118 HR 3433 EH: Give Kids a Chance Act of 2024
U.S. House of Representatives
text/xml
EN
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1.Short title; table of contents
(a)This Act may be cited as the Give Kids a Chance Act of 2024
. (b)The table of contents for this Act is as follows:
Sec. 1. Short title; table of contents.
Title I—Give Kids a Chance
Sec. 101. Research into pediatric uses of drugs; additional authorities of Food and Drug Administration regarding molecularly targeted cancer drugs.
Sec. 102. Ensuring completion of pediatric study requirements.
Sec. 103. FDA report on PREA enforcement.
Sec. 104. Extension of authority to issue priority review vouchers to encourage treatments for rare pediatric diseases.
Sec. 105. Limitations on exclusive approval or licensure of orphan drugs.
Sec. 106. Program for pediatric studies of drugs.
Title II—United States-Abraham Accords Cooperation and Security
Sec. 201. Establishment of Abraham Accords Office within Food and Drug Administration.
Title III—Organ Procurement and Transplantation Network
Sec. 301. Registration fees.
<enum>I</enum><header>Give Kids a Chance</header>
<section id="H9E1778E7CEA847D992D4937B13141F33"><enum>101.</enum><header>Research into pediatric uses of drugs; additional authorities of Food and Drug Administration regarding molecularly targeted cancer drugs</header>
<subsection id="H6377E17EB6EC4AB7A6F35E8F69AB989A"><enum>(a)</enum><header>In general</header>
<paragraph id="H3F684FA080D8453FAD138B83E394A94F"><enum>(1)</enum><header>Additional active ingredient for application drug; limitation regarding novel-combination application drug</header><text>Section 505B(a)(3) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355c">21 U.S.C. 355c(a)(3)</external-xref>) is amended—</text> <subparagraph id="H1AA0DD8DC86A402A9D617D3F159F49C0"><enum>(A)</enum><text>by redesignating subparagraphs (B) and (C) as subparagraphs (C) and (D), respectively; and</text></subparagraph>
<subparagraph id="H2E182568BE6B418EAA77A85A11391BF9"><enum>(B)</enum><text>by striking subparagraph (A) and inserting the following:</text> <quoted-block style="OLC" id="H65E7EAA4F1D2470AA0E2084A5073B8C4"> <subparagraph id="HC10A2DF8C7D24C55B856AA17A23C3398"><enum>(A)</enum><header>In general</header><text>For purposes of paragraph (1)(B), the investigation described in this paragraph is (as determined by the Secretary) a molecularly targeted pediatric cancer investigation of—</text>
<clause id="H3D131A85C59E451A9574380013423FC0"><enum>(i)</enum><text>the drug or biological product for which the application referred to in such paragraph is submitted; or</text></clause> <clause id="HF0D47D4765014DEE93F90F791A034BA4"><enum>(ii)</enum><text>such drug or biological product in combination with—</text>
<subclause id="HE607491BCE304D6180ADB2A672582D61"><enum>(I)</enum><text display-inline="yes-display-inline">an active ingredient of a drug or biological product—</text> <item id="HD913C1014143440E8242661AA7F49809"><enum>(aa)</enum><text>for which an approved application under section 505(j) under this Act or under section 351(k) of the Public Health Service Act is in effect; and</text></item>
<item id="HB47B9C92026D4BC58E04AA3E241E4C84"><enum>(bb)</enum><text display-inline="yes-display-inline">that is determined by the Secretary to be the standard of care for treating a pediatric cancer; or</text></item></subclause> <subclause id="H8CFFCC1E31914F9EBC59A52B0DEB0A96"><enum>(II)</enum><text display-inline="yes-display-inline">an active ingredient of a drug or biological product—</text>
<item id="H6BBE7B673AE341268CE07B3DE0A4E029"><enum>(aa)</enum><text>for which an approved application under section 505(b) of this Act or section 351(a) of the Public Health Service Act to treat an adult cancer is in effect and is held by the same person submitting the application under paragraph (1)(B); and</text></item> <item id="H05F0B8849D6749BA8C035F548207ED5C"><enum>(bb)</enum><text>that is directed at a molecular target that the Secretary determines to be substantially relevant to the growth or progression of a pediatric cancer. </text></item></subclause></clause></subparagraph>
<subparagraph id="H051DA1684F5642A2A9CC14D853927836"><enum>(B)</enum><header>Additional requirements</header>
<clause id="HBA610156E5074D30BFD195BB0012E72B"><enum>(i)</enum><header>Design of investigation</header><text display-inline="yes-display-inline">A molecularly targeted pediatric cancer investigation referred to in subparagraph (A) shall be designed to yield clinically meaningful pediatric study data that is gathered using appropriate formulations for each age group for which the study is required, regarding dosing, safety, and preliminary efficacy to inform potential pediatric labeling.</text></clause> <clause id="HB6AE104226FF4CE2BA514DC75EDA1DBF"><enum>(ii)</enum><header>Limitation</header><text>An investigation described in subparagraph (A)(ii) may be required only if the drug or biological product for which the application referred to in paragraph (1)(B) contains either—</text>
