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42 U.S.C. § 247d — Public health emergencies

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42 U.S.C. § 247d — Public health emergencies

§ 247d. Public health emergencies (a) Emergencies If the Secretary determines, after consulta- tion with such public health officials as may be necessary, that— (1) a disease or disorder presents a public health emergency; or (2) a public health emergency, including sig- nificant outbreaks of infectious diseases or bioterrorist attacks, otherwise exists, the Secretary may take such action as may be appropriate to respond to the public health emergency, including making grants, providing awards for expenses, and entering into contracts and conducting and supporting investigations into the cause, treatment, or prevention of a disease or disorder as described in paragraphs (1) and (2). Any such determination of a public health emergency terminates upon the Sec- retary declaring that the emergency no longer exists, or upon the expiration of the 90-day pe- riod beginning on the date on which the deter- mination is made by the Secretary, whichever occurs first. Determinations that terminate under the preceding sentence may be renewed by the Secretary (on the basis of the same or addi- tional facts), and the preceding sentence applies to each such renewal. Not later than 48 hours after making a determination under this sub- section of a public health emergency (including a renewal), the Secretary shall submit to the Congress written notification of the determina- tion. (b) Public Health Emergency Fund (1) In general There is established in the Treasury a fund to be designated as the ‘‘Public Health Emer- gency Fund’’ to be made available to the Sec- retary without fiscal year limitation to carry out subsection (a) only if a public health emer- gency has been declared by the Secretary under such subsection or if the Secretary de- termines there is t

