Public health emergencies

a disease or disorder presents a public health emergency; or a public health emergency, including significant outbreaks of infectious diseases or bioterrorist attacks, otherwise exists, 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 Secretary to rapidly respond to the immediate needs resulting from such public health emergency or potential public health emergency. The Secretary shall plan for the expedited distribution of funds to appropriate agencies and entities. There is authorized to be appropriated to the Fund such sums as may be necessary. facilitate coordination between and among Federal, State, local, Tribal, and territorial entities and public and private health care entities that the Secretary determines may be affected by a public health emergency or potential public health emergency referred to in paragraph (1) (including communication of such entities with relevant international entities, as applicable); make grants, provide for awards, enter into contracts, and conduct supportive investigations pertaining to a public health emergency or potential public health emergency, including further supporting programs under section 247d–3a, 247d–3b, or 247d–3c of this title; facilitate and accelerate, as applicable, advanced research and development of security countermeasures (as defined in section 247d–6b of this title), qualified countermeasures (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); strengthen biosurveillance capabilities and laboratory capacity to identify, collect, and analyze information regarding such public health emergency or potential public health emergency, including the systems under section 247d–4 of this title; support initial emergency operations and assets related to preparation and deployment of intermittent disaster response personnel under section 300hh–11 of this title and the Medical Reserve Corps under section 300hh–15 of this title; support the initial deployment and distribution of contents of the Strategic National Stockpile, as appropriate; and carry out other activities, as the Secretary determines applicable and appropriate. the amount obligated; the recipient or recipients of such obligated funds; the specific response activities such obligated funds will support; and the declared or potential public health emergency for which such funds were obligated; and each public health emergency for which the expenditures were made and the activities undertaken with respect to each emergency which was conducted or supported by expenditures from the Fund. 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 Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives on policies to improve such Fund for the uses described in paragraph (2). conduct a review of the Fund under this section, including its uses and the resources available in the Fund; and 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 on such review, including recommendations related to such review, as applicable. Funds appropriated under this section shall be used to rapidly respond to public health emergencies or potential public health emergencies and supplement and not supplant other Federal, State, and local public funds provided for activities under this chapter or funds otherwise provided for emergency response. In any case in which the Secretary determines that, wholly or partially as a result of a public health emergency that has been determined pursuant to subsection (a), individuals or public or private entities are unable to comply with deadlines for the submission to the Secretary of data or reports required under any law administered by the Secretary, the Secretary may, notwithstanding any other provision of law, grant such extensions of such deadlines as the circumstances reasonably require, and may waive, wholly or partially, any sanctions otherwise applicable 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 Register a notice of the extension or waiver. Notwithstanding any other provision of law, and subject to paragraph (2), upon request by the Governor of a State or a tribal organization or such Governor or tribal organization’s designee, the Secretary may authorize the requesting State or Indian tribe to temporarily reassign, for purposes of immediately addressing a public health emergency in the State or Indian tribe, State and local public health department or agency personnel funded in whole or in part through programs authorized under this chapter, as appropriate. The Secretary may authorize a temporary reassignment of personnel under paragraph (1) only during the period of a public health emergency determined pursuant to subsection (a). 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. An assurance that the public health emergency would be addressed more efficiently and effectively through the requested temporary reassignment of State and local personnel described in paragraph (1). 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. each Federal program from which personnel would be temporarily reassigned pursuant to the requested authority; and the number of personnel who would be so reassigned from each such program. Such other information and assurances upon which the Secretary and Governor of a State or tribal organization agree. In reviewing a request for temporary reassignment under paragraph (1), the Secretary shall consider the degree to which the program or programs funded in whole or in part by programs authorized under this chapter would be adversely affected by the reassignment. The Secretary’s determination that the public health emergency no longer exists. Subject to clause (ii), the expiration of the 30-day period following the date on which the Secretary approved the State or Indian tribe’s request for such reassignment flexibility. the State or Indian tribe that submitted the initial request for a temporary reassignment of personnel submits a request for an extension of such temporary reassignment; and the request for an extension contains the same information and assurances necessary for the approval of an initial request for such temporary reassignment pursuant to subparagraph (B). shall have the opportunity to volunteer for temporary reassignment; and shall not be required to agree to a temporary reassignment. The Secretary may not condition the award of a grant, contract, or cooperative agreement under this chapter on the requirement that a State or Indian tribe require that personnel eligible for reassignment pursuant to an authorization under paragraph (1) agree to such reassignment. any initial request for temporary reassignment of personnel; and any request for an extension of such temporary reassignment. not later than 6 months after March 13, 2013, issue proposed guidance on the temporary reassignment of personnel under this subsection; and after providing notice and a 60-day