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

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

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Source location: Title 42, Chapter 6A, § 247d; chapter-6a-public-health-service.md

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**(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 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. (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 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); (B) 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; (C) facilitate and accelerate, as applicable, advanced research and development of security countermeasures (as defined in [section 247d–6b of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section247d-6b&num=0&edition=prelim)), qualified countermeasures (as defined in [section 247d–6a of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section247d-6a&num=0&edition=prelim)), or qualified pandemic or epidemic products (as defined in [section 247d–6d of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section247d-6d&num=0&edition=prelim)), 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 public health emergency or potential public health emergency, including the systems under [section 247d–4 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section247d-4&num=0&edition=prelim); (E) support initial emergency operations and assets related to preparation and deployment of intermittent disaster response personnel under [section 300hh–11 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section300hh-11&num=0&edition=prelim) and the Medical Reserve Corps under [section 300hh–15 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section300hh-15&num=0&edition=prelim); (F) support the initial deployment and distribution of contents of the Strategic National Stockpile, as appropriate; and (G) carry out other activities, as the Secretary determines applicable and appropriate. (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, 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— (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 obligated 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 supported 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 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). (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 resources available in the Fund; and (B) 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. **(c) Supplement not supplant** 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. **(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 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. **(e) Temporary reassignment of State and local personnel during a public health emergency** (1) **Emergency reassignment of federally funded personnel** — 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. (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 subsection (a). (B) *Contents of request* — 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: (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 efficiently and effectively through the requested 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section247d-3a&num=0&edition=prelim). (iv) An identification of— (I) each Federal program from which personnel would be temporarily reassigned pursuant to the requested authority; and (II) the number of personnel who would be so reassigned from each such program. (v) Such other information and assurances upon which the Secretary and Governor of a State or tribal organization agree. (C) *Consideration* — 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. (D) *Termination and extension* (i) *Termination* — A State or Indian tribe’s temporary reassignment of personnel under paragraph (1) shall terminate upon the earlier of the following: (I) The Secretary’s determination that the public health emergency no longer exists. (II) 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. (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 submitted the initial request for a temporary reassignment of personnel submits a request for an extension of such temporary reassignment; and (II) 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). (3) **Voluntary nature of temporary reassignment 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 reassignment of personnel under paragraph (1), personnel eligible for reassignment pursuant to such authorization— (i) shall have the opportunity to volunteer 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 requirement that a State or Indian tribe require that personnel eligible for reassignment pursuant to an authorization under paragraph (1) agree to such reassignment. (4) **Notice to Congress** — The Secretary shall give notice to the Congress in conjunction with the approval under this subsection of— (A) any initial request for temporary reassignment 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 temporary reassignment of personnel under this subsection; and (B) after providing notice and a 60-day period for public comment, finalize such guidance. (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 reassignment has been used by States and Indian tribes; (B) an analysis of how such temporary reassignment has assisted States and Indian tribes in responding to public health emergencies; (C) an evaluation of how such temporary reassignment has improved operational efficiencies in responding to public health emergencies; (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 responding to public health emergencies and the impact 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title25-section5304&num=0&edition=prelim); and (B) the term “State” includes, in addition to the entities listed in the definition of such term in [section 201 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section201&num=0&edition=prelim), the Freely Associated States. (8) **Sunset** — This subsection shall terminate on January 30, 2026. **(f) Determination with respect to Paperwork Reduction Act waiver during a public health emergency** (1) **Determination** — If the Secretary determines, after consultation 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 significantly likely to become a public health emergency; and (B) 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), then the requirements of such subchapter I with respect to voluntary collection of information shall not be applicable during the immediate investigation of, and response to, such public health emergency during the period of such public health emergency or the period of time necessary to determine if a disease or disorder, including a novel and emerging public health threat, will become a public health emergency as provided for in this paragraph. The requirements of such subchapter I with respect to voluntary collection of information shall not be applicable during the immediate postresponse review regarding such public health emergency if such immediate postresponse review does not exceed a reasonable 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 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. (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 update the Internet website of the Department of Health and Human Services to reflect the termination 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 requirements 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 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. **(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 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— (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 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 appoint 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 determined in accordance with chapter 51 and subchapter 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 positions; (C) the titles, occupational series, and grades of such positions; (D) the number of positions publicly noticed to be filled under such authority; (E) the number of qualified applicants who apply for such positions; (F) the qualification criteria for such positions; and (G) the demographic information of individuals appointed to such positions. (5) **Notification to Congress** — 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— (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 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. (6) **Reports to Congress** — 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). (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 Strategic National Stockpile under [section 247d–6b(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section247d–6b/a&num=0&edition=prelim) 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section5121&num=0&edition=prelim) 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— (1) the deployment of the contents of the stockpile in response to State, local, and Tribal requests; (2) the amount of such products that remain within the stockpile following such deployment; and (3) plans to replenish such products, as appropriate, including related timeframes and any barriers or limitations to replenishment.

