<enum>I</enum><header>Long COVID Biomedical Research</header><section id="H6B43E208D6A34290A6C4FD37174847F6"><enum>101.</enum><header>Establishment of Long COVID research program</header><text display-inline="no-display-inline">Title IV of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/281">42 U.S.C. 281 et seq.</external-xref>) is amended by adding at the end the following:</text><quoted-block style="OLC" id="H15A2AF54B7A54A3C968F563C5F02FF86" display-inline="no-display-inline"><part id="H82D0C0F9272343E5BCE4DF296F5905A7"><enum>K</enum><header>Long COVID programs</header><section id="HCB6D0E2FF0BB43B7B68CE21BB09B09AA"><enum>499B.</enum><header>Establishment of Long COVID research program</header><subsection id="HCAC4C85783EA4A9A9A73C0B71604B990"><enum>(a)</enum><header>In general</header><text>There is established within the Office of the Director of the National Institutes of Health a research program, to be known as the Long COVID Research Program (referred to in this part as the <quote>Program</quote>), for purposes of expediting research to identify new ways to prevent, detect, manage, and treat symptoms associated with Long COVID.</text></subsection><subsection commented="no" display-inline="no-display-inline" id="H51E45E4F053F4F4BB08A5B4A72DB424C"><enum>(b)</enum><header>Director</header><paragraph commented="no" display-inline="no-display-inline" id="HE007776EEEE047C8806C2B24D6A7B0C1"><enum>(1)</enum><header>Appointment</header><subparagraph commented="no" display-inline="no-display-inline" id="HA10B42E4326C4F178ABFFB57742E19F6"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">The Program shall be headed by a Director, appointed by the Secretary, in consultation with the Director of NIH, who has—</text><clause id="HD0739506867C470284A959BB00DBA514"><enum>(i)</enum><text>experience managing clinical or research programs focused on pathogenic mechanisms and biological pathways related to Long COVID; and</text></clause><clause id="H7607C8EE67274FD5B26D749B3C981B39"><enum>(ii)</enum><text>demonstrated commitment to addressing Long COVID and other infection-associated chronic conditions, such as myalgic encephalomyelitis/chronic fatigue syndrome, postural orthostatic tachycardia syndrome, and post-treatment Lyme disease syndrome/persistent Lyme disease.</text></clause></subparagraph><subparagraph id="H2900F80EF9234C54A8B16B70C4F26A00"><enum>(B)</enum><header>Consultation</header><text>In appointing the Director under subparagraph (A), the Secretary shall consult with independent, patient-led organizations or advocacy groups representing Long COVID patients and their families.</text></subparagraph></paragraph><paragraph id="HA68E660B1F824381A4F1C9D4F1C850B2"><enum>(2)</enum><header>Responsibilities</header><text>The Director of the Program shall—</text><subparagraph commented="no" display-inline="no-display-inline" id="H9382D1868A6A4CA9B447EF382D1A3E53"><enum>(A)</enum><text display-inline="yes-display-inline">act as the primary Federal official with responsibility for coordinating all Long COVID research conducted or supported by the National Institutes of Health;</text></subparagraph><subparagraph id="H162EB72BCC314A909BB1147ACEEAAAA4"><enum>(B)</enum><text>represent the National Institutes of Health Long COVID Research Program at all relevant Executive branch task force meetings and committees; and</text></subparagraph><subparagraph id="H29EBA6E4E1B841F8AA4EE17BFAC2EFF1"><enum>(C)</enum><text>maintain communication with all relevant Federal departments and agencies to ensure the timely transmission of information concerning advances in Long COVID research and the clinical treatment of Long COVID and other infection-associated chronic conditions between such departments and agencies, and for dissemination to affected communities and health care providers. </text></subparagraph></paragraph></subsection><subsection id="HC9BF3D2C9E744C46AA653D117D8912B4"><enum>(c)</enum><header>Activities</header><text>The Program shall—</text><paragraph id="H852F49C66C8D428681FB85B889C42517"><enum>(1)</enum><text>investigate the etiology, pathophysiology, risk factors, and pathology of Long COVID in adults and children;</text></paragraph><paragraph id="H06536DBCFE094B418C08884CFD5BEB67"><enum>(2)</enum><text>explore the best ways to prevent, detect, monitor, manage, and treat Long COVID in adults and children;</text></paragraph><paragraph id="H6BEB6A4268E34027B3E6BD8F7CFF2A75"><enum>(3)</enum><text>contribute knowledge to the understanding, prevention, mitigation, management, and treatment of Long COVID;</text></paragraph><paragraph id="H2595B9FB175942029E2DA7F8E873310E"><enum>(4)</enum><text>develop and facilitate programs on Long COVID, within the National Institutes of Health and in other settings; </text></paragraph><paragraph id="H886D8191F345493394493E4DDCFBDBB3"><enum>(5)</enum><text>conduct comparative research to understand the similarities and differences between Long COVID and other infection-associated chronic conditions with similar phenotypes, such as myalgic encephalomyelitis/chronic fatigue syndrome, postural orthostatic tachycardia syndrome, and post-treatment Lyme disease syndrome/persistent Lyme disease, and how activities funded by the Program could improve understanding of such other conditions; and</text></paragraph><paragraph id="H14A3C871694D4F49AFDCC5FC4973CFB6"><enum>(6)</enum><text>conduct comparative research to understand the similarities and differences between Long COVID and severe, long-term effects from COVID–19 vaccinations.</text></paragraph></subsection><subsection id="H7A5C37D6B6F34A75BD321D32D321E74E"><enum>(d)</enum><header>Duties</header><paragraph id="H8C669FC4FD534D9496CA7FF4545F4428"><enum>(1)</enum><header>Interagency coordination of long covid activities</header><text>The Director of the Program shall coordinate with the national research institutes and national centers, as appropriate, on Long COVID research. In carrying out this paragraph, the Director of the Program shall evaluate the Long COVID activities of each such institute or center and shall provide for the periodic reevaluation of such activities.</text></paragraph><paragraph id="H8F622B4118784AFE93D0C94E70BCC0FE"><enum>(2)</enum><header>Consultation</header><text>The Director of the Program shall carry out all duties, including the development of the research plan under section 499B–1 in consultation with the heads of the national research institutes and national centers, with the advisory councils of such institutes and centers, and with the Long COVID Research Program Advisory Board established under section 499B–4.</text></paragraph></subsection><subsection id="H6D49DDB194A34FEFA6ED939820887DD3"><enum>(e)</enum><header>Non-Duplication of effort</header><text>The Director shall ensure that activities carried out under this section do not unnecessarily duplicate the efforts of other Federal departments or agencies. </text></subsection></section><section id="HFE20648A4A194E2E94C94EC61354C008"><enum>499B–1.</enum><header>Long COVID Research Plan</header><subsection id="HF06A9997DD4345179DE1D3D3F69FA779"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Not later than 1 year after the date of enactment of the <short-title>Long COVID Research Moonshot Act</short-title>, the Director of the Program established under section 499B shall develop and make public a comprehensive research plan for the conduct and support of all Long COVID research activities of the national research institutes and national centers. The Director of the Program shall update such plan annually.</text></subsection><subsection id="H7C48E67DDC5A4331BB641D69F36ED22F"><enum>(b)</enum><header>Contents</header><text>The research plan developed under subsection (a) shall—</text><paragraph id="H8090D8BAA1CC49DCAC50A84612BC8FCB"><enum>(1)</enum><text>identify current Long COVID research conducted or supported by the national research institutes and national centers, opportunities and needs for additional research, including among patients who face the highest disease burden and pediatric patients, and priorities for such research;</text></paragraph><paragraph id="H1B9B08EC5CD347118794C3447FC8AD65"><enum>(2)</enum><text>evaluate the progress of Long COVID research against strategic priorities, goals, and objectives, identified in previous versions of the research plan; </text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H0D981ED3489C46BE85A0ED60FA4A0DED"><enum>(3)</enum><text display-inline="yes-display-inline">make recommendations for the coordination of such research conducted or supported by the National Institutes of Health and other agencies of the Federal Government; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H66352DBF78FB453F8BA595EE82D5EC22"><enum>(4)</enum><text display-inline="yes-display-inline">include goals and objectives of the Program for conducting, supporting, and coordinating Long COVID research.</text></paragraph></subsection><subsection id="H897DC12F501446CA9C90E710F5E68969"><enum>(c)</enum><header>Requirements</header><text>In developing the research plan under subsection (a), the Director of the Program shall—</text><paragraph id="HC2C8ABFA7CF84A9F8E5DD615E505D351"><enum>(1)</enum><text>ensure that the plan establishes priorities among Long COVID research that the Program is authorized to carry out;</text></paragraph><paragraph id="H1881952F492B4E55948F7D0ACAD95F61"><enum>(2)</enum><text>ensure that the plan establishes objectives regarding such research and describes the means for achieving the objectives;</text></paragraph><paragraph id="H2E16EA651E814F3C9DDD7E63C539BD26"><enum>(3)</enum><text>ensure that all amounts appropriated for such research under section 499B–6 are expended in accordance with the plan;</text></paragraph><paragraph id="H5F358EB3C71840FF8D8A7DA084C15FF4"><enum>(4)</enum><text>review the plan not less frequently than annually, and revise the plan as appropriate to prioritize funding and research relative to scientific urgency;</text></paragraph><paragraph id="HD3835C7FA06B460D85E98FD50FE3FE4C"><enum>(5)</enum><text>ensure that the plan serves as a broad, binding statement of policies regarding Long COVID research of the National Institutes of Health, but does not affect the responsibility of any of the national research institutes or centers with respect to the programs or projects of such institutes and centers; and</text></paragraph><paragraph id="H92C4ABD1325549AAB32CA06740A7DF49"><enum>(6)</enum><text>annually prepare and submit to the Director of NIH for review and transmittal by the Director of NIH to the President and to Congress a budget estimate for carrying out the plan for the upcoming fiscal year.