§360bbb–3. Authorization for medical products for use in emergencies — Inbound Citations
21 U.S.C. § 360bbb–3
Code of Federal Regulations Citations
Cited by 8 regulations in the Code of Federal Regulations.
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The definitions in § 54.9816-3T apply to §§ 54.9825-4T through 54.9825-6T unless otherwise specified. In addition, for purposes of §§ 54.9825-4T through 54.9825-6T, the following definitions apply:
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For purposes of this section, the following definitions apply in addition to the definitions in § 2590.716-3:
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(ii) For services furnished on or after January 1 of the year following the year in which the Secretary ends the March 27, 2020 Emergency Use Authorization declaration for drugs and biologicals (issued at 85 FR 18250) pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3), for administration of a COVID-19 vaccine, an amount equal to the amount that would be paid for the administration of a preventive vaccine described in paragraph (h)(1) of this section.
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For purposes of this subpart, the following definitions apply in addition to the definitions in § 149.30:
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(i) If a communicable disease has triggered an ongoing declaration of a public health emergency under Federal law, such as under section 319 of the Public Health Service Act, 42 U.S.C. 247d, or section 564 of the Food, Drug, and Cosmetic Act, 21 U.S.C. 360bbb-3, then an alien is ineligible for asylum under section 208 of the Act on the basis of there being reasonable grounds for regarding the alien as a danger to the security of the United States under section 208(b)(2)(A)(iv) of the Act if the alien—(A) Exhibits symptoms indicating that he or she is afflicted with the disease, per guidance issued by the Secretary or the Attorney General, as appropriate, or(B) Has come into contact with the disease within the number of days equivalent to the longest known incubation and contagion period for the disease, per guidance issued by the Secretary or the Attorney General, as appropriate.
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(ii) If a communicable disease has triggered an ongoing declaration of a public health emergency under Federal law, such as under section 319 of the Public Health Service Act, 42 U.S.C. 247d, or section 564 of the Food, Drug, and Cosmetic Act, 21 U.S.C. 360bbb-3, then an alien is ineligible for withholding of removal under section 241(b)(3) of the Act and under the regulations issued pursuant to the legislation implementing the Convention Against Torture on the basis of there being reasonable grounds for regarding the alien as a danger to the security of the United States under section 241(b)(3)(B)(iv) of the Act if the alien—(A) Exhibits symptoms indicating that he or she is afflicted with the disease, per guidance issued by the Secretary or the Attorney General, as appropriate; or(B) Has come into contact with the disease within the number of days equivalent to the longest known incubation and contagion period for the disease, per guidance issued by the Secretary or the Attorney General, as appropriate.
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(i) If a communicable disease has triggered an ongoing declaration of a public health emergency under Federal law, such as under section 319 of the Public Health Service Act, 42 U.S.C. 247d, or section 564 of the Food, Drug, and Cosmetic Act, 21 U.S.C. 360bbb-3, then an alien is ineligible for asylum under section 208 of the Act on the basis of there being reasonable grounds for regarding the alien as a danger to the security of the United States under section 208(b)(2)(A)(iv) of the Act if the alien:(A) Exhibits symptoms indicating that he or she is afflicted with the disease, per guidance issued by the Secretary or the Attorney General, as appropriate, or(B) Has come into contact with the disease within the number of days equivalent to the longest known incubation and contagion period for the disease, per guidance issued by the Secretary or the Attorney General, as appropriate.
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(ii) If a communicable disease has triggered an ongoing declaration of a public health emergency under Federal law, such as under section 319 of the Public Health Service Act, 42 U.S.C. 247d, or section 564 of the Food, Drug, and Cosmetic Act, 21 U.S.C. 360bbb-3, then an alien is ineligible for withholding of removal under section 241(b)(3) of the Act and under the regulations issued pursuant to the legislation implementing the Convention Against Torture on the basis of there being reasonable grounds for regarding the alien as a danger to the security of the United States under section 241(b)(3)(B)(iv) of the Act if the alien:(A) Exhibits symptoms indicating that he or she is afflicted with the disease, per guidance issued by the Secretary or the Attorney General, as appropriate; or(B) Has come into contact with the disease within the number of days equivalent to the longest known incubation and contagion period for the disease, per guidance issued by the Secretary or the Attorney General, as appropriate.
United States Code Citations
Cited by 32 provisions in release 119-102.
