,capstone award4 ,subtitle ,e--,promoting ,pediatric ,research through the ,national ,institutes of ,health ,sec4 #ajha4 ,national pediatric research network4 ,sec4 #ajhb4 ,global pediatric clinical study network sense of ,congress4 ,sec4 #ajhc4 ,appropriate age groupings in clinical research4 ,subtitle ,f--,advancement of the ,national ,institutes of ,health ,research and ,data ,access ,sec4 #aaja4 ,standardization of data in ,clinical ,trial ,registry ,data ,bank on eligibility for clinical trials4 ,subtitle ,g--,facilitating ,collaborative ,research ,sec4 #aaba4 ,clinical trial data system4 ,sec4 #aabb4 ,national neurological diseases surveillance system4 ,sec4 #aabc4 ,data on natural history of diseases4 ,sec4 #aabd4 ,accessing1 sharing1 and using health data for research purposes4 ,subtitle ,h--,council for #bast ,century ,cures ,sec4 #aada4 ,council for #bast ,century ,cures4 ,title ,,ii--,development ,subtitle ,a--,patient-,focused ,drug ,development ,sec4 #bjja4 ,development and use of patient experience data to enhance structured risk-benefit assessment framework4 ,subtitle ,b--,qualification and ,use of ,drug ,development ,tools ,sec4 #bjba4 ,qualification of drug development tools4 ,sec4 #bjbb4 ,accelerated approval development plan4 ,subtitle ,c--,,fda advancement of ,precision ,medicine ,sec4 #bjda4 ,precision medicine guidance and other programs of ,food and ,drug ,administration4 ,subtitle ,d--,modern ,trial ,design and ,evidence ,development ,sec4 #bjfa4 ,broader application of ,bayesian statistics and adaptive trial designs4 ,sec4 #bjfb4 ,utilizing evidence from clinical experience4 ,sec4 #bjfc4 ,streamlined data review program4 ,subtitle ,e--,expediting ,patient ,access ,sec4 #bjha4 ,sense of ,congress4 ,sec4 #bjhb4 ,expanded access policy4 ,sec4 #bjhc4 ,finalizing draft guidance on expanded access4 ,subtitle ,f--,facilitating responsible manufacturer communications ,sec4 #baja4 ,facilitating dissemination of health care economic information4 ,sec4 #bajb4 ,facilitating responsible communication of scientific and medical developments4 ,subtitle ,g--,antibiotic ,drug ,development ,sec4 #baba4 ,approval of certain drugs for use in a limited population of patients4 ,sec4 #babb4 ,susceptibility test interpretive criteria for microorganisms4 ,sec4 #babc4 ,encouraging the development and use of ,,disarm drugs4 ,subtitle ,h--,vaccine ,access1 ,certainty1 and ,innovation ,sec4 #bada4 ,timely review of vaccines by the ,advisory ,committee on ,immunization ,practices4 ,sec4 #badb4 ,review of processes and consistency of ,,acip recommendations4 ,sec4 #badc4 ,meetings between ,,cdc and vaccine developers4 ,subtitle ,i--,orphan product extensions now2 incentives for certain products for limited populations ,sec4 #baea4 ,extension of exclusivity periods for a drug approved for a new indication for a rare disease or condition4 ,sec4 #baeb4 ,reauthorization of rare pediatric disease priority review voucher incentive program4 ,subtitle ,j--,domestic ,manufacturing and ,export ,efficiencies ,sec4 #bafa4 ,grants for studying the process of continuous drug manufacturing4 ,sec4 #bafb4 ,re-exportation among members of the ,european ,economic ,area4 ,subtitle ,k--,enhancing combination products review ,sec4 #baha4 ,enhancing combination products review4 ,subtitle ,l--,priority ,review for ,breakthrough ,devices ,sec4 #bbja4 ,priority review for breakthrough devices4 ,subtitle ,m--,medical ,device ,regulatory ,process ,improvements ,sec4 #bbba4 ,third-party quality system assessment4 ,sec4 #bbbb4 ,valid scientific evidence4 ,sec4 #bbbc4 ,training and oversight in least burdensome appropriate means concept4 ,sec4 #bbbd4 ,recognition of standards4 ,sec4 #bbbe4 ,easing regulatory burden with respect to certain class ,i and class ,,ii devices4 ,sec4 #bbbf4 ,advisory committee process4 ,sec4 #bbbg4 ,humanitarian device exemption application4 ,sec4 #bbbh4 ,,clia waiver study design guidance for in vitro diagnostics4 ,subtitle ,n--,sensible ,oversight for ,technology ,which ,advances ,regulatory ,efficiency ,sec4 #bbda4 ,health software4 ,sec4 #bbdb4 ,applicability and inapplicability of regulation4 ,sec4 #bbdc4 ,exclusion from definition of device4 ,subtitle ,o--,streamlining ,clinical ,trials ,sec4 #bbfa4 ,protection of human subjects in research2 applicability of rules4 ,sec4 #bbfb4 ,use of non-local institutional review boards for review of investigational device exemptions and human device exemptions4 ,sec4 #bbfc4 ,alteration or waiver of informed consent for clinical investigations4 ,subtitle ,p--,improving ,scientific ,expertise and ,outreach at ,,fda ,sec4 #bbha4 ,silvio ,o4 ,conte ,senior ,biomedical ,research ,service4 ,sec4 #bbhb4 ,enabling ,,fda scientific engagement4 ,sec4 #bbhc4 ,reagan-,udall ,foundation for the ,food and ,drug ,administration4 ,sec4 #bbhd4 ,collection of certain voluntary information exempted from ,paperwork ,reduction ,act4 ,sec4 #bbhe4 ,hiring authority for scientific1 technical1 and professional personnel4 ,subtitle ,q--,exempting from sequestration certain user fees ,sec4 #bcja4 ,exempting from sequestration certain user fees of ,food and ,drug ,administration4 ,subtitle ,r--,other provisions ,sec4 #bcba4 ,sense of ,congress4 ,title ,,iii--,delivery ,subtitle ,a--,interoperability ,sec4 #cjja4 ,ensuring interoperability of health information technology4 ,subtitle ,b--,telehealth ,sec4 #cjba4 ,telehealth services under the ,medicare ,program4 ,subtitle ,c--,encouraging ,continuing ,medical ,education for ,physicians ,sec4 #cjda4 ,exempting from manufacturer transparency reporting certain transfers used for educational purposes4 ,subtitle ,d--,disposable ,medical ,technologies ,sec4 #cjfa4 ,treatment of certain items and devices4 ,subtitle ,e--,local coverage decision reforms ,sec4 #cjha4 ,improvements in the ,medicare local coverage determination 7,,lcd7 process4 ,subtitle ,f--,medicare ,pharmaceutical and ,technology ,ombudsman ,sec4 #caja4 ,medicare pharmaceutical and technology ombudsman4 ,subtitle ,g--,medicare site-of-,service price transparency ,sec4 #caba4 ,medicare site-of-,service price transparency4 ,subtitle ,h--,medicare ,part ,d ,patient ,safety and ,drug ,abuse ,prevention ,sec4 #cada4 ,programs to prevent prescription drug abuse under ,medicare parts ,c and ,d4 ,title ,,iv--,medicaid1 ,medicare1 and ,other ,reforms ,subtitle ,a--,medicaid and ,medicare ,reforms ,sec4 #djja4 ,limiting ,federal ,medicaid reimbursement to ,states for durable medical equipment 7,,dme7 to ,medicare payment rates4 ,sec4 #djjb4 ,excluding authorized generics from calculation of average manufacturer price4 ,sec4 #djjc4 ,medicare payment incentive for the transition from traditional x-ray imaging to digital radiography and other ,medicare imaging payment provision4 ,sec4 #djjd4 ,treatment of infusion drugs furnished through durable medical equipment4 ,sec4 #djje4 ,extension and expansion of prior authorization for power mobility devices 7,p,m,ds7 and accessories and prior authorization audit limitations4 ,sec4 #djjf4 ,civil monetary penalties for violations related to grants1 contracts1 and other agreements4 ,subtitle ,b--,other ,reforms ,sec4 #djda4 ,,spr drawdown4 ,subtitle ,c--,miscellaneous ,sec4 #djfa4 ,lyme disease and other tick-borne diseases4 ,sec4 #djfb4 ,outreach to historically black colleges and universities4 #b4 ,,nih and ,cures ,innovation ,fund 7a7 ,establishment ,there is hereby established in the ,treasury of the ,united ,states a fund to be known as the ,,nih and ,cures ,innovation ,fund4 7b7 ,amounts made available to ,fund 7#a7 ,in general ,there is authorized to be appropriated1 and appropriated1 to the ,,nih and ,cures ,innovation ,fund1 out of any funds in the ,treasury not otherwise appropriated1 #a1hfj1jjj1jjj for each of fiscal years #bjaf through #bjbj4 ,the amounts appropriated to the ,,nih and ,cures ,innovation ,fund by the preceding sentence shall be in addition to any amounts otherwise made available to the ,department of ,health and ,human ,services4 7#b7 ,allocation of amounts ,of the amounts made available from the ,,nih and ,cures ,innovation ,fund for a fiscal year-- 7,a7 #a1gej1jjj1jjj shall be for biomedical research of the ,national ,institutes of ,health under subsection 7c77#a71 of which-- 7i7 not less than #ejj1jjj1jjj shall be for the ,accelerating ,advancement ,program under subsection 7d77#b72 7ii7 not less than #ce percent of such amounts remaining after subtracting the allocation for the ,accelerating ,advancement ,program shall be for early stage investigators as defined in subsection 7g72 7iii7 not less than #bj percent of such amounts remaining after subtracting the allocation for the ,accelerating ,advancement ,program shall be for high-risk1 high-reward research under section #dji,l of the ,public ,health ,service ,act1 as added by section #ajbh2 and 7iv7 not more than #aj percent of such amounts 7without subtracting the allocation for the ,accelerating ,advancement ,program7 shall be for intramural research2 and 7,b7 #aaj1jjj1jjj shall be for carrying out the provisions listed in subsection 7c77#b74 7#c7 ,inapplicability of certain provisions ,amounts in the ,,nih and ,cures ,innovation ,fund 7including amounts made available to the ,national ,institutes of ,health7 shall not be subject to-- 7,a7 any transfer authority of the ,secretary of ,health and ,human ,services or the ,director of the ,national ,institutes of ,health under sections #bda1 #djb;,a7c71 or #djb;,a7d7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bch;j1 #bhb;a7c7 and 7d77 or any other provision of law 7other than this section72 or 7,b7 the ,nonrecurring expenses fund under section #bbc of division ,g of the ,consolidated ,appropriations ,act1 #bjjh 7#db ,u4,s4,c4 #cead;a74 7c7 ,authorized uses 7#a7 ,,nih biomedical research ,amounts in the ,,nih and ,cures ,innovation ,fund that are allocated pursuant to subsection 7b77#b77;,a7 may only be used for the purpose of conducting or supporting biomedical research 7including basic1 translational1 and clinical research7 through the following3 7,a7 ,research in which-- 7i7 a principal investigator has a specific project or specific objectives2 and 7ii7 funding is tied to pursuit of such project or objectives4 7,b7 ,research in which-- 7i7 a principal investigator has shown promise in biomedical research2 and 7ii7 funding is not tied to a specific project or specific objectives4 7,c7 ,research to be carried out by an early stage investigator 7as defined in subsection 7g774 7,d7 ,research to be carried out by a small business concern 7as defined in section #c of the ,small ,business ,act74 7,e7 ,the ,accelerating ,advancement ,program under subsection 7d77#b74 7,f7 ,development and implementation of the strategic plan under subsection 7d77#c74 7#b7 ,cures development ,amounts in the ,,nih and ,cures ,innovation ,fund that are allocated pursuant to subsection 7b77#b77;,b7 may only be used for the purpose of carrying out the following provisions3 7,a7 ,section #bbi;,a of the ,public ,health ,service ,act1 as added by section #aabc 7relating to data on natural history of diseases74 7,b7 ,section #bjja and the amendments made by such section 7relating to development and use of patient experience data to enhance structured risk-benefit assessment framework74 7,c7 ,section #bjba and the amendments made by such section 7relating to qualification of drug development tools74 7,d7 ,section #bjfb and the amendments made by such section 7relating to utilizing evidence from clinical experience74 7,e7 ,section #bafa 7relating to grants for studying the process of continuous drug manufacturing74 7,f7 ,section #bbja and the amendments made by such section 7relating to priority review for breakthrough devices74 7,g7 ,section #bbba and the amendments made by such section 7relating to third-party quality system assessments74 7,h7 ,sections #bbda1 #bbdb1 and #bbdc and the amendments made by such sections 7relating to health software74 7,i7 ,section #eac7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #bbbc 7relating to training and oversight in least burdensome appropriate means concept74 7d7 ,,nih ,innovation ,fund 7#a7 ,coordination ,in conducting or supporting biomedical research pursuant to funds allocated pursuant to subsection 7b77#b77;,a71 the ,secretary of ,health and ,human ,services1 acting through the ,director of the ,national ,institutes of ,health1 shall-- 7,a7 ensure coordination among the national research institutes1 the national centers1 and other departments1 agencies1 and offices of the ,federal ,government2 and 7,b7 minimize unnecessary duplication4 7#b7 ,accelerating ,advancement ,program ,the ,director of the ,national ,institutes of ,health shall establish a program1 to be known as the ,accelerating ,advancement ,program1 under which-- 7,a7 the ,director partners with national research institutes and national centers to accomplish important biomedical research objectives2 and 7,b7 for every #a made available by the ,director to a national research institute or national center for a research project1 the institute or center makes #a available for such project from funds that are not derived from the ,,nih and ,cures ,innovation ,fund4 7#c7 ,strategic plan 7,a7 ,in general ,the ,director of the ,national ,institutes of ,health shall ensure that scientifically based strategic planning is implemented in support of research priorities1 including through development1 use1 and updating of a research strategic plan that-- 7i7 is designed to increase the efficient and effective focus of biomedical research in a manner that leverages the best scientific opportunities through a deliberative planning process2 7ii7 identifies areas1 to be known as strategic focus areas1 in which the resources of the ,,nih and ,cures ,innovation ,fund can contribute to the goals of expanding knowledge to address1 and find more effective treatments for1 unmet medical needs in the ,united ,states1 including the areas of-- 7,i7 biomarkers2 7,,ii7 precision medicine2 7,,iii7 infectious diseases1 including pathogens listed as a qualifying pathogen under section #eje;,e7f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act or listed or designated as a tropical disease under section #ebd of such ,act2 and 7,,iv7 antibiotics2 7iii7 includes objectives for each such strategic focus area2 and 7iv7 ensures that basic research remains a priority4 7,b7 ,updates and reviews ,the ,director of the ,national ,institutes of ,health shall review and1 as appropriate1 update the research strategic plan under subparagraph 7,a7 not less than every #ah months4 7e7 ,transfer authority ,the ,committee on ,appropriations of the ,senate and the ,committee on ,appropriations of the ,house of ,representatives may provide for the transfer of funds in the ,,nih and ,cures ,innovation ,fund for the purposes specified in subsection 7c74 7f7 ,supplement1 not supplant2 limitations ,funds appropriated by subsection 7b7-- 7#a7 shall be used to supplement1 not supplant1 amounts otherwise made available to the ,department of ,health and ,human ,services2 7#b7 are subject to the requirements and limitations of the most recently enacted regular or full-year continuing appropriation ,act or resolution 7as of the date of obligation7 for programs of the ,national ,institutes of ,health or the ,food and ,drug ,administration1 as applicable2 and 7#c7 notwithstanding any transfer authority in any appropriation ,act1 shall not be used for any purpose other than the purposes specified in subsection 7c74 7g7 ,definition ,in this subsection3 7#a7 ,the term early stage investigator means an investigator who-- 7,a7 will be the principal investigator or the program director of the proposed research2 7,b7 has never been awarded1 or has been awarded only once1 a substantial1 competing grant by the ,national ,institutes of ,health for independent research2 and 7,c7 is within #aj years of having completed-- 7i7 the investigator's terminal degree2 or 7ii7 a medical residency 7or the equivalent74 7#b7 ,the terms national center and national research institute have the meanings given to those terms in section #dja7;g7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bha7;g774 ,i ,discovery ,a ,national ,institutes of ,health ,funding #ajja4 ,national ,institutes of ,health reauthorization ,section #djb;,a7a77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhb;a7a77#a77 is amended-- 7#a7 in subparagraph 7,b71 by striking at the end and2 7#b7 in subparagraph 7,c71 by striking at the end the period and inserting a semicolon2 and 7#c7 by adding at the end the following new subparagraphs3 7,d7 #ca1haa1jjj1jjj for fiscal year #bjaf2 7,e7 #cc1cca1jjj1jjj for fiscal year #bjag2 and 7,f7 #cd1hea1jjj1jjj for fiscal year #bjah4 4 #ajjb4 ,prize competitions ,part ,b of title ,,iv of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhd et seq47 is amended by adding at the end the following3 #dji,k4 ,prize competitions for improving health outcomes and reducing ,federal expenditures 7a7 ,establishment2 goals ,the ,director of ,,nih shall establish and implement an ,innovation ,prizes ,program for one or both of the following goals3 7#a7 ,identifying and funding areas of biomedical science that could realize significant advancements through the creation of a prize competition4 7#b7 ,improving health outcomes1 particularly with respect to human diseases and conditions for which public and private investment in research is disproportionately small relative to ,federal ,government expenditures on prevention and treatment activities1 thereby reducing ,federal expenditures on health programs4 7b7 ,design of prize competitions ,not later than #f months after the date of enactment of this section1 the ,director of ,,nih shall-- 7#a7 design prize competitions-- 7,a7 to cooperate with competitors to realize innovations to identify and address areas of biomedical science that could realize significant advancements through the creation of a prize competition2 and 7,b7 to award one or more prizes-- 7i7 if appropriate1 at the beginning of or during the competitions1 to the competitors whose innovations are most promising or demonstrate progress2 and 7ii7 at the end of the competitions1 to the competitors whose innovations prove to be the best solutions2 7#b7 ensure that the design of such competitions-- 7,a7 is realistic1 given the amount of funds to be awarded as prizes2 7,b7 does not reflect any bias concerning the type of innovations which will prove to be the best solutions2 and 7,c7 allows any person to participate as a competitor without regard to the person's place of incorporation1 primary place of business1 citizenship1 and residency1 as applicable2 and 7#c7 submit to the ,congress a report on the design of such competitions4 7c7 ,innovation ,prizes ,advisory ,board 7#a7 ,establishment ,the ,director of ,,nih shall establish and maintain a board1 to be known as the ,i-,prize ,board1 to advise and assist the ,director of ,,nih in carrying out this section4 7#b7 ,composition2 terms 7,a7 ,composition ,the ,i-,prize ,board shall be composed of nine voting members as follows3 7i7 ,the ,director of ,,nih 7or the ,director's designee74 7ii7 ,four members appointed by the ,director of ,,nih4 7iii7 ,one member appointed by the ,speaker of the ,house of ,representatives4 7iv7 ,one member appointed by the majority leader of the ,senate4 7v7 ,one member appointed by the minority leader of the ,house of ,representatives4 7vi7 ,one member appointed by the minority leader in the ,senate4 7,b7 ,inclusion of certain experts ,the members of the ,i-,prize ,board appointed under clauses 7ii7 through 7vi7 of subparagraph 7,a7 shall1 collectively1 include medical1 economic1 budgetary1 innovation1 or venture capital experts from for-profit and not-for-profit private sector entities with experience in awarding prizes similar to the prizes under this section4 7,c7 ,terms ,the appointed members of the ,i-,prize ,board shall each be appointed for a term of #e years4 7,d7 ,appointment of initial members ,the initial appointed members of the ,i-,prize ,board shall be appointed not later than #abj days after the date of enactment of this section4 7#c7 ,responsibilities ,the ,i-,prize ,board shall be responsible for advising the ,director of ,,nih by-- 7,a7 identifying areas of biomedical science that could realize significant advancements through the creation of a prize competition2 7,b7 making recommendations on establishing the criteria for prize competitions under this section2 7,c7 making recommendations on which business organizations or other entities have successfully met the criteria established for the prize competition2 and 7,d7 gaining insight from researchers1 health economists1 academia1 and industry on how to conduct prize competitions4 7d7 ,restrictions 7#a7 ,no financial conflicts of interest ,any member of the ,i-,prize ,board1 and any officer or employee of the ,national ,institutes of ,health responsible for carrying out this section1 may not personally or substantially participate in the consideration or determination by the ,i-,prize ,board of any matter that would directly or predictably effect any financial interest of-- 7,a7 the individual or a relative 7as such term is defined in section #aji7af7 of the ,ethics in ,government ,act of #aigh7 of the individual2 or 7,b7 of any business organization or other entity-- 7i7 of which the individual is an officer or employee2 7ii7 with respect to which the individual is negotiating for employment2 or 7iii7 in which the individual has any other financial interest4 7#b7 ,no awards to competitors likely to reap financial benefit from innovation ,the ,director of ,,nih may not1 with respect to an innovation1 award a prize under this section to any individual or entity that has a vested financial interest in any product or procedure that is likely to be developed or marketed because of such innovation4 7e7 ,process of award ,the full monetary amount of any prize awarded under this section shall be made available to the prize winner not later than #ij days after the date of such award4 7f7 ,simulation ,the ,director of ,,nih may-- 7#a7 award one or more contracts-- 7,a7 to perform a simulation of the prize competitions to be conducted under this section1 based on the designs developed under subsection 7b72 and 7,b7 to use the simulation to assess the effectiveness of the design2 and 7#b7 not later than #d months after awarding such one or more contracts1 submit to the ,congress a report on the results of the simulation and assessment4 7g7 ,implementation of prize competitions 7#a7 ,in general ,the ,director of ,,nih may enter into an agreement with one or more entities described in section #eja7;c71 and exempt from tax under section #eja7;a71 of the ,internal ,revenue ,code of #aihf to implement prize competitions based on the designs developed under subsection 7b74 7#b7 ,minimum percentage for prizes ,if the ,director of ,,nih enters into an agreement under paragraph 7#a7 to provide funds or other assistance 7including in-kind contributions and testing or other technical support7 to an entity to implement a prize competition under this section-- 7,a7 not more than #ae percent of such assistance shall be for administration of the prize competition2 and 7,b7 not less than #he percent of such assistance shall be for activities in direct support of competitors such as demonstration1 testing1 education1 and prize awards4 7h7 ,tracking2 reporting ,the ,director of ,,nih shall-- 7#a7 collect information on-- 7,a7 the medical efficacy of innovations funded through the prize competitions under this section2 and 7,b7 the actual and potential effect of the innovations on ,federal expenditures2 and 7#b7 not later than #a year after the conclusion of the prize competitions under this section1 and not later than the end of each of the #d succeeding years1 submit to the ,congress a report on the information collected under paragraph 7#a74 7i7 ,intellectual property 7#a7 ,prohibition on the government acquiring intellectual property rights ,the ,federal ,government may not gain an interest in intellectual property developed by a participant in a prize competition under this section without the written consent of the participant4 7#b7 ,licenses ,the ,federal ,government may negotiate a license for the use of intellectual property developed by a participant in a prize competition under this section4 4 ,b ,national ,institutes of ,health ,planning and ,administration #ajba4 ,,nih research strategic plan ,section #djb of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhb7 is amended-- 7#a7 in subsection 7b71 by amending paragraph 7#e7 to read as follows3 7#e7 shall ensure that scientifically based strategic planning is implemented in support of research priorities as determined by the agencies of the ,national ,institutes of ,health1 including through development1 use1 and updating of the research strategic plan under subsection 7m72 2 and 7#b7 by adding at the end the following3 7m7 ,research strategic plan 7#a7 ,five-year plans for biomedical research strategy 7,a7 ,in general ,for each successive #e-year period beginning with the period of fiscal years #bjaf through #bjbj1 the ,director of ,,nih1 in consultation with the entities described in subparagraph 7,b71 shall develop and maintain a biomedical research strategic plan that-- 7i7 is designed to increase the efficient and effective focus of biomedical research in a manner that leverages the best scientific opportunities through a deliberative planning process2 7ii7 identifies areas1 to be known as strategic focus areas1 in which the resources of the ,national ,institutes of ,health can best contribute to the goal of expanding knowledge on human health in the ,united ,states through biomedical research2 and 7iii7 includes objectives for each such strategic focus area4 7,b7 ,entities described ,the entities described in this subparagraph are the directors of the national research institutes and national centers1 researchers1 patient advocacy groups1 and industry leaders4 7#b7 ,use of plan ,the ,director of ,,nih and the directors of the national research institutes and national centers shall use the strategic plan-- 7,a7 to identify research opportunities2 and 7,b7 to develop individual strategic plans for the research activities of each of the national research institutes and national centers that-- 7i7 have a common template2 and 7ii7 identify strategic focus areas in which the resources of the national research institutes and national centers can best contribute to the goal of expanding knowledge on human health in the ,united ,states through biomedical research4 7#c7 ,contents of plans 7,a7 ,strategic focus areas ,the strategic focus areas identified pursuant to paragraph 7#a77;,a77ii7 shall-- 7i7 be identified in a manner that-- 7,i7 considers the return on investment to the ,united ,states public through the investments of the ,national ,institutes of ,health in biomedical research2 and 7,,ii7 contributes to expanding knowledge to improve the ,united ,states public's health through biomedical research2 and 7ii7 include overarching and trans-,national ,institutes of ,health strategic focus areas1 to be known as ,mission ,priority ,focus ,areas1 which best serve the goals of preventing or eliminating the burden of a disease or condition and scientifically merit enhanced and focused research over the next #e years4 7,b7 ,rare and pediatric diseases and conditions ,in developing and maintaining a strategic plan under this subsection1 the ,director of ,,nih shall ensure that rare and pediatric diseases and conditions remain a priority4 7,c7 ,workforce ,in developing and maintaining a strategic plan under this subsection1 the ,director of ,,nih shall ensure that maintaining the biomedical workforce of the future1 including the participation by scientists from groups traditionally underrepresented in the scientific workforce1 remains a priority4 7#d7 ,initial plan ,not later than #bgj days after the date of enactment of this subsection1 the ,director of ,,nih and the directors of the national research institutes and national centers shall-- 7,a7 complete the initial strategic plan required by paragraphs 7#a7 and 7#b72 and 7,b7 make such initial strategic plan publicly available on the website of the ,national ,institutes of ,health4 7#e7 ,review2 updates 7,a7 ,progress reviews ,not less than annually1 the ,director of ,,nih1 in consultation with the directors of the national research institutes and national centers1 shall conduct progress reviews for each strategic focus area identified under paragraph 7#a77;,a77ii74 7,b7 ,updates ,not later than the end of the #e-year period covered by the initial strategic plan under this subsection1 and every #e years thereafter1 the ,director of ,,nih1 in consultation with the directors of the national research institutes and national centers1 stakeholders in the scientific field1 advocates1 and the public at large1 shall-- 7i7 conduct a review of the plan1 including each strategic focus area identified under paragraph 7#b77;,b72 and 7ii7 update such plan in accordance with this section4 4 #ajbb4 ,increasing accountability at the ,national ,institutes of ,health 7a7 ,appointment and terms of directors of national research institutes and national centers ,subsection 7a7 of section #dje of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhd7 is amended to read as follows3 7a7 ,appointment2 terms 7#a7 ,appointment ,the ,director of the ,national ,cancer ,institute shall be appointed by the ,president and the directors of the other national research institutes1 as well as the directors of the national centers1 shall be appointed by the ,director of ,,nih4 ,the directors of the national research institutes1 as well as national centers1 shall report directly to the ,director of ,,nih4 7#b7 ,terms 7,a7 ,in general ,the term of office of a director of a national research institute or national center shall be #e years4 7,b7 ,removal ,the director of a national research institute or national center may be removed from office by the ,director of ,,nih prior to the expiration of such director's #e-year term4 7,c7 ,reappointment ,at the end of the term of a director of a national research institute or national center1 the director may be reappointed4 ,there is no limit on the number of terms a director may serve4 7,d7 ,vacancies ,if the office of a director of a national research institute or national center becomes vacant before the end of such director's term1 the director appointed to fill the vacancy shall be appointed for a #e-year term starting on the date of such appointment4 7,e7 ,transitional provision ,each director of a national research institute or national center serving on the date of enactment of the #bast ,century ,cures ,act is deemed to be appointed for a #e-year term under this subsection starting on such date of enactment4 4 7b7 ,compensation to consultants or individual scientists ,section #bjb of the ,departments of ,labor1 ,health and ,human ,services1 and ,education1 and ,related ,agencies ,appropriations ,act1 #aiic 7,public ,law #ajb-cid2 #db ,u4,s4,c4 #bch;f note7 is amended by striking portable structures2 and all that follows and inserting portable structures44 7c7 ,review of certain awards by directors ,section #dje7;b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhd7;b77 is amended by adding at the end the following3 7#c7 ,before an award is made by a national research institute or by a national center for a grant for a research program or project 7commonly referred to as an ,r-series grant71 other than an award constituting a noncompeting renewal of such grant1 or a noncompeting administrative supplement to such grant1 the director of such national research institute or national center-- 7,a7 shall review and approve the award2 and 7,b7 shall take into consideration-- 7i7 the mission of the national research institute or national center and the scientific priorities identified in the strategic plan under section #djb7m72 and 7ii7 whether other agencies are funding programs or projects to accomplish the same goal4 4 7d7 ,,iom study on duplication in ,federal biomedical research ,the ,secretary of ,health and ,human ,services shall enter into an arrangement with the ,institute of ,medicine of the ,national ,academies 7or1 if the ,institute declines1 another appropriate entity7 under which the ,institute 7or other appropriate entity7 not later than #b years after the date of enactment of this ,act will-- 7#a7 complete a study on the extent to which biomedical research conducted or supported by ,federal agencies is duplicative2 and 7#b7 submit a report to the ,congress on the results of such study1 including recommendations on how to prevent such duplication4 #ajbc4 ,reducing administrative burdens of researchers 7a7 ,plan ,preparation and implementation of measures ,to reduce administrative burdens ,the ,director of the ,national ,institutes of ,health shall prepare a plan1 including time frames1 and implement measures to reduce the administrative burdens of researchers funded by the ,national ,institutes of ,health1 taking into account the recommendations1 evaluations1 and plans researched by the following entities3 7#a7 ,the ,scientific ,management ,review ,board4 7#b7 ,the ,national ,academy of ,sciences4 7#c7 ,the #bjjg and #bjab ,faculty ,burden ,survey conducted by ,the ,federal ,demonstration ,partnership4 7#d7 ,relevant recommendations from the ,research ,business ,models ,working ,group4 7b7 ,report ,not later than #b years after the date of enactment of this ,act1 the ,director of the ,national ,institutes of ,health shall submit to ,congress a report on the extent to which the ,director has implemented measures pursuant to subsection 7a74 #ajbd4 ,exemption for the ,national ,institutes of ,health from the ,paperwork ,reduction ,act requirements ,section #ceah7;c77#a7 of title #dd1 ,united ,states ,code1 is amended-- 7#a7 in subparagraph 7,c71 by striking 2 or and inserting a semicolon2 7#b7 in subparagraph 7,d71 by striking the period at the end and inserting 2 or2 and 7#c7 by inserting at the end the following new subparagraph3 7,e7 during the conduct of research by the ,national ,institutes of ,health4 4 #ajbe4 ,,nih travel ,it is the sense of ,congress that participation in or sponsorship of scientific conferences and meetings is essential to the mission of the ,national ,institutes of ,health4 #ajbf4 ,other transactions authority ,section #dhj of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhg;a7 is amended-- 7#a7 in subsection 7b71 by striking the appropriation of funds as described in subsection 7g7 and inserting the availability of funds as described in subsection 7f72 7#b7 in subsection 7e77#c71 by amending subparagraph 7,c7 to read as follows3 7,c7 ,other ,transactions ,authority ,the ,director of the ,center shall have other transactions authority in entering into transactions to fund projects in accordance with the terms and conditions of this section4 2 7#c7 by striking subsection 7f72 and 7#d7 by redesignating subsection 7g7 as subsection 7f74 #ajbg4 ,,ncats phase ,,iib restriction ,section #dgi of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhg7 is amended-- 7#a7 prior to making the amendments under paragraph 7#b71 by striking ,,iib each place it appears and inserting ,,iii2 and 7#b7 by striking ,,iia each place it appears and inserting ,,iib4 #ajbh4 ,high-risk1 high-reward research ,part ,b of title ,,iv of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhd et seq471 as amended by section #ajjb of this ,act1 is amended by adding at the end the following3 #dji,l4 ,high-risk1 high-reward research program ,the director of each national research institute shall1 as appropriate-- 7#a7 establish programs to conduct or support research projects that pursue innovative approaches to major contemporary challenges in biomedical research that involve inherent high risk1 but have the potential to lead to breakthroughs2 and 7#b7 set aside a specific percentage of funding1 to be determined by the ,director of ,,nih for each national research institute1 for such projects4 4 #ajbi4 ,sense of ,congress on increased inclusion of underrepresented communities in clinical trials ,it is the sense of ,congress that the ,national ,institute on ,minority ,health and ,health ,disparities 7,,nimhd7 should include within its strategic plan ways to increase representation of underrepresented communities in clinical trials4 ,c ,supporting ,young ,emerging ,scientists #ajda4 ,improvement of loan repayment programs of the ,national ,institutes of ,health 7a7 ,in general ,part ,g of title ,,iv of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhh et seq47 is amended-- 7#a7 by redesignating the second section #dhg;,f 7#db ,u4,s4,c4 #bhh-f2 relating to pediatric research loan repayment program7 as section #dhg;,g2 and 7#b7 by inserting after section #dhg;,g1 as so redesignated1 the following3 #dhg;,h4 ,loan repayment program 7a7 ,in general ,the ,secretary shall establish a program1 based on workforce and scientific needs1 of entering into contracts with qualified health professionals under which such health professionals agree to engage in research in consideration of the ,federal ,government agreeing to pay1 for each year of engaging in such research1 not more than #ej1jjj of the principal and interest of the educational loans of such health professionals4 7b7 ,adjustment for inflation ,beginning with respect to fiscal year #bjag1 the ,secretary may increase the maximum amount specified in subsection 7a7 by an amount that is determined by the ,secretary1 on an annual basis1 to reflect inflation4 7c7 ,limitation ,the ,secretary may not enter into a contract with a health professional pursuant to subsection 7a7 unless such professional has a substantial amount of educational loans relative to income4 7d7 ,applicability of certain provisions regarding obligated service ,except to the extent inconsistent with this section1 the provisions of sections #cch;,b1 #cch;,c1 and #cch;,e shall apply to the program established under this section to the same extent and in the same manner as such provisions apply to the ,national ,health ,service ,corps ,loan ,repayment ,program established under section #cch;,b4 7e7 ,availability of appropriations ,amounts appropriated for a fiscal year for contracts under subsection 7a7 are authorized to remain available until the expiration of the second fiscal year beginning after the fiscal year for which the amounts were appropriated4 4 7b7 ,update of other loan repayment programs 7#a7 ,section #dfdz-#e7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4#bhet-#b7;a77 is amended-- 7,a7 by striking #ce1jjj and inserting #ej1jjj2 and 7,b7 by adding at the end the following new sentence3 ,subsection 7b7 of section #dhg;,h shall apply with respect to the maximum amount specified in this subsection in the same manner as it applies to the maximum amount specified in subsection 7a7 of such section44 7#b7 ,section #dhg;,a7a7 of such ,act 7#db ,u4,s4,c4 #bhh-a7;a77 is amended-- 7,a7 by striking #ce1jjj and inserting #ej1jjj2 and 7,b7 by adding at the end the following new sentence3 ,subsection 7b7 of section #dhg;,h shall apply with respect to the maximum amount specified in this subsection in the same manner as it applies to the maximum amount specified in subsection 7a7 of such section44 7#c7 ,section #dhg;,b7a7 of such ,act 7#db ,u4,s4,c4 #bhh-b7;a77 is amended-- 7,a7 by striking #ce1jjj and inserting #ej1jjj2 and 7,b7 by adding at the end the following new sentence3 ,subsection 7b7 of section #dhg;,h shall apply with respect to the maximum amount specified in this subsection in the same manner as it applies to the maximum amount specified in such subsection 7a7 of such section44 7#d7 ,section #dhg;,c7a77#a7 of such ,act 7#db ,u4,s4,c4 #bhh-c7;a77#a77 is amended-- 7,a7 by striking #ce1jjj and inserting #ej1jjj2 and 7,b7 by adding at the end the following new sentence3 ,subsection 7b7 of section #dhg;,h shall apply with respect to the maximum amount specified in this paragraph in the same manner as it applies to the maximum amount specified in such subsection 7a7 of such section44 7#e7 ,section #dhg;,e7a77#a7 of such ,act 7#db ,u4,s4,c4 #bhh-e7;a77#a77 is amended-- 7,a7 by striking #ce1jjj and inserting #ej1jjj2 and 7,b7 by adding at the end the following new sentence3 ,subsection 7b7 of section #dhg;,h shall apply with respect to the maximum amount specified in this paragraph in the same manner as it applies to the maximum amount specified in such subsection 7a7 of such section44 7#f7 ,section #dhg;,f7a7 of such ,act 7#db ,u4,s4,c4 #bhh-e;a7a771 as added by section #bje of ,public ,law #ajf-eje1 is amended-- 7,a7 by striking #ce1jjj and inserting #ej1jjj2 and 7,b7 by adding at the end the following new sentence3 ,subsection 7b7 of section #dhg;,h shall apply with respect to the maximum amount specified in this subsection in the same manner as it applies to the maximum amount specified in such subsection 7a7 of such section44 7#g7 ,section #dhg;,g of such ,act 7#db ,u4,s4,c4 #bhh-f1 as redesignated by subsection 7a77#a771 is further amended-- 7,a7 in subsection 7a77#a71 by striking #ce1jjj and inserting #ej1jjj2 and 7,b7 in subsection 7b71 by adding at the end the following new sentence3 ,subsection 7b7 of section #dhg;,h shall apply with respect to the maximum amount specified in subsection 7a77#a7 in the same manner as it applies to the maximum amount specified in such subsection 7a7 of such section44 #ajdb4 ,report ,not later than #ah months after the date of the enactment of this ,act1 the ,director of the ,national ,institutes of ,health shall submit to ,congress a report on efforts of the ,national ,institutes of ,health to attract1 retain1 and develop emerging scientists1 including underrepresented individuals in the sciences1 such as women and other minorities4 ,d ,capstone ,grant ,program #ajfa4 ,capstone award ,part ,g of title ,,iv of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhh et seq47 is amended by adding at the end the following3 #dij4 ,capstone award 7a7 ,in general ,the ,secretary may make awards 7each of which1 hereafter in this section1 referred to as a ,capstone ,award7 to support outstanding scientists who have been funded by the ,national ,institutes of ,health4 7b7 ,purpose ,capstone ,awards shall be made to facilitate the successful transition or conclusion of research programs1 or for other purposes1 as determined by the ,director of ,,nih1 in consultation with the directors of the national research institutes and national centers4 7c7 ,duration and amount ,the duration and amount of each ,capstone ,award shall be determined by the ,director of ,,nih in consultation with the directors of the national research institutes and national centers4 7d7 ,limitation ,individuals who have received a ,capstone ,award shall not be eligible to have principle investigator status on subsequent awards from the ,national ,institutes of ,health4 4 ,e ,promoting ,pediatric ,research through the ,national ,institutes of ,health #ajha4 ,national pediatric research network ,section #dji;,d7d7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhd;h7d77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 by striking in consultation with the ,director of the ,eunice ,kennedy ,shriver ,national ,institute of ,child ,health and ,human ,development and in collaboration with other appropriate national research institutes and national centers that carry out activities involving pediatric research and inserting in collaboration with the national research institutes and national centers that carry out activities involving pediatric research2 7,b7 by striking subparagraph 7,b72 7,c7 by striking may be comprised of1 as appropriate and all that follows through the pediatric research consortia and inserting may be comprised of1 as appropriate1 the pediatric research consortia2 and 7,d7 by striking 2 or at the end and inserting a period2 and 7#b7 in paragraph 7#a71 paragraph 7#b77;,a71 the first sentence of paragraph 7#b77;,e71 and paragraph 7#d71 by striking may each place it appears and inserting shall4 #ajhb4 ,global pediatric clinical study network sense of ,congress ,it is the sense of ,congress that-- 7#a7 the ,national ,institutes of ,health should encourage a global pediatric clinical study network through the allocation of grants1 contracts1 or cooperative agreements to supplement the salaries of new and early investigators who participate in the global pediatric clinical study network2 7#b7 ,national ,institutes of ,health grants1 contracts1 or cooperative agreements should be awarded1 solely for the purpose of supplementing the salaries of new and early investigators1 to entities that participate in the global pediatric clinical study network2 7#c7 the ,food and ,drug ,administration should engage the ,european ,medicines ,agency and other foreign regulatory entities during the formation of the global pediatric clinical study network to encourage their participation2 and 7#d7 once a global pediatric clinical study network is established and becomes operational1 the ,food and ,drug ,administration should continue to engage the ,european ,medicines ,agency and other foreign regulatory entities to encourage and facilitate their participation in the network with the goal of enhancing the global reach of the network4 #ajhc4 ,appropriate age groupings in clinical research 7a7 ,input from experts ,not later than #ahj days after the date of enactment of this ,act1 the ,director of the ,national ,institutes of ,health shall convene a workshop of experts on pediatrics and experts on geriatrics to provide input on-- 7#a7 appropriate age groupings to be included in research studies involving human subjects2 and 7#b7 acceptable scientific justifications for excluding participants from a range of age groups from human subjects research studies4 7b7 ,guidelines ,not later than #ahj days