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

42 U.S.C. § 254b — Health centers

**(a) “Health center” defined** (1) **In general** — For purposes of this section, the term “health center” means an entity that serves a population that is medically underserved, or a special medically underserved population comprised of migratory and seasonal agricultural workers, the homeless, and residents of public housing, by providing, either through the staff and supporting resources of the center or through contracts or cooperative arrangements— (A) required primary health services (as defined in subsection (b)(1)); and (B) as may be appropriate for particular centers, additional health services (as defined in subsection (b)(2)) necessary for the adequate support of the primary health services required under subparagraph (A); for all residents of the area served by the center (hereafter referred to in this section as the “catchment area”). (2) **Limitation** — The requirement in paragraph (1) to provide services for all residents within a catchment area shall not apply in the case of a health center receiving a grant only under subsection (g), (h), or (i). **(b) Definitions** For purposes of this section: (1) **Required primary health services** (A) *In general* — The term “required primary health services” means— (i) basic health services which, for purposes of this section, shall consist of— (I) health services related to family medicine, internal medicine, pediatrics, obstetrics, or gynecology that are furnished by physicians and where appropriate, physician assistants, nurse practitioners, and nurse midwives; (II) diagnostic laboratory and radiologic services; (III) preventive health services, including— (aa) prenatal and perinatal services; (bb) appropriate cancer screening; (cc) well-chil

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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.

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

25 U.S.C. § 5304 — Authorization of appropriations

**(a) In general** There are authorized to be appropriated such sums as may be necessary to carry out this subchapter. **(b) Availability of appropriations** Notwithstanding any other provision of this chapter, the provision of funds under this chapter shall be subject to the availability of appropriations and the Secretary is not required to reduce funding for programs, projects, or activities serving a tribe in order to make funds available to another tribe or tribal organization under this chapter.

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

42 U.S.C. § 201 — Funding

Beginning with fiscal year 2010, the Secretary shall transfer from the Public Health and Social Services Emergency Fund such sums as may be necessary to carry out this part.

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

21 U.S.C. § 360bbb–3 — Authorization for medical products for use in emergencies

**(a) In general** (1) **Emergency uses** — Notwithstanding any provision of this chapter and section 351 of the Public Health Service Act [[42 U.S.C. 262](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim)], and subject to the provisions of this section, the Secretary may authorize the introduction into interstate commerce, during the effective period of a declaration under subsection (b), of a drug, device, or biological product intended for use in an actual or potential emergency (referred to in this section as an “emergency use”). (2) **Approval status of product** — An authorization under paragraph (1) may authorize an emergency use of a product that— (A) is not approved, licensed, or cleared for commercial distribution under section 355, 360(k), 360b, or 360e of this title or section 351 of the Public Health Service Act [[42 U.S.C. 262](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim)] or conditionally approved under [section 360ccc of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360ccc&num=0&edition=prelim) (referred to in this section as an “unapproved product”); or (B) is approved, conditionally approved under [section 360ccc of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360ccc&num=0&edition=prelim), licensed, or cleared under such a provision, but which use is not under such provision an approved, conditionally approved under [section 360ccc of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360ccc&num=0&edition=prelim), licensed, or cleared use of the product (referred to in this section as an “unapproved use of an approved

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360bbb–3

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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

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

5 U.S.C. § 553 — Rule making

**(a)** This section applies, according to the provisions thereof, except to the extent that there is involved— (1) a military or foreign affairs function of the United States; or (2) a matter relating to agency management or personnel or to public property, loans, grants, benefits, or contracts. **(b)** General notice of proposed rule making shall be published in the Federal Register, unless persons subject thereto are named and either personally served or otherwise have actual notice thereof in accordance with law. The notice shall include— (1) a statement of the time, place, and nature of public rule making proceedings; (2) reference to the legal authority under which the rule is proposed; (3) either the terms or substance of the proposed rule or a description of the subjects and issues involved; and (4) the Internet address of a summary of not more than 100 words in length of the proposed rule, in plain language, that shall be posted on the Internet website under section 206(d) of the E-Government Act of 2002 ([44 U.S.C. 3501](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title44-section3501&num=0&edition=prelim) note) (commonly known as regulations.gov). Except when notice or hearing is required by statute, this subsection does not apply— (A) to interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice; or (B) when the agency for good cause finds (and incorporates the finding and a brief statement of reasons therefor in the rules issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest. **(c)** After notice required by this section, the agency shall give interested persons an opportunity to participate in the rule making through subm

