---
kind: "section"
citation: "21 U.S.C. § 379h–1"
title: "21"
title_heading: "Food and Drugs"
number: "379h–1"
heading: "Fees relating to advisory review of prescription-drug television advertising"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/379h-1"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter VII — General Authority"
  - "Part C — Fees"
  - "Subpart 2 — fees relating to drugs"
---

# §379h–1. Fees relating to advisory review of prescription-drug television advertising

- (a) **Types of direct-to-consumer television advertisement review fees—** Beginning in fiscal year 2008, the [Secretary](/usc/21/321.md?p=d) shall assess and collect fees in accordance with this section as follows:
  - (1) **Advisory review fee—**
    - (A) **In general—** With respect to a proposed direct-to-consumer television advertisement (referred to in this section as a “DTC advertisement”), each [person](/usc/21/379g.md?p=9) that on or after October 1, 2007, submits such an advertisement for advisory review by the [Secretary](/usc/21/321.md?p=d) prior to its initial public dissemination shall, except as provided in [subparagraph (B)](#a-1-B), be subject to a fee established under [subsection (c)(3)](#c-3).
    - (B) **Exception for required submissions—** A DTC advertisement that is required to be submitted to the [Secretary](/usc/21/321.md?p=d) prior to initial public dissemination is not subject to a fee under [subparagraph (A)](#a-1-A) unless the [sponsor](/usc/21/360fff.md?p=8) designates the submission as a submission for advisory review.
    - (C) **Notice to Secretary of number of advertisements—** Not later than June 1 of each fiscal year, the [Secretary](/usc/21/321.md?p=d) shall publish a notice in the Federal Register requesting any [person](/usc/21/379g.md?p=9) to notify the [Secretary](/usc/21/321.md?p=d) within 30 days of the number of DTC advertisements the [person](/usc/21/379g.md?p=9) intends to submit for advisory review in the next fiscal year. Notwithstanding the preceding sentence, for fiscal year 2008, the [Secretary](/usc/21/321.md?p=d) shall publish such a notice in the Federal Register not later than 30 days after September 27, 2007.
    - (D) **Payment—**
      - (i) **In general—** The fee required by [subparagraph (A)](#a-1-A) (referred to in this section as “an advisory review fee”) shall be due not later than October 1 of the fiscal year in which the DTC advertisement involved is intended to be submitted for advisory review, subject to [subparagraph (F)(i)](#a-1-F-i). Notwithstanding the preceding sentence, the advisory review fee for any DTC advertisement that is intended to be submitted for advisory review during fiscal year 2008 shall be due not later than 120 days after September 27, 2007, or an earlier date as specified by the [Secretary](/usc/21/321.md?p=d).
      - (ii) **Effect of submission—** Notification of the [Secretary](/usc/21/321.md?p=d) under [subparagraph (C)](#a-1-C) of the number of DTC advertisements a [person](/usc/21/379g.md?p=9) intends to submit for advisory review is a legally binding commitment by that [person](/usc/21/379g.md?p=9) to pay the annual advisory review fee for that number of submissions on or before October 1 of the fiscal year in which the advertisement is intended to be submitted. Notwithstanding the preceding sentence, the commitment shall be a legally binding commitment by that [person](/usc/21/379g.md?p=9) to pay the annual advisory review fee for that number of submissions for fiscal year 2008 by the date specified in [clause (i)](#a-1-D-i).
      - (iii) **Notice regarding carryover submissions—** In making a notification under [subparagraph (C)](#a-1-C), the [person](/usc/21/379g.md?p=9) involved shall in addition notify the [Secretary](/usc/21/321.md?p=d) if under [subparagraph (F)(i)](#a-1-F-i) the [person](/usc/21/379g.md?p=9) intends to submit a DTC advertisement for which the advisory review fee has already been paid. If the [person](/usc/21/379g.md?p=9) does not so notify the [Secretary](/usc/21/321.md?p=d), each DTC advertisement submitted by the [person](/usc/21/379g.md?p=9) for advisory review in the fiscal year involved shall be subject to the advisory review fee.
    - (E) **Modification of advisory review fee—**
      - (i) **Late payment—** If a [person](/usc/21/379g.md?p=9) has submitted a notification under [subparagraph (C)](#a-1-C) with respect to a fiscal year and has not paid all advisory review fees due under [subparagraph (D)](#a-1-D) not later than November 1 of such fiscal year (or, in the case of such a notification submitted with respect to fiscal year 2008, not later than 150 days after September 27, 2007, or an earlier date specified by the [Secretary](/usc/21/321.md?p=d)), the fees shall be regarded as late and an increase in the amount of fees applies in accordance with this clause, notwithstanding any other provision of this section. For such [person](/usc/21/379g.md?p=9), all advisory review fees for such fiscal year shall be due and payable 20 days before any direct-to-consumer advertisement is submitted to the [Secretary](/usc/21/321.md?p=d) for advisory review, and each such fee shall be equal to 150 percent of the fee that otherwise would have applied pursuant to [subsection (c)(3)](#c-3).
      - (ii) **Exceeding identified number of submissions—** If a [person](/usc/21/379g.md?p=9) submits a number of DTC advertisements for advisory review in a fiscal year that exceeds the number identified by the [person](/usc/21/379g.md?p=9) under [subparagraph (C)](#a-1-C), an increase in the amount of fees applies under this clause for each submission in excess of such number, notwithstanding any other provision of this section. For each such DTC advertisement, the advisory review fee shall be due and payable 20 days before the advertisement is submitted to the [Secretary](/usc/21/321.md?p=d), and the fee shall be equal to 150 percent of the fee that otherwise would have applied pursuant to [subsection (c)(3)](#c-3).
