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Title 21, Food and DrugsRelease 119-110

§379d–4 Reporting Requirements

Title 21 › CHAPTER 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT › SUBCHAPTER VII — GENERAL AUTHORITY › Part A — General Administrative Provisions › § 379d–4

Last updated Sep 23, 2026|Official source

Summary

The Secretary must send yearly reports to the Senate Committee on Health, Education, Labor, and Pensions and the House Committee on Energy and Commerce about certain drug application reviews. For generic drugs, from fiscal year 2013 through fiscal year 2017, the report is due within 120 days after the fiscal year ends for years when fees were collected under the FDA’s relevant user-fee program (subpart 7 of part C). The report must say: how many applications met the performance goals set in the Secretary’s letters; the average total time to a decision, including days the FDA spent reviewing and days the sponsor spent answering a complete response letter; how many applications were pending more than 10 months on July 9, 2012; and how many of those got final FDA action in the prior fiscal year. Starting with fiscal year 2014, and due within 120 days after the fiscal year ends when fees were collected under subpart 8 of part C, the Secretary must also report the number of biosimilar applications filed under 42 U.S.C. 262(k) and the percentage approved. That report must also explain how the FDA manages reviews so that user fees collected under subpart 2 are not used to review 262(k) applications.

Full Legal Text

Title 21, §379d–4

Food and Drugs, Source: USLM XML via OLRC

(a)Generic drugs
Beginning with fiscal year 2013 and ending after fiscal year 2017, not later than 120 days after the end of each fiscal year for which fees are collected under subpart 7 of part C, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report concerning, for all applications for approval of a generic drug under section 355(j) of this title, amendments to such applications, and prior approval supplements with respect to such applications filed in the previous fiscal year—
(1)the number of such applications that met the goals identified for purposes of subpart 7 of part C, in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record;
(2)the average total time to decision by the Secretary for applications for approval of a generic drug under section 355(j) of this title, amendments to such applications, and prior approval supplements with respect to such applications filed in the previous fiscal year, including the number of calendar days spent during the review by the Food and Drug Administration and the number of calendar days spent by the sponsor responding to a complete response letter;
(3)the total number of applications under section 355(j) of this title, amendments to such applications, and prior approval supplements with respect to such applications that were pending with the Secretary for more than 10 months on July 9, 2012; and
(4)the number of applications described in paragraph (3) on which the Food and Drug Administration took final regulatory action in the previous fiscal year.
(b)Biosimilar biological products
(1)In general
Beginning with fiscal year 2014, not later than 120 days after the end of each fiscal year for which fees are collected under subpart 8 of part C, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report concerning—
(A)the number of applications for approval filed under section 262(k) of title 42; and
(B)the percentage of applications described in subparagraph (A) that were approved by the Secretary.
(2)Additional information
As part of the performance report described in paragraph (1), the Secretary shall include an explanation of how the Food and Drug Administration is managing the biological product review program to ensure that the user fees collected under subpart 2 are not used to review an application under section 262(k) of title 42.

Legislative History

Notes & Related Subsidiaries

Editorial Notes

Amendments

2012—Subsec. (b). Pub. L. 112–144, § 408, added subsec. (b).

Statutory Notes and Related Subsidiaries

Effective Date

of 2012 AmendmentAmendment by section 408 of Pub. L. 112–144 effective Oct. 1, 2012, see section 405 of Pub. L. 112–144, set out as an Effective and Termination Dates note under section 379j–51 of this title.

Effective Date

Section 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.

Reference

Citations & Metadata

Citation

21 U.S.C. § 379d–4

Title 21, Food and Drugs

Last Updated

Sep 23, 2026

Release point: 119-110