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<bill bill-stage="Introduced-in-House" dms-id="H83DCD5EFDD7544F4B6CAAEDB3E681A05" public-private="public" key="H" bill-type="olc"><metadata xmlns:dc="http://purl.org/dc/elements/1.1/">
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<dc:title>117 HR 5857 IH: Comprehensive TB Elimination Act of 2021</dc:title>
<dc:publisher>U.S. House of Representatives</dc:publisher>
<dc:date>2021-11-04</dc:date>
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<dc:language>EN</dc:language>
<dc:rights>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.</dc:rights>
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<distribution-code display="yes">I</distribution-code><congress display="yes">117th CONGRESS</congress><session display="yes">1st Session</session><legis-num display="yes">H. R. 5857</legis-num><current-chamber>IN THE HOUSE OF REPRESENTATIVES</current-chamber><action display="yes"><action-date date="20211104">November 4, 2021</action-date><action-desc><sponsor name-id="B001287">Mr. Bera</sponsor> (for himself and <cosponsor name-id="Y000033">Mr. Young</cosponsor>) introduced the following bill; which was referred to the <committee-name committee-id="HIF00">Committee on Energy and Commerce</committee-name></action-desc></action><legis-type>A BILL</legis-type><official-title display="yes">To amend the Public Health Service Act to enhance the national strategy for combating and eliminating tuberculosis, and for other purposes.</official-title></form><legis-body id="H28E260040F9A42189CF02CA70E057EB1" style="OLC"><section section-type="section-one" id="H52029E7959AD423388FE628FA67F8F7F"><enum>1.</enum><header>Short title</header><text display-inline="no-display-inline">This Act may be cited as the <quote><short-title>Comprehensive TB Elimination Act of 2021</short-title></quote>.</text></section><section id="H6319BC24D3E6433A923E268F235E02AD"><enum>2.</enum><header>National strategy for combating and eliminating tuberculosis</header><subsection id="H235C871010C64EE693410EB1E7A95011"><enum>(a)</enum><header>In general</header><text>Section 317E of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247b-6">42 U.S.C. 247b–6</external-xref>) is amended—</text><paragraph id="H5A1BF5E43ECA43F89A07140A3BB5720C"><enum>(1)</enum><text>in subsection (a)—</text><subparagraph id="H2E4527A871754536A1459AF52B222DDF"><enum>(A)</enum><text>by striking <quote>The Secretary</quote> and inserting the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H05CEAE27364D429F89CFBE8FAFD9D99D"><paragraph id="H738EC2D9B4D94FAE899DF35A089D1A5A"><enum>(1)</enum><header>Grants</header><text>The Secretary</text></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph><subparagraph id="HB1675197DBB34E739AC56D8B8EC8E222"><enum>(B)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H49366F916F494B75B3B22DF733055929"><paragraph id="HFB59A58797834306B719F9B1CAD894A8"><enum>(2)</enum><header>Priority</header><text>In making grants under this subsection, the Secretary may give priority to State health departments proposing to focus on the prevention, control, and elimination of tuberculosis in high-risk populations, including foreign-born, homeless, incarcerated, HIV-tuberculosis co-infected, and medically underserved populations.</text></paragraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="H395C37390A6C40F49749BA65A7AB4BD8"><enum>(2)</enum><text>in subsection (b)—</text><subparagraph id="HD1B6A2C5B84A48A4AD03C99DF1B226C1"><enum>(A)</enum><text>in paragraph (3)—</text><clause id="H78D357A3F04549B1AA52DABD1F527294"><enum>(i)</enum><text>in subparagraph (C), by redesignating clauses (i) and (ii) as subclauses (I) and (II), respectively, and adjusting the margins accordingly; and</text></clause><clause id="H1800CD735D59498B8286B29D915DBEB1"><enum>(ii)</enum><text>by redesignating subparagraphs (A) through (F) as clauses (i) through (vi), respectively, and adjusting the margins accordingly;</text></clause></subparagraph><subparagraph id="HEF0A6B4444384731B6CDC2E2888019A7"><enum>(B)</enum><text>by redesignating paragraphs (1) through (8) as subparagraphs (A) through (H), respectively, and adjusting the margins accordingly;</text></subparagraph><subparagraph