§379g. Definitions — Inbound Citations
21 U.S.C. § 379g
Cited by 98 provisions in release 119-102.
Citations to 21 U.S.C. § 379g as a whole
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(3) In this subsection, the term “small business” means an entity that has fewer than 500 employees, including employees of affiliates, and does not have a drug product that has been approved under a human drug application (as defined in section 379g of this title) or a biosimilar biological product application (as defined in section 379j–51(4) of this title) and introduced or delivered for introduction into interstate commerce.
Citations to §379g(1)
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(1) The term “human drug application” has the meaning given such term in section 379g(1) of this title.
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(1) The term “priority review”, with respect to a human drug application as defined in section 379g(1) of this title, means review and action by the Secretary on such application not later than 6 months after receipt by the Secretary of such application, as described in the Manual of Policies and Procedures of the Food and Drug Administration and goals identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2012.
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(4) The term “rare pediatric disease product application” means a human drug application, as defined in section 379g(1) of this title, that—(A) is for a drug or biological product that is for the prevention or treatment of a rare pediatric disease;(i) is for such a drug—(I) that contains no active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) that has been previously approved in any other application under subsection (b)(1), (b)(2), or (j) of section 355 of this title; and(II) that is the subject of an application submitted under section 355(b)(1) of this title; or(ii) is for such a biological product—(I) that contains no active ingredient that has been previously approved in any other application under section 351(a) or 351(k) of the Public Health Service Act [42 U.S.C. 262(a), 262(k)]; and(II) that is the subject of an application submitted under section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)];(C) the Secretary deems eligible for priority review;(D) that1 relies on clinical data derived from studies examining a pediatric population and dosages of the drug intended for that population;(E) that1 does not seek approval for an adult indication in the original rare pediatric disease product application; and(F) is approved after September 30, 2016.
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(1) The term “priority review”, with respect to a human drug application as defined in section 379g(1) of this title, means review and action by the Secretary on such application not later than 6 months after receipt by the Secretary of such application, as described in the Manual of Policies and Procedures of the Food and Drug Administration and goals identified in the letters described in section 101(c) of the Food and Drug Administration Amendments Act of 2007.
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(A) is a human drug application as defined in section 379g(1) of this title—(i) for prevention or treatment of a tropical disease;(ii) the Secretary deems eligible for priority review;(iii) that contains reports of one or more new clinical investigations (other than bioavailability studies) that are essential to the approval of the application and conducted or sponsored by the sponsor of such application; and(iv) that contains an attestation from the sponsor of the application that such reports were not submitted as part of an application for marketing approval or licensure by a regulatory authority in India, Brazil, Thailand, or any country that is a member of the Pharmaceutical Inspection Convention or the Pharmaceutical Inspection Cooperation Scheme prior to September 27, 2007.1
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(A) Each person that submits, on or after September 1, 1992, a human drug application shall be subject to a fee as follows:(i) A fee established under subsection (c)(6) 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)(6) for a human drug application for which clinical data (other than bioavailability or bioequivalence studies) with respect to safety or effectiveness are not required for approval. Such fee shall be half of the amount of the fee established under clause (i).
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(i) A fee established under subsection (c)(6) 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.
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(ii) A fee established under subsection (c)(6) for a human drug application for which clinical data (other than bioavailability or bioequivalence studies) with respect to safety or effectiveness are not required for approval. Such fee shall be half of the amount of the fee established under clause (i).
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(C) If a human drug application was submitted by a person that paid the fee for such application, was accepted for filing, and was not approved or was withdrawn prior to approval (without a waiver), the submission of a human drug application 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).
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(E) A human drug application that was submitted but was refused for filing, or was withdrawn before being accepted or refused for filing, shall be subject to the full fee under subparagraph (A) upon being resubmitted or filed over protest, unless the fee is waived or reduced under subsection (d).
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(F) 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.
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(H) A human drug application for a skin-test diagnostic product shall not be subject to a fee under subparagraph (A).
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(i) Except as provided in subparagraphs (B) and (C), 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 the annual prescription drug program fee established for a fiscal year under subsection (c)(6) for each prescription drug product that is identified in such a human drug application approved as of October 1 of such fiscal year. Such fee shall be due on the later of the first business day on or after October 1 of each fiscal year or the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section. Such fee shall be paid only once for each product for a fiscal year in which the fee is payable.