Citations to 21 U.S.C. § 360bbb–3 as a whole
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(D) Each refusal by such a member of a vaccine on the basis that the vaccine is being administered by a health care provider of the Department pursuant to an emergency use authorization granted by the Commissioner of Food and Drugs under section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3).
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(e) The refusal to permit access to or copying of any record as required by section 350a, 350c, 350f(j), 350e, 354, 360bbb–3, 364a, 373, 374(a), 379aa, or 379aa–1 of this title; or the failure to establish or maintain any record, or make any report, required under section 350a, 350c(b), 350f, 350e, 354, 355(i) or (k), 360b(a)(4)(C), 360b(j), (l) or (m), 360ccc–1(i), 360e(f), 360i, 360bbb–3, 364a, 364g, 379aa, 379aa–1, 387i, or 387t of this title or the refusal to permit access to or verification or copying of any such required record; or the violation of any recordkeeping requirement under section 22232 of this title (except when such violation is committed by a farm).
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(i) Nothing in this section shall be construed to affect the authority of the Secretary on March 27, 2020, to expedite the review of devices under section 360e of this title, section 360e–3 of this title relating to the priority review program for devices, and section 360bbb–3 of this title relating to the emergency use authorization authorities.
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(f) The Secretary shall, consistent with applicable standards for approval, authorization, or licensure under this chapter and section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)], allow the sponsor of an application under section 355(b) of this title or section 351(a) of the Public Health Service Act or a request for emergency use authorization under section 360bbb–3 of this title, in order to support approval, licensure, or authorization, to reference or rely upon data and information within an application or request for a drug or biological product that incorporates or utilizes the same platform technology designated under subsection (d), provided that—(1) such data and information was submitted by the same sponsor, pursuant to the application for the drug with respect to which designation of the designated platform technology under subsection (d) was granted; or(2) the sponsor relying on such data and information received a right of reference to such data and information from the sponsor described in paragraph (1).
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(D) there is in effect an authorization pursuant to section 360bbb–3 of this title with respect to such use or intended use of such drug, and such drug, its labeling, and such use conform to any conditions of such authorization.
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(C) is authorized for use under section 360bbb–3 of this title or section 360bbb–3a of this title.
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(B) feedback from the Secretary regarding the data necessary to inform any authorization under section 360bbb–3 of this title;
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(G) as necessary and appropriate, and to the extent practicable, a plan for demonstrating safety and effectiveness in pediatric populations, and for developing pediatric dosing, formulation, and administration with respect to the eligible countermeasure, provided that such plan would not delay authorization under section 360bbb–3 of this title, approval, licensure, or clearance for adults.
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(5) the number of countermeasure applications and submissions submitted, the number of countermeasures approved, licensed, or cleared, the status of remaining submitted applications and submissions, and the number of each type of authorization issued pursuant to section 360bbb–3 of this title;
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(1) For purposes of conducting evaluations regarding whether an in vitro diagnostic product (as defined in section 809.3 of title 21, Code of Federal Regulations (or any successor regulations)) for which a request for emergency use authorization is submitted under section 360bbb–3 of this title meets the criteria for issuance of such authorization, the Secretary may, as appropriate, consult with persons with appropriate expertise with respect to such evaluations or enter into cooperative agreements or contracts with such persons under which such persons conduct such evaluations and make such recommendations, including, as appropriate, evaluations and recommendations regarding the scope of authorization and conditions of authorization.
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(A) In evaluating and making recommendations to the Secretary regarding the validity, accuracy, and reliability of in vitro diagnostic products, as described in paragraph (1), a person shall consider and document whether the relevant criteria under subsection (c)(2) of section 360bbb–3 of this title for issuance of authorization under such section are met with respect to the in vitro diagnostic product.
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(3) Nothing in this subsection shall be construed to require the Secretary to consult with, or enter into cooperative agreements or contracts with, persons as described in paragraph (1) for purposes of authorizing an in vitro diagnostic product or otherwise affecting the emergency use authorization authorities under this section or section 360bbb–3 of this title.
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(3) alter the authority of the Secretary under this Act [this chapter] or the Public Health Service Act [42 U.S.C. 201 et seq.] to determine the types of data or information previously submitted by a sponsor or any other person that may be incorporated by reference in an application, request, or notification for a drug, biological product, or device submitted under sections 355(i), 355(b), 355(j), 360b(b)(1), 360b(b)(2), 360b(j), 360bbb–3, 360ccc, 360j(g), 360e(c), 360c(f)(2), or 360(k) of this title, or subsection (a) or (k) of section 351 of the Public Health Service Act [42 U.S.C. 262], including a supplement or amendment to any such submission, and the requirements associated with such reference.