<subclause id="H715A162ADD1C4E93A0CF9CAC2A666765"><enum>(I)</enum><text>a single new active ingredient; or </text></subclause> <subclause id="H8F77059315634E66824B70EC00C2974C"><enum>(II)</enum><text>more than one active ingredient, if an application for the combination of active ingredients has not previously been approved but each active ingredient has been previously approved to treat an adult cancer. </text></subclause></clause>
<clause id="HDBC64E3A8AD64D1982C98B10C72F7AAC"><enum>(iii)</enum><header>Results of already-completed preclinical studies of application drug</header><text>The Secretary may require that reports on an investigation required pursuant to paragraph (1)(B) include the results of all preclinical studies on which the decision to conduct such investigation was based.</text></clause> <clause id="H5C6952D5C64C4976BC1988E651AF482C"><enum>(iv)</enum><header>Rule of construction regarding inactive ingredients</header><text>With respect to a combination of active ingredients referred to in subparagraph (A)(ii), such subparagraph shall not be construed as addressing the use of inactive ingredients with such combination.</text></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph>
<paragraph id="H0551FE7AF4BB4DB1884C33CFAB41CD6D"><enum>(2)</enum><header>Determination of applicable requirements</header><text display-inline="yes-display-inline">Section 505B(e)(1) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355c">21 U.S.C. 355c(e)(1)</external-xref>) is amended by adding at the end the following: <quote>The Secretary shall determine whether subparagraph (A) or (B) of subsection (a)(1) shall apply with respect to an application before the date on which the applicant is required to submit the initial pediatric study plan under paragraph (2)(A).</quote>. </text></paragraph> <paragraph id="H17E7B2FC5AE04A618C3C16A28CF775AA"><enum>(3)</enum><header>Clarifying applicability</header><text display-inline="yes-display-inline"><italic></italic>Section 505B(a)(1) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355c">21 U.S.C. 355c(a)(1)</external-xref>) is amended by adding at the end the following:</text>
<quoted-block style="OLC" id="H1E473882D14544F9810BA50BA068ABDB" display-inline="no-display-inline">
<subparagraph id="H9A0ED9BF83E1490B81CBE6C4E63A0015"><enum>(C)</enum><header>Rule of construction</header><text display-inline="yes-display-inline">No application that is subject to the requirements of subparagraph (B) shall be subject to the requirements of subparagraph (A), and no application (or supplement to an application) that is subject to the requirements of subparagraph (A) shall be subject to the requirements of subparagraph (B).</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph> <paragraph id="H09698095BC204D578F783880E7CEEA3B"><enum>(4)</enum><header>Conforming amendments</header><text>Section 505B(a) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355c">21 U.S.C. 355c(a)</external-xref>) is amended—</text>
<subparagraph id="H353C9341656F4199ADB56CFBCF4A44AA"><enum>(A)</enum><text>in paragraph (3)(C), as redesignated by paragraph (1)(A) of this subsection, by striking <quote>investigations described in this paragraph</quote> and inserting <quote>investigations referred to in subparagraph (A)</quote>; and</text></subparagraph> <subparagraph id="HA7BDFFA1B7214001AC8F9E84B099A79F"><enum>(B)</enum><text>in paragraph (3)(D), as redesignated by paragraph (1)(A) of this subsection, by striking <quote>the assessments under paragraph (2)(B)</quote> and inserting <quote>the assessments required under paragraph (1)(A)</quote>.</text></subparagraph></paragraph></subsection>
<subsection id="H1C79C62C929F40BBA4390C5FA745AE7D"><enum>(b)</enum><header>Guidance</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall—</text> <paragraph id="H666D40AB77AA489BAD1B925630D2C1BD"><enum>(1)</enum><text>not later than 12 months after the date of enactment of this Act, issue draft guidance on the implementation of the amendments made by subsection (a); and</text></paragraph>