</text></paragraph></subsection><subsection id="HD53B9802084A4A4E81CF7A26192233F4"><enum>(d)</enum><header>Consultation</header><text>In developing, implementing, reviewing, and prioritizing elements of the research plan under this section, the Director of the Program shall consult, as appropriate with—</text><paragraph id="H4C63C1480B9E4901A80CC6D1784C2158"><enum>(1)</enum><text>representatives of other Federal agencies involved in Long COVID research, including the Centers for Disease Control and Prevention, the Agency for Healthcare Research and Quality, and the Administration for Community Living;</text></paragraph><paragraph id="H19FF25CECC1443739F32E4BD065D3581"><enum>(2)</enum><text>the Long COVID Research Advisory Board established under section 499B–4;</text></paragraph><paragraph id="HF14FC8E557164808BE0A65BEA10FFAF0"><enum>(3)</enum><text>the Office of Long COVID Research and Practice of the Department of Health and Human Services;</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H9CA6EA68532E4B1C99FE6E9AF313EB24"><enum>(4)</enum><text>leading scientific experts on Long COVID; and</text></paragraph><paragraph id="H24B7B4A66CC34FC9A786F6087F696EFC"><enum>(5)</enum><text>independent, patient-led organizations or advocacy groups representing patients with Long COVID and other infection-associated chronic conditions with similar phenotypes, and the families of such patients.</text></paragraph></subsection><subsection id="H9204C33E4A804B66A9FD88C977901CF6"><enum>(e)</enum><header>Report</header><text>The Director of the Program shall submit the research plan developed under subsection (a), and updates to such plan, to—</text><paragraph id="H1F51E54DE03B4A278A46AC75419E19BA"><enum>(1)</enum><text>the Committee on Health, Education, Labor, and Pensions of the Senate;</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H72CE9FC615404DD8A669FB490C72754E"><enum>(2)</enum><text>the Committee on Energy and Commerce of the House of Representatives;</text></paragraph><paragraph id="H5989430A1C134724AC0BA8957853FEC8"><enum>(3)</enum><text>the Secretary;</text></paragraph><paragraph id="H5E26C70A7C18424DADDFA7F444392CC8"><enum>(4)</enum><text>the Office of Long COVID Research and Practice of the Department of Health and Human Services; and</text></paragraph><paragraph id="H807AAB9F08B3462ABB9F918AB555E80A" commented="no" display-inline="no-display-inline"><enum>(5)</enum><text>the Director of NIH, who shall post the plan, and updates to the plan, on the website of the National Institutes of Health.</text></paragraph></subsection></section><section id="HB1107BCEB091426884946CBD730B1D3C"><enum>499B–2.</enum><header>Expedited Long COVID research</header><subsection id="H58D630D5A43D403FBC2347B7FF7865A8"><enum>(a)</enum><header>In general</header><text>The Director of NIH shall establish a process to expedite the award of grants, contracts, and cooperative agreements for research projects conducted or supported by the National Institutes of Health and relating to Long COVID.</text></subsection><subsection id="H8420AD25122E436C9592570020BB22CF"><enum>(b)</enum><header>Requirements for making external funding available</header><text>With respect to programs of grants, contracts, and cooperative agreements described in subsection (a), the Director of NIH shall—</text><paragraph id="HA7E5BEDBE33F428B89B9AFB324F327CC"><enum>(1)</enum><text>make publicly available the deadlines for submitting applications for such programs, and ensure that such deadlines provide applicants with sufficient time from the date of the announcement for such grant, contract, and cooperative agreement to submit an application;</text></paragraph><paragraph id="H3AB0A844716944C3A823F61206249A52"><enum>(2)</enum><text>ensure that applicants receive a final decision on their applications within 120 days of submission; and</text></paragraph><paragraph id="H7D55363D367A420B8D822443990EBBB9"><enum>(3)</enum><text>with respect to applications that are denied, provide a written explanation to the applicant on the reasons for the denial.</text></paragraph></subsection><subsection id="HD5AE8969296241699A68840A8D94D33E"><enum>(c)</enum><header>Evaluation of Grant Applications</header><text>In making a determination to award a grant, contract, and cooperative agreement for research projects described in subsection (a), the Director of NIH shall—</text><paragraph id="H28D11BB135C7431FBC3BF086C63EAB00"><enum>(1)</enum><text>give priority to research that—</text><subparagraph commented="no" display-inline="no-display-inline" id="H93F94599458143DB9E0CAFFCFD57DAD2"><enum>(A)</enum><text display-inline="yes-display-inline">tests the outcomes of existing drug and device interventions in patients with Long COVID;</text></subparagraph><subparagraph id="HACA79007A41A4C70BD96B719E3F0DE5B"><enum>(B)</enum><text>focuses on identifying interventions for pediatric patients with Long COVID;</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H8085881641D04A85A3F34615BC2FD916"><enum>(C)</enum><text display-inline="yes-display-inline">aids in the development of new interventions that have evidence to suggest effectiveness in treating or curing Long COVID; or</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H15FCF2D2FD754F25A935F84879A6C144"><enum>(D)</enum><text display-inline="yes-display-inline">includes institutions that represent, or have a successful track record of providing equitable care or services to, historically underserved communities;</text></subparagraph></paragraph><paragraph id="HFD22AAC2A8CD43319A5FAAA90E5D2E5E"><enum>(2)</enum><text>consider research that has the ability to begin interventions in a timely manner; </text></paragraph><paragraph id="H320E027E9CB747B0A7F505D3A53D2B7B"><enum>(3)</enum><text>consider research that uses decentralized trials or remote monitoring techniques for data collection; and </text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H5B7C0B9367D04BD2BDF2C553757F3239"><enum>(4)</enum><text display-inline="yes-display-inline">consider research that includes patients with other infection-associated chronic conditions with similar phenotypes, such as myalgic encephalomyelitis/chronic fatigue syndrome, postural orthostatic tachycardia syndrome, and post-treatment Lyme disease syndrome/persistent Lyme disease. </text></paragraph></subsection><subsection id="H20E6EDC2B7D744B4AFD0459DD3918675"><enum>(d)</enum><header>Reasonable pricing</header><text>In awarding contracts, grants, and cooperative agreements for research projects described in subsection (a) that relates to the development of a drug or device for the potential treatment or management of Long COVID, or identifying a new indication or use specific to the treatment or management of Long COVID in a drug or device that is already approved or cleared by the Food and Drug Administration, the Director of NIH shall include terms and conditions requiring that the price of such a drug or device for purposes of procurement by the Federal Government or if sold on the commercial market, whether procured from, or sold by, the recipient of such Federal award or another person—</text><paragraph commented="no" display-inline="no-display-inline" id="H302C9921331548D2B28EE98B8E6F4651"><enum>(1)</enum><text display-inline="yes-display-inline">is fair and reasonable, taking into account—</text><subparagraph id="HF42E18196BFC4B49AB02D74EA5E26FDA"><enum>(A)</enum><text>the value of the drug and device to the public health, including the impact of the price on access to the drug or device;</text></subparagraph><subparagraph id="HD778E61E48C2416897B93C9DFFFBA10C"><enum>(B)</enum><text>the costs incurred by the Federal Government in research and development of the drug or device;</text></subparagraph><subparagraph id="H1D1F8AAE346E4DBF8872DE21D8E8823F"><enum>(C)</enum><text>the costs incurred by the recipient of the award in research and development of the drug or device, and the costs of manufacturing such drug or device;</text></subparagraph><subparagraph id="HE2AADD023A7448C29447E092CB3ECD91"><enum>(D)</enum><text>whether the drug or device provided a significant improvement in health outcomes, compared to other therapies available at the time of its approval or authorization;</text></subparagraph><subparagraph id="H831CDF9A93FA46FD8D215418FA3E1711"><enum>(E)</enum><text>the cumulative expected global revenues generated by the drug or device; and</text></subparagraph><subparagraph id="H3D150A02A7BD4FA0A83C929763E90660"><enum>(F)</enum><text>other factors, as the Secretary determines appropriate; and</text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HE5E224EED507456E834903AD0CE50262"><enum>(2)</enum><text>does not exceed the lowest price charged for such drug or device, among Canada, France, Germany, Italy, Japan, and the United Kingdom.</text></paragraph></subsection><subsection id="H8027D1CFC59040C0BB65EA847DBD24CE" commented="no" display-inline="no-display-inline"><enum>(e)</enum><header>Consultation</header><text>In making a determination to award a grant, contract, or cooperative agreement for research projects relating to Long COVID, the Director of NIH shall consult with the Long COVID Research Advisory Board. Members of the Long COVID Research Advisory Board shall provide a recommendation on any final funding decisions. If the Director of NIH makes a decision that is different than the recommendation, the Director of NIH shall provide a written justification for the decision within 5 days.</text></subsection></section><section id="H147C3C66A564439583D3FDCF52AD1422"><enum>499B–3.</enum><header>Scientific Review Group</header><subsection id="HCE2ECB58AC8F4F358EEA913A0453084A"><enum>(a)</enum><header>In general</header><text>In order to ensure high quality, rigorous scientific review of applications for grants, contracts, and cooperative agreements described in section 499B–2(a), consistent with section 492, the Director of NIH shall establish a scientific review group on Long COVID and other infection-associated chronic conditions, and shall convene a group of leading scientific experts to serve on such group, for terms of up to 5 years.