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Page 228 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 247c–2 which the delivery of services under sub- section (a) may be improved. The Secretary may make such grants only to grantees under such subsection and to public and nonprofit private entities that are carrying out pro- grams substantially similar to programs car- ried out under such subsection. (2) Authorization of appropriations For the purpose of carrying out paragraph (1), there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1993 through 1998. (July 1, 1944, ch. 373, title III, § 318A, as added Pub. L. 102–531, title III, § 304, Oct. 27, 1992, 106 Stat. 3490; amended Pub. L. 103–43, title XX, § 2008(i)(1)(B)(ii), June 10, 1993, 107 Stat. 212; Pub. L. 103–183, title IV, § 402, Dec. 14, 1993, 107 Stat. 2236; Pub. L. 107–251, title VI, § 601(a), Oct. 26, 2002, 116 Stat. 1664; Pub. L. 108–163, § 2(m)(1), Dec. 6, 2003, 117 Stat. 2023.) Editorial Notes REFERENCES IN TEXT The reference to section 254b of this title the first place appearing, referred to in subsec. (e), was in the original a reference to section 329, meaning section 329 of act July 1, 1944, which was omitted in the general amendment of subpart I (§ 254b et seq.) of part D of this subchapter by Pub. L. 104–299, § 2, Oct. 11, 1996, 110 Stat. 3626. Section 256a of this title, referred to in subsec. (e), was repealed by Pub. L. 104–299, § 4(a)(3), Oct. 11, 1996, 110 Stat. 3645. AMENDMENTS 2003—Subsec. (e). Pub. L. 108–163 substituted ‘‘254b’’ for ‘‘254c, 254b(h)’’ before ‘‘, 256a’’. 2002—Subsec. (e). Pub. L. 107–251 substituted ‘‘254b(h)’’ for ‘‘256’’. 1993—Pub. L. 103–43 made technical amendment to di- rectory language of Pub. L. 102–531, § 304, which enacted this section. Subsec. (o)(2). Pub. L. 103–183, § 402(a), substituted ‘‘subsection (q)’’ for ‘‘subsection (s)’’. Subsec. (q). Pub. L. 103–183, § 402(b)(1), substituted ‘‘through 1998’’ for ‘‘and 1995’’. Subsec. (r)(2). Pub. L. 103–183, § 402(b)(2), substituted ‘‘1998’’ for ‘‘1995’’. Statutory Notes and Related Subsidiaries CHANGE OF NAME Committee on Labor and Human Resources of Senate changed to Committee on Health, Education, Labor, and Pensions of Senate by Senate Resolution No. 20, One Hundred Sixth Congress, Jan. 19, 1999. Committee on Energy and Commerce of House of Representatives treated as referring to Committee on Commerce of House of Representatives by section 1(a) of Pub. L. 104–14, set out as a note preceding section 21 of Title 2, The Congress. Committee on Commerce of House of Representatives changed to Committee on En- ergy and Commerce of House of Representatives, and jurisdiction over matters relating to securities and ex- changes and insurance generally transferred to Com- mittee on Financial Services of House of Representa- tives by House Resolution No. 5, One Hundred Seventh Congress, Jan. 3, 2001. EFFECTIVE DATE OF 2003 AMENDMENT Amendment by Pub. L. 108–163 deemed to have taken effect immediately after the enactment of Pub. L. 107–251, see section 3 of Pub. L. 108–163, set out as a note under section 233 of this title. § 247c–2. Data collection regarding programs under subchapter XXIV For the purpose of collecting and providing data for program planning and evaluation ac- tivities under subchapter XXIV, there are au- thorized to be appropriated to the Secretary (acting through the Director of the Centers for Disease Control and Prevention) such sums as may be necessary for each of the fiscal years 2001 through 2005. Such authorization of appro- priations is in addition to other authorizations of appropriations that are available for such purpose. (July 1, 1944, ch. 373, title III, § 318B, as added Pub. L. 106–345, title IV, § 412, Oct. 20, 2000, 114 Stat. 1350.) § 247d. Public health emergencies (a) Emergencies If the Secretary determines, after consulta- tion with such public health officials as may be necessary, that— (1) a disease or disorder presents a public health emergency; or (2) a public health emergency, including sig- nificant outbreaks of infectious diseases or bioterrorist attacks, otherwise exists, the Secretary may take such action as may be appropriate to respond to the public health emergency, including making grants, providing awards for expenses, and entering into contracts and conducting and supporting investigations into the cause, treatment, or prevention of a disease or disorder as described in paragraphs (1) and (2). Any such determination of a public health emergency terminates upon the Sec- retary declaring that the emergency no longer exists, or upon the expiration of the 90-day pe- riod beginning on the date on which the deter- mination is made by the Secretary, whichever occurs first. Determinations that terminate under the preceding sentence may be renewed by the Secretary (on the basis of the same or addi- tional facts), and the preceding sentence applies to each such renewal. Not later than 48 hours after making a determination under this sub- section of a public health emergency (including a renewal), the Secretary shall submit to the Congress written notification of the determina- tion. (b) Public Health Emergency Fund (1) In general There is established in the Treasury a fund to be designated as the ‘‘Public Health Emer- gency Fund’’ to be made available to the Sec- retary without fiscal year limitation to carry out subsection (a) only if a public health emer- gency has been declared by the Secretary under such subsection or if the Secretary de- termines there is the significant potential for a public health emergency, to allow the Sec- retary to rapidly respond to the immediate needs resulting from such public health emer- gency or potential public health emergency. The Secretary shall plan for the expedited dis- tribution of funds to appropriate agencies and entities. There is authorized to be appro- priated to the Fund such sums as may be nec- essary. Page 229 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 247d (2) Uses The Secretary may use amounts in the Fund established under paragraph (1), to— (A) facilitate coordination between and among Federal, State, local, Tribal, and ter- ritorial entities and public and private health care entities that the Secretary de- termines may be affected by a public health emergency or potential public health emer- gency referred to in paragraph (1) (including communication of such entities with rel- evant international entities, as applicable); (B) make grants, provide for awards, enter into contracts, and conduct supportive in- vestigations pertaining to a public health emergency or potential public health emer- gency, including further supporting pro- grams under section 247d–3a, 247d–3b, or 247d–3c of this title; (C) facilitate and accelerate, as applicable, advanced research and development of secu- rity countermeasures (as defined in section 247d–6b of this title), qualified counter- measures (as defined in section 247d–6a of this title), or qualified pandemic or epidemic products (as defined in section 247d–6d of this title), that are applicable to the public health emergency or potential public health emergency under paragraph (1); (D) strengthen biosurveillance capabilities and laboratory capacity to identify, collect, and analyze information regarding such pub- lic health emergency or potential public health emergency, including the systems under section 247d–4 of this title; (E) support initial emergency operations and assets related to preparation and de- ployment of intermittent disaster response personnel under section 300hh–11 of this title and the Medical Reserve Corps under section 300hh–15 of this title; (F) support the initial deployment and dis- tribution of contents of the Strategic Na- tional Stockpile, as appropriate; and (G) carry out other activities, as the Sec- retary determines applicable and appro- priate. (3) Report Not later than 90 days after the end of each fiscal year, the Secretary shall prepare and submit to the Committee on Health, Edu- cation, Labor, and Pensions and the Com- mittee on Appropriations of the Senate and the Committee on Commerce and the Com- mittee on Appropriations of the House of Rep- resentatives a report describing— (A) the expenditures made from the Public Health Emergency Fund in such fiscal year, including— (i) the amount obligated; (ii) the recipient or recipients of such ob- ligated funds; (iii) the specific response activities such obligated funds will support; and (iv) the declared or potential public health emergency for which such funds were obligated; and (B) each public health emergency for which the expenditures were made and the activities undertaken with respect to each emergency which was conducted or sup- ported by expenditures from the Fund. (4) Review Not later than 2 years after June 24, 2019, the Secretary, in coordination with the Assistant Secretary for Preparedness and Response, shall conduct a review of the Fund under this section and provide recommendations to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropria- tions of the Senate and the Committee on En- ergy and Commerce and the Committee on Ap- propriations of the House of Representatives on policies to improve such Fund for the uses described in paragraph (2). (5) GAO report Not later than 4 years after June 24, 2019, the Comptroller General of the United States shall— (A) conduct a review of the Fund under this section, including its uses and the re- sources available in the Fund; and (B) submit to the Committee on Health, Education, Labor, and Pensions of the Sen- ate and the Committee on Energy and Com- merce of the House of Representatives a re- port on such review, including recommenda- tions related to such review, as applicable. (c) Supplement not supplant Funds appropriated under this section shall be used to rapidly respond to public health emer- gencies or potential public health emergencies and supplement and not supplant other Federal, State, and local public funds provided for activi- ties under this chapter or funds otherwise pro- vided for emergency response. (d) Data submittal and reporting deadlines In any case in which the Secretary determines that, wholly or partially as a result of a public health emergency that has been determined pur- suant to subsection (a), individuals or public or private entities are unable to comply with dead- lines for the submission to the Secretary of data or reports required under any law administered by the Secretary, the Secretary may, notwith- standing any other provision of law, grant such extensions of such deadlines as the cir- cumstances reasonably require, and may waive, wholly or partially, any sanctions otherwise ap- plicable to such failure to comply. Before or promptly after granting such an extension or waiver, the Secretary shall notify the Congress of such action and publish in the Federal Reg- ister a notice of the extension or waiver. (e) Temporary reassignment of State and local personnel during a public health emergency (1) Emergency reassignment of federally fund- ed personnel Notwithstanding any other provision of law, and subject to paragraph (2), upon request by the Governor of a State or a tribal organiza- tion or such Governor or tribal organization’s designee, the Secretary may authorize the re- questing State or Indian tribe to temporarily reassign, for purposes of immediately address- ing a public health emergency in the State or Indian tribe, State and local public health de- Page 230 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 247d partment or agency personnel funded in whole or in part through programs authorized under this chapter, as appropriate. (2) Activation of emergency reassignment (A) Public health emergency The Secretary may authorize a temporary reassignment of personnel under paragraph (1) only during the period of a public health emergency determined pursuant to sub- section (a). (B) Contents of request To seek authority for a temporary reas- signment of personnel under paragraph (1), the Governor of a State or a tribal organiza- tion shall submit to the Secretary a request for such reassignment flexibility and shall include in the request each of the following: (i) An assurance that the public health emergency in the geographic area of the requesting State or Indian tribe cannot be adequately and appropriately addressed by the public health workforce otherwise available. (ii) An assurance that the public health emergency would be addressed more effi- ciently and effectively through the re- quested temporary reassignment of State and local personnel described in paragraph (1). (iii) An assurance that the requested temporary reassignment of personnel is consistent with any applicable All-Hazards Public Health Emergency Preparedness and Response Plan under section 247d–3a of this title. (iv) An identification of— (I) each Federal program from which personnel would be temporarily reas- signed pursuant to the requested author- ity; and (II) the number of personnel who would be so reassigned from each such pro- gram. (v) Such other information and assur- ances upon which the Secretary and Gov- ernor of a State or tribal organization agree. (C) Consideration In reviewing a request for temporary reas- signment under paragraph (1), the Secretary shall consider the degree to which the pro- gram or programs funded in whole or in part by programs authorized under this chapter would be adversely affected by the reassign- ment. (D) Termination and extension (i) Termination A State or Indian tribe’s temporary reas- signment of personnel under paragraph (1) shall terminate upon the earlier of the fol- lowing: (I) The Secretary’s determination that the public health emergency no longer exists. (II) Subject to clause (ii), the expira- tion of the 30-day period following the date on which the Secretary approved the State or Indian tribe’s request for such reassignment flexibility. (ii) Extension of reassignment flexibility The Secretary may extend reassignment flexibility of personnel under paragraph (1) beyond the date otherwise applicable under clause (i)(II) if the public health emergency still exists as of such date, but only if— (I) the State or Indian tribe that sub- mitted the initial request for a tem- porary reassignment of personnel sub- mits a request for an extension of such temporary reassignment; and (II) the request for an extension con- tains the same information and assur- ances necessary for the approval of an initial request for such temporary reas- signment pursuant to subparagraph (B). (3) Voluntary nature of temporary reassign- ment of State and local personnel (A) In general Unless otherwise provided under the law or regulation of the State or Indian tribe that receives authorization for temporary reas- signment of personnel under paragraph (1), personnel eligible for reassignment pursuant to such authorization— (i) shall have the opportunity to volun- teer for temporary reassignment; and (ii) shall not be required to agree to a temporary reassignment. (B) Prohibition on conditioning Federal awards The Secretary may not condition the award of a grant, contract, or cooperative agreement under this chapter on the re- quirement that a State or Indian tribe re- quire that personnel eligible for reassign- ment pursuant to an authorization under paragraph (1) agree to such reassignment. (4) Notice to Congress The Secretary shall give notice to the Con- gress in conjunction with the approval under this subsection of— (A) any initial request for temporary reas- signment of personnel; and (B) any request for an extension of such temporary reassignment. (5) Guidance The Secretary shall— (A) not later than 6 months after March 13, 2013, issue proposed guidance on the tem- porary reassignment of personnel under this subsection; and (B) after providing notice and a 60-day pe- riod for public comment, finalize such guid- ance. (6) Report to Congress Not later than 4 years after March 13, 2013, the Comptroller General of the United States shall conduct an independent evaluation, and submit to the appropriate committees of the Congress a report, on temporary reassignment under this subsection, including— (A) a description of how, and under what circumstances, such temporary reassign- Page 231 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 247d ment has been used by States and Indian tribes; (B) an analysis of how such temporary re- assignment has assisted States and Indian tribes in responding to public health emer- gencies; (C) an evaluation of how such temporary reassignment has improved operational effi- ciencies in responding to public health emer- gencies; (D) an analysis of the extent to which, if any, Federal programs from which personnel have been temporarily reassigned have been adversely affected by the reassignment; and (E) recommendations on how medical surge capacity could be improved in respond- ing to public health emergencies and the im- pact of the reassignment flexibility under this section on such surge capacity. (7) Definitions In this subsection— (A) the terms ‘‘Indian tribe’’ and ‘‘tribal organization’’ have the meanings given such terms in section 5304 of title 25; and (B) the term ‘‘State’’ includes, in addition to the entities listed in the definition of such term in section 201 of this title, the Freely Associated States. (8) Sunset This subsection shall terminate on March 31, 2025. (f) Determination with respect to Paperwork Re- duction Act waiver during a public health emergency (1) Determination If the Secretary determines, after consulta- tion with such public health officials as may be necessary, that— (A)(i) the criteria set forth for a public health emergency under paragraph (1) or (2) of subsection (a) has been met; or (ii) a disease or disorder, including a novel and emerging public health threat, is signifi- cantly likely to become a public health emergency; and (B) the circumstances of such public health emergency, or potential for such sig- nificantly likely public health emergency, including the specific preparation for and re- sponse to such public health emergency or threat, necessitate a waiver from the re- quirements of subchapter I of chapter 35 of title 44 (commonly referred to as the Paper- work Reduction Act), then the requirements of such subchapter I with