<paragraph id="H1E063AF765284AB4A455163299D1DC5B"><enum>(2)</enum><text>not later than 12 months after closing the comment period on such draft guidance, finalize such guidance.</text></paragraph></subsection> <subsection id="H16BE4DC46693401E80DE43DA724D224C" commented="no"><enum>(c)</enum><header>Applicability</header><text display-inline="yes-display-inline">The amendments made by this section apply with respect to any application under section 505(b) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355(b)</external-xref>) and any application under section 351(a) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262(a)</external-xref>), that is submitted on or after the date that is 3 years after the date of enactment of this Act.</text></subsection>
<subsection id="HEA7163ACB0E84C2094D313EFD8A97B1E"><enum>(d)</enum><header>Reports to Congress</header>
<paragraph id="HC993954DCE7F48B9A2BE2617B0BCBFD7"><enum>(1)</enum><header>Secretary of Health and Human Services</header><text display-inline="yes-display-inline">Not later than 2 years after the date of enactment of this Act, 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 Health, Education, Labor, and Pensions of the Senate a report on the Secretary’s efforts, in coordination with industry, to ensure implementation of the amendments made by subsection (a).</text></paragraph> <paragraph id="HC70D07684ADC4EB2AEC6F21CCCF135FC"><enum>(2)</enum><header>GAO study and report</header> <subparagraph id="H703645629C3449D5B1D58A9576EE0961"><enum>(A)</enum><header>Study</header><text>Not later than 3 years after the date of enactment of this Act, the Comptroller General of the United States shall conduct a study of the effectiveness of requiring assessments and investigations described in section 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.355c), as amended by subsection (a), in the development of drugs and biological products for pediatric cancer indications.</text></subparagraph>
<subparagraph id="H4133D8AD3E61451DABDAE8C58141B2F3"><enum>(B)</enum><header>Findings</header><text>Not later than 7 years after the date of enactment of this Act, the Comptroller General shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report containing the findings of the study conducted under subparagraph (A).</text></subparagraph></paragraph></subsection></section> <section id="H74C56626E4CA4319BC1C7F1A69EEC7FA"><enum>102.</enum><header>Ensuring completion of pediatric study requirements</header> <subsection id="HE3752340EC8245878CAB567E14778F73"><enum>(a)</enum><header>Equal accountability for pediatric study requirements</header><text>Section 505B(d) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355c">21 U.S.C. 355c(d)</external-xref>) is amended—</text>
<paragraph id="H22784C86374D4130A9418343B594B6AF"><enum>(1)</enum><text>in paragraph (1), by striking <quote>Beginning 270</quote> and inserting <quote><header-in-text level="paragraph" style="OLC">Noncompliance letter.—</header-in-text>Beginning 270</quote>; </text></paragraph> <paragraph id="H59CD5A93FC3A46698E474EDAEE96F095"><enum>(2)</enum><text>in paragraph (2)—</text>
<subparagraph id="H45E282226C024D11ABE862F31A6FF353"><enum>(A)</enum><text>by striking <quote>The drug or</quote> and inserting <quote><header-in-text level="paragraph" style="OLC">Effect of noncompliance.—</header-in-text>The drug or</quote>; and </text></subparagraph> <subparagraph id="HE78332AD0DE84E82A0ADDAE47E624818"><enum>(B)</enum><text>by striking <quote>(except that the drug or biological product shall not be subject to action under section 303)</quote> and inserting <quote>(except that the drug or biological product shall be subject to action under section 303 only if such person demonstrated a lack of due diligence in satisfying the applicable requirement)</quote>; and</text></subparagraph></paragraph>
<paragraph id="HFE3F0BD4EC3347A7BA663B3615A7C5FE"><enum>(3)</enum><text>by adding at the end the following:</text> <quoted-block style="OLC" id="H23469BAF15954092AAD6D207B1DEB0F7" display-inline="no-display-inline"> <paragraph id="HDEDE64C198BA4FD49E1A40A08BFF9AAD"><enum>(3)</enum><header>Limitation</header><text>The Secretary shall not issue enforcement actions under section 303 for failures under this subsection in the case of a drug or biological product that is no longer marketed.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection>
<subsection id="H852EE572C1FE47F080875C4B2960885B"><enum>(b)</enum><header>Due diligence</header><text>Section 505B(d) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355c">21 U.S.C. 355c(d)</external-xref>), as amended by subsection (a), is further amended by adding at the end the following:</text> <quoted-block id="H0E604E20CF88484BB72AD4DA759E4901" style="OLC"> <paragraph id="H4DCF06CED4824AF4AB65813825901536"><enum>(4)</enum><header>Due diligence</header><text>Before the Secretary may conclude that a person failed to submit or otherwise meet a requirement as described in the matter preceding paragraph (1), the Secretary shall—</text>