</text></subsection><subsection id="HC6DCCAD3795545B5B1EB655C7576A63F"><enum>(b)</enum><header>Duties</header><text>The scientific research group shall conduct an initial review of applications for grants, contracts, and other cooperative agreements described in section 499B–2(a), and submit a funding recommendation to the Director of NIH for final determination.</text></subsection></section><section id="H7626110C5C3F4874893558031C4D348E"><enum>499B–4.</enum><header>Long COVID Research Program Advisory Board</header><subsection id="H2389AB68F2614B33A96BCEFC30DD5098"><enum>(a)</enum><header>In general</header><text>The Director of NIH shall establish the Long COVID Research Program Advisory Board (referred to in this section as the <quote>Advisory Board</quote>).</text></subsection><subsection id="H82170841767D44D2BF5277DF047C0364"><enum>(b)</enum><header>Membership</header><paragraph commented="no" display-inline="no-display-inline" id="H29BCCCF93B2A48B1A91C625AB07AC2FC"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">The Advisory Board shall be comprised of 18 members, including appointed members and nonvoting ex officio members, as follows:</text><subparagraph id="HDEDD38CC5EB642628274B2C45517FC84"><enum>(A)</enum><text>The Secretary shall conduct a nomination process that allows for public input on nominees. The Secretary shall appoint nominated individuals, giving particular consideration to individuals from backgrounds that represent the diversity of the Long COVID population, with an emphasis on patients who face the highest disease burden. Individuals so appointed shall include the following:</text><clause id="HDC33F0100DEC4BAD849FDE09F8CC2E10"><enum>(i)</enum><text>10 members who are scientists, physicians, and other health care professionals, who are not officers or employees of the Federal Government, and who have primary expertise in Long COVID and other infection-associated chronic conditions, with consideration given to such individuals with expertise in pediatric populations.</text></clause><clause id="H7269862B61E24F95943B3D04CD641A9F"><enum>(ii)</enum><text>5 members who live with Long COVID.</text></clause><clause id="H907AA4482717450493103D2585BB084E"><enum>(iii)</enum><text>1 member who is a caregiver to an individual with Long COVID.</text></clause><clause commented="no" display-inline="no-display-inline" id="H6F058B2D4B7446E6A43D1FD01E61E57C"><enum>(iv)</enum><text display-inline="yes-display-inline">2 members who are employed by the National Institutes of Health and have expertise in Long COVID research.</text></clause></subparagraph><subparagraph id="H291A2CCFAC1046339E42FC814880377F"><enum>(B)</enum><text>The following shall be ex officio members of the Advisory Board:</text><clause id="H5A4AC568A7954035B62C446E4E6851BB"><enum>(i)</enum><text>A representative of the Long COVID Research Program established under section 499.</text></clause><clause id="HD23466F960F74853A364719475B7BB7F"><enum>(ii)</enum><text>A representative of the National Institutes of Health.</text></clause><clause id="H20C0879A8FBC440185F4F5E9B46B784B"><enum>(iii)</enum><text>A representative of the National Institutes of Neurological Disorders and Stroke.</text></clause><clause id="HB2AC93B76E3B441894D54600C550AB72"><enum>(iv)</enum><text>A representative of the National Heart, Lung, and Blood Institute.</text></clause><clause id="H3DF3BE77D2AB42B59B833A6A9B698B03"><enum>(v)</enum><text>A representative of the National Institute of Allergy and Infectious Diseases.</text></clause><clause id="H8C03C4FCF11B437F8C085D2246F9CEC3"><enum>(vi)</enum><text>A representative of the Office of the Assistant Secretary for Health.</text></clause><clause id="H095416E7AAAD4D32A171F6E55B1E7C5C"><enum>(vii)</enum><text>A representative of the Centers for Disease Control and Prevention.</text></clause><clause id="HDFD192C0CE9241B5ABB16F975402C3D1"><enum>(viii)</enum><text>A representative of the Administration for Community Living.</text></clause><clause commented="no" display-inline="no-display-inline" id="H3A5B6D9897834456B0F1B1820130CCB1"><enum>(ix)</enum><text display-inline="yes-display-inline">A representative of the Agency for Healthcare Research and Quality.</text></clause><clause commented="no" display-inline="no-display-inline" id="H6BF6F62E188F4E1E900650743288EC97"><enum>(x)</enum><text display-inline="yes-display-inline">Representatives of any other agency or office of the Department of Health and Human Services that the Secretary determines appropriate for the Advisory Board to carry out its function.</text></clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H141EF1ACD77645299BB0CC2FF5496EB8"><enum>(2)</enum><header>Engagement with organizations</header><text display-inline="yes-display-inline">In appointing individuals to the Advisory Board, the Secretary shall engage with leading scientific experts on Long COVID and independent, patient-led organizations of advocacy groups representing Long COVID patients.</text></paragraph></subsection><subsection id="HF039BB97AF034FADB60E844DEAD9C69B"><enum>(c)</enum><header>Compensation</header><text>Ex officio members of the Advisory Board who are officers or employees of the Federal Government shall not receive any compensation for service on the Advisory Board. Non-Federal members of the Advisory Board may receive, for each day (including travel time) they are engaged in the performance of the functions of the advisory committee, compensation at rates not to exceed the daily equivalent to the annual rate of basic pay for level III of the Executive Schedule under section 5314 of title 5, United States Code.</text></subsection><subsection id="H47C739431B0347B599AA95844E5083E0"><enum>(d)</enum><header>Terms</header><text>The term of office of an appointed member of the Advisory Board is 5 years. Any member appointed to fill a vacancy for an unexpired term shall be appointed for the remainder of such term. A member may serve after the expiration of the member’s term until a successor has taken office. If a vacancy occurs in the Advisory Board, the Secretary shall make an appointment to fill the vacancy not later than 60 days from the date the vacancy occurred.</text></subsection><subsection id="H41418F4BF48242F6B95732C529ADF439"><enum>(e)</enum><header>Chair</header><text>The members of the Advisory Board shall select a chair from among the appointed members. The term of the Office of Chair shall be 2 years.</text></subsection><subsection id="H7E881B77C27F413286E70C9555B58579"><enum>(f)</enum><header>Meetings</header><paragraph id="H4C8B25CFA6DC4C8ABF45D7C0F81C0C54"><enum>(1)</enum><header>In general</header><text>The Advisory Board shall meet at the call of the chairman or upon request of the Director of the Program established under section 499B, but not less often than monthly in the first year after establishment, then not less often than 6 times a year for each subsequent year. The meetings of the Advisory Board may be held virtually.</text></paragraph><paragraph id="H5CE47C3E3B3D42C6B33A08479B6DBDE2"><enum>(2)</enum><header>Purpose</header><text>Of the meetings held, one or more shall be held to address research priorities of the National Institutes of Health relating to Long COVID.</text></paragraph><paragraph id="H36EAF1DD40CC4E85B6E115B487FC3417"><enum>(3)</enum><header>Publication of summary</header><text>For each meeting held, the Director of NIH shall post on the website of the National Institutes of Health a summary of the proceedings.</text></paragraph></subsection><subsection id="H7B5BC5D33E184C08B6F31E633883246C"><enum>(g)</enum><header>Duties</header><text>The Advisory Board shall, subject to the direction and supervision of the Director of NIH—</text><paragraph id="HCBDE288CF4B14FBA80EA2227CF05DA2A"><enum>(1)</enum><text>review, approve, and evaluate the implementation of the research plan issued under section 499B–1, and advise in updating the plan;</text></paragraph><paragraph id="H12DB130F74244A9D9C3E3FE9FBF98794"><enum>(2)</enum><text>provide guidance to the Director of the Program established under section 499B with respect to appropriate research activities to be undertaken regarding the clinical treatment of Long COVID, which may include—</text><subparagraph id="H7BF3F6A0E4DF4720980D123A8B81F04F"><enum>(A)</enum><text>research on interventions for preventing, treating, and understanding the mechanisms of Long COVID;</text></subparagraph><subparagraph id="HB5BD1113377747C9BDBB5E29FE9EB7FC"><enum>(B)</enum><text>research on the effectiveness of treating Long COVID with drugs that are not yet approved by the Food and Drug Administration for the treatment of Long COVID;</text></subparagraph><subparagraph id="H0184978BE71B43B79295E8609AD68CED"><enum>(C)</enum><text>reviewing ongoing publicly- and privately-supported research on treatments for Long COVID;</text></subparagraph><subparagraph id="H2E6AF729D4C34FACBA6F64814F829CC1"><enum>(D)</enum><text>issue and make available to health care professionals and the public reports describing and evaluating research described in subparagraphs (A), (B), and (C); and</text></subparagraph><subparagraph id="HA86C60B40BD240CCBF3D469136A0EB6B"><enum>(E)</enum><text>convene accessible meetings for the purpose of determining the recommendations which may inform development of clinical guidelines by health care provider organizations; and</text></subparagraph></paragraph><paragraph id="H2CB999C470864DC4ABFE2151D52A3910" commented="no" display-inline="no-display-inline"><enum>(3)</enum><text>engage in other necessary activities to contribute to the National Institutes of Health’s overall research priorities related to Long COVID, and ensure accountability, transparency, and communication of results of the Program established under section 499B.</text></paragraph></subsection></section><section id="H1B5D53ADA93841B8BF8500C75088F9CF"><enum>499B–5.