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(ii) If a drug product that is identified in a human drug application approved as of October 1 of a fiscal year is not a prescription drug product as of that date because the drug product is in the discontinued section of a list referenced in section 379g(3)(A)(iii) of this title, and on any subsequent day during such fiscal year the drug product is a prescription drug product, then except as provided in subparagraphs (B) and (C), each person who is named as the applicant in a human drug application with respect to such product, and who, after September 1, 1992, had pending before the Secretary a human drug application or supplement, shall pay the annual prescription drug program fee established for a fiscal year under subsection (c)(6) for such prescription drug product. Such fee shall be due on the last business day of such fiscal year and shall be paid only once for each such product for a fiscal year in which the fee is payable.
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(C) A person who is named as the applicant in an approved human drug application shall not be assessed more than 5 prescription drug program fees for a fiscal year for prescription drug products identified in such approved human drug application.
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(A) 20 percent shall be derived from human drug application fees under subsection (a)(1); and
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(A) establish, for each such fiscal year, human drug application fees and prescription drug program fees under subsection (a), based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection; and
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(1) The Secretary shall grant to a person who is named as the applicant in a human drug application a waiver from or a reduction of one or more fees assessed to that person under subsection (a) 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, or(C) the applicant involved is a small business submitting its first human drug application to the Secretary for review.
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(C) the applicant involved is a small business submitting its first human drug application to the Secretary for review.
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(A) In paragraph (1)(C), the term “small business” means an entity that has fewer than 500 employees, including employees of affiliates, and that does not have a drug product that has been approved under a human drug application and introduced or delivered for introduction into interstate commerce.
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(B) The Secretary shall waive under paragraph (1)(C) 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 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.
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(e) A human drug application or supplement submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for filing by the Secretary until all such fees owed by such person have been paid.
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(2) If the Secretary does not assess fees under subsection (a) 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 prescription drug program fees at any time in such fiscal year notwithstanding the provisions of subsection (a) relating to the date fees are to be paid.
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(j) 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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(2) The report under this subsection for a fiscal year shall include information on all previous cohorts for which the Secretary has not given a complete response on all human drug applications and supplements in the cohort.
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(D) data, analysis, and discussion of the changes in the average full-time equivalent hours required to complete review of each type of human drug application.
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(A) The difference between the aggregate number of human drug applications filed and the aggregate number of approvals, accounting for—(i) such applications filed during one fiscal year for which a decision is not scheduled to be made until the following fiscal year;(ii) the aggregate number of applications for each fiscal year that did not meet the goals identified in the letters described in section 101(b)1 of the Prescription Drug User Fee Amendments of 2022 for the applicable fiscal year.
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(1) For each fiscal year, if the Secretary determines, based on the analysis under subsection (a)(5), that each of the goals identified in the letters described in section 101(b)1 of the Prescription Drug User Fee Amendments of 2022 for the applicable fiscal year have been met, the corrective action report shall include recommendations on ways in which the Secretary can improve and streamline the human drug application review process.
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(A) a detailed justification for such determination and a description, as applicable, of the types of circumstances and trends under which human drug applications that missed the review goal time were approved during the first cycle review, or application review goals were missed; and
Citations to §379g(2)
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(i) Except as provided in subparagraphs (B) and (C), 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 the annual prescription drug program fee established for a fiscal year under subsection (c)(6) for each prescription drug product that is identified in such a human drug application approved as of October 1 of such fiscal year. Such fee shall be due on the later of the first business day on or after October 1 of each fiscal year or the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section. Such fee shall be paid only once for each product for a fiscal year in which the fee is payable.
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(ii) If a drug product that is identified in a human drug application approved as of October 1 of a fiscal year is not a prescription drug product as of that date because the drug product is in the discontinued section of a list referenced in section 379g(3)(A)(iii) of this title, and on any subsequent day during such fiscal year the drug product is a prescription drug product, then except as provided in subparagraphs (B) and (C), each person who is named as the applicant in a human drug application with respect to such product, and who, after September 1, 1992, had pending before the Secretary a human drug application or supplement, shall pay the annual prescription drug program fee established for a fiscal year under subsection (c)(6) for such prescription drug product. Such fee shall be due on the last business day of such fiscal year and shall be paid only once for each such product for a fiscal year in which the fee is payable.