<subparagraph id="H2FD2AB8F55104994B59020CB1539AFFC"><enum>(A)</enum><text>issue a noncompliance letter pursuant to paragraph (1);</text></subparagraph> <subparagraph id="HCBD40C960B504EFBBE2AB4DC97A8E9A3"><enum>(B)</enum><text>provide such person with a 45-day period beginning on the date of receipt of such noncompliance letter to respond in writing as set forth in such paragraph; and</text></subparagraph>
<subparagraph id="HCF4D8C567F2246848B845B7B109B3080"><enum>(C)</enum><text>after reviewing such written response, determine whether the person demonstrated a lack of due diligence in satisfying such requirement.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="H3E2FCA4FEEE4441CAC8A508DB7DC4CE9"><enum>(c)</enum><header>Conforming amendments</header><text>Section 303(f)(4)(A) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/333">21 U.S.C. 333(f)(4)(A)</external-xref>) is amended by striking <quote>or 505–1</quote> and inserting <quote>505–1, or 505B</quote>.</text></subsection>
<subsection id="H051CB92A6D994370BF57D3AB9594756F"><enum>(d)</enum><header>Transition rule</header><text>The Secretary of Health and Human Services may take enforcement action under section 303 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/333">21 U.S.C. 333</external-xref>) only for failures described in section 505B(d) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355c">21 U.S.C. 355c(d)</external-xref>) that occur on or after the date that is 180 days after the date of enactment of this Act.</text></subsection></section> <section id="H1870BF667C03408893DE1A6E5C2A5C56"><enum>103.</enum><header>FDA report on PREA enforcement</header><text display-inline="no-display-inline">Section 508(b) of the Food and Drug Administration Safety and Innovation Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355c-1">21 U.S.C. 355c–1(b)</external-xref>) is amended—</text>
<paragraph id="H7B531EC3BC4344A2845CBC3FF42F08B7"><enum>(1)</enum><text>in paragraph (11), by striking the semicolon at the end and inserting <quote>, including an evaluation of compliance with deadlines provided for in deferrals and deferral extensions;</quote>;</text></paragraph> <paragraph id="HE02D8718E8534B1FA2B29009CCA713F3"><enum>(2)</enum><text>in paragraph (15), by striking <quote>and</quote> at the end;</text></paragraph>
<paragraph id="HADE2E054003D432C92188EA6B29D9781"><enum>(3)</enum><text>in paragraph (16), by striking the period at the end and inserting <quote>; and</quote>; and</text></paragraph> <paragraph id="HBC00D908DD994A0790BD2E3A10E78308"><enum>(4)</enum><text>by adding at the end the following:</text>
<quoted-block id="H38273D23A04C49869CA7F5292C4AECC3" style="OLC">
<paragraph id="HE5C488B9EFE74F3E85401E4CBBF67BD5"><enum>(17)</enum><text>a listing of penalties, settlements, or payments under section 303 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/353">21 U.S.C. 353</external-xref>) for failure to comply with requirements under such section 505B, including, for each penalty, settlement, or payment, the name of the drug, the sponsor thereof, and the amount of the penalty, settlement, or payment imposed; and</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section> <section id="H211AF97D73D84607B68E8C81353D573E"><enum>104.</enum><header>Extension of authority to issue priority review vouchers to encourage treatments for rare pediatric diseases</header> <subsection id="H9C5C1DF5E3B741CCBB4E015CAD8AC892"><enum>(a)</enum><header>Extension</header><text display-inline="yes-display-inline">Paragraph (5) of section 529(b) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360ff">21 U.S.C. 360ff(b)</external-xref>) is amended by striking <quote>September 30, 2024, unless</quote> and all that follows through the period at the end and inserting <quote>September 30, 2029.</quote>.</text></subsection>
<subsection id="H5F5EF97781454536B86A0FCEB31BB541"><enum>(b)</enum><header>GAO report on effectiveness of rare pediatric disease priority voucher awards in incentivizing rare pediatric disease drug development</header>
<paragraph id="HBD9D8FF37439424796DD0EC31C839648"><enum>(1)</enum><header>GAO study</header>
<subparagraph id="HCE9BEBDF14F643619254AD5DC5CB7E1D"><enum>(A)</enum><header>Study</header><text display-inline="yes-display-inline">The Comptroller General of the United States shall conduct a study of the effectiveness of awarding rare pediatric disease priority vouchers under section 529 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360ff">21 U.S.C. 360ff</external-xref>), as amended by subsection (a), in the development of human drug products that treat or prevent rare pediatric diseases (as defined in such section 529).</text></subparagraph> <subparagraph id="H0583FA69BCE54C37A402CF72C9637DCD"><enum>(B)</enum><header>Contents of study</header><text display-inline="yes-display-inline">In conducting the study under subparagraph (A), the Comptroller General shall examine the following: </text>