</enum><header>Data system and clearinghouse on research information</header><subsection id="H850C1FA5A6AD483BA27CDB8437AA3EA2"><enum>(a)</enum><header>Data system</header><paragraph id="H6C5AA19E514C4219AF2AAB2C0F9EC8A4"><enum>(1)</enum><header>In general</header><text>The Director of the National Institutes of Health, in consultation with the Director of the Program established under section 499B and the Director of the National Library of Medicine shall establish, maintain, and operate a data system for the collection, storage, analysis, retrieval, and timely dissemination of primary data regarding research on Long COVID that is conducted or supported by the Program. Information from the data system shall be available through information systems available to health care professionals and providers, researchers, and members of the public.</text></paragraph><paragraph id="HDDD8932560D247BB9207B67726394436"><enum>(2)</enum><header>Registry</header><subparagraph commented="no" display-inline="no-display-inline" id="H01538ACB313D4F979D25722EEC6E2A34"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">The data system established under paragraph (1) shall include a registry of clinical trials of experimental treatments that have been developed for research on Long COVID. Such registry shall include information on patient eligibility criteria, including the definition of Long COVID, and, as applicable, demographic information, including sex, age, disability status, ethnicity, and race, and the location of the trial site or sites. </text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H2714635268D948C2B1224CEA49CE056D"><enum>(B)</enum><header>Submission of information</header><text display-inline="yes-display-inline">Principal investigators of trials described in subparagraph (A) shall provide such information to the registry not later than 30 days after public announcement of the clinical trial. Once a trial has been completed, the principal investigator shall provide the registry with information pertaining to the results, including potential toxicities or adverse effects associated with the experimental treatment or treatments evaluated.</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HA2609BD0F45B43BAA429F300C49F9890"><enum>(C)</enum><header>Public availability</header><text>The registry described in this paragraph shall be made available to researchers and the general public, in a machine-readable format.</text></subparagraph></paragraph></subsection><subsection id="H8797DA912EBB4701BD013EFDD0C07D99"><enum>(b)</enum><header>Clearinghouse</header><text>The Director of NIH, in consultation with the Director of the Program and with the National Library of Medicine, shall establish, maintain, and operate a program to provide information on research and prevention activities of the national research institutes that relate to research on Long COVID.</text></subsection></section><section id="H7BAEC059450A444F8C054DEA6AE05015"><enum>499B–6.</enum><header>Appropriations</header><text display-inline="no-display-inline">For purposes of carrying out this part, there are appropriated, out of amounts in the Treasury not otherwise appropriated, $1,000,000,000 for each of fiscal years 2025 through 2034, to remain available until expended.</text></section></part><after-quoted-block>.</after-quoted-block></quoted-block></section>

118 HR 9907 IH: Long COVID Research Moonshot Act U.S. House of Representatives 2024-10-01 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

118th CONGRESS2d Session

H. R. 9907

IN THE HOUSE OF REPRESENTATIVES

October 1, 2024

Ms. Omar (for herself, Ms. Pressley, Ms. Norton, Mrs. Watson Coleman, Mr. Grijalva, Ms. Tlaib, Mr. Smith of Washington, Ms. Bush, Ms. Jayapal, Ms. Lee of California, Mr. McGovern, Mrs. Hayes, Ms. Velázquez, Mr. Bowman, Mrs. Ramirez, Ms. Moore of Wisconsin, Ms. Lofgren, Mr. Mullin, Mr. Frost, Mr. Robert Garcia of California, Ms. Schakowsky, and Ms. Chu) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on Education and the Workforce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned

A BILL

To provide for a comprehensive Federal response to Long COVID, including research, education, and support for affected individuals, to direct the National Institutes of Health to establish a Long COVID research program, and for other purposes.

Short title

This Act may be cited as the

Long COVID Research Moonshot Act

<enum>I</enum><header>Long COVID Biomedical Research</header><section id="H6B43E208D6A34290A6C4FD37174847F6"><enum>101.</enum><header>Establishment of Long COVID research program</header><text display-inline="no-display-inline">Title IV of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/281">42 U.S.C. 281 et seq.</external-xref>) is amended by adding at the end the following:</text><quoted-block style="OLC" id="H15A2AF54B7A54A3C968F563C5F02FF86" display-inline="no-display-inline"><part id="H82D0C0F9272343E5BCE4DF296F5905A7"><enum>K</enum><header>Long COVID programs</header><section id="HCB6D0E2FF0BB43B7B68CE21BB09B09AA"><enum>499B.</enum><header>Establishment of Long COVID research program</header><subsection id="HCAC4C85783EA4A9A9A73C0B71604B990"><enum>(a)</enum><header>In general</header><text>There is established within the Office of the Director of the National Institutes of Health a research program, to be known as the Long COVID Research Program (referred to in this part as the <quote>Program</quote>), for purposes of expediting research to identify new ways to prevent, detect, manage, and treat symptoms associated with Long COVID.</text></subsection><subsection commented="no" display-inline="no-display-inline" id="H51E45E4F053F4F4BB08A5B4A72DB424C"><enum>(b)</enum><header>Director</header><paragraph commented="no" display-inline="no-display-inline" id="HE007776EEEE047C8806C2B24D6A7B0C1"><enum>(1)</enum><header>Appointment</header><subparagraph commented="no" display-inline="no-display-inline" id="HA10B42E4326C4F178ABFFB57742E19F6"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">The Program shall be headed by a Director, appointed by the Secretary, in consultation with the Director of NIH, who has—</text><clause id="HD0739506867C470284A959BB00DBA514"><enum>(i)</enum><text>experience managing clinical or research programs focused on pathogenic mechanisms and biological pathways related to Long COVID; and</text></clause><clause id="H7607C8EE67274FD5B26D749B3C981B39"><enum>(ii)</enum><text>demonstrated commitment to addressing Long COVID and other infection-associated chronic conditions, such as myalgic encephalomyelitis/chronic fatigue syndrome, postural orthostatic tachycardia syndrome, and post-treatment Lyme disease syndrome/persistent Lyme disease.</text></clause></subparagraph><subparagraph id="H2900F80EF9234C54A8B16B70C4F26A00"><enum>(B)</enum><header>Consultation</header><text>In appointing the Director under subparagraph (A), the Secretary shall consult with independent, patient-led organizations or advocacy groups representing Long COVID patients and their families.</text></subparagraph></paragraph><paragraph id="HA68E660B1F824381A4F1C9D4F1C850B2"><enum>(2)</enum><header>Responsibilities</header><text>The Director of the Program shall—</text><subparagraph commented="no" display-inline="no-display-inline" id="H9382D1868A6A4CA9B447EF382D1A3E53"><enum>(A)</enum><text display-inline="yes-display-inline">act as the primary Federal official with responsibility for coordinating all Long COVID research conducted or supported by the National Institutes of Health;</text></subparagraph><subparagraph id="H162EB72BCC314A909BB1147ACEEAAAA4"><enum>(B)</enum><text>represent the National Institutes of Health Long COVID Research Program at all relevant Executive branch task force meetings and committees; and</text></subparagraph><subparagraph id="H29EBA6E4E1B841F8AA4EE17BFAC2EFF1"><enum>(C)</enum><text>maintain communication with all relevant Federal departments and agencies to ensure the timely transmission of information concerning advances in Long COVID research and the clinical treatment of Long COVID and other infection-associated chronic conditions between such departments and agencies, and for dissemination to affected communities and health care providers. </text></subparagraph></paragraph></subsection><subsection id="HC9BF3D2C9E744C46AA653D117D8912B4"><enum>(c)</enum><header>Activities</header><text>The Program shall—</text><paragraph id="H852F49C66C8D428681FB85B889C42517"><enum>(1)</enum><text>investigate the etiology, pathophysiology, risk factors, and pathology of Long COVID in adults and children;</text></paragraph><paragraph id="H06536DBCFE094B418C08884CFD5BEB67"><enum>(2)</enum><text>explore the best ways to prevent, detect, monitor, manage, and treat Long COVID in adults and children;</text></paragraph><paragraph id="H6BEB6A4268E34027B3E6BD8F7CFF2A75"><enum>(3)</enum><text>contribute knowledge to the understanding, prevention, mitigation, management, and treatment of Long COVID;</text></paragraph><paragraph id="H2595B9FB175942029E2DA7F8E873310E"><enum>(4)</enum><text>develop and facilitate programs on Long COVID, within the National Institutes of Health and in other settings; </text></paragraph><paragraph id="H886D8191F345493394493E4DDCFBDBB3"><enum>(5)</enum><text>conduct comparative research to understand the similarities and differences between Long COVID and other infection-associated chronic conditions with similar phenotypes, such as myalgic encephalomyelitis/chronic fatigue syndrome, postural orthostatic tachycardia syndrome, and post-treatment Lyme disease syndrome/persistent Lyme disease, and how activities funded by the Program could improve understanding of such other conditions; and</text></paragraph><paragraph id="H14A3C871694D4F49AFDCC5FC4973CFB6"><enum>(6)</enum><text>conduct comparative research to understand the similarities and differences between Long COVID and severe, long-term effects from COVID–19 vaccinations.</text></paragraph></subsection><subsection id="H7A5C37D6B6F34A75BD321D32D321E74E"><enum>(d)</enum><header>Duties</header><paragraph id="H8C669FC4FD534D9496CA7FF4545F4428"><enum>(1)</enum><header>Interagency coordination of long covid activities</header><text>The Director of the Program shall coordinate with the national research institutes and national centers, as appropriate, on Long COVID research. In carrying out this paragraph, the Director of the Program shall evaluate the Long COVID activities of each such institute or center and shall provide for the periodic reevaluation of such activities.