§379h. Authority to assess and use drug fees
(a) Types of fees
Beginning in fiscal year 1993, the Secretary shall assess and collect fees in accordance with this section as follows:
(1) Human drug application and supplement fee
(A) In general
Each person that submits, on or after September 1, 1992, a human drug application or a supplement shall be subject to a fee as follows:
(i) A fee established in subsection (b) of this section for a human drug application for which clinical data (other than bioavailability or bioequivalence studies) with respect to safety or effectiveness are required for approval.
(ii) A fee established in subsection (b) of this section for a human drug application for which clinical data with respect to safety or effectiveness are not required or a supplement for which clinical data (other than bioavailability or bioequivalence studies) with respect to safety or effectiveness are required.
(B) Payment schedule
(i) First payment
50 percent of the fee required by subparagraph (A) shall be due upon submission of the application or supplement.
(ii) Final payment
The remaining 50 percent of the fee required by subparagraph (A) shall be due upon-
(I) the expiration of 30 days from the date the Secretary sends to the applicant a letter designated by the Secretary as an action letter described in section 379g(6)(B) of this title, or
(II) the withdrawal of the application or supplement after it is filed unless the Secretary waives the fee or a portion of the fee because no substantial work was performed on such application or supplement after it was filed.
The designation under subclause (I) or the waiver under subclause (II) shall be solely in the discretion of the Secretary and shall not be reviewable.
(C) Exception for previously filed application or supplement
If a human drug application or supplement was submitted by a person that paid the fee for such application or supplement, was accepted for filing, and was not approved or was withdrawn (without a waiver), the submission of a human drug application or a supplement for the same product by the same person (or the person's licensee, assignee, or successor) shall not be subject to a fee under subparagraph (A).
(D) Refund of fee if application not accepted for filing
The Secretary shall refund 50 percent of the fee paid under subparagraph (B)(i) for any application or supplement which is not accepted for filing.
(2) Prescription drug establishment fee
Each person that-
(A) owns a prescription drug establishment, at which is manufactured at least 1 prescription drug product which is not the, or not the same as a, product approved under an application filed under section 355(b)(2) or 355(j) of this title, and
(B) after September 1, 1992, had pending before the Secretary a human drug application or supplement,
shall be subject to the annual fee established in subsection (b) of this section for each such establishment, payable on or before January 31 of each year.
(3) Prescription drug product fee
(A) In general
Except as provided in subparagraph (B), each person-
(i) who is named as the applicant in a human drug application for a prescription drug product which is listed under section 360 of this title, and
(ii) who, after September 1, 1992, had pending before the Secretary a human drug application or supplement,
shall pay for each such prescription drug product the annual fee established in subsection (b) of this section. Such fee shall be payable at the time of the first such listing of such product in each calendar year. Such fee shall be paid only once each year for each listed prescription drug product irrespective of the number of times such product is listed under section 360 of this title.
(B) Exception
The listing of a prescription drug product under section 360 of this title shall not require the person who listed such product to pay the fee prescribed by subparagraph (A) if such product is the same product as a product approved under an application filed under section 355(b)(2) or 355(j) of this title.
(b) Fee amounts
(1) Schedule
Except as provided in paragraph (2) and subsections (c), (d), (f), and (g) of this section, the fees required under subsection (a) of this section shall be paid in accordance with the following schedule:
| Fiscal Year 1993 | Fiscal Year 1994 | Fiscal Year 1995 | Fiscal Year 1996 | Fiscal Year 1997 | |
|---|---|---|---|---|---|
| Drug application fee: | |||||
| Subsection (a)(1)(A)(i) fee | $100,000 | $150,000 | $208,000 | $217,000 | $233,000 |
| Subsection (a)(1)(A)(ii) fee | $50,000 | $75,000 | $104,000 | $108,000 | $116,000 |
| Fee revenue | $12,000,000 | $18,000,000 | $25,000,000 | $26,000,000 | $28,000,000 |
| Annual establishment fee: | |||||
| Fee per establishment | $60,000 | $88,000 | $126,000 | $131,000 | $138,000 |
| Fee revenue | $12,000,000 | $18,000,000 | $25,000,000 | $26,000,000 | $28,000,000 |
| Annual product fee: | |||||
| Fee per product | $6,000 | $9,000 | $12,500 | $13,000 | $14,000 |
| Fee revenue | $12,000,000 | $18,000,000 | $25,000,000 | $26,000,000 | $28,000,000 |
| Total fee revenues | $36,000,000 | $54,000,000 | $75,000,000 | $78,000,000 | $84,000,000 |
(2) Small business exception
Any business which has fewer than 500 employees, including employees of affiliates, and which does not have a prescription drug product introduced or delivered for introduction into interstate commerce shall pay one-half the amount of the fee for human drug applications it submits and shall pay the entire amount of the fee for supplements it submits. Such a business shall not be required to pay any portion of any fee required under subsection (a)(1)(A) of this section until 1 year after the date of the submission of the application involved. For purposes of this paragraph, one business is an affiliate of another business when, directly or indirectly, one business controls, or has the power to control, the other business or a third party controls, or has the power to control, both businesses.