respect to voluntary collection of infor- mation shall not be applicable during the im- mediate investigation of, and response to, such public health emergency during the pe- riod of such public health emergency or the period of time necessary to determine if a dis- ease or disorder, including a novel and emerg- ing public health threat, will become a public health emergency as provided for in this para- graph. The requirements of such subchapter I with respect to voluntary collection of infor- mation shall not be applicable during the im- mediate postresponse review regarding such public health emergency if such immediate postresponse review does not exceed a reason- able length of time. (2) Transparency If the Secretary determines that a waiver is necessary under paragraph (1), the Secretary shall promptly post on the Internet website of the Department of Health and Human Services a brief justification for such waiver, the an- ticipated period of time such waiver will be in effect, and the agencies and offices within the Department of Health and Human Services to which such waiver shall apply, and update such information posted on the Internet website of the Department of Health and Human Services, as applicable. (3) Effectiveness of waiver Any waiver under this subsection shall take effect on the date on which the Secretary posts information on the Internet website as provided for in this subsection. (4) Termination of waiver Upon determining that the circumstances necessitating a waiver under paragraph (1) no longer exist, the Secretary shall promptly up- date the Internet website of the Department of Health and Human Services to reflect the ter- mination of such waiver. (5) Limitations (A) Period of waiver The period of a waiver under paragraph (1) shall not exceed the period of time for the related public health emergency, including a public health emergency declared pursuant to subsection (a), and any immediate postresponse review regarding the public health emergency consistent with the re- quirements of this subsection. (B) Subsequent compliance An initiative subject to a waiver under paragraph (1) that is ongoing after the date on which the waiver expires, shall be subject to the requirements of subchapter I of chap- ter 35 of title 44 and the Secretary shall en- sure that compliance with such require- ments occurs in as timely a manner as pos- sible based on the applicable circumstances, but not to exceed 30 calendar days after the expiration of the applicable waiver. (g) Certain appointments to support public health emergency responses (1) In general In order to support the initial response to a public health emergency declared by the Sec- retary under this section, the Secretary may, subject to paragraph (2) and without regard to sections 3309 through 3318 of title 5, appoint in- dividuals directly to positions in the Depart- ment of Health and Human Services for which the Secretary has provided public notice in order to— (A) address a critical hiring need directly related to responding to a public health emergency declared by the Secretary under this section; or (B) address a severe shortage of candidates that impacts the operational capacity of the Page 232 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 247d Department of Health and Human Services to respond in the event of a public health emergency declared by the Secretary under this section. (2) Number of appointments Each fiscal year in which the Secretary makes a determination of a public health emergency under subsection (a) (not including a renewal), the Secretary may directly ap- point not more than— (A) 400 individuals under paragraph (1)(A); and (B) 100 individuals under paragraph (1)(B). (3) Compensation The annual rate of basic pay of an individual appointed under this subsection shall be deter- mined in accordance with chapter 51 and sub- chapter III of chapter 53 of title 5. (4) Reporting The Secretary shall establish and maintain records regarding the use of the authority under this subsection, including— (A) the number of positions filled through such authority; (B) the types of appointments of such posi- tions; (C) the titles, occupational series, and grades of such positions; (D) the number of positions publicly no- ticed to be filled under such authority; (E) the number of qualified applicants who apply for such positions; (F) the qualification criteria for such posi- tions; and (G) the demographic information of indi- viduals appointed to such positions. (5) Notification to Congress In the event the Secretary, within a single fiscal year, directly appoints more than 50 per- cent of the individuals allowable under either subparagraph (A) or (B) of paragraph (2), the Secretary shall, not later than 15 days after the date of such action, notify the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives. Such notification shall, in a manner that pro- tects personal privacy, to the extent required by applicable Federal and State privacy law, at a minimum, include— (A) information on each such appointment within such fiscal year; (B) a description of how each such position relates to the requirements of subparagraph (A) or (B) of paragraph (1); and (C) the additional number of personnel, if any, the Secretary anticipates to be nec- essary to adequately support a response to a public health emergency declared under this section using the authorities described in paragraph (1) within such fiscal year. (6) Reports to Congress Not later than September 30, 2023, and annu- ally thereafter for each fiscal year in which the authority under this subsection is used, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report describing the total number of appoint- ments filled under this subsection within the fiscal year and a description of how the posi- tions relate to the requirements of subpara- graph (A) or (B) of paragraph (1). (7) Sunset The authority under this subsection shall expire on September 30, 2028. (h) Stockpile depletion reporting The Secretary shall, not later than 30 days after the deployment of contents of the Stra- tegic National Stockpile under section 247d–6b(a) of this title to respond to a public health emergency declared by the Secretary under this section or an emergency or major dis- aster declared by the President under the Rob- ert T. Stafford Disaster Relief and Emergency Assistance Act [42 U.S.C. 5121 et seq.], and every 30 days thereafter until the expiration or termi- nation of such public health emergency, emer- gency, or major disaster, submit a report to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropria- tions of the House of Representatives on— (1) the deployment of the contents of the stockpile in response to State, local, and Trib- al requests; (2) the amount of such products that remain within the stockpile following such deploy- ment; and (3) plans to replenish such products, as ap- propriate, including related timeframes and any barriers or limitations to replenishment. (July 1, 1944, ch. 373, title III, § 319, as added Pub. L. 106–505, title I, § 102, Nov. 13, 2000, 114 Stat. 2315; amended Pub. L. 107–188, title I, §§ 141, 144(a), 158, June 12, 2002, 116 Stat. 626, 630, 633; Pub. L. 113–5, title II, § 201, Mar. 13, 2013, 127 Stat. 170; Pub. L. 114–255, div. A, title III, § 3087, Dec. 13, 2016, 130 Stat. 1147; Pub. L. 116–22, title II, § 206, title VII, § 701(c), June 24, 2019, 133 Stat. 925, 961; Pub. L. 117–328, div. FF, title II, §§ 2103(a), 2223(a), 2407, Dec. 29, 2022, 136 Stat. 5711, 5747, 5788; Pub. L. 118–15, div. B, title III, § 2332, Sept. 30, 2023, 137 Stat. 96; Pub. L. 118–22, div. B, title II, § 203(a), Nov. 17, 2023, 137 Stat. 120; Pub. L. 118–35, div. B, title I, § 103(a), Jan. 19, 2024, 138 Stat. 5; Pub. L. 118–42, div. G, title I, § 103(a), Mar. 9, 2024, 138 Stat. 398; Pub. L. 118–158, div. C, title I, § 3103(a), Dec. 21, 2024, 138 Stat. 1763.) Editorial Notes REFERENCES IN TEXT The Robert T. Stafford Disaster Relief and Emer- gency Assistance Act, referred to in subsec. (h), is Pub. L. 93–288, May 22, 1974, 88 Stat. 143, which is classified principally to chapter 68 (§ 5121 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under section 5121 of this title and Tables. PRIOR PROVISIONS A prior section 247d, act July 1, 1944, ch. 373, title III, § 319, as added Pub. L. 98–49, July 13, 1983, 97 Stat. 245; amended Pub. L. 100–607, title II, § 256(a), Nov. 4, 1988, Page 233 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 247d 102 Stat. 3110; Pub. L. 102–321, title I, § 163(b)(2), July 10, 1992, 106 Stat. 376; Pub. L. 102–531, title III, § 312(d)(2), Oct. 27, 1992, 106 Stat. 3504, authorized the Secretary to take appropriate action relating to public health emer- gencies, prior to repeal by Pub. L. 106–505, title I, § 102, Nov. 13, 2000, 114 Stat. 2315. Another prior section 247d, act July 1, 1944, ch. 373, title III, § 319, formerly § 310, as added Sept. 25, 1962, Pub. L. 87–692, 76 Stat. 592, and amended and renum- bered, which related to migrant health centers, was re- numbered section 329 of act July 1, 1944, by Pub. L. 95–626, title I, § 102(a), Nov. 10, 1978, 92 Stat. 3551, and transferred to section 254b of this title, prior to being omitted in the general amendment of subpart I (§ 254b et seq.) of part D of this subchapter by Pub. L. 104–299, § 2. AMENDMENTS 2024—Subsec. (e)(8). Pub. L. 118–158 substituted ‘‘March 31, 2025’’ for ‘‘December 31, 2024’’. Pub. L. 118–42 substituted ‘‘December 31, 2024’’ for ‘‘March 8, 2024’’. Pub. L. 118–35 substituted ‘‘March 8, 2024’’ for ‘‘Janu- ary 19, 2024’’. 2023—Subsec. (e)(8). Pub. L. 118–22 substituted ‘‘Janu- ary 19, 2024’’ for ‘‘November 17, 2023’’. Pub. L. 118–15 substituted ‘‘November 17, 2023’’ for ‘‘September 30, 2023’’. 2022—Subsec. (b)(2)(F), (G). Pub. L. 117–328, § 2103(a)(1), added subpar. (F) and redesignated former subpar. (F) as (G). Subsec. (b)(3)(A). Pub. L. 117–328, § 2103(a)(2), amended subpar. (A) generally. Prior to amendment, subpar. (A) read as follows: ‘‘the expenditures made from the Pub- lic Health Emergency Fund in such fiscal year; and’’. Subsec. (g). Pub. L. 117–328, § 2223(a), added subsec. (g). Subsec. (h). Pub. L. 117–328, § 2407, added subsec. (h). 2019—Subsec. (b)(1). Pub. L. 116–22, § 206(1)(A), sub- stituted ‘‘under such subsection or if the Secretary de- termines there is the significant potential for a public health emergency, to allow the Secretary to rapidly re- spond to the immediate needs resulting from such pub- lic health emergency or potential public health emer- gency. The Secretary shall plan for the expedited dis- tribution of funds to appropriate agencies and enti- ties.’’ for ‘‘under such subsection.’’ Subsec. (b)(2), (3). Pub. L. 116–22, § 206(1)(B), (C), added par. (2) and redesignated former par. (2) as (3). Subsec. (b)(4), (5). Pub. L. 116–22, § 206(1)(D), added pars. (4) and (5). Subsec. (c). Pub. L. 116–22, § 206(2), inserted ‘‘rapidly respond to public health emergencies or potential pub- lic health emergencies and’’ after ‘‘used to’’ and sub- stituted ‘‘activities under this chapter or funds other- wise provided for emergency response.’’ for ‘‘activities under this section.’’ Subsec. (e)(8). Pub. L. 116–22, § 701(c), substituted ‘‘2023’’ for ‘‘2018’’. 2016—Subsec. (f). Pub. L. 114–255 added subsec. (f). 2013—Subsec. (e). Pub. L. 113–5 added subsec. (e). 2002—Subsec. (a). Pub. L. 107–188, § 158, substituted ‘‘grants, providing awards for expenses, and’’ for ‘‘grants and’’ in concluding provisions. Pub. L. 107–188, § 144(a), inserted at end of concluding provisions ‘‘Any such determination of a public health emergency terminates upon the Secretary declaring that the emergency no longer exists, or upon the expi- ration of the 90-day period beginning on the date on which the determination is made by the Secretary, whichever occurs first. Determinations that terminate under the preceding sentence may be renewed by the Secretary (on the basis of the same or additional facts), and the preceding sentence applies to each such re- newal. Not later than 48 hours after making a deter- mination under this subsection of a public health emer- gency (including a renewal), the Secretary shall submit to the Congress written notification of the determina- tion.’’ Subsec. (d). Pub. L. 107–188, § 141, added subsec. (d). Statutory Notes and Related Subsidiaries CHANGE OF NAME Committee on Commerce of House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and jurisdiction over matters relating to securities and exchanges and insurance gen- erally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh Congress, Jan. 3, 2001. EFFECTIVE DATE OF 2002 AMENDMENT Pub. L. 107–188, title I, § 144(b), June 12, 2002, 116 Stat. 630, provided that: ‘‘The amendment made by sub- section (a) [amending this section] applies to any pub- lic health emergency under section 319(a) of the Public Health Service Act [42 U.S.C. 247d(a)], including any such emergency that was in effect as of the day before the date of the enactment of this Act [June 12, 2002]. In the case of such an emergency that was in effect as of such day, the 90-day period described in such section with respect to the termination of the emergency is deemed to begin on such date of enactment.’’ CONSIDERATION OF UNIQUE CHALLENGES IN NONCONTIGUOUS STATES AND TERRITORIES Pub. L. 117–328, div. FF, title II, § 2115, Dec. 29, 2022, 136 Stat. 5726, provided that: ‘‘During any public health emergency declared under section 319 of the Public Health Service Act (42 U.S.C. 247d), the Secretary of Health and Human Services shall conduct quarterly meetings or consultations, as applicable or appropriate, with noncontiguous States and territories with regard to addressing unique public health challenges in such States and territories associated with such public health emergency.’’ FUNDING FOR COVID–19 VACCINE ACTIVITIES AT THE CENTERS FOR DISEASE CONTROL AND PREVENTION Pub. L. 117–2, title II, § 2301, Mar. 11, 2021, 135 Stat. 37, provided that: ‘‘(a) IN GENERAL.—In addition to amounts otherwise available, there is appropriated to the Secretary of Health and Human Services (in this subtitle [subtitle D (§§ 2301–2305) of title II of Pub. L. 117–2, see Tables for classification] referred to as the ‘Secretary’) for fiscal year 2021, out of any money in the Treasury not other- wise appropriated, $7,500,000,000, to remain available until expended, to carry out activities to plan, prepare for, promote, distribute, administer, monitor, and track COVID–19 vaccines. ‘‘(b) USE OF FUNDS.—The Secretary, acting through the Director of the Centers for Disease Control and Pre- vention, and in consultation with other agencies, as ap- plicable, shall, in conducting activities referred to in subsection (a)— ‘‘(1) conduct activities to enhance, expand, and im- prove nationwide COVID–19 vaccine distribution and administration, including activities related to dis- tribution of ancillary medical products and supplies related to vaccines; and ‘‘(2) provide technical assistance, guidance, and support to, and award grants or cooperative agree- ments to, State, local, Tribal, and territorial public health departments for enhancement of COVID–19 vaccine distribution and administration capabilities, including— ‘‘(A) the distribution and administration of vac- cines licensed under section 351 of the Public Health Service Act (42 U.S.C. 262) or authorized under section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3) and ancillary medical products and supplies related to vaccines; ‘‘(B) the establishment and expansion, including staffing support, of community vaccination centers, particularly in underserved areas; ‘‘(C) the deployment of mobile vaccination units, particularly in underserved areas; ‘‘(D) information technology, standards-based data, and reporting enhancements, including im- Page 234 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 247d provements necessary to support standards-based sharing of data related to vaccine distribution and vaccinations and systems that enhance vaccine safety, effectiveness, and uptake, particularly among underserved populations; ‘‘(E) facilities enhancements; ‘‘(F) communication with the public regarding when, where, and how to receive COVID–19 vac- cines; and ‘‘(G) transportation of individuals to facilitate vaccinations, including at community vaccination centers and mobile vaccination units, particularly for underserved populations. ‘‘(c) SUPPLEMENTAL FUNDING FOR STATE VACCINATION GRANTS.— ‘‘(1) DEFINITIONS.—In this subsection: ‘‘(A) BASE FORMULA.—The term ‘base formula’ means the allocation formula that applied to the Public Health Emergency Preparedness cooperative agreement in fiscal year 2020. ‘‘(B) ALTERNATIVE ALLOCATION.—The term ‘alter- native allocation’ means an allocation to each State, territory, or locality calculated using the percentage derived from the allocation received by such State, territory, or locality of the aggregate amount of fiscal year 2020 Public Health Emergency Preparedness cooperative agreement awards under section 319C–1 of the Public Health Service Act (42 U.S.C. 247d–3a). ‘‘(2) SUPPLEMENTAL FUNDING.— ‘‘(A) IN GENERAL.—Not later than 21 days after the date of enactment of this Act [Mar. 11, 2021], the Secretary shall, out of amounts described in sub- section (a), provide supplemental funding to any State, locality, or territory that received less of the amounts that were appropriated under title III of division M of Public Law 116–260 [see Tables for classification] for vaccination grants to be issued by the Centers for Disease Control and Prevention than such State, locality, or territory would have received had such amounts been allocated using the alternative allocation. ‘‘(B) AMOUNT.—The amount of supplemental fund- ing provided under this subsection shall be equal to the difference between— ‘‘(i) the amount the State, locality, or territory received, or would receive, under the base for- mula; and ‘‘(ii) the amount the State, locality, or terri- tory would receive under the alternative alloca- tion.’’ FUNDING FOR COVID–19 TESTING, CONTACT TRACING, AND MITIGATION ACTIVITIES Pub. L. 117–2, title II, § 2401, Mar. 11, 2021, 135 Stat. 40, provided that: ‘‘(a) IN GENERAL.