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§ 379h. Authority to assess and use drug fees
(a)
Types of fees
Beginning in fiscal year 2003, 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 under subsection (c)(4) 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 under subsection (c)(4) 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. Such fee shall be half of the amount of the fee established under clause (i).
(B)
Payment
The fee required by subparagraph (A) shall be due upon submission of the application or supplement.
(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by a person that paid the fee for such application or supplement, was accepted for filing, and was not approved or was withdrawn (without a waiver), the submission of a human drug application or a supplement for the same product by the same person (or the person’s licensee, assignee, or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 refused for filing
The Secretary shall refund 75 percent of the fee paid under subparagraph (B) for any application or supplement which is refused for filing.
(E)
Exception for designated orphan drug or indication
A human drug application for a prescription drug product that has been designated as a drug for a rare disease or condition pursuant to section
360bb of this title shall not be subject to a fee under subparagraph (A), unless the human drug application includes an indication for other than a rare disease or condition. A supplement proposing to include a new indication for a rare disease or condition in a human drug application shall not be subject to a fee under subparagraph (A), if the drug has been designated pursuant to section
360bb of this title as a drug for a rare disease or condition with regard to the indication proposed in such supplement.
(F)
Refund of fee if application withdrawn
If an application or supplement is withdrawn after the application or supplement was filed, the Secretary may refund the fee or a portion of the fee if no substantial work was performed on the application or supplement after the application or supplement was filed. The Secretary shall have the sole discretion to refund a fee or a portion of the fee under this subparagraph. A determination by the Secretary concerning a refund under this paragraph shall not be reviewable.
(2)
Prescription drug establishment fee
(A)
In general
Except as provided in subparagraph (B), each person that—
(ii)
after September 1, 1992, had pending before the Secretary a human drug application or supplement,
shall be assessed an annual fee established under subsection (c)(4) of this section for each prescription drug establishment listed in its approved human drug application as an establishment that manufactures the prescription drug product named in the application. The annual establishment fee shall be assessed in each fiscal year in which the prescription drug product named in the application is assessed a fee under paragraph (3) unless the prescription drug establishment listed in the application does not engage in the manufacture of the prescription drug product during the fiscal year. The establishment fee shall be payable on or before October 1 of each year. Each such establishment shall be assessed only one fee per establishment, notwithstanding the number of prescription drug products manufactured at the establishment. In the event an establishment is listed in a human drug application by more than one applicant, the establishment fee for the fiscal year shall be divided equally and assessed among the applicants whose prescription drug products are manufactured by the establishment during the fiscal year and assessed product fees under paragraph (3).
(B)
Exception
If, during the fiscal year, an applicant initiates or causes to be initiated the manufacture of a prescription drug product at an establishment listed in its human drug application—
(ii)
for which the full establishment fee has been assessed in the fiscal year at a time before manufacture of the prescription drug product was begun;
the applicant will not be assessed a share of the establishment fee for the fiscal year in which the manufacture of the product began.
(3)
Prescription drug product fee
(A)
In general
Except as provided in subparagraph (B), each person who is named as the applicant in a human drug application, and 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 under subsection (c)(4) of this section. Such fee shall be payable on or before October 1 of each year. Such fee shall be paid only once for each product for a fiscal year in which the fee is payable.
(B)
Exception
A prescription drug product shall not be assessed a fee under subparagraph (A) if such product is identified on the list compiled under section
355
(j)(7)(A) of this title with a potency described in terms of per 100 mL, or if such product is the same product as another product approved under an application filed under section
355
(b) or
355
(j) of this title, under an abbreviated application filed under section
357 of this title (as in effect on the day before November 21, 1997), or under an abbreviated new drug application pursuant to regulations in effect prior to the implementation of the Drug Price Competition and Patent Term Restoration Act of 1984.
(b)
Fee revenue amounts
Total Fee Revenue$222,900,000$231,000,000$252,000,000$259,300,000$259,300,000
Except as provided in subsections (c), (d), (f), and (g) of this section, fees under subsection (a) of this section shall be established to generate the following revenue amounts:
| Type of Fee Revenue | Fiscal Year 2003 | Fiscal Year 2004 | Fiscal Year 2005 | Fiscal Year 2006 | Fiscal Year 2007 |
|---|---|---|---|---|---|
| Application/Supplement | $74,300,000 | $77,000,000 | $84,000,000 | $86,434,000 | $86,434,000 |
| Establishment | $74,300,000 | $77,000,000 | $84,000,000 | $86,433,000 | $86,433,000 |
| Product | $74,300,000 | $77,000,000 | $84,000,000 | $86,433,000 | $86,433,000 |
| Total Fee Revenue | $222,900,000 | $231,000,000 | $252,000,000 | $259,300,000 | $259,300,000 |
If, after June 12, 2002, legislation is enacted requiring the Secretary to fund additional costs of the retirement of Federal personnel, fee revenue amounts shall be increased in each year by the amount necessary to fully fund the portion of such additional costs that are attributable to the process for the review of human drug applications.
