---
kind: "section"
citation: "21 U.S.C. § 379j–31"
title: "21"
title_heading: "Food and Drugs"
number: "379j–31"
heading: "Authority to collect and use fees"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/379j-31"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter VII — General Authority"
  - "Part C — Fees"
  - "Subpart 6 — fees related to food"
---

# §379j–31. Authority to collect and use fees

- (a) **In general—**
  - (1) **Purpose and authority—** For fiscal year 2010 and each subsequent fiscal year, the [Secretary](/usc/21/321.md?p=d) shall, in accordance with this section, assess and collect fees from—
    - (A) the responsible party for each domestic [facility](/usc/21/364.md?p=3-A) (as defined in [section 350d(b)](/usc/21/350d.md?p=b)[^1] of this title) and the United States agent for each foreign [facility](/usc/21/364.md?p=3-A) subject to a reinspection in such fiscal year, to cover reinspection-related costs for such year;
    - (B) the responsible party for a domestic [facility](/usc/21/364.md?p=3-A) (as defined in [section 350d(b)](/usc/21/350d.md?p=b)[^1] of this title) and an importer who does not comply with a recall order under [section 350l](/usc/21/350l.md) of this title or under [section 350a(f) of this title](/usc/21/350a.md?p=f) in such fiscal year, to cover [food](/usc/21/321.md?p=f) recall activities associated with such order performed by the [Secretary](/usc/21/321.md?p=d), including technical assistance, follow-up effectiveness checks, and public notifications, for such year;
    - (C) each importer participating in the voluntary qualified importer program under [section 384b of this title](/usc/21/384b.md) in such year, to cover the administrative costs of such program for such year; and
    - (D) each importer subject to a reinspection in such fiscal year, to cover reinspection-related costs for such year.
  - (2) **Definitions—** For purposes of this section—
    - (A) the term “reinspection” means—
      - (i) with respect to domestic [facilities](/usc/21/364.md?p=3-A) (as defined in [section 350d(b)](/usc/21/350d.md?p=b)[^1] of this title), 1 or more inspections conducted under [section 374 of this title](/usc/21/374.md) subsequent to an inspection conducted under such provision which identified noncompliance materially related to a [food](/usc/21/321.md?p=f) safety requirement of this chapter, specifically to determine whether compliance has been achieved to the [Secretary](/usc/21/321.md?p=d)’s satisfaction; and
      - (ii) with respect to importers, 1 or more examinations conducted under [section 381 of this title](/usc/21/381.md) subsequent to an examination conducted under such provision which identified noncompliance materially related to a [food](/usc/21/321.md?p=f) safety requirement of this chapter, specifically to determine whether compliance has been achieved to the [Secretary](/usc/21/321.md?p=d)’s satisfaction;
    - (B) the term “reinspection-related costs” means all expenses, including administrative expenses, incurred in connection with—
      - (i) arranging, conducting, and evaluating the results of reinspections; and
      - (ii) assessing and collecting reinspection fees under this section; and
    - (C) the term “responsible party” has the meaning given such term in [section 350f(a)(1) of this title](/usc/21/350f.md?p=a-1).
- (b) **Establishment of fees—**
  - (1) **In general—** Subject to subsections [(c)](#c) and [(d)](#d), the [Secretary](/usc/21/321.md?p=d) shall establish the fees to be collected under this section for each fiscal year specified in [subsection (a)(1)](#a-1), based on the methodology described under [paragraph (2)](#b-2), and shall publish such fees in a Federal Register notice not later than 60 days before the start of each such year.
  - (2) **Fee methodology—**
    - (A) **Fees—** Fees amounts established for collection—
      - (i) under [subparagraph (A)](#a-1-A) of subsection (a)(1) for a fiscal year shall be based on the [Secretary](/usc/21/321.md?p=d)’s estimate of 100 percent of the costs of the reinspection-related activities (including by type or level of reinspection activity, as the [Secretary](/usc/21/321.md?p=d) determines applicable) described in such [subparagraph (A)](#b-2-A) for such year;
