21 U.S.C. § 379d–3 — Streamlined hiring authority
submitted 88 years ago by Pub. L. 112-144 to r/title-21-FOOD-AND-DRUGS · 214 words · no verdicts yet
This law lets the FDA hire staff faster, skipping normal competitive-service rules. It only applies to jobs supporting device application reviews or generic drug programs. The Secretary must set internal controls, and this hiring power ended three years after July 9, 2012.
This section gives the FDA a faster way to hire staff for two specific programs, for a limited time.
(a) In general. Besides any other hiring power under other laws, the Secretary* may appoint employees to FDA positions without following title 5's usual competitive-service appointment rules, to perform, run, or support the activities described in (b), if the Secretary decides such appointments are needed to reach the goals described in (c).
(b) Activities described. Those activities are: (1) activities under this chapter tied to reviewing device applications, as defined in section 379i(9) of this title; and (2) activities under this chapter tied to human generic drug* work, as defined in section 379j–41 of this title.
(c) Objectives specified. The goals are: (1) for the device-review activities in (b)(1), the goals referred to in section 379j–1(a)(1) of this title; and (2) for the generic-drug activities in (b)(2), the goals referred to in section 379j–43(a) of this title.
(d) Internal controls. The Secretary must set up appropriate internal controls for appointments made under this section.
(e) Sunset. This hiring authority ended three years after July 9, 2012.
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).
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(9) of this title); and
activities under this chapter related to human generic drug activities (as defined in section 379j–41 of this title).
The objectives specified in this subsection are—
with respect to the activities under subsection (b)(1), the goals referred to in section 379j–1(a)(1) of this title; and
with respect to the activities under subsection (b)(2), the goals referred to in section 379j–43(a) of this title.
The Secretary shall institute appropriate internal controls for appointments under this section.
The authority to appoint employees under this section shall terminate on the date that is 3 years after July 9, 2012.
Source credit: (June 25, 1938, ch. 675, § 714, as added and amended Pub. L. 112–144, title II, § 208, title III, § 307, July 9, 2012, 126 Stat. 1007, 1025; Pub. L. 115–52, title II, § 202(b), Aug. 18, 2017, 131 Stat. 1013.)
- 1938Enacted · Pub. L. 112-144 · 126 Stat. 1007, 1025
- 2017Amended · Pub. L. 115-52 · 131 Stat. 1013
A history note hasn’t been published yet. The record shows enactment by Pub. L. 112-144 on 1938-06-25.
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