after the conclusion of the workshop under subsection 7a71 the ,director of the ,national ,institutes of ,health shall publish guidelines-- 7#a7 addressing the consideration of age as an inclusion variable in research involving human subjects2 and 7#b7 identifying criteria for justifications for any age-related exclusions in such research4 7c7 ,public availability of findings and conclusions ,the ,director of the ,national ,institutes of ,health shall-- 7#a7 make the findings and conclusions resulting from the workshop under subsection 7a7 available to the public on the website of the ,national ,institutes of ,health2 and 7#b7 not less than biennially1 disclose to the public on such website the number of children included in research that is conducted or supported by the ,national ,institutes of ,health1 disaggregated by developmentally appropriate age group1 race1 and gender4 ,f ,advancement of the ,national ,institutes of ,health ,research and ,data ,access #aaja4 ,standardization of data in ,clinical ,trial ,registry ,data ,bank on eligibility for clinical trials 7a7 ,standardization 7#a7 ,in general ,section #djb7;j7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhb7;j77 is amended-- 7,a7 by redesignating paragraph 7#g7 as paragraph 7#h72 and 7,b7 by inserting after paragraph 7#f7 the following3 7#g7 ,standardization ,the ,director of ,,nih shall-- 7,a7 ensure that the registry and results data bank is easily used by the public2 7,b7 ensure that entries in the registry and results data bank are easily compared2 7,c7 ensure that information required to be submitted to the registry and results data bank1 including recruitment information under paragraph 7#b77;,a77ii77,,ii71 is submitted by persons and posted by the ,director of ,,nih in a standardized format and includes at least-- 7i7 the disease or indication being studied2 7ii7 inclusion criteria such as age1 gender1 diagnosis or diagnoses1 laboratory values1 or imaging results2 and 7iii7 exclusion criteria such as specific diagnosis or diagnoses1 laboratory values1 or prohibited medications2 and 7,d7 to the extent possible1 in carrying out this paragraph1 make use of standard health care terminologies1 such as the ,international ,classification of ,diseases or the ,current ,procedural ,terminology1 that facilitate electronic matching to data in electronic health records or other relevant health information technologies4 4 7#b7 ,conforming amendment ,clause 7iv7 of section #djb7;j77#b77;,b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhb7;j77#b77;,b77 is hereby stricken4 7b7 ,consultation ,not later than #ij days after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall consult with stakeholders 7including patients1 researchers1 physicians1 industry representatives1 health information technology providers1 the ,food and ,drug ,administration1 and standard setting organizations such as ,,cdisc that have experience working with ,federal agencies to standardize health data submissions7 to receive advice on enhancements to the clinical trial registry data bank under section #djb7;j7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhb7;j77 7including enhancements to usability1 functionality1 and search capability7 that are necessary to implement paragraph 7#g7 of section #djb7;j7 of such ,act1 as added by subsection 7a74 7c7 ,applicability ,not later than #ah months after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall begin implementation of paragraph 7#g7 of section #djb7;j7 of the ,public ,health ,service ,act1 as added by subsection 7a74 ,g ,facilitating ,collaborative ,research #aaba4 ,clinical trial data system 7a7 ,establishment ,the ,secretary1 acting through the ,commissioner of ,food and ,drugs and the ,director of the ,national ,institutes of ,health1 shall enter into a cooperative agreement1 contract1 or grant for a period of #g years1 to be known as the ,clinical ,trial ,data ,system ,agreement1 with one or more eligible entities to implement a pilot program with respect to all clinical trial data obtained from qualified clinical trials for purposes of registered users conducting further research on such data4 7b7 ,application ,eligible entities seeking to enter into a cooperative agreement1 contract1 or grant with the ,secretary under this section shall submit to the ,secretary an application in such time and manner1 and containing such information1 as the ,secretary may require in accordance with this section4 ,the ,secretary shall not enter into a cooperative agreement1 contract1 or grant under this section with an eligible entity unless such entity submits an application including the following3 7#a7 ,a certification that the eligible entity is not currently and does not plan to be involved in sponsoring1 operating1 or participating in a clinical trial nor collaborating with another entity for the purposes of sponsoring1 operating1 or participating in a clinical trial4 7#b7 ,information demonstrating that the eligible entity can compile clinical trial data in standardized formats using terminologies and standards that have been developed by recognized standards developing organizations with input from diverse stakeholder groups1 and information demonstrating that the eligible entity can de-identify clinical trial data consistent with the requirements of section #afd4ead of title #de1 ,code of ,federal ,regulations 7or successor regulations74 7#c7 ,a description of the system the eligible entity will use to store and maintain such data1 and information demonstrating that this system will comply with applicable standards and requirements for ensuring the security of the clinical trial data4 7#d7 ,a certification that the eligible entity will allow only registered users to access and use de-identified clinical trial data1 gathered from qualified clinical trials1 and that the eligible entity will allow each registered user to access and use such data only after such registered user agrees in writing to the terms described in 7e77#d77;,b71 and such other carefully controlled contractual terms as may be defined by the ,secretary4 7#e7 ,evidence demonstrating the ability of the eligible entity to ensure that registered users disseminate the results of the research conducted in accordance with this section to interested parties to serve as a guide to future medical product development or scientific research4 7#f7 ,the plan of the eligible entity for securing funding for the activities it would conduct under the clinical trial data system agreement from governmental sources and private foundations1 entities1 and individuals4 7#g7 ,evidence demonstrating a proven track record of-- 7,a7 being a neutral third party in working with medical product manufacturers1 academic institutions1 and the ,food and ,drug ,administration2 and 7,b7 having the ability to protect confidential data4 7#h7 ,an agreement that the eligible entity will work with the ,comptroller ,general of the ,united ,states for purposes of the study and report under subsection 7d74 7c7 ,extension1 expansion1 termination ,the ,secretary1 acting through the ,commissioner of ,food and ,drugs and the ,director of the ,national ,institutes of ,health1 upon the expiration of the #g-year period referred to in subsection 7a71 may extend 7including permanently71 expand1 or terminate the pilot program established under such subsection1 in whole or in part4 7d7 ,study and report 7#a7 ,in general ,the ,comptroller ,general of the ,united ,states shall conduct a study and issue a report to the ,congress and the ,secretary with respect to the pilot program established under subsection 7a71 not later than #f years after the date on which the pilot program is established under subsection 7a74 7#b7 ,study ,the study under paragraph 7#a7 shall-- 7,a7 review the effectiveness of the pilot program established under subsection 7a72 and 7,b7 be designed to formulate recommendations on improvements to the program4 7#c7 ,report ,the report under paragraph 7#a7 shall contain at least the following information3 7,a7 ,the new discoveries1 research inquiries1 or clinical trials that have resulted from accessing clinical trial data under the pilot program established under subsection 7a74 7,b7 ,the number of times scientists have accessed such data1 disaggregated by research area and clinical trial phase4 7,c7 ,an analysis of whether the program has helped to reduce adverse events in clinical trials4 7,d7 ,an analysis of whether scientists have raised any concerns about the burden of having to share data with the system established under the program and1 if so1 a description of such concerns4 7,e7 ,an analysis of privacy and data integrity practices used in the program4 7e7 ,definitions ,in this section3 7#a7 ,the term eligible entity means an entity that has experienced personnel with clinical and other technical expertise in the biomedical sciences and biomedical ethics and that is-- 7,a7 an institution of higher education 7as such term is defined in section #ajja of the ,higher ,education ,act of #aife 7#bj ,u4,s4,c4 #ajja77 or a consortium of such institutions2 or 7,b7 an organization described in section #eja7;c77#c7 of title #bf of the ,internal ,revenue ,code of #aihf and exempt from tax under section #eja7;a7 of such title4 7#b7 ,the term medical product means a drug 7as defined in section #bja7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7;g7771 a device 7as defined in section #bja7;h7 of such ,act 7#ba ,u4,s4,c4 #cca7;h771 a biological product 7as defined in section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb771 or any combination thereof4 7#c7 ,the term qualified clinical trial means a clinical trial sponsored solely by an agency of the ,department of ,health and ,human ,services with respect to a medical product-- 7,a7 that-- 7i7 was approved or cleared under section #eje1 #eaj7k71 or #eae1 or has an exemption for investigational use in effect under section #eje or #ebj7m71 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#db ,u4,s4,c4 #cja et seq472 or 7ii7 was licensed under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 or has an exemption for investigational use in effect under such section #cea2 or 7,b7 that is an investigational product for which the original development was discontinued and with respect to which-- 7i7 no additional work to support approval1 licensure1 or clearance of such medical product is being or is planned to be undertaken by the sponsor of the original development program1 its successors1 assigns1 or collaborators2 and 7ii7 the sponsor of the original investigational development program has provided its consent to the ,secretary for inclusion of data regarding such product in the system established under this section4 7#d7 ,the term registered user means a scientific or medical researcher who has-- 7,a7 a legitimate biomedical research purpose for accessing information from the clinical trials data system and has appropriate qualifications to conduct such research2 and 7,b7 agreed in writing not to transfer to any other person that is not a registered user de-identified clinical trial data from qualified clinical trials accessed through an eligible entity1 use such data for reasons not specified in the research proposal1 or seek to re-identify qualified clinical trial participants4 7#e7 ,the term ,secretary means the ,secretary of ,health and ,human ,services4 #aabb4 ,national neurological diseases surveillance system ,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 following3 #cii,v-#f ,surveillance of neurological diseases 7a7 ,in general ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention and in coordination with other agencies as determined appropriate by the ,secretary1 shall-- 7#a7 enhance and expand infrastructure and activities to track the epidemiology of neurological diseases1 including multiple sclerosis and ,parkinson's disease2 and 7#b7 incorporate information obtained through such activities into a statistically sound1 scientifically credible1 integrated surveillance system1 to be known as the ,national ,neurological ,diseases ,surveillance ,system4 7b7 ,research ,the ,secretary shall ensure that the ,national ,neurological ,diseases ,surveillance ,system is designed in a manner that facilitates further research on neurological diseases4 7c7 ,content ,in carrying out subsection 7a71 the ,secretary-- 7#a7 shall provide for the collection and storage of information on the incidence and prevalence of neurological diseases in the ,united ,states2 7#b7 to the extent practicable1 shall provide for the collection and storage of other available information on neurological diseases1 such as information concerning-- 7,a7 demographics and other information associated or possibly associated with neurological diseases1 such as age1 race1 ethnicity1 sex1 geographic location1 and family history2 7,b7 risk factors associated or possibly associated with neurological diseases1 including genetic and environmental risk factors2 and 7,c7 diagnosis and progression markers2 7#c7 may provide for the collection and storage of information relevant to analysis on neurological diseases1 such as information concerning-- 7,a7 the epidemiology of the diseases2 7,b7 the natural history of the diseases2 7,c7 the prevention of the diseases2 7,d7 the detection1 management1 and treatment approaches for the diseases2 and 7,e7 the development of outcomes measures2 and 7#d7 may address issues identified during the consultation process under subsection 7d74 7d7 ,consultation ,in carrying out this section1 the ,secretary shall consult with individuals with appropriate expertise1 including-- 7#a7 epidemiologists with experience in disease surveillance or registries2 7#b7 representatives of national voluntary health associations that-- 7,a7 focus on neurological diseases1 including multiple sclerosis and ,parkinson's disease2 and 7,b7 have demonstrated experience in research1 care1 or patient services2 7#c7 health information technology experts or other information management specialists2 7#d7 clinicians with expertise in neurological diseases2 and 7#e7 research scientists with experience conducting translational research or utilizing surveillance systems for scientific research purposes4 7e7 ,grants ,the ,secretary may award grants to1 or enter into contracts or cooperative agreements with1 public or private nonprofit entities to carry out activities under this section4 7f7 ,coordination with other ,federal1 ,state1 and local agencies ,subject to subsection 7h71 the ,secretary shall make information and analysis in the ,national ,neurological ,diseases ,surveillance ,system available1 as appropriate-- 7#a7 to ,federal departments and agencies1 such as the ,national ,institutes of ,health1 the ,food and ,drug ,administration1 the ,centers for ,medicare ,medicaid ,services1 the ,agency for ,healthcare ,research and ,quality1 the ,department of ,veterans ,affairs1 and the ,department of ,defense2 and 7#b7 to ,state and local agencies4 7g7 ,public access ,subject to subsection 7h71 the ,secretary shall make information and analysis in the ,national ,neurological ,diseases ,surveillance ,system available1 as appropriate1 to the public1 including researchers4 7h7 ,privacy ,the ,secretary shall ensure that privacy and security protections applicable to the ,national ,neurological ,diseases ,surveillance ,system are at least as stringent as the privacy and security protections under ,,hipaa privacy and security law 7as defined in section #cjji7;a77#b774 7i7 ,report ,not later than #d years after the date of the enactment of this section1 the ,secretary shall submit a report to the ,congress concerning the implementation of this section4 ,such report shall include information on-- 7#a7 the development and maintenance of the ,national ,neurological ,diseases ,surveillance ,system2 7#b7 the type of information collected and stored in the ,system2 7#c7 the use and availability of such information1 including guidelines for such use2 and 7#d7 the use and coordination of databases that collect or maintain information on neurological diseases4 7j7 ,definition ,in this section1 the term national voluntary health association means a national nonprofit organization with chapters1 other affiliated organizations1 or networks in ,states throughout the ,united ,states4 7k7 ,authorization of appropriations ,to carry out this section1 there is authorized to be appropriated #e1jjj1jjj for each of fiscal years #bjaf through #bjbj4 4 #aabc4 ,data on natural history of diseases 7a7 ,sense of ,congress ,it is the sense of the ,congress that studies on the natural history of diseases can help to facilitate and expedite the development of medical products for such diseases4 7b7 ,authority ,part ,a of title ,,ii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bjb et seq47 is amended by adding at the end the following3 #bbi;,a4 ,data on natural history of diseases 7a7 ,in general ,the ,secretary1 acting through the ,commissioner of ,food and ,drugs1 may1 for the purposes described in subsection 7b7-- 7#a7 participate in public-private partnerships engaged in one or more activities specified in subsection 7c72 and 7#b7 award grants to patient advocacy groups or other organizations determined appropriate by the ,secretary4 7b7 ,purposes described ,the purposes described in this subsection are to establish or facilitate the collection1 maintenance1 analysis1 and interpretation of data regarding the natural history of diseases1 with a particular focus on rare diseases4 7c7 ,activities of public-,private partnerships ,the activities of public-private partnerships in which the ,secretary may participate for purposes of this section include-- 7#a7 cooperating with other entities that sponsor or maintain disease registries1 including disease registries and disease registry platforms for rare diseases2 7#b7 developing or enhancing a secure information technology system that-- 7,a7 has the capacity to support data needs across a wide range of disease studies2 7,b7 is easily modified as knowledge is gained during such studies2 and 7,c7 is capable of handling increasing amounts of data as more studies are carried out2 and 7#c7 providing advice to clinical researchers1 patient advocacy groups1 and other entities with respect to-- 7,a7 the design and conduct of disease studies2 7,b7 the modification of any such ongoing studies2 and 7,c7 addressing associated patient privacy issues4 7d7 ,availability of data on natural history of diseases ,data relating to the natural history of diseases obtained1 aggregated1 or otherwise maintained by a public-private partnership in which the ,secretary participates under subsection 7a7 shall be made available1 consistent with otherwise applicable ,federal and ,state privacy laws1 to the public 7including patient advocacy groups1 researchers1 and drug developers7 to help to facilitate and expedite medical product development programs4 7e7 ,confidentiality ,notwithstanding subsection 7d71 nothing in this section authorizes the disclosure of any information that is a trade secret or commercial or financial information that is privileged or confidential and subject to section #eeb7;b77#d7 of title #e1 ,united ,states ,code1 or section #aije of title #ah1 ,united ,states ,code4 7f7 ,authorization of appropriations ,there is authorized to be appropriated to carry out this section #e1jjj1jjj for each of fiscal years #bjaf through #bjbj4 4 #aabd4 ,accessing1 sharing1 and using health data for research purposes 7a7 ,in general 7#a7 ,the ,,hitech ,act 7title ,,xiii of division ,a of ,public ,law #aaa-e7 is amended by adding at the end of subtitle ,d of such ,act 7#db ,u4,s4,c4 #agiba et seq47 the following3 #d ,accessing1 sharing1 and using health data for research purposes #acdda4 ,references ,in this part3 7#a7 ,the rule ,references to the ,rule refer to part #afj or part #afd1 as appropriate1 of title #de1 ,code of ,federal ,regulations 7or any successor regulation74 7#b7 ,part #afd ,references to a specified section of part #afd1 refer to such specified section of part #afd of title #de1 ,code of ,federal ,regulations 7or any successor section74 #acddb4 ,defining health data research as part of health care operations 7a7 ,in general ,subject to subsection 7b71 the ,secretary shall revise or clarify the ,rule to allow the use and disclosure of protected health information by a covered entity for research purposes1 including studies whose purpose is to obtain generalizable knowledge1 to be treated as the use and disclosure of such information for health care operations described in subparagraph 7#a7 of the definition of health care operations in section #afd4eja of part #afd4 7b7 ,modifications to rules for disclosures for health care operations ,in applying section #afd4ejf of part #afd to the disclosure of protected health information described in subsection 7a7-- 7#a7 the ,secretary shall revise or clarify the ,rule so that the disclosure may be made by the covered entity to only-- 7,a7 another covered entity for health care operations 7as defined in section #afd4eja of part #afd72 7,b7 a business associate that has entered into a contract under section #afd4ejd7;e7 of part #afd with a disclosing covered entity to perform health care operations2 or 7,c7 a business associate that has entered into a contract under section #afd4ejd7;e7 of part #afd for the purpose of data aggregation 7as defined in section #afd4eja of part #afd72 and 7#b7 the ,secretary shall further revise or clarify the ,rule so that the limitation specified by section #afd4ejf7;c77#d7 of part #afd does not apply to disclosures that are described by subsection 7a74 7c7 ,rule of construction ,this section shall not be construed as prohibiting or restricting a use or disclosure of protected health information for research purposes that is otherwise permitted under part #afd4 #acddc4 ,treating disclosures of protected health information for research similarly to disclosures of such information for public health purposes 7a7 ,remuneration ,the ,secretary shall revise or clarify the ,rule so that disclosures of protected health information for research purposes are not subject to the limitation on remuneration described in section #afd4ejb7;a77#e77;ii77,b77#b77;ii7 of part #afd4 7b7 ,permitted uses and disclosures ,the ,secretary shall revise or clarify the ,rule so that research activities1 including comparative research activities1 related to the quality1 safety1 or effectiveness of a product or activity that is regulated by the ,food and ,drug ,administration are included as public health activities for purposes of which a covered entity may disclose protected health information to a person described in section #afd4eab7;b77#a77;iii7 of part #afd4 #acddd4 ,permitting remote access to protected health information by researchers ,the ,secretary shall revise or clarify the ,rule so that subparagraph 7,b7 of section #afd4eab7;i77#a77;ii7 of part #afd 7prohibiting the removal of protected health information by a researcher7 does not prohibit remote access to health information by a researcher so long as-- 7#a7 appropriate security and privacy safeguards are maintained by the covered entity and the researcher2 and 7#b7 the protected health information is not copied or otherwise retained by the researcher4 #acdde4 ,allowing one-time authorization of use and disclosure of protected health information for research purposes 7a7 ,in general ,the ,secretary shall revise or clarify the ,rule to specify that an authorization for the use or disclosure of protected health information1 with respect to an individual1 for future research purposes shall be deemed to contain a sufficient description of the purpose of the use or disclosure if the authorization-- 7#a7 sufficiently describes the purposes such that it would be reasonable for the individual to expect that the protected health information could be used or disclosed for such future research2 7#b7 either-- 7,a7 states that the authorization will expire on a particular date or on the occurrence of a particular event2 or 7,b7 states that the authorization will remain valid unless and until it is revoked by the individual2 and 7#c7 provides instruction to the individual on how to revoke such authorization at any time4 7b7 ,revocation of authorization ,the ,secretary shall revise or clarify the ,rule to specify that1 if an individual revokes an authorization for future research purposes such as is described by subsection 7a71 the covered entity may not make any further uses or disclosures based on that authorization1 except1 as provided in paragraph 7b77#e7 of section #afd4ejh of part #afd1 to the extent that the covered entity has taken action in reliance on the authorization4 4 7#b7 ,the table of sections in section #acjja7;b7 of such ,act is amended by adding at the end of the items relating to subtitle ,d the following new items3 ,part #d--;,accessing1 ,sharing1 and ,using ,health ,data for ,research ,purposes ,sec4 #acdda4 ,references4 ,sec4 #acddb4 ,defining health data research as part of health care operations4 ,sec4 #acddc4 ,treating disclosures of protected health information for research similarly to disclosures of such information for public health purposes4 ,sec4 #acddd4 ,permitting remote access to protected health information by researchers4 ,sec4 #acdde4 ,allowing one-time authorization of use and disclosure of protected health information for research purposes4 4 7b7 ,revision of regulations ,not later than #ab months after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall revise and clarify the provisions of title #de1 ,code of ,federal ,regulations1 for consistency with part #d of subtitle ,d of the ,,hitech ,act1 as added by subsection 7a74 ,h ,council for #bast ,century ,cures #aada4 ,council for #bast ,century ,cures ,title ,,ii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bjb et seq47 is amended by adding at the end the following3 ,e ,council for #bast ,century ,cures #bha4 ,establishment ,a nonprofit corporation to be known as the ,council for #bast ,century ,cures 7referred to in this part as the ,council7 shall be established in accordance with this section4 ,the ,council shall be a public-private partnership headed by an ,executive ,director 7referred to in this part as the ,executive ,director71 appointed by the members of the ,board of ,directors4 ,the ,council shall not be an agency or instrumentality of the ,united ,states ,government4 #bha;,a4 ,purpose ,the purpose of the ,council is to accelerate the discovery1 development1 and delivery in the ,united ,states of innovative cures1 treatments1 and preventive measures for patients4 #bha;,b4 ,duties ,for the purpose described in section #bha;,a1 the ,council shall-- 7#a7 foster collaboration and coordination among the entities that comprise the ,council1 including academia1 government agencies1 industry1 health care payors and providers1 patient advocates1 and others engaged in the cycle of discovery1 development1 and delivery of life-saving and health-enhancing innovative interventions2 7#b7 undertake communication and dissemination activities2 7#c7 publish information on the activities funded under section #bha;,d2 7#d7 establish a strategic agenda for accelerating the discovery1 development1 and delivery in the ,united ,states of innovative cures1 treatments1 and preventive measures for patients2 7#e7 identify gaps and opportunities within and across the discovery1 development1 and delivery cycle2 7#f7 develop and propose recommendations based on the gaps and opportunities so identified2 7#g7 facilitate the interoperability of the components of the discovery1 development1 and delivery cycle2 7#h7 propose recommendations that will facilitate precompetitive collaboration2 7#i7 identify opportunities to work with1 but not duplicate the efforts of1 nonprofit organizations and other public-private partnerships2 and 7#aj7 identify opportunities for collaboration with organizations operating outside of the ,united ,states1 such as the ,innovative ,medicines ,initiative of the ,european ,union4 #bha;,c4 ,organization2 administration 7a7 ,board of directors 7#a7 ,establishment 7,a7 ,in general ,the ,council shall have a ,board of ,directors 7in this part referred to as the ,board of ,directors71 which shall be composed of the ex officio members under subparagraph 7,b7 and the appointed members under subparagraph 7,c74 ,all members of the ,board shall be voting members4 7,b7 ,ex officio members ,the ex officio members of the ,board shall be the following individuals or their designees3 7i7 ,the ,director of the ,national ,institutes of ,health4 7ii7 ,the ,commissioner of ,food and ,drugs4 7iii7 ,the ,administrator of the ,centers for ,medicare ,medicaid ,services4 7iv7 ,the heads of five other ,federal agencies deemed by the ,secretary to be engaged in biomedical research and development4 7,c7 ,appointed members ,the appointed members of the ,board shall consist of #ag individuals1 of whom-- 7i7 eight shall be appointed by the ,comptroller ,general of the ,united ,states from a list of nominations submitted by leading trade associations-- 7,i7 four of whom shall be representatives of the biopharmaceutical industry2 7,,ii7 two of whom shall be representatives of the medical device industry2 and 7,,iii7 two of whom shall be representatives of the information and digital technology industry2 and 7ii7 nine shall be appointed by the ,comptroller ,general of the ,united ,states1 after soliciting nominations-- 7,i7 two of whom shall be representatives of academic researchers2 7,,ii7 three of whom shall be representatives of patients2 7,,iii7 two of whom shall be representatives of health care providers2 and 7,,iv7 two of whom shall be representatives of health care plans and insurers4 7,d7 ,chair ,the ,chair of the ,board shall be selected by the members of the ,board by majority vote from among the members of the ,board4 7#b7 ,terms and vacancies 7,a7 ,in general ,the term of office of each member of the ,board appointed under paragraph 7#a77;,c7 shall be #e years4 7,b7 ,vacancy ,any vacancy in the membership of the ,board-- 7i7 shall not affect the power of the remaining members to execute the duties of the ,board2 and 7ii7 shall be filled by appointment by the appointed members described in paragraph 7#a77;,c7 by majority vote4 7,c7 ,partial term ,if a member of the ,board does not serve the full term applicable under subparagraph 7,a71 the individual appointed under subparagraph 7,b7 to fill the resulting vacancy shall be appointed for the remainder of the term of the predecessor of the individual4 7#c7 ,responsibilities ,not later than #ij days after the date on which the ,council is incorporated and its ,board of ,directors is fully constituted1 the ,board of ,directors shall establish bylaws and policies for the ,council that-- 7,a7 are published in the ,federal ,register and available for public comment2 7,b7 establish policies for the selection and1 as applicable1 appointment of-- 7i7 the officers1 employees1 agents1 and contractors of the ,council2 and 7ii7 the members of any committees of the ,council2 7,c7 establish policies1 including ethical standards1 for the conduct of programs and other activities under section #bha;,d2 and 7,d7 establish specific duties of the ,executive ,director4 7#d7 ,meetings 7,a7 ,in general ,the ,board of ,directors shall-- 7i7 meet on a quarterly basis2 and 7ii7 submit to ,congress1 and make publicly available1 the minutes of such meetings4 7,b7 ,agenda ,the ,board of ,directors shall1 not later than #c months after the incorporation of the ,council-- 7i7 issue an agenda 7in this part referred to as the agenda7 outlining how the ,council will achieve the purpose described in section #bha;,a2 and 7ii7 annually thereafter1 in consultation with the ,executive ,director1 review and update such agenda4 7b7 ,appointment and incorporation ,not later than #f months after the date of enactment of the #bast ,century ,cures ,act-- 7#a7 the ,comptroller ,general of the ,united ,states shall appoint the appointed members of the ,board of ,directors under subsection 7a77#a77;,c72 and 7#b7 the ex officio members of the ,board of ,directors under subsection 7a77#a77;,b7 shall serve as incorporators and shall take whatever actions are necessary to incorporate the ,council4 7c7 ,nonprofit ,status ,in carrying out this part1 the ,board of ,directors shall establish such policies and bylaws1 and the ,executive ,director shall carry out such activities1 as may be necessary to ensure that the ,council maintains status as an organization that-- 7#a7 is described in subsection 7c77#c7 of section #eja of the ,internal ,revenue ,code of #aihf2 and 7#b7 is1 under subsection 7a7 of such section1 exempt from taxation4 7d7 ,executive ,director ,the ,executive ,director shall-- 7#a7 be the chief executive officer of the ,council2 and 7#b7 subject to the oversight of the ,board of ,directors1 be responsible for the day-to-day management of the ,council4 #bha;,d4 ,operational activities and assistance 7a7 ,in general ,the ,council shall establish a sufficient operational infrastructure to fulfill the duties specified in section #bha;,b4 7b7 ,private sector matching funds ,the ,council may accept financial or in-kind support from participating entities or private foundations or organizations when such support is deemed appropriate4 #bha;,e4 ,termination2 report 7a7 ,in general ,the ,council shall terminate on ,september #cj1 #bjbc4 7b7 ,report ,not later than #a year after the date on which the ,council is established and each year thereafter1 the ,executive ,director shall submit to the appropriate congressional committees a report on the performance of the ,council4 ,in preparing such report1 the ,council shall consult with a nongovernmental consultant with appropriate expertise4 #bha;,f4 ,funding ,for the each of fiscal years #bjaf through #bjbc1 there is authorized to be appropriated #aj1jjj1jjj to the ,council for purposes of carrying out the duties of the ,council under this part4 4 ,,ii ,development ,a ,patient-,focused ,drug ,development #bjja4 ,development and use of patient experience data to enhance structured risk-benefit assessment framework 7a7 ,in general ,section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 is amended-- 7#a7 in subsection 7d71 by striking ,the ,secretary shall implement and all that follows through premarket approval of a drug42 and 7#b7 by adding at the end the following new subsections3 7x7 ,structured risk-,benefit assessment framework 7#a7 ,in general ,the ,secretary shall implement a structured risk-benefit assessment framework in the new drug approval process-- 7,a7 to facilitate the balanced consideration of benefits and risks2 and 7,b7 to develop and implement a consistent and systematic approach to the discussion of1 regulatory decisionmaking with respect to1 and the communication of1 the benefits and risks of new drugs4 7#b7 ,rule of construction ,nothing in paragraph 7#a7 shall alter the criteria for evaluating an application for premarket approval of a drug4 7y7 ,development and use of patient experience data ,to enhance structured risk-,benefit assessment framework 7#a7 ,in general ,not later than #b years after the date of the enactment of this subsection1 the ,secretary shall establish and implement processes under which-- 7,a7 an entity seeking to develop patient experience data may submit to the ,secretary-- 7i7 initial research concepts for feedback from the ,secretary2 and 7ii7 with respect to patient experience data collected by the entity1 draft guidance documents1 completed data1 and summaries and analyses of such data2 7,b7 the ,secretary may request such an entity to submit such documents1 data1 and summaries and analyses2 and 7,c7 patient experience data may be developed and used to enhance the structured risk-benefit assessment framework under subsection 7x74 7#b7 ,patient experience data ,in this subsection1 the term patient experience data means data collected by patients1 parents1 caregivers1 patient advocacy organizations1 disease research foundations1 medical researchers1 research sponsors1 or other parties determined appropriate by the ,secretary that is intended to facilitate or enhance the ,secretary's risk-benefit assessments1 including information about the impact of a disease or a therapy on patients' lives4 4 7b7 ,guidance 7#a7 ,in general ,the ,secretary of ,health and ,human ,services shall publish guidance on the implementation of subsection 7y7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 as added by subsection 7a74 ,such guidance shall include-- 7,a7 with respect to draft guidance documents1 data1 or summaries and analyses submitted to the ,secretary under paragraph 7#a77;,a7 of such subsection1 guidance-- 7i7 specifying the timelines for the review of such documents1 data1 or summaries and analyses by the ,secretary2 and 7ii7 on how the ,secretary will use such documents1 data1 or summaries and analyses to update any guidance documents published under this subsection or publish new guidance2 7,b7 with respect to the collection and analysis of patient experience data 7as defined in paragraph 7#b7 of such subsection 7y771 guidance on-- 7i7 methodological considerations for the collection of patient experience data1 which may include structured approaches to gathering information on-- 7,i7 the experience of a patient living with a particular disease2 7,,ii7 the burden of living with or managing the disease2 7,,iii7 the impact of the disease on daily life and long-term functioning2 and 7,,iv7 the effect of current therapeutic options on different aspects of the disease2 and 7ii7 the establishment and maintenance of registries designed to increase understanding of the natural history of a disease2 7,c7 methodological approaches that may be used to assess patients' beliefs with respect to the benefits and risks in the management of the patient's disease2 and 7,d7 methodologies1 standards1 and potential experimental designs for patient-reported outcomes4 7#b7 ,timing ,not later than #c years after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall issue draft guidance on the implementation of subsection 7y7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 as added by subsection 7a74 ,the ,secretary shall issue final guidance on the implementation of such subsection not later than #a year after the date on which the comment period for the draft guidance closes4 7#c7 ,workshops 7,a7 ,in general ,not later than #f months after the date of the enactment of this ,act and once every #f months during the following #ab-month period1 the ,secretary of ,health and ,human ,services shall convene a workshop to obtain input regarding methodologies for developing the guidance under paragraph 7#a71 including the collection of patient experience data4 7,b7 ,attendees ,a workshop convened under this paragraph shall include-- 7i7 patients2 7ii7 representatives from patient advocacy organizations1 biopharmaceutical companies1 and disease research foundations2 7iii7 representatives of the reviewing divisions of the ,food and ,drug ,administration2 and 7iv7 methodological experts with significant expertise in patient experience data4 7#d7 ,public meeting ,not later than #ij days after the date on which the draft guidance is published under this subsection1 the ,secretary of ,health and ,human ,services shall convene a public meeting to solicit input on the guidance4 ,b ,qualification and ,use of ,drug ,development ,tools #bjba4 ,qualification of drug development tools 7a7 ,findings ,congress finds the following3 7#a7 ,development of new drugs has become increasingly challenging and resource intensive4 7#b7 ,development of drug development tools can benefit the availability of new medical therapies by helping to translate scientific discoveries into clinical applications4 7#c7 ,biomedical research consortia 7as defined in section #ejg7;f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7c77 can play a valuable role in helping to develop and qualify drug development tools4 7b7 ,sense of ,congress ,it is the sense of ,congress that-- 7#a7 ,congress should promote and facilitate a collaborative effort among the biomedical research consortia described in subsection 7a77#c7-- 7,a7 to develop1 through a transparent public process1 data standards and scientific approaches to data collection accepted by the medical and clinical research community for purposes of qualifying drug development tools2 7,b7 to coordinate efforts toward developing and qualifying drug development tools in key therapeutic areas2 and 7,c7 to encourage the development of accessible databases for collecting relevant drug development tool data for such purposes2 and 7#b7 an entity seeking to qualify a drug development tool should be encouraged1 in addition to consultation with the ,secretary1 to consult with biomedical research consortia and other individuals and entities with expert knowledge and insights that may assist the requestor and benefit the process for such qualification4 7c7 ,qualification of drug development tools ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended by inserting after section #ejf;,f the following new section3 #ejg4 ,qualification of drug development tools 7a7 ,process for qualification 7#a7 ,in general ,the ,secretary shall establish a process for the qualification of drug development tools for a proposed context of use under which-- 7,a7 7i7 a requestor initiates such process by submitting a letter of intent to the ,secretary2 and 7ii7 the ,secretary accepts or declines to accept such letter of intent2 7,b7 7i7 if the ,secretary accepts the letter of intent1 a requestor submits a qualification plan to the ,secretary2 and 7ii7 the ,secretary accepts or declines to accept the qualification plan2 and 7,c7 7i7 if the ,secretary accepts the qualification plan1 the requestor submits to the ,secretary a full qualification package2 7ii7 the ,secretary determines whether to accept such qualification package for review2 and 7iii7 if the ,secretary accepts such qualification package for review1 the ,secretary conducts such review in accordance with this section4 7#b7 ,acceptance and review of submissions 7,a7 ,in general ,the succeeding provisions of this paragraph shall apply with respect to the treatment of a letter of intent1 a qualification plan1 or a full qualification package submitted under paragraph 7#a7 7referred to in this paragraph as qualification submissions74 7,b7 ,acceptance factors2 nonacceptance ,the ,secretary shall determine whether to accept a qualification submission based on factors which may include the scientific merit of the submission and the available resources of the ,food and ,drug ,administration to review the qualification submission4 ,a determination not to accept a submission under paragraph 7#a7 shall not be construed as a final determination by the ,secretary under this section regarding the qualification of a drug development tool for its proposed context of use4 7,c7 ,prioritization of qualification review ,the ,secretary may prioritize the review of a full qualification package submitted under paragraph 7#a7 with respect to a drug development tool1 based on factors determined appropriate by the ,secretary1 including-- 7i7 as applicable1 the severity1 rarity1 or prevalence of the disease or condition targeted by the drug development tool and the availability or lack of alternative treatments for such disease or condition2 and 7ii7 the identification1 by the ,secretary or by biomedical research consortia and other expert stakeholders1 of such a drug development tool and its proposed context of use as a public health priority4 7,d7 ,engagement of external experts ,the ,secretary may1 for purposes of the review of qualification submissions1 through the use of cooperative agreements1 grants1 or other appropriate mechanisms1 consult with biomedical research consortia and may consider the recommendations of such consortia with respect to the review of any qualification plan submitted under paragraph 7#a7 or the review of any full qualification package under paragraph 7#c74 7#c7 ,review of full qualification package ,the ,secretary shall-- 7,a7 conduct a comprehensive review of a full qualification package accepted under paragraph 7#a77;,c72 and 7,b7 determine whether the drug development tool at issue is qualified for its proposed context of use4 7#d7 ,qualification ,the ,secretary shall determine whether a drug development tool is qualified for a proposed context of use based on the scientific merit of a full qualification package reviewed under paragraph 7#c74 7b7 ,effect of qualification 7#a7 ,in general ,a drug development tool determined to be qualified under subsection 7a77#d7 for a proposed context of use specified by the requestor may be used by any person in such context of use for the purposes described in paragraph 7#b74 7#b7 ,use of a drug development tool ,subject to paragraph 7#c71 a drug development tool qualified under this section may be used for-- 7,a7 supporting or obtaining approval or licensure 7as applicable7 of a drug or biological product 7including in accordance with section #ejf7;c77 under section #eje of this ,act or section #cea of the ,public ,health ,service ,act2 or 7,b7 supporting the investigational use of a drug or biological product under section #eje7;i7 of this ,act or section #cea7;a77#c7 of the ,public ,health ,service ,act4 7#c7 ,rescission or modification 7,a7 ,in general ,the ,secretary may rescind or modify a determination under this section to qualify a drug development tool if the ,secretary determines that the drug development tool is not appropriate for the proposed context of use specified by the requestor4 ,such a determination may be based on new information that calls into question the basis for such qualification4 7,b7 ,meeting for review ,if the ,secretary rescinds or modifies under subparagraph 7,a7 a determination to qualify a drug development tool1 