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Title 21, Food and DrugsRelease 119-73not60

§379d–3 Streamlined Hiring Authority

Title 21 › Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part A— General Administrative Provisions › § 379d–3

Last updated Apr 5, 2026|Official source

Summary

The Secretary can hire people for the FDA without following the usual federal competitive hiring rules when those hires are needed to meet specific goals. Device review activities means work on reviewing device applications. Human generic drug activities means work on programs for human generic drugs. The goals to be met are the ones in section 379j–1(a)(1) for devices and section 379j–43(a) for generic drugs. The Secretary must create proper internal controls for these hires. The special hiring authority ends on the date that is 3 years after July 9, 2012.

Full Legal Text

Title 21, §379d–3

Food and Drugs, Source: USLM XML via OLRC

(a)In addition to any other personnel authorities under other provisions of law, the Secretary may, without regard to the provisions of title 5 governing appointments in the competitive service, appoint employees to positions in the Food and Drug Administration to perform, administer, or support activities described in subsection (b), if the Secretary determines that such appointments are needed to achieve the objectives specified in subsection (c).
(b)The activities described in this subsection are—
(1)activities under this chapter related to the process for the review of device applications (as defined in section 379i(9) of this title); and
(2)activities under this chapter related to human generic drug activities (as defined in section 379j–41 of this title).
(c)The objectives specified in this subsection are—
(1)with respect to the activities under subsection (b)(1), the goals referred to in section 379j–1(a)(1) of this title; and
(2)with respect to the activities under subsection (b)(2), the goals referred to in section 379j–43(a) of this title.
(d)The Secretary shall institute appropriate internal controls for appointments under this section.
(e)The authority to appoint employees under this section shall terminate on the date that is 3 years after July 9, 2012.

Legislative History

Notes & Related Subsidiaries

Editorial Notes

Amendments

2017—Subsec. (b)(1). Pub. L. 115–52 substituted “379i(9)” for “379i(8)”. 2012—Subsec. (b). Pub. L. 112–144, § 307(1), amended subsec. (b) generally. Prior to amendment, text read as follows: “The activities described in this subsection are activities under this chapter related to the process for the review of device applications (as defined in section 379i(8) of this title).” Subsec. (c). Pub. L. 112–144, § 307(2), amended subsec. (c) generally. Prior to amendment, text read as follows: “The objectives specified in this subsection are with respect to the activities under subsection (b), the goals referred to in section 379j–1(a)(1) of this title.”

Statutory Notes and Related Subsidiaries

Effective Date

of 2017 AmendmentAmendment by Pub. L. 115–52 effective Oct. 1, 2017, with fees under subpart 3 of part C of this subchapter to be assessed for all submissions listed in section 379j(a)(2)(A) of this title received on or after Oct. 1, 2017, see section 209 of Pub. L. 115–52, set out as a note under section 379i of this title.

Effective Date

of 2012 AmendmentAmendment by section 307 of Pub. L. 112–144 effective Oct. 1, 2012, see section 305 of Pub. L. 112–144, set out as an Effective and Termination Dates note under section 379j–41 of this title.

Effective Date

Section effective Oct. 1, 2012, see section 206 of Pub. L. 112–144, set out as an

Effective Date

of 2012 Amendment note under section 379i of this title.

Reference

Citations & Metadata

Citation

21 U.S.C. § 379d–3

Title 21, Food and Drugs

Last Updated

Apr 5, 2026

Release point: 119-73not60