• United States Code
    • TITLE 21 - FOOD AND DRUGS
      • CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
        • SUBCHAPTER VII - GENERAL AUTHORITY
          • PART C - FEES
            • SUBPART 2 - FEES RELATING TO DRUGS
              • Section 379h
                • Section 379h. Authority to assess and use drug fees


(a) Types of fees Beginning in fiscal year 1998, 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 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by a person that paid the fee for such application or supplement, was accepted for filing, and was not approved or was withdrawn (without a waiver), the submission of a human drug application or a supplement for the same product by the same person (or the person's licensee, assignee, or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 - (i) is named as the applicant in a human drug application; and (ii) after September 1, 1992, had pending before the Secretary a human drug application or supplement, shall be assessed an annual fee established in subsection (b) 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 January 31 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 - (i) that did not manufacture the product in the previous fiscal year; and (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 - (i) who is named as the applicant in a human drug application for a prescription drug product which has been submitted for listing 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 for the fiscal year in which the product is first submitted for listing under section 360 of this title, or is submitted for relisting under section 360 of this title if the product has been withdrawn from listing and relisted. After such fee is paid for that fiscal year, such fee shall be payable on or before January 31 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 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, 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 amounts Except as provided in subsections (c), (d), (f), and (g) of this section, the fees required under subsection (a) of this section shall be determined and assessed as follows: (1) Application and supplement fees (A) Full fees The application fee under subsection (a)(1)(A)(i) of this section shall be $250,704 in fiscal year 1998, $256,338 in each of fiscal years 1999 and 2000, $267,606 in fiscal year 2001, and $258,451 in fiscal year 2002. (B) Other fees The fee under subsection (a)(1)(A)(ii) of this section shall be $125,352 in fiscal year 1998, $128,169 in each of fiscal years 1999 and 2000, $133,803 in fiscal year 2001, and $129,226 in fiscal year 2002. (2) Total fee revenues for establishment fees The total fee revenues to be collected in establishment fees under subsection (a)(2) of this section shall be $35,600,000 in fiscal year 1998, $36,400,000 in each of fiscal years 1999 and 2000, $38,000,000 in fiscal year 2001, and $36,700,000 in fiscal year 2002. (3) Total fee revenues for product fees The total fee revenues to be collected in product fees under subsection (a)(3) of this section in a fiscal year shall be equal to the total fee revenues collected in establishment fees under subsection (a)(2) of this section in that fiscal year. (c) Adjustments (1) Inflation adjustment The fees and total fee 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 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 change 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. 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 1997 under this subsection. (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 September 30, 1997, adjust the establishment and product fees described in subsection (b) of this section for the fiscal year in which the adjustment occurs so that the revenues collected from each of the categories of fees described in paragraphs (2) and (3) of subsection (b) of this section shall be set to be equal to the revenues collected from the category of application and supplement fees described in paragraph (1) of subsection (b) of this section. (3) Limit The total amount of fees charged, as adjusted under this subsection, 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 (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 - (A) such waiver or reduction is necessary to protect the public health, (B) the assessment of the fee would present a significant barrier to innovation because of limited resources available to such person or other circumstances, (C) 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, (D) 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, or (E) the applicant involved is a small business submitting its first human drug application to the Secretary for review. (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)(E), 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)(E) 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 - (i) application fees for all subsequent human drug applications submitted to the Secretary for review in the same manner as an entity that does not qualify as a small business; and (ii) all supplement fees for all supplements to human drug applications submitted to the Secretary for review in the same manner as an entity that does not qualify as a small business. (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 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 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. 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 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, or otherwise made available for obligation, 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, excluding costs paid from fees collected under this section, for fiscal year 1997 multiplied by the adjustment factor. (3) Authorization of appropriations There are authorized to be appropriated for fees under this section - (A) $106,800,000 for fiscal year 1998; (B) $109,200,000 for fiscal year 1999; (C) $109,200,000 for fiscal year 2000; (D) $114,000,000 for fiscal year 2001; and (E) $110,100,000 for fiscal year 2002, 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. (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) 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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