the requestor involved shall1 on request1 be granted a meeting with the ,secretary to discuss the basis of the ,secretary's decision to rescind or modify the determination before the effective date of the rescission or modification4 7c7 ,transparency 7#a7 ,in general ,subject to paragraph 7#c71 the ,secretary shall make publicly available1 and update on at least a biannual basis1 on the ,internet website of the ,food and ,drug ,administration the following3 7,a7 ,information with respect to each qualification submission under the qualification process under subsection 7a71 including-- 7i7 the stage of the review process applicable to the submission2 7ii7 the date of the most recent change in stage status2 7iii7 whether the external scientific experts were utilized in the development of a qualification plan or the review of a full qualification package2 and 7iv7 submissions from requestors under the qualification process under subsection 7a71 including any data and evidence contained in such submissions1 and any updates to such submissions4 7,b7 ,the ,secretary's formal written determinations in response to such qualification submissions4 7,c7 ,any rescissions or modifications under subsection 7b77#c7 of a determination to qualify a drug development tool4 7,d7 ,summary reviews that document conclusions and recommendations for determinations to qualify drug development tools under subsection 7a74 7,e7 ,a comprehensive list of-- 7i7 all drug development tools qualified under subsection 7a72 and 7ii7 all surrogate endpoints which were the basis of approval or licensure 7as applicable7 of a drug or biological product 7including in accordance with section #ejf7;c77 under section #eje of this ,act or section #cea of the ,public ,health ,service ,act4 7#b7 ,relation to ,trade ,secrets ,act ,information made publicly available by the ,secretary under paragraph 7#a7 shall be considered a disclosure authorized by law for purposes of section #aije of title #ah1 ,united ,states ,code4 7#c7 ,applicability ,nothing in this section shall be construed as authorizing the ,secretary to disclose any information contained in an application submitted under section #eje of this ,act or section #cea of the ,public ,health ,service ,act that is confidential commercial or trade secret information subject to section #eeb7;b77#d7 of title #e1 ,united ,states ,code1 or section #aije of title #ah1 ,united ,states ,code4 7d7 ,rule of construction ,nothing in this section shall be construed-- 7#a7 to alter the standards of evidence under subsection 7c7 or 7d7 of section #eje1 including the substantial evidence standard in such subsection 7d71 or under section #cea of the ,public ,health ,service ,act 7as applicable72 or 7#b7 to limit the authority of the ,secretary to approve or license products under this ,act or the ,public ,health ,service ,act1 as applicable 7as in effect before the date of the enactment of the #bast ,century ,cures ,act74 7e7 ,definitions ,in this section3 7#a7 ,biomarker 7,a7 ,the term biomarker means a characteristic 7such as a physiologic1 pathologic1 or anatomic characteristic or measurement7 that is objectively measured and evaluated as an indicator of normal biologic processes1 pathologic processes1 or biological responses to a therapeutic intervention2 and 7,b7 such term includes a surrogate endpoint4 7#b7 ,biomedical research consortia ,the term biomedical research consortia means collaborative groups that may take the form of public-private partnerships and may include government agencies1 institutions of higher education 7as defined in section #aja7;a7 of the ,higher ,education ,act of #aife71 patient advocacy groups1 industry representatives1 clinical and scientific experts1 and other relevant entities and individuals4 7#c7 ,clinical outcome assessment 7,a7 ,the term clinical outcome assessment means a measurement of a patient's symptoms1 overall mental state1 or the effects of a disease or condition on how the patient functions2 and 7,b7 such term includes a patient-reported outcome4 7#d7 ,context of use ,the term context of use means1 with respect to a drug development tool1 the circumstances under which the drug development tool is to be used in drug development and regulatory review4 7#e7 ,drug development tool ,the term drug development tool includes-- 7,a7 a biomarker2 7,b7 a clinical outcome assessment2 and 7,c7 any other method1 material1 or measure that the ,secretary determines aids drug development and regulatory review for purposes of this section4 7#f7 ,patient-reported outcome ,the term patient-reported outcome means a measurement based on a report from a patient regarding the status of the patient's health condition without amendment or interpretation of the patient's report by a clinician or any other person4 7#g7 ,qualification ,the terms qualification and qualified mean a determination by the ,secretary that a drug development tool and its proposed context of use can be relied upon to have a specific interpretation and application in drug development and regulatory review under this ,act4 7#h7 ,requestor ,the term requestor means an entity or entities1 including a drug sponsor or a biomedical research consortia1 seeking to qualify a drug development tool for a proposed context of use under this section4 7#i7 ,surrogate endpoint ,the term surrogate endpoint means a marker1 such as a laboratory measurement1 radiographic image1 physical sign1 or other measure1 that is not itself a direct measurement of clinical benefit1 and-- 7,a7 is known to predict clinical benefit and could be used to support traditional approval of a drug or biological product2 or 7,b7 is reasonably likely to predict clinical benefit and could be used to support the accelerated approval of a drug or biological product in accordance with section #ejf7;c74 7f7 ,authorization of appropriations ,there are authorized to be appropriated to carry out this section1 #aj1jjj1jjj for each of fiscal years #bjaf through #bjbj4 4 7d7 ,guidance 7#a7 ,in general ,the ,secretary of ,health and ,human ,services shall1 in consultation with biomedical research consortia 7as defined in subsection 7f7 of section #ejg the ,federal ,food1 ,drug1 and ,cosmetic ,act 7as added by subsection 7c777 and other interested parties through a collaborative public process1 issue guidance to implement such section #ejg that-- 7,a7 provides a conceptual framework describing appropriate standards and scientific approaches to support the development of biomarkers delineated under the taxonomy established under paragraph 7#c72 7,b7 makes recommendations for demonstrating that a surrogate endpoint is reasonably likely to predict clinical benefit for the purpose of supporting the accelerated approval of a drug under section #ejf7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;c772 7,c7 with respect to the qualification process under such section #ejg-- 7i7 describes the requirements that entities seeking to qualify a drug development tool under such section shall observe when engaging in such process2 7ii7 outlines reasonable timeframes for the ,secretary's review of letters1 qualification plans1 or full qualification packages submitted under such process2 and 7iii7 establishes a process by which such entities or the ,secretary may consult with biomedical research consortia and other individuals and entities with expert knowledge and insights that may assist the ,secretary in the review of qualification plans and full qualification submissions under such section2 and 7,d7 includes such other information as the ,secretary determines appropriate4 7#b7 ,timing ,not later than #bd months after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall issue draft guidance under paragraph 7#a7 on the implementation of section #ejg of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7as added by subsection 7c774 ,the ,secretary shall issue final guidance on the implementation of such section not later than #f months after the date on which the comment period for the draft guidance closes4 7#c7 ,taxonomy 7,a7 ,in general ,for purposes of informing guidance under this subsection1 the ,secretary of ,health and ,human ,services shall1 in consultation with biomedical research consortia and other interested parties through a collaborative public process1 establish a taxonomy for the classification of biomarkers 7and related scientific concepts7 for use in drug development4 7,b7 ,public availability ,not later than #ab months after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall make such taxonomy publicly available in draft form for public comment4 ,the ,secretary shall finalize the taxonomy not later than #ab months after the close of the public comment period4 7e7 ,meeting and report 7#a7 ,meeting ,not later than #ab months after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall convene a public meeting to describe and solicit public input regarding the qualification process under section #ejg of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7c74 7#b7 ,report ,not later than #e years after the date of the enactment of this ,act1 the ,secretary shall make publicly available on the ,internet website of the ,food and ,drug ,administration a report4 ,such report shall include1 with respect to the qualification process under section #ejg of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7c71 information on-- 7,a7 the number of requests submitted1 as a letter of intent1 for qualification of a drug development tool 7as defined in subsection 7f7 of such section72 7,b7 the number of such requests accepted and determined to be eligible for submission of a qualification plan or full qualification package 7as such terms are defined in such subsection71 respectively2 7,c7 the number of such requests for which external scientific experts were utilized in the development of a qualification plan or review of a full qualification package2 7,d7 the number of qualification plans and full qualification packages1 respectively1 submitted to the ,secretary2 and 7,e7 the drug development tools qualified through such qualification process1 specified by type of tool1 such as a biomarker or clinical outcome assessment 7as such terms are defined in subsection 7f7 of such section #ejg74 #bjbb4 ,accelerated approval development plan 7a7 ,in general ,section #ejf of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7 is amended by adding the following subsection3 7g7 ,accelerated approval development plan 7#a7 ,in general ,in the case of a drug that the ,secretary determines may be eligible for accelerated approval in accordance with subsection 7c71 the sponsor of such drug may request1 at any time after the submission of an application for the investigation of the drug under section #eje7;i7 of this ,act or section #cea7;a77#c7 of the ,public ,health ,service ,act1 that the ,secretary agree to an accelerated approval development plan described in paragraph 7#b74 7#b7 ,plan described ,a plan described in this paragraph1 with respect to a drug described in paragraph 7#a71 is an accelerated approval development plan1 which shall include agreement on-- 7,a7 the surrogate endpoint to be assessed under such plan2 7,b7 the design of the study that will utilize the surrogate endpoint2 and 7,c7 the magnitude of the effect of the drug on the surrogate endpoint that is the subject of the agreement that would be sufficient to form the primary basis of a claim that the drug is effective4 7#c7 ,modification2 termination ,the ,secretary may require the sponsor of a drug that is the subject of an accelerated approval development plan to modify or terminate the plan if additional data or information indicates that-- 7,a7 the plan as originally agreed upon is no longer sufficient to demonstrate the safety and effectiveness of the drug involved2 or 7,b7 the drug is no longer eligible for accelerated approval under subsection 7c74 7#d7 ,sponsor consultation ,if the ,secretary requires the modification or termination of an accelerated approval development plan under paragraph 7#c71 the sponsor shall be granted a request for a meeting to discuss the basis of the ,secretary's decision before the effective date of the modification or termination4 7#e7 ,definition ,in this section1 the term accelerated approval development plan means a development plan agreed upon by the ,secretary and the sponsor submitting the plan that contains study parameters for the use of a surrogate endpoint that-- 7,a7 is reasonably likely to predict clinical benefit2 and 7,b7 is intended to be the basis of the accelerated approval of a drug in accordance with subsection 7c74 4 7b7 ,technical amendments ,section #ejf of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7 is amended-- 7#a7 by striking 7f7 ,awareness efforts and inserting 7e7 ,awareness efforts2 and 7#b7 by striking 7e7 ,construction and inserting 7f7 ,construction4 ,c ,,fda advancement of ,precision ,medicine #bjda4 ,precision medicine guidance and other programs of ,food and ,drug ,administration ,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 ,j ,precision ,medicine #eia4 ,general agency guidance on precision medicine 7a7 ,in general ,the ,secretary shall issue and periodically update guidance to assist sponsors in the development of a precision drug or biological product4 ,such guidance shall-- 7#a7 define the term precision drug or biological product2 and 7#b7 address the topics described in subsection 7b74 7b7 ,certain issues ,the topics to be addressed by guidance under subsection 7a7 are-- 7#a7 the evidence needed to support the use of biomarkers 7as defined in section #ejg7;e77 that identify subsets of patients as likely responders to therapies in order to streamline the conduct of clinical trials2 7#b7 recommendations for the design of studies to demonstrate the validity of a biomarker as a predictor of drug or biological product response2 7#c7 the manner and extent to which a benefit-risk assessment may be affected when clinical trials are limited to patient population subsets that are identified using biomarkers2 7#d7 the development of companion diagnostics in the context of a drug development program2 and 7#e7 considerations for developing biomarkers that inform prescribing decisions for a drug or biological product1 and when information regarding a biomarker may be included in the approved prescription labeling for a precision drug or biological product4 7c7 ,date certain for initial guidance ,the ,secretary shall issue guidance under subsection 7a7 not later than #ah months after the date of the enactment of the #bast ,century ,cures ,act4 #eib4 ,precision medicine regarding orphan-drug and expedited-approval programs 7a7 ,in general ,in the case of a precision drug or biological product that is the subject of an application submitted under section #eje7;b77#a71 or section #cea7;a7 of the ,public ,health ,service ,act1 for the treatment of a serious or life-threatening disease or condition and has been designated under section #ebf as a drug for a rare disease or condition1 the ,secretary may-- 7#a7 consistent with applicable standards for approval1 rely upon data or information previously submitted by the sponsor of the precision drug or biological product1 or another sponsor1 provided that the sponsor of the precision drug or biological product has obtained a contractual right of reference to such other sponsor's data and information1 in an application approved under section #eje7;c7 or licensed under section #cea7;a7 of the ,public ,health ,service ,act1 as applicable-- 7,a7 for a different drug or biological product2 or 7,b7 for a different indication for such precision drug or biological product1 in order to expedite clinical development for a precision drug or biological product that is using the same or similar approach as that used to support approval of the prior approved application or license1 as appropriate2 and 7#b7 as appropriate1 consider the application for approval of such precision drug or biological product to be eligible for expedited review and approval programs described in section #ejf1 including accelerated approval in accordance with subsection 7c7 of such section4 7b7 ,rule of construction ,nothing in this section shall be construed to-- 7#a7 limit the authority of the ,secretary to approve products pursuant to this ,act and the ,public ,health ,service ,act as authorized prior to the date of enactment of this section2 or 7#b7 confer any new rights1 beyond those authorized under this ,act prior to enactment of this section1 with respect to a sponsor's ability to reference information contained in another application submitted under section #eje7;b77#a7 of this ,act or section #cea7;a7 of the ,public ,health ,service ,act4 4 ,d ,modern ,trial ,design and ,evidence ,development #bjfa4 ,broader application of ,bayesian statistics and adaptive trial designs 7a7 ,proposals for use of innovative statistical methods in clinical protocols for drugs and biological products ,for purposes of assisting sponsors in incorporating adaptive trial design and ,bayesian methods into proposed clinical protocols and applications for new drugs under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 and biological products under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb71 the ,secretary shall conduct a public meeting and issue guidance in accordance with subsection 7b74 7b7 ,guidance addressing use of adaptive trial designs and ,bayesian methods 7#a7 ,in general ,the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs 7in this subsection referred to as the ,secretary71 shall-- 7,a7 update and finalize the draft guidance addressing the use of adaptive trial design for drugs and biological products2 and 7,b7 issue draft guidance on the use of ,bayesian methods in the development and regulatory review and approval or licensure of drugs and biological products4 7#b7 ,contents ,the guidances under paragraph 7#a7 shall address-- 7,a7 the use of adaptive trial designs and ,bayesian methods in clinical trials1 including clinical trials proposed or submitted to help to satisfy the substantial evidence standard under section #eje7;d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;d772 7,b7 how sponsors may obtain feedback from the ,secretary on technical issues related to modeling and simulations prior to-- 7i7 completion of such modeling or simulations2 or 7ii7 the submission of resulting information to the ,secretary2 7,c7 the types of quantitative and qualitative information that should be submitted for review2 and 7,d7 recommended analysis methodologies4 7#c7 ,public meeting ,prior to updating or developing the guidances required by paragraph 7#a71 the ,secretary shall consult with stakeholders1 including representatives of regulated industry1 academia1 patient advocacy organizations1 and disease research foundations1 through a public meeting to be held not later than #a year after the date of enactment of this ,act4 7#d7 ,schedule ,the ,secretary shall publish-- 7,a7 the final guidance required by paragraph 7#a77;,a7 not later than #ah months after the date of the public meeting required by paragraph 7#c72 and 7,b7 the guidance required by paragraph 7#a77;,b7 not later than #dh months after the date of the public meeting required by paragraph 7#c74 #bjfb4 ,utilizing evidence from clinical experience ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended by inserting after section #eje;,e of such ,act 7#ba ,u4,s4,c4 #cee;f7 the following3 #eje;,f4 ,utilizing evidence from clinical experience 7a7 ,in general ,the ,secretary shall establish a program to evaluate the potential use of evidence from clinical experience-- 7#a7 to help to support the approval of a new indication for a drug approved under section #eje7;b72 and 7#b7 to help to support or satisfy postapproval study requirements4 7b7 ,evidence from clinical experience defined ,in this section1 the term evidence from clinical experience means data regarding the usage1 or the potential benefits or risks1 of a drug derived from sources other than randomized clinical trials1 including from observational studies1 registries1 and therapeutic use4 7c7 ,program framework 7#a7 ,in general ,not later than #ah months after the date of enactment of this section1 the ,secretary shall establish a draft framework for implementation of the program under this section4 7#b7 ,contents of framework ,the framework shall include information describing-- 7,a7 the current sources of data developed through clinical experience1 including ongoing safety surveillance1 registry1 claims1 and patient-centered outcomes research activities2 7,b7 the gaps in current data collection activities2 7,c7 the current standards and methodologies for collection and analysis of data generated through clinical experience2 and 7,d7 the priority areas1 remaining challenges1 and potential pilot opportunities that the program established under this section will address4 7#c7 ,consultation 7,a7 ,in general ,in developing the program framework under this subsection1 the ,secretary shall consult with regulated industry1 academia1 medical professional organizations1 representatives of patient advocacy organizations1 disease research foundations1 and other interested parties4 7,b7 ,process ,the consultation under subparagraph 7,a7 may be carried out through approaches such as-- 7i7 a public-private partnership with the entities described in such subparagraph in which the ,secretary may participate2 or 7ii7 a contract1 grant1 or other arrangement1 as determined appropriate by the ,secretary with such a partnership or an independent research organization4 7d7 ,program implementation ,the ,secretary shall1 not later than #bd months after the date of enactment of this section and in accordance with the framework established under subsection 7c71 implement the program to evaluate the potential use of evidence from clinical experience4 7e7 ,guidance for industry ,the ,secretary shall-- 7#a7 utilize the program established under subsection 7a71 its activities1 and any subsequent pilots or written reports1 to inform a guidance for industry on-- 7,a7 the circumstances under which sponsors of drugs and the ,secretary may rely on evidence from clinical experience for the purposes described in subsection 7a77#a7 or 7a77#b72 and 7,b7 the appropriate standards and methodologies for collection and analysis of evidence from clinical experience submitted for such purposes2 7#b7 not later than #cf months after the date of enactment of this section1 issue draft guidance for industry as described in paragraph 7#a72 and 7#c7 not later than #dh months after the date of enactment of this section1 after providing an opportunity for public comment on the draft guidance1 issue final guidance4 7f7 ,rule of construction 7#a7 ,subject to paragraph 7#b71 nothing in this section prohibits the ,secretary from using evidence from clinical experience for purposes not specified in this section1 provided the ,secretary determines that sufficient basis exists for any such nonspecified use4 7#b7 ,this section shall not be construed to alter-- 7,a7 the standards of evidence under-- 7i7 subsection 7c7 or 7d7 of section #eje1 including the substantial evidence standard in such subsection 7d72 or 7ii7 section #cea7;a7 of the ,public ,health ,service ,act2 or 7,b7 the ,secretary's authority to require postapproval studies or clinical trials1 or the standards of evidence under which studies or trials are evaluated4 #eje;,g4 ,collecting evidence from clinical experience through targeted extensions of the ,sentinel ,system 7a7 ,in general ,the ,secretary shall1 in parallel to implementing the program established under section #eje;,f and in order to build capacity for utilizing the evidence from clinical experience described in that section1 identify and execute pilot demonstrations to extend existing use of the ,sentinel ,system surveillance infrastructure authorized under section #eje7k74 7b7 ,pilot demonstrations 7#a7 ,in general ,the ,secretary-- 7,a7 shall design and implement pilot demonstrations to utilize data captured through the ,sentinel ,system surveillance infrastructure authorized under section #eje7k7 for purposes of1 as appropriate-- 7i7 generating evidence from clinical experience to improve characterization or assessment of risks or benefits of a drug approved under section #eje7;c72 7ii7 protecting the public health2 or 7iii7 advancing patient-centered care2 and 7,b7 may make strategic linkages with sources of complementary public health data and infrastructure the ,secretary determines appropriate and necessary4 7#b7 ,consultation ,in developing the pilot demonstrations under this subsection1 the ,secretary shall-- 7,a7 consult with regulated industry1 academia1 medical professional organizations1 representatives of patient advocacy organizations1 disease research foundations1 and other interested parties through a public process2 and 7,b7 develop a framework to promote appropriate transparency and dialogue about research conducted under these pilot demonstrations1 including by-- 7i7 providing adequate notice to a sponsor of a drug approved under section #eje or section #cea of the ,public ,health ,service ,act of the ,secretary's intent to conduct analyses of such sponsor's drug or drugs under these pilot demonstrations2 7ii7 providing adequate notice of the findings related to analyses described in clause 7i7 and an opportunity for the sponsor of such drug or drugs to comment on such findings2 and 7iii7 ensuring the protection from public disclosure of 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 7#c7 ,,hipaa privacy rule2 human subject research regulation ,the ,secretary may deem such pilot demonstrations-- 7,a7 public health activities1 for purposes of which a use or disclosure of protected health information would be permitted as described in section #afd4eab7;b77#a7 of title #de1 ,code of ,federal ,regulations 7or any successor regulation72 and 7,b7 outside the scope of research as defined in section #df4ajb7;d7 of title #de1 ,code of ,federal ,regulations 7or any successor regulation74 7c7 ,authorization of appropriations ,there are authorized to be appropriated to carry out this section #c1jjj1jjj for each of fiscal years #bjaf through #bjbj4 4 #bjfc4 ,streamlined data review program 7a7 ,in general ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as amended by section #bjfb1 is further amended by inserting after section #eje;,g of such ,act the following3 #eje;,h4 ,streamlined data review program 7a7 ,in general ,the ,secretary shall establish a streamlined data review program under which a holder of an approved application submitted under section #eje7;b77#a7 or under section #cea7;a7 of the ,public ,health ,service ,act may1 to support the approval or licensure 7as applicable7 of the use of the drug that is the subject of such approved application for a new qualified indication1 submit qualified data summaries4 7b7 ,eligibility ,in carrying out the streamlined data review program under subsection 7a71 the ,secretary may authorize the holder of the approved application to include one or more qualified data summaries described in subsection 7a7 in a supplemental application if-- 7#a7 the drug has been approved under section #eje7;c7 of this ,act or licensed under section #cea7;a7 of the ,public ,health ,service ,act for one or more indications1 and such approval or licensure remains in effect2 7#b7 the supplemental application is for approval or licensure 7as applicable7 under such section #eje7;c7 or #cea7;a7 of the use of the drug for a new qualified indication under such section #eje7;c7 or #cea7;a72 7#c7 there is an existing database acceptable to the ,secretary regarding the safety of the drug developed for one or more indications of the drug approved under such section #eje7;c7 or licensed under such section #cea7;a72 7#d7 the supplemental application incorporates or supplements the data submitted in the application for approval or licensure referred to in paragraph 7#a72 and 7#e7 the full data sets used to develop the qualified data summaries are submitted1 unless the ,secretary determines that the full data sets are not required4 7c7 ,public availability of information on program ,the ,secretary shall post on the public website of the ,food and ,drug ,administration and update annually-- 7#a7 the number of applications reviewed under the streamlined data review program2 7#b7 the average time for completion of review under the streamlined data review program versus other review of applications for new indications2 and 7#c7 the number of applications reviewed under the streamlined data review program for which the ,food and ,drug ,administration made use of full data sets in addition to the qualified data summary4 7d7 ,definitions ,in this section3 7#a7 ,the term qualified indication means-- 7,a7 an indication for the treatment of cancer1 as determined appropriate by the ,secretary2 or 7,b7 such other types of indications as the ,secretary determines to be subject to the streamlined data review program under this section4 7#b7 ,the term qualified data summary means a summary of clinical data intended to demonstrate safety and effectiveness with respect to a qualified indication for use of a drug4 4 7b7 ,sense of ,congress ,it is the sense of ,congress that the streamlined data review program under section #eje;,h of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7a71 should enable the ,food and ,drug ,administration to make approval decisions for certain supplemental applications based on qualified data summaries 7as defined in such section #eje;,h74 7c7 ,guidance2 regulations ,the ,commissioner of ,food and ,drugs-- 7#a7 shall-- 7,a7 issue final guidance for implementation of the streamlined data review program established under section #eje;,h of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7a71 not later than #bd months after the date of enactment of this ,act2 and 7,b7 include in such guidance the process for expanding the types of indications to be subject to the streamlined data review program1 as authorized by section #eje;,h7c77#a77;,b7 of such ,act2 and 7#b7 in addition to issuing guidance under paragraph 7#a71 may issue such regulations as may be necessary for implementation of the program4 ,e ,expediting ,patient ,access #bjha4 ,sense of ,congress ,it is the sense of ,congress that the ,food and ,drug ,administration should continue to expedite the approval of drugs designated as breakthrough therapies pursuant to section #ejf7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;a77 by approving drugs so designated as early as possible in the clinical development process1 regardless of the phase of development1 provided that the ,secretary of ,health and ,human ,services determines that an application for such a drug meets the standards of evidence of safety and effectiveness under section #eje of such ,act 7#ba ,u4,s4,c4 #cee71 including the substantial evidence standard under subsection 7d7 of such section or under section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a774 #bjhb4 ,expanded access policy ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended by inserting after section #efa 7#ba ,u4,s4,c4 #cfj;bbb7 the following3 #efa;,a4 ,expanded access policy required for investigational drugs 7a7 ,in general ,the manufacturer or distributor of one or more investigational drugs for the diagnosis1 monitoring1 or treatment of one or more serious diseases or conditions shall make publicly available the policy of the manufacturer or distributor on evaluating and responding to requests submitted under section #efa7;b7 for provision of such a drug4 ,a manufacturer or distributor may satisfy the requirement of the preceding sentence by posting such policy as generally applicable to all of such manufacturer's or distributor's investigational drugs4 7b7 ,content of policy ,a policy described in subsection 7a7 shall include making publicly available-- 7#a7 contact information for the manufacturer or distributor to facilitate communication about requests described in subsection 7a72 7#b7 procedures for making such requests2 7#c7 the general criteria the manufacturer or distributor will consider or use to approve such requests2 and 7#d7 the length of time the manufacturer or distributor anticipates will be necessary to acknowledge receipt of such requests4 7c7 ,no guarantee of access ,the posting of policies by manufacturers and distributors under subsection 7a7 shall not serve as a guarantee of access to any specific investigational drug by any individual patient4 7d7 ,revised policy ,a manufacturer or distributor that has made a policy publicly available as required by this section may revise the policy at any time4 7e7 ,application ,this section shall apply to a manufacturer or distributor with respect to an investigational drug beginning on the later of-- 7#a7 the date that is #fj days after the date of enactment of the #bast ,century ,cures ,act2 or 7#b7 the first initiation of a phase #b or phase #c study 7as such terms are defined in section #cab4ba7;b7 and 7c7 of title #ba1 ,code of ,federal ,regulations 7or any successor regulations77 with respect to such investigational new drug4 4 #bjhc4 ,finalizing draft guidance on expanded access 7a7 ,in general ,not later than #ab months after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall finalize the draft guidance entitled ,expanded ,access to ,investigational ,drugs for ,treatment ,use--,qs ,as and dated ,may #bjac4 7b7 ,contents ,the final guidance referred to in subsection 7a7 shall clearly define how the ,secretary of ,health and ,human ,services interprets and uses adverse drug event data reported by investigators in the case of data reported from use under a request submitted under section #efa7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb7b774 ,f ,facilitating responsible manufacturer communications #baja4 ,facilitating dissemination of health care economic information ,section #ejb7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7;a77 is amended-- 7#a7 by striking 7a7 ,if its and inserting 7a77#a7 ,if its2 7#b7 by striking a formulary committee1 or other similar entity1 in the course of the committee or the entity carrying out its responsibilities for the selection of drugs for managed care or other similar organizations and inserting a payor1 formulary committee1 or other similar entity with knowledge and expertise in the area of health care economic analysis1 carrying out its responsibilities for the selection of drugs for coverage or reimbursement2 7#c7 by striking directly relates and inserting relates2 7#d7 by striking and is based on competent and reliable scientific evidence4 ,the requirements set forth in section #eje7;a7 or in section #cea7;a7 of the ,public ,health ,service ,act shall not apply to health care economic information provided to such a committee or entity in accordance with this paragraph and inserting 1 is based on competent and reliable scientific evidence1 and includes1 where applicable1 a conspicuous and prominent statement describing any material differences between the health care economic information and the labeling approved for the drug under section #eje or under section #cea of the ,public ,health ,service ,act4 ,the requirements set forth in section #eje7;a7 or in subsections 7a7 and 7k7 of section #cea of the ,public ,health ,service ,act shall not apply to health care economic information provided to such a payor1 committee1 or entity in accordance with this paragraph2 and 7#e7 by striking ,in this paragraph1 the term and all that follows and inserting the following3 7#b7 7,a7 ,for purposes of this paragraph1 the term health care economic information means any analysis 7including the clinical data1 inputs1 clinical or other assumptions1 methods1 results1 and other components underlying or comprising the analysis7 that identifies1 measures1 or describes the economic consequences1 which may be based on the separate or aggregated clinical consequences of the represented health outcomes1 of the use of a drug4 ,such analysis may be comparative to the use of another drug1 to another health care intervention1 or to no intervention4 7,b7 ,such term does not include any analysis that relates only to an indication that is not approved under section #eje or under section #cea of the ,public ,health ,service ,act for such drug4 4 #bajb4 ,facilitating responsible communication of scientific and medical developments 7a7 ,guidance ,not later than #ah months after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall issue draft guidance on facilitating the responsible dissemination of truthful and nonmisleading scientific and medical information not included in the approved labeling of drugs and devices4 7b7 ,definition ,in this section1 the terms drug and device have the meaning given to such terms in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba74 ,g ,antibiotic ,drug ,development #baba4 ,approval of certain drugs for use in a limited population of patients 7a7 ,purpose ,the purpose of this section is to help to expedite the development and availability of treatments for serious or life-threatening bacterial or fungal infections in patients with unmet needs1 while maintaining safety and effectiveness standards for such treatments1 taking into account the severity of the infection and the availability or lack of alternative treatments4 7b7 ,approval of certain antibacterial and antifungal drugs ,section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 as amended by section #bjja1 is further amended by adding at the end the following new subsection3 7z7 ,approval of certain antibacterial and antifungal drugs for use in a limited population of patients 7#a7 ,process ,at the request of the sponsor of an antibacterial or antifungal drug that is intended to treat a serious or life-threatening infection1 the ,secretary-- 7,a7 may execute a written agreement with the sponsor on the process for developing data to support an application for approval of such drug1 for use in a limited population of patients in accordance with this subsection2 7,b7 shall proceed in accordance with this subsection only if a written agreement is reached under subparagraph 7,a72 7,c7 shall provide the sponsor with an opportunity to request meetings under paragraph 7#b72 7,d7 if a written agreement is reached under subparagraph 7,a71 may approve the drug under this subsection for such use-- 7i7 in a limited population of patients for which there is an unmet medical need2 7ii7 based on a streamlined development program2 and 7iii7 only if the standards for approval under subsections 7c7 and 7d7 of this section or licensure under section #cea of the ,public ,health ,service ,act1 as applicable1 are met2 and 7,e7 in approving a drug in accordance with this subsection1 subject to subparagraph 7,d77iii71 may rely upon-- 7i7 traditional endpoints1 alternate endpoints1 or a combination of traditional and alternate endpoints1 and1 as appropriate1 data sets of a limited size2 and 7ii7 7,i7 additional data1 including preclinical1 pharmacologic1 or pathophysiologic evidence2 7,,ii7 nonclinical susceptibility and pharmacokinetic data2 7,,iii7 data from phase #b clinical trials2 and 7,,iv7 such other confirmatory evidence as the ,secretary determines appropriate to approve the drug4 7#b7 ,formal meetings 7,a7 ,in general ,to help to expedite and facilitate the development and review of a drug for which a sponsor intends to request approval in accordance with this subsection1 the ,secretary may1 at the request of the sponsor1 conduct meetings that provide early consultation1 timely advice1 and sufficient opportunities to develop an agreement described in paragraph 7#a77;,a7 and help the sponsor design and conduct a drug development program as efficiently as possible1 including the following types of meetings3 7i7 ,an early consultation meeting4 7ii7 ,an assessment meeting4 7iii7 ,a postapproval meeting4 7,b7 ,no altering of goals ,nothing in this paragraph shall be construed to alter agreed-upon goals and procedures identified in the letters described in section #aja7;b7 of the ,prescription ,drug ,user ,fee ,amendments of #bjab4 7,c7 ,breakthrough therapies ,in the case of a drug designated as a breakthrough therapy under section #ejf7;a71 the sponsor of such drug may elect to utilize meetings provided under such section with respect to such drug in lieu of meetings described in subparagraph 7,a74 7#c7 ,labeling requirement ,the labeling of an antibacterial or antifungal drug approved in accordance with this subsection shall contain the statement ,limited ,population in a prominent manner and adjacent to1 and not more prominent than1 the brand name of the product4 ,the prescribing information for such antibacterial or antifungal drug required by section #bja4eg of title #ba1 ,code of ,federal ,regulations 7or any successor regulation7 shall also include the following statement3 ,this drug is indicated for use in a limited and specific population of patients44 7#d7 ,promotional materials ,the provisions of section #ejf7;c77#b77;,b7 shall apply with respect to approval in accordance with this subsection to the same extent and in the same manner as such provisions apply with respect to accelerated approval in accordance with section #ejf7;c77#a74 7#e7 ,termination of requirements or conditions ,if a drug is approved in accordance with this subsection for an indication in a limited population of patients and is subsequently approved or licensed under this section or section #cea of the ,public ,health ,service ,act1 other than in accordance with this subsection1 for-- 7,a7 the same indication and the same conditions of use1 the ,secretary shall remove any labeling requirements or postmarketing conditions that were made applicable to the drug under this subsection2 or 7,b7 a different indication or condition of use1 the ,secretary shall not apply the labeling requirements and postmarketing conditions that were made applicable to the drug under this subsection to the subsequent approval of the drug for such different indication or condition of use4 7#f7 ,relation to other provisions ,nothing in this subsection shall be construed to prohibit the approval of a drug for use in a limited population of patients in accordance with this subsection1 in combination with-- 7,a7 an agreement on the design and size of a clinical trial pursuant to subparagraphs 7,b7 and 7,c7 of subsection 7b77#e72 7,b7 designation and treatment of the drug as a breakthrough therapy under section #ejf7;a72 7,c7 designation and treatment of the drug as a fast track product under section #ejf7;b72 or 7,d7 accelerated approval of the drug in accordance with section #ejf7;c74 7#g7 ,rule of construction ,nothing in this subsection shall be construed-- 7,a7 to alter the standards of evidence under subsection 7c7 or 7d7 7including the substantial evidence standard in subsection 7d772 7,b7 to waive or otherwise preclude the application of requirements under subsection 7o72 7,c7 to otherwise1 in any way1 limit the authority of the ,secretary to approve products pursuant to this ,act and the ,public ,health ,service ,act as authorized prior to the date of enactment of this subsection2 or 7,d7 to restrict in any manner1 the prescribing of antibiotics or other products by health care providers1 or to otherwise limit or restrict the practice of health care4 7#h7 ,effective immediately ,the ,secretary shall have the authorities vested in the ,secretary by this subsection beginning on the date of enactment of this subsection1 irrespective of when and whether the ,secretary promulgates final regulations or guidance4 7#i7 ,definitions ,in this subsection3 7,a7 ,early consultation meeting ,the term early consultation meeting means a pre-investigational new drug meeting or an end-of-phase-#a meeting that-- 7i7 is conducted to review and reach a written agreement-- 7,i7 on the scope of the streamlined development plan for a drug for which a sponsor intends to request approval in accordance with this subsection2 and 7,,ii7 which1 as appropriate1 may include agreement on the design and size of necessary preclinical and clinical studies early in the development process1 including clinical trials whose data are intended to form the primary basis for an effectiveness claim2 and 7ii7 provides an opportunity to discuss expectations of the ,secretary regarding studies or other information that the ,secretary deems appropriate for purposes of applying paragraph 7#e71 relating to the termination of labeling requirements or postmarketing conditions4 7,b7 ,assessment meeting ,the term assessment meeting means an end-of-phase-#b meeting1 pre-new drug application meeting1 or pre-biologics license application meeting conducted to resolve questions and issues raised during the course of clinical investigations1 and details addressed in the written agreement regarding postapproval commitments or expansion of approved uses4 7,c7 ,postapproval meeting ,the term postapproval meeting means a meeting following initial approval or licensure of the drug for use in a limited population1 to discuss any issues identified by the ,secretary or the sponsor regarding postapproval commitments or expansion of approved uses4 4 7c7 ,guidance ,not later than #ah months after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall issue draft guidance describing criteria1 process1 and other general considerations for demonstrating the safety and effectiveness of antibacterial and antifungal drugs to be approved for use in a limited population in accordance with section #eje7z7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7b74 7d7 ,conforming amendments 7#a7 ,licensure of certain biological products ,section #cea7;j7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;j77 is amended-- 7,a7 by striking 7j7 and inserting 7j77#a72 7,b7 by inserting #eje7z71 after #eje7p712 and 7,c7 by adding at the end the following new