<clause id="HFA7A671D50604CDDBE5553D6AFD183B4"><enum>(i)</enum><text display-inline="yes-display-inline">The indications for each drug or biological product that—</text> <subclause id="H5638A47A0A2C40FBA59AC0A7298DCE62"><enum>(I)</enum><text>is the subject of a rare pediatric disease product application (as defined in section 529 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360ff">21 U.S.C. 360ff</external-xref>)) for which a priority review voucher was awarded; and</text></subclause>
<subclause id="HF4B3A58C1CEA4A41B1A36D800E0D70A0"><enum>(II)</enum><text>was approved under section 505 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/42/355">42 U.S.C. 355</external-xref>) or licensed under section 351 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262</external-xref>).</text></subclause></clause> <clause id="H1F8D39A959794315A8CD40FF53DC8128"><enum>(ii)</enum><text>Whether, and to what extent, an unmet need related to the treatment or prevention of a rare pediatric disease was met through the approval or licensure of such a drug or biological product. </text></clause>
<clause id="H0409B0B76209486696CD9D43294C74A0"><enum>(iii)</enum><text display-inline="yes-display-inline">The size of the company to which a priority review voucher was awarded under section 529 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360ff">21 U.S.C. 360ff</external-xref>) for such a drug or biological product.</text></clause> <clause id="H32995DA02D63476091C0785F57ACE1D8"><enum>(iv)</enum><text>The value of such priority review voucher if transferred. </text></clause>
<clause id="H759EA4627D9040E3B513E0DE8C61E48D"><enum>(v)</enum><text>Identification of each drug for which a priority review voucher awarded under such section 529 was used. </text></clause> <clause id="H465B042237A844A387C23AA5040D99FA"><enum>(vi)</enum><text>The size of the company using each priority review voucher awarded under such section 529.</text></clause>
<clause id="HAB229A257D8549909A4D1CF09D59E56A"><enum>(vii)</enum><text display-inline="yes-display-inline">The length of the period of time between the date on which a priority review voucher was awarded under such section 529 and the date on which it was used. </text></clause> <clause id="H4FA5819A95794F77A3B673DBD329EC67"><enum>(viii)</enum><text display-inline="yes-display-inline">Whether, and to what extent, an unmet need related to the treatment or prevention of a rare pediatric disease was met through the approval under section 505 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/42/355">42 U.S.C. 355</external-xref>) or licensure under section 351 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262</external-xref>) of a drug for which a priority review voucher was used.</text></clause>
<clause id="HB16C3DBDC8744CA483A71282CE669744"><enum>(ix)</enum><text display-inline="yes-display-inline">Whether, and to what extent, companies were motivated by the availability of priority review vouchers under section 529 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360ff">21 U.S.C. 360ff</external-xref>) to attempt to develop a drug for a rare pediatric disease.</text></clause> <clause id="H0F3B6063D9244AD5826F67393B47E341"><enum>(x)</enum><text>Whether, and to what extent, pediatric review vouchers awarded under such section were successful in stimulating development and expedited patient access to drug products for treatment or prevention of a rare pediatric disease that wouldn’t otherwise take place without the incentive provided by such vouchers.</text></clause>
<clause id="H86B013D1C8B4496AB67024AA12AD1F85"><enum>(xi)</enum><text>The impact of such priority review vouchers on the workload, review process, and public health prioritization efforts of the Food and Drug Administration.</text></clause> <clause id="H4DE65F8E95764670A9F2F43D7745FBE8"><enum>(xii)</enum><text>Any other incentives in Federal law that exist for companies developing drugs or biological products described in clause (i).</text></clause></subparagraph></paragraph>
<paragraph id="H96252A31CAA8457F979834C4FF7A9831"><enum>(2)</enum><header>Report on findings</header><text display-inline="yes-display-inline">Not later than 5 years after the date of the enactment of this Act, 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 Health, Education, Labor, and Pensions of the Senate a report containing the findings of the study conducted under paragraph (1).</text></paragraph></subsection></section> <section id="H0E062C829460476F9F05B97B5F3F3916"><enum>105.</enum><header>Limitations on exclusive approval or licensure of orphan drugs</header> <subsection id="HF0F45645064045C4BB6D7859F5710FAC"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 527 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360cc">21 U.S.C. 360cc</external-xref>) is amended—</text>