    - (F) **Limits—**
      - (i) **Submissions—** For each advisory review fee paid by a [person](/usc/21/379g.md?p=9) for a fiscal year, the [person](/usc/21/379g.md?p=9) is entitled to acceptance for advisory review by the [Secretary](/usc/21/321.md?p=d) of one DTC advertisement and acceptance of one resubmission for advisory review of the same advertisement. The advertisement shall be submitted for review in the fiscal year for which the fee was assessed, except that a [person](/usc/21/379g.md?p=9) may carry over not more than one paid advisory review submission to the next fiscal year. Resubmissions may be submitted without regard to the fiscal year of the initial advisory review submission.
      - (ii) **No refunds—** Except as provided by subsections [(d)(4)](#d-4) and [(f)](#f), fees paid under this section shall not be refunded.
      - (iii) **No waivers, exemptions, or reductions—** The [Secretary](/usc/21/321.md?p=d) shall not grant a waiver, exemption, or reduction of any fees due or payable under this section.
      - (iv) **Right to advisory review not transferable—** The right to an advisory review under this paragraph is not transferable, except to a successor in interest.
  - (2) **Operating reserve fee—**
    - (A) **In general—** Each [person](/usc/21/379g.md?p=9) that on or after October 1, 2007, is assessed an advisory review fee under [paragraph (1)](#a-1) shall be subject to fee[^1] established under [subsection (d)(2)](#d-2) (referred to in this section as an “operating reserve fee”) for the first fiscal year in which an advisory review fee is assessed to such [person](/usc/21/379g.md?p=9). The [person](/usc/21/379g.md?p=9) is not subject to an operating reserve fee for any other fiscal year.
    - (B) **Payment—** Except as provided in [subparagraph (C)](#a-2-C), the operating reserve fee shall be due no later than—
      - (i) October 1 of the first fiscal year in which the [person](/usc/21/379g.md?p=9) is required to pay an advisory review fee under [paragraph (1)](#a-1); or
      - (ii) for fiscal year 2008, 120 days after September 27, 2007, or an earlier date specified by the [Secretary](/usc/21/321.md?p=d).
    - (C) **Late notice of submission—** If, in the first fiscal year of a [person](/usc/21/379g.md?p=9)’s participation in the program under this section, that [person](/usc/21/379g.md?p=9) submits any DTC advertisements for advisory review that are in excess of the number identified by that [person](/usc/21/379g.md?p=9) in response to the Federal Register notice described in [subsection (a)(1)(C)](#a-1-C), that [person](/usc/21/379g.md?p=9) shall pay an operating reserve fee for each of those advisory reviews equal to the advisory review fee for each submission established under [paragraph (1)(E)(ii)](#a-1-E-ii). Fees required by this subparagraph shall be in addition to any fees required by [subparagraph (A)](#a-2-A). Fees under this subparagraph shall be due 20 days before any DTC advertisement is submitted by such [person](/usc/21/379g.md?p=9) to the [Secretary](/usc/21/321.md?p=d) for advisory review.
    - (D) **Late payment—**
      - (i) **In general—** Notwithstanding [subparagraph (B)](#a-2-B), and subject to [clause (ii)](#a-2-D-ii), an operating reserve fee shall be regarded as late if the [person](/usc/21/379g.md?p=9) required to pay the fee has not paid the complete operating reserve fee by—
        - (I) for fiscal year 2008, 150 days after September 27, 2007, or an earlier date specified by the [Secretary](/usc/21/321.md?p=d); or
        - (II) in any subsequent year, November 1.
      - (ii) **Complete payment—** The complete operating reserve fee shall be due and payable 20 days before any DTC advertisement is submitted by such [person](/usc/21/379g.md?p=9) to the [Secretary](/usc/21/321.md?p=d) for advisory review.
      - (iii) **Amount—** Notwithstanding any other provision of this section, an operating reserve fee that is regarded as late under this subparagraph shall be equal to 150 percent of the operating reserve fee that otherwise would have applied pursuant to [subsection (d)](#d).
- (b) **Advisory review fee revenue amounts—** Fees under [subsection (a)(1)](#a-1) shall be established to generate revenue amounts of $6,250,000 for each of fiscal years 2008 through 2012, as adjusted pursuant to subsections [(c)](#c) and [(g)(4)](#g-4).
- (c) **Adjustments—**
  - (1) **Inflation adjustment—** Beginning with fiscal year 2009, the revenues established in [subsection (b)](#b) shall be adjusted by the [Secretary](/usc/21/321.md?p=d) by notice, published in the Federal Register, for a fiscal year to reflect the greater of—
    - (A) the total percentage change that occurred in the Consumer Price Index for all urban consumers (all items; U.S. city average), for the 12-month period ending June 30 preceding the fiscal year for which fees are being established;
    - (B) the total percentage change for the previous fiscal year in basic pay under the General Schedule in accordance with [section 5332 of title 5](/usc/5/5332.md), as adjusted by any locality-based comparability payment pursuant to [section 5304](/usc/5/5304.md) of such title for Federal employees stationed in the District of Columbia; or
    - (C) the average annual change in the cost, per full-time equivalent position of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration, of all personnel compensation and benefits paid with respect to such positions for the first 5 fiscal years of the previous 6 fiscal years.