paragraph3 7#b7 ,in applying section #eje7z7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act to the licensure of biological products under this section-- 7,a7 references to an antibacterial or antifungal drug that is intended to treat a serious or life-threatening infection shall be construed to refer to a biological product intended to treat a serious or life-threatening bacterial or fungal infection2 and 7,b7 references to approval of a drug under section #eje7;c7 of such ,act shall be construed to refer to a licensure of a biological product under subsection 7a7 of this section4 4 7#b7 ,misbranding ,section #ejb of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7 is amended by adding at the end the following new subsection3 7dd7 ,if it is a drug approved in accordance with section #eje7z7 and its labeling does not meet the requirements under paragraph 7#c7 of such subsection1 subject to paragraph 7#e7 of such subsection4 4 7e7 ,evaluation 7#a7 ,assessment ,not later than #dh months after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall publish for public comment an assessment of the program established under section #eje7z7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7b74 ,such assessment shall determine if the limited-use pathway established under such section #eje7z7 has improved or is likely to improve patient access to novel antibacterial or antifungal treatments and assess how the pathway could be expanded to cover products for serious or life-threatening diseases or conditions beyond bacterial and fungal infections4 7#b7 ,meeting ,not later than #ij days after the date of the publication of such assessment1 the ,secretary1 acting through the ,commissioner of ,food and ,drugs1 shall hold a public meeting to discuss the findings of the assessment1 during which public stakeholders may present their views on the success of the program established under section #eje7z7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7b71 and the appropriateness of expanding such program4 7f7 ,expansion of program ,if the ,secretary of ,health and ,human ,services determines1 based on the assessment under subsection 7e77#a71 evaluation of the assessment1 and any other relevant information1 that the public health would benefit from expansion of the limited-use pathway established under section #eje7z7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7as added by subsection 7b77 beyond the drugs approved in accordance with such section1 the ,secretary may expand such limited-use pathway in accordance with such a determination4 ,the approval of any drugs under any such expansion shall be subject to the considerations and requirements described in such section #eje7z7 for purposes of expansion to other serious or life-threatening diseases or conditions4 7g7 ,monitoring ,the ,public ,health ,service ,act is amended by inserting after section #cag,t 7#db ,u4,s4,c4 #bdg;b-#bb7 the following3 #cag,u4 ,monitoring antibacterial and antifungal drug use and resistance 7a7 ,monitoring ,the ,secretary shall use an appropriate monitoring system to monitor-- 7#a7 the use of antibacterial and antifungal drugs1 including those receiving approval or licensure for a limited population pursuant to section #eje7z7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 and 7#b7 changes in bacterial and fungal resistance to drugs4 7b7 ,public availability of data ,the ,secretary shall make summaries of the data derived from monitoring under this section publicly available for the purposes of-- 7#a7 improving the monitoring of important trends in antibacterial and antifungal resistance2 and 7#b7 ensuring appropriate stewardship of antibacterial and antifungal drugs1 including those receiving approval or licensure for a limited population pursuant to section #eje7z7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act4 4 #babb4 ,susceptibility test interpretive criteria for microorganisms 7a7 ,in general ,section #eaa of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;a7 is amended to read as follows3 #eaa4 ,identifying and updating susceptibility test interpretive criteria for microorganisms 7a7 ,purpose2 ,identification of criteria 7#a7 ,purpose ,the purpose of this section is to provide the ,secretary with an expedited1 flexible method for-- 7,a7 clearance or premarket approval of antimicrobial susceptibility testing devices utilizing updated1 recognized susceptibility test interpretive criteria to characterize the in vitro susceptibility of particular bacteria1 fungi1 or other microorganisms to antimicrobial drugs2 and 7,b7 providing public notice of the availability of recognized interpretive criteria to meet premarket submission requirements or other requirements under this ,act for antimicrobial susceptibility testing devices4 7#b7 ,in general ,the ,secretary shall identify appropriate susceptibility test interpretive criteria with respect to antimicrobial drugs-- 7,a7 if such criteria are available on the date of approval of the drug under section #eje of this ,act or licensure of the drug under section #cea of the ,public ,health ,service ,act 7as applicable71 upon such approval or licensure2 or 7,b7 if such criteria are unavailable on such date1 on the date on which such criteria are available for such drug4 7#c7 ,bases for initial identification ,the ,secretary shall identify appropriate susceptibility test interpretive criteria under paragraph 7#b71 based on the ,secretary's review of1 to the extent available and relevant-- 7,a7 preclinical and clinical data1 including pharmacokinetic1 pharmacodynamic1 and epidemiological data2 7,b7 ,bayesian and pharmacometric statistical methodologies2 and 7,c7 such other evidence and information as the ,secretary considers appropriate4 7b7 ,susceptibility test ,interpretive ,criteria ,website 7#a7 ,in general ,not later than #a year after the date of the enactment of the #bast ,century ,cures ,act1 the ,secretary shall establish1 and maintain thereafter1 on the website of the ,food and ,drug ,administration1 a dedicated website that contains a list of any appropriate new or updated susceptibility test interpretive criteria standards in accordance with paragraph 7#b7 7referred to in this section as the ,interpretive ,criteria ,website74 7#b7 ,listing of susceptibility test interpretive criteria standards 7,a7 ,in general ,the list described in paragraph 7#a7 shall consist of any new or updated susceptibility test interpretive criteria standards that are-- 7i7 established by a nationally or internationally recognized standard development organization that-- 7,i7 establishes and maintains procedures to address potential conflicts of interest and ensure transparent decisionmaking2 7,,ii7 holds open meetings to ensure that there is an opportunity for public input by interested parties1 and establishes and maintains processes to ensure that such input is considered in decisionmaking2 and 7,,iii7 permits its standards to be made publicly available1 through the ,national ,library of ,medicine or another similar source acceptable to the ,secretary2 and 7ii7 recognized in whole1 or in part1 by the ,secretary under subsection 7c74 7,b7 ,other list ,the ,interpretive ,criteria ,website shall1 in addition to the list described in subparagraph 7,a71 include a list of interpretive criteria1 if any1 that the ,secretary has determined to be appropriate with respect to legally marketed antimicrobial drugs1 where-- 7i7 the ,secretary does not recognize1 in whole or in part1 an interpretive criteria standard described under subparagraph 7,a7 otherwise applicable to such a drug2 7ii7 the ,secretary withdraws under subsection 7c77#a77;,b7 recognition of a standard1 in whole or in part1 otherwise applicable to such a drug2 7iii7 the ,secretary approves an application under section #eje of this ,act or section #cea of the ,public ,health ,service ,act1 as applicable1 with respect to marketing of such a drug for which there are no relevant interpretive criteria included in a standard recognized by the ,secretary under subsection 7c72 or 7iv7 because the characteristics of such a drug differ from other drugs with the same active ingredient1 the interpretive criteria with respect to such drug-- 7,i7 differ from otherwise applicable interpretive criteria included in a standard listed under subparagraph 7,a7 or interpretive criteria otherwise listed under this subparagraph2 and 7,,ii7 are determined by the ,secretary to be appropriate for the drug4 7,c7 ,required statements of limitations of information ,the ,interpretive ,criteria ,website shall include the following3 7i7 ,a statement that-- 7,i7 the website provides information about the susceptibility of bacteria1 fungi1 or other microorganisms to a certain drug 7or drugs72 and 7,,ii7 the safety and efficacy of the drug in treating clinical infections due to such bacteria1 fungi1 or other microorganisms may not have been established in adequate and well-controlled clinical trials and the clinical significance of such susceptibility information in such trials is unknown4 7ii7 ,a statement that directs health care practitioners to consult the approved product labeling for specific drugs to determine the uses for which the ,food and ,drug ,administration has approved the product4 7iii7 ,any other statement that the ,secretary determines appropriate to adequately convey the limitations of the data supporting susceptibility test interpretive criteria standard listed on the website4 7#c7 ,notice ,not later than the date on which the ,interpretive ,criteria ,website is established1 the ,secretary shall publish a notice of that establishment in the ,federal ,register4 7#d7 ,inapplicability of misbranding provision ,the inclusion in the approved labeling of an antimicrobial drug of a reference or hyperlink to the ,interpretive ,criteria ,website1 in and of itself1 shall not cause the drug to be misbranded in violation of section #ejb1 or the regulations promulgated thereunder4 7#e7 ,trade secrets and confidential information ,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 ,code4 7c7 ,recognition of susceptibility test interpretive criteria from standard development organizations 7#a7 ,in general ,beginning on the date of the establishment of the ,interpretive ,criteria ,website1 and at least every #f months thereafter1 the ,secretary shall-- 7,a7 evaluate any appropriate new or updated susceptibility test interpretive criteria standards established by a nationally or internationally recognized standard development organization described in subsection 7b77#b77;,a77i72 and 7,b7 publish on the public website of the ,food and ,drug ,administration a notice-- 7i7 withdrawing recognition of any different susceptibility test interpretive criteria standard1 in whole or in part2 7ii7 recognizing the new or updated standards2 7iii7 recognizing one or more parts of the new or updated interpretive criteria specified in such a standard and declining to recognize the remainder of such standard2 and 7iv7 making any necessary updates to the lists under subsection 7b77#b74 7#b7 ,bases for updating interpretive criteria standards ,in evaluating new or updated susceptibility test interpretive criteria standards under paragraph 7#a77;,a71 the ,secretary may consider-- 7,a7 the ,secretary's determination that such a standard is not applicable to a particular drug because the characteristics of the drug differ from other drugs with the same active ingredient2 7,b7 information provided by interested third parties1 including public comment on the annual compilation of notices published under paragraph 7#c72 7,c7 any bases used to identify susceptibility test interpretive criteria under subsection 7a77#b72 and 7,d7 such other information or factors as the ,secretary determines appropriate4 7#c7 ,annual compilation of notices ,each year1 the ,secretary shall compile the notices published under paragraph 7#a77;,b7 and publish such compilation in the ,federal ,register and provide for public comment4 ,if the ,secretary receives comments1 the ,secretary shall review such comments and1 if the ,secretary determines appropriate1 update pursuant to this subsection susceptibility test interpretive criteria standards-- 7,a7 recognized by the ,secretary under this subsection2 or 7,b7 otherwise listed on the ,interpretive ,criteria ,website under subsection 7b77#b74 7#d7 ,relation to section #ead7;c7 ,any susceptibility test interpretive standard recognized under this subsection or any criteria otherwise listed under subsection 7b77#b77;,b7 shall be deemed to be recognized as a standard by the ,secretary under section #ead7;c77#a74 7#e7 ,voluntary use of interpretive criteria ,nothing in this section prohibits a person from seeking approval or clearance of a drug or device1 or changes to the drug or the device1 on the basis of susceptibility test interpretive criteria standards which differ from those recognized pursuant to paragraph 7#a74 7d7 ,antimicrobial drug labeling 7#a7 ,drugs marketed prior to establishment of ,interpretive ,criteria ,website ,with respect to an antimicrobial drug lawfully introduced or delivered for introduction into interstate commerce for commercial distribution before the establishment of the ,interpretive ,criteria ,website1 a holder of an approved application under section #eje of this ,act or section #cea of the ,public ,health ,service ,act1 as applicable1 for each such drug-- 7,a7 not later than #a year after establishment of the ,interpretive ,criteria ,website1 shall submit to the ,secretary a supplemental application for purposes of changing the drug's labeling to substitute a reference or hyperlink to such ,website for any susceptibility test interpretive criteria and related information2 and 7,b7 may begin distribution of the drug involved upon receipt by the ,secretary of the supplemental application for such change4 7#b7 ,drugs marketed subsequent to establishment of ,interpretive ,criteria ,website ,with respect to antimicrobial drugs lawfully introduced or delivered for introduction into interstate commerce for commercial distribution on or after the date of the establishment of the ,interpretive ,criteria ,website1 the labeling for such a drug shall include1 in lieu of susceptibility test interpretive criteria and related information1 a reference to such ,website4 7e7 ,special condition for marketing of antimicrobial susceptibility testing devices 7#a7 ,in general ,notwithstanding sections #eja1 #ejb1 #eaj1 #eac1 and #eae1 if the conditions specified in paragraph 7#b7 are met 7in addition to other applicable provisions under this chapter7 with respect to an antimicrobial susceptibility testing device described in subsection 7f77#a71 the ,secretary may authorize the marketing of such device for a use described in such subsection4 7#b7 ,conditions applicable to antimicrobial susceptibility testing devices ,the conditions specified in this paragraph are the following3 7,a7 ,the device is used to make a determination of susceptibility using susceptibility test interpretive criteria that are-- 7i7 included in a standard recognized by the ,secretary under subsection 7c72 or 7ii7 otherwise listed on the ,interpretive ,criteria ,website under subsection 7b77#b74 7,b7 ,the labeling of such device prominently and conspicuously-- 7i7 includes a statement that-- 7,i7 the device provides information about the susceptibility of bacteria and fungi to certain drugs2 and 7,,ii7 the safety and efficacy of such drugs in treating clinical infections due to such bacteria or fungi may not have been established in adequate and well-controlled clinical trials and the clinical significance of such susceptibility information in those instances is unknown2 7ii7 includes a statement directing health care practitioners to consult the approved labeling for drugs tested using such a device1 to determine the uses for which the ,food and ,drug ,administration has approved such drugs2 and 7iii7 includes any other statement the ,secretary determines appropriate to adequately convey the limitations of the data supporting the interpretive criteria described in subparagraph 7,a74 7f7 ,definitions ,in this section3 7#a7 ,the term antimicrobial susceptibility testing device means a device that utilizes susceptibility test interpretive criteria to determine and report the in vitro susceptibility of certain microorganisms to a drug 7or drugs74 7#b7 ,the term qualified infectious disease product means a qualified infectious disease product designated under section #eje;,e7d74 7#c7 ,the term susceptibility test interpretive criteria means-- 7,a7 one or more specific numerical values which characterize the susceptibility of bacteria or other microorganisms to the drug tested2 and 7,b7 related categorizations of such susceptibility1 including categorization of the drug as susceptible1 intermediate1 resistant1 or such other term as the ,secretary determines appropriate4 7#d7 7,a7 ,the term antimicrobial drug means1 subject to subparagraph 7,b71 a systemic antibacterial or antifungal drug that-- 7i7 is intended for human use in the treatment of a disease or condition caused by a bacterium or fungus2 7ii7 may include a qualified infectious disease product designated under section #eje;,e7d72 and 7iii7 is subject to section #ejc7;b77#a74 7,b7 ,if provided by the ,secretary through regulations1 such term may include-- 7i7 drugs other than systemic antibacterial and antifungal drugs2 and 7ii7 biological products 7as such term is defined in section #cea of the ,public ,health ,service ,act7 to the extent such products exhibit antimicrobial activity4 7g7 ,rule of construction ,nothing in this section shall be construed-- 7#a7 to alter the standards of evidence-- 7,a7 under subsection 7c7 or 7d7 of section #eje1 including the substantial evidence standard in section #eje7;d71 or under section #cea of the ,public ,health ,service ,act 7as applicable72 or 7,b7 with respect to marketing authorization for devices1 under section #eaj1 #eac1 or #eae2 7#b7 to apply with respect to any drug1 device1 or biological product1 in any context other than-- 7,a7 an antimicrobial drug2 or 7,b7 an antimicrobial susceptibility testing device that uses susceptibility test interpretive criteria to characterize and report the in vitro susceptibility of certain bacteria1 fungi1 or other microorganisms to antimicrobial drugs in accordance with this section2 or 7#c7 unless specifically stated1 to have any effect on authorities provided under other sections of this ,act1 including any regulations issued under such sections4 4 7b7 ,conforming amendments 7#a7 ,repeal of related authority ,section #aaaa of the ,food and ,drug ,administration ,amendments ,act of #bjjg 7#db ,u4,s4,c4 #bdg;d-#e;a2 relating to identification of clinically susceptible concentrations of antimicrobials7 is repealed4 7#b7 ,clerical amendment ,the table of contents in section #b of the ,food and ,drug ,administration ,amendments ,act of #bjjg is amended by striking the item relating to section #aaaa4 7#c7 ,misbranding ,section #ejb of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb71 as amended by section #baba1 is further amended by adding at the end the following3 7ee7 ,if it is an antimicrobial drug and its labeling fails to conform with the requirements under section #eaa7;d74 4 7#d7 ,recognition of interpretive criteria as device standard ,section #ead7;c77#a77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;d7c77#a77;,a77 is amended by inserting after the ,secretary shall1 by publication in the ,federal ,register the following3 7or1 with respect to susceptibility test interpretive criteria or standards recognized or otherwise listed under section #eaa1 by posting on the ,interpretive ,criteria ,website in accordance with such section74 7c7 ,report to ,congress ,not later than #b years after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services 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 progress made in implementing section #eaa of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;a71 as amended by this section4 7d7 ,requests for updates to ,interpretive ,criteria ,website ,chapter #ce of title #dd1 ,united ,states ,code1 shall not apply to the collection of information from interested parties regarding the updating of lists under paragraph 7#b7 of subsection 7b7 section #eaa of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7as amended by subsection 7a77 and posted on the ,interpretive ,criteria ,website established under paragraph 7#a7 of such subsection 7b74 7e7 ,no effect on health care practice ,nothing in this subtitle 7including the amendments made by this subtitle7 shall be construed to restrict1 in any manner1 the prescribing or administering of antibiotics or other products by health care practitioners1 or to limit the practice of health care4 #babc4 ,encouraging the development and use of ,,disarm drugs 7a7 ,additional payment for ,,disarm drugs under ,medicare 7#a7 ,in general ,section #ahhf7;d77#e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7d77#e77 is amended by adding at the end the following new subparagraph3 7,m7 7i7 ,as part of the annual rulemaking conducted with respect to payment for subsection 7d7 hospitals for each fiscal year beginning with fiscal year #bjah1 the ,secretary shall-- 7,i7 include a list of the ,,disarm drugs for such fiscal year2 and 7,,ii7 with respect to discharges by eligible hospitals that involve a drug so listed1 provide for an additional payment to be made under this subsection in accordance with the provisions of this subparagraph4 7ii7 ,additional payments may not be made for a drug under this subparagraph-- 7,i7 other than during the #e-;fiscal-year period beginning with the fiscal year for which the drug is first included in the list described in clause 7i77,i72 and 7,,ii7 with respect to which payment has ever been made pursuant to subparagraph 7,k74 7iii7 ,for purposes of this subparagraph1 the term ,,disarm drug means a product that is approved for use1 or a product for which an indication is first approved for use1 by the ,food and ,drug ,administration on or after ,december #a1 #bjad1 and that the ,food and ,drug ,administration determines is an antimicrobial product 7as defined in clause 7iv77 and is intended to treat an infection-- 7,i7 for which there is an unmet medical need2 and 7,,ii7 which is associated with high rates of mortality or significant patient morbidity1 as determined in consultation with the ,director of the ,centers for ,disease ,control and ,prevention and the infectious disease professional community4 7iv7 ,for purposes of clause 7iii71 the term antimicrobial product means a product that either-- 7,i7 is intended to treat an infection caused by1 or likely to be caused by1 a qualifying pathogen 7as defined under section #eje;,e7f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act72 or 7,,ii7 meets the definition of a qualified infectious disease product under section #eje;,e7g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act4 ,such determination may be revoked only upon a finding that the request for such determination contained an untrue statement of material fact4 7v7 ,for purposes of this subparagraph1 the term eligible hospital means a subsection 7d7 hospital that participates in the ,national ,healthcare ,safety ,network of the ,centers for ,disease ,control and ,prevention 7or1 to the extent a similar surveillance system that includes reporting about antimicrobial drugs is determined by the ,secretary to be available to such hospitals1 such similar surveillance system as the ,secretary may specify74 7vi7 ,subject to the succeeding provisions of this subparagraph1 the additional payment under this subparagraph1 with respect to a drug1 shall be in the amount provided for such drug under section #ahdg;,a4 7vii7 ,as part of the rulemaking referred to in clause 7i7 for each fiscal year1 the ,secretary shall estimate-- 7,i7 total add-on payments 7as defined in subclause 7,i7 of clause 7ix772 and 7,,ii7 total hospital payments 7as defined in subclause 7,,ii7 of such clause74 7viii7 ,if the total add-on payments estimated pursuant to clause 7vii77,i7 for a fiscal year exceed #j4jb percent of the total hospital payments estimated pursuant to clause 7vii77,,ii7 for such fiscal year1 the ,secretary shall reduce in a pro rata manner the amount of each additional payment under this subsection pursuant to this subparagraph for such fiscal year in order to ensure that the total add-on payments estimated for such fiscal year do not exceed #j4jb percent of the total hospital payments estimated for such fiscal year4 7ix7 ,in this subparagraph3 7,i7 ,the term total add-on payments means1 with respect to a fiscal year1 the total amount of the additional payments under this subsection pursuant to this subparagraph for discharges in such fiscal year without regard to the application of clause 7viii74 7,,ii7 ,the term total hospital payments means1 with respect to a fiscal year1 the total amount of payments made under this subsection for all discharges in such fiscal year4 4 7#b7 ,conforming amendments 7,a7 ,no duplicative ,,ntap payments ,section #ahhf7;d77#e77,k77vi7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7d77#e77,k77vi77 is amended by inserting and if additional payment has never been made under this subsection pursuant to subparagraph 7,m7 with respect to the service or technology before the period at the end4 7,b7 ,access to price information ,section #aibg7;b77#c77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77;,a77 is amended-- 7i7 in clause 7ii7-- 7,i7 by striking for each and inserting 1 for each2 and 7,,ii7 by striking and at the end2 7ii7 in clause 7iii7-- 7,i7 in subclause 7,,ii71 by inserting or under section #ahhf7;d7 pursuant to paragraph 7#e77,m7 of such section1 after #ahdg;,a12 7,,ii7 in the matter following subclause 7,,iii71 by striking or #ahha7;b77#ac77;,a77ii7 and inserting 1 section #ahha7;b77#ac77;,a77ii71 or section #ahhf7;d77#e77,m72 and 7,,iii7 by striking the period at the end and inserting 2 and2 and 7iii7 in clause 7iv71 by striking the semicolon at the end and inserting a period4 7b7 ,study and report on removing barriers to development of ,,disarm drugs 7#a7 ,study ,the ,comptroller ,general of the ,united ,states shall1 in consultation with the ,director of the ,national ,institutes of ,health1 the ,commissioner of ,food and ,drugs1 and the ,director of the ,centers for ,disease ,control and ,prevention1 conduct a study to-- 7,a7 identify and examine the barriers that prevent the development of ,,disarm drugs1 as defined in section #ahhf7;d77#e77,m77iii7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7d77#e77,m77iii771 as added by subsection 7a77#a72 and 7,b7 develop recommendations for actions to be taken in order to overcome any barriers identified under subparagraph 7,a74 7#b7 ,report ,not later than #a year after the date of the enactment of this ,act1 the ,comptroller ,general shall submit to ,congress a report on the study conducted under paragraph 7#a74 7c7 ,study and report on the impact of additional ,medicare payment for ,,disarm drugs on usage practices and development of resistance 7#a7 ,study ,the ,director of the ,centers for ,disease ,control and ,prevention shall conduct a study to examine the effects of the additional payment for ,,disarm drugs under the ,medicare ,program provided under subparagraph 7,m7 of section #ahhf7;d77#e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7d77#e771 as added by subsection 7a71 on-- 7,a7 the usage of ,,disarm drugs 7as defined by clause 7iii7 of such subparagraph7 by subsection 7d7 hospitals 7as defined in section #ahhf7;d77#a77;,b7 of such ,act72 and 7,b7 the development of resistance by individuals to such ,,disarm drugs4 7#b7 ,report ,not later than #c years after the date of the enactment of this ,act1 such ,director shall submit to ,congress a report on the study conducted under paragraph 7#a74 ,h ,vaccine ,access1 ,certainty1 and ,innovation #bada4 ,timely review of vaccines by the ,advisory ,committee on ,immunization ,practices ,section #bajb7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;aa-#b7;a77 is amended by adding at the end the following3 7#aj7 ,advisory ,committee on ,immunization ,practices 7,a7 ,standard periods of time for making recommendations ,upon the licensure of any vaccine or any new indication for a vaccine1 the ,director of the ,program shall direct the ,advisory ,committee on ,immunization ,practices1 at its next regularly scheduled meeting1 to consider the use of the vaccine4 7,b7 ,expedited review pursuant to request by sponsor or manufacturer ,if the ,advisory ,committee does not make recommendations with respect to the use of a vaccine at the ,advisory ,committee's first regularly scheduled meeting after the licensure of the vaccine or any new indication for the vaccine1 the ,advisory ,committee1 at the request of the sponsor of the vaccine1 shall make such recommendations on an expedited basis4 7,c7 ,expedited review for breakthrough therapies and for use during public health emergencies ,if a vaccine is designated as a breakthrough therapy under section #ejf of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 and is licensed under section #cea of this ,act1 the ,advisory ,committee shall make recommendations with respect to the use of the vaccine on an expedited basis4 7,d7 ,definition ,in this paragraph1 the terms ,advisory ,committee on ,immunization ,practices and ,advisory ,committee mean the advisory committee on immunization practices established by the ,secretary pursuant to section #bbb1 acting through the ,director of the ,centers for ,disease ,control and ,prevention4 4 #badb4 ,review of processes and consistency of ,,acip recommendations 7a7 ,review ,the ,director of the ,centers for ,disease ,control and ,prevention shall conduct a review of the process used by the ,advisory ,committee on ,immunization ,practices to evaluate consistency in formulating and issuing recommendations pertaining to vaccines4 7b7 ,considerations ,the review under subsection 7a7 shall include assessment of-- 7#a7 the criteria used to evaluate new and existing vaccines2 7#b7 the ,grading of ,recommendations1 ,assessment1 ,development1 and ,evaluation 7,,grade7 approach to the review and analysis of scientific and economic data1 including the scientific basis for such approach2 and 7#c7 the extent to which the processes used by the working groups of the ,advisory ,committee on ,immunization ,practices are consistent among groups4 7c7 ,stakeholders ,in carrying out the review under subsection 7a71 the ,director of the ,centers for ,disease ,control and ,prevention shall solicit input from vaccine stakeholders4 7d7 ,report ,not later than #ah months after the date of enactment of this ,act1 the ,director of the ,centers for ,disease ,control and ,prevention shall submit to the appropriate committees of the ,congress and make publicly available a report on the results of the review under subsection 7a71 including recommendations on improving the consistency of the process described in such subsection4 7e7 ,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 #badc4 ,meetings between ,,cdc and vaccine developers ,section #caj of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdbo7 is amended by adding at the end the following3 7c7 7#a7 ,in this subsection1 the term vaccine developer means a nongovernmental entity engaged in-- 7,a7 7i7 the development of a vaccine with the intent to pursue licensing of the vaccine by the ,food and ,drug ,administration2 or 7ii7 the production of a vaccine licensed by the ,food and ,drug ,administration2 and 7,b7 vaccine research4 7#b7 7,a7 ,upon the submission of a written request for a meeting by a vaccine developer1 that includes a valid justification for the meeting1 the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall convene a meeting of representatives of the vaccine developer and experts from the ,centers for ,disease ,control and ,prevention in immunization programs1 epidemiology1 and other relevant areas at which the ,director 7or the ,director's designee71 for the purpose of informing the vaccine developer's understanding of public health needs and priorities1 shall provide the perspectives of the ,centers for ,disease ,control and ,prevention and other relevant ,federal agencies regarding-- 7i7 public health needs1 epidemiology1 and implementation considerations with regard to a vaccine developer's potential vaccine profile2 and 7ii7 potential implications of such perspectives for the vaccine developer's vaccine research and development planning4 7,b7 ,in addition to the representatives specified in subparagraph 7,a71 the ,secretary may1 with the agreement of the vaccine developer requesting a meeting under such subparagraph1 include in such meeting representatives of-- 7i7 the ,food and ,drug ,administration2 and 7ii7 the ,national ,vaccine ,program4 7,c7 ,the ,secretary shall convene a meeting requested with a valid justification under subparagraph 7,a7 not later than #abj days after receipt of the request for the meeting4 7#c7 7,a7 ,upon the submission of a written request by a vaccine developer1 the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall provide to the vaccine developer any age-based or other demographically assessed disease epidemiological analyses or data that-- 7i7 are specified in the request2 7ii7 have been published2 7iii7 have been performed by or are in the possession of the ,centers2 7iv7 are not a trade secret or commercial or financial information that is privileged or confidential and subject to section #eeb7;b77#d7 of title #e1 ,united ,states ,code1 or section #aije of title #ah1 ,united ,states ,code2 and 7v7 do not contain individually identifiable information4 7,b7 ,the ,secretary shall provide analyses requested by a vaccine manufacturer under subparagraph 7,a7 not later than #abj calendar days after receipt of the request for the analyses4 7#d7 ,the ,secretary shall promptly notify a vaccine developer if-- 7,a7 the ,secretary becomes aware of any significant change to information that was-- 7i7 shared by the ,secretary with the vaccine developer during a meeting under paragraph 7#b72 or 7ii7 provided by the ,secretary to the vaccine developer in one or more analyses under paragraph 7#c72 and 7,b7 the change to such information may have implications for the vaccine developer's vaccine research and development4 4 ,i ,orphan product extensions now2 incentives for certain products for limited populations #baea4 ,extension of exclusivity periods for a drug approved for a new indication for a rare disease or condition 7a7 ,in general ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as amended by sections #bjfb and #bjfc1 is further amended by inserting after section #eje;,h of such ,act the following3 #eje;,i4 ,extension of exclusivity periods for a drug approved for a new indication for a rare disease or condition 7a7 ,designation 7#a7 ,in general ,the ,secretary shall designate a drug as a drug approved for a new indication to prevent1 diagnose1 or treat a rare disease or condition for purposes of granting the extensions under subsection 7b7 if-- 7,a7 prior to approval of an application or supplemental application for the new indication1 the drug was approved or licensed for marketing under section #eje7;c7 of this ,act or section #cea7;a7 of the ,public ,health ,service ,act but was not so approved or licensed for the new indication2 7,b7 7i7 the sponsor of the approved or licensed drug files an application or a supplemental application for approval of the new indication for use of the drug to prevent1 diagnose1 or treat the rare disease or condition2 and 7ii7 the ,secretary approves the application or supplemental application2 and 7,c7 the application or supplemental application for the new indication contains the consent of the applicant to notice being given by the ,secretary under paragraph 7#d7 respecting the designation of the drug4 7#b7 ,revocation of designation 7,a7 ,in general ,except as provided in subparagraph 7,b71 a designation under paragraph 7#a7 shall not be revoked for any reason4 7,b7 ,exception ,the ,secretary may revoke a designation of a drug under paragraph 7#a7 if the ,secretary finds that the application or supplemental application resulting in such designation contained an untrue statement of material fact4 7#c7 ,notification prior to discontinuance of production for solely commercial reasons ,a designation of a drug under paragraph 7#a7 shall be subject to the condition that the sponsor of the drug will notify the ,secretary of any discontinuance of the production of the drug for solely commercial reasons at least #a year before such discontinuance4 7#d7 ,notice to public ,notice respecting the designation of a drug under paragraph 7#a7 shall be made available to the public4 7b7 ,extension ,if the ,secretary designates a drug as a drug approved for a new indication for a rare disease or condition1 as described in subsection 7a77#a7-- 7#a7 7,a7 the #d-1 #e-1 and #g-year periods described in subsections 7c77#c77;,e77ii7 and 7j77#e77;,f77ii7 of section #eje1 the #c-year periods described in clauses 7iii7 and 7iv7 of subsection 7c77#c77;,e7 and clauses 7iii7 and 7iv7 of subsection 7j77#e77;,f7 of section #eje1 and the #g-year period described in section #ebg1 as applicable1 shall be extended by #f months2 or 7,b7 the #d- and #ab-year periods described in subparagraphs 7,a7 and 7,b7 of section #cea7k77#g7 of the ,public ,health ,service ,act and the #g-year period described in section #ebg1 as applicable1 shall be extended by #f months2 and 7#b7 7,a7 if the drug is the subject of a listed patent for which a certification has been submitted under subsection 7b77#b77;,a77ii7 or 7j77#b77;,a77vii77,,ii7 of section #eje or a listed patent for which a certification has been submitted under subsections 7b77#b77;,a77iii7 or 7j77#b77;,a77vii77,,iii7 of section #eje1 the period during which an application may not be approved under section #eje7;c77#c7 or section #eje7;j77#e77;,b7 shall be extended by a period of #f months after the date the patent expires 7including any patent extensions72 or 7,b7 if the drug is the subject of a listed patent for which a certification has been submitted under subsection 7b77#b77;,a77iv7 or 7j77#b77;,a77vii77,,iv7 of section #eje1 and in the patent infringement litigation resulting from the certification the court determines that the patent is valid and would be infringed1 the period during which an application may not be approved under section #eje7;c77#c7 or section #eje7;j77#e77;,b7 shall be extended by a period of #f months after the date the patent expires 7including any patent extensions74 7c7 ,relation to pediatric and qualified infectious disease product exclusivity ,any extension under subsection 7b7 of a period shall be in addition to any extension of the periods under sections #eje;,a and #eje;,e of this ,act and section #cea7m7 of the ,public ,health ,service ,act1 as applicable1 with respect to the drug4 7d7 ,limitations ,the extension described in subsection 7b7 shall not apply if the drug designated under subsection 7a77#a7 has previously received an extension by operation of subsection 7b74 7e7 ,definition ,in this section1 the term rare disease or condition has the meaning given to such term in section #ebf7;a77#b74 4 7b7 ,application ,section #eje;,g of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7a71 applies only with respect to a drug for which an application or supplemental application described in subsection 7a77#a77;,b77i7 of such section #eje;,g is first approved under section #eje7;c7 of such ,act 7#ba ,u4,s4,c4 #cee7;c77 or section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a77 on or after the date of the enactment of this ,act4 7c7 ,conforming amendments 7#a7 ,relation to pediatric exclusivity for drugs ,section #eje;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;a7 is amended-- 7,a7 in subsection 7b71 by adding at the end the following3 7#c7 ,relation to exclusivity for a drug approved for a new indication for a rare disease or condition ,notwithstanding the references in paragraph 7#a7 to the lengths of the exclusivity periods after application of pediatric exclusivity1 the #f-month extensions described in paragraph 7#a7 shall be in addition to any extensions under section #eje;,g4 2 and 7,b7 in subsection 7c71 by adding at the end the following3 7#c7 ,relation to exclusivity for a drug approved for a new indication for a rare disease or condition ,notwithstanding the references in paragraph 7#a7 to the lengths of the exclusivity periods after application of pediatric exclusivity1 the #f-month extensions described in paragraph 7#a7 shall be in addition to any extensions under section #eje;,g4 4 7#b7 ,relation to exclusivity for new qualified infectious disease products that are drugs ,subsection 7b7 of section #eje;,e of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;f7 is amended-- 7,a7 by amending the subsection heading to read as follows3 ,relation to pediatric exclusivity and exclusivity for a drug approved for a new indication for a rare disease or condition4--2 and 7,b7 by striking any extension of the period under section #eje;,a and inserting any extension of the periods under sections #eje;,a and #eje;,g1 as applicable14 7#c7 ,relation to pediatric exclusivity for biological products ,section #cea7m7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7m77 is amended by adding at the end the following3 7#e7 ,relation to exclusivity for a biological product approved for a new indication for a rare disease or condition ,notwithstanding the references in paragraphs 7#b77;,a71 7#b77;,b71 7#c77;,a71 and 7#c77;,b7 to the lengths of the exclusivity periods after application of pediatric exclusivity1 the #f-month extensions described in such paragraphs shall be in addition to any extensions under section #eje;,g4 4 #baeb4 ,reauthorization of rare pediatric disease priority review voucher incentive program 7a7 ,in general ,section #ebi of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ff7 is amended-- 7#a7 in subsection 7a7-- 7,a7 in paragraph 7#c71 by amending subparagraph 7,a7 to read as follows3 7,a7 ,the disease is a serious or life-threatening disease in which the serious or life-threatening manifestations primarily affect individuals aged from birth to #ah years1 including age groups often called neonates1 infants1 children1 and adolescents4 2 and 7,b7 in paragraph 7#d7-- 7i7 in subparagraph 7,e71 by striking and at the end2 7ii7 in subparagraph 7,f71 by striking the period at the end and inserting 2 and2 and 7iii7 by adding at the end the following3 7,g7 is for a drug or biological product for which a priority review voucher has not been issued under section #ebd 7relating to tropical disease products74 2 and 7#b7 in subsection 7b71 by striking paragraph 7#e7 and inserting the following3 7#e7 ,termination of authority 7,a7 ,in general ,the ,secretary may not award any priority review vouchers under paragraph 7#a7 after ,december #ca1 #bjah4 7,b7 ,exception ,notwithstanding subparagraph 7,a71 the sponsor of a drug that is designated under subsection 7d7 as a drug for a rare pediatric disease and that is the subject of a rare pediatric disease product application that is submitted during the period beginning on the date of enactment of the #bast ,century ,cures ,act and ending the date specified in subparagraph 7,a7 shall remain eligible to receive a priority review voucher under paragraph 7#a7 irrespective of whether the rare pediatric disease product application with respect to such drug is approved after the end of such period4 4 7b7 ,,gao study and report 7#a7 ,study ,the ,comptroller ,general of the ,united ,states shall conduct a study on the effectiveness of awarding priority review vouchers under section #ebi of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ff7 in providing incentives for the development of drugs that treat or prevent rare pediatric diseases 7as defined in subsection 7a77#c7 of such section7 that would not otherwise have been developed4 ,in conducting such study1 the ,comptroller ,general shall examine the following3 7,a7 ,the indications for which each drug for which a priority review voucher was awarded under such section #ebi was approved under section #eje of such ,act 7#ba ,u4,s4,c4 #cee7 or section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb74 7,b7 ,whether the priority review voucher impacted a sponsor's decision to invest in developing a drug to treat or prevent a rare pediatric disease4 7,c7 ,an analysis of the drugs that utilized such priority review vouchers1 which shall include-- 7i7 the indications for which such drugs were approved 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 #bfb72 7ii7 whether unmet medical needs were addressed through the approval of such drugs1 including1 for each such drug-- 7,i7 if an alternative therapy was previously available to treat the indication2 and 7,,ii7 the benefit or advantage the drug provided over another available therapy2 7iii7 the number of patients potentially treated by such drugs2 7iv7 the value of the priority review voucher if transferred2 and 7v7 the length of time between the date on which a priority review voucher was awarded and the date on which it was used4 7,d7 ,with respect to the priority review voucher program under section #ebi of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ff7-- 7i7 the resources used by1 and burden placed on1 the ,food and ,drug ,administration in implementing such program1 including the effect of such program on the ,food and ,drug ,administration's review of drugs for which a priority review voucher was not awarded or used2 7ii7 the impact of the program on the public health as a result of the expedited review of applications for drugs that treat or prevent non-serious indications that are generally used by the broader public2 and 7iii7 alternative approaches