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(B) For purposes of this paragraph, the Secretary shall employ the capacity planning methodology utilized by the Secretary in setting fees for fiscal year 2021, as described in the notice titled “Prescription Drug User Fee Rates for Fiscal Year 2021” published in the Federal Register on August 3, 2020 (85 Fed. Reg. 46651). The workload categories used in applying such methodology in forecasting shall include only the activities described in that notice and, as feasible, additional activities that are directly related to the direct review of applications and supplements, including additional formal meeting types, the direct review of postmarketing commitments and requirements, the direct review of risk evaluation and mitigation strategies, and the direct review of annual reports for approved prescription drug products. Subject to the exceptions in the preceding sentence, the Secretary shall not include as workload categories in applying such methodology in forecasting any non-core review activities, including those activities that the Secretary referenced for potential future use in such notice but did not utilize in setting fees for fiscal year 2021.
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(e) A human drug application or supplement submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for filing by the Secretary until all such fees owed by such person have been paid.
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(iii) the number of standard efficacy supplements filed per fiscal year for each review division;
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(iv) the number of priority efficacy supplements filed per fiscal year for each review division;
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(2) The report under this subsection for a fiscal year shall include information on all previous cohorts for which the Secretary has not given a complete response on all human drug applications and supplements in the cohort.
Citations to §379g(3)
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(4) The term “direct-to-consumer television advertisement” means an advertisement for a prescription drug product (as defined in section 379g(3) of this title) intended to be displayed on any television channel for less than 3 minutes.
Citations to §379g(3)(A)
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(F) 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.
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(i) Except as provided in subparagraphs (B) and (C), 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 the annual prescription drug program fee established for a fiscal year under subsection (c)(6) for each prescription drug product that is identified in such a human drug application approved as of October 1 of such fiscal year. Such fee shall be due on the later of the first business day on or after October 1 of each fiscal year or the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section. Such fee shall be paid only once for each product for a fiscal year in which the fee is payable.
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(ii) If a drug product that is identified in a human drug application approved as of October 1 of a fiscal year is not a prescription drug product as of that date because the drug product is in the discontinued section of a list referenced in section 379g(3)(A)(iii) of this title, and on any subsequent day during such fiscal year the drug product is a prescription drug product, then except as provided in subparagraphs (B) and (C), each person who is named as the applicant in a human drug application with respect to such product, and who, after September 1, 1992, had pending before the Secretary a human drug application or supplement, shall pay the annual prescription drug program fee established for a fiscal year under subsection (c)(6) for such prescription drug product. Such fee shall be due on the last business day of such fiscal year and shall be paid only once for each such product for a fiscal year in which the fee is payable.
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(B) A prescription drug program fee shall not be assessed for a prescription drug product under subparagraph (A) if such product is—(i) a large volume parenteral product (a sterile aqueous drug product packaged in a single-dose container with a volume greater than or equal to 100 mL, not including powders for reconstitution or pharmacy bulk packages) identified on the list compiled under section 355(j)(7) of this title;(ii) pharmaceutically equivalent (as defined in section 314.3 of title 21, Code of Federal Regulations (or any successor regulation)) to another product on the list of products compiled under section 355(j)(7) of this title (not including the discontinued section of such list); or(iii) a skin-test diagnostic product.
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(C) A person who is named as the applicant in an approved human drug application shall not be assessed more than 5 prescription drug program fees for a fiscal year for prescription drug products identified in such approved human drug application.
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(B) For purposes of this paragraph, the Secretary shall employ the capacity planning methodology utilized by the Secretary in setting fees for fiscal year 2021, as described in the notice titled “Prescription Drug User Fee Rates for Fiscal Year 2021” published in the Federal Register on August 3, 2020 (85 Fed. Reg. 46651). The workload categories used in applying such methodology in forecasting shall include only the activities described in that notice and, as feasible, additional activities that are directly related to the direct review of applications and supplements, including additional formal meeting types, the direct review of postmarketing commitments and requirements, the direct review of risk evaluation and mitigation strategies, and the direct review of annual reports for approved prescription drug products. Subject to the exceptions in the preceding sentence, the Secretary shall not include as workload categories in applying such methodology in forecasting any non-core review activities, including those activities that the Secretary referenced for potential future use in such notice but did not utilize in setting fees for fiscal year 2021.