</text></paragraph><paragraph id="H8F622B4118784AFE93D0C94E70BCC0FE"><enum>(2)</enum><header>Consultation</header><text>The Director of the Program shall carry out all duties, including the development of the research plan under section 499B–1 in consultation with the heads of the national research institutes and national centers, with the advisory councils of such institutes and centers, and with the Long COVID Research Program Advisory Board established under section 499B–4.</text></paragraph></subsection><subsection id="H6D49DDB194A34FEFA6ED939820887DD3"><enum>(e)</enum><header>Non-Duplication of effort</header><text>The Director shall ensure that activities carried out under this section do not unnecessarily duplicate the efforts of other Federal departments or agencies. </text></subsection></section><section id="HFE20648A4A194E2E94C94EC61354C008"><enum>499B–1.</enum><header>Long COVID Research Plan</header><subsection id="HF06A9997DD4345179DE1D3D3F69FA779"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Not later than 1 year after the date of enactment of the <short-title>Long COVID Research Moonshot Act</short-title>, the Director of the Program established under section 499B shall develop and make public a comprehensive research plan for the conduct and support of all Long COVID research activities of the national research institutes and national centers. The Director of the Program shall update such plan annually.</text></subsection><subsection id="H7C48E67DDC5A4331BB641D69F36ED22F"><enum>(b)</enum><header>Contents</header><text>The research plan developed under subsection (a) shall—</text><paragraph id="H8090D8BAA1CC49DCAC50A84612BC8FCB"><enum>(1)</enum><text>identify current Long COVID research conducted or supported by the national research institutes and national centers, opportunities and needs for additional research, including among patients who face the highest disease burden and pediatric patients, and priorities for such research;</text></paragraph><paragraph id="H1B9B08EC5CD347118794C3447FC8AD65"><enum>(2)</enum><text>evaluate the progress of Long COVID research against strategic priorities, goals, and objectives, identified in previous versions of the research plan; </text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H0D981ED3489C46BE85A0ED60FA4A0DED"><enum>(3)</enum><text display-inline="yes-display-inline">make recommendations for the coordination of such research conducted or supported by the National Institutes of Health and other agencies of the Federal Government; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H66352DBF78FB453F8BA595EE82D5EC22"><enum>(4)</enum><text display-inline="yes-display-inline">include goals and objectives of the Program for conducting, supporting, and coordinating Long COVID research.</text></paragraph></subsection><subsection id="H897DC12F501446CA9C90E710F5E68969"><enum>(c)</enum><header>Requirements</header><text>In developing the research plan under subsection (a), the Director of the Program shall—</text><paragraph id="HC2C8ABFA7CF84A9F8E5DD615E505D351"><enum>(1)</enum><text>ensure that the plan establishes priorities among Long COVID research that the Program is authorized to carry out;</text></paragraph><paragraph id="H1881952F492B4E55948F7D0ACAD95F61"><enum>(2)</enum><text>ensure that the plan establishes objectives regarding such research and describes the means for achieving the objectives;</text></paragraph><paragraph id="H2E16EA651E814F3C9DDD7E63C539BD26"><enum>(3)</enum><text>ensure that all amounts appropriated for such research under section 499B–6 are expended in accordance with the plan;</text></paragraph><paragraph id="H5F358EB3C71840FF8D8A7DA084C15FF4"><enum>(4)</enum><text>review the plan not less frequently than annually, and revise the plan as appropriate to prioritize funding and research relative to scientific urgency;</text></paragraph><paragraph id="HD3835C7FA06B460D85E98FD50FE3FE4C"><enum>(5)</enum><text>ensure that the plan serves as a broad, binding statement of policies regarding Long COVID research of the National Institutes of Health, but does not affect the responsibility of any of the national research institutes or centers with respect to the programs or projects of such institutes and centers; and</text></paragraph><paragraph id="H92C4ABD1325549AAB32CA06740A7DF49"><enum>(6)</enum><text>annually prepare and submit to the Director of NIH for review and transmittal by the Director of NIH to the President and to Congress a budget estimate for carrying out the plan for the upcoming fiscal year.</text></paragraph></subsection><subsection id="HD53B9802084A4A4E81CF7A26192233F4"><enum>(d)</enum><header>Consultation</header><text>In developing, implementing, reviewing, and prioritizing elements of the research plan under this section, the Director of the Program shall consult, as appropriate with—</text><paragraph id="H4C63C1480B9E4901A80CC6D1784C2158"><enum>(1)</enum><text>representatives of other Federal agencies involved in Long COVID research, including the Centers for Disease Control and Prevention, the Agency for Healthcare Research and Quality, and the Administration for Community Living;</text></paragraph><paragraph id="H19FF25CECC1443739F32E4BD065D3581"><enum>(2)</enum><text>the Long COVID Research Advisory Board established under section 499B–4;</text></paragraph><paragraph id="HF14FC8E557164808BE0A65BEA10FFAF0"><enum>(3)</enum><text>the Office of Long COVID Research and Practice of the Department of Health and Human Services;</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H9CA6EA68532E4B1C99FE6E9AF313EB24"><enum>(4)</enum><text>leading scientific experts on Long COVID; and</text></paragraph><paragraph id="H24B7B4A66CC34FC9A786F6087F696EFC"><enum>(5)</enum><text>independent, patient-led organizations or advocacy groups representing patients with Long COVID and other infection-associated chronic conditions with similar phenotypes, and the families of such patients.</text></paragraph></subsection><subsection id="H9204C33E4A804B66A9FD88C977901CF6"><enum>(e)</enum><header>Report</header><text>The Director of the Program shall submit the research plan developed under subsection (a), and updates to such plan, to—</text><paragraph id="H1F51E54DE03B4A278A46AC75419E19BA"><enum>(1)</enum><text>the Committee on Health, Education, Labor, and Pensions of the Senate;</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H72CE9FC615404DD8A669FB490C72754E"><enum>(2)</enum><text>the Committee on Energy and Commerce of the House of Representatives;</text></paragraph><paragraph id="H5989430A1C134724AC0BA8957853FEC8"><enum>(3)</enum><text>the Secretary;</text></paragraph><paragraph id="H5E26C70A7C18424DADDFA7F444392CC8"><enum>(4)</enum><text>the Office of Long COVID Research and Practice of the Department of Health and Human Services; and</text></paragraph><paragraph id="H807AAB9F08B3462ABB9F918AB555E80A" commented="no" display-inline="no-display-inline"><enum>(5)</enum><text>the Director of NIH, who shall post the plan, and updates to the plan, on the website of the National Institutes of Health.</text></paragraph></subsection></section><section id="HB1107BCEB091426884946CBD730B1D3C"><enum>499B–2.</enum><header>Expedited Long COVID research</header><subsection id="H58D630D5A43D403FBC2347B7FF7865A8"><enum>(a)</enum><header>In general</header><text>The Director of NIH shall establish a process to expedite the award of grants, contracts, and cooperative agreements for research projects conducted or supported by the National Institutes of Health and relating to Long COVID.</text></subsection><subsection id="H8420AD25122E436C9592570020BB22CF"><enum>(b)</enum><header>Requirements for making external funding available</header><text>With respect to programs of grants, contracts, and cooperative agreements described in subsection (a), the Director of NIH shall—</text><paragraph id="HA7E5BEDBE33F428B89B9AFB324F327CC"><enum>(1)</enum><text>make publicly available the deadlines for submitting applications for such programs, and ensure that such deadlines provide applicants with sufficient time from the date of the announcement for such grant, contract, and cooperative agreement to submit an application;</text></paragraph><paragraph id="H3AB0A844716944C3A823F61206249A52"><enum>(2)</enum><text>ensure that applicants receive a final decision on their applications within 120 days of submission; and</text></paragraph><paragraph id="H7D55363D367A420B8D822443990EBBB9"><enum>(3)</enum><text>with respect to applications that are denied, provide a written explanation to the applicant on the reasons for the denial.</text></paragraph></subsection><subsection id="HD5AE8969296241699A68840A8D94D33E"><enum>(c)</enum><header>Evaluation of Grant Applications</header><text>In making a determination to award a grant, contract, and cooperative agreement for research projects described in subsection (a), the Director of NIH shall—</text><paragraph id="H28D11BB135C7431FBC3BF086C63EAB00"><enum>(1)</enum><text>give priority to research that—</text><subparagraph commented="no" display-inline="no-display-inline" id="H93F94599458143DB9E0CAFFCFD57DAD2"><enum>(A)</enum><text display-inline="yes-display-inline">tests the outcomes of existing drug and device interventions in patients with Long COVID;</text></subparagraph><subparagraph id="HACA79007A41A4C70BD96B719E3F0DE5B"><enum>(B)</enum><text>focuses on identifying interventions for pediatric patients with Long COVID;</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H8085881641D04A85A3F34615BC2FD916"><enum>(C)</enum><text display-inline="yes-display-inline">aids in the development of new interventions that have evidence to suggest effectiveness in treating or curing Long COVID; or</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H15FCF2D2FD754F25A935F84879A6C144"><enum>(D)</enum><text display-inline="yes-display-inline">includes institutions that represent, or have a successful track record of providing equitable care or services to, historically underserved communities;</text></subparagraph></paragraph><paragraph id="HFD22AAC2A8CD43319A5FAAA90E5D2E5E"><enum>(2)</enum><text>consider research that has the ability to begin interventions in a timely manner; </text></paragraph><paragraph id="H320E027E9CB747B0A7F505D3A53D2B7B"><enum>(3)</enum><text>consider research that uses decentralized trials or remote monitoring techniques for data