<paragraph id="H134386720ACC437F84A33292A16F15F1"><enum>(1)</enum><text>in subsection (a), in the matter following paragraph (2), by striking <quote>same disease or condition</quote> and inserting <quote>same approved use or indication within such rare disease or condition</quote>;</text></paragraph> <paragraph id="HE55448D10EE0454AB51DB82E6A8BA511"><enum>(2)</enum><text>in subsection (b)—</text>
<subparagraph id="H997A57C092E84A32AD073B9CD22729A1"><enum>(A)</enum><text>in the matter preceding paragraph (1), by striking <quote>same rare disease or condition</quote> and inserting <quote>same approved use or indication for which such 7-year period applies to such already approved or licensed drug</quote>; and</text></subparagraph> <subparagraph id="H06552FA34D9B4F8F97FCFC4B0E42844F"><enum>(B)</enum><text>in paragraph (1), by inserting <quote>, relating to the approved use or indication,</quote> after <quote>the needs</quote>;</text></subparagraph></paragraph>
<paragraph id="H2F281D845F684549AAF2D0CC40521AEA"><enum>(3)</enum><text>in subsection (c)(1), by striking <quote>same rare disease or condition as the already approved drug</quote> and inserting <quote>same use or indication for which the already approved or licensed drug was approved or licensed</quote>; and</text></paragraph> <paragraph id="H6720D6B055E24B8190EF3D893E9740CB"><enum>(4)</enum><text>by adding at the end the following:</text>
<quoted-block style="OLC" display-inline="no-display-inline" id="H898101C5AACA4F67BE3E6DA6E139656E">
<subsection id="HE9BAE508910449B28AE37A1766BE5AF3"><enum>(f)</enum><header>Approved use or indication defined</header><text>In this section, the term <term>approved use or indication</term> means the use or indication approved under section 505 of this Act or licensed under section 351 of the Public Health Service Act for a drug designated under section 526 for a rare disease or condition.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection> <subsection id="HDC69255BF8E84647B539CA6357E4EB08"><enum>(b)</enum><header>Application of amendments</header><text>The amendments made by subsection (a) shall apply with respect to any drug designated under section 526 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360bb">21 U.S.C. 360bb</external-xref>), regardless of the date on which the drug was so designated, and regardless of the date on which the drug was approved under section 505 of such Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355</external-xref>) or licensed under section 351 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262</external-xref>).</text></subsection></section>
<section id="HE08D749BB1D84B4CBF0B1DE1FCF925FD" section-type="subsequent-section"><enum>106.</enum><header>Program for pediatric studies of drugs</header><text display-inline="no-display-inline">Section 409I(d) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/284m">42 U.S.C. 284m(d)</external-xref>) is amended to read as follows:</text> <quoted-block style="OLC" id="H9AF503EAB73F4417919B2C0DEF2F3C75" display-inline="no-display-inline"> <subsection id="HC26DBC8E9A0E4EBA90C898CF1DEB7446"><enum>(d)</enum><header>Funding</header><text display-inline="yes-display-inline">Of the amount made available for pediatric research to each national research institute and national center under this title for each of fiscal years 2025, 2026, and 2027, the Director of NIH is authorized to make available up to one percent of such amount for pediatric research under this section.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></section>
<enum>II</enum><header>United States-Abraham Accords Cooperation and Security</header>
<section id="H45DA36316CFF4544867B7B9E4002F985"><enum>201.</enum><header>Establishment of Abraham Accords Office within Food and Drug Administration</header>
<subsection id="H7B4754EF3D32477581DFC70688B1D540"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Chapter X of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/391">21 U.S.C. 391 et seq.</external-xref>) is amended by adding at the end the following:</text> <quoted-block style="OLC" id="H363C310E1DAA45B5B87DB0DF3E87E7B9" display-inline="no-display-inline"> <section id="H9EE9599366504D5D8EBB457F301938DE"><enum>1015.</enum><header>Abraham Accords Office</header> <subsection id="HCA38E30AAF1B4F118A7E6A11130C95B1"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary, acting through the Commissioner of Food and Drugs, shall establish within the Food and Drug Administration an office, to be known as the Abraham Accords Office, to be headed by a director.</text></subsection>