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(4) The term “direct-to-consumer television advertisement” means an advertisement for a prescription drug product (as defined in section 379g(3) of this title) intended to be displayed on any television channel for less than 3 minutes.
Citations to §379g(3)(A)(iii)
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(ii) If a drug product that is identified in a human drug application approved as of October 1 of a fiscal year is not a prescription drug product as of that date because the drug product is in the discontinued section of a list referenced in section 379g(3)(A)(iii) of this title, and on any subsequent day during such fiscal year the drug product is a prescription drug product, then except as provided in subparagraphs (B) and (C), each person who is named as the applicant in a human drug application with respect to such product, and who, after September 1, 1992, had pending before the Secretary a human drug application or supplement, shall pay the annual prescription drug program fee established for a fiscal year under subsection (c)(6) for such prescription drug product. Such fee shall be due on the last business day of such fiscal year and shall be paid only once for each such product for a fiscal year in which the fee is payable.
Citations to §379g(6)
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(i) the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 years of the preceding 4 fiscal years, multiplied by the proportion of personnel compensation and benefits costs to total costs of the process for the review of human drug applications (as defined in section 379g(6) of this title) for the first 3 years of the preceding 4 fiscal years; and
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(ii) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Arlington-Alexandria, DC–VA–MD–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of the process for the review of human drug applications (as defined in section 379g(6) of this title) for the first 3 years of the preceding 4 fiscal years.
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(A) For each fiscal year, after the annual base revenue established in subsection (b)(1)(A) is adjusted in accordance with paragraphs (1) and (2), such revenue shall be adjusted further for such fiscal year, in accordance with this paragraph, to reflect changes in the resource capacity needs of the Secretary for the process for the review of human drug applications.
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(A) For fiscal year 2023 and subsequent fiscal years, the Secretary shall, in addition to adjustments under paragraphs (1), (2), and (3), further increase the fee revenue and fees if such an adjustment is necessary to provide for operating reserves of carryover user fees for the process for the review of human drug applications for each fiscal year in at least the following amounts:(i) For fiscal year 2023, at least 8 weeks of operating reserves.(ii) For fiscal year 2024, at least 9 weeks of operating reserves.(iii) For fiscal year 2025 and subsequent fiscal years, at least 10 weeks of operating reserves.
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(7) 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.
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(1) Subject to paragraph (2)(C), fees authorized under subsection (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 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.
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(I) for fiscal year 2023, 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; and
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(II) for fiscal year 2024 and each subsequent fiscal year, to defray the costs of the resources allocated for the process for the review of human drug applications (including 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), only if the sum of the amounts allocated by the Secretary for such costs, excluding costs paid from fees collected under this section, plus other costs for the maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, and other necessary materials and supplies in connection with the process for the review of human drug applications, is no less than the amount allocated for such costs, excluding any such costs paid from fees collected under this section, for fiscal year 1997, multiplied by the adjustment factor.
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(i) The number and titles of draft and final guidance on topics related to the process for the review of human drug applications, and whether such guidances were issued as required by statute or pursuant to a commitment under the letters described in section 101(b)1 of the Prescription Drug User Fee Amendments of 2022.
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(ii) The number and titles of public meetings held on topics related to the process for the review of human drug applications, and whether such meetings were required by statute or pursuant to a commitment under the letters described in section 101(b)1 of the Prescription Drug User Fee Amendments of 2022.
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(B) data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of human drug applications, including identifying—(i) drivers of such changes; and(ii) changes in the average total cost per full-time equivalent in the prescription drug review program;
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(1) In developing recommendations to present to the Congress with respect to the goals, and plans for meeting the goals, for the process for the review of human drug applications for the first 5 fiscal years after fiscal year 2027, and for the reauthorization of this subpart for such fiscal years, the Secretary shall consult with—(A) the Committee on Energy and Commerce of the House of Representatives;(B) the Committee on Health, Education, Labor, and Pensions of the Senate;(C) scientific and academic experts;(D) health care professionals;(E) representatives of patient and consumer advocacy groups; and(F) the regulated industry.