id="H11A44B32D22242F99B21703E4195D6FF"><enum>(C)</enum><text>in the matter preceding subparagraph (A), as so redesignated, by striking <quote>With respect to</quote> and inserting the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HA3DDFC0AD6C64EE7B452D51BFF34722D"><paragraph id="H007876360EAB456BBF39618773E21855"><enum>(1)</enum><header>In general</header><text>With respect to</text></paragraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph><subparagraph id="H8622B360D3B2428D8881858001E6886B"><enum>(D)</enum><text>by striking subparagraph (B), as so redesignated, and inserting the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HD5949A78B81C41D8ABA72A8016BD256E"><subparagraph id="H36DA1A2733F54B2B8DF5899A746EE435"><enum>(B)</enum><text>Research, investigations, experiments, demonstrations, and studies in the health sciences that are related to—</text><clause id="H11A61ACB47334A6085DF9064B70C47FE"><enum>(i)</enum><text>the development of new tools, including vaccines and antimicrobial drugs, to prevent and treat tuberculosis;</text></clause><clause id="H662EB39C8F974BEAAEE78481BA561BA6"><enum>(ii)</enum><text>novel therapeutics for special populations, including pediatric populations, immunosuppressed individuals, and pregnant women;</text></clause><clause id="H3609798E70024DEEAF6215700AE06164"><enum>(iii)</enum><text>the development or testing of medical diagnostics to detect tuberculosis;</text></clause><clause id="H836D0D2FE7324A299EF800E32B850BA2"><enum>(iv)</enum><text>research to address the epidemiology, mechanisms, and pathogenesis of tuberculosis;</text></clause><clause id="H25D6465331DA4B2CADF72E6A94A781FB"><enum>(v)</enum><text>public health interventions to address the prevention, treatment, and control of tuberculosis, such as directly observed therapy and non-pharmaceutical intervention;</text></clause><clause id="HA3765F5D190B43CEBF80689743282EDF"><enum>(vi)</enum><text>methods to enhance detection and response to outbreaks of tuberculosis, including multidrug resistant tuberculosis; and</text></clause><clause id="HD3B80FB921B34E48856C0BB901256C81"><enum>(vii)</enum><text>other relevant research areas.</text></clause></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph><subparagraph id="HB1F0466B9FBE48549385732D55916B0B"><enum>(E)</enum><text>in subparagraph (C), as so redesignated—</text><clause id="H268396AC01794321A36752E531FB49BE"><enum>(i)</enum><text>by redesignating clause (vi), as so redesignated, as clause (vii);</text></clause><clause id="H5B54974ABA3F47C3A3A31C370F4F67B1"><enum>(ii)</enum><text>in clause (v), as so redesignated, by striking <quote>; and</quote> and inserting <quote>;</quote>; and</text></clause><clause id="H3E04F559F16D400FA3FE4327CC389B7B"><enum>(iii)</enum><text>by inserting after clause (v), as so redesignated, the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H67CB4A04D6F8438BBFAC5B35B941BF09"><clause id="HCF5A7A323B1D474F9D2A9CBCEC94EA26"><enum>(vi)</enum><text>the intensification of efforts to prevent, detect, and treat latent tuberculosis; and</text></clause><after-quoted-block>;</after-quoted-block></quoted-block></clause></subparagraph><subparagraph id="H8DEA73E8E7BD4E11A25E478774D214D2"><enum>(F)</enum><text>in subparagraph (D), as so redesignated, by inserting before the period the following: <quote>, including public awareness campaigns and development of educational, risk, and media communications, using materials in languages appropriate to target audiences.</quote>;</text></subparagraph><subparagraph id="HFBBF9B41A8014B9D8AE7656D94C2B542"><enum>(G)</enum><text>in subparagraph (F), as so redesignated, by striking <quote>paragraphs (1) through (4)</quote> and inserting <quote>subparagraphs (A) through (D)</quote>; and</text></subparagraph><subparagraph id="H6D00F6B33E634D4E8D6FC6C8781B9D68"><enum>(H)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H9E1A314A78C848ECBBEE0D97CDBF6E52"><paragraph id="HB359A206EB0C41CEA6D26DDEC68B10CF"><enum>(2)</enum><header>Selection</header><text>In carrying out the activities described in paragraph (1), the Secretary—</text><subparagraph id="H7370418F359C4AF9B58218AF3C2AF22C"><enum>(A)</enum><text>is encouraged to give priority to programmatically relevant research so that new tools can be utilized in public health practice; and</text></subparagraph><subparagraph id="HB81953EA2AC141579E66CBC482AD39AA"><enum>(B)</enum><text>may seek input from the Biomedical Advanced Research and Development Authority in identifying novel candidates to utilize in the efforts under this subsection to prevent, diagnose, and control tuberculosis.