      - (ii) under [subparagraph (B)](#a-1-B) of subsection (a)(1) for a fiscal year shall be based on the [Secretary](/usc/21/321.md?p=d)’s estimate of 100 percent of the costs of the activities described in such [subparagraph (B)](#b-2-B) for such year;
      - (iii) under [subparagraph (C)](#a-1-C) of subsection (a)(1) for a fiscal year shall be based on the [Secretary](/usc/21/321.md?p=d)’s estimate of 100 percent of the costs of the activities described in such [subparagraph (C)](#a-1-C) for such year; and
      - (iv) under [subparagraph (D)](#a-1-D) of subsection (a)(1) for a fiscal year shall be based on the [Secretary](/usc/21/321.md?p=d)’s estimate of 100 percent of the costs of the activities described in such [subparagraph (D)](#a-1-D) for such year.
    - (B) **Other considerations—**
      - (i) **Voluntary qualified importer program—** In establishing the fee amounts under [subparagraph (A)(iii)](#b-2-A-iii) for a fiscal year, the [Secretary](/usc/21/321.md?p=d) shall provide for the number of importers who have submitted to the [Secretary](/usc/21/321.md?p=d) a notice under [section 384b(c) of this title](/usc/21/384b.md?p=c) informing the [Secretary](/usc/21/321.md?p=d) of the intent of such importer to participate in the program under [section 384b of this title](/usc/21/384b.md) in such fiscal year.
    - (II) **2 Recoupment—** In establishing the fee amounts under [subparagraph (A)(iii)](#b-2-A-iii) for the first 5 fiscal years after January 4, 2011, the [Secretary](/usc/21/321.md?p=d) shall include in such fee a reasonable surcharge that provides a recoupment of the costs expended by the [Secretary](/usc/21/321.md?p=d) to establish and implement the first year of the program under [section 384b of this title](/usc/21/384b.md).
- (ii) **Crediting of fees—** In establishing the fee amounts under subparagraph (A) for a fiscal year, the [Secretary](/usc/21/321.md?p=d) shall provide for the crediting of fees from the previous year to the next year if the [Secretary](/usc/21/321.md?p=d) overestimated the amount of fees needed to carry out such activities, and consider the need to account for any adjustment of fees and such other factors as the [Secretary](/usc/21/321.md?p=d) determines appropriate.
- (iii) **Published guidelines—** Not later than 180 days after January 4, 2011, the [Secretary](/usc/21/321.md?p=d) shall publish in the Federal Register a proposed set of guidelines in consideration of the burden of fee amounts on small business. Such consideration may include reduced fee amounts for small businesses. The [Secretary](/usc/21/321.md?p=d) shall provide for a period of public comment on such guidelines. The [Secretary](/usc/21/321.md?p=d) shall adjust the fee schedule for small businesses subject to such fees only through notice and comment rulemaking.
- (c) **Limitations—**
  - (1) **In general—** Fees under [subsection (a)](#a) shall be refunded for a fiscal year beginning after fiscal year 2010 unless the amount of the total appropriations for [food](/usc/21/321.md?p=f) safety activities at the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) is equal to or greater than the amount of appropriations for [food](/usc/21/321.md?p=f) safety activities at the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration for fiscal year 2009 (excluding the amount of fees appropriated for such fiscal year), multiplied by the adjustment factor under [paragraph (3)](#c-3).
  - (2) **Authority—** If—
    - (A) the [Secretary](/usc/21/321.md?p=d) does not assess fees under [subsection (a)](#a) for a portion of a fiscal year because [paragraph (1)](#c-1) applies; and
    - (B) at a later date in such fiscal year, such [paragraph (1)](#c-1) ceases to apply,

    the [Secretary](/usc/21/321.md?p=d) may assess and collect such fees under [subsection (a)](#a), without any modification to the rate of such fees, notwithstanding the provisions of [subsection (a)](#a) relating to the date fees are to be paid.