    The adjustment made each fiscal year by this subsection shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2008 under this subsection.

  - (2) **Workload adjustment—** Beginning with fiscal year 2009, after the fee revenues established in [subsection (b)](#b) are adjusted for a fiscal year for inflation in accordance with [paragraph (1)](#c-1), the fee revenues shall be adjusted further for such fiscal year to reflect changes in the workload of the [Secretary](/usc/21/321.md?p=d) with respect to the submission of DTC advertisements for advisory review prior to initial dissemination. With respect to such adjustment:
    - (A) The adjustment shall be determined by the [Secretary](/usc/21/321.md?p=d) based upon the number of DTC advertisements identified pursuant to [subsection (a)(1)(C)](#a-1-C) for the upcoming fiscal year, excluding allowable previously paid carry over submissions. The adjustment shall be determined by multiplying the number of such advertisements projected for that fiscal year that exceeds 150 by $27,600 (adjusted each year beginning with fiscal year 2009 for inflation in accordance with [paragraph (1)](#c-1)). The [Secretary](/usc/21/321.md?p=d) shall publish in the Federal Register the fee revenues and fees resulting from the adjustment and the supporting methodologies.
    - (B) Under no circumstances shall the adjustment result in fee revenues for a fiscal year that are less than the fee revenues established for the prior fiscal year.
  - (3) **Annual fee setting for advisory review—**
    - (A) **In general—** Not later than August 1 of each fiscal year (or, with respect to fiscal year 2008, not later than 90 days after September 27, 2007), the [Secretary](/usc/21/321.md?p=d) shall establish for the next fiscal year the DTC advertisement advisory review fee under [subsection (a)(1)](#a-1), based on the revenue amounts established under [subsection (b)](#b), the adjustments provided under paragraphs [(1)](#c-1) and [(2)](#c-2), and the number of DTC advertisements identified pursuant to [subsection (a)(1)(C)](#a-1-C), excluding allowable previously-paid carry over submissions. The annual advisory review fee shall be established by dividing the fee revenue for a fiscal year (as adjusted pursuant to this subsection) by the number of DTC advertisements so identified, excluding allowable previously-paid carry over submissions under [subsection (a)(1)(F)(i)](#a-1-F-i).
    - (B) **Fiscal year 2008 fee limit—** Notwithstanding [subsection (b)](#b) and the adjustments pursuant to this subsection, the fee established under [subparagraph (A)](#c-3-A) for fiscal year 2008 may not be more than $83,000 per submission for advisory review.
    - (C) **Annual fee limit—** Notwithstanding [subsection (b)](#b) and the adjustments pursuant to this subsection, the fee established under [subparagraph (A)](#c-3-A) for a fiscal year after fiscal year 2008 may not be more than 50 percent more than the fee established for the prior fiscal year.
    - (D) **Limit—** The total amount of fees obligated for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process for the advisory review of [prescription drug](/usc/21/360eee.md?p=12) advertising.
- (d) **Operating reserves—**
  - (1) **In general—** The [Secretary](/usc/21/321.md?p=d) shall establish in the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration salaries and expenses appropriation account without fiscal year limitation a Direct-to-Consumer Advisory Review Operating Reserve, of at least $6,250,000 in fiscal year 2008, to continue the program under this section in the event the fees collected in any subsequent fiscal year pursuant to [subsection (a)(1)](#a-1) do not generate the fee revenue amount established for that fiscal year.
  - (2) **Fee setting—** The [Secretary](/usc/21/321.md?p=d) shall establish the operating reserve fee under [subsection (a)(2)(A)](#a-2-A) for each [person](/usc/21/379g.md?p=9) required to pay the fee by multiplying the number of DTC advertisements identified by that [person](/usc/21/379g.md?p=9) pursuant to [subsection (a)(1)(C)](#a-1-C) by the advisory review fee established pursuant to [subsection (c)(3)](#c-3) for that fiscal year, except that in no case shall the operating reserve fee assessed be less than the operating reserve fee assessed if the [person](/usc/21/379g.md?p=9) had first participated in the program under this section in fiscal year 2008.
