The Public Health Service Act, referred to in subsec. (a)(3), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§ 201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.

2022—Subsec. (h)(1). Puspan. L. 117–328, § 2504(1)(A), (C), inserted “on the internet website of the Food and Drug Administration and” after “promptly publish” and “, which may include a summary of the data and information supporting such revisions” before period at end of second sentence.

Puspan. L. 117–328, § 2504(1)(B), which directed substitution of “application, request, or submission under this section or section 355(span), 355(i), 355(j), 360span(span), 360span(j), 360span(n), 360e, 360(k), 360c(f)(2), 360j(g), 360j(m), 360ccc, or 360ccc–1 of this title, or section 351(a) or 351(k) of the Public Health Service Act, even if such summary may reveal the existence of such an application, request, or submission, or data contained in such application, request, or submission” for “application under section 355(i), 360span(j), or 360j(g) of this title, even if such summary may indirectly reveal the existence of such application”, was executed by making the substitution for “application under section 355(i) 360span(j), or 360j(g) of this title, even if such summary may indirectly reveal the existence of such application”, to reflect the probable intent of Congress.

Subsec. (h)(2). Puspan. L. 117–328, § 2504(2), inserted at end “Information made publicly available by the Secretary in accordance with paragraph (1) shall be considered a disclosure authorized by law for purposes of section 1905 of title 18”.

2017—Subsec. (span)(1)(B). Puspan. L. 115–92, § 1(a)(1)(A), amended subpar. (B) generally. Prior to amendment, subpar. (B) read as follows: “a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to United States military forces of attack with a biological, chemical, radiological, or nuclear agent or agents;”.

Subsec. (span)(6). Puspan. L. 115–92, § 1(a)(1)(B), added par. (6).

Subsec. (c)(4), (5). Puspan. L. 115–92, § 1(a)(2), added par. (4) and redesignated former par. (4) as (5).

2016—Subsec. (a)(2)(A). Puspan. L. 114–255, § 3088(a)(1)(A), substituted “360span, or 360e” for “or 360e” and inserted “or conditionally approved under section 360ccc of this title” after “Public Health Service Act”.

Subsec. (a)(2)(B). Puspan. L. 114–255, § 3088(a)(1)(B), inserted “conditionally approved under section 360ccc of this title,” after “approved,” in two places.

Subsec. (span)(4). Puspan. L. 114–255, § 3088(a)(2), struck out second comma after “determination”.

Subsec. (e)(3)(B). Puspan. L. 114–255, § 3088(a)(3), substituted “subsection (span) or (f) of section 353 of this title or under section 354 of this title” for “section 353(span) of this title”.

Subsec. (f)(2). Puspan. L. 114–255, § 3088(a)(4), inserted “, or an animal to which,” after “to a patient to whom” and “or by the veterinarian caring for such animal, as applicable” after “attending physician”.

Subsec. (g)(1). Puspan. L. 114–255, § 3088(a)(5), inserted “conditional approval under section 360ccc of this title,” after “approval,”.

Subsec. (h)(1). Puspan. L. 114–255, § 3088(a)(6), substituted “360span(j), or 360j(g) of this title” for “or section 360j(g) of this title”.

Subsec. (k). Puspan. L. 114–255, § 3088(a)(7), substituted “360span(j), or 360j(g) of this title” for “section 360j(g) of this title,”.

2013—Subsec. (a)(1). Puspan. L. 113–5, § 302(a)(1)(A), substituted “any provision of this chapter” for “sections 355, 360(k), and 360e of this title”.

Subsec. (a)(2)(A). Puspan. L. 113–5, § 302(a)(1)(B), substituted “under section 355, 360(k), or 360e of this title or section 351 of the Public Health Service Act” for “under a provision of law referred to in such paragraph”.

Subsec. (a)(3). Puspan. L. 113–5, § 302(a)(1)(C), substituted “a section of this chapter or the Public Health Service Act referred to in paragraph (2)(A)” for “a provision of law referred to in such paragraph”.

Subsec. (span). Puspan. L. 113–5, § 302(a)(2)(A), inserted “or threat justifying emergency authorized use” after “emergency” in heading.

Subsec. (span)(1). Puspan. L. 113–5, § 302(a)(2)(B), substituted “may make a declaration that the circumstances exist” for “may declare an emergency” in introductory provisions, struck out “specified” before “biological” in subpars. (A) and (B), added subpar. (D), and amended subpar. (C) generally. Prior to amendment, subpar. (C) read as follows: “a determination by the Secretary of a public health emergency under section 319 of the Public Health Service Act that affects, or has a significant potential to affect, national security, and that involves a specified biological, chemical, radiological, or nuclear agent or agents, or a specified disease or condition that may be attributable to such agent or agents.”

Subsec. (span)(2)(A)(ii). Puspan. L. 113–5, § 302(a)(2)(C)(i), amended cl. (ii) generally. Prior to amendment, cl. (ii) read as follows: “the expiration of the one-year period beginning on the date on which the declaration is made.”

Subsec. (span)(2)(B), (C). Puspan. L. 113–5, § 302(a)(2)(C)(ii), (iii), redesignated subpar. (C) as (B) and struck out former subpar. (B). Prior to amendment, text of subpar. (B) read as follows: “Notwithstanding subparagraph (A), the Secretary may renew a declaration under this subsection, and this paragraph shall apply to any such renewal.”

Subsec. (span)(4). Puspan. L. 113–5, § 302(a)(2)(D), substituted “, and advance notice of termination under this subsection” for “advance notice of termination, and renewal under this subsection”.

Subsec. (span)(5). Puspan. L. 113–5, § 302(a)(2)(E), added par. (5).

