---
kind: "section"
citation: "21 U.S.C. § 379d–4"
title: "21"
title_heading: "Food and Drugs"
number: "379d–4"
heading: "Reporting requirements"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/379d-4"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter VII — General Authority"
  - "Part A — General Administrative Provisions"
---

# §379d–4. Reporting requirements

- (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](/usc/21/321.md?p=d) shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and [Commerce](/usc/21/360hh.md?p=4) of the House of Representatives a report concerning, for all applications for approval of a generic [drug](/usc/21/321.md?p=g-1) under [section 355(j) of this title](/usc/21/355.md?p=j), 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](/usc/21/321.md?p=d) 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](/usc/21/360hh.md?p=4) of the House of Representatives, as set forth in the Congressional Record;
  - (2) the average total time to decision by the [Secretary](/usc/21/321.md?p=d) for applications for approval of a generic [drug](/usc/21/321.md?p=g-1) under [section 355(j) of this title](/usc/21/355.md?p=j), 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](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration and the number of calendar days spent by the [sponsor](/usc/21/360fff.md?p=8) responding to a complete response letter;
  - (3) the total number of applications under [section 355(j) of this title](/usc/21/355.md?p=j), amendments to such applications, and prior approval supplements with respect to such applications that were pending with the [Secretary](/usc/21/321.md?p=d) for more than 10 months on July 9, 2012; and
  - (4) the number of applications described in [paragraph (3)](#a-3) on which the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) 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](/usc/21/321.md?p=d) shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and [Commerce](/usc/21/360hh.md?p=4) of the House of Representatives a report concerning—
    - (A) the number of applications for approval filed under [section 262(k) of title 42](/usc/42/262.md?p=k); and
    - (B) the percentage of applications described in [subparagraph (A)](#b-1-A) that were approved by the [Secretary](/usc/21/321.md?p=d).
  - (2) **Additional information—** As part of the performance report described in [paragraph (1)](#b-1), the [Secretary](/usc/21/321.md?p=d) shall include an explanation of how the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration is managing the biological [product](/usc/21/360eee.md?p=13) review program to ensure that the user fees collected under subpart 2[^1] are not used to review an application under [section 262(k) of title 42](/usc/42/262.md?p=k).

## Footnotes

[^1]: So in original. Probably means subpart 2 of part C.

## Source credit

(June 25, 1938, ch. 675, § 715, as added and amended Pub. L. 112–144, title III, § 308, title IV, § 408, July 9, 2012, 126 Stat. 1025, 1039.)

## Notes

### Editorial Notes

### Amendments

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

### Statutory Notes and Related Subsidiaries

### Effective Date of 2012 Amendment

Amendment 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.