collection; and </text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H5B7C0B9367D04BD2BDF2C553757F3239"><enum>(4)</enum><text display-inline="yes-display-inline">consider research that includes patients with other infection-associated chronic conditions with similar phenotypes, such as myalgic encephalomyelitis/chronic fatigue syndrome, postural orthostatic tachycardia syndrome, and post-treatment Lyme disease syndrome/persistent Lyme disease. </text></paragraph></subsection><subsection id="H20E6EDC2B7D744B4AFD0459DD3918675"><enum>(d)</enum><header>Reasonable pricing</header><text>In awarding contracts, grants, and cooperative agreements for research projects described in subsection (a) that relates to the development of a drug or device for the potential treatment or management of Long COVID, or identifying a new indication or use specific to the treatment or management of Long COVID in a drug or device that is already approved or cleared by the Food and Drug Administration, the Director of NIH shall include terms and conditions requiring that the price of such a drug or device for purposes of procurement by the Federal Government or if sold on the commercial market, whether procured from, or sold by, the recipient of such Federal award or another person—</text><paragraph commented="no" display-inline="no-display-inline" id="H302C9921331548D2B28EE98B8E6F4651"><enum>(1)</enum><text display-inline="yes-display-inline">is fair and reasonable, taking into account—</text><subparagraph id="HF42E18196BFC4B49AB02D74EA5E26FDA"><enum>(A)</enum><text>the value of the drug and device to the public health, including the impact of the price on access to the drug or device;</text></subparagraph><subparagraph id="HD778E61E48C2416897B93C9DFFFBA10C"><enum>(B)</enum><text>the costs incurred by the Federal Government in research and development of the drug or device;</text></subparagraph><subparagraph id="H1D1F8AAE346E4DBF8872DE21D8E8823F"><enum>(C)</enum><text>the costs incurred by the recipient of the award in research and development of the drug or device, and the costs of manufacturing such drug or device;</text></subparagraph><subparagraph id="HE2AADD023A7448C29447E092CB3ECD91"><enum>(D)</enum><text>whether the drug or device provided a significant improvement in health outcomes, compared to other therapies available at the time of its approval or authorization;</text></subparagraph><subparagraph id="H831CDF9A93FA46FD8D215418FA3E1711"><enum>(E)</enum><text>the cumulative expected global revenues generated by the drug or device; and</text></subparagraph><subparagraph id="H3D150A02A7BD4FA0A83C929763E90660"><enum>(F)</enum><text>other factors, as the Secretary determines appropriate; and</text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HE5E224EED507456E834903AD0CE50262"><enum>(2)</enum><text>does not exceed the lowest price charged for such drug or device, among Canada, France, Germany, Italy, Japan, and the United Kingdom.</text></paragraph></subsection><subsection id="H8027D1CFC59040C0BB65EA847DBD24CE" commented="no" display-inline="no-display-inline"><enum>(e)</enum><header>Consultation</header><text>In making a determination to award a grant, contract, or cooperative agreement for research projects relating to Long COVID, the Director of NIH shall consult with the Long COVID Research Advisory Board. Members of the Long COVID Research Advisory Board shall provide a recommendation on any final funding decisions. If the Director of NIH makes a decision that is different than the recommendation, the Director of NIH shall provide a written justification for the decision within 5 days.</text></subsection></section><section id="H147C3C66A564439583D3FDCF52AD1422"><enum>499B–3.</enum><header>Scientific Review Group</header><subsection id="HCE2ECB58AC8F4F358EEA913A0453084A"><enum>(a)</enum><header>In general</header><text>In order to ensure high quality, rigorous scientific review of applications for grants, contracts, and cooperative agreements described in section 499B–2(a), consistent with section 492, the Director of NIH shall establish a scientific review group on Long COVID and other infection-associated chronic conditions, and shall convene a group of leading scientific experts to serve on such group, for terms of up to 5 years.</text></subsection><subsection id="HC6DCCAD3795545B5B1EB655C7576A63F"><enum>(b)</enum><header>Duties</header><text>The scientific research group shall conduct an initial review of applications for grants, contracts, and other cooperative agreements described in section 499B–2(a), and submit a funding recommendation to the Director of NIH for final determination.</text></subsection></section><section id="H7626110C5C3F4874893558031C4D348E"><enum>499B–4.</enum><header>Long COVID Research Program Advisory Board</header><subsection id="H2389AB68F2614B33A96BCEFC30DD5098"><enum>(a)</enum><header>In general</header><text>The Director of NIH shall establish the Long COVID Research Program Advisory Board (referred to in this section as the <quote>Advisory Board</quote>).</text></subsection><subsection id="H82170841767D44D2BF5277DF047C0364"><enum>(b)</enum><header>Membership</header><paragraph commented="no" display-inline="no-display-inline" id="H29BCCCF93B2A48B1A91C625AB07AC2FC"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">The Advisory Board shall be comprised of 18 members, including appointed members and nonvoting ex officio members, as follows:</text><subparagraph id="HDEDD38CC5EB642628274B2C45517FC84"><enum>(A)</enum><text>The Secretary shall conduct a nomination process that allows for public input on nominees. The Secretary shall appoint nominated individuals, giving particular consideration to individuals from backgrounds that represent the diversity of the Long COVID population, with an emphasis on patients who face the highest disease burden. Individuals so appointed shall include the following:</text><clause id="HDC33F0100DEC4BAD849FDE09F8CC2E10"><enum>(i)</enum><text>10 members who are scientists, physicians, and other health care professionals, who are not officers or employees of the Federal Government, and who have primary expertise in Long COVID and other infection-associated chronic conditions, with consideration given to such individuals with expertise in pediatric populations.</text></clause><clause id="H7269862B61E24F95943B3D04CD641A9F"><enum>(ii)</enum><text>5 members who live with Long COVID.</text></clause><clause id="H907AA4482717450493103D2585BB084E"><enum>(iii)</enum><text>1 member who is a caregiver to an individual with Long COVID.</text></clause><clause commented="no" display-inline="no-display-inline" id="H6F058B2D4B7446E6A43D1FD01E61E57C"><enum>(iv)</enum><text display-inline="yes-display-inline">2 members who are employed by the National Institutes of Health and have expertise in Long COVID research.</text></clause></subparagraph><subparagraph id="H291A2CCFAC1046339E42FC814880377F"><enum>(B)</enum><text>The following shall be ex officio members of the Advisory Board:</text><clause id="H5A4AC568A7954035B62C446E4E6851BB"><enum>(i)</enum><text>A representative of the Long COVID Research Program established under section 499.</text></clause><clause id="HD23466F960F74853A364719475B7BB7F"><enum>(ii)</enum><text>A representative of the National Institutes of Health.</text></clause><clause id="H20C0879A8FBC440185F4F5E9B46B784B"><enum>(iii)</enum><text>A representative of the National Institutes of Neurological Disorders and Stroke.</text></clause><clause id="HB2AC93B76E3B441894D54600C550AB72"><enum>(iv)</enum><text>A representative of the National Heart, Lung, and Blood Institute.</text></clause><clause id="H3DF3BE77D2AB42B59B833A6A9B698B03"><enum>(v)</enum><text>A representative of the National Institute of Allergy and Infectious Diseases.</text></clause><clause id="H8C03C4FCF11B437F8C085D2246F9CEC3"><enum>(vi)</enum><text>A representative of the Office of the Assistant Secretary for Health.</text></clause><clause id="H095416E7AAAD4D32A171F6E55B1E7C5C"><enum>(vii)</enum><text>A representative of the Centers for Disease Control and Prevention.</text></clause><clause id="HDFD192C0CE9241B5ABB16F975402C3D1"><enum>(viii)</enum><text>A representative of the Administration for Community Living.</text></clause><clause commented="no" display-inline="no-display-inline" id="H3A5B6D9897834456B0F1B1820130CCB1"><enum>(ix)</enum><text display-inline="yes-display-inline">A representative of the Agency for Healthcare Research and Quality.</text></clause><clause commented="no" display-inline="no-display-inline" id="H6BF6F62E188F4E1E900650743288EC97"><enum>(x)</enum><text display-inline="yes-display-inline">Representatives of any other agency or office of the Department of Health and Human Services that the Secretary determines appropriate for the Advisory Board to carry out its function.</text></clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H141EF1ACD77645299BB0CC2FF5496EB8"><enum>(2)</enum><header>Engagement with organizations</header><text display-inline="yes-display-inline">In appointing individuals to the Advisory Board, the Secretary shall engage with leading scientific experts on Long COVID and independent, patient-led organizations of advocacy groups representing Long COVID patients.</text></paragraph></subsection><subsection id="HF039BB97AF034FADB60E844DEAD9C69B"><enum>(c)</enum><header>Compensation</header><text>Ex officio members of the Advisory Board who are officers or employees of the Federal Government shall not receive any compensation for service on the Advisory Board. Non-Federal members of the Advisory Board may receive, for each day (including travel time) they are engaged in the performance of the functions of the advisory committee, compensation at rates not to exceed the daily equivalent to the annual rate of basic pay for level III of the Executive Schedule under section 5314 of title 5, United States Code.</text></subsection><subsection id="H47C739431B0347B599AA95844E5083E0"><enum>(d)</enum><header>Terms</header><text>The term of office of an appointed member of the Advisory Board is 5 years. Any member appointed to fill a vacancy for an unexpired term shall be appointed for the remainder of such term. A member may serve after the expiration of the member’s term until a successor has taken office. If a vacancy occurs in the Advisory Board, the Secretary shall make an appointment to fill the vacancy not later than 60 days from the date the vacancy occurred.