  - (3) **Use of operating reserve—** The [Secretary](/usc/21/321.md?p=d) may use funds from the reserves only to the extent necessary in any fiscal year to make up the difference between the fee revenue amount established for that fiscal year under subsections [(b)](#b) and [(c)](#c) and the amount of fees actually collected for that fiscal year pursuant to [subsection (a)(1)](#a-1), or to pay costs of ending the program under this section if it is terminated pursuant to [subsection (f)](#f) or not reauthorized beyond fiscal year 2012.
  - (4) **Refund of operating reserves—** Within 120 days after the end of fiscal year 2012, or if the program under this section ends early pursuant to [subsection (f)](#f), the [Secretary](/usc/21/321.md?p=d), after setting aside sufficient operating reserve amounts to terminate the program under this section, shall refund all amounts remaining in the operating reserve on a pro rata basis to each [person](/usc/21/379g.md?p=9) that paid an operating reserve fee assessment. In no event shall the refund to any [person](/usc/21/379g.md?p=9) exceed the total amount of operating reserve fees paid by such [person](/usc/21/379g.md?p=9) pursuant to [subsection (a)(2)](#a-2).
- (e) **Effect of failure to pay fees—** Notwithstanding any other requirement, a submission for advisory review of a DTC advertisement submitted by a [person](/usc/21/379g.md?p=9) subject to fees under [subsection (a)](#a) shall be considered incomplete and shall not be accepted for review by the [Secretary](/usc/21/321.md?p=d) until all fees owed by such [person](/usc/21/379g.md?p=9) under this section have been paid.
- (f) **Effect of inadequate funding of program—**
  - (1) **Initial funding—** If on November 1, 2007, or 120 days after September 27, 2007, whichever is later, the [Secretary](/usc/21/321.md?p=d) has not received at least $11,250,000 in advisory review fees and operating reserve fees combined, the program under this section shall not commence and all collected fees shall be refunded.
  - (2) **Later fiscal years—** Beginning in fiscal year 2009, if, on November 1 of the fiscal year, the combination of the operating reserves, annual fee revenues from that fiscal year, and unobligated fee revenues from prior fiscal years falls below $9,000,000, adjusted for inflation (as described in [subsection (c)(1)](#c-1)), the program under this section shall terminate, and the [Secretary](/usc/21/321.md?p=d) shall notify all participants, retain any money from the unused advisory review fees and the operating reserves needed to terminate the program, and refund the remainder of the unused fees and operating reserves. To the extent required to terminate the program, the [Secretary](/usc/21/321.md?p=d) shall first use unobligated advisory review fee revenues from prior fiscal years, then the operating reserves, and finally, unused advisory review fees from the relevant fiscal year.
- (g) **Crediting and availability of fees—**
  - (1) **In general—** 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 advance 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 appropriation 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 process for the advisory review of [prescription drug](/usc/21/360eee.md?p=12) advertising.
  - (2) **Collections and appropriation acts—**
    - (A) **In general—** The fees [authorized](/usc/21/360eee.md?p=2) by this section—
      - (i) shall be retained in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation for such fiscal year; and
      - (ii) shall be available for obligation only if the amounts appropriated as budget authority for such fiscal year are sufficient to support a number of full-time equivalent review employees that is not fewer than the number of such employees supported in fiscal year 2007.
    - (B) **Review employees—** For purposes of [subparagraph (A)(ii)](#g-2-A-ii), the term “full-time equivalent review employees” means the total combined number of full-time equivalent employees in—
      - (i) the Center for [Drug](/usc/21/321.md?p=g-1) Evaluation and Research, Division of [Drug](/usc/21/321.md?p=g-1) Marketing, Advertising, and Communications, [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration; and
      - (ii) the Center for Biologics Evaluation and Research, Advertising and Promotional [Labeling](/usc/21/321.md?p=m) Branch, [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration.
  - (3) **Authorization of appropriations—** For each of the fiscal years 2008 through 2012, 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 pursuant to [subsection (c)](#c) and paragraph (4) of this subsection, plus amounts collected for the reserve fund under [subsection (d)](#d).