—In addition to amounts otherwise available, there is appropriated to the Secretary of Health and Human Services (in this subtitle [subtitle E (§§ 2401–2404) of title II of Pub. L. 117–2, see Tables for classification] referred to as the ‘Secretary’) for fiscal year 2021, out of any money in the Treasury not other- wise appropriated, $47,800,000,000, to remain available until expended, to carry out activities to detect, diag- nose, trace, and monitor SARS–CoV–2 and COVID–19 in- fections and related strategies to mitigate the spread of COVID–19. ‘‘(b) USE OF FUNDS.—From amounts appropriated by subsection (a), the Secretary shall— ‘‘(1) implement a national, evidence-based strategy for testing, contact tracing, surveillance, and mitiga- tion with respect to SARS–CoV–2 and COVID–19, in- cluding through activities authorized under section 319(a) of the Public Health Service Act [42 U.S.C. 247d(a)]; ‘‘(2) provide technical assistance, guidance, and support, and award grants or cooperative agreements to State, local, and territorial public health depart- ments for activities to detect, diagnose, trace, and monitor SARS–CoV–2 and COVID–19 infections and related strategies and activities to mitigate the spread of COVID–19; ‘‘(3) support the development, manufacturing, pro- curement, distribution, and administration of tests to detect or diagnose SARS–CoV–2 and COVID–19, in- cluding through— ‘‘(A) support for the development, manufacture, procurement, and distribution of supplies necessary for administering tests, such as personal protective equipment; and ‘‘(B) support for the acquisition, construction, al- teration, or renovation of non-federally owned fa- cilities for the production of diagnostics and ancil- lary medical products and supplies where the Sec- retary determines that such an investment is nec- essary to ensure the production of sufficient amounts of such supplies; ‘‘(4) establish and expand Federal, State, local, and territorial testing and contact tracing capabilities, including— ‘‘(A) through investments in laboratory capacity, such as— ‘‘(i) academic and research laboratories, or other laboratories that could be used for proc- essing of COVID–19 testing; ‘‘(ii) community-based testing sites and com- munity-based organizations; or ‘‘(iii) mobile health units, particularly in medi- cally underserved areas; and ‘‘(B) with respect to quarantine and isolation of contacts; ‘‘(5) enhance information technology, data mod- ernization, and reporting, including improvements necessary to support sharing of data related to public health capabilities; ‘‘(6) award grants to, or enter into cooperative agreements or contracts with, State, local, and terri- torial public health departments to establish, expand, and sustain a public health workforce; and ‘‘(7) to cover administrative and program support costs necessary to conduct activities related to sub- paragraph (a).’’ IMPORTANCE OF THE BLOOD SUPPLY Pub. L. 116–136, div. A, title III, § 3226, Mar. 27, 2020, 134 Stat. 383, provided that: ‘‘(a) IN GENERAL.—The Secretary of Health and Human Services (referred to in this section as the ‘Sec- retary’) shall carry out a national campaign to improve awareness of, and support outreach to the public and health care providers about the importance and safety of blood donation and the need for donations for the blood supply during the public health emergency de- clared by the Secretary under section 319 of the Public Health Service Act (42 U.S.C. 247d) with respect to COVID–19. ‘‘(b) AWARENESS CAMPAIGN.—In carrying out sub- section (a), the Secretary may enter into contracts with one or more public or private nonprofit entities, to establish a national blood donation awareness cam- paign that may include television, radio, internet, and newspaper public service announcements, and other ac- tivities to provide for public and professional aware- ness and education. ‘‘(c) CONSULTATION.—In carrying out subsection (a), the Secretary shall consult with the Commissioner of Food and Drugs, the Assistant Secretary for Health, the Director of the Centers for Disease Control and Pre- vention, the Director of the National Institutes of Health, and the heads of other relevant Federal agen- cies, and relevant accrediting bodies and representative organizations. ‘‘(d) REPORT TO CONGRESS.—Not later than 2 years after the date of enactment of this Act [Mar. 27, 2020], the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report that shall include— ‘‘(1) a description of the activities carried out under subsection (a); Page 235 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 247d ‘‘(2) a description of trends in blood supply dona- tions; and ‘‘(3) an evaluation of the impact of the public awareness campaign, including any geographic or population variations.’’ REPORTING BY LABORATORIES OF RESULTS OF TESTS TO DETECT SARS–COV–2 OR TO DIAGNOSE COVID–19 Pub. L. 116–136, div. B, title VIII, § 18115(a)–(c), Mar. 27, 2020, 134 Stat. 574, provided that: ‘‘(a) IN GENERAL.—Every laboratory that performs or analyzes a test that is intended to detect SARS–CoV–2 or to diagnose a possible case of COVID–19 shall report the results from each such test, to the Secretary of Health and Human Services in such form and manner, and at such timing and frequency, as the Secretary may prescribe until the end of the Secretary’s Public Health Emergency declaration with respect to COVID–19 or any extension of such declaration. ‘‘(b) LABORATORIES COVERED.—The Secretary may prescribe which laboratories must submit reports pur- suant to this section. ‘‘(c) IMPLEMENTATION.—The Secretary may make pre- scriptions under this section by regulation, including by interim final rule, or by guidance, and may issue such regulations or guidance without regard to the pro- cedures otherwise required by section 553 of title 5, United States Code.’’ Executive Documents EX. ORD. NO. 13987. ORGANIZING AND MOBILIZING THE UNITED STATES GOVERNMENT TO PROVIDE A UNIFIED AND EFFECTIVE RESPONSE TO COMBAT COVID–19 AND TO PROVIDE UNITED STATES LEADERSHIP ON GLOBAL HEALTH AND SECURITY Ex. Ord. No. 13987, Jan. 20, 2021, 86 F.R. 7019, provided: By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows: SECTION 1. Purpose. The Federal Government must act swiftly and aggressively to combat coronavirus disease 2019 (COVID–19). To that end, this order creates the po- sition of Coordinator of the COVID–19 Response and Counselor to the President and takes other steps to or- ganize the White House and activities of the Federal Government to combat COVID–19 and prepare for fu- ture biological and pandemic threats. SEC. 2. Organizing the White House to Combat COVID–19. (a) In order to effectively, fully, and imme- diately respond to COVID–19, there is established with- in the Executive Office of the President the position of Coordinator of the COVID–19 Response and Counselor to the President (COVID–19 Response Coordinator) and the position of Deputy Coordinator of the COVID–19 Re- sponse. The COVID–19 Response Coordinator shall re- port directly to the President; advise and assist the President and executive departments and agencies (agencies) in responding to the COVID–19 pandemic; co- ordinate all elements of the COVID–19 response; and perform such duties as the President may otherwise di- rect. These duties shall include: (i) coordinating a Government-wide effort to reduce disparities in the response, care, and treatment of COVID–19, including racial and ethnic disparities; (ii) coordinating the Federal Government’s efforts to produce, supply, and distribute personal protective equipment, vaccines, tests, and other supplies for the Nation’s COVID–19 response, including through the use of the Defense Production Act, as amended (50 U.S.C. 4501 et seq.); (iii) coordinating the Federal Government’s efforts to expand COVID–19 testing and the use of testing as an effective public health response; (iv) coordinating the Federal Government’s efforts to support the timely, safe, and effective delivery of COVID–19 vaccines to the United States population; (v) coordinating the Federal Government’s efforts to support the safe reopening and operation of schools, child care providers, and Head Start programs, and to help ensure the continuity of educational and other services for young children and elementary and sec- ondary students during the COVID–19 pandemic; and (vi) coordinating, as appropriate, with State, local, Tribal, and territorial authorities. (b) The COVID–19 Response Coordinator shall have the authority to convene principals from relevant agencies, in consultation with the Assistant to the President for Domestic Policy (APDP) on matters in- volving the domestic COVID–19 response, and in con- sultation with the Assistant to the President for Na- tional Security Affairs (APNSA) on matters involving the global COVID–19 response. The COVID–19 Response Coordinator shall also coordinate any corresponding deputies and interagency processes. (c) The COVID–19 Response Coordinator may act through designees in performing these or any other du- ties. SEC. 3. United States Leadership on Global Health and Security and the Global COVID–19 Response. (a) Preparing to Respond to Biological Threats and Pandemics. To identify, monitor, prepare for, and, if necessary, respond to emerging biological and pan- demic threats: (i) The APNSA shall convene the National Security Council (NSC) Principals Committee as necessary to coordinate the Federal Government’s efforts to address such threats and to advise the President on the global response to and recovery from COVID–19, including matters regarding: the intersection of the COVID–19 re- sponse and other national security equities; global health security; engaging with and strengthening the World Health Organization; public health, access to healthcare, and the secondary impacts of COVID–19; and emerging biological risks and threats, whether nat- urally occurring, deliberate, or accidental. (ii) Within 180 days of the date of this order [Jan. 20, 2021], the APNSA shall, in coordination with relevant agencies, the COVID–19 Response Coordinator, and the APDP, complete a review of and recommend actions to the President concerning emerging domestic and global biological risks and national biopreparedness policies. The review and recommended actions shall incorporate lessons from the COVID–19 pandemic and, among other things, address: the readiness of the pandemic supply chain, healthcare workforce, and hospitals; the devel- opment of a framework of pandemic readiness with spe- cific triggers for when agencies should take action in response to large-scale biological events; pandemic bor- der readiness; the development and distribution of med- ical countermeasures; epidemic forecasting and mod- eling; public health data modernization; bio-related in- telligence; bioeconomic investments; biotechnology risks; the development of a framework for coordinating with and distributing responsibilities as between the Federal Government and State, local, Tribal, and terri- torial authorities; and State, local, Tribal, and terri- torial preparedness for biological events. (b) NSC Directorate on Global Health Security and Bio- defense. There shall be an NSC Directorate on Global Health Security and Biodefense, which shall be headed by a Senior Director for Global Health Security and Biodefense. The Senior Director shall be responsible for monitoring current and emerging biological threats, and shall report concurrently to the APNSA and to the COVID–19 Response Coordinator on matters relating to COVID–19. The Senior Director shall oversee the Global Health Security Agenda Interagency Review Council, which was established pursuant to Executive Order 13747 of November 4, 2016 (Advancing the Global Health Security Agenda To Achieve a World Safe and Secure From Infectious Disease Threats) [50 U.S.C. 3021 note], and is hereby reconvened as described in that order. (c) Responsibility for National Biodefense Preparedness. Notwithstanding any statements in the National Secu- rity Presidential Memorandum–14 of September 18, 2018 (Support for National Biodefense), the APNSA shall be responsible for coordinating the Nation’s biodefense preparedness efforts, and, as stated in sections 1 and 2 Page 236 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 247d of this order, the COVID–19 Response Coordinator shall be responsible for coordinating the Federal Govern- ment’s response to the COVID–19 pandemic. SEC. 4. Prompt Resolution of Issues Related to the United States COVID–19 Response. The heads of agencies shall, as soon as practicable, bring any procedural, depart- mental, legal, or funding obstacle to the COVID–19 re- sponse to the attention of the COVID–19 Response Coor- dinator. The COVID–19 Response Coordinator shall, in coordination with relevant agencies, the APDP, and the APNSA, as appropriate, immediately bring to the President’s attention any issues that require Presi- dential guidance or decision-making. SEC. 5. General Provisions. (a) Nothing in this order shall be construed to impair or otherwise affect: (i) the authority granted by law to an executive de- partment or agency, or the head thereof; or (ii) the functions of the Director of the Office of Man- agement and Budget relating to budgetary, administra- tive, or legislative proposals. (b) This order shall be implemented consistent with applicable law and subject to availability of appropria- tions. (c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforce- able at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person. J.R. BIDEN, JR. [Positions of COVID–19 Response Coordinator and Deputy Coordinator of the COVID–19 Response, as es- tablished by section 2 of Ex. Ord. No. 13987, set out above, terminated, and responsibilities and duties transferred to Director of the Office of Pandemic Pre- paredness and Response Policy, by Ex. Ord. No. 14122, § 3, Apr. 12, 2024, 89 F.R. 27355, set out in a note under section 300hh–3 of this title.] EXECUTIVE ORDER NO. 13991 Ex. Ord. No. 13991, Jan. 20, 2021, 86 F.R. 7045, which re- quired compliance with CDC guidelines with respect to wearing masks, maintaining physical distance, and other public health measures by Federal employees and contractors and all persons in Federal buildings or on Federal lands, and HHS promotion of public health best practices identified by the CDC, was revoked by Ex. Ord. No. 14122, § 2, Apr. 12, 2024, 89 F.R. 27355, set out in a note under section 300hh–3 of this title. EX. ORD. NO. 13994. ENSURING A DATA-DRIVEN RESPONSE TO COVID–19 AND FUTURE HIGH-CONSEQUENCE PUBLIC HEALTH THREATS Ex. Ord. No. 13994, Jan. 21, 2021, 86 F.R. 7189, provided: By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows: SECTION 1. Policy. It is the policy of my Administra- tion to respond to the coronavirus disease 2019 (COVID–19) pandemic through effective approaches guided by the best available science and data, including by building back a better public health infrastructure. This stronger public health infrastructure must help the Nation effectively prevent, detect, and respond to future biological threats, both domestically and inter- nationally. Consistent with this policy, the heads of all executive departments and agencies (agencies) shall facilitate the gathering, sharing, and publication of COVID–19-re- lated data, in coordination with the Coordinator of the COVID–19 Response and Counselor to the President (COVID–19 Response Coordinator), to the extent per- mitted by law, and with appropriate protections for confidentiality, privacy, law enforcement, and national security. These efforts shall assist Federal, State, local, Tribal, and territorial authorities in developing and implementing policies to facilitate informed com- munity decision-making, to further public under- standing of the pandemic and the response, and to deter the spread of misinformation and disinformation. SEC. 2. Enhancing Data Collection and Collaboration Ca- pabilities for High-Consequence Public Health Threats, Such as the COVID–19 Pandemic. (a) The Secretary of Defense, the Attorney General, the Secretary of Com- merce, the Secretary of Labor, the Secretary of Health and Human Services (HHS), the Secretary of Edu- cation, the Director of the Office of Management and Budget (OMB), the Director of National Intelligence, the Director of the Office of Science and Technology Policy (OSTP), and the Director of the National Science Foundation shall each promptly designate a senior official to serve as their agency’s lead to work on COVID–19- and pandemic-related data issues. This official, in consultation with the COVID–19 Response Coordinator, shall take steps to make data relevant to high-consequence public health threats, such as the COVID–19 pandemic, publicly available and accessible. (b) The COVID–19 Response Coordinator shall, as nec- essary, convene appropriate representatives from rel- evant agencies to coordinate the agencies’ collection, provision, and analysis of data, including key equity indicators, regarding the COVID–19 response, as well as their sharing of such data with State, local, Tribal, and territorial authorities. (c) The Director of OMB, in consultation with the Di- rector of OSTP, the United States Chief Technology Of- ficer, and the COVID–19 Response Coordinator, shall promptly review the Federal Government’s existing ap- proaches to open data, and shall issue supplemental guidance, as appropriate and consistent with applicable law, concerning how to de-identify COVID–19-related data; how to make data open to the public in human- and machine-readable formats as rapidly as possible; and any other topic the Director of OMB concludes would appropriately advance the policy of this order. Any guidance shall include appropriate protections for the information described in section 5 of this order. (d) The Director of the Office of Personnel Manage- ment, in consultation with the Director of OMB, shall promptly: (i) review the ability of agencies to hire personnel ex- peditiously into roles related to information tech- nology and the collection, provision, analysis, or other use of data to address high-consequence public health threats, such as the COVID–19 pandemic; and (ii) take action, as appropriate and consistent with applicable law, to support agencies in such efforts. SEC. 3. Public Health Data Systems. The Secretary of HHS, in consultation with