<subsection id="H46D7CDD849784F25965B72DC511C1B51"><enum>(b)</enum><header>Office</header><text display-inline="yes-display-inline">Not later than two years after the date of enactment of this section, the Secretary shall—</text> <paragraph id="HBA9132D182704358B6F966878391D89E"><enum>(1)</enum><text display-inline="yes-display-inline">in consultation with the governments of Abraham Accords countries, as well as appropriate United States Government diplomatic and security personnel—</text>
<subparagraph id="HFC6672D3D0CC4962A60C0F41071E860B"><enum>(A)</enum><text>select the location of the Abraham Accords Office in an Abraham Accords country; and</text></subparagraph> <subparagraph id="H63BCF1651E894352A591950F0CE75CBB"><enum>(B)</enum><text>establish such office; and</text></subparagraph></paragraph>
<paragraph id="H02C370AD2FC14EB3B1C41323987CD80E"><enum>(2)</enum><text>assign to such office such personnel of the Food and Drug Administration as the Secretary determines necessary to carry out the functions of such office.</text></paragraph></subsection> <subsection id="H6DF87E2F50664D85A1DEFDB744EB6870"><enum>(c)</enum><header>Duties</header><text display-inline="yes-display-inline">The Secretary, acting through the Director of the Abraham Accords Office, shall—</text>
<paragraph id="H719DEB16064849628E65E333DE8DC8E5"><enum>(1)</enum><text display-inline="yes-display-inline">after the Abraham Accords Office is established—</text> <subparagraph id="H20C24D890476484290065BB3664DD2F5"><enum>(A)</enum><text display-inline="yes-display-inline">as part of the Food and Drug Administration’s work to strengthen the international oversight of regulated commodities, provide technical assistance to regulatory partners in Abraham Accords countries on strengthening regulatory oversight and converging regulatory requirements for the oversight of regulated products, including good manufacturing practices and other issues relevant to manufacturing medical products that are regulated by the Food and Drug Administration;</text></subparagraph>
<subparagraph id="H96265FB2F66A42E4B2A51BCFC9966A50"><enum>(B)</enum><text display-inline="yes-display-inline">facilitate interactions between the Food and Drug Administration and interested parties in Abraham Accords countries, including by sharing relevant information regarding United States regulatory pathways with such parties; and</text></subparagraph> <subparagraph id="H9F7EAA4B2E2B4740A7095E39B0FDA1F3"><enum>(C)</enum><text display-inline="yes-display-inline">facilitate feedback between the Food and Drug Administration and such parties located within Abraham Accords countries prior to submission of an application under section 505(b), 505(j), or 515 of this Act or section 351(a) or 351(k) of the Public Health Service Act, or a notification under section 510(k) of this Act, such as feedback on research, development, and manufacturing of drugs, biologics, and medical devices; and</text></subparagraph></paragraph>
<paragraph id="H48AFFDF9F2204900BEB65BC45A200CB7"><enum>(2)</enum><text display-inline="yes-display-inline">carry out other functions and activities as the Secretary determines to be necessary to carry out this section.</text></paragraph></subsection> <subsection id="HA1B89E1D1A4D4823BB89508000557700"><enum>(d)</enum><header>Abraham Accords country defined</header><text>In this section, the term <term>Abraham Accords country</term> means a country identified by the Department of State as having signed the Abraham Accords Declaration.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection>
<subsection id="HB1B5EC98B503464F9D5F356B8E6B9BD3"><enum>(b)</enum><header>Report to Congress</header>
<paragraph id="HED94844AF0554BF3B486A1204426A774"><enum>(1)</enum><header>In general</header><text>Not later than 3 years after the date of enactment of this Act, the Secretary of Health and Human Services shall submit to the Congress a report on the Abraham Accords Office, including—</text> <subparagraph id="HAEF9797EA5454217974034D76B85BEB5"><enum>(A)</enum><text display-inline="yes-display-inline">an evaluation of how the Office has advanced progress toward conformance with Food and Drug Administration regulatory requirements by manufacturers in the Abraham Accords countries;</text> </subparagraph>
<subparagraph id="HE6657A86ED554FB89A69EEB8A54E79C8"><enum>(B)</enum><text display-inline="yes-display-inline">a numerical count of parties that the Office has helped facilitate interactions or feedback pursuant to subparagraphs (B) and (C) of section 1015(c)(1) of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a));</text></subparagraph> <subparagraph id="HF98C1E860C794221B97A0B146A62C443"><enum>(C)</enum><text display-inline="yes-display-inline">a summary of technical assistance provided to regulatory partners in Abraham Accords countries pursuant to subparagraph (A) of such section 1015(c)(1); and </text></subparagraph>