  - (4) **Offset—** Any amount of fees collected for a fiscal year under this section that exceeds the amount of fees specified in appropriation Acts for such fiscal year shall be credited to the appropriation account of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration as provided in [paragraph (1)](#g-1), and shall be subtracted from the amount of fees that would otherwise be collected under this section pursuant to appropriation Acts for a subsequent fiscal year.
- (h) **Definitions—** For purposes of this section:
  - (1) The term “advisory review” means reviewing and providing advisory comments on DTC advertisements regarding compliance of a proposed advertisement with the requirements of this chapter prior to its initial public dissemination.
  - (2) The term “advisory review fee” has the meaning indicated for such term in [subsection (a)(1)(D)](#a-1-D).
  - (3) The term “carry over submission” means a submission for an advisory review for which a fee was paid in one fiscal year that is submitted for review in the following fiscal year.
  - (4) The term “direct-to-consumer television advertisement” means an advertisement for a [prescription drug product](/usc/21/379g.md?p=3-A) (as defined in [section 379g(3) of this title](/usc/21/379g.md?p=3)) intended to be displayed on any television channel for less than 3 minutes.
  - (5) The term “DTC advertisement” has the meaning indicated for such term in [subsection (a)(1)(A)](#a-1-A).
  - (6) The term “operating reserve fee” has the meaning indicated for such term in [subsection (a)(2)(A)](#a-2-A).
  - (7) The term “[person](/usc/21/379g.md?p=9)” includes an individual, partnership, corporation, and association, and any [affiliate](/usc/21/379g.md?p=11) thereof or successor in interest.
  - (8) The term “process for the advisory review of [prescription drug](/usc/21/360eee.md?p=12) advertising” means the activities necessary to review and provide advisory comments on DTC advertisements prior to public dissemination and, to the extent the [Secretary](/usc/21/321.md?p=d) has additional staff resources available under the program under this section that are not necessary for the advisory review of DTC advertisements, the activities necessary to review and provide advisory comments on other proposed advertisements and promotional material prior to public dissemination.
  - (9) The term “resources allocated for the process for the advisory review of [prescription drug](/usc/21/360eee.md?p=12) advertising” means the expenses incurred in connection with the process for the advisory review of [prescription drug](/usc/21/360eee.md?p=12) advertising for—
    - (A) officers and employees of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration, contractors of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration, [advisory committees](/usc/21/360fff.md?p=1), and costs related to such officers, employees, and committees, and to contracts with such contractors;
    - (B) management of information, and the acquisition, maintenance, and repair of computer resources;
    - (C) leasing, maintenance, renovation, and repair of [facilities](/usc/21/364.md?p=3-A) and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies;
    - (D) collection of fees under this section and accounting for resources allocated for the advisory review of [prescription drug](/usc/21/360eee.md?p=12) advertising; and
    - (E) terminating the program under this section pursuant to [subsection (f)(2)](#f-2) if that becomes necessary.
  - (10) The term “resubmission” means a subsequent submission for advisory review of a direct-to-consumer television advertisement that has been revised in response to the [Secretary](/usc/21/321.md?p=d)’s comments on an original submission. A resubmission may not introduce significant new concepts or creative themes into the television advertisement.
  - (11) The term “submission for advisory review” means an original submission of a direct-to-consumer television advertisement for which the [sponsor](/usc/21/360fff.md?p=8) voluntarily requests advisory comments before the advertisement is publicly disseminated.

## Footnotes

[^1]: So in original. Probably should be “the fee”.

## Source credit

(June 25, 1938, ch. 675, § 736A, as added Pub. L. 110–85, title I, § 104, Sept. 27, 2007, 121 Stat. 832.)

## Notes

### Statutory Notes and Related Subsidiaries

### Effective Date

Section effective Oct. 1, 2007, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2007, see section 107 of Pub. L. 110–85, set out as an Effective and Termination Dates of 2007 Amendment note under section 379g of this title.