Citations to §379g(7)(C)
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(3) Beginning on October 1, 2023, the authorities under section 379g(7)(C) of this title shall include only expenditures for leasing and necessary scientific equipment.
Citations to §379g(8)
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(1) Fees under subsection (a) 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.
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(I) for fiscal year 2023, 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; and
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(II) for fiscal year 2024 and each subsequent fiscal year, to defray the costs of the resources allocated for the process for the review of human drug applications (including 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), only if the sum of the amounts allocated by the Secretary for such costs, excluding costs paid from fees collected under this section, plus other costs for the maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, and other necessary materials and supplies in connection with the process for the review of human drug applications, is no less than the amount allocated for such costs, excluding any such costs paid from fees collected under this section, for fiscal year 1997, multiplied by the adjustment factor.
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(10) The term “adjustment factor” applicable to a fiscal year refers to the formula set forth in section 379g(8) of this title with the base or comparator month being October 2002.
Citations to §379g(9)
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(A) Each person that submits, on or after September 1, 1992, a human drug application shall be subject to a fee as follows:(i) A fee established under subsection (c)(6) 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)(6) for a human drug application for which clinical data (other than bioavailability or bioequivalence studies) with respect to safety or effectiveness are not required for approval. Such fee shall be half of the amount of the fee established under clause (i).
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(C) If a human drug application was submitted by a person that paid the fee for such application, was accepted for filing, and was not approved or was withdrawn prior to approval (without a waiver), the submission of a human drug application 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).
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(i) Except as provided in subparagraphs (B) and (C), 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 the annual prescription drug program fee established for a fiscal year under subsection (c)(6) for each prescription drug product that is identified in such a human drug application approved as of October 1 of such fiscal year. Such fee shall be due on the later of the first business day on or after October 1 of each fiscal year or the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section. Such fee shall be paid only once for each product for a fiscal year in which the fee is payable.
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(ii) If a drug product that is identified in a human drug application approved as of October 1 of a fiscal year is not a prescription drug product as of that date because the drug product is in the discontinued section of a list referenced in section 379g(3)(A)(iii) of this title, and on any subsequent day during such fiscal year the drug product is a prescription drug product, then except as provided in subparagraphs (B) and (C), each person who is named as the applicant in a human drug application with respect to such product, and who, after September 1, 1992, had pending before the Secretary a human drug application or supplement, shall pay the annual prescription drug program fee established for a fiscal year under subsection (c)(6) for such prescription drug product. Such fee shall be due on the last business day of such fiscal year and shall be paid only once for each such product for a fiscal year in which the fee is payable.
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(C) A person who is named as the applicant in an approved human drug application shall not be assessed more than 5 prescription drug program fees for a fiscal year for prescription drug products identified in such approved human drug application.
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(1) The Secretary shall grant to a person who is named as the applicant in a human drug application a waiver from or a reduction of one or more fees assessed to that person under subsection (a) 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, or(C) the applicant involved is a small business submitting its first human drug application to the Secretary for review.
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(B) the assessment of the fee would present a significant barrier to innovation because of limited resources available to such person or other circumstances, or
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(e) A human drug application or supplement submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for filing by the Secretary until all such fees owed by such person have been paid.
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(i) To qualify for consideration for a waiver or reduction under subsection (d), an exemption under subsection (k), or the return of any fee paid under this section, including if the fee is claimed to have been paid in error, a person shall—(1) not later than 180 days after such fee is due, submit to the Secretary a written request justifying such waiver, reduction, exemption, or return; and(2) include in the request any legal authorities under which the request is made.
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(A) With respect to a proposed direct-to-consumer television advertisement (referred to in this section as a “DTC advertisement”), each person that on or after October 1, 2007, submits such an advertisement for advisory review by the Secretary prior to its initial public dissemination shall, except as provided in subparagraph (B), be subject to a fee established under subsection (c)(3).
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(C) Not later than June 1 of each fiscal year, the Secretary shall publish a notice in the Federal Register requesting any person to notify the Secretary within 30 days of the number of DTC advertisements the person intends to submit for advisory review in the next fiscal year. Notwithstanding the preceding sentence, for fiscal year 2008, the Secretary shall publish such a notice in the Federal Register not later than 30 days after September 27, 2007.