</text></subsection><subsection id="H41418F4BF48242F6B95732C529ADF439"><enum>(e)</enum><header>Chair</header><text>The members of the Advisory Board shall select a chair from among the appointed members. The term of the Office of Chair shall be 2 years.</text></subsection><subsection id="H7E881B77C27F413286E70C9555B58579"><enum>(f)</enum><header>Meetings</header><paragraph id="H4C8B25CFA6DC4C8ABF45D7C0F81C0C54"><enum>(1)</enum><header>In general</header><text>The Advisory Board shall meet at the call of the chairman or upon request of the Director of the Program established under section 499B, but not less often than monthly in the first year after establishment, then not less often than 6 times a year for each subsequent year. The meetings of the Advisory Board may be held virtually.</text></paragraph><paragraph id="H5CE47C3E3B3D42C6B33A08479B6DBDE2"><enum>(2)</enum><header>Purpose</header><text>Of the meetings held, one or more shall be held to address research priorities of the National Institutes of Health relating to Long COVID.</text></paragraph><paragraph id="H36EAF1DD40CC4E85B6E115B487FC3417"><enum>(3)</enum><header>Publication of summary</header><text>For each meeting held, the Director of NIH shall post on the website of the National Institutes of Health a summary of the proceedings.</text></paragraph></subsection><subsection id="H7B5BC5D33E184C08B6F31E633883246C"><enum>(g)</enum><header>Duties</header><text>The Advisory Board shall, subject to the direction and supervision of the Director of NIH—</text><paragraph id="HCBDE288CF4B14FBA80EA2227CF05DA2A"><enum>(1)</enum><text>review, approve, and evaluate the implementation of the research plan issued under section 499B–1, and advise in updating the plan;</text></paragraph><paragraph id="H12DB130F74244A9D9C3E3FE9FBF98794"><enum>(2)</enum><text>provide guidance to the Director of the Program established under section 499B with respect to appropriate research activities to be undertaken regarding the clinical treatment of Long COVID, which may include—</text><subparagraph id="H7BF3F6A0E4DF4720980D123A8B81F04F"><enum>(A)</enum><text>research on interventions for preventing, treating, and understanding the mechanisms of Long COVID;</text></subparagraph><subparagraph id="HB5BD1113377747C9BDBB5E29FE9EB7FC"><enum>(B)</enum><text>research on the effectiveness of treating Long COVID with drugs that are not yet approved by the Food and Drug Administration for the treatment of Long COVID;</text></subparagraph><subparagraph id="H0184978BE71B43B79295E8609AD68CED"><enum>(C)</enum><text>reviewing ongoing publicly- and privately-supported research on treatments for Long COVID;</text></subparagraph><subparagraph id="H2E6AF729D4C34FACBA6F64814F829CC1"><enum>(D)</enum><text>issue and make available to health care professionals and the public reports describing and evaluating research described in subparagraphs (A), (B), and (C); and</text></subparagraph><subparagraph id="HA86C60B40BD240CCBF3D469136A0EB6B"><enum>(E)</enum><text>convene accessible meetings for the purpose of determining the recommendations which may inform development of clinical guidelines by health care provider organizations; and</text></subparagraph></paragraph><paragraph id="H2CB999C470864DC4ABFE2151D52A3910" commented="no" display-inline="no-display-inline"><enum>(3)</enum><text>engage in other necessary activities to contribute to the National Institutes of Health’s overall research priorities related to Long COVID, and ensure accountability, transparency, and communication of results of the Program established under section 499B.</text></paragraph></subsection></section><section id="H1B5D53ADA93841B8BF8500C75088F9CF"><enum>499B–5.</enum><header>Data system and clearinghouse on research information</header><subsection id="H850C1FA5A6AD483BA27CDB8437AA3EA2"><enum>(a)</enum><header>Data system</header><paragraph id="H6C5AA19E514C4219AF2AAB2C0F9EC8A4"><enum>(1)</enum><header>In general</header><text>The Director of the National Institutes of Health, in consultation with the Director of the Program established under section 499B and the Director of the National Library of Medicine shall establish, maintain, and operate a data system for the collection, storage, analysis, retrieval, and timely dissemination of primary data regarding research on Long COVID that is conducted or supported by the Program. Information from the data system shall be available through information systems available to health care professionals and providers, researchers, and members of the public.</text></paragraph><paragraph id="HDDD8932560D247BB9207B67726394436"><enum>(2)</enum><header>Registry</header><subparagraph commented="no" display-inline="no-display-inline" id="H01538ACB313D4F979D25722EEC6E2A34"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">The data system established under paragraph (1) shall include a registry of clinical trials of experimental treatments that have been developed for research on Long COVID. Such registry shall include information on patient eligibility criteria, including the definition of Long COVID, and, as applicable, demographic information, including sex, age, disability status, ethnicity, and race, and the location of the trial site or sites. </text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H2714635268D948C2B1224CEA49CE056D"><enum>(B)</enum><header>Submission of information</header><text display-inline="yes-display-inline">Principal investigators of trials described in subparagraph (A) shall provide such information to the registry not later than 30 days after public announcement of the clinical trial. Once a trial has been completed, the principal investigator shall provide the registry with information pertaining to the results, including potential toxicities or adverse effects associated with the experimental treatment or treatments evaluated.</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HA2609BD0F45B43BAA429F300C49F9890"><enum>(C)</enum><header>Public availability</header><text>The registry described in this paragraph shall be made available to researchers and the general public, in a machine-readable format.</text></subparagraph></paragraph></subsection><subsection id="H8797DA912EBB4701BD013EFDD0C07D99"><enum>(b)</enum><header>Clearinghouse</header><text>The Director of NIH, in consultation with the Director of the Program and with the National Library of Medicine, shall establish, maintain, and operate a program to provide information on research and prevention activities of the national research institutes that relate to research on Long COVID.</text></subsection></section><section id="H7BAEC059450A444F8C054DEA6AE05015"><enum>499B–6.</enum><header>Appropriations</header><text display-inline="no-display-inline">For purposes of carrying out this part, there are appropriated, out of amounts in the Treasury not otherwise appropriated, $1,000,000,000 for each of fiscal years 2025 through 2034, to remain available until expended.</text></section></part><after-quoted-block>.</after-quoted-block></quoted-block></section><enum>II</enum><header>Public Health Research, Surveillance and Related Activities</header><section id="H8E22CA9114AF46FC817A70FA405E9693"><enum>201.</enum><header>Long COVID programs</header><text display-inline="no-display-inline">Title III of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/241">42 U.S.C. 241 et seq.</external-xref>) is amended by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H7B5A56B937E845D28F03426F1AF5A7EE"><part id="H45DF09112BCE4D1D80513B9FA99F6D46" style="OLC"><enum>X</enum><header>Long COVID activities</header><section id="HF3F76B37DED048498EE2EF228695023F"><enum>399PP.</enum><header>Public Health Surveillance of Long COVID and infection-associated chronic conditions</header><subsection id="H683CEABF7BFC4DF280FD5EDC698A5334"><enum>(a)</enum><header>In general</header><text>The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall establish or continue, as applicable, surveillance activities to better understand the burden and severity of Long COVID and related infection-associated chronic conditions, with specific consideration given to vulnerable populations, such as children. In carrying out this section, the Secretary shall—</text><paragraph id="H886E21D225014C239DC30044BE37FD98"><enum>(1)</enum><text>collect data on the incidence, prevalence, and severity of Long COVID and related infection-associated chronic conditions;</text></paragraph><paragraph id="HB47D79B09310469CA96977B2BBA15070"><enum>(2)</enum><text>monitor for Long COVID and Long COVID-like conditions, as appropriate, to enable early intervention and identification of factors associated with severity of symptoms;</text></paragraph><paragraph id="HAC5C20FF042F4FAEBE7116C9D64A1536"><enum>(3)</enum><text>compile, and make publicly available, in accessible formats, Long COVID data collected under paragraph (1);</text></paragraph><paragraph id="HAAC287B14B854911AE7E42B6995A5610"><enum>(4)</enum><text>develop and disseminate best practices for conducting surveillance for State, local, and Tribal public health officials, and other relevant public health stakeholders;</text></paragraph><paragraph id="H4C591E3726934A7A9F87459D1F0750B2"><enum>(5)</enum><text>provide technical assistance to international organizations, as applicable, regarding the monitoring of Long COVID; and</text></paragraph><paragraph id="HA6C598E01C164132BD743D404B522DB7"><enum>(6)</enum><text>conduct additional surveillance activities, as the Secretary determines appropriate, to better understand the burden and severity of Long COVID.</text></paragraph></subsection><subsection id="HB5C1A5D536784D3DA3B577C8D8EF6102"><enum>(b)</enum><header>Authorization of appropriations</header><text>For purposes of carrying out this section, there are authorized to be appropriated $32,000,000 for each of fiscal years 2025 through 2034.</text></subsection></section><section id="HF4F595A6CA614BA49EBE01578FCE30F2"><enum>399PP–1.</enum><header>Public health programming</header><subsection id="HC21981627FD34B048F953CDA27BC64D1"><enum>(a)</enum><header>In general</header><text>The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall make grants to State, local, and Tribal health departments for the purpose of carrying out activities related to Long COVID.