the COVID–19 Response Co- ordinator and the heads of relevant agencies, shall promptly: (a) review the effectiveness, interoperability, and connectivity of public health data systems supporting the detection of and response to high-consequence pub- lic health threats, such as the COVID–19 pandemic; (b) review the collection of morbidity and mortality data by State, local, Tribal, and territorial govern- ments during high-consequence public health threats, such as the COVID–19 pandemic; and (c) issue a report summarizing the findings of the re- views detailed in subsections (a) and (b) of this section and any recommendations for addressing areas for im- provement identified in the reviews. SEC. 4. Advancing Innovation in Public Health Data and Analytics. The Director of OSTP, in coordination with the National Science and Technology Council, as ap- propriate, shall develop a plan for advancing innova- tion in public health data and analytics in the United States. SEC. 5. Privileged Information. Nothing in this order shall compel or authorize the disclosure of privileged information, law-enforcement information, national-se- curity information, personal information, or informa- tion the disclosure of which is prohibited by law. SEC. 6. General Provisions. (a) Nothing in this order shall be construed to impair or otherwise affect: (i) the authority granted by law to an executive de- partment or agency, or the head thereof; or (ii) the functions of the Director of the Office of Man- agement and Budget relating to budgetary, administra- tive, or legislative proposals. Page 237 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 247d (b) This order shall be implemented consistent with applicable law and subject to the availability of appro- priations. (c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforce- able at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person. J.R. BIDEN, JR. [Position of COVID–19 Response Coordinator termi- nated, and responsibilities and duties of COVID–19 Re- sponse Coordinator specified in Ex. Ord. No. 13994, set out above, transferred to Director of the Office of Pan- demic Preparedness and Response Policy, by Ex. Ord. No. 14122, § 3, Apr. 12, 2024, 89 F.R. 27355, set out in a note under section 300hh–3 of this title.] EX. ORD. NO. 13995. ENSURING AN EQUITABLE PANDEMIC RESPONSE AND RECOVERY Ex. Ord. No. 13995, Jan. 21, 2021, 86 F.R. 7193, provided: By the authority vested in me as President by the Constitution and the laws of the United States of America, and in order to address the disproportionate and severe impact of coronavirus disease 2019 (COVID–19) on communities of color and other under- served populations, it is hereby ordered as follows: SECTION 1. Purpose. The COVID–19 pandemic has ex- posed and exacerbated severe and pervasive health and social inequities in America. For instance, people of color experience systemic and structural racism in many facets of our society and are more likely to be- come sick and die from COVID–19. The lack of complete data, disaggregated by race and ethnicity, on COVID–19 infection, hospitalization, and mortality rates, as well as underlying health and social vulnerabilities, has fur- ther hampered efforts to ensure an equitable pandemic response. Other communities, often obscured in the data, are also disproportionately affected by COVID–19, including sexual and gender minority groups, those liv- ing with disabilities, and those living at the margins of our economy. Observed inequities in rural and Tribal communities, territories, and other geographically iso- lated communities require a place-based approach to data collection and the response. Despite increased State and local efforts to address these inequities, COVID–19’s disparate impact on communities of color and other underserved populations remains unrelent- ing. Addressing this devastating toll is both a moral im- perative and pragmatic policy. It is impossible to change the course of the pandemic without tackling it in the hardest-hit communities. In order to identify and eliminate health and social inequities resulting in disproportionately higher rates of exposure, illness, and death, I am directing a Government-wide effort to ad- dress health equity. The Federal Government must take swift action to prevent and remedy differences in COVID–19 care and outcomes within communities of color and other underserved populations. SEC. 2. COVID–19 Health Equity Task Force. There is established within the Department of Health and Human Services (HHS) a COVID–19 Health Equity Task Force (Task Force). (a) Membership. The Task Force shall consist of the Secretary of HHS; an individual designated by the Sec- retary of HHS to Chair the Task Force (COVID–19 Health Equity Task Force Chair); the heads of such other executive departments, agencies, or offices (agen- cies) as the Chair may invite; and up to 20 members from sectors outside of the Federal Government ap- pointed by the President. (i) Federal members may designate, to perform the Task Force functions of the member, a senior-level offi- cial who is a part of the member’s agency and a full- time officer or employee of the Federal Government. (ii) Nonfederal members shall include individuals with expertise and lived experience relevant to groups suffering disproportionate rates of illness and death in the United States; individuals with expertise and lived experience relevant to equity in public health, health care, education, housing, and community-based serv- ices; and any other individuals with expertise the President deems relevant. Appointments shall be made without regard to political affiliation and shall reflect a diverse set of perspectives. (iii) Members of the Task Force shall serve without compensation for their work on the Task Force, but members shall be allowed travel expenses, including per diem in lieu of subsistence, as authorized by law for persons serving intermittently in the Government serv- ice (5 U.S.C. 5701–5707). (iv) At the direction of the Chair, the Task Force may establish subgroups consisting exclusively of Task Force members or their designees under this section, as appropriate. (b) Mission and Work. (i) Consistent with applicable law and as soon as practicable, the Task Force shall provide specific rec- ommendations to the President, through the Coordi- nator of the COVID–19 Response and Counselor to the President (COVID–19 Response Coordinator), for miti- gating the health inequities caused or exacerbated by the COVID–19 pandemic and for preventing such inequi- ties in the future. The recommendations shall include: (A) recommendations for how agencies and State, local, Tribal, and territorial officials can best allo- cate COVID–19 resources, in light of disproportion- ately high rates of COVID–19 infection, hospitaliza- tion, and mortality in certain communities and dis- parities in COVID–19 outcomes by race, ethnicity, and other factors, to the extent permitted by law; (B) recommendations for agencies with responsi- bility for disbursing COVID–19 relief funding regard- ing how to disburse funds in a manner that advances equity; and (C) recommendations for agencies regarding effec- tive, culturally aligned communication, messaging, and outreach to communities of color and other un- derserved populations. (ii) The Task Force shall submit a final report to the COVID–19 Response Coordinator addressing any ongo- ing health inequities faced by COVID–19 survivors that may merit a public health response, describing the fac- tors that contributed to disparities in COVID–19 out- comes, and recommending actions to combat such dis- parities in future pandemic responses. (c) Data Collection. To address the data shortfalls identified in section 1 of this order, and consistent with applicable law, the Task Force shall: (i) collaborate with the heads of relevant agencies, consistent with the Executive Order entitled ‘‘Ensur- ing a Data-Driven Response to COVID–19 and Future High-Consequence Public Health Threats,’’ [Ex. Ord. No. 13994, set out above] to develop recommendations for expediting data collection for communities of color and other underserved populations and identi- fying data sources, proxies, or indices that would en- able development of short-term targets for pandemic- related actions for such communities and popu- lations; (ii) develop, in collaboration with the heads of rel- evant agencies, a set of longer-term recommendations to address these data shortfalls and other foundational data challenges, including those relating to data intersectionality, that must be tackled in order to bet- ter prepare and respond to future pandemics; and (iii) submit the recommendations described in this subsection to the President, through the COVID–19 Re- sponse Coordinator. (d) External Engagement. Consistent with the objec- tives set out in this order and with applicable law, the Task Force may seek the views of health professionals; policy experts; State, local, Tribal, and territorial health officials; faith-based leaders; businesses; health providers; community organizations; those with lived experience with homelessness, incarceration, discrimi- nation, and other relevant issues; and other stake- holders. (e) Administration. Insofar as the Federal Advisory Committee Act, as amended ([former] 5 U.S.C. App.) Page 238 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 247d [see 5 U.S.C. 1001 et seq.], may apply to the Task Force, any functions of the President under the Act, except for those in section 6 of the Act, shall be performed by the Secretary of HHS in accordance with the guidelines that have been issued by the Administrator of General Services. HHS shall provide funding and administrative support for the Task Force to the extent permitted by law and within existing appropriations. The Chair shall convene regular meetings of the Task Force, determine its agenda, and direct its work. The Chair shall des- ignate an Executive Director of the Task Force, who shall coordinate the work of the Task Force and head any staff assigned to the Task Force. (f) Termination. Unless extended by the President, the Task Force shall terminate within 30 days of accom- plishing the objectives set forth in this order, including the delivery of the report and recommendations speci- fied in this section, or 2 years from the date of this order [Jan. 21, 2021], whichever comes first. SEC. 3. Ensuring an Equitable Pandemic Response. To address the inequities identified in section 1 of this order, it is hereby directed that: (a) The Secretary of Agriculture, the Secretary of Labor, the Secretary of HHS, the Secretary of Housing and Urban Development, the Secretary of Education, the Administrator of the Environmental Protection Agency, and the heads of all other agencies with au- thorities or responsibilities relating to the pandemic response and recovery shall, as appropriate and con- sistent with applicable law: (i) consult with the Task Force to strengthen equity data collection, reporting, and use related to COVID–19; (ii) assess pandemic response plans and policies to de- termine whether personal protective equipment, tests, vaccines, therapeutics, and other resources have been or will be allocated equitably, including by considering: (A) the disproportionately high rates of COVID–19 infection, hospitalization, and mortality in certain communities; and (B) any barriers that have restricted access to pre- ventive measures, treatment, and other health serv- ices for high-risk populations; (iii) based on the assessments described in subsection (a)(ii) of this section, modify pandemic response plans and policies to advance equity, with consideration to: (A) the effect of proposed policy changes on the dis- tribution of resources to, and access to health care by, communities of color and other underserved popu- lations; (B) the effect of proposed policy changes on agen- cies’ ability to collect, analyze, and report data nec- essary to monitor and evaluate the impact of pan- demic response plans and policies on communities of color and other underserved populations; and (C) policy priorities expressed by communities that have suffered disproportionate rates of illness and death as a result of the pandemic; (iv) strengthen enforcement of anti-discrimination requirements pertaining to the availability of, and ac- cess to, COVID–19 care and treatment; and (v) partner with States, localities, Tribes, and terri- tories to explore mechanisms to provide greater assist- ance to individuals and families experiencing dis- proportionate economic or health effects from COVID–19, such as by expanding access to food, hous- ing, child care, or income support. (b) The Secretary of HHS shall: (i) provide recommendations to State, local, Tribal, and territorial leaders on how to facilitate the place- ment of contact tracers and other workers in commu- nities that have been hardest hit by the pandemic, re- cruit such workers from those communities, and con- nect such workers to existing health workforce train- ing programs and other career advancement programs; and (ii) conduct an outreach campaign to promote vac- cine trust and uptake among communities of color and other underserved populations with higher levels of vaccine mistrust due to discriminatory medical treat- ment and research, and engage with leaders within those communities. SEC. 4. General Provisions. (a) Nothing in this order shall be construed to impair or otherwise affect: (i) the authority granted by law to an executive de- partment or agency, or the head thereof; or (ii) the functions of the Director of the Office of Man- agement and Budget relating to budgetary, administra- tive, or legislative proposals. (b) This order shall be implemented consistent with applicable law and subject to the availability of appro- priations. (c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforce- able at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person. J.R. BIDEN, JR. EX. ORD. NO. 13996. ESTABLISHING THE COVID–19 PAN- DEMIC TESTING BOARD AND ENSURING A SUSTAINABLE PUBLIC HEALTH WORKFORCE FOR COVID–19 AND OTHER BIOLOGICAL THREATS Ex. Ord. No. 13996, Jan. 21, 2021, 86 F.R. 7197, provided: By the authority vested in me as President by the Constitution and the laws of the United States of America, including section 301 of title 3, United States Code, it is hereby ordered as follows: SECTION 1. Policy. It is the policy of my Administra- tion to control coronavirus disease 2019 (COVID–19) by using a Government-wide, unified approach that in- cludes: establishing a national COVID–19 testing and public health workforce strategy; working to expand the supply of tests; working to bring test manufac- turing to the United States, where possible; working to enhance laboratory testing capacity; working to ex- pand the public health workforce; supporting screening testing for schools and priority populations; and ensur- ing a clarity of messaging about the use of tests and in- surance coverage. SEC. 2. COVID–19 Pandemic Testing Board. (a) Establishment and Membership. There is established a COVID–19 Pandemic Testing Board (Testing Board), chaired by the Coordinator of the COVID–19 Response and Counselor to the President (COVID–19 Response Co- ordinator) or his designee. The Testing Board shall in- clude representatives from executive departments and agencies (agencies) that are designated by the Presi- dent. The heads of agencies so designated shall des- ignate officials from their respective agencies to rep- resent them on the Testing Board. (b) Mission and Functions. To support the implementa- tion and oversight of the policy laid out in section 1 of this order, the Testing Board shall: (i) coordinate Federal Government efforts to promote COVID–19 diagnostic, screening, and surveillance test- ing; (ii) make recommendations to the President with re- spect to prioritizing the Federal Government’s assist- ance to State, local, Tribal, and territorial authorities, in order to expand testing and reduce disparities in ac- cess to testing; (iii) identify barriers to access and use of testing in, and coordinate Federal Government efforts to increase testing for: (A) priority populations, including healthcare workers and other essential workers; (B) communities with major shortages in testing availability and use; (C) at-risk settings, including long-term care facili- ties, correctional facilities, immigration custodial settings, detention facilities, schools, child care set- tings, and food processing and manufacturing facili- ties; and (D) high-risk groups, including people experiencing homelessness, migrants, and seasonal workers; (iv) identify methods to expand State, local, Tribal, and territorial capacity to conduct testing, contact tracing, and isolation and quarantine, in order for schools, businesses, and travel to be conducted safely; (v) provide guidance on how to enhance the clarity, consistency, and transparency of Federal Government Page 239 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 247d communication with the public about the goals and purposes of testing; (vi) identify options for the Federal Government to maximize testing capacity of commercial labs and aca- demic labs; and (vii) propose short- and long-term reforms for the Federal Government to: increase State, local, Tribal, and territorial capacity to conduct testing; expand genomic sequencing; and improve the effectiveness and speed of the Federal Government’s response to future pandemics and other biological emergencies. (d) The Chair of the Testing Board shall coordinate with the Secretary of Health and Human Services (HHS) and the heads of other relevant agencies or their designees, as necessary, to ensure that the Testing Board’s work is coordinated with the Public Health Emergency Countermeasures Enterprise within HHS. SEC. 3. Actions to Address the Cost of COVID–19 Testing. (a) The Secretary of the Treasury, the Secretary of HHS, and the Secretary of Labor, in coordination with the COVID–19 Response Coordinator, shall promptly, and as appropriate and consistent with applicable law: (i) facilitate the provision of COVID–19 testing free of charge to those who lack comprehensive health insur- ance; and (ii) clarify group health plans’ and health insurance issuers’ obligations to provide