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(ii) Notification of the Secretary under subparagraph (C) of the number of DTC advertisements a person intends to submit for advisory review is a legally binding commitment by that person 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 to pay the annual advisory review fee for that number of submissions for fiscal year 2008 by the date specified in clause (i).
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(iii) In making a notification under subparagraph (C), the person involved shall in addition notify the Secretary if under subparagraph (F)(i) the person intends to submit a DTC advertisement for which the advisory review fee has already been paid. If the person does not so notify the Secretary, each DTC advertisement submitted by the person for advisory review in the fiscal year involved shall be subject to the advisory review fee.
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(i) If a person has submitted a notification under subparagraph (C) with respect to a fiscal year and has not paid all advisory review fees due under subparagraph (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), 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, 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 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).
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(ii) If a person submits a number of DTC advertisements for advisory review in a fiscal year that exceeds the number identified by the person under subparagraph (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, and the fee shall be equal to 150 percent of the fee that otherwise would have applied pursuant to subsection (c)(3).
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(i) For each advisory review fee paid by a person for a fiscal year, the person is entitled to acceptance for advisory review by the Secretary 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 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.
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(A) Each person that on or after October 1, 2007, is assessed an advisory review fee under paragraph (1) shall be subject to fee1 established under subsection (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. The person is not subject to an operating reserve fee for any other fiscal year.
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(i) October 1 of the first fiscal year in which the person is required to pay an advisory review fee under paragraph (1); or
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(C) If, in the first fiscal year of a person’s participation in the program under this section, that person submits any DTC advertisements for advisory review that are in excess of the number identified by that person in response to the Federal Register notice described in subsection (a)(1)(C), that person 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). Fees required by this subparagraph shall be in addition to any fees required by subparagraph (A). Fees under this subparagraph shall be due 20 days before any DTC advertisement is submitted by such person to the Secretary for advisory review.
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(i) Notwithstanding subparagraph (B), and subject to clause (ii), an operating reserve fee shall be regarded as late if the person 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; or(II) in any subsequent year, November 1.
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(2) The Secretary shall establish the operating reserve fee under subsection (a)(2)(A) for each person required to pay the fee by multiplying the number of DTC advertisements identified by that person pursuant to subsection (a)(1)(C) by the advisory review fee established pursuant to subsection (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 had first participated in the program under this section in fiscal year 2008.
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(4) Within 120 days after the end of fiscal year 2012, or if the program under this section ends early pursuant to subsection (f), the Secretary, 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 that paid an operating reserve fee assessment. In no event shall the refund to any person exceed the total amount of operating reserve fees paid by such person pursuant to subsection (a)(2).
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(e) Notwithstanding any other requirement, a submission for advisory review of a DTC advertisement submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for review by the Secretary until all fees owed by such person under this section have been paid.
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(v) For fiscal years 2023 and 2024, of the meeting requests from sponsors for which the Secretary has determined that a face-to-face meeting is appropriate, the number of face-to-face meetings requested by sponsors to be conducted in person (in such manner as the Secretary shall prescribe on the website of the Food and Drug Administration), and the number of such in-person meetings granted by the Secretary, with both such numbers disaggregated by the relevant agency center.
Citations to §379g(11)
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(2) In determining whether to grant a waiver or reduction of a fee under paragraph (1), the Secretary shall consider only the circumstances and assets of the applicant involved and any affiliate of the applicant.
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(A) In paragraph (1)(C), the term “small business” means an entity that has fewer than 500 employees, including employees of affiliates, and that does not have a drug product that has been approved under a human drug application and introduced or delivered for introduction into interstate commerce.
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(B) The Secretary shall waive under paragraph (1)(C) 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 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.
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(12) The term “affiliate” refers to the definition set forth in section 379g(11) of this title.
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(10) The term “person” includes an affiliate thereof (as such term is defined in section 379g(11) of this title).
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(1) The term “affiliate” has the meaning given such term in section 379g(11) of this title.
Citations to §379g(12)
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(H) A human drug application for a skin-test diagnostic product shall not be subject to a fee under subparagraph (A).
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(iii) a skin-test diagnostic product.