(c)
Adjustments
(1)
Inflation adjustment
The revenues established in subsection (b) of this section shall be adjusted by the Secretary 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, or
(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, as adjusted by any locality-based comparability payment pursuant to section 5304 of such title for Federal employees stationed in the District of Columbia.
The adjustment made each fiscal year by this subsection will be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2003 under this subsection.
(2)
Workload adjustment
Beginning with fiscal year 2004, after the fee revenues established in subsection (b) of this section are adjusted for a fiscal year for inflation in accordance with paragraph (1), the fee revenues shall be adjusted further for such fiscal year to reflect changes in the workload of the Secretary for the process for the review of human drug applications. With respect to such adjustment:
(A)
The adjustment shall be determined by the Secretary based on a weighted average of the change in the total number of human drug applications, commercial investigational new drug applications, efficacy supplements, and manufacturing supplements submitted to the Secretary. The Secretary shall publish in the Federal Register the fee revenues and fees resulting from the adjustment and the supporting methodologies.
(3)
Final year adjustment
For fiscal year 2007, the Secretary may, in addition to adjustments under paragraphs (1) and (2), further increase the fee revenues and fees established in subsection (b) of this section if such an adjustment is necessary to provide for not more than three months of operating reserves of carryover user fees for the process for the review of human drug applications for the first three months of fiscal year 2008. If such an adjustment is necessary, the rationale for the amount of the increase shall be contained in the annual notice establishing fee revenues and fees for fiscal year 2007. If the Secretary has carryover balances for such process in excess of three months of such operating reserves, the adjustment under this paragraph shall not be made.
(4)
Annual fee setting
The Secretary shall, 60 days before the start of each fiscal year that begins after September 30, 2002, establish, for the next fiscal year, application, product, and establishment fees under subsection (a) of this section, based on the revenue amounts established under subsection (b) of this section and the adjustments provided under this subsection.
(d)
Fee waiver or reduction
(1)
In general
The Secretary shall grant a waiver from or a reduction of one or more fees assessed under subsection (a) of this section where the Secretary finds that—
(B)
the assessment of the fee would present a significant barrier to innovation because of limited resources available to such person or other circumstances,
(2)
Use of standard costs
In making the finding in paragraph (1)(C), the Secretary may use standard costs.
(3)
Rules relating to small businesses
(A)
“Small business” defined
In paragraph (1)(D), the term “small business” means an entity that has fewer than 500 employees, including employees of affiliates.
(B)
Waiver of application fee
The Secretary shall waive under paragraph (1)(D) the application fee for the first human drug application that a small business or its affiliate submits to the Secretary for review. After a small business or its affiliate is granted such a waiver, the small business or its affiliate shall pay—
(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)
Limitations
(1)
In general
Fees under subsection (a) of this section shall be refunded for a fiscal year beginning after fiscal year 1997 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 1997 (excluding the amount of fees appropriated for such fiscal year) 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 authorized under subsection (a) of this section 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 to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug 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 review of human drug applications.
(2)
Collections and appropriation acts
(A)
In general
The fees authorized 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 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, excluding costs paid from fees collected under this section, for fiscal year 1997 multiplied by the adjustment factor.
(B)
Compliance
The Secretary shall be considered to have met the requirements of subparagraph (A)(ii) in any fiscal year if the costs funded by appropriations and allocated for the process for the review of human drug applications—
(3)
Authorization of appropriations
There are authorized to be appropriated for fees under this section—
as adjusted to reflect adjustments in the total fee revenues made under this section and changes in the total amounts collected by application, supplement, establishment, and product fees.
(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 and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation Acts for a subsequent fiscal year.
(i)
Written requests for waivers, reductions, and refunds
To qualify for consideration for a waiver or reduction under subsection (d) of this section, or for a refund of any fee collected in accordance with subsection (a) of this section, a person shall submit to the Secretary a written request for such waiver, reduction, or refund not later than 180 days after such fee is due.
(j)
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.
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Notes
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Notes
2 Update(s)
Parallel authorities (CFR)
PDF (10 pages)
Title 21 RSS
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