period for public comment, finalize such guidance. a description of how, and under what circumstances, such temporary reassignment has been used by States and Indian tribes; an analysis of how such temporary reassignment has assisted States and Indian tribes in responding to public health emergencies; an evaluation of how such temporary reassignment has improved operational efficiencies in responding to public health emergencies; 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 recommendations on how medical surge capacity could be improved in responding to public health emergencies and the impact of the reassignment flexibility under this section on such surge capacity. the terms “Indian tribe” and “tribal organization” have the meanings given such terms in section 5304 of title 25; and 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. This subsection shall terminate on January 30, 2026. the criteria set forth for a public health emergency under paragraph (1) or (2) of subsection (a) has been met; or a disease or disorder, including a novel and emerging public health threat, is significantly likely to become a public health emergency; and the circumstances of such public health emergency, or potential for such significantly likely public health emergency, including the specific preparation for and response to such public health emergency or threat, necessitate a waiver from the requirements of subchapter I of chapter 35 of title 44 (commonly referred to as the Paperwork Reduction Act), 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 anticipated 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. 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. Upon determining that the circumstances necessitating a waiver under paragraph (1) no longer exist, the Secretary shall promptly update the Internet website of the Department of Health and Human Services to reflect the termination of such 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 requirements of this subsection. 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 chapter 35 of title 44 and the Secretary shall ensure that compliance with such requirements occurs in as timely a manner as possible based on the applicable circumstances, but not to exceed 30 calendar days after the expiration of the applicable waiver. address a critical hiring need directly related to responding to a public health emergency declared by the Secretary under this section; or address a severe shortage of candidates that impacts the operational capacity of the Department of Health and Human Services to respond in the event of a public health emergency declared by the Secretary under this section. 400 individuals under paragraph (1)(A); and 100 individuals under paragraph (1)(B). The annual rate of basic pay of an individual appointed under this subsection shall be determined in accordance with chapter 51 and subchapter III of chapter 53 of title 5. the number of positions filled through such authority; the types of appointments of such positions; the titles, occupational series, and grades of such positions; the number of positions publicly noticed to be filled under such authority; the number of qualified applicants who apply for such positions; the qualification criteria for such positions; and the demographic information of individuals appointed to such positions. information on each such appointment within such fiscal year; a description of how each such position relates to the requirements of subparagraph (A) or (B) of paragraph (1); and the additional number of personnel, if any, the Secretary anticipates to be necessary 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. Not later than September 30, 2023, and annually 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 appointments filled under this subsection within the fiscal year and a description of how the positions relate to the requirements of subparagraph (A) or (B) of paragraph (1). The authority under this subsection shall expire on September 30, 2028. the deployment of the contents of the stockpile in response to State, local, and Tribal requests; the amount of such products that remain within the stockpile following such deployment; and plans to replenish such products, as appropriate, including related timeframes and any barriers or limitations to replenishment. 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 otherwise 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. conduct activities to enhance, expand, and improve nationwide COVID–19 vaccine distribution and administration, including activities related to distribution of ancillary medical products and supplies related to vaccines; and the distribution and administration of vaccines 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; the establishment and expansion, including staffing support, of community vaccination centers, particularly in underserved areas; the deployment of mobile vaccination units, particularly in underserved areas; information technology, standards-based data, and reporting enhancements, including improvements 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; facilities enhancements; communication with the public regarding when, where, and how to receive COVID–19 vaccines; and transportation of individuals to facilitate vaccinations, including at community vaccination centers and mobile vaccination units, particularly for underserved populations. The term ‘base formula’ means the allocation formula that applied to the Public Health Emergency Preparedness cooperative agreement in fiscal year 2020. The term ‘alternative 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). Not later than 21 days after the date of enactment of this Act [Mar. 11, 2021], the Secretary shall, out of amounts described in subsection (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. the amount the State, locality, or territory received, or would receive, under the base formula; and the amount the State, locality, or territory would receive under the alternative allocation.” 