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Title 21, Food and DrugsRelease 119-73not60

§356–1 Accelerated Approval of Priority Countermeasures

Title 21 › Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices › § 356–1

Last updated Apr 5, 2026|Official source

Summary

The Health and Human Services Secretary can call a priority countermeasure a fast-track drug or give a device priority review under section 356 or section 360e(d)(5). The Secretary can do this before the company asks for it or before an investigational application is filed under sections 355(i) or 262(a)(3). A drug seeking approval under sections 355(b) or 262 based on animal-study evidence under section 1231 can also get fast-track status. A priority countermeasure that is a drug or biological product will be treated as a priority product for FDA performance goals agreed with the Commissioner of Food and Drugs. priority countermeasure — defined in section 247d–6(h)(4) of title 42. priority drugs or biological products — drugs or biologics covered by an application described in section 101(4) of the Food and Drug Administration Modernization Act of 1997.

Full Legal Text

Title 21, §356–1

Food and Drugs, Source: USLM XML via OLRC

(a)The Secretary of Health and Human Services may designate a priority countermeasure as a fast-track product pursuant to section 356 of this title or as a device granted review priority pursuant to section 360e(d)(5) 11 See References in Text note below. of this title. Such a designation may be made prior to the submission of—
(1)a request for designation by the sponsor or applicant; or
(2)an application for the investigation of the drug under section 355(i) of this title or section 262(a)(3) of title 42.
(b)A drug for which approval is sought under section 355(b) of this title or section 262 of title 42 on the basis of evidence of effectiveness that is derived from animal studies pursuant to section 123 1 may be designated as a fast track product for purposes of this section.
(c)A priority countermeasure that is a drug or biological product shall be considered a priority drug or biological product for purposes of performance goals for priority drugs or biological products agreed to by the Commissioner of Food and Drugs.
(d)For purposes of this title: 1
(1)The term “priority countermeasure” has the meaning given such term in section 247d–6(h)(4) 1 of title 42.
(2)The term “priority drugs or biological products” means a drug or biological product that is the subject of a drug or biologics application referred to in section 101(4) of the Food and Drug Administration Modernization Act of 1997.

Legislative History

Notes & Related Subsidiaries

Editorial Notes

References in Text

section 360e(d)(5) of this title, referred to in subsec. (a), was struck out and former subsec. (d)(6) redesignated subsec. (d)(5) of section 360e by Pub. L. 114–255, div. A, title III, § 3051(c)(1), Dec. 13, 2016, 130 Stat. 1124. section 360e(d)(5) no longer relates to grants of review priority. section 123, referred to in subsec. (b), is section 123 of Pub. L. 107–188, title I,
June 12, 2002, 116 Stat. 613, which is not classified to the Code. This title, referred to in subsec. (d), is title I of Pub. L. 107–188,
June 12, 2002, 116 Stat. 596, which enacted this section, section 669a of Title 29, Labor, and section 244, 245, 247d–3a, 247d–3b, 247d–7a to 247d–7d, 300hh, 300hh–11 to 300hh–13, 1320b–5, and 7257d of Title 42, The Public Health and Welfare, amended sections 247d to 247d–6, 264, 266, 290hh–1, and 5196b of Title 42, and enacted provisions set out as notes preceding section 8101 of Title 38, Veterans’ Benefits, and under section 201, 244, 247d, 247d–6, 300hh, 300hh–12, and 1320b–5 of Title 42. For complete classification of this title to the Code, see Tables. section 247d–6(h)(4) of title 42, referred to in subsec. (d)(1), was redesignated section 247d–6(e)(4) by Pub. L. 109–417, title III, § 304(3), Dec. 19, 2006, 120 Stat. 2861. section 101(4) of the Food and Drug Administration Modernization Act of 1997, referred to in subsec. (d)(2), is section 101(4) of Pub. L. 105–115, which is set out as a note under section 379g of this title. Codification Section was enacted as part of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

Reference

Citations & Metadata

Citation

21 U.S.C. § 356–1

Title 21, Food and Drugs

Last Updated

Apr 5, 2026

Release point: 119-73not60