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(2) The term “medical countermeasure submission” means an investigational new drug application under section 355(i) of this title, a new drug application under section 355(b) of this title, or an abbreviated new drug application under section 355(j) of this title, a biological product license application under section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] or a biosimilar biological product license application under section 351(k) of the Public Health Service Act [42 U.S.C. 262(k)], a new animal drug application under section 360b(b)(1) of this title or abbreviated new animal drug application under section 360b(b)(2) of this title, an application for conditional approval of a new animal drug under section 360ccc of this title, an investigational device application under section 360j(g) of this title, an application with respect to a device under section 360e(c) of this title, a request for classification of a device under section 360c(f)(2) of this title, a notification with respect to a device under section 360(k) of this title, or a request for an emergency use authorization under section 360bbb–3 of this title to support—(A) the approval, licensure, classification, clearance, conditional approval, or authorization of a security countermeasure, qualified countermeasure, or qualified pandemic or epidemic product; or(B) a new indication to an approved security countermeasure, qualified countermeasure, or qualified pandemic or epidemic product.
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(k) For a device authorized for emergency use under section 360bbb–3 of this title for which, in accordance with section 360bbb–3(m) of this title, the Secretary has deemed a laboratory examination or procedure associated with such device to be in the category of examinations and procedures described in section 263a(d)(3) of title 42, the sponsor of such device may, when submitting a request for classification under subsection (f)(2), submit a single submission containing—(1) the information needed for such a request; and(2) sufficient information to enable the Secretary to determine whether such laboratory examination or procedure satisfies the criteria to be categorized under section 263a(d)(3) of title 42.
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(1) Beginning after the issuance of final guidance implementing this paragraph, presubmissions and submissions for devices under section 360(k), 360c(f)(2)(A), 360e(c), 360e(d), 360e(f), 360j(g), 360j(m), or 360bbb–3 of this title or section 262 of title 42, and any supplements to such presubmissions or submissions, shall include an electronic copy of such presubmissions or submissions.
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(ii) is authorized for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360bbb–3].
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(i) The term “enforcement action” means a criminal prosecution, an action seeking an injunction, a seizure action, a civil monetary proceeding based on willful misconduct, a mandatory recall of a product because voluntary recall was refused, a proceeding to compel repair or replacement of a product, a termination of an exemption under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(i), 360j(g)], a debarment proceeding, an investigator disqualification proceeding where an investigator is an employee or agent of the manufacturer, a revocation, based on willful misconduct, of an authorization under section 564 of such Act [21 U.S.C. 360bbb–3], or a suspension or withdrawal, based on willful misconduct, of an approval or clearance under chapter V of such Act [21 U.S.C. 351 et seq.] or of a licensure under section 262 of this title.
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(I) that is a criminal conviction, an injunction, or a condemnation, a civil monetary payment, a product recall, a repair or replacement of a product, a termination of an exemption under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(i), 360j(g)], a debarment, an investigator disqualification, a revocation of an authorization under section 564 of such Act [21 U.S.C. 360bbb–3], or a suspension or withdrawal of an approval or clearance under chapter 51 of such Act or of a licensure under section 262 of this title; and
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(C) a drug (as such term is defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)), biological product (as such term is defined by section 262(i) of this title), or device (as such term is defined by section 201(h) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 321(h)) that is authorized for emergency use in accordance with section 564, 564A, or 564B of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360bbb–3, 360bbb–3a, 360bbb–3b]; or
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(iii) authorized for emergency use in accordance with section 564, 564A, or 564B of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360bbb–3, 360bbb–3a, 360bbb–3b].