to improving such program so that the program is appropriately targeted toward providing incentives for the development of clinically important drugs that-- 7,i7 prevent or treat rare pediatric diseases2 and 7,,ii7 would likely not otherwise have been developed to prevent or treat such diseases4 7#b7 ,report ,not later than ,december #ca1 #bjag1 the ,comptroller ,general of the ,united ,states 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 containing the results of the study of conducted under paragraph 7#a74 ,j ,domestic ,manufacturing and ,export ,efficiencies #bafa4 ,grants for studying the process of continuous drug manufacturing 7a7 ,in general ,the ,commissioner of ,food and ,drugs may award grants to institutions of higher education and nonprofit organizations for the purpose of studying and recommending improvements to the process of continuous manufacturing of drugs and biological products and similar innovative monitoring and control techniques4 7b7 ,definitions ,in this section3 7#a7 ,the term drug has the meaning given to such term in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba74 7#b7 ,the term biological product has the meaning given to such term in section #cea7;i7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;i774 7#c7 ,the term institution of higher education has the meaning given to such term in section #aja of the ,higher ,education ,act of #aife 7#bj ,u4,s4,c4 #ajja74 7c7 ,authorization of appropriations ,there is authorized to be appropriated to carry out this section #e1jjj1jjj for each of fiscal years #bjaf through #bjbj4 #bafb4 ,re-exportation among members of the ,european ,economic ,area ,section #ajjc of the ,controlled ,substances ,import and ,export ,act 7#ba ,u4,s4,c4 #iec7 is amended-- 7#a7 in subsection 7f7-- 7,a7 in paragraph 7#e7-- 7i7 by striking 7#e7 and inserting 7#e77;,a72 7ii7 by inserting 1 except that the controlled substance may be exported from the second country to another country that is a member of the ,european ,economic ,area before the period at the end2 and 7iii7 by adding at the end the following3 7,b7 ,subsequent to any re-exportation described in subparagraph 7,a71 a controlled substance may continue to be exported from any country that is a member of the ,european ,economic ,area to any other such country1 provided that-- 7i7 the conditions applicable with respect to the first country under paragraphs 7#a71 7#b71 7#c71 7#d71 7#f71 and 7#g7 are met by each subsequent country from which the controlled substance is exported pursuant to this paragraph2 and 7ii7 the conditions applicable with respect to the second country under such paragraphs are met by each subsequent country to which the controlled substance is exported pursuant to this paragraph4 2 and 7,b7 in paragraph 7#f7-- 7i7 by striking 7#f7 and inserting 7#f77;,a72 and 7ii7 by adding at the end the following3 7,b7 ,in the case of re-exportation among members of the ,european ,economic ,area1 within #cj days after each re-exportation1 the person who exported the controlled substance from the ,united ,states delivers to the ,attorney ,general-- 7i7 documentation certifying that such re-exportation has occurred2 and 7ii7 information concerning the consignee1 country1 and product4 2 and 7#b7 by adding at the end the following3 7g7 ,limitation ,subject to paragraphs 7#e7 and 7#f7 of subsection 7f7 in the case of any controlled substance in schedule ,i or ,,ii or any narcotic drug in schedule ,,iii or ,,iv1 the ,attorney ,general shall not promulgate nor enforce any regulation1 subregulatory guidance1 or enforcement policy which impedes re-exportation of any controlled substance among ,european ,economic ,area countries1 including by promulgating or enforcing any requirement that-- 7#a7 re-exportation from the first country to the second country or re-exportation from the second country to another country occur within a specified period of time2 or 7#b7 information concerning the consignee1 country1 and product be provided prior to exportation of the controlled substance from the ,united ,states or prior to each re-exportation among members of the ,european ,economic ,area4 4 ,k ,enhancing combination products review #baha4 ,enhancing combination products review ,section #ejc7;g77#d77;,c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7;g77#d77;,c77 is amended by adding at the end the following new clause3 7iii7 ,not later than #ah months after the date of the enactment of the #bast ,century ,cures ,act1 the ,secretary shall issue final guidance that describes the responsibilities of each agency center regarding its review of combination products4 ,the ,secretary shall1 after soliciting public comment1 review and update the guidance periodically4 4 ,l ,priority ,review for ,breakthrough ,devices #bbja4 ,priority review for breakthrough devices 7a7 ,in general ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended-- 7#a7 in section #eae7;d7-- 7,a7 by striking paragraph 7#e72 and 7,b7 by redesignating paragraph 7#f7 as paragraph 7#e72 and 7#b7 by inserting after section #eae;,a 7#ba ,u4,s4,c4 #cfj;e-#a7 the following3 #eae;,b4 ,priority review for breakthrough devices 7a7 ,in general ,in order to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions1 the ,secretary shall establish a program to provide priority review for devices-- 7#a7 representing breakthrough technologies2 7#b7 for which no approved alternatives exist2 7#c7 offering significant advantages over existing approved or cleared alternatives1 including the potential to1 compared to existing approved or cleared alternatives1 reduce or eliminate the need for hospitalization1 improve patient quality of life1 facilitate patients' ability to manage their own care 7such as through self-directed personal assistance71 or establish long-term clinical efficiencies2 or 7#d7 the availability of which is in the best interest of patients4 7b7 ,request for designation ,a sponsor of a device may request that the ,secretary designate the device for priority review under this section4 ,any such request for designation may be made at any time prior to the submission of an application under section #eae7;c71 a petition for classification under section #eac7;f77#b71 or a notification under section #eaj7k74 7c7 ,designation process 7#a7 ,in general ,not later than #fj calendar days after the receipt of a request under subsection 7b71 the ,secretary shall determine whether the device that is the subject of the request meets the criteria described in subsection 7a74 ,if the ,secretary determines that the device meets the criteria1 the ,secretary shall designate the device for priority review4 7#b7 ,review ,review of a request under subsection 7b7 shall be undertaken by a team that is composed of experienced staff and managers of the ,food and ,drug ,administration and is chaired by a senior manager4 7#c7 ,designation determination ,a determination approving or denying a request under subsection 7b7 shall be considered a significant decision under section #eag;,a and the ,secretary shall provide a written1 substantive summary of the basis for the determination in accordance with section #eag;,a7a74 7#d7 ,reconsideration 7,a7 ,request for reconsideration ,any person whose request under subsection 7b7 is denied may1 within #cj days of the denial1 request reconsideration of the denial in accordance with section #eag;,a7b7-- 7i7 based upon the submission of documents by such person2 or 7ii7 based upon such documents and a meeting or teleconference4 7,b7 ,response ,reconsideration of a designation determination under this paragraph shall be conducted in accordance with section #eag;,a7b74 7#e7 ,withdrawal ,if the ,secretary approves a priority review designation for a device under this section1 the ,secretary may not withdraw the designation based on the fact that the criteria specified in subsection 7a7 are no longer met because of the subsequent clearance or approval of another device that was designated under-- 7,a7 this section2 or 7,b7 section #eae7;d77#e7 7as in effect immediately prior to the enactment of the #bast ,century ,cures ,act74 7d7 ,priority review 7#a7 ,actions ,for purposes of expediting the development and review of devices designated under subsection 7c71 the ,secretary shall-- 7,a7 assign a team of staff1 including a team leader with appropriate subject matter expertise and experience1 for each device for which a request is submitted under subsection 7b72 7,b7 provide for oversight of the team by senior agency personnel to facilitate the efficient development of the device and the efficient review of any submission described in subsection 7b7 for the device2 7,c7 adopt an efficient process for timely dispute resolution2 7,d7 provide for interactive communication with the sponsor of the device during the review process2 7,e7 expedite the ,secretary's review of manufacturing and quality systems compliance1 as applicable2 7,f7 disclose to the sponsor in advance the topics of any consultation concerning the sponsor's device that the ,secretary intends to undertake with external experts or an advisory committee and provide the sponsor an opportunity to recommend such external experts2 7,g7 for applications submitted under section #eae7;c71 provide for advisory committee input1 as the ,secretary determines appropriate 7including in response to the request of the sponsor72 and 7,h7 assign staff to be available within a reasonable time to address questions posed by institutional review committees concerning the conditions and clinical testing requirements applicable to the investigational use of the device pursuant to an exemption under section #ebj7;g74 7#b7 ,additional actions ,in addition to the actions described in paragraph 7#a71 for purposes of expediting the development and review of devices designated under subsection 7c71 the ,secretary1 in collaboration with the device sponsor1 may1 as appropriate-- 7,a7 coordinate with the sponsor regarding early agreement on a data development plan2 7,b7 take steps to ensure that the design of clinical trials is as efficient as practicable1 such as through adoption of shorter or smaller clinical trials1 application of surrogate endpoints1 and use of adaptive trial designs and ,bayesian statistics1 to the extent scientifically appropriate2 7,c7 facilitate1 to the extent scientifically appropriate1 expedited and efficient development and review of the device through utilization of timely postmarket data collection1 with regard to applications for approval under section #eae7;c72 and 7,d7 agree to clinical protocols that the ,secretary will consider binding on the ,secretary and the sponsor1 subject to-- 7i7 changes agreed to by the sponsor and the ,secretary2 7ii7 changes that the ,secretary determines are required to prevent an unreasonable risk to the public health2 or 7iii7 the identification of a substantial scientific issue determined by the ,secretary to be essential to the safety or effectiveness of the device involved4 7e7 ,priority review guidance 7#a7 ,content ,the ,secretary shall issue guidance on the implementation of this section4 ,such guidance shall include the following3 7,a7 ,the process for a person to seek a priority review designation4 7,b7 ,a template for requests under subsection 7b74 7,c7 ,the criteria the ,secretary will use in evaluating a request for priority review4 7,d7 ,the standards the ,secretary will use in assigning a team of staff1 including team leaders1 to review devices designated for priority review1 including any training required for such personnel on effective and efficient review4 7#b7 ,process ,prior to finalizing the guidance under paragraph 7#a71 the ,secretary shall propose such guidance for public comment4 7f7 ,construction 7#a7 ,purpose ,this section is intended to encourage the ,secretary and provide the ,secretary sufficient authorities to apply efficient and flexible approaches to expedite the development of1 and prioritize the agency's review of1 devices that represent breakthrough technologies4 7#b7 ,construction ,nothing in this section shall be construed to alter the criteria and standards for evaluating an application pursuant to section #eae7;c71 a report and request for classification under section #eac7;f77#b71 or a report under section #eaj7k71 including the recognition of valid scientific evidence as described in section #eac7;a77#c77;,b71 and consideration of the least burdensome means of evaluating device effectiveness or demonstrating substantial equivalence between devices with differing technological characteristics1 as applicable4 ,nothing in this section alters the authority of the ,secretary to act on an application pursuant to section #eae7;d7 before completion of an establishment inspection1 as the ,secretary deems appropriate4 4 7b7 ,conforming amendment related to designation determinations ,section #eag;,a7a77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;g-#a7;a77#a77 is amended by inserting a request for designation under section #eae;,b1 after an application under section #eae14 ,m ,medical ,device ,regulatory ,process ,improvements #bbba4 ,third-party quality system assessment 7a7 ,establishment of third-,party quality system assessment program ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended by inserting after section #ebd;,a 7#ba ,u4,s4,c4 #cfjn-#a7 the following new section3 #ebd;,b4 ,third-party quality system assessment 7a7 ,accreditation and assessment 7#a7 ,in general2 certification of device quality system ,the ,secretary shall1 in accordance with this section1 establish a third-party quality system assessment program-- 7,a7 to accredit persons to assess whether a requestor's quality system1 including its design controls1 can reasonably assure the safety and effectiveness of in-scope devices subject to device-related changes2 7,b7 under which accredited persons shall 7as applicable7 certify that a requestor's quality system meets the criteria included in the guidance issued under paragraph 7#e7 with respect to the in-scope devices at issue2 and 7,c7 under which the ,secretary shall rely on such certifications for purposes of determining the safety and effectiveness 7or as applicable1 substantial equivalence7 of in-scope devices subject to the device-related changes involved1 in lieu of compliance with the following submission requirements3 7i7 ,a premarket notification4 7ii7 ,a #cj-;day notice4 7iii7 ,a ,special ,,pma supplement4 7#b7 ,definitions ,for purposes of this section 7,a7 the term device-related changes means changes made by a requestor with respect to in-scope devices1 which are-- 7i7 changes to a device found to be substantially equivalent under sections #eac7;i7 and #eaj7k7 to a predicate device1 that-- 7,i7 would otherwise be subject to a premarket notification2 and 7,,ii7 do not alter-- 7aa7 the intended use of the changed device2 or 7bb7 the fundamental scientific technology of such device2 7ii7 manufacturing changes subject to a #cj-;day notice2 7iii7 changes that qualify for a ,special ,,pma ,supplement2 and 7iv7 such other changes relating to the devices or the device manufacturing process as the ,secretary determines appropriate2 7,b7 the term in-scope device means a device within the scope of devices agreed to by the requestor and the accredited person for purposes of a request for certification under this section2 7,c7 the term premarket notification means a premarket notification under section #eaj7k72 7,d7 the term quality system means the methods used in1 and the facilities and controls used for1 the design1 manufacture1 packaging1 labeling1 storage1 installation1 and servicing of devices1 as described in section #ebj7;f72 7,e7 the term requestor means a device manufacturer that is seeking certification under this section of a quality system used by such manufacturer2 7,f7 the term ,special ,,pma means a ,special ,,pma supplement under section #had4ci7;d7 of title #ba1 ,code of ,federal ,regulations 7or any successor regulations72 and 7,g7 the term #cj-;day notice means a notice described in section #eae7;d77#f74 7#c7 ,accreditation process2 accreditation renewal ,except as inconsistent with this section1 the process and qualifications for accreditation of persons and renewal of such accreditation under section #gjd7;g7 shall apply with respect to accreditation of persons and renewal of such accreditation under this section4 7#d7 ,use of accredited parties to conduct assessments 7,a7 ,initiation of assessment services 7i7 ,date assessments authorized ,beginning after the date on which the final guidance is issued under paragraph 7#e71 an accredited person may conduct an assessment under this section4 7ii7 ,initiation of assessments ,use of one or more accredited persons to assess a requestor's quality system under this section with respect to in-scope devices shall be at the initiation of the person who registers and lists the devices at issue under section #eaj4 7,b7 ,compensation ,compensation for such accredited persons shall-- 7i7 be determined by agreement between the accredited person and the person who engages the services of the accredited person2 and 7ii7 be paid by the person who engages such services4 7,c7 ,accredited person selection ,each person who chooses to use an accredited person to assess a requestor's quality system1 as described in this section1 shall select the accredited person from a list of such persons published by the ,secretary in accordance with section #gjd7;g77#d74 7#e7 ,guidance2 criteria for certification 7,a7 ,in general ,the criteria for certification of a quality system under this section shall be as specified by the ,secretary in guidance issued under this paragraph4 7,b7 ,contents2 criteria ,the guidance under this paragraph shall include specification of-- 7i7 evaluative criteria to be used by an accredited person to assess and1 as applicable1 certify a requestor's quality system under this section with respect to in-scope devices2 and 7ii7 criteria for accredited persons to apply for a waiver of1 and exemptions from1 the criteria under clause 7i74 7,c7 ,timeframe for issuing guidance ,the ,secretary shall issue under this paragraph-- 7i7 draft guidance not later than #ab months after the enactment of the #bast ,century ,cures ,act2 and 7ii7 final guidance not later than #ab months after issuance of the draft guidance under clause 7i74 7b7 ,use of third-,party assessment 7#a7 ,assessment summary2 certification 7,a7 ,submission of assessment to secretary ,an accredited person who assesses a requestor's quality system under subsection 7a7 shall submit to the ,secretary a summary of the assessment-- 7i7 within #cj days of the assessment2 and 7ii7 which shall include 7as applicable7-- 7,i7 the accredited person's certification that the requestor has satisfied the criteria specified in the guidance issued under subsection 7a77#e7 for quality system certification with respect to the in-scope devices at issue2 and 7,,ii7 any waivers or exemptions from such criteria applied by the accredited person4 7,b7 ,treatment of assessments ,subject to action by the ,secretary under subparagraph 7,c71 with respect to assessments which include a certification under this section-- 7i7 the ,secretary's review of the assessment summary shall be deemed complete on the day that is #cj days after the date on which the ,secretary receives the summary under subparagraph 7,a72 and 7ii7 the assessment summary and certification of the quality system of a requestor shall be deemed accepted by the ,secretary on such #cjth day4 7,c7 ,actions by secretary 7i7 ,in general ,within #cj days of receiving an assessment summary and certification under subparagraph 7,a71 the ,secretary may1 by written notice to the accredited person submitting such assessment certification1 deem any such certification to be provisional beyond such #cj-;day period1 suspended pending further review by the ,secretary1 or otherwise qualified or cancelled1 based on the ,secretary's determination that 7as applicable7-- 7,i7 additional information is needed to support such certification2 7,,ii7 such assessment or certification is unwarranted2 or 7,,iii7 such action with regard to the certification is otherwise justified according to such factors and criteria as the ,secretary finds appropriate4 7ii7 ,acceptance of certification ,if following action by the ,secretary under clause 7i7 with respect to a certification1 the ,secretary determines that such certification is acceptable1 the ,secretary shall issue written notice to the applicable accredited person indicating such acceptance4 7#b7 ,notifications to ,secretary by certified requestors or accredited persons for program evaluation purposes 7,a7 ,annual summary report for device-related changes otherwise subject to premarket notification ,a requestor whose quality system is certified under this section that effectuates device-related changes with respect to in-scope devices1 without prior submission of a premarket notification1 shall ensure that an annual summary report is submitted to the ,secretary by the accredited person which-- 7i7 describes the changes made to the in-scope device2 and 7ii7 indicates the effective dates of such changes4 7,b7 ,periodic notification for manufacturing changes otherwise subject to #cj-;day notice ,a requestor whose quality system is certified under this section that effectuates device-related changes with respect to in-scope devices1 without prior submission of a #cj-;day notice1 shall provide notification to the ,secretary of such changes in the requestor's next periodic report under section #had4hd7;b7 of title #ba1 ,code of ,federal ,regulations 7or any successor regulation74 ,such notification shall-- 7i7 describe the changes made2 and 7ii7 indicate the effective dates of such changes4 7,c7 ,periodic notification for device-related changes otherwise subject to special pma supplement ,a requestor whose quality system is certified under this section that effectuates device-related changes with respect to in-scope devices1 without prior submission of a ,special ,,pma ,supplement1 shall provide notification to the ,secretary of such changes in the requestor's next periodic report under section #had4hd7;b7 of title #ba1 ,code of ,federal ,regulations 7or any successor regulation74 ,such notification shall-- 7i7 describe the changes made1 including a full explanation of the basis for the changes2 and 7ii7 indicate the effective dates of such changes4 7,d7 ,use of notifications for program evaluation purposes ,information submitted to the ,secretary under subparagraphs 7,a7 through 7,c7 shall be used by the ,secretary for purposes of the program evaluation under subsection 7d74 7c7 ,duration and effect of certification ,a certification under this section-- 7#a7 shall remain in effect for a period of #b years from the date such certification is accepted by the ,secretary1 subject to paragraph 7#f72 7#b7 may be renewed through the process described in subsection 7a77#c72 7#c7 shall continue to apply with respect to device-related changes made during such #b-year period1 provided the certification remains in effect1 irrespective of whether such certification is renewed after such #b-year period2 7#d7 shall have no effect on the need to comply with applicable submission requirements specified in subsection 7a77#a77;,c7 with respect to any change pertaining to in-scope devices which is not a device-related change under subsection 7a77#b72 7#e7 shall have no effect on the authority of the ,secretary to conduct an inspection or otherwise determine whether the requestor has complied with the applicable requirements of this ,act2 and 7#f7 may be revoked by the ,secretary upon a determination that the requestor's quality system no longer meets the criteria specified in the guidance issued under subsection 7a77#e7 with respect to the in-scope devices at issue4 7d7 ,notice of revocation ,the ,secretary shall provide written notification to the requestor of a revocation pursuant to subsection 7c77#f7 not later than #aj business days after the determination described in such subsection4 ,upon receipt of the written notification1 the requestor shall satisfy the applicable submission requirements specified in subsection 7a77#a77;,c7 for any device-related changes effectuated after the date of such determination4 ,after such revocation1 such requestor is eligible to seek re-certification under this section of its quality system4 7e7 ,program evaluation2 sunset 7#a7 ,program evaluation and report 7,a7 ,evaluation ,the ,secretary shall complete an evaluation of the third-party quality system assessment program under this section no later than ,january #ca1 #bjba1 based on-- 7i7 analysis of information from a representative group of device manufacturers obtained from notifications provided by certified requestors or accredited persons under subsection 7b77#b72 and 7ii7 such other available information and data as the ,secretary determines appropriate4 7,b7 ,report ,no later than #a year after completing the evaluation under subparagraph 7,a71 the ,secretary shall issue a report of the evaluation's findings on the website of the ,food and ,drug ,administration1 which shall include the ,secretary's recommendations with respect to continuation and as applicable expansion of the program under this section to encompass-- 7i7 device submissions beyond those identified in subsection 7a77#a77;,c72 and 7ii7 device changes beyond those described in subsection 7a77#b77;,a74 7#b7 ,sunset ,this section shall cease to be effective ,october #a1 #bjbb4 7f7 ,rule of construction ,nothing in this section shall be construed to limit the authority of the ,secretary to request and review the complete assessment of a certified requestor under this section on a for-cause basis4 4 7b7 ,conforming amendments 7#a7 ,requirements for premarket approval supplements ,section #eae7;d77#e77;,a77i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e7d77#e77;,a77i771 as redesignated by section #bbja1 is further amended by inserting 1 subject to section #ebd;,b after that affects safety or effectiveness4 7#b7 ,requirements for #cj-;day notice ,section #eae7;d77#e77;,a77ii7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e7d77#e77;,a77ii771 as redesignated by section #bbja1 is further amended by inserting 1 subject to section #ebd;,b after the date on which the ,secretary receives the notice4 7#c7 ,requirements for premarket notification2 technical correction to reference to section #eaj7k7 ,section #eaj7l7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7l77 is amended by striking of this subsection under subsection 7m7 and inserting of subsection 7k7 under subsection 7m7 or section #ebd;,b4 7#d7 ,misbranded devices ,section #ejb7t7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7t77 is amended by inserting or #ebd;,b after section #eai4 #bbbb4 ,valid scientific evidence ,section #eac7;a77#c77;,b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;c7a77#c77;,b77 is amended-- 7#a7 by redesignating clauses 7i7 and 7ii7 as subclauses 7,i7 and 7,,ii71 respectively2 7#b7 by striking 7,b7 ,if the ,secretary and inserting 7,b77i7 ,if the ,secretary2 and 7#c7 by adding at the end the following3 7ii7 ,for purposes of clause 7i71 valid scientific evidence may include-- 7,i7 evidence described in well-documented case histories1 including registry data1 that are collected and monitored under a protocol determined to be acceptable by the ,secretary2 7,,ii7 studies published in peer-reviewed journals2 and 7,,iii7 data collected in countries other than the ,united ,states so long as such data otherwise meet the criteria specified in this subparagraph4 7iii7 ,in the case of a study published in a peer-reviewed journal that is offered as valid scientific evidence for purposes of clause 7i71 the ,secretary may request data underlying the study if-- 7,i7 the ,secretary1 in making such request1 complies with the requirement of subparagraph 7,d77ii7 to consider the least burdensome appropriate means of evaluating device effectiveness or subsection 7i77#a77;,d7 to consider the least burdensome means of determining substantial equivalence1 as applicable2 7,,ii7 the ,secretary furnishes a written rationale for so requesting the underlying data together with such request2 and 7,,iii7 if the requested underlying data for such a study are unavailable1 the ,secretary shall consider such study to be part of the totality of the evidence with respect to the device1 as the ,secretary determines appropriate4 4 #bbbc4 ,training and oversight in least burdensome appropriate means concept 7a7 ,in general ,section #eac of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;c7 is amended by adding at the end the following3 7j7 ,training and oversight in least burdensome appropriate means concept 7#a7 ,training ,each employee of the ,food and ,drug ,administration who is involved in the review of premarket submissions under section #eae or section #eaj7k71 including supervisors1 shall receive training regarding the meaning and implementation of the least burdensome appropriate means concept in the context of the use of that term in subsections 7a77#c77;,d7 and 7i77#a77;,d7 of this section and in section #eae7;c77#e74 7#b7 ,guidance documents 7,a7 ,draft updated guidance ,not later than #ab months after the date of enactment of the #bast ,century ,cures ,act1 the ,secretary shall issue a draft guidance document updating the ,october #d1 #bjjb1 guidance document entitled ,the ,least ,burdensome ,provision of the ,,fda ,modernization ,act of #aiig3 ,concept and ,principles2 ,final ,guidance for ,,fda and ,industry4 7,b7 ,meeting of stakeholders ,in developing such draft guidance document1 the ,secretary shall convene a meeting of stakeholders to ensure a full record to support the publication of such document4 7#c7 ,ombudsman audit ,not later than #ah months after the date of issuance of final version of the draft guidance under paragraph 7#b71 the ombudsman for the organizational unit of the ,food and ,drug ,administration responsible for the premarket review of devices shall-- 7,a7 conduct1 or have conducted1 an audit of the training described in paragraph 7#a72 and 7,b7 include in such audit interviews with a representative sample of persons from industry regarding their experience in the device premarket review process4 4 7b7 ,additional information regarding premarket applications ,subsection 7c7 of section #eae of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e7 is amended by adding at the end the following3 7#e7 7,a7 ,whenever the ,secretary requests additional information from an applicant regarding an application under paragraph 7#a71 the ,secretary shall consider the least burdensome appropriate means necessary to demonstrate device safety and effectiveness1 and request information accordingly4 7,b7 ,for purposes of subparagraph 7,a71 the term necessary means the minimum required information that would support a determination by the ,secretary that an application provides a reasonable assurance of the safety and effectiveness of the device4 7,c7 ,nothing in this paragraph alters the standards for premarket approval of a device4 4 #bbbd4 ,recognition of standards ,section #ead7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;d7c77 is amended-- 7#a7 in paragraph 7#a71 by inserting after subparagraph 7,b7 the following new subparagraphs3 7,c7 7i7 ,any person may submit a request for recognition under subparagraph 7,a7 of all or part of an appropriate standard established by a nationally or internationally recognized standard organization4 7ii7 ,not later than #fj days after the ,secretary receives such a request1 the ,secretary shall-- 7,i7 make a determination to recognize all1 part1 or none of the standard that is the subject of the request2 and 7,,ii7 issue to the person who submitted such request a response in writing that states the ,secretary's rationale for that determination1 including the scientific1 technical1 regulatory1 or other basis for such determination4 7iii7 ,the ,secretary shall make a response issued under clause 7ii77,,ii7 publicly available1 in such manner as the ,secretary determines appropriate4 7iv7 ,the ,secretary shall take such actions as may be necessary to implement all or part of a standard recognized under clause 7i77,i71 in accordance with subparagraph 7,a74 7,d7 ,the ,secretary shall make publicly available1 in such manner as the ,secretary determines appropriate1 the rationale for recognition under subparagraph 7,a7 of part of a standard1 including the scientific1 technical1 regulatory1 or other basis for such recognition4 2 and 7#b7 by adding at the end the following new paragraphs3 7#d7 ,training on use of standards ,the ,secretary shall provide to all employees of the ,food and ,drug ,administration who review premarket submissions for devices periodic training on the concept and use of recognized standards for purposes of meeting a premarket submission requirement or other applicable requirement under this ,act1 including standards relevant to an employee's area of device review4 7#e7 ,guidance 7,a7 ,draft guidance ,the ,secretary shall publish guidance identifying the principles for recognizing standards under this section4 ,in publishing such guidance1 the ,secretary shall consider-- 7i7 the experience with1 and reliance on1 a standard by other ,federal regulatory authorities and the device industry2 and 7ii7 whether recognition of a standard will promote harmonization among regulatory authorities in the regulation of devices4 7,b7 ,timing ,the ,secretary shall publish-- 7i7 draft guidance under subparagraph 7,a7 not later than #ab months after the date of the enactment of the #bast ,century ,cures ,act2 and 7ii7 final guidance not later than #ab months after the close of the public comment period for the draft guidance under clause 7i74 4 #bbbe4 ,easing regulatory burden with respect to certain class ,i and class ,,ii devices 7a7 ,class ,i devices ,section #eaj7l7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7l77 is amended-- 7#a7 by striking ,a report under subsection 7k7 and inserting 7#a7 ,a report under subsection 7k72 and 7#b7 by adding at the end the following new paragraph3 7#b7 ,not later than #abj days after the date of the enactment of the #bast ,century ,cures ,act1 the ,secretary shall identify1 through publication in the ,federal ,register1 any type of class ,i device that the ,secretary determines no longer requires a report under subsection 7k7 to provide reasonable assurance of safety and effectiveness4 ,upon such publication-- 7,a7 each type of class ,i device so identified shall be exempt from the requirement for a report under subsection 7k72 and 7,b7 the classification regulation applicable to each such type of device shall be deemed amended to incorporate such exemption4 4 7b7 ,class ,,ii devices ,section #eaj7m7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7m77 is amended-- 7#a7 by striking paragraph 7#a7 and inserting the following new paragraph3 7#a7 ,the ,secretary shall-- 7,a7 not later than #fj days after the date of the enactment of the #bast ,century ,cures ,act-- 7i7 publish in the ,federal ,register a notice that contains a list of each type of class ,,ii device that the ,secretary determines no longer requires a report under subsection 7k7 to provide reasonable assurance of safety and effectiveness2 and 7ii7 provide for a period of not less than #fj days for public comment beginning on the date of the publication of such notice2 and 7,b7 not later than #ahj days after the date of the enactment of #bast ,century ,cures ,act1 publish in the ,federal ,register a list representing the ,secretary's final determination with respect to the devices included in the list published under subparagraph 7,a74 2 7#b7 in paragraph 7#b7-- 7,a7 by striking #a day after the date of the publication of a list under this subsection1 and inserting #a day after the date of publication of the final list under paragraph 7#a77;,b712 and 7,b7 by striking #cj-;day period and inserting #fj-;day period2 and 7#c7 by adding at the end the following new paragraph3 7#c7 ,upon the publication of the final list under paragraph 7#a77;,b7-- 7,a7 each type of class ,,ii device so listed shall be exempt from the requirement for a report under subsection 7k72 and 7,b7 the classification regulation applicable to each such type of device shall be deemed amended to incorporate such exemption4 4 #bbbf4 ,advisory committee process 7a7 ,classification panels ,paragraph 7#e7 of section #eac7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;c7b77 is amended-- 7#a7 by striking 7#e7 and inserting 7#e77;,a72 and 7#b7 by adding at the end the following3 7,b7 ,when a device is specifically the subject of review by a classification panel1 the ,secretary shall-- 7i7 ensure that adequate expertise is represented on the classification panel to assess-- 7,i7 the disease or condition which the device is intended to cure1 treat1 mitigate1 prevent1 or diagnose2 and 7,,ii7 the technology of the device2 and 7ii7 as part of the process to ensure adequate expertise under clause 7i71 give due consideration to the recommendations of the person whose premarket submission is subject to panel review on the expertise needed among the voting members of the panel4 7,c7 ,for purposes of subparagraph 7,b77ii71 the term adequate expertise means1 with respect to the membership of the classification panel reviewing a premarket submission1 that such membership includes-- 7i7 two or more voting members1 with a specialty or other expertise clinically relevant to the device under review2 and 7ii7 at least one voting member who is knowledgeable about the technology of the device4 4 7b7 ,panel review process ,section #eac7;b77#f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;c7b77#f77 is amended-- 7#a7 in subparagraph 7,a77iii71 by inserting before the period at the end 1 including by designating a representative who will be provided a time during the panel meeting to address the panel individually 7or accompanied by experts selected by such representative7 for the purpose of correcting misstatements of fact or providing clarifying information1 subject to the discretion of the panel chairperson2 and 7#b7 by striking subparagraph 7,b7 and inserting the following new subparagraph3 7,b7 7i7 ,any meeting of a classification panel for a device that is specifically the subject of review shall-- 7,i7 provide adequate time for initial presentations by the person whose device is specifically the subject of a classification panel review and by the ,secretary2 and 7,,ii7 encourage free and open participation by all interested persons4 7ii7 ,following the initial presentations described in clause 7i71 the panel may-- 7,i7 pose questions to a designated representative described in subparagraph 7,a77iii72 and 7,,ii7 consider the responses to such questions in the panel's review of the device that is specifically the subject of review by the panel4 4 #bbbg4 ,humanitarian device exemption application 7a7 ,in general ,section #ebj7m7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7 is amended-- 7#a7 in paragraph 7#a7 by striking fewer than #d1jjj and inserting not more than #h1jjj2 7#b7 in paragraph 7#b77;,a7 by striking fewer than #d1jjj and inserting not more than #h1jjj2 and 7#c7 in paragraph 7#f77;,a77ii71 by striking #d1jjj and inserting #h1jjj4 7b7 ,guidance document on probable benefit ,not later than #ah months after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall publish a draft guidance document that defines the criteria for establishing probable benefit as that term is used in section #ebj7m77#b77;,c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7m77#b77;,c774 #bbbh4 ,,clia waiver study design guidance for in vitro diagnostics 7a7 ,draft revised guidance ,not later than #ab months after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall publish a draft guidance that-- 7#a7 revises ,section ,v4 ,demonstrating ,insignificant ,risk of an ,erroneous ,result--,accuracy of the guidance entitled ,recommendations for ,clinical ,laboratory ,improvement ,amendments of #aihh 7,,clia7 ,waiver ,applications for ,manufacturers of ,in ,vitro ,diagnostic ,devices and dated ,january #cj1 #bjjh2 and 7#b7 includes guidance on the appropriate use of comparable performance between a waived user and a moderately complex laboratory user to demonstrate accuracy4 7b7 ,final revised guidance ,the ,secretary of ,health and ,human ,services shall finalize the draft guidance published under subsection 7a7 not later than #ab months after the comment period for such draft guidance closes4 ,n ,sensible ,oversight for ,technology ,which ,advances ,regulatory ,efficiency #bbda4 ,health software ,section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7 is amended by adding at the end the following3 7ss7 7#a7 ,the term health software means software that does not1 through use of an in vitro diagnostic device or signal acquisition system1 acquire1 process1 or analyze an image or physiological signal1 is not an accessory1 is not an integral part of a device necessary to support the use of the device1 is not used in the manufacture and transfusion of blood and blood components to assist in the prevention of disease in humans1 and-- 7,a7 is intended for use for administrative or operational support or the processing and maintenance of financial records2 7,b7 is intended for use in clinical1 laboratory1 or administrative workflow and related recordkeeping2 7,c7 7i7 is intended for use solely in the transfer1 aggregation1 conversion 7in accordance with a present specification71 storage1 management1 retrieval1 or transmission of data or information2 7ii7 utilizes a connectivity software platform1 electronic or electrical hardware1 or a physical communications infrastructure2 and 7iii7 is not intended for use-- 7,i7 in active patient monitoring2 or 7,,ii7 in controlling or altering the functions or parameters of a device that is connected to such software2 7,d7 is intended for use to organize and present information for health or wellness education or for use in maintaining a healthy lifestyle1 including medication adherence and health management tools2 7,e7 is intended for use to analyze information to provide general health information that does not include patient-specific recommended options to consider in the prevention1 diagnosis1 treatment1 cure1 or mitigation of a particular disease or condition2 or 7,f7 is intended for use to analyze information to provide patient-specific recommended options to consider in the prevention1 diagnosis1 treatment1 cure1 or mitigation of a particular disease or condition4 7#b7 ,the term accessory means a product that-- 7,a7 is intended for use with one or more parent devices2 7,b7 is intended to support1 supplement1 or augment the performance of one or more parent devices2 and 7,c7 shall be classified by the ,secretary-- 7i7 according to its intended use2 and 7ii7 independently of any classification of any parent device with which it is used4 4 #bbdb4 ,applicability and inapplicability of regulation ,subchapter ,a of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq471 as amended by section #bbba7;a71 is further amended by adding at the end the following3 #ebd;,c4 ,health software 7a7 ,inapplicability of regulation to health software ,except as provided in subsection 7b71 health software shall not be subject to regulation under this ,act4 7b7 ,exception 7#a7 ,in general ,subsection 7a7 shall not apply with respect to a software product-- 7,a7 of a type described in subparagraph 7,f7 of section #bja7ss77#a72 and 7,b7 that the ,secretary determines poses a significant risk to patient safety4 7#b7 ,considerations ,in making a determination under subparagraph 7,b7 of paragraph 7#a7 with respect to a product to which such paragraph applies1 the ,secretary shall consider the following3 7,a7 ,the likelihood and severity of patient harm if the product were to not perform as intended4 7,b7 ,the extent to which the product is intended to support the clinical judgment of a medical professional4 7,c7 ,whether there is a reasonable opportunity for a medical professional to review the basis of the information or treatment recommendation provided by the product4 7,d7 ,the intended user and user environment1 such as whether a medical professional will use a software product of a type described in subparagraph 7,f7 of section #bja7ss77#a74 7c7 ,delegation ,the ,secretary shall delegate primary jurisdiction for regulating a software product determined under subsection 7b7 to be subject to regulation under this ,act to the center at the ,food and ,drug ,administration charged with regulating devices4 7d7 ,regulation of software 7#a7 ,in general ,the ,secretary shall review existing regulations and guidance regarding the regulation of software under this ,act4 ,the ,secretary may implement a new framework for the regulation of software and shall1 as appropriate1 modify such regulations and guidance or issue new regulations or guidance4 7#b7 ,issuance by order ,notwithstanding subchapter ,,ii of chapter #e of title #e1 ,united ,states ,code1 the ,secretary may modify or issue regulations for the regulation of software under this ,act by administrative order published in the ,federal ,register following the publication of a proposed order4 7#c7 ,areas under review ,the review of existing regulations and guidance under paragraph 7#a7 may include review of the following areas3 7,a7 ,classification of software4 7,b7 ,standards for development of software4 7,c7 ,standards for validation and verification of software4 7,d7 ,review of software4 7,e7 ,modifications to software4 7,f7 ,manufacturing of software4 7,g7 ,quality systems for software4 7,h7 ,labeling requirements for software4 7,i7 ,postmarketing requirements for reporting of adverse events4 7#d7 ,process for issuing proposed regulations1 administrative order1 and guidance ,not later than #ah months after the date of enactment