<subparagraph id="H5B55A06EF2434C18A80FEB96FBB73A74"><enum>(D)</enum><text display-inline="yes-display-inline">recommendations for increasing and improving coordination between the Food and Drug Administration and entities in Abraham Accords countries.</text></subparagraph></paragraph> <paragraph id="H35521A3271534990B731EF0E249D6F9E"><enum>(2)</enum><header>Abraham Accords country defined</header><text>In this subsection, the term <quote>Abraham Accords country</quote> has the meaning given such term in section 1015(d) of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)).</text></paragraph> </subsection> </section>
<enum>III</enum><header>Organ Procurement and Transplantation Network</header>
<section id="HFF56D2BE124B475F93A54E5539BCE99B"><enum>301.</enum><header>Registration fees</header><text display-inline="no-display-inline">Section 372 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/274">42 U.S.C. 274</external-xref>) is amended by adding at the end the following:</text> <quoted-block style="OLC" id="H93F1592DE954465683751D6375C29DC3" display-inline="no-display-inline"> <subsection id="H8BEBCE2ABED94566B481FEAAED9F93CE"><enum>(d)</enum><header>Registration fees</header> <paragraph id="H1361DE1122C14D15BFC3E959363697A2"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary may collect registration fees from any member of the Organ Procurement and Transplantation Network for each transplant candidate such member places on the list described in subsection (b)(2)(A)(i). Such registration fees shall only be collected and distributed to support the operation of the Organ Procurement and Transplantation Network. Such registration fees are authorized to remain available until expended.</text></paragraph>
<paragraph id="HFF7E759D9B3E49C68B880BE7348C8058"><enum>(2)</enum><header>Collection</header><text>The Secretary may collect the registration fees under paragraph (1) directly or through awards made under subsection (b)(1)(A).</text></paragraph> <paragraph id="HBC203D63B602411A9DBDC146AE83C5E9"><enum>(3)</enum><header>Distribution</header><text display-inline="yes-display-inline">Any amounts collected under this subsection shall—</text>
<subparagraph id="H949815A429FF40A8B2E36365615304AF"><enum>(A)</enum><text>be credited to the currently applicable appropriation, account, or fund of the Department of Health and Human Services as discretionary offsetting collections; and</text></subparagraph> <subparagraph id="H5BEA7B84E6264596AD1A2B83D5D8D33E"><enum>(B)</enum><text>be available, only to the extent and in the amounts provided in advance in appropriations Acts, to distribute such fees among the awardees described in subsection (b)(1)(A).</text></subparagraph></paragraph>
<paragraph id="H5278BF009DD345A8977F9D159BD263F8"><enum>(4)</enum><header>Transparency</header><text>The Secretary shall—</text> <subparagraph id="H678C7FC044B94E6A9C6C910688436826"><enum>(A)</enum><text>promptly post on the Internet website of the Organ Procurement and Transplant Network—</text>
<clause id="H6100831AA9C6468DB770A5D7B0E9E162"><enum>(i)</enum><text>the amount of registration fees collected under this subsection from each member of the Organ Procurement and Transplantation Network; and</text></clause> <clause id="H977C04E023904AA590ACFC3BFBBA8400"><enum>(ii)</enum><text>a list of activities such fees are used to support; and</text></clause></subparagraph>
<subparagraph id="HB68CA9BB0C1344848CE06A51B5F8991C"><enum>(B)</enum><text>update the information posted pursuant to subparagraph (A), as applicable for each calendar quarter for which fees are collected under paragraph (1).</text></subparagraph></paragraph> <paragraph id="H51016C97650A47F3B3F05D888C1B0B93"><enum>(5)</enum><header>GAO review</header><text>Not later than 2 years after the date of enactment of this subsection, the Comptroller General of the United States shall, to the extent data are available—</text>
<subparagraph id="HE4BF3925EB754AE3A995C20E551D8FDA"><enum>(A)</enum><text>conduct a review concerning the activities under this subsection; and</text></subparagraph> <subparagraph id="H621BAF08B8CD4A34BAE6948064B7A0B1"><enum>(B)</enum><text>submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Finance of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report on such review, including related recommendations, as applicable.</text></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></section>
Passed the House of Representatives September 23, 2024.Kevin F. McCumber,Clerk.