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(J) identify the use of authority and activities undertaken pursuant to sections 247d–6a(b)(1), 247d–6a(b)(2), 247d–6a(b)(3), 247d–6a(c), 247d–6a(d), 247d–6a(e), 247d–6b(c)(7)(C)(iii), 247d–6b(c)(7)(C)(iv), and 247d–6b(c)(7)(C)(v) of this title, and subsections (a)(1), (b)(1), and (e) of section 564 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360bbb–3], by summarizing—(i) the particular actions that were taken under the authorities specified, including, as applicable, the identification of the threat agent, emergency, or the biomedical countermeasure with respect to which the authority was used;(ii) the reasons underlying the decision to use such authorities, including, as applicable, the options that were considered and rejected with respect to the use of such authorities;(iii) the number of, nature of, and other information concerning the persons and entities that received a grant, cooperative agreement, or contract pursuant to the use of such authorities, and the persons and entities that were considered and rejected for such a grant, cooperative agreement, or contract, except that the report need not disclose the identity of any such person or entity;(iv) whether, with respect to each procurement that is approved by the President under section 247d–6b(c)(6) of this title, a contract was entered into within one year after such approval by the President; and(v) with respect to section 247d–6a(d) of this title, for the 2-year period for which the report is submitted, the number of persons who were paid amounts totaling $100,000 or greater and the number of persons who were paid amounts totaling at least $50,000 but less than $100,000; and
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(C) for the period beginning on December 29, 2022, and ending on December 31, 2026, an oral antiviral drug that may be dispensed only upon a prescription and is authorized under section 360bbb–3 of title 21, on the basis of the declaration published in the Federal Register by the Secretary of Health and Human Services on April 1, 2020 (85 Fed. Reg. 18250 et seq.),
Citations to §360bbb–3(a)(2)(A)
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(3) Notwithstanding any other provision of this chapter or the Public Health Service Act [42 U.S.C. 201 et seq.], an eligible product shall not be considered an unapproved product (as defined in section 360bbb–3(a)(2)(A) of this title) and shall not be deemed adulterated or misbranded under this chapter because, with respect to such product, the Secretary has, under paragraph (1), extended the expiration date and authorized the introduction or delivery for introduction into interstate commerce of such product after the expiration date provided by the manufacturer.
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(2) Notwithstanding any other provision of this chapter or the Public Health Service Act [42 U.S.C. 201 et seq.], an eligible product shall not be considered an unapproved product (as defined in section 360bbb–3(a)(2)(A) of this title) and shall not be deemed adulterated or misbranded under this chapter because, with respect to such product, the Secretary has authorized deviations from current good manufacturing practices under paragraph (1).
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(d) The requirements of subsections (b) and (f) of section 353, section 354, and section 360j(e) of this title shall not apply to an eligible product, and the product shall not be considered an unapproved product (as defined in section 360bbb–3(a)(2)(A) of this title) and shall not be deemed adulterated or misbranded under this chapter because it is dispensed without an individual prescription, if—(1) the product is dispensed during the circumstances described in subsection (a)(1)(C); and(2) such dispensing without an individual prescription occurs—(B) in accordance with an order issued by the Secretary, for the purposes and duration of the circumstances described in subsection (a)(1)(C).
Citations to §360bbb–3(a)(4)
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It is not a violation of any section of this chapter or of the Public Health Service Act [42 U.S.C. 201 et seq.] for a government entity (including a Federal, State, local, or tribal government entity), or a person acting on behalf of such a government entity, to introduce into interstate commerce a product (as defined in section 360bbb–3(a)(4) of this title) intended for emergency use, if that product—
Citations to §360bbb–3(b)(1)
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(1) a determination described in subparagraph (A), (B), or (C) of section 360bbb–3(b)(1) of this title has been made by the Secretary of Homeland Security, the Secretary of Defense, or the Secretary, respectively; or
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(2) the identification of a material threat described in subparagraph (D) of section 360bbb–3(b)(1) of this title has been made pursuant to section 247d–6b of title 42.
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(i) a determination described in subparagraph (A), (B), or (C) of section 360bbb–3(b)(1) of this title has been made by the Secretary of Homeland Security, the Secretary of Defense, or the Secretary, respectively; or
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(ii) the identification of a material threat described in subparagraph (D) of section 360bbb–3(b)(1) of this title has been made pursuant to section 319F–2 of the Public Health Service Act [42 U.S.C. 247d–6b].
Citations to §360bbb–3(m)
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(k) For a device authorized for emergency use under section 360bbb–3 of this title for which, in accordance with section 360bbb–3(m) of this title, the Secretary has deemed a laboratory examination or procedure associated with such device to be in the category of examinations and procedures described in section 263a(d)(3) of title 42, the sponsor of such device may, when submitting a request for classification under subsection (f)(2), submit a single submission containing—(1) the information needed for such a request; and(2) sufficient information to enable the Secretary to determine whether such laboratory examination or procedure satisfies the criteria to be categorized under section 263a(d)(3) of title 42.