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 otherwise appropriated, $47,800,000,000, to remain available until expended, to carry out activities to detect, diagnose, trace, and monitor SARS–CoV–2 and COVID–19 infections and related strategies to mitigate the spread of COVID–19. implement a national, evidence-based strategy for testing, contact tracing, surveillance, and mitigation with respect to SARS–CoV–2 and COVID–19, including through activities authorized under section 319(a) of the Public Health Service Act [42 U.S.C. 247d(a)]; provide technical assistance, guidance, and support, and award grants or cooperative agreements to State, local, and territorial public health departments 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; support for the development, manufacture, procurement, and distribution of supplies necessary for administering tests, such as personal protective equipment; and support for the acquisition, construction, alteration, or renovation of non-federally owned facilities for the production of diagnostics and ancillary medical products and supplies where the Secretary determines that such an investment is necessary to ensure the production of sufficient amounts of such supplies; academic and research laboratories, or other laboratories that could be used for processing of COVID–19 testing; community-based testing sites and community-based organizations; or mobile health units, particularly in medically underserved areas; and with respect to quarantine and isolation of contacts; enhance information technology, data modernization, and reporting, including improvements necessary to support sharing of data related to public health capabilities; award grants to, or enter into cooperative agreements or contracts with, State, local, and territorial public health departments to establish, expand, and sustain a public health workforce; and to cover administrative and program support costs necessary to conduct activities related to subparagraph (a).” The Secretary of Health and Human Services (referred to in this section as the ‘Secretary’) 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 declared by the Secretary under section 319 of the Public Health Service Act (42 U.S.C. 247d) with respect to COVID–19. In carrying out subsection (a), the Secretary may enter into contracts with one or more public or private nonprofit entities, to establish a national blood donation awareness campaign that may include television, radio, internet, and newspaper public service announcements, and other activities to provide for public and professional awareness and education. 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 Prevention, the Director of the National Institutes of Health, and the heads of other relevant Federal agencies, and relevant accrediting bodies and representative organizations. a description of the activities carried out under subsection (a); a description of trends in blood supply donations; and an evaluation of the impact of the public awareness campaign, including any geographic or population variations.” 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. The Secretary may prescribe which laboratories must submit reports pursuant to this section. The Secretary may make prescriptions under this section by regulation, including by interim final rule, or by guidance, and may issue such regulations or guidance without regard to the procedures otherwise required by section 553 of title 5, United States Code.” If the Secretary determines, after consultation with such public health officials as may be necessary, that— The Secretary may use amounts in the Fund established under paragraph (1), to— Not later than 90 days after the end of each fiscal year, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Commerce and the Committee on Appropriations of the House of Representatives a report describing— the expenditures made from the Public Health Emergency Fund in such fiscal year, including— Not later than 4 years after June 24, 2019, the Comptroller General of the United States shall— To seek authority for a temporary reassignment of personnel under paragraph (1), the Governor of a State or a tribal organization shall submit to the Secretary a request for such reassignment flexibility and shall include in the request each of the following: An identification of— A State or Indian tribe’s temporary reassignment of personnel under paragraph (1) shall terminate upon the earlier of the following: 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— Unless otherwise provided under the law or regulation of the State or Indian tribe that receives authorization for temporary reassignment of personnel under paragraph (1), personnel eligible for reassignment pursuant to such authorization— The Secretary shall give notice to the Congress in conjunction with the approval under this subsection of— The Secretary shall— 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— In this subsection— If the Secretary determines, after consultation with such public health officials as may be necessary, that— In order to support the initial response to a public health emergency declared by the Secretary under this section, the Secretary may, subject to paragraph (2) and without regard to sections 3309 through 3318 of title 5, appoint individuals directly to positions in the Department of Health and Human Services for which the Secretary has provided public notice in order to— 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 appoint not more than— The Secretary shall establish and maintain records regarding the use of the authority under this subsection, including— In the event the Secretary, within a single fiscal year, directly appoints more than 50 percent 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 protects personal privacy, to the extent required by applicable Federal and State privacy law, at a minimum, include— The Secretary shall, not later than 30 days after the deployment of contents of the Strategic 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 disaster declared by the President under the Robert T. Stafford Disaster Relief and Emergency Assistance Act [42 U.S.C. 5121 et seq.], and every 30 days thereafter until the expiration or termination of such public health emergency, emergency, 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 Appropriations of the House of Representatives on— The Secretary, acting through the Director of the Centers for Disease Control and Prevention, and in consultation with other agencies, as applicable, shall, in conducting activities referred to in subsection (a)— provide technical assistance, guidance, and support to, and award grants or cooperative agreements to, State, local, Tribal, and territorial public health departments for enhancement of COVID–19 vaccine distribution and administration capabilities, including— In this subsection: The amount of supplemental funding provided under this subsection shall be equal to the difference between— From amounts appropriated by subsection (a), the Secretary shall— support the development, manufacturing, procurement, distribution, and administration of tests to detect or diagnose SARS–CoV–2 and COVID–19, including through— establish and expand Federal, State, local, and territorial testing and contact tracing capabilities, including— through investments in laboratory capacity, such as— 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— (Source: (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; Pub. L. 119–4, div. B, title I, § 2103(a), Mar. 15, 2025, 139 Stat. 41; Pub. L. 119–37, div. F, title I, § 6103(a), Nov. 12, 2025, 139 Stat. 630.))