coverage for COVID–19 testing. (b) The Secretary of HHS, the Secretary of Edu- cation, and the Secretary of Homeland Security, through the Administrator of the Federal Emergency Management Agency (FEMA), in coordination with the COVID–19 Response Coordinator, shall promptly, and as appropriate and consistent with applicable law: (i) provide support for surveillance tests for settings such as schools; and (ii) expand equitable access to COVID–19 testing. SEC. 4. Establishing a Public Health Workforce Program. (a) The Secretary of HHS and the Secretary of Labor shall promptly consult with State, local, Tribal, and territorial leaders to understand the challenges they face in pandemic response efforts, including challenges recruiting and training sufficient personnel to ensure adequate and equitable community-based testing, and testing in schools and high-risk settings. (b) The Secretary of HHS shall, as appropriate and consistent with applicable law, as soon as practicable: (i) provide technical support to State, local, Tribal, and territorial public health agencies with respect to testing and contact-tracing efforts; and (ii) assist such authorities in the training of public health workers. This may include technical assistance to non-Federal public health workforces in connection with testing, contact tracing, and mass vaccinations, as well as other urgent public health workforce needs, such as combating opioid use. (c) The Secretary of HHS shall submit to the Presi- dent, through the COVID–19 Response Coordinator, the Assistant to the President for Domestic Policy (APDP), and the Assistant to the President for National Secu- rity Affairs (APNSA), a plan detailing: (i) how the Secretary of HHS would deploy personnel in response to future high-consequence public health threats; and (ii) five-year targets and budget requirements for achieving a sustainable public health workforce, as well as options for expanding HHS capacity, such as by expanding the U.S. Public Health Service Commis- sioned Corps and Epidemic Intelligence Service, so that the Department can better respond to future pandemics and other biological threats. (d) The Secretary of HHS, the Secretary of Homeland Security, the Secretary of Labor, the Secretary of Edu- cation, and the Chief Executive Officer of the Corpora- tion for National and Community Service, in coordina- tion with the COVID–19 Response Coordinator, the APDP, and the APNSA, shall submit a plan to the President for establishing a national contact tracing and COVID–19 public health workforce program, to be known as the U.S. Public Health Job Corps, which shall be modeled on or developed as a component of the FEMA Corps program. Such plan shall include means by which the U.S. Public Health Job Corps can be part of the National Civilian Community Corps program, as well as recommendations about whether it would be ap- propriate for the U.S. Public Health Job Corps to im- mediately assign personnel from any of the agencies in- volved in the creation of the plan, including existing AmeriCorps members, to join or aid the U.S. Public Health Job Corps. The U.S. Public Health Job Corps will: (i) conduct and train individuals in contact tracing related to the COVID–19 pandemic; (ii) assist in outreach for vaccination efforts, includ- ing by administering vaccination clinics; (iii) assist with training programs for State, local, Tribal, and territorial governments to provide testing, including in schools; and (iv) provide other necessary services to Americans af- fected by the COVID–19 pandemic. SEC. 5. General Provisions. (a) Nothing in this order shall be construed to impair or otherwise affect: (i) the authority granted by law to an executive de- partment or agency, or the head thereof; or (ii) the functions of the Director of the Office of Man- agement and Budget relating to budgetary, administra- tive, or legislative proposals. (b) This order shall be implemented consistent with applicable law and subject to the availability of appro- priations. (c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforce- able at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person. J.R. BIDEN, JR. [Position of COVID–19 Response Coordinator termi- nated, and responsibilities and duties of COVID–19 Re- sponse Coordinator specified in Ex. Ord. No. 13996, set out above, transferred to Director of the Office of Pan- demic Preparedness and Response Policy, by Ex. Ord. No. 14122, § 3, Apr. 12, 2024, 89 F.R. 27355, set out in a note under section 300hh–3 of this title.] EX. ORD. NO. 13997. IMPROVING AND EXPANDING ACCESS TO CARE AND TREATMENTS FOR COVID–19 Ex. Ord. No. 13997, Jan. 21, 2021, 86 F.R. 7201, provided: By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows: SECTION 1. Policy. It is the policy of my Administra- tion to improve the capacity of the Nation’s healthcare systems to address coronavirus disease 2019 (COVID–19), to accelerate the development of novel therapies to treat COVID–19, and to improve all Americans’ access to quality and affordable healthcare. SEC. 2. Accelerating the Development of Novel Therapies. To enhance the Nation’s ability to quickly develop the most promising COVID–19 interventions, the Secretary of Health and Human Services (HHS), in consultation with the Director of the National Institutes of Health, shall: (a) develop a plan for supporting a range of studies, including large-scale randomized trials, for identifying optimal clinical management strategies, and for sup- porting the most promising treatments for COVID–19 and future high-consequence public health threats, that can be easily manufactured, distributed, and adminis- tered, both domestically and internationally; (b) develop a plan, in consultation with non-govern- mental partners, as appropriate, to support research: (i) in rural hospitals and other rural locations; and (ii) that studies the emerging evidence concerning the long-term impact of COVID–19 on patient health; and (c) consider steps to ensure that clinical trials in- clude populations that have been historically underrep- resented in such trials. SEC. 3. Improving the Capacity of the Nation’s Healthcare Systems to Address COVID–19. To bolster the Page 240 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 247d capacity of the Nation’s healthcare systems to support healthcare workers and patients: (a) The Secretary of Defense, the Secretary of HHS, the Secretary of Veterans Affairs, and the heads of other relevant executive departments and agencies (agencies), in coordination with the Coordinator of the COVID–19 Response and Counselor to the President (COVID–19 Response Coordinator), shall promptly, as appropriate and consistent with applicable law, provide targeted surge assistance to critical care and long-term care facilities, including nursing homes and skilled nursing facilities, assisted living facilities, inter- mediate care facilities for individuals with disabilities, and residential treatment centers, in their efforts to combat the spread of COVID–19. (b) The COVID–19 Response Coordinator, in coordina- tion with the Secretary of Defense, the Secretary of HHS, the Secretary of Veterans Affairs, and the heads of other relevant agencies, shall review the needs of Federal facilities providing care to COVID–19 patients and develop recommendations for further actions such facilities can take to support active military personnel, veterans, and Tribal nations during this crisis. (c) The Secretary of HHS shall promptly: (i) issue recommendations on how States and healthcare providers can increase the capacity of their healthcare workforces to address the COVID–19 pan- demic; and (ii) through the Administrator of the Health Re- sources and Services Administration and the Adminis- trator of the Substance Abuse and Mental Health Serv- ices Administration, take appropriate actions, as con- sistent with applicable law, to expand access to pro- grams and services designed to meet the long-term health needs of patients recovering from COVID–19, in- cluding through technical assistance and support to community health centers. SEC. 4. Improving Access to Quality and Affordable Healthcare. (a) To facilitate the equitable and effective distribution of therapeutics and bolster clinical care capacity where needed to support patient care, the Sec- retary of Defense, the Secretary of HHS, and the Sec- retary of Veterans Affairs, in coordination with the COVID–19 Response Coordinator, shall establish targets for the production, allocation, and distribution of COVID–19 treatments. To meet those targets, the Sec- retary of Defense, the Secretary of HHS, and the Sec- retary of Veterans Affairs shall consider prioritizing, including through grants for research and development, investments in therapeutics that can be readily admin- istered and scaled. (b) To facilitate the utilization of existing COVID–19 treatments, the Secretary of HHS shall identify bar- riers to maximizing the effective and equitable use of existing COVID–19 treatments and shall, as appropriate and consistent with applicable law, provide support to State, local, Tribal, and territorial authorities aimed at overcoming those barriers. (c) To address the affordability of treatments and clinical care, the Secretary of HHS shall, promptly and as appropriate and consistent with applicable law: (i) evaluate the COVID–19 Uninsured Program, oper- ated by the Health Resources and Services Administra- tion within HHS, and take any available steps to pro- mote access to treatments and clinical care for those without adequate coverage, to support safety-net pro- viders in delivering such treatments and clinical care, and to make the Program easy to use and accessible for patients and providers, with information about the Program widely disseminated; and (ii) evaluate Medicare, Medicaid, group health plans, and health insurance issuers, and take any available steps to promote insurance coverage for safe and effec- tive COVID–19 treatments and clinical care. SEC. 5. General Provisions. (a) Nothing in this order shall be construed to impair or otherwise affect: (i) the authority granted by law to an executive de- partment or agency, or the head thereof; or (ii) the functions of the Director of the Office of Man- agement and Budget relating to budgetary, administra- tive, or legislative proposals. (b) This order shall be implemented consistent with applicable law and subject to the availability of appro- priations. (c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforce- able at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person. J.R. BIDEN, JR. EXECUTIVE ORDER NO. 13998 Ex. Ord. No. 13998, Jan. 21, 2021, 86 F.R. 7205, which re- lated to promoting COVID–19 safety in domestic and international travel, was revoked by Ex. Ord. No. 14122, § 2, Apr. 12, 2024, 89 F.R. 27355, set out in a note under section 300hh–3 of this title. EX. ORD. NO. 13999. PROTECTING WORKER HEALTH AND SAFETY Ex. Ord. No. 13999, Jan. 21, 2021, 86 F.R. 7211, provided: By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows: SECTION 1. Policy. Ensuring the health and safety of workers is a national priority and a moral imperative. Healthcare workers and other essential workers, many of whom are people of color and immigrants, have put their lives on the line during the coronavirus disease 2019 (COVID–19) pandemic. It is the policy of my Ad- ministration to protect the health and safety of work- ers from COVID–19. The Federal Government must take swift action to reduce the risk that workers may contract COVID–19 in the workplace. That will require issuing science-based guidance to help keep workers safe from COVID–19 ex- posure, including with respect to mask-wearing; partnering with State and local governments to better protect public employees; enforcing worker health and safety requirements; and pushing for additional re- sources to help employers protect employees. SEC. 2. Protecting Workers from COVID–19 Under the Oc- cupational Safety and Health Act. The Secretary of Labor, acting through the Assistant Secretary of Labor for Occupational Safety and Health, in furtherance of the policy described in section 1 of this order and con- sistent with applicable law, shall: (a) issue, within 2 weeks of the date of this order [Jan. 21, 2021] and in conjunction or consultation with the heads of any other appropriate executive depart- ments and agencies (agencies), revised guidance to em- ployers on workplace safety during the COVID–19 pan- demic; (b) consider whether any emergency temporary standards on COVID–19, including with respect to masks in the workplace, are necessary, and if such standards are determined to be necessary, issue them by March 15, 2021; (c) review the enforcement efforts of the Occupa- tional Safety and Health Administration (OSHA) re- lated to COVID–19 and identify any short-, medium-, and long-term changes that could be made to better protect workers and ensure equity in enforcement; (d) launch a national program to focus OSHA enforce- ment efforts related to COVID–19 on violations that put the largest number of workers at serious risk or are contrary to anti-retaliation principles; and (e) coordinate with the Department of Labor’s Office of Public Affairs and Office of Public Engagement and all regional OSHA offices to conduct, consistent with applicable law, a multilingual outreach campaign to in- form workers and their representatives of their rights under applicable law. This campaign shall include en- gagement with labor unions, community organizations, and industries, and place a special emphasis on commu- nities hit hardest by the pandemic. SEC. 3. Protecting Other Categories of Workers from COVID–19. (a) The Secretary of Labor, acting through the Assistant Secretary of Labor for Occupational Safe- ty and Health and consistent with applicable law, shall: Page 241 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 247d (i) coordinate with States that have occupational safety and health plans approved under section 18 of the Occupational Safety and Health Act (Act) (29 U.S.C. 667) to seek to ensure that workers covered by such plans are adequately protected from COVID–19, con- sistent with any revised guidance or emergency tem- porary standards issued by OSHA; and (ii) in States that do not have such plans, consult with State and local government entities with respon- sibility for public employee safety and health and with public employee unions to bolster protection from COVID–19 for public sector workers. (b) The Secretary of Agriculture, the Secretary of Labor, the Secretary of Health and Human Services, the Secretary of Transportation, and the Secretary of Energy, in consultation with the heads of any other ap- propriate agencies, shall, consistent with applicable law, explore mechanisms to protect workers not pro- tected under the Act [29 U.S.C. 651 et seq.] so that they remain healthy and safe on the job during the COVID–19 pandemic. (c) The Secretary of Labor, acting through the As- sistant Secretary of Labor for Mine Safety and Health, shall consider whether any emergency temporary standards on COVID–19 applicable to coal and metal or non-metal mines are necessary, and if such standards are determined to be necessary and consistent with ap- plicable law, issue them as soon as practicable. SEC. 4. General Provisions. (a) Nothing in this order shall be construed to impair or otherwise affect: (i) the authority granted by law to an executive de- partment or agency, or the head thereof; or (ii) the functions of the Director of the Office of Man- agement and Budget relating to budgetary, administra- tive, or legislative proposals. (b) This order shall be implemented consistent with applicable law and subject to the availability of appro- priations. (c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforce- able at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person. J.R. BIDEN, JR. EX. ORD. NO. 14000. SUPPORTING THE REOPENING AND CONTINUING OPERATION OF SCHOOLS AND EARLY CHILD- HOOD EDUCATION PROVIDERS Ex. Ord. No. 14000, Jan. 21, 2021, 86 F.R. 7215, provided: By the authority vested in me as President by the Constitution and the laws of the United States of America, to ensure that students receive a high-quality education during the coronavirus disease 2019 (COVID–19) pandemic, and to support the safe reopen- ing and continued operation of schools, child care pro- viders, Head Start programs, and institutions of higher education, it is hereby ordered as follows: SECTION 1. Policy. Every student in America deserves a high-quality education in a safe environment. This promise, which was already out of reach for too many, has been further threatened by the COVID–19 pandemic. School and higher education administrators, educators, faculty, child care providers, custodians and other staff, and families have gone above and beyond to sup- port children’s and students’ learning and meet their needs during this crisis. Students and teachers alike have found new ways to teach and learn. Many child care providers continue to provide care and learning opportunities to children in homes and centers across the country. However, leadership and support from the Federal Government is needed. Two principles should guide the Federal Government’s response to the COVID–19 crisis with respect to schools, child care pro- viders, Head Start programs, and higher education in- stitutions. First, the health and safety of children, stu- dents, educators, families, and communities is para- mount. Second, every student in the United States should have the opportunity to receive a high-quality education, during and beyond the pandemic. Accordingly, it is the policy of my Administration to provide support to help create the conditions for safe, in-person learning as quickly as possible; ensure high- quality instruction and the delivery of essential serv- ices often received by students and young children at school, institutions of higher education, child care pro- viders, and Head Start programs; mitigate learning loss caused by the pandemic; and address educational dis- parities and inequities that the pandemic has created and exacerbated. SEC. 2. Agency Roles and Responsibilities. The following assignments of responsibility shall be exercised in fur- therance of the policy described in