§397 — Title 21 Food and Drugs | U.S. Code

Summary

The Secretary may hire outside experts or organizations (not Department employees) to review part or all of any application or request, such as petitions or notifications, for approval or classification under this chapter or under section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)) for a biological product. Any contract must follow the confidentiality rules in section 379 of this title. The Secretary can use outside reviewers when doing so will make reviews faster or better, unless it would lower quality or unduly raise costs. Extra scientific or technical help can be used for new therapies and technologies. The FDA official responsible for the matter must review the outside expert’s recommendations and make the final decision in a timely way. The decision must meet the time limits set in this chapter or in the Public Health Service Act (42 U.S.C. 201 et seq.).

Title 21, §397

Food and Drugs — Source: USLM XML via OLRC

(a)(1)The Secretary may enter into a contract with any organization or any individual (who is not an employee of the Department) with relevant expertise, to review and evaluate, for the purpose of making recommendations to the Secretary on, part or all of any application or submission (including a petition, notification, and any other similar form of request) made under this chapter for the approval or classification of an article or made under section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)) with respect to a biological product. Any such contract shall be subject to the requirements of section 379 of this title relating to the confidentiality of information.

(2)The Secretary may use the authority granted in paragraph (1) whenever the Secretary determines that use of a contract described in paragraph (1) will improve the timeliness of the review of an application or submission described in paragraph (1), unless using such authority would reduce the quality, or unduly increase the cost, of such review. The Secretary may use such authority whenever the Secretary determines that use of such a contract will improve the quality of the review of an application or submission described in paragraph (1), unless using such authority would unduly increase the cost of such review. Such improvement in timeliness or quality may include providing the Secretary increased scientific or technical expertise that is necessary to review or evaluate new therapies and technologies.

(b)(1)Subject to paragraph (2), the official of the Food and Drug Administration responsible for any matter for which expert review is used pursuant to subsection (a) shall review the recommendations of the organization or individual who conducted the expert review and shall make a final decision regarding the matter in a timely manner.

(2)A final decision by the Secretary on any such application or submission shall be made within the applicable prescribed time period for review of the matter as set forth in this chapter or in the Public Health Service Act (42 U.S.C. 201 et seq.).

Notes & Related Subsidiaries

Editorial Notes

References in Text

The Public Health Service Act, referred to in subsec. (b)(2), 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.

Statutory Notes and Related Subsidiaries

Effective Date

Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an

Effective Date

of 1997 Amendment note under section 321 of this title.

§397 Contracts for expert review

Summary

Title 21, §397

Notes & Related Subsidiaries

Editorial Notes

References in Text

Short Title

Statutory Notes and Related Subsidiaries

Effective Date

Effective Date

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