  - (3) **Adjustment factor—**
    - (A) **In general—** The adjustment factor described in [paragraph (1)](#c-1) shall be the total percentage change that occurred in the Consumer Price Index for all urban consumers (all items; United States city average) for the 12-month period ending June 30 preceding the fiscal year, but in no case shall such adjustment factor be negative.
    - (B) **Compounded basis—** The adjustment under [subparagraph (A)](#c-3-A) made each fiscal year shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2009.
  - (4) **Limitation on amount of certain fees—**
    - (A) **In general—** Notwithstanding any other provision of this section and subject to [subparagraph (B)](#c-4-B), the [Secretary](/usc/21/321.md?p=d) may not collect fees in a fiscal year such that the amount collected—
      - (i) under [subparagraph (B)](#a-1-B) of subsection (a)(1) exceeds $20,000,000; and
      - (ii) under subparagraphs [(A)](#a-1-A) and [(D)](#a-1-D) of subsection (a)(1) exceeds $25,000,000 combined.
    - (B) **Exception—** If a domestic [facility](/usc/21/364.md?p=3-A) (as defined in [section 350d(b)](/usc/21/350d.md?p=b)[^1] of this title) or an importer becomes subject to a fee described in subparagraph [(A)](#a-1-A), [(B)](#a-1-B), or [(D)](#a-1-D) of subsection (a)(1) after the maximum amount of fees has been collected by the [Secretary](/usc/21/321.md?p=d) under [subparagraph (A)](#c-4-A), the [Secretary](/usc/21/321.md?p=d) may collect a fee from such [facility](/usc/21/364.md?p=3-A) or importer.
- (d) **Crediting and availability of fees—** Fees [authorized](/usc/21/360eee.md?p=2) under [subsection (a)](#a) shall be collected and available for obligation only to the extent and in the amount provided in appropriations Acts. Such fees are [authorized](/usc/21/360eee.md?p=2) to remain available until expended. Such sums as may be necessary may be transferred from the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration salaries and expenses account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the purpose of paying the operating expenses of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration employees and contractors performing activities associated with these [food](/usc/21/321.md?p=f) safety fees.
- (e) **Collection of fees—**
  - (1) **In general—** The [Secretary](/usc/21/321.md?p=d) shall specify in the Federal Register notice described in [subsection (b)(1)](#b-1) the time and manner in which fees assessed under this section shall be collected.
  - (2) **Collection of unpaid fees—** In any case where the [Secretary](/usc/21/321.md?p=d) does not receive payment of a fee assessed under this section within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to provisions of subchapter II of chapter 37 of title 31.
- (f) **Annual report to Congress—** Not later than 120 days after each fiscal year for which fees are assessed under this section, the [Secretary](/usc/21/321.md?p=d) shall submit a report 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, to include a description of fees assessed and collected for each such year and a summary description of the entities paying such fees and the types of business in which such entities engage.
- (g) **Authorization of appropriations—** For fiscal year 2010 and each fiscal year thereafter, there is [authorized](/usc/21/360eee.md?p=2) to be appropriated for fees under this section an amount equal to the total revenue amount determined under [subsection (b)](#b) for the fiscal year, as adjusted or otherwise affected under the other provisions of this section.

## Footnotes

[^1]: See References in Text note below.
[^2]: So in original. No subcl. (I) has been enacted.
[^3]: So in original. Probably should be “clauses”.

## Source credit

(June 25, 1938, ch. 675, § 743, as added Pub. L. 111–353, title I, § 107(a), Jan. 4, 2011, 124 Stat. 3906.)

## Notes

### Editorial Notes

### References in Text

Section 350d(b) of this title, referred to in subsecs. (a)(1)(A), (B), (2)(A)(i) and (c)(4)(B), was redesignated section 350d(c) by Pub. L. 111–353, title I, § 102(b)(1)(B), Jan. 4, 2011, 124 Stat. 3887.

### Statutory Notes and Related Subsidiaries

### Construction

Nothing in this section to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title.