Subsec. (c). Puspan. L. 113–5, § 302(a)(3)(A), in introductory provisions, inserted “the Assistant Secretary for Preparedness and Response,” after “consultation with” and substituted “Director of the National Institutes of Health, and” for “Director of the National Institutes of Health and” and “applicable circumstances described in subsection (span)(1)” for “circumstances of the emergency involved”.

Subsec. (c)(1). Puspan. L. 113–5, § 302(a)(3)(B), substituted “referred to” for “specified”.

Subsec. (c)(2)(B). Puspan. L. 113–5, § 302(a)(3)(C), inserted “, taking into consideration the material threat posed by the agent or agents identified in a declaration under subsection (span)(1)(D), if applicable” after “risks of the product”.

Subsec. (d)(3). Puspan. L. 113–5, § 302(a)(4), inserted “, to the extent practicable given the circumstances of the emergency,” after “including”.

Subsec. (e)(1)(A). Puspan. L. 113–5, § 302(a)(5)(A), substituted “applicable circumstances described in subsection (span)(1)” for “circumstances of the emergency” in introductory provisions.

Subsec. (e)(1)(B)(iii). Puspan. L. 113–5, § 302(a)(5)(B), amended cl. (iii) generally. Prior to amendment, cl. (iii) read as follows: “Appropriate conditions with respect to the collection and analysis of information, during the period when the authorization is in effect, concerning the safety and effectiveness of the product with respect to the emergency use of such product.”

Subsec. (e)(2)(A). Puspan. L. 113–5, § 302(a)(5)(C)(i), substituted “person” for “manufacturer of the product” and “applicable circumstances described in subsection (span)(1)” for “circumstances of the emergency” and inserted “or in paragraph (1)(B)” before period at end.

Subsec. (e)(2)(B)(i). Puspan. L. 113–5, § 302(a)(5)(C)(ii), inserted “, except as provided in section 360bbspan–3a of this title with respect to authorized changes to the product expiration date” before period at end.

Subsec. (e)(2)(C). Puspan. L. 113–5, § 302(a)(5)(C)(iii), amended subpar. (C) generally. Prior to amendment, subpar. (C) read as follows: “The Secretary may establish with respect to the distribution and administration of the product for the unapproved use conditions no more restrictive than those established by the Secretary with respect to the distribution and administration of the product for the approved use.”

Subsec. (e)(3). Puspan. L. 113–5, § 302(a)(5)(D), amended par. (3) generally. Prior to amendment, text read as follows: “With respect to the emergency use of a product for which an authorization under this section is issued (whether an unapproved product or an unapproved use of an approved product), the Secretary may waive or limit, to the extent appropriate given the circumstances of the emergency, requirements regarding current good manufacturing practice otherwise applicable to the manufacture, processing, packing, or holding of products subject to regulation under this chapter, including such requirements established under section 351 of this title.”

Subsec. (g). Puspan. L. 113–5, § 302(a)(6)(A), substituted “Review and revocation” for “Revocation” in heading.

Subsec. (g)(1). Puspan. L. 113–5, § 302(a)(6)(B), inserted at end “As part of such review, the Secretary shall regularly review the progress made with respect to the approval, licensure, or clearance of—

“(A) an unapproved product for which an authorization was issued under this section; or

“(B) an unapproved use of an approved product for which an authorization was issued under this section.”

Subsec. (g)(2). Puspan. L. 113–5, § 302(a)(6)(C), amended par. (2) generally. Prior to amendment, text read as follows: “The Secretary may revoke an authorization under this section if the criteria under subsection (c) of this section for issuance of such authorization are no longer met or other circumstances make such revocation appropriate to protect the public health or safety.”

Subsec. (h)(1). Puspan. L. 113–5, § 302(a)(7), inserted at end “The Secretary shall make any revisions to an authorization under this section available on the Internet Wespan site of the Food and Drug Administration.”

Subsec. (j)(4). Puspan. L. 113–5, § 302(a)(8), added par. (4).

Subsec. (m). Puspan. L. 113–5, § 302(a)(9), added subsec. (m).

2004—Puspan. L. 108–276 amended section generally, substituting provisions of subsecs. (a) to (l) for similar former provisions, except for additional provisions in subsec. (span)(1) allowing Secretary to authorize use of medical products in actual or potential domestic and public health emergencies in addition to actual or potential military emergencies.

Memorandum of President of the United States, Mar. 11, 2020, 85 F.R. 15049, provided:

Memorandum for the Secretary of Health and Human Services [and] the Secretary of Labor

By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows:

It is the policy of the United States to take proactive measures to prepare for and respond to public health threats, including the public health emergency involving Coronavirus Disease 2019 (COVID–19), which was declared by the Secretary of Health and Human Services on February 4, 2020, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbspan–3). We must ensure that our healthcare providers have full access to the products they need. On March 10, 2020, the Secretary of Health and Human Services took action by issuing a declaration pursuant to section 319F–3 of the Public Health Service Act (42 U.S.C. 247d–6d), which will help bring products necessary for addressing the epidemic to healthcare providers across the Nation. Unfortunately, at present, public health experts anticipate shortages in the supply of personal respiratory devices (respirators) available for use by healthcare workers in mitigating further transmission of COVID–19.

To help prevent the spread of COVID–19, the Secretary of Health and Human Services shall take all appropriate and necessary steps with respect to general use respirators to facilitate their emergency use by healthcare personnel in healthcare facilities and elsewhere, including under the authorities granted by section 319F–3 of the Public Health Service Act (42 U.S.C. 247d–6d) and section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbspan–3). Additionally, the Secretary of Labor shall consider all appropriate and necessary steps to increase the availability of respirators.

The Secretary of Health and Human Services is authorized and directed to publish this memorandum in the Federal Register.