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

10 U.S.C. § 1096 — Military-civilian health services partnership program; medical surge program

**(a) Resources Sharing Agreements.—** The Secretary of Defense may enter into an agreement providing for the sharing of resources between facilities of the uniformed services and facilities of a civilian health care provider or providers that the Secretary contracts with under section 1079, 1086, or 1097 of this title if the Secretary determines that such an agreement would result in the delivery of health care to which covered beneficiaries are entitled under this chapter in a more effective, efficient, or economical manner. **(b) Eligible Resources.—** An agreement entered into under subsection (a) may provide for the sharing of— (1) personnel (including support personnel); (2) equipment; (3) supplies; and (4) any other items or facilities necessary for the provision of health care services. **(c) Computation of Charges.—** A covered beneficiary who is a dependent, with respect to care provided to such beneficiary in facilities of the uniformed services under a sharing agreement entered into under subsection (a), shall pay the charges prescribed by [section 1078 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section1078&num=0&edition=prelim). **(d) Reimbursement for License Fees.—** In any case in which it is necessary for a member of the uniformed services to pay a professional license fee imposed by a government in order to provide health care services at a facility of a civilian health care provider pursuant to an agreement entered into under subsection (a), the Secretary of Defense may reimburse the member for up to $500 of the amount of the license fee paid by the member. **(e) Medical Surge Program.—** (1) The Secretary of Defense, in collaboration with the Secretary of Health and Human Services, shall carry out a p

Source: Supplied U.S. Code snapshot — release unconfirmed · 10 U.S.C. § 1096

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

10 U.S.C. § 1144 — Employment assistance, job training assistance, and other transitional services: Department of Labor

**(a) In General.—** (1) The Secretary of Labor, in conjunction with the Secretary of Defense, the Secretary of Homeland Security, and the Secretary of Veterans Affairs, shall establish and maintain a program to furnish counseling, assistance in identifying employment and training opportunities, help in obtaining such employment and training, and other related information and services to members of the armed forces under the jurisdiction of the Secretary concerned who are being separated from active duty and the spouses of such members. Subject to subsection (f)(2), such services shall be provided to a member within the time periods provided under paragraph (3) of [section 1142(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section1142/a&num=0&edition=prelim), except that the Secretary concerned shall not provide preseparation counseling to a member described in paragraph (4)(A) of such section. (2) The Secretary of Defense, the Secretary of Homeland Security, and the Secretary of Veterans Affairs shall cooperate with the Secretary of Labor in establishing and maintaining the program under this section. (3) The Secretaries referred to in paragraph (1) shall enter into a detailed agreement to carry out this section. **(b) Elements of Program.—** In establishing and carrying out a program under this section, the Secretary of Labor shall do the following: (1) Provide information concerning employment and training assistance, including (A) labor market information, (B) civilian work place requirements and employment opportunities (including apprenticeship programs approved under chapters 30 through 36 of title 38), (C) instruction in resumé preparation, and (D) job analysis techniques, job search techniques, and job interview te

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

15 U.S.C. § 2066 — Imported products

**(a) Refusal of admission** Any consumer product offered for importation into the customs territory of the United States (as defined in general note 2 of the Harmonized Tariff Schedule of the United States) shall be refused admission into such customs territory if such product— (1) fails to comply with an applicable consumer product safety rule; (2) is not accompanied by a certificate required by this chapter or any other Act enforced by the Commission, or is accompanied by a false certificate, if the manufacturer in the exercise of due care has reason to know that the certificate is false or misleading in any material respect, or is not accompanied by any label or certificate (including tracking labels) required under [section 2063 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section2063&num=0&edition=prelim) or any rule or regulation under such section; (3) is or has been determined to be an imminently hazardous consumer product in a proceeding brought under [section 2061 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section2061&num=0&edition=prelim); (4) has a product defect which constitutes a substantial product hazard (within the meaning of section 2064(a)(2)) of this title; or (5) is a product which was manufactured by a person who the Commission has informed the Secretary of the Treasury is in violation of subsection (g). **(b) Samples** The Secretary of the Treasury shall obtain without charge and deliver to the Commission, upon the latter’s request, a reasonable number of samples of consumer products being offered for import. Except for those owners or consignees who are or have been afforded an opportunity for a hearing in a proceeding under [section 2061 of this title](https:

Source: Supplied U.S. Code snapshot — release unconfirmed · 15 U.S.C. § 2066

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