of this section1 the ,secretary shall consult with external stakeholders 7including patients1 industry1 health care providers1 academia1 and government7 to gather input before issuing regulations1 an administrative order1 and guidance under this subsection4 7e7 ,rule of construction ,nothing in this section shall be construed as providing the ,secretary with the authority to regulate under this ,act any health software product of the type described in subparagraph 7,f7 of section #bja7ss77#a7 unless and until the ,secretary has made a determination described in subsection 7b77#a77;,b7 with respect to such product4 4 #bbdc4 ,exclusion from definition of device ,section #bja7;h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7 is amended-- 7#a7 in subparagraph 7#b71 by striking or after or other animals12 7#b7 in subparagraph 7#c71 by striking and and inserting or2 and 7#c7 by inserting after subparagraph 7#c7 the following3 7#d7 not health software 7other than software determined to be a risk to patient safety under section #ebd;,b7b771 and 4 ,o ,streamlining ,clinical ,trials #bbfa4 ,protection of human subjects in research2 applicability of rules 7a7 ,in general ,in order to simplify and facilitate compliance by researchers with applicable regulations for the protection of human subjects in research1 the ,secretary of ,health and ,human ,services shall1 to the extent possible and consistent with other statutory provisions1 harmonize differences between the ,,hhs ,human ,subject ,regulations and the ,,fda ,human ,subject ,regulations in accordance with subsection 7b74 7b7 ,avoiding regulatory duplication and unnecessary delays 7#a7 ,in general ,the ,secretary shall-- 7,a7 make such modifications to the provisions of the ,,hhs ,human ,subject ,regulations1 the ,,fda ,human ,subject ,regulations1 and the vulnerable-populations rules as may be necessary-- 7i7 to reduce regulatory duplication and unnecessary delays2 7ii7 to modernize such provisions in the context of multisite and cooperative research projects2 and 7iii7 to incorporate local considerations1 community values1 and mechanisms to protect vulnerable populations2 and 7,b7 ensure that human subject research that is subject to the ,,hhs ,human ,subject ,regulations or to the ,,fda ,human ,subject ,regulations may-- 7i7 use joint or shared review2 7ii7 rely upon the review of-- 7,i7 an independent institutional review board2 or 7,,ii7 an institutional review board of an entity other than the sponsor of the research2 or 7iii7 use similar arrangements to avoid duplication of effort4 7#b7 ,regulations and guidance ,not later than #cf months after the date of enactment of this ,act1 the ,secretary1 acting through the relevant agencies and offices of the ,department of ,health and ,human ,services1 including the ,office for ,human ,research ,protections and relevant agencies and offices of the ,food and ,drug ,administration1 shall issue such regulations and guidance and take such other actions as may be necessary to implement this section and help to facilitate the broader use of single1 central1 or lead institutional review boards4 ,such regulations and guidance shall clarify the requirements and policies relating to the following3 7,a7 ,arrangements to avoid duplication described in paragraph 7#a77;,a77i71 including-- 7i7 delineating the roles of institutional review boards in multisite or cooperative1 multisite studies where one or more local institutional review boards are relied upon1 or similar arrangements are used2 7ii7 the risks and benefits to human subjects2 7iii7 standardizing the informed consent and other processes and legal documents2 and 7iv7 incorporating community values through the use of local institutional review boards while continuing to use central or lead institutional review boards4 7,b7 ,concerns about regulatory and legal liability contributing to decisions by the sponsors of research to rely on local institutional review boards for multisite research4 7#c7 ,consultation ,in issuing regulations or guidance under paragraph 7#b71 the ,secretary shall consult with stakeholders 7including researchers1 academic organizations1 hospitals1 institutional research boards1 pharmaceutical1 biotechnology and medical device developers1 clinical research organizations1 patient groups1 and others74 7c7 ,timing ,the ,secretary shall complete the harmonization described in subsection 7a7 not later than #cf months after the date of enactment of this ,act4 7d7 ,progress report ,not later than #bd months after the date of enactment of this ,act1 the ,secretary shall submit to ,congress a report on the progress made toward completing such harmonization4 7e7 ,draft ,,nih policy ,not later than #ab months after the date of enactment of this ,act1 the ,secretary1 acting through the ,director of the ,national ,institutes of ,health1 shall finalize the draft policy entitled ,draft ,,nih ,policy on ,use of a ,single ,institutional ,review ,board for ,multi-,site ,research4 7f7 ,definitions 7#a7 ,human subject regulations ,in this section3 7,a7 ,,fda human subject regulations ,the term ,,fda ,human ,subject ,regulations means the provisions of parts #ej1 #ef1 #cab1 and #hab of title #ba1 ,code of ,federal ,regulations 7or any successor regulations74 7,b7 ,,hhs human subject regulations ,the term ,,hhs ,human ,subject ,regulations means the provisions of subpart ,a of part #df of title #de1 ,code of ,federal ,regulations 7or any successor regulations74 7,c7 ,vulnerable-populations rules ,the term vulnerable-populations rules-- 7i7 subject to clause 7ii71 means the provisions of subparts ,b through ,d of such part #df 7or any successor regulations72 or 7ii7 as applicable to research that is subject to the ,,fda ,human ,subject ,regulations1 means the provisions applicable to vulnerable populations under part #ef of such title #ba 7or any successor regulations7 and subpart ,d of part #ej of such title #ba 7or any successor regulations74 7#b7 ,other definitions ,in this section3 7,a7 ,institutional review board ,the term institutional review board has the meaning that applies to the term institutional review board under the ,,hhs ,human ,subject ,regulations4 7,b7 ,lead institutional review board ,the term lead institutional review board means an institutional review board that otherwise meets the requirements of the ,,hhs ,human ,subject ,regulations and enters into a written agreement with an institution1 another institutional review board1 a sponsor1 or a principal investigator to approve and oversee human subject research that is conducted at multiple locations4 ,references to an institutional review board include an institutional review board that serves a single institution as well as a lead institutional review board4 #bbfb4 ,use of non-local institutional review boards for review of investigational device exemptions and human device exemptions 7a7 ,in general ,section #ebj of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7;j77 is amended-- 7#a7 in subsection 7g77#c7-- 7,a7 by striking local each place it appears2 and 7,b7 in subparagraph 7,a77i71 by striking which has been2 and 7#b7 in subsection 7m77#d7-- 7,a7 by striking local each place it appears2 and 7,b7 by striking subparagraph 7,a7 and inserting the following new subparagraph3 7,a7 in facilities in which clinical testing of devices is supervised by an institutional review committee established in accordance with the regulations of the ,secretary1 and 4 7b7 ,regulations ,not later than #ab months after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall revise or issue such regulations or guidance as may be necessary to carry out the amendments made by subsection 7a74 #bbfc4 ,alteration or waiver of informed consent for clinical investigations 7a7 ,devices ,section #ebj7;g77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7g77#c77 is amended-- 7#a7 in subparagraph 7,d71 by striking except where subject to such conditions as the ,secretary may prescribe1 the investigator and inserting the following3 except where1 subject to such conditions as the ,secretary may prescribe-- 7i7 the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights1 safety1 and welfare of the human subject2 or 7ii7 the investigator 2 and 7#b7 in the matter following subparagraph 7,d71 by striking subparagraph 7,d7 and inserting subparagraph 7,d77ii74 7b7 ,drugs ,section #eje7;i77#d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;i77#d77 is amended by striking except where it is not feasible or it is contrary to the best interests of such human beings and inserting except where it is not feasible1 it is contrary to the best interests of such human beings1 or the proposed clinical testing poses no more than minimal risk to such human beings and includes appropriate safeguards as prescribed to protect the rights1 safety1 and welfare of such human beings4 ,p ,improving ,scientific ,expertise and ,outreach at ,,fda #bbha4 ,silvio ,o4 ,conte ,senior ,biomedical ,research ,service 7a7 ,hiring and retention authority ,section #bbh of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bcg7 is amended-- 7#a7 in the section heading1 by inserting and ,biomedical ,product ,assessment after ,research2 7#b7 in subsection 7a77#a71 by striking ,silvio ,o4 ,conte ,senior ,biomedical ,research ,service1 not to exceed #ejj members and inserting ,silvio ,o4 ,conte ,senior ,biomedical ,research and ,biomedical ,product ,assessment ,service 7in this section referred to as the ,service71 the purpose of which is to recruit and retain competitive and qualified scientific and technical experts outstanding in the field of biomedical research1 clinical research evaluation1 and biomedical product assessment2 7#c7 by amending subsection 7a77#b7 to read as follows3 7#b7 ,the authority established in paragraph 7#a7 may not be construed to require the ,secretary to reduce the number of employees serving under any other employment system in order to offset the number of members serving in the ,service4 2 7#d7 in subsection 7b7-- 7,a7 in the matter preceding paragraph 7#a71 by striking or clinical research evaluation and inserting 1 clinical research evaluation or biomedical product assessment2 and 7,b7 in paragraph 7#a71 by inserting or a master's level degree in engineering1 bioinformatics1 or a related or emerging field1 after the comma2 7#e7 in subsection 7d77#b71 by striking and shall not exceed the rate payable for level ,i of the ,executive ,schedule unless approved by the ,president under section #ecgg7;d77#b7 of title #e1 ,united ,states ,code and inserting and shall not exceed the rate payable for the ,president2 7#f7 by striking subsection 7e72 and 7#g7 by redesignating subsections 7f7 and 7g7 as subsections 7e7 and 7f71 respectively4 7b7 ,report ,not later than #c years after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall submit1 and publish on the website of the ,department of ,health and ,human ,services a report on the implementation of the amendments made by subsection 7a71 including whether the amendments have improved the ability of the ,food and ,drug ,administration to hire and retain qualified experts to fulfill obligations specified under user fee agreements4 #bbhb4 ,enabling ,,fda scientific engagement ,it is the sense of ,congress that the participation in1 or sponsorship of1 scientific conferences and meetings is essential to the mission of the ,food and ,drug ,administration4 #bbhc4 ,reagan-,udall ,foundation for the ,food and ,drug ,administration 7a7 ,board of ,directors 7#a7 ,composition and size ,section #ggj7;d77#a77;,c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;dd7d77#a77;,c77 is amended-- 7,a7 by redesignating clause 7ii7 as clause 7iii72 7,b7 by inserting after clause 7i7 the following3 7ii7 ,additional members ,the ,board1 through amendments to the bylaws of the ,foundation1 may provide that the number of voting members of the ,board shall be a number 7to be specified in such amendment7 greater than #ad4 ,any ,board positions that are established by any such amendment shall be appointed 7by majority vote7 by the individuals who1 as of the date of such amendment1 are voting members of the ,board and persons so appointed may represent any of the categories specified in subclauses 7,i7 through 7,v7 of clause 7i71 so long as no more than #cj percent of the total voting members of the ,board 7including members whose positions are established by such amendment7 are representatives of the general pharmaceutical1 device1 food1 cosmetic1 and biotechnology industries4 2 and 7,c7 in clause 7iii77,i71 as redesignated by subparagraph 7,a71 by striking ,the ex officio members shall ensure and inserting ,the ex officio members1 acting pursuant to clause 7i71 and the ,board1 acting pursuant to clause 7ii71 shall ensure4 7#b7 ,federal employees allowed to serve on ,board ,clause 7iii77,,ii7 of section #ggj7;d77#a77;,c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;dd7d77#a77;,c771 as redesignated by paragraph 7#a77;,a71 is amended by adding at the end the following3 ,for purposes of this section1 the term employee of the ,federal ,government does not include a special ,government employee1 as that term is defined in section #bjb7;a7 of title #ah1 ,united ,states ,code44 7#c7 ,staggered terms ,subparagraph 7,a7 of section #ggj7;d77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;dd7d77#c77 is amended to read as follows3 7,a7 ,term ,the term of office of each member of the ,board appointed under paragraph 7#a77;,c77i71 and the term of office of any member of the ,board whose position is established pursuant to paragraph 7#a77;,c77ii71 shall be #d years1 except that-- 7i7 the terms of offices for the members of the ,board initially appointed under paragraph 7#a77;,c77i7 shall expire on a staggered basis as determined by the ex officio members2 and 7ii7 the terms of office for the persons initially appointed to positions established pursuant to paragraph 7#a77;,c77ii7 may be made to expire on a staggered basis1 as determined by the individuals who1 as of the date of the amendment establishing such positions1 are members of the ,board4 4 7b7 ,executive ,director compensation ,section #ggj7;g77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;dd7g77#b77 is amended by striking but shall not be greater than the compensation of the ,commissioner4 7c7 ,separation of ,funds ,section #ggj7m7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;dd7m77 is amended by striking are held in separate accounts from funds received from entities under subsection 7i7 and inserting are managed as individual programmatic funds under subsection 7i71 according to best accounting practices4 #bbhd4 ,collection of certain voluntary information exempted from ,paperwork ,reduction ,act ,chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended by inserting after section #gjh of such ,act 7#ba ,u4,s4,c4 #cgi7 the following3 #gjh;,a4 ,collection of certain voluntary information exempted from ,paperwork ,reduction ,act ,chapter #ce of title #dd1 ,united ,states ,code1 shall not apply to the collection from patients1 industry1 academia1 and other stakeholders1 of voluntary information such as through voluntary surveys or questionnaires1 initiated by the ,secretary4 4 #bbhe4 ,hiring authority for scientific1 technical1 and professional personnel 7a7 ,in general ,the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended by inserting after section #gad 7#ba ,u4,s4,c4 #cgi;d-#c7 the following3 #gad;,a4 ,additional hiring authority 7a7 ,in general ,the ,secretary may1 without regard to the provisions of title #e1 ,united ,states ,code1 governing appointments in the competitive service1 appoint qualified candidates to scientific1 technical1 or professional positions within the following centers of the ,food and ,drug ,administration3 7#a7 ,the ,center for ,drug ,evaluation and ,research4 7#b7 ,the ,center for ,biologics ,evaluation and ,research4 7#c7 ,the ,center for ,devices and ,radiological ,health4 ,such positions shall be within the competitive service4 7b7 ,compensation 7#a7 ,in general ,notwithstanding any other provision of law1 including any requirement with respect to ,general ,schedule pay rates under subchapter ,,iii of chapter #ec of title #e1 ,united ,states ,code1 and consistent with the requirements of paragraph 7#b71 the ,secretary may determine and fix-- 7,a7 the annual rate of pay of any individual appointed under subsection 7a72 and 7,b7 for purposes of retaining qualified employees1 the annual rate of pay for any highly qualified scientific1 technical1 or professional personnel appointed to a position at any of the centers listed under subsection 7a7 before the date of enactment of this section4 7#b7 ,limitation ,the annual rate of pay established pursuant to paragraph 7#a7 may not exceed the annual rate of pay of the ,president4 7c7 ,report 7#a7 ,in general ,not later than ,september #cj1 #bjba1 the ,secretary shall submit a report to ,congress that examines the extent to which the authority to appoint and retain personnel under this section enhanced the ,food and ,drug ,administration's ability to meet the agency's critical need for highly qualified individuals for scientific1 technical1 or professional positions4 7#b7 ,recommendations ,the report under paragraph 7#a7 shall include the recommendations of the ,secretary on-- 7,a7 whether the authority to appoint personnel under this section should be reauthorized2 and 7,b7 other personnel authorities that would help the ,food and ,drug ,administration to better recruit and retain highly qualified individuals for scientific1 technical1 or professional positions in the agency's medical product centers4 4 7b7 ,rule of construction ,the authority provided by section #gad;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7as added by subsection 7a77 shall not be construed to affect the authority provided under section #gad of such ,act4 ,q ,exempting from sequestration certain user fees #bcja4 ,exempting from sequestration certain user fees of ,food and ,drug ,administration ,the ,balanced ,budget and ,emergency ,deficit ,control ,act of #aihe is amended-- 7#a7 in section #bee7;g77#a77;,a7 7#b ,u4,s4,c4 #ije7;g77#a77;,a771 by inserting after the item relating to ,financial ,agent ,services the following new item3 ,food and ,drug ,administration1 ,salaries and ,expenses1 but only the portion of appropriations under such account corresponding to fees collected under sections #gcf1 #gch1 #gdj1 #gda1 #gdd;,b1 and #gdd;,h of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ge-iiaa-j-a-eed74 2 and 7#b7 in section #bef7;h7 7#b ,u4,s4,c4 #ijf7;h771 by adding at the end the following new paragraph3 7#e7 ,notwithstanding any other provision of law1 this subsection shall not apply with respect to the portion of administrative expenses incurred by the ,food and ,drug ,administration that are funded through fees collected under sections #gcf1 #gch1 #gdj1 #gda1 #gdd;,b1 and #gdd;,h of the ,federal ,food1 ,drug1 and ,cosmetic ,act4 4 ,r ,other provisions #bcba4 ,sense of ,congress ,it is the sense of the ,congress that recording unique device identifiers at the point-of-care in electronic health record systems could significantly enhance the availability of medical device data for postmarket surveillance purposes4 ,,iii ,delivery ,a ,interoperability #cjja4 ,ensuring interoperability of health information technology 7a7 ,interoperability standards 7#a7 ,in general ,subtitle ,a of title ,,xxx of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;jj-#aa et seq47 is amended by adding at the end the following new section3 #cjaj4 ,ensuring interoperability of health information technology 7a7 ,interoperability ,in order for health information technology to be considered interoperable1 such technology must satisfy the following criteria3 7#a7 ,secure transfer ,the technology allows the secure transfer of all electronically accessible health information to and from any and all health information technology for authorized use under applicable ,state or ,federal law4 7#b7 ,complete ,access to ,health ,information ,the technology allows for complete access1 exchange1 and use of all electronically accessible health information for authorized use under applicable ,state or ,federal law without special effort by the requestor of such health information4 7#c7 ,no information blocking ,the technology is not configured1 set up1 or implemented to information block1 as defined in section #cjaj;,a7d74 7b7 ,categories for interoperability standards ,the categories described in this subsection1 with respect to standards and the corresponding implementation specifications for determining if health information technology is interoperable1 consistent with the criteria described in subsection 7a71 include at least categories of standards and implementation specifications with respect to the following3 7#a7 ,vocabulary and terminology4 7#b7 ,content and structure4 7#c7 ,transport4 7#d7 ,security4 7#e7 ,services4 7#f7 ,querying and requesting health information for access1 exchange1 and use4 7c7 ,allowing for flexibility ,a standard and implementation specification1 with respect to such standard1 that is determined under section #cjja7;c77#e77;,d7 to be compatible with baseline standards and implementation specifications 7as defined in clause 7ii7 of such section7 shall be treated as in compliance with this section4 4 7#b7 ,guidance ,not later than ,january #a1 #bjag1 the ,secretary of ,health and ,human ,services1 in consultation with the ,national ,coordinator of the ,office of the ,national ,coordinator for ,health ,information ,technology1 shall issue guidance with respect to the implementation of section #cjaj of the ,public ,health ,service ,act1 as added by paragraph 7#a71 including with respect to defining and providing examples of authorized use under applicable ,state or ,federal law of health information4 7b7 ,improvements to recommendation process 7#a7 ,,hit ,policy ,committee to incorporate policies for updates to interoperability standards ,section #cjjb of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;jj-#ab7 is amended-- 7,a7 in subsection 7a7-- 7i7 by striking ,national ,coordinator and inserting ,secretary1 in consultation with the ,national ,coordinator12 and 7ii7 by adding at the end the following new sentence3 ,the ,,hit ,policy ,committee is authorized only to provide policy and priority recommendations to the ,secretary and not authorized to otherwise affect the development or modification of any standard1 implementation specification1 or certification criterion under this title42 and 7,b7 in subsection 7b77#b7-- 7i7 in subparagraph 7,a71 in the first sentence-- 7,i7 by striking ,the ,,hit ,policy ,committee and inserting ,subject to subparagraph 7,d71 the ,,hit ,policy ,committee2 and 7,,ii7 by inserting 7including the areas in which modifications and additions to interoperability standards and implementation specifications1 with respect to such interoperability standards1 under section #cjaj are needed for the electronic access1 exchange1 and use of health information for purposes of adoption of such modifications and additions under section #cjjd7 after section #cjjd4 7ii7 by adding at the end the following new subparagraph3 7,d7 ,special rule related to interoperability ,any recommendation made by the ,,hit ,policy ,committee on or after the date of the enactment of this subparagraph with respect to interoperability of health information technology shall be consistent with the criteria described in subsection 7a7 of section #cjaj4 4 7#b7 ,sunset of ,,hit ,standards ,committee ,section #cjjc of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;jj-#ac7 is amended by adding at the end the following new subsection3 7f7 ,termination ,the ,,hit ,standards ,committee shall terminate on the date that is #ij days after the date of the enactment of this subsection4 4 7#c7 ,standards development organizations ,title ,,xxx of the ,public ,health ,service ,act is amended by inserting after section #cjjc the following new section3 #cjjc;,a4 ,recommendations for standards through contracts with standards development organizations 7a7 ,contracts 7#a7 ,in general ,for purposes of activities conducted under this title1 the ,secretary shall enter into one or more contracts with health care standards development organizations accredited by the ,american ,national ,standards ,institute 7or with the ,american ,national ,standards ,institute7 to carry out1 directly or through contracts with subcontractors1 the duties described in subsection 7b71 as applicable4 7#b7 ,timing for first contract ,as soon as practicable after the date of the enactment of this section1 the ,secretary shall enter into the first contracts under paragraph 7#a74 7#c7 ,period of contract ,each contract under paragraph 7#a7 shall be for a period determined necessary by the ,secretary1 in consultation with the ,national ,coordinator1 to carry out the applicable duties described in subsection 7b74 7#d7 ,appropriate entities ,the ,secretary shall ensure the most appropriate entities described in paragraph 7#a7 are selected for each contract under such paragraph4 7b7 ,duties 7#a7 ,initial contract ,the ,secretary shall initially enter into one or more contracts under subsection 7a77#a7 with entities described in such subsection1 under which the entities-- 7,a7 shall recommend to the ,secretary-- 7i7 for adoption under section #cjjd1 an initial set of interoperability standards and implementation specifications1 with respect to such standards1 identified or1 as appropriate1 developed by such entities that are consistent with the criteria described in subsection 7a7 of section #cjaj1 and with respect to the categories described in subsection 7b7 of such section2 and 7ii7 as applicable1 for purposes of section #cjja7;c77#e77;,d71 methods to test if health information technology is compatible with health information technology that applies baseline standards and implementation specifications 7as defined in clause 7ii7 of such section72 and 7,b7 may provide to the ,secretary recommendations described in paragraph 7#b74 7#b7 ,subsequent contracts ,under each subsequent contract entered into under this section with entities described in subsection 7a77#a7 pursuant to subsection 7c71 the entities shall recommend to the ,secretary-- 7,a7 for adoption under section #cjjd any standards 7including interoperability standards71 implementation specifications1 and1 to the extent necessary1 certification criteria 7and modifications1 including additions1 to such standards1 specifications1 and1 to the extent necessary1 criteria71 which are in accordance with the criteria described in section #cjaj2 and 7,b7 as applicable1 for purposes of section #cjja7;c77#e77;,d71 methods to test if health information technology is compatible with baseline standards and implementation specifications 7as defined in clause 7ii7 of such section74 7#c7 ,submission to ,,nist ,under each contract with an entity under this section1 the entity shall submit to the ,director of the ,national ,institute of ,standards and ,technology each recommendation submitted to the ,secretary by such entity under this section4 7#d7 ,consultation ,for the purposes of developing methods to test interoperability standards and implementation specifications with respect to such standards1 the entities with a contract under this section may consult with the ,director of the ,national ,institute of ,standards and ,technology4 7c7 ,modifications and subsequent contracts 7#a7 ,in general ,the ,secretary1 in consultation with the ,national ,coordinator1 shall periodically conduct hearings to evaluate and review the standards1 implementation specifications1 and certification criteria adopted under section #cjjd for purposes of determining if modifications1 including any additions1 are needed with respect to such standards1 specifications1 and criteria4 7#b7 ,contract trigger ,based on the needs for standards1 implementation specifications1 and certification criteria 7and modifications1 including additions1 to such standards1 specifications1 and criteria7 under this title1 as determined by the ,secretary1 with due consideration to section #cjaj7;b7 and in consultation with the ,national ,coordinator1 the ,secretary shall1 as needed1 enter into contracts under subsection 7a7 to carry out the duties described in subsection 7b77#b7 in addition to any contract entered into to carry out the duties described in subsection 7b77#a74 7d7 ,authorization of appropriations ,there is authorized to be appropriated #aj1jjj1jjj for contracts under subsection 7a71 to remain available until expended4 4 7#d7 ,modifications to role of the ,national ,coordinator ,section #cjja7;c77#a77;,a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;jj-#aa7;c77#a77;,a77 is amended by inserting for recommendations made before the date of the enactment of the #bast ,century ,cures ,act1 before review and determine4 7c7 ,adoption ,section #cjjd of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;jj-#ad7 is amended-- 7#a7 in subsection 7a7-- 7,a7 in paragraph 7#a71 by inserting after section #cjja7;c7 the following3 7or1 subject to subsection 7c71 in the case of a standard1 implementation specification1 or criterion recommended on or after the date of the enactment of the #bast ,century ,cures ,act1 after the date of submission of the recommendation to the ,secretary under section #cjjc;,a72 and 7,b7 in paragraph 7#b77;,b71 by striking and the ,,hit ,standards ,committee2 7#b7 in subsection 7b7-- 7,a7 in paragraph 7#c71 by striking with the schedule published under section #cjjc7;b77#b7 and inserting with subsection 7d72 and 7,b7 by adding at the end the following new paragraph3 7#d7 ,limitation ,the ,secretary may not adopt any policies1 priorities1 standards1 implementation specifications1 or certification criteria under this subsection or subsection 7a7 that are inconsistent with or duplicative of an interoperability standard or implementation specification with respect to such standard adopted under this section1 in accordance with subsections 7c7 and 7d74 ,in the case of a standard1 specification1 or criterion that has been adopted under this section and is inconsistent or duplicative of such an interoperability standard or specification that is subsequently adopted under this section1 such interoperability standard or specification shall supercede such other standard1 specification1 or criterion and such other standard1 specification1 or criterion shall no longer be considered adopted under this section beginning on the date that such interoperability standard or specification becomes effective4 2 and 7#c7 by adding at the end the following new subsections3 7c7 ,adoption of initial interoperability standards and implementation specifications ,notwithstanding the previous subsections of this section1 the following shall apply in the case of the initial set of interoperability standards and implementation specifications with respect to such standards recommended under section #cjjc;,a3 7#a7 ,review of standards ,not later than #ij days after the date of receipt of recommendations for such interoperability standards and implementation specifications1 the ,secretary1 in consultation with the ,national ,coordinator and representatives of other relevant ,federal agencies1 such as the ,national ,institute of ,standards and ,technology1 shall jointly review such standards and implementation specifications and shall determine whether or not to propose adoption of such standards and implementation specifications4 7#b7 ,determination to adopt ,if1 subject to subsection 7d77#c71 the ,secretary determines-- 7,a7 to propose adoption of such standards and implementation specifications1 the ,secretary shall1 by regulation under section #eec of title #e1 ,united ,states ,code1 determine whether or not to adopt such standards and implementation specifications2 or 7,b7 not to propose adoption of such standards and implementation specifications1 the ,secretary shall notify the applicable entity with a contract under section #cjjc;,a in writing of such determination and the reasons for not proposing the adoption of the recommendation for such standards and implementation specifications4 7#c7 ,publication ,the ,secretary shall provide for publication in the ,federal ,register of all determinations made by the ,secretary under paragraph 7#a74 7d7 ,rules for adoption ,in the case of a standard 7including interoperability standard71 implementation specification1 or certification criterion adopted under this section on or after the date of the enactment of the #bast ,century ,cures ,act1 the following shall apply3 7#a7 ,in general ,except as provided in paragraphs 7#b7 and 7#c71 any such standard 7including interoperability standard71 implementation specification1 or certification criterion shall be a standard1 specification1 or criterion that has been recommended by the entities with which the ,secretary has entered into a contract under section #cjjc;,a4 7#b7 ,special rule if no standard1 specification1 or criterion recommended ,if no standard1 implementation specification1 or1 to the extent necessary1 certification criterion is recommended under paragraph 7#a7-- 7,a7 in the case of interoperability standards and implementation specifications with respect to such standards1 relating to a category described in section #cjaj7;b7-- 7i7 paragraph 7#a7 shall not apply2 and 7ii7 paragraph 7#d7 shall apply2 or 7,b7 in the case of any other standard1 implementation specification1 or1 to the extent necessary1 certification criterion1 relating to a policy or priority to carry out this title1 as determined by the ,secretary1 in consultation with the ,national ,coordinator-- 7i7 paragraph 7#a7 shall not apply2 and 7ii7 paragraph 7#d7 shall apply4 7#c7 ,authority to modify implementation specifications ,if1 following public comment pursuant to subsection 7c71 the ,secretary would propose adoption of interoperability standards recommended under section #cjjc;,a but for the implementation specifications1 with respect to such standards1 so recommended1 the ,secretary may modify such implementation specifications and adopt such standards and specifications in accordance with subsection 7c77#b74 7#d7 ,effective date ,in the case of a standard1 implementation specification1 or certification criterion for which there is a determination to adopt such standard1 implementation specification1 or certification criterion1 such standard1 implementation specification1 or certification criterion shall be considered adopted under this section and shall be effective beginning on the date that is #ab months after the date of publication of the final rule to adopt such standard1 implementation specification1 or certification criterion4 7#e7 ,assistance to the ,secretary ,in complying with the requirements of this subsection1 the ,secretary shall give due consideration to any recommendations of the ,national ,committee on ,vital and ,health ,statistics established under section #cjf7k71 and shall consult with appropriate ,federal and ,state agencies and private organizations4 ,the ,secretary shall publish in the ,federal ,register any recommendation of the ,national ,committee on ,vital and ,health ,statistics regarding the adoption of a standard1 implementation specification1 or certification criterion under this section4 ,any standard1 implementation specification1 or certification criterion adopted pursuant to this paragraph shall be promulgated in accordance with the rulemaking procedures of subchapter ,,iii of chapter #e of title #e1 ,united ,states ,code4 7e7 ,allowing for flexibility through compatibility with baseline standards and implementation specifications ,for purposes of this title1 title ,,xviii of the ,social ,security ,act1 title ,,xix of such ,act1 and any other provision of law1 a standard and implementation specification1 with respect to such standard1 that is determined under section #cjja7;c77#e77;,d7 to be compatible with baseline standards and implementation specifications 7as defined in clause 7ii7 of such section7 shall be treated as if such standard and specification were an interoperability standard and implementation specification1 with respect to such interoperability standard1 adopted under this section4 4 7d7 ,reports and notifications ,section #cjaj of the ,public ,health ,service ,act1 as added by subsection 7a71 is amended by adding at the end the following new subsection3 7c7 ,dissemination of information 7#a7 ,initial summary report ,not later than ,july #a1 #bjag1 the ,secretary1 after consultation with relevant stakeholders1 shall submit to ,congress and provide for publication in the ,federal ,register and the posting on the ,internet website of the ,office of the ,national ,coordinator for ,health ,information ,technology a report on the following3 7,a7 ,the initial set of interoperability standards and implementation specifications adopted under section #cjjd7;c74 7,b7 ,the strategies for achieving widespread interoperability4 7,c7 ,any barriers that are preventing widespread interoperability4 7,d7 ,the plan and milestones1 including specific steps1 to achieve widespread interoperability4 7#b7 ,ongoing publication of recommendations ,the ,secretary shall provide for publication in the ,federal ,register1 and the posting on the ,internet website of the ,office of the ,national ,coordinator for ,health ,information ,technology1 of all recommendations made under this section4 4 7e7 ,certification and other enforcement provisions 7#a7 ,certification of qualified electronic health records 7,a7 ,in general ,section #cjjg7;b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;jj-#ag7;b77 is amended by striking under section #cjja7;c77#c7 to be in compliance with and all that follows through the period at the end and inserting under section #cjja7;c77#c7-- 7#a7 for certifications made before ,january #a1 #bjah1 to be in compliance with applicable standards adopted under subsections 7a7 and 7b7 of section #cjjd2 and 7#b7 for certifications made on or after ,january #a1 #bjah1 to be in compliance with applicable standards adopted under subsections 7a7 and 7b7 of section #cjjd and to be interoperable in accordance with section #cjaj and in compliance with interoperability standards adopted under section #cjjd4 4 7,b7 ,requirements of ,secretary ,section #cjja7;c77#e7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;jj-#aa7;c77#e77 is amended-- 7i7 in subparagraph 7,b71 by inserting before the period at the end the following3 and1 for certifications made on or after ,january #a1 #bjah1 with respect to health information technology1 additional criteria to establish that the technology is interoperable1 in accordance with section #cjaj1 and in compliance with interoperability standards and implementation specifications1 with respect to such standards1 adopted under section #cjjd2 and 7ii7 by adding at the end the following new subparagraphs3 7,c7 ,enforcement2 decertifications 7i7 ,requirements ,under any program kept or recognized under subparagraph 7,a71 the ,secretary shall ensure that any vendor of or other entity offering to health care providers 7as defined in section #cjaj;,a7g77 qualified electronic health records seeking a certification of such records under such program on or after ,january #a1 #bjah1 shall1 as a condition of certification 7and maintenance of certification7 of such a record under such program-- 7,i7 provide to the ,secretary an attestation-- 7aa7 the entity has implemented interoperability standards and implementation specifications1 with respect to such standards1 adopted under section #cjjd 7including through application of subsection 7e7 of such section72 7bb7 that the entity1 unless for a legitimate purpose specified by the ,secretary1 has not taken and will not take any action that constitutes information blocking 7as defined in section #cjaj;,a7d771 with respect to such qualified electronic health records2 7cc7 that includes the pricing information described in clause 7iii7 for purposes of inclusion under subsection 7f7 of such information on the ,internet website of the ,department of ,health and ,human ,services2 that such information will be available on a public ,internet website of such entity2 and that the entity will voluntarily provide such information to customers prior to offering any qualified electronic health records or related product or service 7including subsequent updates1 add-ons1 or additional products or services to be provided during the course of an on-going contract71 prospective customers 7such as persons who request or receive a quotation or estimate71 and other persons who request such information2 7dd7 that the technology with respect to such records has published application programming interfaces1 with respect to health information within such records1 for search and indexing1 semantic harmonization and vocabulary translation1 and user interface applications2 7ee7 that the entity has successfully and rigorously tested the real world use of the record in the type of setting in which it would be marketed2 and 7ff7 that the entity has in place data sharing programs or capabilities based on common data elements through such mechanisms as application programming interfaces without the requirement for vendor-specific interfaces2 7,,ii7 publish application programming interfaces and associated documentation1 with respect to health information within such records1 for search and indexing1 semantic harmonization and vocabulary translation1 and user interface applications2 and 7,,iii7 demonstrate to the satisfaction of the ,secretary that health information from such records are able to be exchanged1 accessed1 and used through the use of application programming interfaces without special effort1 as authorized under applicable law4 7ii7 ,decertification ,under any program kept or recognized under subparagraph 7,a71 the ,secretary shall ensure that beginning ,january #a1 #bjai1 any qualified electronic health records that do not satisfy the certification criteria described in subparagraph 7,b7 or with respect to which the vendor or other entity described in clause 7i7 does not satisfy the requirements under such clause 7or is determined to be in violation of the terms of the attestation or other requirements under such clause7 shall no longer be considered as certified under such program4 7iii7 ,pricing information ,for purposes of clause 7i77,i77cc71 the pricing information described in this clause1 with respect to a vendor of or other entity offering a qualified electronic health record1 is the following3 7,i7 ,additional types of costs or fees 7whether fixed1 recurring1 transaction based1 or otherwise7 imposed by the entity 7or any third-party from whom the entity purchases1 licenses1 or obtains any technology1 products1 or services in connection with the qualified electronic health record7 to purchase1 license1 implement1 maintain1 upgrade1 use1 or otherwise enable and support the use of capabilities to which such record is to be certified under this section2 or in connection with any health information generated in the course of using any capability to which the record is to be so certified4 7,,ii7 ,limitations1 whether by contract or otherwise1 on the use of any capability to which the record is to be certified under this section for any purpose within the scope of the record's certification2 or in connection with any health information generated in the course of using any capability to which the record is to be certified under this section4 7,,iii7 ,limitations1 including technical or practical limitations of technology or its capabilities1 that could prevent or impair the successful implementation1 configuration1 customization1 maintenance1 support1 or use of any capabilities to which the record is to be certified under this section2 or that could prevent or limit the access1 use1 exchange1 or portability of any health information generated in the course of using any capability to which the record is to be so certified4 7,d7 ,flexibility through compatibility 7i7 ,in general ,under any program kept or recognized under subparagraph 7,a71 the ,secretary shall provide for a method and process by which a vendor of or other entity offering to health care providers 7as defined in section #cjaj;,a7g77 qualified electronic health records seeking a certification of such records under such program on or after ,january #a1 #bjah1 may demonstrate1 using such mechanisms as a reference implementation model or other means1 that the standards and implementation specifications applied by such entity with respect to such records are compatible with baseline standards and implementation specifications1 including by demonstrating such records are able to transmit information that is compatible with qualified electronic health records that would receive such information and that apply the baseline standards and implementation specifications4 ,such a method and process shall ensure that any such entity using a standard or implementation specification other than a baseline standard or implementation specification demonstrates1 through testing1 compatibility with the baseline standard and implementation specification with respect to receiving information4 7ii7 ,baseline standards and implementation specifications ,for purposes of clause 7i71 the term baseline standards and implementation specifications means the interoperability standards and implementation specifications1 with respect to such standards1 adopted under section #cjjd 7without application of subsection 7e7 of such section74 4 7#b7 ,additional enforcement provisions under the ,public ,health ,service ,act ,subtitle ,a of title ,,xxx of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;jj-#aa et seq471 as amended by subsections 7a77#a7 and 7d71 is further amended by adding at the end the following new section3 #cjaj;,a4 ,enforcement mechanisms 7a7 ,inspector ,general authority ,the ,inspector ,general of the ,department of ,health and ,human ,services shall have the authority to investigate claims of-- 7#a7 7,a7 vendors of1 or other entities offering to health care providers 7as defined in subsection 7g771 qualified electronic health records 7as defined in section #cjjj7ac77 being in violation of an attestation 7whether providing false information at the time of such attestation or by act or practice conducted after such attestation7 made under section #cjja7;c77#e77;,c77i77,i71 with respect to the use of such records by a health care provider with respect to items and services furnished under the ,medicare ,program under title ,,xviii of the ,social ,security ,act or ,medicaid program under title ,,xix of such ,act2 and 7,b7 vendors of1 or other entities offering to health care providers 7as defined in subsection 7g771 health information technology having engaged in information blocking 7as defined in subsection 7d771 unless for a legitimate purpose specified by the ,secretary1 with respect to the use of such technology by a health care provider with respect to items and services furnished under such a program2 7#b7 health care providers having engaged in information blocking 7as so defined71 with respect to the use of health information technology with respect to items and services furnished under such a program1 unless for a legitimate purpose specified by the ,secretary2 and 7#c7 health information system providers 7such as operators of health information exchanges1 clinical data registries1 and other systems that facilitate the exchange of information7 having engaged in information blocking 7as so defined71 unless for a legitimate purpose specified by the ,secretary1 with respect to the use of health information technology with respect to items and services furnished under such a program4 7b7 ,information sharing provisions 7#a7 ,in general ,the ,national ,coordinator may serve as a technical consultant to the ,inspector ,general of the ,department of ,health and ,human ,services and the ,federal ,trade ,commission for purposes of carrying out this section4 ,as such technical consultant1 the ,national ,coordinator may1 notwithstanding any other provision of law1 share information related to claims or investigations under subsection 7a7 with the ,federal ,trade ,commission for purposes of such investigations and shall share information with the ,inspector ,general1 as required by law4 7#b7 ,protection from disclosure of information ,any information that is received by the ,national ,coordinator in connection with a claim or suggestion of possible information blocking and that could reasonably be expected to facilitate identification of the source of the information-- 7,a7 shall not be disclosed by the ,national ,coordinator except as may be necessary to carry out the purpose of this section2 and 7,b7 shall be exempt from mandatory disclosure under section #eeb of title #e1 ,united ,states ,code1 as provided by subsection 7b77#c7 of such section4 ,such information may be used by the ,inspector ,general of the ,department of ,health and ,human ,services or ,federal ,trade ,commission for reporting purposes to the extent that such information could not reasonably be expected to facilitate identification of the source of such information4 7#c7 ,non-application of ,paperwork ,reduction ,act ,chapter #ce of title #dd1 ,united ,states ,code 7commonly referred to as the ,paperwork ,reduction ,act of #aiie7 shall not apply to the ,national ,coordinator or to the ,office of the ,national ,coordinator for ,health ,information ,technology with respect to the collection of complaints relating to claims described in subsection 7a74 7#d7 ,standardized process ,the ,national ,coordinator shall implement a standardized process for the public to submit reports on claims of-- 7,a7 health information technology products of vendors 7or other entities offering such products to health care providers 7as defined in subsection 7g777 not being interoperable or resulting in information blocking2 or 7,b7 actions by such entities1 health care providers1 or health information system providers that result in such technology not being interoperable or in information blocking with respect to such technology2 and 7,c7 any other act described in subsection 7a74 ,the standardized process shall provide for the collection of such information as the originating institution1 location1 type of transaction1 system and version1 timestamp1 terminating institution1 locations1 system and version1 failure notice1 and other related information4 7c7 ,penalty 7#a7 ,in general ,any person or entity described in paragraph 7#a71 7#b71 or 7#c7 of subsection 7a7 determined to have committed on or after ,january #a1 #bjah1 an act described in such respective paragraph with respect to the use of a qualified electronic health record or health information technology1 as applicable under such respective paragraph1 with respect to items and services furnished under the ,medicare ,program under title ,,xviii of the ,social ,security ,act or the ,medicaid program under title ,,xix of such ,act1 shall be subject to a civil monetary penalty in such amount as determined appropriate by the ,secretary through rulemaking4 7#b7 ,application ,subject to paragraph 7#c71 the provisions of section #aabh;,a 7other than subsections 7a7 and 7b77 of such ,act 7#db ,u4,s4,c4 #acbj;a-#g;a7 shall apply to a civil money penalty applied under this subsection in the same manner as they apply to a civil money penalty or proceeding under subsection 7a7 of such section #aabh;,a4 7#c7 ,recovery of funds ,notwithstanding section #ccjb of title #ca1 ,united ,states ,code1 or any other provision of law affecting the crediting of collections1 the ,inspector ,general of the ,department of ,health and ,human ,services may receive and retain for current use any amounts recovered under this subsection4 ,in addition to amounts otherwise available to the ,inspector ,general1 funds received by the ,inspector ,general under this paragraph shall be deposited1 as an offsetting collection1 to the credit of any appropriation available for purposes of carrying out this subsection and subsection 7a7 and shall be available without fiscal year limitation and without further appropriation4 7d7 ,information blocking 7#a7 ,in general ,for purposes of this section and section #cjaj1 subject to paragraph 7#c71 the term information blocking means1 with respect to the access1 use1 and exchange of qualified electronic health records and other health information technology1 business1 technical1 and organizational practices1 including practices described in paragraph 7#b71 that-- 7,a7 prevent or materially discourage the access1 exchange1 or use of electronic health information2 and 7,b7 the actor knows or should know 7as defined in section #aabh;,a7i77#g7 of the ,social ,security ,act7 are likely to interfere with the access1 exchange1 or use of electronic health information4 7#b7 ,practices described ,for purposes of paragraph 7#a71 the practices described in this paragraph shall include the following3 7,a7 ,contract terms1 policies1 or business or organizational practices that restrict authorized use under applicable ,state or ,federal law of electronic health information or restrict the authorized exchange under applicable ,state or ,federal law of such information for treatment and other permitted purposes under such applicable law1 including transitions between certified ,,ehr technologies4 7,b7 ,charging unreasonable prices or fees 7such as for health information exchange1 portability1 interfaces1 and full export of health information7 that make accessing1 exchanging1 or using electronic health information cost prohibitive4 7,c7 ,developing or implementing health information technology in nonstandard ways that are likely to substantially increase the costs1 complexity1 or burden of sharing electronic health information1 especially in cases in which relevant interoperability standards or methods to measure interoperability have been adopted by the ,secretary4 7,d7 ,developing or implementing health information technology in ways that are likely to lock in users or electronic health information1 such as not allowing for the full export of health information2 lead to fraud1 waste1 or abuse2 or impede innovations and advancements in health information access1 exchange1 and use1 including health information technology-enabled care delivery4 7#c7 ,exceptions 7,a7 ,in general ,the term information blocking shall not include practices that-- 7i7 are required by applicable law2 or 7ii7 that the ,secretary1 through regulation1 identifies as necessary to protect patient safety1 to maintain the privacy or security of individuals' health information1 or to promote competition and consumer welfare4 7,b7 ,process ,for purposes of subparagraph 7,a77ii71 not later than #ab months after the date of the enactment of this section1 the ,secretary shall issue regulations following the notice and comment procedures of section #eec of title #e1 ,united ,states ,code1 except that the ,secretary may issue the first such regulation as an interim final regulation4 7,c7 ,no enforcement before exceptions identified ,the term information blocking shall not include any practice or conduct occurring before the date that is #cj days after the date on which the first regulation 7as described in subparagraph 7,b77 is issued under such subparagraph4 7,d7 ,consultation ,to the extent that regulations issued under this paragraph define practices that are necessary to promote competition and consumer welfare1 the ,secretary may consult with the ,federal ,trade ,commission in issuing such regulations4 7,e7 ,application ,the term information blocking1 with respect to an individual or entity1 shall not include an act or practice other than an act or practice committed by such individual or entity4 7e7 ,treatment of vendors with respect to patient safety organizations ,in applying part ,c of title ,,ix-- 7#a7 vendors shall be treated as a provider 7as defined in section #iba7 for purposes of reporting requirements under such part1 to the extent that such reports are related to attestation requirements under section #cjja7;c77#e77;,c77i77,i72 7#b7 claims of information blocking described in subsection 7a7 shall be treated as a patient safety activity under such part for purposes of reporting requirements under such part2 and 7#c7 health care providers that are not members of patient safety organizations shall be treated in the same manner as health care providers that are such members for purposes of such reporting requirements with respect to claims of information blocking described in subsection 7a74 7f7 ,rulemaking and guidance 7#a7 ,in general ,not later than #ab months after the date of the enactment of this section1 the ,secretary1 in consultation with the ,national ,coordinator and the ,inspector ,general of the ,department of ,health and ,human ,services1 shall1 through rulemaking1 implement the provisions of section #cjja of the #bast ,century ,cures ,act1 including amendments made by such section1 relating to information blocking4 7#b7 ,non-duplication of penalty structures ,in carrying out paragraph 7#a71 in determining the scope of penalties1 assessments1 or exclusions under such section #cjja1 including amendments made by such section1 relating to information blocking1 the ,secretary shall ensure to the extent possible that such penalties1 assessments1 and exclusions do not duplicate penalty1 assessment1 and exclusion structures that would otherwise apply with respect to information blocking and the type of individual or entity involved as of the day before the date of the enactment of this section4 7#c7 ,clarification ,in carrying out paragraph 7#a71 the ,secretary shall ensure that health care providers are not penalized for actions of vendor of1 and other entities offering to such providers1 health information technology for the failure of such technology to meet requirements for such technology to be certified under this title4 7#d7 ,guidance relating to ,,hipaa ,not later than ,january #a1 #bjag1 the ,national ,coordinator shall publish guidance to clarify the relationship of the provisions of the ,,hipaa privacy and security law1 as defined in section #cjji7;a77#b7 to information blocking1 including-- 7,a7 examples of how such provisions may result in information blocking2 and 7,b7 clarifying that a health care provider 7as defined in subsection 7g77 who discloses health information as allowed under applicable ,state and ,federal law is not liable for unlawful actions1 including breaches that occur in the custody of the recipient unless the disclosure proximately cause the breach4 7g7 ,health care provider defined ,for purposes of this section1 the term health care provider means a provider of services under subsection 7u7 of section #ahfa of the ,social ,security ,act and a supplier under subsection 7d7 of such section4 7h7 ,authorization of appropriations ,in addition to amounts made available under subsection 7c77#c71 there is authorized to be appropriated #aj1jjj1jjj for fiscal year #bjag to carry out subsection 7a71 to remain available until expended4 4 7#c7 ,postings relating to enforcement on ,,hhs ,internet website ,section #cjja of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;jj-#aa7 is amended by adding at the end the following new subsection3 7f7 ,enforcement information posted on ,,hhs ,internet website 7#a7 ,pricing information ,not later than ,january #a1 #bjai1 the ,national ,coordinator shall post the information described in subsection 7c77#e77;,c77,i77i77cc7 on the public ,internet website of the ,office of the ,national ,coordinator for ,health ,information ,technology in a manner that allows for comparison of functionality1 price information1 and other features among health information technology products that aids in making informed decisions for purchasing such a product4 7#b7 ,annual posting ,for #bjai and each subsequent year1 the ,secretary shall post on the public ,internet website of the ,department of ,health and ,human ,services a list of any qualified electronic health records with respect to which certification has been withdrawn under subsection 7c77#e77;,c77ii7 during such year and the vendor of or other entity offering to health care providers 7as defined in section #cjaj;,a7g77 such qualified electronic health records4 7#c7 ,periodic review ,the ,secretary shall periodically review and confirm that vendors of and other entities offering to health care providers 7as defined in section #cjaj;,a7g77 qualified electronic health records have publicly published application programming interfaces and associated documentation as required by subsection 7c77#e77;,c77i77,,ii7 for purposes of certification and maintaining certification under any program kept or recognized under subsection 7c77#e77;,a74 4 7#d7 ,demonstration required for meaningful ,,ehr use under ,medicare 7,a7 ,eligible professionals 7i7 ,in general ,section #ahdh7o77#b77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7o77#b77;,a77 is amended by inserting after clause 7iii7 the following new clause3 7iv7 ,interoperability ,with respect to ,,ehr reporting periods for payment years beginning with #bjbj1 the eligible professional demonstrates to the satisfaction of the ,secretary1 in accordance with subparagraph 7,c77i71 that during such period the professional has not taken any action described in subsection 7a77#b7 of section #cjaj;,a of the ,public ,health ,service ,act1 with respect to the use of any certified ,,ehr technology4 4 7ii7 ,hardship exemption in case of decertified ,,ehr ,subparagraph 7,b7 of section #ahdh7;a77#g7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7;a77#g77 is amended to read as follows3 7,b7 ,significant hardship exception 7i7 ,in general ,the ,secretary may1 on a case-by-case basis1 exempt an eligible professional from the application of the payment adjustment under subparagraph 7,a7 if the ,secretary determines1 subject to annual renewal1 that compliance with the requirement for being a meaningful ,,ehr user would result in a significant hardship1 such as in the case of an eligible professional who practices in a rural area without sufficient ,internet access4 7ii7 ,decertification ,the ,secretary shall exempt an eligible professional from the application of the payment adjustment under subparagraph 7,a7 if the ,secretary determines that such professional was determined to not be a meaningful ,,ehr user because the certified ,,ehr technology used by such professional is decertified under section #cjja7;c77#e77;,c7 of the ,public ,health ,service ,act4 ,an exemption under the previous sentence may be applied to an eligible professional only1 subject to clause 7iii71 during the first payment year with respect to the first ,,ehr reporting period to which such decertification applies4 7iii7 ,duration of decertification 7,i7 ,in general ,notwithstanding clause 7iv77,i71 in no case shall an exemption by reason of clause 7ii7 be for a period of less than #ab months4 7,,ii7 ,extension ,an exemption under clause 7ii7 may be extended1 on a case-by-case basis1 for a period of an additional #ab months subject to the limitation described in clause 7iv77,i74 7iv7 ,limitation 7,i7 ,in general ,subject to subclause 7,,ii71 in no case may an eligible professional be granted an exemption under this subparagraph for more than #e years4 7,,ii7 ,exception ,subclause 7,i7 shall not apply to an exemption by reason of clause 7ii7 to the extent necessary to satisfy clause 7iii77,i74 4 7iii7 ,further application ,section #ahdh7o77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7o77#b77 is amended by adding at the end the following new subparagraph3 7,e7 ,hardship exemption in case of decertified ,,ehr ,in the case of certified ,,ehr technology used by an eligible professional that is decertified under section #cjja7;c77#e77;,c71 during the first payment year with respect to the first ,,ehr reporting period to which such decertification applies1 the ,secretary shall not treat the professional as not being a meaningful ,,ehr user solely because the technology used by such professional was so decertified4 ,the treatment of a professional under the previous sentence shall be for a period of at least #ab months and may1 on a case-by-case basis1 be for a period of an additional #ab months4 4 7,b7 ,eligible hospitals 7i7 ,in general ,section #ahhf7n77#c77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7n77#c77;,a77 is amended by inserting after clause 7iii7 the following new clause3 7iv7 ,interoperability ,with respect to ,,ehr reporting periods for payment years beginning with #bjbj1 the hospital demonstrates to the satisfaction of the ,secretary1 in accordance with subparagraph 7,c77i71 that during such period the hospital has not taken any action described in subsection 7a77#b7 of section #cjaj;,a of the ,public ,health ,service ,act1 with respect to the use of any certified ,,ehr technology4 4 7ii7 ,hardship exemption in case of decertified ,,ehr ,subclause 7,,ii7 of section #ahhf7;b77#c77;,b77ix7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7b77#c77;,b77ix77 is amended to read as follows3 7,,ii7 7aa7 ,the ,secretary may1 on a case-by-case basis1 exempt a subsection 7d7 hospital from the application of subclause 7,i7 with respect to a fiscal year if the ,secretary determines1 subject to annual renewal1 that requiring such hospital to be a meaningful ,,ehr user during such fiscal year would result in a significant hardship1 such as in the case of a hospital in a rural area without sufficient ,internet access4 7bb7 ,the ,secretary shall exempt a subsection 7d7 hospital from the application of subclause 7,i7 with respect to a fiscal year if the ,secretary determines that such hospital was determined to not be a meaningful ,,ehr user because the certified ,,ehr technology used by such hospital is decertified under section #cjja7;c77#e77;,c7 of the ,public ,health ,service ,act4 ,an exemption under the previous sentence may be applied to a subsection 7d7 hospital only1 subject to items 7cc7 and 7dd71 during the first payment year with respect to the first ,,ehr reporting period to which such decertification applies4 7cc7 ,notwithstanding item 7ee71 in no case shall an exemption by reason of item 7bb7 be for a period of less than #ab months4 7dd7 ,an exemption under item 7bb7 may1 on a case-by-case basis1 be extended for a period of an additional #ab months subject to the limitation described in item 7ee74 7ee7 ,subject to item 7ff71 in no case may a hospital be granted an exemption under this subclause for more than #e years4 7ff7 ,item 7ee7 shall not apply to an exemption by reason of item 7bb7 to the extent necessary to satisfy item 7cc74 4 7,c7 ,demonstration required for meaningful ,,ehr use under ,medicaid ,section #aijc7t77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7t77#b77 is amended by adding at the end the following3 ,an eligible professional shall not qualify as a ,medicaid provider under this subsection1 with respect to a year beginning with #bjbj1 unless such provider demonstrates to the ,secretary1 through means such as an attestation1 that the provider has not taken any action described in subsection 7a77#b7 of section #cjaj;,a of the ,public ,health ,service ,act1 with respect to the use of any certified ,,ehr technology44 7#e7 ,guidance ,not later than ,january #a1 #bjah1 the ,secretary of ,health and ,human ,services shall issue guidance to further the voluntary transition of health care providers between different certified ,,ehr technology 7as defined in section #cjjj7a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;jj7#a77 by removing disincentives to such transition1 which may include applying to instances of such a transition the hardship exemption authority under section #ahdh7;a77#g7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7;a77#g771 section #ahhf7;b77#c77;,b77ix7 of such ,act 7#db ,u4,s4,c4 #acieww7b77#c77;,b77ix771 and other provisions of law in existence as of the date of the enactment of this ,act4 ,in developing such guidance1 the ,secretary may consult with the relevant ,federal agencies4 7f7 ,definitions 7#a7 ,certified ,,ehr technology ,paragraph 7#a7 of section #cjjj of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;jj7 is amended to read as follows3 7#a7 ,certified ,,ehr technology ,the term certified ,,ehr technology means a qualified electronic health record that is certified pursuant to section #cjja7;c77#e7 as meeting the certification criteria defined in subparagraph 7,b7 of such section that are applicable to the type of record involved 7as determined by the ,secretary1 such as an ambulatory electronic health record for office-based physicians or an inpatient hospital electronic health record for hospitals7 including1 beginning ,january #a1 #bjah1 with respect to which the vendor or other entity offering such technology is in compliance with the requirements under section #cjja7;c77#e77;,c77i74 4 7#b7 ,widespread interoperability ,section #cjjj of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;jj7 is amended by adding at the end the following new paragraph3 7#ae7 ,widespread interoperability ,the term widespread interoperability means that1 on a nationwide basis-- 7,a7 health information technology is interoperable1 in accordance with section #cjaj2 and 7,b7 such technology is employed by meaningful ,,ehr users under the ,medicare ,program under title ,,xviii of the ,social ,security ,act and the ,medicaid program under title ,,xix of such ,act and by other clinicians and health care providers4 4 7g7 ,conforming amendments 7#a7 ,voluntary use of standards ,section #cjjf of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;jj-#af7 is amended-- 7,a7 in subsection 7a77#a71 by inserting 1 including an interoperability standard or implementation specification1 with respect to such interoperability standard1 adopted under such section after section #cjjd4 7,b7 in subsection 7b71 by inserting 1 including the interoperability standards and implementation specifications1 with respect to such interoperability standards1 adopted under such section after section #cjjd4 7#b7 ,,hipaa privacy and security law definition correction ,section #cjji7;a77#b77;,a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;jj-#ai7;a77#b77;,a77 is amended by striking title ,,iv and inserting title ,,xiii4 7#c7 ,coordination of ,federal activities ,section #acaaa of the ,,hitech ,act is amended-- 7,a7 in subsection 7a71 by inserting before the period at the end the following3 7and1 beginning on ,january #a1 #bjah1 that are also interoperable under section #cjaj of such ,act and in compliance with interoperability standards and implementation specifications1 with respect to such interoperability standards1 adopted under section #cjjd of such ,act 72 and 7,b7 in subsection 7b71 by inserting 7and1 beginning on ,january #a1 #bjah1 including an interoperability standard or implementation specification1 with respect to such interoperability standard1 adopted under section #cjjd of such ,act7 before the ,president4 7#d7 ,application to private entities ,section #acaab of the ,,hitech ,act is amended by inserting before the period at the end the following3 7and1 beginning on ,january #a1 #bjah1 that are also interoperable under section #cjaj of such ,act and in compliance with interoperability standards and implementation specifications1 with respect to such interoperability standards1 adopted under section #cjjd of such ,act74 7#e7 ,,nist testing ,section #acbja of the ,,hitech ,act 7#db ,u4,s4,c4 #agiaa7 is amended-- 7,a7 in subsection 7a71 by inserting 7or1 beginning ,january #a1 #bjah1 in coordination with the entities with contracts under section #cjjc;,a1 with respect to standards1 and implementation specifications under section #cjjd7 before 1 the ,director2 7,b7 in subsection 7b71 by inserting 7or1 beginning ,january #a1 #bjah1 in coordination with the entities with contracts under section #cjjc;,a1 with respect to standards and implementation specifications under section #cjjd7 before 1 the ,director2 and 7,c7 by adding at the end the following new subsection3 7c7 ,funding ,for purposes of carrying out this section1 in addition to any other funds made available to carry out this section1 there is authorized to be appropriated #ae1jjj1jjj1 to remain available until expended4 4 7#f7 ,coordination with recommendations for achieving widespread ,,ehr interoperability ,section #ajf of the ,medicare ,access and ,,chip ,reauthorization ,act of #bjae 7,public ,law #aad-aj7 is amended by striking subsection 7b74 4 7h7 ,patient engagement and empowerment ,it is the sense of ,congress that-- 7#a7 if the strategic goals that ,congress set forth in the ,,hitech ,act are to be achieved1 interoperability is best achieved with individuals and authorized representatives having equal access to the health information of such individuals in electronic format2 7#b7 patients have the right to the entirety of the health information of such individuals1 including such information contained in an electronic health record of such individuals2 7#c7 such right extends to both structured and unstructured data2 7#d7 such right extends to authorized representatives of the individual involved1 such as caretakers of such individual1 family members of such individual1 and guardians of such individual2 and 7#e7 to further facilitate access of an individual to health information of such individual-- 7,a7 health care providers should not have the ability to deny a request of the individual for access to the entirety of such health information of such individual2 7,b7 health care providers do not need the consent of individuals to share personal health information of such individuals with other covered entities1 in compliance with the ,,hipaa privacy regulations promulgated pursuant to section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif for the purposes of supporting patient care1 except in situations where consent is specifically required under such regulations1 such as in cases related to the psychiatric records of the individual involved2 7,c7 mechanisms should be utilized that allow for the bidirectional exchange of information through such mechanisms as web portals1 appointments1 and prescription refills1 for the purpose of patients partnering with providers to assist in managing health and care2 7,d7 mechanisms described in subparagraph 7,c7 should allow for connecting individuals across the continuum of care2 7,e7 an individual has the right to access the health information of the individual without cost to the individual2 7,f7 mechanisms described in subparagraph 7,c7 should allow for data of an individual generated by the individual to be integrated into such platforms as electronic health records2 7,g7 such access should be timely1 in accordance with the ,,hipaa privacy regulations described in subparagraph 7,b71 and take into account communications preferences of the individual involved2 7,h7 an individual should have the right to be confident that the data in the electronic health record of the individual pertains to such individual2 and 7,i7 the right described in subparagraph 7,h7 will promote safety and care coordination for individuals4 ,b ,telehealth #cjba4 ,telehealth services under the ,medicare ,program 7a7 ,provision of information by ,centers for ,medicare ,medicaid ,services ,not later than #a year after the date of the enactment of this ,act1 the ,administrator of the ,centers for ,medicare ,medicaid ,services shall provide to the committees of jurisdiction of the ,house of ,representatives and the ,senate information on the following3 7#a7 ,the populations of ,medicare beneficiaries1 such as those who are dually eligible for the ,medicare ,program under title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq47 and the ,medicaid program under title ,,xix of such ,act 7#db ,u4,s4,c4 #acif et seq47 and those with chronic conditions1 whose care may be improved most in terms of quality and efficiency by the expansion1 in a manner that meets or exceeds the existing in-person standard of care under the ,medicare ,program under title ,,xviii of such ,act1 of telehealth services under section #ahcd7m77#d7 of such ,act 7#db ,u4,s4,c4 #aciem7m77#d774 7#b7 ,activities by the ,center for ,medicare and ,medicaid ,innovation which examine the use of telehealth services in models1 projects1 or initiatives funded through section #aaae;,a of the ,social ,security ,act 7#db ,u4,s4,c4 #acae;a74 7#c7 ,the types of high-volume services 7and related diagnoses7 under such title ,,xviii which might be suitable to the furnishing of services via telehealth4 7#d7 ,barriers that might prevent the expansion of telehealth services under section #ahcd7m77#d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77#d77 beyond such services that are in effect as of the date of the enactment of this ,act4 7b7 ,provision of information by ,med,p,a,c ,not later than ,march #ae1 #bjag1 the ,medicare ,payment ,advisory ,commission established under section #ahje of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;b-#f7 shall1 using quantitative and qualitative research methods1 provide information to the committees of jurisdiction of the ,house of ,representatives and the ,senate that identifies-- 7#a7 the telehealth services for which payment can be made1 as of the date of the enactment of this ,act1 under the fee-for-service program under parts ,a and ,b of title ,,xviii of such ,act2 7#b7 the telehealth services for which payment can be made1 as of such date1 under private health insurance plans2 7#c7 with respect to services identified under paragraph 7#b7 but not under paragraph 7#a71 ways in which payment for such services might be incorporated into such fee-for-service program 7including any recommendations for ways to accomplish this incorporation74 7c7 ,sense of ,congress ,it is the sense of ,congress that-- 7#a7 eligible originating sites should be expanded beyond those originating sites described in section #ahcd7m77#d77;,c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77#d77;,c772 and 7#b7 any expansion of telehealth services under the ,medicare ,program should-- 7,a7 recognize that telemedicine is the delivery of safe1 effective1 quality health care services1 by a health care provider1 using technology as the mode of care delivery2 7,b7 meet or exceed the conditions of coverage and payment with respect to the ,medicare ,program under title ,,xviii unless specifically address in subsequent statute1 of such ,act if the service were furnished in person1 including standards of care2 and 7,c7 involve clinically appropriate means to furnish such services4 ,c ,encouraging ,continuing ,medical ,education for ,physicians #cjda4 ,exempting from manufacturer transparency reporting certain transfers used for educational purposes 7a7 ,in general ,section #aabh;,g7e77#aj77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;h7e77#aj77;,b77 is amended-- 7#a7 in clause 7iii71 by inserting 1 including peer-reviewed journals1 journal reprints1 journal supplements1 medical conference reports1 and medical textbooks after patient use2 and 7#b7 by adding at the end the following new clause3 7xiii7 ,in the case of a covered recipient who is a physician1 an indirect payment or transfer of value to the covered recipient-- 7,i7 for speaking at1 or preparing educational materials for1 an educational event for physicians or other health care professionals that does not commercially promote a covered drug1 device1 biological1 or medical supply2 or 7,,ii7 that serves the sole purpose of providing the covered recipient with medical education1 such as by providing the covered recipient with the tuition required to attend an educational event or with materials provided to physicians at an educational event4 4 7b7 ,effective date ,the amendments made by this section shall apply with respect to transfers of value made on or after the date of the enactment of this ,act4 ,d ,disposable ,medical ,technologies #cjfa4 ,treatment of certain items and devices 7a7 ,in general ,section #ahcd of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7 is amended by adding at the end the following new subsection3 7r7 ,payment for certain disposable devices 7#a7 ,in general ,the ,secretary shall make separate payment in the amount established under paragraph 7#c7 to a home health agency for a device described in paragraph 7#b7 when furnished to an individual who receives home health services for which payment is made under section #ahie7;b74 7#b7 ,device described ,for purposes of paragraph 7#a71 a device described in this paragraph is a disposable device for which1 as of ,january #a1 #bjae1 there is-- 7,a7 a ,level ,i ,healthcare ,common ,procedure ,coding ,system 7,,hcpcs7 code for which the description for a professional service includes the furnishing of such device2 and 7,b7 a separate ,level ,i ,,hcpcs code for a professional service that uses durable medical equipment instead of such device4 7#c7 ,payment amount ,the ,secretary shall establish the separate payment amount for such a device such that such amount does not exceed the payment that would be made for the ,,hcpcs code described in paragraph 7#b77;,a7 under section #ahcc7t7 7relating to payment for covered ,,opd services74 4 7b7 ,conforming amendment ,section #ahfa7m77#e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7m77#e77 is amended by inserting and devices described in section #ahcd7r77#b7 after durable medical equipment4 7c7 ,effective date ,the amendments made by this section shall apply to devices furnished on or after ,january #a1 #bjag4 ,e ,local coverage decision reforms #cjha4 ,improvements in the ,medicare local coverage determination 7,,lcd7 process 7a7 ,in general ,section #ahfb7l77#e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciey7l77#e77 is amended by adding at the end the following new subparagraph3 7,d7 ,local coverage determinations ,the ,secretary shall require each ,medicare administrative contractor that develops a local coverage determination to make available on the website of such contractor and on the ,medicare website1 at least #de days before the effective date of such determination1 the following information3 7i7 ,such determination in its entirety4 7ii7 ,where and when the proposed determination was first made public4 7iii7 ,hyperlinks to the proposed determination and a response to comments submitted to the contractor with respect to such proposed determination4 7iv7 ,a summary of evidence that was considered by the contractor during the development of such determination and a list of the sources of such evidence4 7v7 ,an explanation of the rationale that supports such determination4 4 7b7 ,effective date ,the amendment made by subsection 7a7 shall apply with respect to local coverage determinations that are proposed or revised on or after the date that is #ahj days after the date of the enactment of this ,act4 ,f ,medicare ,pharmaceutical and ,technology ,ombudsman #caja4 ,medicare pharmaceutical and technology ombudsman ,section #ahjh7;c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;b-#i7;c77 is amended by adding at the end the following new paragraph3 7#d7 ,pharmaceutical and technology ombudsman ,not later than #ab months after the date of the enactment of this paragraph1 the ,secretary shall provide for a pharmaceutical and technology ombudsman within the ,centers for ,medicare ,medicaid ,services who shall receive and respond to complaints1 grievances1 and requests that-- 7,a7 are from entities that manufacture pharmaceutical1 biotechnology1 medical device1 or diagnostic products that are covered or for which coverage is being sought under this title2 and 7,b7 are with respect to coverage1 coding1 or payment under this title for such products4 ,the second sentence of paragraph 7#b7 shall apply to this paragraph in the same manner as such sentence applies to paragraph 7#b74 4 ,g ,medicare site-of-,service price transparency #caba4 ,medicare site-of-,service price transparency ,section #ahcd of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem71 as amended by section #cjfa1 is further amended by adding at the end the following new subsection3 7s7 ,site-of-,service price transparency 7#a7 ,in general ,in order to facilitate price transparency with respect to items and services for which payment may be made either to a hospital outpatient department or to an ambulatory surgical center under this title1 the ,secretary shall1 for #bjag and each year thereafter1 make available to the public via a searchable website1 with respect to an appropriate number of such items and services-- 7,a7 the estimated payment amount for the item or service under the outpatient department fee schedule under subsection 7t7 of section #ahcc and the ambulatory surgical center payment system under subsection 7i7 of such section2 and 7,b7 the estimated amount of beneficiary liability applicable to the item or service4 7#b7 ,calculation of estimated beneficiary liability ,for purposes of paragraph 7#a77;,b71 the estimated amount of beneficiary liability1 with respect to an item or service1 is the amount for such item or service for which an individual who does not have coverage under a ,medicare supplemental policy certified under section #ahhb or any other supplemental insurance coverage is responsible4 7#c7 ,implementation ,in carrying out this subsection1 the ,secretary-- 7,a7 shall include in the notice described in section #ahjd7;a7 a notification of the availability of the estimated amounts made available under paragraph 7#a72 and 7,b7 may utilize mechanisms in existence on the date of the enactment of this subsection1 such as the portion of the website of the ,centers for ,medicare ,medicaid ,services on which information comparing physician performance is posted 7commonly referred to as the ,physician ,compare website71 to make available such estimated amounts under such paragraph4 7#d7 ,funding ,for purposes of implementing this subsection1 the ,secretary shall provide for the transfer1 from the ,supplemental ,medical ,insurance ,trust ,fund under section #ahda to the ,centers for ,medicare ,medicaid ,services ,program ,management ,account1 of #f1jjj1jjj for fiscal year #bjae1 to remain available until expended4 4 ,h ,medicare ,part ,d ,patient ,safety and ,drug ,abuse ,prevention #cada4 ,programs to prevent prescription drug abuse under ,medicare parts ,c and ,d 7a7 ,drug management program for at-,risk beneficiaries 7#a7 ,in general ,section #ahfj;,d-#d7;c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aj7;c77 is amended by adding at the end the following3 7#e7 ,drug management program for at-risk beneficiaries 7,a7 ,authority to establish ,a ,,pdp sponsor may establish a drug management program for at-risk beneficiaries under which1 subject to subparagraph 7,b71 the ,,pdp sponsor may1 in the case of an at-risk beneficiary for prescription drug abuse who is an enrollee in a prescription drug plan of such ,,pdp sponsor1 limit such beneficiary's access to coverage for frequently abused drugs under such plan to frequently abused drugs that are prescribed for such beneficiary by one or more prescribers selected under subparagraph 7,d71 and dispensed for such beneficiary by one or more pharmacies selected under such subparagraph4 7,b7 ,requirement for notices 7i7 ,in general ,a ,,pdp sponsor may not limit the access of an at-risk beneficiary for prescription drug abuse to coverage for frequently abused drugs under a prescription drug plan until such sponsor-- 7,i7 provides to the beneficiary an initial notice described in clause 7ii7 and a second notice described in clause 7iii72 and 7,,ii7 verifies with the providers of the beneficiary that the beneficiary is an at-risk beneficiary for prescription drug abuse4 7ii7 ,initial notice ,an initial notice described in this clause is a notice that provides to the beneficiary-- 7,i7 notice that the ,,pdp sponsor has identified the beneficiary as potentially being an at-risk beneficiary for prescription drug abuse2 7,,ii7 information describing all ,state and ,federal public health resources that are designed to address prescription drug abuse to which the beneficiary has access1 including mental health services and other counseling services2 7,,iii7 notice of1 and information about1 the right of the beneficiary to appeal such identification under subsection 7h7 and the option of an automatic escalation to external review2 7,,iv7 a request for the beneficiary to submit to the ,,pdp sponsor preferences for which prescribers and pharmacies the beneficiary would prefer the ,,pdp sponsor to select under subparagraph 7,d7 in the case that the beneficiary is identified as an at-risk beneficiary for prescription drug abuse as described in clause 7iii77,i72 7,v7 an explanation of the meaning and consequences of the identification of the beneficiary as potentially being an at-risk beneficiary for prescription drug abuse1 including an explanation of the drug management program established by the ,,pdp sponsor pursuant to subparagraph 7,a72 7,,vi7 clear instructions that explain how the beneficiary can contact the ,,pdp sponsor in order to submit to the ,,pdp sponsor the preferences described in subclause 7,,iv7 and any other communications relating to the drug management program for at-risk beneficiaries established by the ,,pdp sponsor2 and 7,,vii7 contact information for other organizations that can provide the beneficiary with assistance regarding such drug management program 7similar to the information provided by the ,secretary in other standardized notices provided to part ,d eligible individuals enrolled in prescription drug plans under this part74 7iii7 ,second notice ,a second notice described in this clause is a notice that provides to the beneficiary notice-- 7,i7 that the ,,pdp sponsor has identified the beneficiary as an at-risk beneficiary for prescription drug abuse2 7,,ii7 that such beneficiary is subject to the requirements of the drug management program for at-risk beneficiaries established by such ,,pdp sponsor for such plan2 7,,iii7 of the prescriber 7or prescribers7 and pharmacy 7or pharmacies7 selected for such individual under subparagraph 7,d72 7,,iv7 of1 and information about1 the beneficiary's right to appeal such identification under subsection 7h7 and the option of an automatic escalation to external review2 7,v7 that the beneficiary can1 in the case that the beneficiary has not previously submitted to the ,,pdp sponsor preferences for which prescribers and pharmacies the beneficiary would prefer the ,,pdp sponsor select under subparagraph 7,d71 submit such preferences to the ,,pdp sponsor2 and 7,,vi7 that includes clear instructions that explain how the beneficiary can contact the ,,pdp sponsor4 7iv7 ,timing of notices 7,i7 ,in general ,subject to subclause 7,,ii71 a second notice described in clause 7iii7 shall be provided to the beneficiary on a date that is not less than #fj days after an initial notice described in clause 7ii7 is provided to the beneficiary4 7,,ii7 ,exception ,in the case that the ,,pdp sponsor1 in conjunction with the ,secretary1 determines that concerns identified through rulemaking by the ,secretary regarding the health or safety of the beneficiary or regarding significant drug diversion activities require the ,,pdp sponsor to provide a second notice described in clause 7iii7 to the beneficiary on a date that is earlier than the date described in subclause 7,i71 the ,,pdp sponsor may provide such second notice on such earlier date4 7,c7 ,at-risk beneficiary for prescription drug abuse 7i7 ,in general ,for purposes of this paragraph1 the term at-risk beneficiary for prescription drug abuse means a part ,d eligible individual who is not an exempted individual described in clause 7ii7 and-- 7,i7 who is identified as such