</text></subparagraph></paragraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="HB976AB70534A4118B055F7ED6D334249"><enum>(3)</enum><text>by redesignating subsections (c) through (h) as subsections (d) through (i), respectively;</text></paragraph><paragraph id="H826183FF6009449B90DF8A1312528E74"><enum>(4)</enum><text>by inserting after subsection (b) the following—</text><quoted-block style="OLC" display-inline="no-display-inline" id="H6E601BF74C0A4654AB937DC4332D9FA2"><subsection id="H2EF33CE175F0469C8B0882DB015F32DB"><enum>(c)</enum><header>Grants for coordination of programs and services for prevention, diagnosis, and treatment</header><paragraph id="H41762E372273495E9A56F089EEA0F816"><enum>(1)</enum><header>Grants</header><text>The Secretary, acting through the Administrator of the Health Resources and Services Administration, may award grants to State and local governments, territories, Indian Tribes, Tribal organization, urban Indian health organizations, health service providers to Indian Tribes, Native Hawaiian health organizations, community health centers, and Federally qualified health centers for coordinating the programs and services of such entities to ensure timely and appropriate prevention, risk-based screening, diagnosis, and treatment of latent and active tuberculosis.</text></paragraph><paragraph id="HD5EDABDA3E904F22ACE6FF04534A8539"><enum>(2)</enum><header>Definition</header><text>In this subsection, the term <term>Federally qualified health center</term> has the meaning given to such term in section 1861(aa) of the Social Security Act.</text></paragraph></subsection><after-quoted-block>;</after-quoted-block></quoted-block></paragraph><paragraph id="H1E1E88C132BA47E79B7BCD01C94C9311"><enum>(5)</enum><text>in subsections (d), (e), and (f), as so redesignated, by striking <quote>(a) or (b)</quote> each place it appears and inserting <quote>(a), (b), or (c)</quote>;</text></paragraph><paragraph id="H3C609F782C7C47788E0A782A0C1277AE"><enum>(6)</enum><text>in subsection (g)(4), as so redesignated, by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HE5DE78BAAE1741C485305D656402C6B6"><subparagraph id="H508DF1DC301343C7ABB245F2A750E0F0"><enum>(C)</enum><header>Report to Congress</header><text>The Secretary is encouraged to make the reports under subparagraph (A), or other publications relevant to domestic tuberculosis surveillance, publicly available on the internet website of the Centers for Disease Control and Prevention and to disseminate such information to stakeholders.</text></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block></paragraph><paragraph id="H829A94A707FD4D089409E345B4FEED18"><enum>(7)</enum><text>in subsection (h), as so redesignated—</text><subparagraph id="H2DDEC9E239CA41A3B16322774FD48AEB"><enum>(A)</enum><text>in paragraph (1)—</text><clause commented="no" id="H036875B0666C4CC7AFA9FDED32B1EFD9"><enum>(i)</enum><text>by striking <quote>research into new tools under subsection (b)(2)</quote> and inserting <quote>the research, investigations, experiments, demonstrations, and studies in health science under subsection (b)(1)(B)</quote>; and</text></clause><clause id="H73B58AC5E1DB49FB8A880DD6EDD94BED"><enum>(ii)</enum><text>by inserting <quote>ensuring access to the products developed as a result of such research, investigations, experiments, demonstrations, and studies and</quote> after <quote>advice regarding</quote>; and</text></clause></subparagraph><subparagraph id="HF8A270E54440423785BD52426B3CFF57"><enum>(B)</enum><text>in paragraph (3)—</text><clause id="H6B918AE3A1DB4D8E92142F7336136051"><enum>(i)</enum><text>by redesignating subparagraphs (D) and (E) as subparagraphs (E) and (F), respectively; and</text></clause><clause id="HB5879977690142B2A6957060444AD195"><enum>(ii)</enum><text>by inserting after subparagraph (C) the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H4490E272225F4C6E9AF844C56FCFF230"><subparagraph