(c) Increases and adjustments
(1) Revenue increase
The total fee revenues established by the schedule in subsection (b)(1) of this section shall be increased by the Secretary by notice, published in the Federal Register, for a fiscal year to reflect the greater of-
(A) the total percentage increase that occurred during the preceding fiscal year in the Consumer Price Index for all urban consumers (all items; U.S. city average), or
(B) the total percentage increase for such fiscal year in basic pay under the General Schedule in accordance with section 5332 of title 5, as adjusted by any locality-based comparability payment pursuant to section 5304 of such title for Federal employees stationed in the District of Columbia.
(2) Annual fee adjustment
Subject to the amount appropriated for a fiscal year under subsection (g) of this section, the Secretary shall, within 60 days after the end of each fiscal year beginning after October 1, 1992, adjust the fees established by the schedule in subsection (b)(1) of this section for the following fiscal year to achieve the total fee revenues, as may be increased under paragraph (1). Such fees shall be adjusted under this paragraph to maintain the proportions established in such schedule.
(3) Limit
The total amount of fees charged, as adjusted under paragraph (2), for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of human drug applications.
(d) Fee waiver or reduction
The Secretary shall grant a waiver from or a reduction of 1 or more fees under subsection (a) of this section where the Secretary finds that-
(1) such waiver or reduction is necessary to protect the public health,
(2) the assessment of the fee would present a significant barrier to innovation because of limited resources available to such person or other circumstances,
(3) the fees to be paid by such person will exceed the anticipated present and future costs incurred by the Secretary in conducting the process for the review of human drug applications for such person, or
(4) assessment of the fee for an application or a supplement filed under section 355(b)(1) of this title pertaining to a drug containing an active ingredient would be inequitable because an application for a product containing the same active ingredient filed by another person under section 355(b)(2) of this title could not be assessed fees under subsection (a)(1) of this section.
In making the finding in paragraph (3), the Secretary may use standard costs.
(e) Effect of failure to pay fees
A human drug application or supplement submitted by a person subject to fees under subsection (a) of this section shall be considered incomplete and shall not be accepted for filing by the Secretary until all fees owed by such person have been paid.
(f) Assessment of fees
(1) Limitation
Fees may not be assessed under subsection (a) of this section for a fiscal year beginning after fiscal year 1993 unless appropriations for salaries and expenses of the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) are equal to or greater than the amount of appropriations for the salaries and expenses of the Food and Drug Administration for the fiscal year 1992 multiplied by the adjustment factor applicable to the fiscal year involved.
(2) Authority
If the Secretary does not assess fees under subsection (a) of this section during any portion of a fiscal year because of paragraph (1) and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate, for human drug applications and supplements, prescription drug establishments, and prescription drug products at any time in such fiscal year notwithstanding the provisions of subsection (a) of this section relating to the date fees are to be paid.
(g) Crediting and availability of fees
(1) In general
Fees collected for a fiscal year pursuant to subsection (a) of this section shall be credited to the appropriation account for salaries and expenses of the Food and Drug Administration and shall be available in accordance with appropriation Acts until expended without fiscal year limitation.
(2) Collections and appropriation acts
The fees authorized by this section-
(A) shall be collected in each fiscal year in an amount equal to the amount specified in appropriation Acts for such fiscal year, and
(B) shall only be collected and available to defray increases in the costs of the resources allocated for the process for the review of human drug applications (including increases in such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process) over such costs for fiscal year 1992 multiplied by the adjustment factor.
(3) Authorization of appropriations
There are authorized to be appropriated for fees under this section-
(A) $36,000,000 for fiscal year 1993,
(B) $54,000,000 for fiscal year 1994,
(C) $75,000,000 for fiscal year 1995,
(D) $78,000,000 for fiscal year 1996, and
(E) $84,000,000 for fiscal year 1997,
as adjusted to reflect increases in the total fee revenues made under subsection (c)(1) of this section.
(h) Collection of unpaid fees
In any case where the Secretary does not receive payment of a fee assessed under subsection (a) of this section within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of chapter 37 of title 31.
(i) Construction
This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employers, and advisory committees not engaged in the process of the review of human drug applications, be reduced to offset the number of officers, employees, and advisory committees so engaged.
(June 25, 1938, ch. 675, §736, as added Oct. 29, 1992,
Termination of Section
For termination of section by section 105 of
Termination Date
Section not in effect after Oct. 1, 1997, see section 105 of
Section Referred to in Other Sections
This section is referred to in section 379g of this title.