</text></subsection><subsection id="HF1A897BC3A4949B188A1917EAD40142B"><enum>(b)</enum><header>Use of funds</header><text>A State, local, or Tribal health department that receives a grant under subsection (a) may use funds received through such grant to—</text><paragraph id="HDFA243F374104F459DB1684F20B0C327"><enum>(1)</enum><text>provide training on the identification of Long COVID to clinicians, public health experts, and other relevant health care professionals;</text></paragraph><paragraph id="HDE61D949CED94475B9455E5027BDF68A"><enum>(2)</enum><text>link individuals with Long COVID to care, as appropriate and applicable;</text></paragraph><paragraph id="HBA341BD69BA44A53B40B9D4DE97D67A8"><enum>(3)</enum><text>support the development and dissemination of public information and educational materials on Long COVID, including materials to address misinformation and disinformation;</text></paragraph><paragraph id="H745CF755C97D4869BD12417D6E64AABE"><enum>(4)</enum><text>support laboratory capacity for screening and diagnosis of Long COVID and associated symptoms; and</text></paragraph><paragraph id="HC1E67FBF4D2542AFACA730780FAC4E09"><enum>(5)</enum><text>build, maintain, and sustain jurisdiction-level infrastructure related to preparedness for post-infectious syndromes.</text></paragraph></subsection><subsection id="H081D222C4B224D2DA15954CA07744EDF"><enum>(c)</enum><header>Authorization of appropriations</header><text>For purposes of carrying out this section, there are authorized to be appropriated $45,000,000 for each of fiscal years 2025 through 2034.</text></subsection></section><section id="H3573F64C0FCA4756812E4C9443A2B312"><enum>399PP–2.</enum><header>National public education campaign on Long COVID</header><subsection id="HA0D618D88A744E54B30BC4CC0B484C65"><enum>(a)</enum><header>In general</header><text>The Secretary, acting through the Director of the Centers for Disease Control and Prevention, and in collaboration with national, State, local, and Tribal public health partners, shall develop a public education campaign for patients, families, and caregivers to educate and increase awareness about Long COVID in children and adults. Such campaign shall include information on—</text><paragraph id="H46AFDBC04740464F808B00546AF36CC5"><enum>(1)</enum><text>the signs and symptoms of Long COVID;</text></paragraph><paragraph id="HF02B0FFA6F8A4A9294D00194B6E8D6AB"><enum>(2)</enum><text>how to prevent and seek treatment for Long COVID;</text></paragraph><paragraph id="HEE87BCB2C1F44C28A27552CA3EDC83C0"><enum>(3)</enum><text>self-management tools and support services; and</text></paragraph><paragraph id="H33C5E1BB2C9046B093AC139BC8333C49"><enum>(4)</enum><text>other topics, as the Secretary determines appropriate.</text></paragraph></subsection><subsection id="H65F122D45137415EBB222C28614AF11B"><enum>(b)</enum><header>Consultation</header><text>In developing materials for the campaign, the Secretary shall consult with independent, patient-led organizations or advocacy groups representing Long COVID patients and their families and other relevant stakeholders.</text></subsection><subsection id="HC001E2D945C74343848A18DBB27E4EAB"><enum>(c)</enum><header>Accessibility</header><text>The public education campaign under this section shall be made available in multiple languages, including American Sign Language.</text></subsection><subsection id="HBA180DF51351419E8884A39769A6B501"><enum>(d)</enum><header>Authorization of appropriations</header><text>For purposes of carrying out this section, there are authorized to be appropriated $21,500,000 for each of fiscal years 2025 through 2029.</text></subsection></section><section id="H0C07B5DC395D419D8A6542BEA5DEED0B"><enum>399PP–3.</enum><header>Provider education</header><subsection id="H33AB4413E69F41379621BB5469C48FB7"><enum>(a)</enum><header>In general</header><text>The Secretary shall—</text><paragraph id="H4BD900FA382B4400A0E95212943DEA17"><enum>(1)</enum><text>develop and make publicly available best practices for coordinated, multidisciplinary care for individuals with Long COVID;</text></paragraph><paragraph id="HEE26199B0B024D14BB1D5C9A17A10275"><enum>(2)</enum><text>develop, update, as appropriate, and make publicly available clinical guidance and provider education materials, including for providers working with pediatric populations; and</text></paragraph><paragraph id="H9B39AFD0C79A457ABD9C5236FF56DBFA"><enum>(3)</enum><text>facilitate provider education on Long COVID signs, symptoms, maintenance, and treatment, including through technology-enabled collaborative learning.</text></paragraph></subsection><subsection id="HA3F2E25F2EB64688B018B69488070B36"><enum>(b)</enum><header>Authorization of appropriations</header><text>For the purpose of carrying out this section, there are authorized to be appropriated $3,000,000 for each of fiscal years 2025 through 2034.</text></subsection></section></part><after-quoted-block>.</after-quoted-block></quoted-block></section><section id="H2FA6C0D9B21D45A49129CE09D056B3BF"><enum>202.</enum><header>Rehabilitation Research and Training Center on Long COVID among people with disabilities</header><subsection id="H2E7CE577EC484D2986D7100FCCA1BA49"><enum>(a)</enum><header>In general</header><text>Section 240(b)(2)(C) of the Rehabilitation Act of 1973 (<external-xref legal-doc="usc" parsable-cite="usc/29/764">29 U.S.C. 764(b)(2)(C)</external-xref>) is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="HC6DEA5FC215B439F963BFAE3F61F7E26"><enum>(1)</enum><text display-inline="yes-display-inline">in clause (v), by striking <quote>; and</quote> and inserting a semicolon;</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H88EE5F1875014AFBA054E1B373D16162"><enum>(2)</enum><text>in clause (vi), by striking the period and inserting <quote>; and</quote>; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HEE04523A8BB54D86B6DABEFC4C6DCE36"><enum>(3)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HFD7B7A670D2D4ABD9C897FB193ACFB91"><clause id="H27BBA8E2EC294C57AC1517B3592E2D81"><enum>(vii)</enum><text>applied research regarding evidence-based treatments, services, and supports for individuals with disabilities with Long COVID or other infection-associated chronic conditions.</text></clause><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="HEE1B2ED61BE645569A6B0E6231809AB7" commented="no"><enum>(b)</enum><header>Authorization of appropriations</header><text>To carry out the amendment made by subsection (b), there are authorized to be appropriated to the Director of the National Institute on Disability, Independent Living, and Rehabilitation Research, $10,000,000 for the period of fiscal years 2025 through 2029. </text></subsection></section><section id="H2FCF829DED1A478988D4A85FC8025831"><enum>203.</enum><header>Clinical outcomes assessments</header><subsection id="HF3C166C686D0403ABA3C0F0ABD9379D8"><enum>(a)</enum><header>In general</header><text>The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall establish or continue the development and validation of clinical outcomes assessments to support regulatory decision making for drugs, including biological products, and devices used to treat Long COVID. </text></subsection><subsection id="H5B18153BEF034CA68CAB3C71ADDBA0CA"><enum>(b)</enum><header>Authorization of appropriations</header><text>For purposes of carrying out this section, there are authorized to be appropriated $9,000,000 for each of fiscal years 2025 through 2034.</text></subsection></section><section id="HF389065E536C41C6B413536EB85160DF"><enum>204.</enum><header>Electronic reporting form</header><subsection id="HC97C275E833543C7B687AE2A1600F18D"><enum>(a)</enum><header>In general</header><text>The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall establish or continue the development, refinement, and maintenance of a Long COVID electronic reporting form for patients to identify current treatments and treatments under development for Long COVID.</text></subsection><subsection id="HC8FBC992199844E09598ADDFF63D6298"><enum>(b)</enum><header>Authorization of appropriations</header><text>For purposes of carrying out this section, there are authorized to be appropriated $16,600,000 for each of fiscal years 2025 through 2034. </text></subsection></section><section commented="no" display-inline="no-display-inline" section-type="subsequent-section" id="H3B62DFC8095F479C8383795C502C5086"><enum>205.</enum><header display-inline="yes-display-inline">Long COVID care network</header><subsection id="H28B39541476843A49258AF4FD6EBB87A"><enum>(a)</enum><header>In general</header><text>The Secretary of Health and Human Services, acting through the Director of the Agency for Healthcare Research and Quality, shall develop, or continue to support, multidisciplinary Long COVID clinics to provide access to comprehensive, coordinated care for individuals with Long COVID, particularly underserved populations that are disproportionately impacted by the effects of Long COVID.</text></subsection><subsection id="HDB2B815F97ED4AB5B7C07754227D5F89"><enum>(b)</enum><header>Authorizations of appropriations</header><text>For purposes of carrying out this section, there are authorized to be appropriated $10,000,000 for each of fiscal years 2025 through 2034.</text></subsection></section><section id="HAA340FBB363446239873628D324C6C4F"><enum>206.</enum><header>Research on long covid best practices</header><subsection id="H90CFEC0E99BE4713A0D50B2E2C472BF9"><enum>(a)</enum><header>In general</header><text>The Secretary of Health and Human Services, in coordination with the Director of the Agency for Healthcare Research and Quality, shall develop, test, synthesize, and disseminate best practices and decision support tools related to the clinical care organization, delivery, and integration of clinical and social services for Long COVID and other infection-associated chronic conditions.</text></subsection><subsection id="H724A8BF8060E4EDB87EBE450BEC82219"><enum>(b)</enum><header>Authorization of appropriations</header><text>For the purposes of carrying out this section, there are authorized to be appropriated $10,000,000 for each of fiscal years 2025 through 2034. </text></subsection></section>