section 1 of this order: (a) The Secretary of Education shall, consistent with applicable law: (i) provide, in consultation with the Secretary of Health and Human Services, evidence-based guidance to assist States and elementary and secondary schools in deciding whether and how to reopen, and how to re- main open, for in-person learning; and in safely con- ducting in-person learning, including by implementing mitigation measures such as cleaning, masking, proper ventilation, and testing; (ii) provide, in consultation with the Secretary of Health and Human Services, evidence-based guidance to institutions of higher education on safely reopening for in-person learning, which shall take into account considerations such as the institution’s setting, re- sources, and the population it serves; (iii) provide advice to State, local, Tribal, and terri- torial educational authorities, institutions of higher education, local education agencies, and elementary and secondary schools regarding distance and online learning, blended learning, and in-person learning; and the promotion of mental health, social-emotional well- being, and communication with parents and families; (iv) develop a Safer Schools and Campuses Best Prac- tices Clearinghouse to enable schools and institutions of higher education to share lessons learned and best practices for operating safely during the pandemic; (v) provide technical assistance to schools and insti- tutions of higher education so that they can ensure high-quality learning during the pandemic; (vi) direct the Department of Education’s Assistant Secretary for Civil Rights to deliver a report as soon as practicable on the disparate impacts of COVID–19 on students in elementary, secondary, and higher edu- cation, including those attending historically black colleges and universities, Tribal colleges and univer- sities, Hispanic-serving institutions, and other minor- ity-serving institutions; (vii) coordinate with the Director of the Institute of Education Sciences to facilitate, consistent with appli- cable law, the collection of data necessary to fully un- derstand the impact of the COVID–19 pandemic on stu- dents and educators, including data on the status of in- person learning. These data shall be disaggregated by student demographics, including race, ethnicity, dis- ability, English-language-learner status, and free or re- duced lunch status or other appropriate indicators of family income; and (viii) consult with those who have been struggling for months with the enormous challenges the COVID–19 pandemic poses for education, including students; edu- cators; unions; families; State, local, Tribal, and terri- torial officials; and members of civil rights and dis- ability rights organizations, in carrying out the direc- tives in this order. (b) The Secretary of Health and Human Services shall, consistent with applicable law: (i) facilitate the collection of data needed to inform the safe reopening and continued operation of elemen- tary and secondary schools, child care providers, and Head Start programs, and ensure that such data are readily available to State, local, Tribal, and territorial leaders and the public, consistent with privacy inter- ests, and that such data are disaggregated by race, eth- nicity, and other factors as appropriate; (ii) ensure, in coordination with the Coordinator of the COVID–19 Response and Counselor to the President Page 242 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 247d (COVID–19 Response Coordinator) and other relevant agencies, that COVID–19-related supplies the Secretary administers, including testing materials, are equitably allocated to elementary and secondary schools, child care providers, and Head Start programs to support in- person care and learning; (iii) to the maximum extent possible, support the de- velopment and operation of contact tracing programs at the State, local, Tribal, and territorial level, by pro- viding guidance and technical support to ensure that contact tracing is available to facilitate the reopening and safe operation of elementary and secondary schools, child care providers, Head Start programs, and institutions of higher education; (iv) provide guidance needed for child care providers and Head Start programs for safely reopening and oper- ating, including procedures for mitigation measures such as cleaning, masking, proper ventilation, and test- ing, as well as guidance related to meeting the needs of children, families, and staff who have been affected by the COVID–19 pandemic, including trauma-informed care, behavioral and mental health support, and family support, as appropriate; and (v) provide technical assistance to States, localities, Tribes, and territories to support the accelerated dis- tribution of Federal COVID–19 relief funds to child care providers, and identify strategies to help child care providers safely remain open during the pandemic and beyond while the sector experiences widespread finan- cial disruption due to increased costs and less revenue. (c) The Secretary of Education and the Secretary of Health and Human Services shall submit a report to the Assistant to the President for Domestic Policy and the COVID–19 Response Coordinator identifying strate- gies to address the impact of COVID–19 on educational outcomes, especially along racial and socioeconomic lines, and shall share those strategies with State, local, Tribal, and territorial officials. In developing these strategies, the Secretaries shall, as appropriate and consistent with applicable law, consult with such offi- cials, as well as with education experts; educators; unions; civil rights advocates; Tribal education ex- perts; public health experts; child development experts; early educators, including child care providers; Head Start staff; school technology practitioners; founda- tions; families; students; community advocates; and others. (d) The Federal Communications Commission is en- couraged, consistent with applicable law, to increase connectivity options for students lacking reliable home broadband, so that they can continue to learn if their schools are operating remotely. SEC. 3. General Provisions. (a) Nothing in this order shall be construed to impair or otherwise affect: (i) the authority granted by law to an executive de- partment or agency, or the head thereof; or (ii) the functions of the Director of the Office of Man- agement and Budget relating to budgetary, administra- tive, or legislative proposals. (b) This order shall be implemented consistent with applicable law and subject to the availability of appro- priations. (c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforce- able at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person. J.R. BIDEN, JR. ADDRESSING THE LONG-TERM EFFECTS OF COVID–19 Memorandum of President of the United States, Apr. 5, 2022, 87 F.R. 20995, provided: Memorandum for the Heads of Executive Depart- ments and Agencies By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows: SECTION 1. Policy. My Administration has made com- bating the coronavirus disease 2019 (COVID–19) pan- demic, and guiding the Nation through the worst public health crisis in more than a century, our top priority. When I came into office, COVID–19 was wreaking havoc on our country—closing our businesses, keeping our kids out of school, and forcing us into isolation. Today, America has the tools to protect against COVID–19 and to dramatically decrease its risks. We move towards a future in which COVID–19 does not disrupt our daily lives and is something we prevent, protect against, and treat. As we chart the path forward, we remember the more than 950,000 people in the United States lost to COVID–19. They were beloved parents, grandparents, children, siblings, spouses, neighbors, and friends. More than 200,000 children in the United States have lost a parent or caregiver to the disease. Each soul is irre- placeable, and the families and communities left be- hind are still reeling from profound loss. Many families and communities have already received support from Federal programs that help with the loss they have ex- perienced. As we move forward, we commit to ensuring that families and communities can access these sup- port programs and connect to resources they may need to help with their healing, health, and well-being. At the same time, many of our family members, neighbors, and friends continue to experience negative long-term effects of COVID–19. Many individuals report debilitating, long-lasting effects of having been in- fected with COVID–19, often called ‘‘long COVID.’’ These symptoms can happen to anyone who has had COVID–19—including individuals across ages, races, genders, and ethnicities; individuals with or without disabilities; individuals with or without underlying health conditions; and individuals whether or not they had initial symptoms. Individuals experiencing long COVID report experiencing new or recurrent symptoms, which can include anxiety and depression, fatigue, shortness of breath, difficulty concentrating, heart pal- pitations, disordered sleep, chest and joint pain, head- aches, and other symptoms. These symptoms can per- sist long after the acute COVID–19 infection has re- solved. Even young people and otherwise healthy peo- ple have reported long COVID symptoms that last for many months. These symptoms may be affecting indi- viduals’ ability to work, conduct daily activities, en- gage in educational activities, and participate in their communities. Our world-class research and public health organizations have begun the difficult work of understanding these new conditions, their causes, and potential prevention and treatment options. Our health care and support programs are working to help meet the needs of individuals experiencing the lasting effects of COVID–19. To organize the Federal Government’s re- sponse, executive departments and agencies (agencies) must work together to use the expertise, resources, and benefit programs of the Federal Government to ensure that we are accelerating scientific progress and pro- viding individuals with the support and services they need. In addition, the American public is grappling with a mental health crisis exacerbated by the pandemic. Too many have felt the effects of social isolation, sickness, economic insecurity, increased caregiver burdens, and grief. My Administration has made significant invest- ments in mental health as well as substance use dis- order prevention, treatment, and recovery support for the American public, including by expanding access to community-based behavioral health services. We are committed to advancing these behavioral health efforts in order to better identify the effects of the pandemic on mental health, substance use, and well-being, and to take steps to address these effects for the people we serve. Our Nation can continue to protect the public—and spare countless families from the deepest pain imag- inable—if everybody does their part. Today, we have numerous tools to protect ourselves and our loved ones from COVID–19—from vaccines to tests, treatments, masks, and more. My Administration recognizes the toll of this pandemic on the American public and com- Page 243 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 247d–1 mits to redoubling our efforts to support the American people in addressing the long-term effects of COVID–19 on their lives and on society. SEC. 2. Organizing the Government-Wide Response to the Long-Term Effects of COVID–19. (a) The Secretary of Health and Human Services (Secretary) shall coordi- nate the Government-wide response to the long-term effects of COVID–19. My Administration will harness the full potential of the Federal Government, in coordi- nation with public- and private-sector partners, to mount a full and effective response. The Secretary shall report on the coordination efforts to the Coordi- nator of the COVID–19 Response and Counselor to the President and to the Assistant to the President for Do- mestic Policy. (b) The heads of agencies shall assist and provide in- formation to the Secretary, consistent with applicable law, as may be necessary to carry out the Secretary’s duties described in subsection (a) of this section. (c) In performing the duties described in subsection (a) of this section, the Secretary shall seek information from relevant nongovernmental experts, organizations, and stakeholders, including individuals affected di- rectly by the long-term effects of COVID–19. The Sec- retary shall consider using all available legal authori- ties, as appropriate and consistent with applicable law, to assist in gathering relevant information, including a waiver under 42 U.S.C. 247d(f). SEC. 3. Report on the Long-Term Effects of COVID–19. The Secretary, supported within the Department of Health and Human Services by the Assistant Secretary for Health and the Assistant Secretary for Mental Health and Substance Use, shall publish a public report within 120 days of the date of this memorandum [Apr. 5, 2022] outlining services and mechanisms of support across agencies to assist the American public in the face of the far-reaching and long-term effects of COVID–19. The report shall outline Federal Govern- ment services to support individuals experiencing long COVID, individuals and families experiencing a loss due to COVID–19, and all those grappling with mental health and substance use issues in the wake of this pan- demic. The report shall also specifically address the long-term effects of COVID–19 on underserved commu- nities and efforts to address disparities in availability and adoption of services and support for such commu- nities. SEC. 4. National Research Action Plan on Long COVID. (a) Coordinated efforts across the public and private sectors are needed to advance progress in prevention, diagnosis, treatment, and provision of services for indi- viduals experiencing long COVID. The Secretary, sup- ported by the Assistant Secretary for Health and in collaboration with the Secretary of Defense, the Sec- retary of Labor, the Secretary of Energy, and the Sec- retary of Veterans Affairs, shall coordinate a Govern- ment-wide effort to develop the first-ever interagency national research agenda on long COVID, to be re- flected in a National Research Action Plan. The Na- tional Research Action Plan will build on ongoing ef- forts across the Federal Government, including the landmark RECOVER Initiative implemented by the Na- tional Institutes of Health. The Secretary shall release the jointly developed National Research Action Plan within 120 days of the date of this memorandum. (b) The National Research Action Plan shall build upon existing research efforts and include strategies to: (i) help measure and characterize long COVID in both children and adults, including with respect to its fre- quency, severity, duration, risk factors, and trends over time; (ii) support the development of estimates on preva- lence and incidence of long COVID disaggregated by de- mographic groups and symptoms; (iii) better understand the epidemiology, course of ill- ness, risk factors, and vaccine effectiveness in preven- tion of long COVID; (iv) advance our understanding of the health and so- cioeconomic burdens on individuals affected by long COVID, including among different race and ethnicity groups, pregnant people, and those with underlying dis- abilities; (v) foster development of new treatments and care models for long COVID based on a better understanding of the pathophysiological mechanisms of the SARS–CoV–2 virus; (vi) inform decisions related to high-quality support, services, and interventions for long COVID; (vii) improve data-sharing between agencies and aca- demic and industry researchers about long COVID, to the extent permitted by law; and (viii) specifically account for the pandemic’s effect on underserved communities and rural populations. SEC. 5. General Provisions. (a) Nothing in this memo- randum shall be construed to impair or otherwise af- fect: (i) the authority granted by law to an executive de- partment or agency, or the head thereof; or (ii) the functions of the Director of the Office of Man- agement and Budget relating to budgetary, administra- tive, or legislative proposals. (b) This memorandum shall be implemented con- sistent with applicable law and subject to the avail- ability of appropriations. (c) This memorandum is not intended to, and does not, create any right or benefit, substantive or proce- dural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person. (d) The Secretary is authorized and directed to pub- lish this memorandum in the Federal Register. J.R. BIDEN, JR. § 247d–1. Vaccine tracking and distribution (a) Tracking The Secretary, together with relevant manu- facturers, wholesalers, and distributors as may agree to cooperate, may track the initial dis- tribution of federally purchased influenza vac- cine in an influenza pandemic, or other federally purchased vaccine to address another pandemic. Such tracking information shall be used to in- form Federal, State, local, and tribal decision makers during an influenza pandemic or other pandemic. (b) Distribution The Secretary shall promote communication between State, local, and tribal public health of- ficials and such manufacturers, wholesalers, and distributors as agree to participate, regarding the effective distribution of seasonal influenza vaccine. Such communication shall include esti- mates of high priority populations, as deter- mined by the Secretary, in State, local, and tribal jurisdictions in order to inform Federal, State, local, and tribal decision makers during vaccine shortages and supply disruptions. (c) Confidentiality The information submitted to the Secretary or its contractors, if any, under this section or under any other section of this chapter related to vaccine distribution information shall remain confidential in accordance with the exception from the public disclosure of trade secrets, com- mercial or financial information, and informa- tion obtained from an individual that is privi- leged and confidential, as provided for in section 552(b)(4) of title 5, and subject to the penalties and exceptions under sections 1832 and 1833 of title 18 relating to the protection and theft of trade secrets, and subject to privacy protections

