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21 U.S.C. § 379d–3 — Streamlined hiring authority
Federal law — U.S. Code and appendices · legal_authorities
**(a) In general** 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) Activities described** 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section379i/9&num=0&edition=prelim)); and
(2) activities under this chapter related to human generic drug activities (as defined in [section 379j–41 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section379j-41&num=0&edition=prelim)).
**(c) Objectives specified** 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section379j–1/a/1&num=0&edition=prelim); and
(2) with respect to the activities under subsection (b)(2), the goals referred to in [section 379j–43(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section379j–43/a&num=0&edition=prelim).
**(d) Internal controls** The Secretary shall institute appropriate internal controls for appointments under this section.
**(e) Sunset** The authority to appoint employees under this section shall terminate on the dat
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Stable record: federal_law:legal_authorities:record_usc_410561d6c66bc79a4144f18e
Source file: Laws/federal/codes/united-states-code/title-21/section-379d3-streamlined-hiring-authority--b2511f0f38.md
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Source location: Title 21, Chapter 9, § 379d–3; chapter-009-federal-food-drug-and-cosmetic-act.md
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**(a) In general** 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) Activities described** 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section379i/9&num=0&edition=prelim)); and
(2) activities under this chapter related to human generic drug activities (as defined in [section 379j–41 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section379j-41&num=0&edition=prelim)).
**(c) Objectives specified** 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section379j–1/a/1&num=0&edition=prelim); and
(2) with respect to the activities under subsection (b)(2), the goals referred to in [section 379j–43(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section379j–43/a&num=0&edition=prelim).
**(d) Internal controls** The Secretary shall institute appropriate internal controls for appointments under this section.
**(e) Sunset** The authority to appoint employees under this section shall terminate on the date that is 3 years after July 9, 2012.
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Federal law — U.S. Code and appendices · legal_authorities
For purposes of this subpart:
(1) The term “premarket application” means—
(A) an application for approval of a device submitted under [section 360e(c) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360e/c&num=0&edition=prelim) or [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim); or
(B) a product development protocol described in [section 360e(f) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360e/f&num=0&edition=prelim).
Such term does not include a supplement, a premarket report, or a premarket notification submission.
(2) The term “premarket report” means a report submitted under [section 360e(c)(2) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360e/c/2&num=0&edition=prelim).
(3) The term “premarket notification submission” means a report submitted under [section 360(k) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360/k&num=0&edition=prelim).
(4)
(A) The term “supplement”, with respect to a panel-track supplement, a 180-day supplement, a real-time supplement, or an efficacy supplement, means a request to the Secretary to approve a change in a device for which—
(i) an application or report has been approved under [section 360e(d) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360e/d&num=0&edition=prelim), or an application has been approved under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim); or
(ii) a notice of completion has become effective under [section 360e(f) o
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 379i
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