an at-risk beneficiary through the use of clinical guidelines developed by the ,secretary in consultation with ,,pdp sponsors and other stakeholders described in section #cada7;f77#b77;,a7 of the #bast ,century ,cures ,act2 or 7,,ii7 with respect to whom the ,,pdp sponsor of a prescription drug plan1 upon enrolling such individual in such plan1 received notice from the ,secretary that such individual was identified under this paragraph to be an at-risk beneficiary for prescription drug abuse under the prescription drug plan in which such individual was most recently previously enrolled and such identification has not been terminated under subparagraph 7,f74 7ii7 ,exempted individual described ,an exempted individual described in this clause is an individual who-- 7,i7 receives hospice care under this title2 7,,ii7 is a resident of a long-term care facility1 of an intermediate care facility for the mentally retarded1 or of another facility for which frequently abused drugs are dispensed for residents through a contract with a single pharmacy2 or 7,,iii7 the ,secretary elects to treat as an exempted individual for purposes of clause 7i74 7,d7 ,selection of prescribers and pharmacies 7i7 ,in general ,with respect to each at-risk beneficiary for prescription drug abuse enrolled in a prescription drug plan offered by such sponsor1 a ,,pdp sponsor shall1 based on the preferences submitted to the ,,pdp sponsor by the beneficiary pursuant to clauses 7ii77,,iv7 and 7iii77,v7 of subparagraph 7,b7 7except as otherwise provided in this subparagraph71 select-- 7,i7 one or more individuals who are authorized to prescribe frequently abused drugs 7referred to in this paragraph as prescribers7 who may write prescriptions for such drugs for such beneficiary2 and 7,,ii7 one or more pharmacies that may dispense such drugs to such beneficiary4 7ii7 ,reasonable access ,in making the selections under this subparagraph-- 7,i7 a ,,pdp sponsor shall ensure that the beneficiary continues to have reasonable access to frequently abused drugs 7as defined in subparagraph 7,g771 taking into account geographic location1 beneficiary preference1 impact on costsharing1 and reasonable travel time2 and 7,,ii7 a ,,pdp sponsor shall ensure such access 7including access to prescribers and pharmacies with respect to frequently abused drugs7 in the case of individuals with multiple residences and in the case of natural disasters and similar emergency situations4 7iii7 ,beneficiary preferences ,if an at-risk beneficiary for prescription drug abuse submits preferences for which in-network prescribers and pharmacies the beneficiary would prefer the ,,pdp sponsor select in response to a notice under subparagraph 7,b71 the ,,pdp sponsor shall-- 7,i7 review such preferences2 7,,ii7 select or change the selection of prescribers and pharmacies for the beneficiary based on such preferences2 and 7,,iii7 inform the beneficiary of such selection or change of selection4 7iv7 ,exception regarding beneficiary preferences ,in the case that the ,,pdp sponsor determines that a change to the selection of prescriber or pharmacy under clause 7iii77,,ii7 by the ,,pdp sponsor is contributing or would contribute to prescription drug abuse or drug diversion by the beneficiary1 the ,,pdp sponsor may change the selection of prescriber or pharmacy for the beneficiary without regard to the preferences of the beneficiary described in clause 7iii74 7v7 ,confirmation ,before selecting a prescriber 7or prescribers7 or pharmacy 7or pharmacies7 under this subparagraph1 a ,,pdp sponsor must request and receive confirmation from such a prescriber or pharmacy acknowledging and accepting that the beneficiary involved is in the drug management program for at-risk beneficiaries4 7,e7 ,terminations and appeals ,the identification of an individual as an at-risk beneficiary for prescription drug abuse under this paragraph1 a coverage determination made under a drug management program for at-risk beneficiaries1 and the selection of prescriber or pharmacy under subparagraph 7,d7 with respect to such individual shall be subject to reconsideration and appeal under subsection 7h7 and the option of an automatic escalation to external review to the extent provided by the ,secretary4 7,f7 ,termination of identification 7i7 ,in general ,the ,secretary shall develop standards for the termination of identification of an individual as an at-risk beneficiary for prescription drug abuse under this paragraph4 ,under such standards such identification shall terminate as of the earlier of-- 7,i7 the date the individual demonstrates that the individual is no longer likely1 in the absence of the restrictions under this paragraph1 to be an at-risk beneficiary for prescription drug abuse described in subparagraph 7,c77i72 and 7,,ii7 the end of such maximum period of identification as the ,secretary may specify4 7ii7 ,rule of construction ,nothing in clause 7i7 shall be construed as preventing a plan from identifying an individual as an at-risk beneficiary for prescription drug abuse under subparagraph 7,c77i7 after such termination on the basis of additional information on drug use occurring after the date of notice of such termination4 7,g7 ,frequently abused drug ,for purposes of this subsection1 the term frequently abused drug means a drug that is a controlled substance that the ,secretary determines to be frequently abused or diverted4 7,h7 ,data disclosure ,in the case of an at-risk beneficiary for prescription drug abuse whose access to coverage for frequently abused drugs under a prescription drug plan has been limited by a ,,pdp sponsor under this paragraph1 such ,,pdp sponsor shall disclose data1 including any necessary individually identifiable health information1 in a form and manner specified by the ,secretary1 about the decision to impose such limitations and the limitations imposed by the sponsor under this part to other ,,pdp sponsors that request such data4 7,i7 ,education ,the ,secretary shall provide education to enrollees in prescription drug plans of ,,pdp sponsors and providers regarding the drug management program for at-risk beneficiaries described in this paragraph1 including education-- 7i7 provided by ,medicare administrative contractors through the improper payment outreach and education program described in section #ahgd;,a7h72 and 7ii7 through current education efforts 7such as ,state health insurance assistance programs described in subsection 7a77#a77;,a7 of section #aai of the ,medicare ,improvements for ,patients and ,providers ,act of #bjjh 7#db ,u4,s4,c4 #acie;b-#c note77 and materials directed toward such enrollees4 7,j7 ,application under ,,ma-,,pd plans ,pursuant to section #ahfj;,d-#ba7;c77#a71 the provisions of this paragraph apply under part ,d to ,,ma organizations offering ,,ma-,,pd plans to ,,ma eligible individuals in the same manner as such provisions apply under this part to a ,,pdp sponsor offering a prescription drug plan to a part ,d eligible individual4 4 7#b7 ,information for consumers ,section #ahfj;,d-#d7;a77#a77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;a77#a77;,b77 is amended by adding at the end the following3 7v7 ,the drug management program for at-risk beneficiaries under subsection 7c77#e74 4 7b7 ,utilization management programs ,section #ahfj;,d-#d7;c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;c771 as amended by subsection 7a77#a71 is further amended-- 7#a7 in paragraph 7#a71 by inserting after subparagraph 7,d7 the following new subparagraph3 7,e7 ,a utilization management tool to prevent drug abuse 7as described in paragraph 7#f77;,a774 2 and 7#b7 by adding at the end the following new paragraph3 7#f7 ,utilization management tool to prevent drug abuse 7,a7 ,in general ,a tool described in this paragraph is any of the following3 7i7 ,a utilization tool designed to prevent the abuse of frequently abused drugs by individuals and to prevent the diversion of such drugs at pharmacies4 7ii7 ,retrospective utilization review to identify-- 7,i7 individuals that receive frequently abused drugs at a frequency or in amounts that are not clinically appropriate2 and 7,,ii7 providers of services or suppliers that may facilitate the abuse or diversion of frequently abused drugs by beneficiaries4 7iii7 ,consultation with the contractor described in subparagraph 7,b7 to verify if an individual enrolling in a prescription drug plan offered by a ,,pdp sponsor has been previously identified by another ,,pdp sponsor as an individual described in clause 7ii77,i74 7,b7 ,reporting ,a ,,pdp sponsor offering a prescription drug plan 7and an ,,ma organization offering an ,,ma-,,pd plan7 in a ,state shall submit to the ,secretary and the ,medicare drug integrity contractor with which the ,secretary has entered into a contract under section #ahic with respect to such ,state a report1 on a monthly basis1 containing information on-- 7i7 any provider of services or supplier described in subparagraph 7,a77ii77,,ii7 that is identified by such plan sponsor 7or organization7 during the #cj-;day period before such report is submitted2 and 7ii7 the name and prescription records of individuals described in paragraph 7#e77;,c74 4 7c7 ,expanding ,activities of ,medicare ,drug ,integrity ,contractors 7,m,e,d,i,cs7 7#a7 ,in general ,section #ahic of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;ddd7 is amended by adding at the end the following new subsection3 7j7 ,expanding ,activities of ,medicare ,drug ,integrity ,contractors 7,m,e,d,i,cs7 7#a7 ,access to information ,under contracts entered into under this section with ,medicare drug integrity contractors 7including any successor entity to a ,medicare drug integrity contractor71 the ,secretary shall authorize such contractors to directly accept prescription and necessary medical records from entities such as pharmacies1 prescription drug plans1 ,,ma-,,pd plans1 and physicians with respect to an individual in order for such contractors to provide information relevant to the determination of whether such individual is an at-risk beneficiary for prescription drug abuse1 as defined in section #ahfj;,d-#d7;c77#e77;,c74 7#b7 ,requirement for acknowledgment of referrals ,if a ,,pdp sponsor or ,,ma organization refers information to a contractor described in paragraph 7#a7 in order for such contractor to assist in the determination described in such paragraph1 the contractor shall-- 7,a7 acknowledge to the sponsor or organization receipt of the referral2 and 7,b7 in the case that any ,,pdp sponsor or ,,ma organization contacts the contractor requesting to know the determination by the contractor of whether or not an individual has been determined to be an individual described such paragraph1 shall inform such sponsor or organization of such determination on a date that is not later than #ae days after the date on which the sponsor or organization contacts the contractor4 7#c7 ,making data available to other entities 7,a7 ,in general ,for purposes of carrying out this subsection1 subject to subparagraph 7,b71 the ,secretary shall authorize ,m,e,d,i,cs to respond to requests for information from ,,pdp sponsors and ,,ma organizations1 ,state prescription drug monitoring programs1 and other entities delegated by such sponsors or organizations using available programs and systems in the effort to prevent fraud1 waste1 and abuse4 7,b7 ,,hipaa compliant information only ,information may only be disclosed by a ,,medic under subparagraph 7,a7 if the disclosure of such information is permitted under the ,federal regulations 7concerning the privacy of individually identifiable health information7 promulgated under section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif 7#db ,u4,s4,c4 #acbj;d-#b note74 4 7#b7 ,,oig study and report on effectiveness of ,m,e,d,i,cs 7,a7 ,study ,the ,inspector ,general of the ,department of ,health and ,human ,services shall conduct a study on the effectiveness of ,medicare drug integrity contractors with which the ,secretary of ,health and ,human ,services has entered into a contract under section #ahic of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;ddd7 in identifying1 combating1 and preventing fraud under the ,medicare ,program1 including under the authority provided under section #ahic7;j7 of the ,social ,security ,act1 added by paragraph 7#a74 7,b7 ,report ,not later than #a year after the date of the enactment of this ,act1 the ,inspector ,general shall submit to ,congress a report on the study conducted under subparagraph 7,a74 ,such report shall include such recommendations for improvements in the effectiveness of such contractors as the ,inspector ,general determines appropriate4 7d7 ,treatment of certain complaints for purposes of quality or performance assessment ,section #ahfj;,d-#db of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aeb7 is amended by adding at the end the following new subsection3 7d7 ,treatment of certain complaints for purposes of quality or performance assessment ,in conducting a quality or performance assessment of a ,,pdp sponsor1 the ,secretary shall develop or utilize existing screening methods for reviewing and considering complaints that are received from enrollees in a prescription drug plan offered by such ,,pdp sponsor and that are complaints regarding the lack of access by the individual to prescription drugs due to a drug management program for at-risk beneficiaries4 4 7e7 ,sense of congress regarding use of technology tools ,to combat fraud ,it is the sense of ,congress that ,,ma organizations and ,,pdp sponsors should consider using e-prescribing and other health information technology tools to support combating fraud under ,,ma-,,pd plans and prescription drug plans under parts ,c and ,d of the ,medicare ,program4 7f7 ,effective date 7#a7 ,in general ,the amendments made by this section shall apply to prescription drug plans 7and ,,ma-,,pd plans7 for plan years beginning more than #a year after the date of the enactment of this ,act4 7#b7 ,stakeholder meetings prior to effective date 7,a7 ,in general ,not later than ,january #a1 #bjaf1 the ,secretary of ,health and ,human ,services shall convene stakeholders1 including individuals entitled to benefits under part ,a of title ,,xviii of the ,social ,security ,act or enrolled under part ,b of such title of such ,act1 advocacy groups representing such individuals1 physicians1 pharmacists1 and other clinicians1 retail pharmacies1 plan sponsors1 entities delegated by plan sponsors1 and biopharmaceutical manufacturers for input regarding the topics described in subparagraph 7,b74 7,b7 ,topics described ,the topics described in this subparagraph are the topics of-- 7i7 the anticipated impact of drug management programs for at-risk beneficiaries under paragraph 7#e7 of section #ahfj;,d-#d7;c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;c77 on cost-sharing and ensuring accessibility to prescription drugs for enrollees in prescription drug plans of ,,pdp sponsors1 and enrollees in ,,ma-,,pd plans1 who are at-risk beneficiaries for prescription drug abuse 7as defined in subparagraph 7,c7 of such paragraph72 7ii7 the use of an expedited appeals process under which such an enrollee may appeal an identification of such enrollee as an at-risk beneficiary for prescription drug abuse under such paragraph 7similar to the processes established under the ,medicare ,advantage program under part ,c of title ,,xviii of the ,social ,security ,act that allow an automatic escalation to external review of claims submitted under such part72 7iii7 the types of enrollees that should be treated as exempted individuals1 as described in subparagraph 7,c77ii7 of such paragraph2 7iv7 the manner in which terms and definitions in such paragraph should be applied1 such as the use of clinical appropriateness in determining whether an enrollee is an at-risk beneficiary for prescription drug abuse as defined in subparagraph 7,c7 of such paragraph2 7v7 the information to be included in the notices described in subparagraph 7,b7 of such paragraph and the standardization of such notices2 and 7vi7 with respect to a ,,pdp sponsor 7or ,medicare ,advantage organization7 that establishes a drug management program for at-risk beneficiaries under such paragraph1 the responsibilities of such ,,pdp sponsor 7or organization7 with respect to the implementation of such program4 7g7 ,rulemaking ,the ,secretary of ,health and ,human ,services shall promulgate regulations based on the input gathered pursuant to subsection 7f77#b77;,a74 ,,iv ,medicaid1 ,medicare1 and ,other ,reforms ,a ,medicaid and ,medicare ,reforms #djja4 ,limiting ,federal ,medicaid reimbursement to ,states for durable medical equipment 7,,dme7 to ,medicare payment rates 7a7 ,medicaid reimbursement 7#a7 ,in general ,section #aijc7;i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7i77 is amended-- 7,a7 in paragraph 7#be71 by striking or at the end2 7,b7 in paragraph 7#bf71 by striking the period at the end and inserting 2 or2 and 7,c7 by inserting after paragraph 7#bf7 the following new paragraph3 7#bg7 with respect to any amounts expended by the ,state on the basis of a fee schedule for items described in section #ahfa7n71 as determined in the aggregate with respect to each class of such items as defined by the ,secretary1 in excess of the aggregate amount1 if any1 that would be paid for such items within such class on a fee-for-service basis under the program under part ,b of title ,,xviii1 including1 as applicable1 under a competitive acquisition program under section #ahdg in an area of the ,state4 4 7#b7 ,effective date ,the amendments made by this subsection shall be effective with respect to payments for items furnished on or after ,january #a1 #bjbj4 7b7 ,medicare ombudsman ,section #ahjh7;c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;b7c771 as amended by section #caja1 is further amended by adding at the end the following new paragraph3 7#e7 ,monitoring ,,dme reimbursement under ,medicaid ,the ombudsmen under each of paragraphs 7#a7 and 7#d7 shall evaluate the impact of the competitive acquisition program under section #ahdg1 including as applied under section #aijc7;i77#bg71 on beneficiary health status and health outcomes4 4 #djjb4 ,excluding authorized generics from calculation of average manufacturer price 7a7 ,in general ,subparagraph 7,c7 of section #aibg7k77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77#a77 is amended-- 7#a7 in the subparagraph heading1 by striking ,inclusion and inserting ,exclusion2 7#b7 by striking a new drug application and inserting the manufacturer's new drug application2 and 7#c7 by striking inclusive and inserting exclusive4 7b7 ,effective date ,the amendments made by this section take effect on ,october #a1 #bjae4 #djjc4 ,medicare payment incentive for the transition from traditional x-ray imaging to digital radiography and other ,medicare imaging payment provision 7a7 ,physician fee schedule 7#a7 ,payment incentive for transition 7,a7 ,in general ,section #ahdh7;b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7;b77 is amended by adding at the end the following new paragraph3 7#i7 ,special rule to incentivize transition from traditional x-ray imaging to digital radiography 7,a7 ,limitation on payment for film x-ray imaging services ,in the case of an imaging service 7including the imaging portion of a service7 that is an ,x-ray taken using film and that is furnished during #bjag or a subsequent year1 the payment amount for the technical component 7including the technical component portion of a global service7 of such service that would otherwise be determined under this section 7without application of this paragraph and before application of any other adjustment under this section7 for such year shall be reduced by #bj percent4 7,b7 ,phased-in limitation on payment for computed radiography imaging services ,in the case of an imaging service 7including the imaging portion of a service7 that is an ,x-ray taken using computed radiography technology-- 7i7 in the case of such a service furnished during #bjah1 #bjai1 #bjbj1 #bjba1 or #bjbb1 the payment amount for the technical component 7including the technical component portion of a global service7 of such service that would otherwise be determined under this section 7without application of this paragraph and before application of any other adjustment under this section7 for such year shall be reduced by #g percent2 and 7ii7 in the case of such a service furnished during #bjbc or a subsequent year1 the payment amount for the technical component 7including the technical component portion of a global service7 of such service that would otherwise be determined under this section 7without application of this paragraph and before application of any other adjustment under this section7 for such year shall be reduced by #aj percent4 7,c7 ,computed radiography technology defined ,for purposes of this paragraph1 the term computed radiography technology means cassette-based imaging which utilizes an imaging plate to create the image involved4 7,d7 ,implementation ,in order to implement this paragraph1 the ,secretary shall adopt appropriate mechanisms which may include use of modifiers4 4 7,b7 ,exemption from budget neutrality ,section #ahdh7;c77#b77;,b77v7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7;c77#b77;,b77v77 is amended by adding at the end the following new subclause3 7,x7 ,reduced expenditures attributable to incentives to transition to digital radiography ,effective for fee schedules established beginning with #bjag1 reduced expenditures attributable to subparagraph 7,a7 of subsection 7b77#i7 and effective for fee schedules established beginning with #bjah1 reduced expenditures attributable to subparagraph 7,b7 of such subsection4 4 7#b7 ,elimination of application of multiple procedure payment reduction 7,a7 ,in general ,section #ahdh7;b77#d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7;b77#d77 is amended by adding at the end the following new subparagraph3 7,e7 ,elimination of application of multiple procedure payment reduction 7i7 ,in general ,for services furnished on or after ,january #a1 #bjag1 the ,secretary shall not apply a multiple procedure payment reduction to the professional component of imaging services unless the ,secretary has published as part of a ,medicare ,physician ,fee ,schedule ,proposed ,rule the empirical analysis described in clause 7ii7 with tables made available on the website of the ,centers for ,medicare ,medicaid ,services4 7ii7 ,empirical analysis described ,the empirical analysis described in this clause is an analysis of the ,resource-,based ,relative ,value ,scale ,data ,manager information or other information that is used to determine what1 if any1 efficiencies exist within the professional component of imaging services when two or more studies are furnished to the same individual on the same day4 ,such empirical analysis shall include-- 7,i7 information detailing which physician work activities overlap and the reductions applicable to such overlap2 7,,ii7 a discussion of the clinical aspects that informed the assignment of the reduction percentages described in subclause 7,i72 7,,iii7 to the extent that such reductions are used for proposed payment reductions1 an explanation of how the percentage reductions for pre-service1 intra-service1 and post-service work were determined and calculated2 7,,iv7 other data used to determine a reduction2 and 7,v7 a demonstration that the ,secretary has consulted with practicing radiologists to gain knowledge of how radiologists interpret studies of multiple body parts on the same individual on the same day4 4 7,b7 ,conforming amendment ,section #bbj7;i7 of the ,protecting ,access to ,medicare ,act of #bjad 7#db ,u4,s4,c4 #aciew-#d note7 is repealed4 7b7 ,payment incentive for transition under hospital outpatient prospective payment system ,section #ahcc7t77#af7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acie7t77#af77 is amended by adding at the end the following new subparagraph3 7,f7 ,payment incentive for the transition from traditional x-ray imaging to digital radiography ,notwithstanding the previous provisions of this subsection3 7i7 ,limitation on payment for film x-ray imaging services ,in the case of an imaging service that is an ,x-ray taken using film and that is furnished during #bjag or a subsequent year1 the payment amount for such service 7including the ,x-ray component of a packaged service7 that would otherwise be determined under this section 7without application of this paragraph and before application of any other adjustment under this subsection7 for such year shall be reduced by #bj percent4 7ii7 ,phased-in limitation on payment for computed radiography imaging services ,in the case of an imaging service that is an ,x-ray taken using computed radiography technology 7as defined in section #ahdh7;b77#i77;,c77-- 7,i7 in the case of such a service furnished during #bjah1 #bjai1 #bjbj1 #bjba1 or #bjbb1 the payment amount for such service 7including the ,x-ray component of a packaged service7 that would otherwise be determined under this section 7without application of this paragraph and before application of any other adjustment under this subsection7 for such year shall be reduced by #g percent2 and 7,,ii7 in the case of such a service furnished during #bjbc or a subsequent year1 the payment amount for such service 7including the ,x-ray component of a packaged service7 that would otherwise be determined under this section 7without application of this paragraph and before application of any other adjustment under this subsection7 for such year shall be reduced by #aj percent4 7iii7 ,application without regard to budget neutrality ,the reductions made under this paragraph-- 7,i7 shall not be considered an adjustment under paragraph 7#b77;,e72 and 7,,ii7 shall not be implemented in a budget neutral manner4 7iv7 ,implementation ,in order to implement this subparagraph1 the ,secretary shall adopt appropriate mechanisms which may include use of modifiers4 4 #djjd4 ,treatment of infusion drugs furnished through durable medical equipment ,section #ahdb7o77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieu7o77#a77 is amended-- 7#a7 in subparagraph 7,c71 by inserting 7and including a drug or biological described in subparagraph 7,d77i7 furnished on or after ,january #a1 #bjag7 after #bjje2 and 7#b7 in subparagraph 7,d7-- 7,a7 by striking infusion drugs and inserting infusion drugs or biologicals each place it appears2 and 7,b7 in clause 7i7-- 7i7 by striking #bjjd and inserting #bjjd1 and before ,january #a1 #bjag2 and 7ii7 by striking for such drug4 #djje4 ,extension and expansion of prior authorization for power mobility devices 7,p,m,ds7 and accessories and prior authorization audit limitations ,section #ahcd7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7a77 is amended-- 7#a7 in paragraph 7#ae71 by adding at the end the following new subparagraph3 7,d7 ,limitation on audits after advance determination ,a claim for an item that has received a provisional affirmation under an advance determination under this paragraph or a prior authorization under paragraph 7#bc7 shall not be subject to review under section #ahic7;h7 but may be subject to audits for potential fraud1 inappropriate utilization1 changes in billing patterns1 or information that could not have been considered during the advance determination 7such as proof of item delivery74 2 and 7#b7 by adding at the end the following new paragraph3 7#bc7 ,prior authorization for power mobility devices 7,p,m,ds7 and accessories ,not later than #ij days after the date of the enactment of this paragraph1 the ,secretary shall1 using funds provided under paragraph 7#b7 of section #djb7;a7 of the ,social ,security ,amendments of #aifg and other funds available to the ,secretary-- 7,a7 extend at least through ,august #ca1 #bjah1 the ,,pmd ,prior ,authorization ,demonstration 7being conducted under paragraph 7#a77;,j7 of such section72 7,b7 begin to expand1 as appropriate1 such demonstration to include additional power mobility devices and accessories as part of initial claims for payment under this part for such devices2 and 7,c7 begin to expand such demonstration to such additional ,states or geographic areas as may be appropriate4 4 #djjf4 ,civil monetary penalties for violations related to grants1 contracts1 and other agreements 7a7 ,in general ,section #aabh;,a of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;a7 is amended by adding at the end the following new subsection3 7o7 ,any person 7including an organization1 agency1 or other entity1 but excluding a program beneficiary1 as defined in subsection 7r77#d77 that1 with respect to a grant1 contract1 or other agreement for which the ,secretary of ,health and ,human ,services provides funding-- 7#a7 knowingly presents or causes to be presented a specified claim 7as defined in subsection 7r77#f77 under such grant1 contract1 or other agreement that the person knows or should know is false or fraudulent2 7#b7 knowingly makes1 uses1 or causes to be made or used any false statement1 omission1 or misrepresentation of a material fact in any application1 proposal1 bid1 progress report1 or other document that is required to be submitted in order to directly or indirectly receive or retain funds provided in whole or in part by such ,secretary pursuant to such grant1 contract1 or other agreement2 7#c7 knowingly makes1 uses1 or causes to be made or used1 a false record or statement material to a false or fraudulent specified claim under such grant1 contract1 or other agreement2 7#d7 knowingly makes1 uses1 or causes to be made or used1 a false record or statement material to an obligation to pay or transmit funds or property to such ,secretary with respect to such grant1 contract1 or other agreement1 or knowingly conceals or knowingly and improperly avoids or decreases an obligation to pay or transmit funds or property to such ,secretary with respect to such grant1 contract1 or other agreement2 or 7#e7 fails to grant timely access1 upon reasonable request 7as defined by such ,secretary in regulations71 to the ,inspector ,general of the ,department1 for the purpose of audits1 investigations1 evaluations1 or other statutory functions of such ,inspector ,general in matters involving such grants1 contracts1 or other agreements2 shall be subject1 in addition to any other penalties that may be prescribed by law1 to a civil money penalty in cases under paragraph 7#a71 of not more than #aj1jjj for each specified claim2 in cases under paragraph 7#b71 not more than #ej1jjj for each false statement1 omission1 or misrepresentation of a material fact2 in cases under paragraph 7#c71 not more than #ej1jjj for each false record or statement2 in cases under paragraph 7#d71 not more than #ej1jjj for each false record or statement or #aj1jjj for each day that the person knowingly conceals or knowingly and improperly avoids or decreases an obligation to pay2 or in cases under paragraph 7#e71 not more than #ae1jjj for each day of the failure described in such paragraph4 ,in addition1 in cases under paragraphs 7#a7 and 7#c71 such a person shall be subject to an assessment of not more than #c times the amount claimed in the specified claim described in such paragraph in lieu of damages sustained by the ,united ,states or a specified ,state agency because of such specified claim1 and in cases under paragraphs 7#b7 and 7#d71 such a person shall be subject to an assessment of not more than #c times the total amount of the funds described in paragraph 7#b7 or 7#d71 respectively 7or1 in the case of an obligation to transmit property to the ,secretary ,health and ,human ,services described in paragraph 7#d71 of the value of the property described in such paragraph7 in lieu of damages sustained by the ,united ,states or a specified ,state agency because of such case4 ,in addition1 the ,secretary of ,health and ,human ,services may make a determination in the same proceeding to exclude the person from participation in the ,federal health care programs 7as defined in section #aabh;,b7f77#a77 and to direct the appropriate ,state agency to exclude the person from participation in any ,state health care program4 7p7 ,the provisions of subsections 7c71 7d71 and 7g7 shall apply to a civil money penalty or assessment under subsection 7o7 in the same manner as such provisions apply to a penalty1 assessment1 or proceeding under subsection 7a74 7q7 ,with respect to a penalty or assessment under subsection 7o71 the ,inspector ,general of the ,department is authorized to receive1 and to retain for current use1 such amounts of such penalty or assessment as are necessary to provide reimbursement for the costs of conducting investigations and audits with respect to such subsection and for monitoring compliance plans with respect to such subsection when such penalty or assessment is ordered by a court1 voluntarily agreed to by the payor1 or otherwise4 ,funds received by such ,inspector ,general as reimbursement under the preceding sentence shall be deposited to the credit of the appropriations from which initially paid1 or to appropriations for similar purposes currently available at the time of deposit1 and shall remain available for obligation for #a year from the date of the deposit of such funds4 7r7 ,for purposes of this subsection and subsections 7o71 7p71 and 7q73 7#a7 ,the term ,department means the ,department of ,health and ,human ,services4 7#b7 ,the term material means having a natural tendency to influence1 or be capable of influencing1 the payment or receipt of money or property4 7#c7 ,the term other agreement includes a cooperative agreement1 scholarship1 fellowship1 loan1 subsidy1 payment for a specified use1 donation agreement1 award1 or sub-award 7regardless of whether one or more of the persons entering into the agreement is a contractor or sub-contractor74 7#d7 ,the term program beneficiary means1 in the case of a grant1 contract1 or other agreement designed to accomplish the objective of awarding or otherwise furnishing benefits or assistance to individuals and for which the ,secretary of ,health and ,human ,services provides funding1 an individual who applies for1 or who receives1 such benefits or assistance from such grant1 contract1 or other agreement4 ,such term does not include1 with respect to such grant1 contract1 or other agreement1 an officer1 employee1 or agent of a person or entity that receives such grant or that enters into such contract or other agreement4 7#e7 ,the term recipient includes a sub-recipient or subcontractor4 7#f7 ,the term specified claim means any application1 request1 or demand under a grant1 contract1 or other agreement for money or property1 whether or not the ,united ,states or a specified ,state agency has title to the money or property1 that is not a claim 7as defined in subsection 7i77#b77 and that-- 7,a7 is presented or caused to be presented to an officer1 employee1 or agent of the ,department or agency thereof1 or of any specified ,state agency2 or 7,b7 is made to a contractor1 grantee1 or any other recipient if the money or property is to be spent or used on the ,department's behalf or to advance a ,department program or interest1 and if the ,department-- 7i7 provides or has provided any portion of the money or property requested or demanded2 or 7ii7 will reimburse such contractor1 grantee or other recipient for any portion of the money or property which is requested or demanded4 7#g7 ,the term specified ,state agency means an agency of a ,state government established or designated to administer or supervise the administration of a grant1 contract1 or other agreement funded in whole or in part by the ,secretary of ,health and ,human ,services4 7s7 ,for purposes of subsection 7o71 the term obligation means an established duty1 whether or not fixed1 arising from an express or implied contractual1 grantor-grantee1 or licensor-licensee relationship1 for a fee-based or similar relationship1 from statute or regulation1 or from the retention of any overpayment4 4 7b7 ,conforming amendments ,section #aabh;,a of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;a7 is amended-- 7#a7 in subsection 7d7-- 7,a7 in paragraph 7#a71 by inserting or specified claims after claims2 and 7,b7 in paragraph 7#b71 by inserting or specified claims after claims2 7#b7 in subsection 7e71 by inserting or specified claim after claim2 and 7#c7 in subsection 7f7-- 7,a7 by inserting or specified claim 7as defined in subsection 7r77#f77 after district where the claim2 7,b7 by inserting 7or1 with respect to a person described in subsection 7o71 the person7 after claimant2 7,c7 by inserting that are not received by the ,inspector ,general of the ,department of ,health and ,human ,services under subsection 7q7 as reimbursement after amounts recovered2 and 7,d7 by inserting 7or1 in the case of a penalty or assessment under subsection 7o71 by a specified ,state agency 7as defined in subsection 7r77#g77 after or a ,state agency4 ,b ,other ,reforms #djda4 ,,spr drawdown 7a7 ,drawdown and sale ,notwithstanding section #afa of the ,energy ,policy and ,conservation ,act 7#db ,u4,s4,c4 #fbda71 except as provided in subsection 7b7 the ,secretary of ,energy shall draw down and sell-- 7#a7 #d million barrels of crude oil from the ,strategic ,petroleum ,reserve during fiscal year #bjah2 7#b7 #e million barrels of crude oil from the ,strategic ,petroleum ,reserve during fiscal year #bjai2 7#c7 #h million barrels of crude oil from the ,strategic ,petroleum ,reserve during fiscal year #bjbj2 7#d7 #h million barrels of crude oil from the ,strategic ,petroleum ,reserve during fiscal year #bjba2 7#e7 #aj million barrels of crude oil from the ,strategic ,petroleum ,reserve during fiscal year #bjbb2 7#f7 #ae million barrels of crude oil from the ,strategic ,petroleum ,reserve during fiscal year #bjbc2 7#g7 #ae million barrels of crude oil from the ,strategic ,petroleum ,reserve during fiscal year #bjbd2 and 7#h7 #ae million barrels of crude oil from the ,strategic ,petroleum ,reserve during fiscal year #bjbe4 ,amounts received for a sale under this subsection shall be deposited in the ,general ,fund of the ,treasury during the fiscal year in which the sale occurs4 7b7 ,emergency protection ,the ,secretary shall not draw down and sell crude oil under this section in amounts that would result in a ,strategic ,petroleum ,reserve that contains an inventory of petroleum products representing less than #ij days of emergency reserves1 based on the average daily level of net imports of crude oil and petroleum products in the previous calendar year4 7c7 ,proceeds ,proceeds from a sale under this section shall be deposited into the general fund of the ,treasury of the ,united ,states4 ,c ,miscellaneous #djfa4 ,lyme disease and other tick-borne diseases 7a7 ,in general ,title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bda et seq47 is amended by adding at the end the following new part3 ,w ,lyme disease and other tick-borne diseases #cii,,oo4 ,research 7a7 ,in general ,the ,secretary shall conduct or support epidemiological1 basic1 translational1 and clinical research regarding ,lyme disease and other tick-borne diseases4 7b7 ,biennial reports ,the ,secretary shall ensure that each biennial report under section #djc includes information on actions undertaken by the ,national ,institutes of ,health to carry out subsection 7a7 with respect to ,lyme disease and other tick-borne diseases1 including an assessment of the progress made in improving the outcomes of ,lyme disease and such other tick-borne diseases4 #cii,,oo-#a4 ,working ,group 7a7 ,establishment ,the ,secretary shall establish a permanent working group1 to be known as the ,interagency ,lyme and ,tick-,borne ,disease ,working ,group 7in this section and section #cii,,oo-#b referred to as the ,working ,group71 to review all efforts within the ,department of ,health and ,human ,services concerning ,lyme disease and other tick-borne diseases to ensure interagency coordination1 minimize overlap1 and examine research priorities4 7b7 ,responsibilities ,the ,working ,group shall-- 7#a7 not later than #bd months after the date of enactment of this part1 and every #bd months thereafter1 develop or update a summary of-- 7,a7 ongoing ,lyme disease and other tick-borne disease research related to causes1 prevention1 treatment1 surveillance1 diagnosis1 diagnostics1 duration of illness1 intervention1 and access to services and supports for individuals with ,lyme disease or other tick-borne diseases2 7,b7 advances made pursuant to such research2 7,c7 the engagement of the ,department of ,health and ,human ,services with persons that participate at the public meetings required by paragraph 7#e72 and 7,d7 the comments received by the ,working ,group at such public meetings and the ,secretary's response to such comments2 7#b7 ensure that a broad spectrum of scientific viewpoints is represented in each such summary2 7#c7 monitor ,federal activities with respect to ,lyme disease and other tick-borne diseases2 7#d7 make recommendations to the ,secretary regarding any appropriate changes to such activities2 and 7#e7 ensure public input by holding annual public meetings that address scientific advances1 research questions1 surveillance activities1 and emerging strains in species of pathogenic organisms4 7c7 ,membership 7#a7 ,in general ,the ,working ,group shall be composed of a total of #ad members as follows3 7,a7 ,federal members ,seven ,federal members1 consisting of one or more representatives of each of-- 7i7 the ,office of the ,assistant ,secretary for ,health2 7ii7 the ,food and ,drug ,administration2 7iii7 the ,centers for ,disease ,control and ,prevention2 7iv7 the ,national ,institutes of ,health2 and 7v7 such other agencies and offices of the ,department of ,health and ,human ,services as the ,secretary determines appropriate4 7,b7 ,non-,federal public members ,seven non-,federal public members1 consisting of representatives of the following categories3 7i7 ,physicians and other medical providers with experience in diagnosing and treating ,lyme disease and other tick-borne diseases4 7ii7 ,scientists or researchers with expertise4 7iii7 ,patients and their family members4 7iv7 ,nonprofit organizations that advocate for patients with respect to ,lyme disease and other tick-borne diseases4 7v7 ,other individuals whose expertise is determined by the ,secretary to be beneficial to the functioning of the ,working ,group4 7#b7 ,appointment ,the members of the ,working ,group shall be appointed by the ,secretary1 except that of the non-,federal public members under paragraph 7#a77;,b7-- 7,a7 one shall be appointed by the ,speaker of the ,house of ,representatives2 and 7,b7 one shall be appointed by the majority leader of the ,senate4 7#c7 ,diversity of scientific perspectives ,in making appointments under paragraph 7#b71 the ,secretary1 the ,speaker of the ,house of ,representatives1 and the majority leader of the ,senate shall ensure that the non-,federal public members of the ,working ,group represent a diversity of scientific perspectives4 7#d7 ,terms ,the non-,federal public members of the ,working ,group shall each be appointed to serve a #d-year term and may be reappointed at the end of such term4 7d7 ,meetings ,the ,working ,group shall meet as often as necessary1 as determined by the ,secretary1 but not less than twice each year4 7e7 ,applicability of ,,faca ,the ,working ,group shall be treated as an advisory committee subject to the ,federal ,advisory ,committee ,act4 7f7 ,reporting ,not later than #bd months after the date of enactment of this part1 and every #bd months thereafter1 the ,working ,group-- 7#a7 shall submit a report on its activities1 including an up-to-date summary under subsection 7b77#a7 and any recommendations under subsection 7b77#d71 to the ,secretary1 the ,committee on ,energy and ,commerce of the ,house of ,representatives1 and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate2 7#b7 shall make each such report publicly available on the website of the ,department of ,health and ,human ,services2 and 7#c7 shall allow any member of the ,working ,group to include in any such report minority views4 #cii,,oo-#b4 ,strategic plan ,not later than #c years after the date of enactment of this section1 and every #e years thereafter1 the ,secretary shall submit to the ,congress a strategic plan1 informed by the most recent summary under section #cii,,oo-#a7;b77#a71 for the conduct and support of ,lyme disease and tick-borne disease research1 including-- 7#a7 proposed budgetary requirements2 7#b7 a plan for improving outcomes of ,lyme disease and other tick-borne diseases1 including progress related to chronic or persistent symptoms and chronic or persistent infection and co-infections2 7#c7 a plan for improving diagnosis1 treatment1 and prevention2 7#d7 appropriate benchmarks to measure progress on achieving the improvements described in paragraphs 7#b7 and 7#c72 and 7#e7 a plan to disseminate each summary under section #cii,,oo-#a7;b77#a7 and other relevant information developed by the ,working ,group to the public1 including health care providers1 public health departments1 and other relevant medical groups4 4 7b7 ,no additional authorization of appropriations ,no additional funds are authorized to be appropriated for the purpose of carrying out this section and the amendment made by this section1 and this section and such amendment shall be carried out using amounts otherwise available for such purpose4 #djfb4 ,outreach to historically black colleges and universities ,the ,secretary of ,health and ,human ,services shall conduct outreach to historically ,black colleges and universities1 ,hispanic-serving institutions1 ,native ,american colleges1 and rural colleges to ensure that health professionals from underrepresented populations are aware of research opportunities under this ,act4 ,passed the ,house of ,representatives ,july #aj1 #bjae4;,clerk4