Cross-references

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 360bbb — Expanded access to unapproved therapies and diagnostics

**(a) Emergency situations** The Secretary may, under appropriate conditions determined by the Secretary, authorize the shipment of investigational drugs or investigational devices for the diagnosis, monitoring, or treatment of a serious disease or condition in emergency situations. **(b) Individual patient access to investigational products intended for serious diseases** Any person, acting through a physician licensed in accordance with State law, may request from a manufacturer or distributor, and any manufacturer or distributor may, after complying with the provisions of this subsection, provide to such physician an investigational drug or investigational device for the diagnosis, monitoring, or treatment of a serious disease or condition if— (1) the licensed physician determines that the person has no comparable or satisfactory alternative therapy available to diagnose, monitor, or treat the disease or condition involved, and that the probable risk to the person from the investigational drug or investigational device is not greater than the probable risk from the disease or condition; (2) the Secretary determines that there is sufficient evidence of safety and effectiveness to support the use of the investigational drug or investigational device in the case described in paragraph (1); (3) the Secretary determines that provision of the investigational drug or investigational device will not interfere with the initiation, conduct, or completion of clinical investigations to support marketing approval; and (4) the sponsor, or clinical investigator, of the investigational drug or investigational device submits to the Secretary a clinical protocol consistent with the provisions of section 355(i) or 360j(g) of this title, including any regulations promulgated under

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360bbb

Stored review status: release_metadata_unconfirmed. The source passage cites 21 U.S.C. § 360bbb. This identifies an authority to review, not proof of applicability.

Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 360bbb — Expanded access to unapproved thera-

§ 360bbb. Expanded access to unapproved thera- pies and diagnostics (a) Emergency situations The Secretary may, under appropriate condi- tions determined by the Secretary, authorize the shipment of investigational drugs or inves- tigational devices for the diagnosis, monitoring, or treatment of a serious disease or condition in emergency situations. (b) Individual patient access to investigational products intended for serious diseases Any person, acting through a physician li- censed in accordance with State law, may re- quest from a manufacturer or distributor, and any manufacturer or distributor may, after complying with the provisions of this sub- section, provide to such physician an investiga- tional drug or investigational device for the di- agnosis, monitoring, or treatment of a serious disease or condition if— (1) the licensed physician determines that the person has no comparable or satisfactory alternative therapy available to diagnose, monitor, or treat the disease or condition in- volved, and that the probable risk to the per- son from the investigational drug or investiga- tional device is not greater than the probable risk from the disease or condition; (2) the Secretary determines that there is sufficient evidence of safety and effectiveness to support the use of the investigational drug or investigational device in the case described in paragraph (1); (3) the Secretary determines that provision of the investigational drug or investigational device will not interfere with the initiation, conduct, or completion of clinical investiga- tions to support marketing approval; and (4) the sponsor, or clinical investigator, of the investigational drug or investigational de- Page 415 TITLE 21—FOOD AND DRUGS § 360bbb vice submits to the

Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 360bbb

Stored review status: historical_2024_not_currentness_verified. The source passage cites 21 U.S.C. § 360bbb. This identifies an authority to review, not proof of applicability.

Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 247d — Public health emergencies

**(a) Emergencies** If the Secretary determines, after consultation with such public health officials as may be necessary, that— (1) a disease or disorder presents a public health emergency; or (2) a public health emergency, including significant outbreaks of infectious diseases or bioterrorist attacks, otherwise exists, the Secretary may take such action as may be appropriate to respond to the public health emergency, including making grants, providing awards for expenses, and entering into contracts and conducting and supporting investigations into the cause, treatment, or prevention of a disease or disorder as described in paragraphs (1) and (2). Any such determination of a public health emergency terminates upon the Secretary declaring that the emergency no longer exists, or upon the expiration of the 90-day period beginning on the date on which the determination is made by the Secretary, whichever occurs first. Determinations that terminate under the preceding sentence may be renewed by the Secretary (on the basis of the same or additional facts), and the preceding sentence applies to each such renewal. Not later than 48 hours after making a determination under this subsection of a public health emergency (including a renewal), the Secretary shall submit to the Congress written notification of the determination. **(b) Public Health Emergency Fund** (1) **In general** — There is established in the Treasury a fund to be designated as the “Public Health Emergency Fund” to be made available to the Secretary without fiscal year limitation to carry out subsection (a) only if a public health emergency has been declared by the Secretary under such subsection or if the Secretary determines there is the significant potential for a public health emergency, to allow the Se

Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 247d

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 262 — Regulation of biological products

**(a) Biologics license** (1) No person shall introduce or deliver for introduction into interstate commerce any biological product unless— (A) a biologics license under this subsection or subsection (k) is in effect for the biological product; and (B) each package of the biological product is plainly marked with— (i) the proper name of the biological product contained in the package; (ii) the name, address, and applicable license number of the manufacturer of the biological product; and (iii) the expiration date of the biological product. (2) (A) The Secretary shall establish, by regulation, requirements for the approval, suspension, and revocation of biologics licenses. (B) *Pediatric studies.—* — A person that submits an application for a license under this paragraph shall submit to the Secretary as part of the application any assessments required under section 505B of the Federal Food, Drug, and Cosmetic Act [[21 U.S.C. 355c](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c&num=0&edition=prelim)]. (C) The Secretary shall approve a biologics license application— (i) on the basis of a demonstration that— (I) the biological product that is the subject of the application is safe, pure, and potent; and (II) the facility in which the biological product is manufactured, processed, packed, or held meets standards designed to assure that the biological product continues to be safe, pure, and potent; and (ii) if the applicant (or other appropriate person) consents to the inspection of the facility that is the subject of the application, in accordance with subsection (c). (D) *Postmarket studies and clinical trials; labeling; risk evaluation and mitigation strategy.—* — A person that sub

Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 262

Stored review status: release_metadata_unconfirmed. The source passage cites 42 U.S.C. § 262. This identifies an authority to review, not proof of applicability.

Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 262 — Regulation of biological products

§ 262. Regulation of biological products (a) Biologics license (1) No person shall introduce or deliver for in- troduction into interstate commerce any bio- logical product unless— (A) a biologics license under this subsection or subsection (k) is in effect for the biological product; and (B) each package of the biological product is plainly marked with— (i) the proper name of the biological prod- uct contained in the package; (ii) the name, address, and applicable li- cense number of the manufacturer of the bi- ological product; and (iii) the expiration date of the biological product. (2)(A) The Secretary shall establish, by regula- tion, requirements for the approval, suspension, and revocation of biologics licenses. (B) PEDIATRIC STUDIES.—A person that submits an application for a license under this paragraph shall submit to the Secretary as part of the ap- plication any assessments required under sec- tion 505B of the Federal Food, Drug, and Cos- metic Act [21 U.S.C. 355c]. (C) The Secretary shall approve a biologics li- cense application— (i) on the basis of a demonstration that— (I) the biological product that is the sub- ject of the application is safe, pure, and po- tent; and (II) the facility in which the biological product is manufactured, processed, packed, or held meets standards designed to assure that the biological product continues to be safe, pure, and potent; and (ii) if the applicant (or other appropriate person) consents to the inspection of the facil- ity that is the subject of the application, in accordance with subsection (c). (D) POSTMARKET STUDIES AND CLINICAL TRIALS; LABELING; RISK EVALUATION AND MITIGATION STRATEGY.—A person that submits an applica- tion for a license under this paragraph is subject to sections 505(o)

Source: Supplied 2024 U.S. Code historical extraction · 42 U.S.C. § 262

Stored review status: historical_2024_not_currentness_verified. The source passage cites 42 U.S.C. § 262. This identifies an authority to review, not proof of applicability.

Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 5121 — Congressional findings and declarations

**(a)** The Congress hereby finds and declares that— (1) because disasters often cause loss of life, human suffering, loss of income, and property loss and damage; and (2) because disasters often disrupt the normal functioning of governments and communities, and adversely affect individuals and families with great severity; special measures, designed to assist the efforts of the affected States in expediting the rendering of aid, assistance, and emergency services, and the reconstruction and rehabilitation of devastated areas, are necessary. **(b)** It is the intent of the Congress, by this chapter, to provide an orderly and continuing means of assistance by the Federal Government to State and local governments in carrying out their responsibilities to alleviate the suffering and damage which result from such disasters by— (1) revising and broadening the scope of existing disaster relief programs; (2) encouraging the development of comprehensive disaster preparedness and assistance plans, programs, capabilities, and organizations by the States and by local governments; (3) achieving greater coordination and responsiveness of disaster preparedness and relief programs; (4) encouraging individuals, States, and local governments to protect themselves by obtaining insurance coverage to supplement or replace governmental assistance; (5) encouraging hazard mitigation measures to reduce losses from disasters, including development of land use and construction regulations; (6) providing Federal assistance programs for both public and private losses sustained in disasters; and (7) identifying and improving the climate and natural hazard resilience of vulnerable communities.

Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 5121

Stored review status: release_metadata_unconfirmed. The source passage cites 42 U.S.C. § 5121. This identifies an authority to review, not proof of applicability.

Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 5121 — Congressional findings and declarations

§ 5121. Congressional findings and declarations (a) The Congress hereby finds and declares that— (1) because disasters often cause loss of life, human suffering, loss of income, and property loss and damage; and (2) because disasters often disrupt the nor- mal functioning of governments and commu- nities, and adversely affect individuals and families with great severity; special measures, designed to assist the efforts of the affected States in expediting the ren- dering of aid, assistance, and emergency serv- ices, and the reconstruction and rehabilitation of devastated areas, are necessary. (b) It is the intent of the Congress, by this chapter, to provide an orderly and continuing means of assistance by the Federal Government to State and local governments in carrying out their responsibilities to alleviate the suffering and damage which result from such disasters by— (1) revising and broadening the scope of ex- isting disaster relief programs; (2) encouraging the development of com- prehensive disaster preparedness and assist- ance plans, programs, capabilities, and organi- zations by the States and by local govern- ments; (3) achieving greater coordination and re- sponsiveness of disaster preparedness and re- lief programs; (4) encouraging individuals, States, and local governments to protect themselves by obtain- ing insurance coverage to supplement or re- place governmental assistance; (5) encouraging hazard mitigation measures to reduce losses from disasters, including de- velopment of land use and construction regu- lations; (6) providing Federal assistance programs for both public and private losses sustained in disasters; and (7) identifying and improving the climate and natural hazard resilience of vulnerable communities. (Pub. L.

Source: Supplied 2024 U.S. Code historical extraction · 42 U.S.C. § 5121

Stored review status: historical_2024_not_currentness_verified. The source passage cites 42 U.S.C. § 5121. This identifies an authority to review, not proof of applicability.