id="H4BE5CB7BEFE94A6492D0E74D7B9D4A4D"><enum>(D)</enum><text>members of the Biomedical Advanced Research and Development Authority;</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></clause></subparagraph></paragraph><paragraph id="H0EC1ED8A7F4940DCAAE8F27A208B7B7F" commented="no"><enum>(8)</enum><text>in subsection (i)(1)(A), as so redesignated, by striking <quote>$200,000,000</quote> and all that follows through the period and inserting <quote>$142,200,000 for fiscal year 2022, $195,700,000 for fiscal year 2023, $225,000,000 for fiscal year 2024, $236,250,000 for fiscal year 2025, $248,062,500 for fiscal year 2026, and $260,465,625 for fiscal year 2027.</quote>.</text></paragraph></subsection><subsection id="HB66A6CEB881C4BF6969B1F00E2F010C3"><enum>(b)</enum><header>NIH tuberculosis activities</header><text>Section 424C(b) of the Public Health Service Act (42 U.S.C. 285b–7c(b)) is amended by striking paragraph (1) and inserting the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H5FD695AE54B242F09054E77BFCF74D03"><paragraph id="H69775031079249059776055720DEEFAB"><enum>(1)</enum><text>enhancing basic, clinical, and operational research on tuberculosis, including with respect to—</text><subparagraph id="H0653207A93A7429D822E86BF18D0066A"><enum>(A)</enum><text>drug-resistant tuberculosis;</text></subparagraph><subparagraph id="H16BFEB6F5613488CB3F3097E8009D8CC"><enum>(B)</enum><text>infection with tuberculosis and latency and progression of tuberculosis; and</text></subparagraph><subparagraph id="HAE827AA09A674031B37484F7288148B1"><enum>(C)</enum><text>pediatric tuberculosis;</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section><section commented="no" id="HEA8C1472736A4BD580030588692003C6"><enum>3.</enum><header>GAO studies</header><subsection id="H5A88C2E1C36B4E8F9CE956659428AE94"><enum>(a)</enum><header>Tuberculosis prevention and elimination study</header><text display-inline="yes-display-inline">Not later than 2 years after the date of enactment of this Act, the Comptroller General of the United States shall issue a report on the coordination of efforts in the United States to—</text><paragraph commented="no" id="HAD3630141E544791847FB111BED0198C"><enum>(1)</enum><text display-inline="yes-display-inline">prevent, control, and eliminate tuberculosis; and</text></paragraph><paragraph commented="no" id="HD4BD10873E8E4296AF6C2DF83B6AC572"><enum>(2)</enum><text display-inline="yes-display-inline">implement the activities under section 317E of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247b-6">42 U.S.C. 247b–6</external-xref>), as amended by this Act, and the National Action Plan for Combating Multidrug-Resistant Tuberculosis, issued in December 2015.</text></paragraph></subsection><subsection id="H7BE0CE6C7B04439F97B69B6B270CE3FB"><enum>(b)</enum><header>Study on tuberculosis activities</header><text display-inline="yes-display-inline">Not later than 6 months after the date of enactment of this Act, the Comptroller General of the United States shall issue 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 coordination of activities between the Food and Drug Administration and the Centers for Disease Control and Prevention with respect to—</text><paragraph id="HDA52A0EDBF444D3C9DB2D99A2E3173E2" commented="no"><enum>(1)</enum><text display-inline="yes-display-inline">shortages of critical tuberculosis drugs in the United States;</text></paragraph><paragraph id="H02C5ACD27FF64745BDFAC3FC15D72481" commented="no"><enum>(2)</enum><text display-inline="yes-display-inline">efforts to increase the availability of pediatric tuberculosis drug formulations in the United States;</text></paragraph><paragraph id="H702698F4947549BE97720E32628D2765"><enum>(3)</enum><text display-inline="yes-display-inline">mitigating the cost of tuberculosis drugs for States, including efforts to ensure States have timely access to treatments for individuals with tuberculosis; and</text></paragraph><paragraph id="H993D4A2F294141D0827E096FA7BA7882"><enum>(4)</enum><text display-inline="yes-display-inline">consideration for the introduction in the United States of pediatric tuberculosis drug formulations that are available in foreign countries.</text></paragraph></subsection></section></legis-body></bill> 

