§ 379h. Authority to assess and use drug fees

Footnotes

1. 1 So in original. The word “of” probably should not appear. See sections 379j–42(c)(2)(D) and 379j–52(c)(3)(D) of this title.

Legislative history

Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.

1. 1938

   Prescription Drug User Fee Act of 1992

   Pub. L. 102–571 title I § 103 · 106 Stat. 4491

   Enacted · 21 U.S.C. § 379h

   June 25, 1938, ch. 675, § 736, as added Pub. L. 102–571, title I, § 103, Oct. 29, 1992, 106 Stat. 4494

   Source evidence

   Code source credit
   June 25, 1938, ch. 675, § 736, as added Pub. L. 102–571, title I, § 103, Oct. 29, 1992, 106 Stat. 4494

   Enacted provision · exact public law section
   SEC. 103. FEES RELATING TO DRUGS. Chapter VII, as amended by section 106, is amended by adding at the end of subchapter C the following: “PART 2— FEES RELATING TO DRUGS “SEC. 735. DEFINITIONS. “For purposes of this subchapter: “(1) The term ‘human drug application’ means an application for— “(A) approval of a new drug submitted under section 505(b)(1), “(B) approval of a new drug submitted under section 505(b)(2) after September 30, 1992, which requests approval of— “(i) a molecular entity which is an active ingredient (including any salt or ester of an active ingredient), or “(ii) an indication for a use, that had not been approved under an application submitted under section 505(b), “(C) initial certification or initial approval of an antibiotic drug under section 507, or “(D) licensure of a biological product under section 351 of the Public Health Service Act. Such term does not include a supplement to such an application, does not include an application with respect to whole blood or a blood component for transfusion, does not include an application with respect to a bovine blood product for topical application licensed before September 1, 1992, an allergenic extract product, or an in vitro diagnostic biologic product licensed under section 351 of the Public Health Service Act, and does not include an application with respect to a large volume parenteral drug product approved before September 1, 1992. “(2) The term ‘supplement’ means a request to the Secretary to approve a change in a human drug application which has been approved. “(3) The term ‘prescription drug product’ means a specific strength or potency of a drug in final dosage form— “(A) for which a human drug application has been approved, and “(B) which may be dispensed only under prescription pursuant to section 503(b). Such term does not include whole blood or a blood component for transfusion, does not include a bovine blood product for topical application licensed before September 1, 1992, an allergenic extract product, or an in vitro diagnostic biologic product licensed under section 351 of the Public Health Service Act, and does not include a large volume parenteral drug product approved before September 1, 1992. “(4) The term ‘final dosage form’ means, with respect to a prescription drug product, a finished dosage form which is approved for administration to a patient without further manufacturing. “(5) The term ‘prescription drug establishment’ means a foreign or domestic place of business which is— “(A) at one general physical location consisting of one or more buildings all of which are within 5 miles of each other, at which one or more prescription drug products are manufactured in final dosage form, and “(B) under the management of a person that is listed as the applicant in a human drug application for a prescription drug product with respect to at least one such product. For purposes of this paragraph, the term ‘manufactured’ does not include packaging. “(6) The term ‘process for the review of human drug applications’ means the following activities of the Secretary with respect to the review of human drug applications and supplements: “(A) The activities necessary for the review of human drug applications and supplements. “(B) The issuance of action letters which approve human drug applications or which set forth in detail the specific deficiencies in such applications and, where appropriate, the actions necessary to place such applications in condition for approval. “(C) The inspection of prescription drug establishments and other facilities undertaken as part of the Secretary’s review of pending human drug applications and supplements. “(D) Activities necessary for the review of applications for licensure of establishments subject to section 351 of the Public Health Service Act and for the release of lots of biologies under such section. “(E) Monitoring of research conducted in connection with the review of human drug applications. “(7) The term ‘costs of resources allocated for the process for the review of human drug applications’ means the expenses incurred in connection with the process for the review of human drug applications for— “(A) officers and employees of the Food and Drug Administration, employees under contract with the Food and Drug Administration who work in facilities owned or leased for the Food and Drug Administration, advisory committees, and costs related to such officers, employees, and committees, “(B) management of information, and the acquisition, maintenance, and repair of computer resources, “(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies, and “(D) collecting fees under section 736 and accounting for resources allocated for the review of human drug applications and supplements. “(8) The term ‘adjustment factor’ applicable to a fiscal year is the lower of— “(A) the Consumer Price Index for all urban consumers (all items; United States city average) for August of the preceding fiscal year divided by such Index for August 1992, or “(B) the total of discretionary budget authority provided for programs in the domestic category for the immediately preceding fiscal year (as reported in the Office of Management and Budget sequestration preview report, if available, required under section 254(d) of the Balanced Budget and Emergency Deficit Control Act of 1985) divided by such budget authority for fiscal year 1992 (as reported in the Office of Management and Budget final sequestration report submitted after the end of the 102d Congress, 2d Session). The terms ‘budget authority’ and ‘category’ in subparagraph (B) are as defined in the Balanced Budget and Emergency Deficit Control Act of 1985, as in effect as of September 1, 1992. “SEC. 736. 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) 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) 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 735(6)(B), 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 505(b)(2) or 505(j), 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) 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 510, 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). 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 510. “(B) Exception.— The listing of a prescription drug product under section 510 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 505(b)(2) or 505(j). “(b) Fee Amounts.— “(1) Schedule.— Except as provided in paragraph (2) and subsections (c), (d), (f), and (g), the fees required under subsection (a) 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) 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) 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, United States Code, 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), 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) 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) 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 505(b)(1) 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 505(b)(2) could not be assessed fees under subsection (a)(1). 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) 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) 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) 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) 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) 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). “(h) Collection of Unpaid Fees.— In any case where the Secretary does not receive payment of a fee assessed under subsection (a) 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, United States Code. “(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.”.

2. 1997

   Food and Drug Administration Modernization Act of 1997

   Pub. L. 105–115 § 103(a)(1) · 111 Stat. 2296

   Substituted · 21 U.S.C. § 379h(a)

   Pub. L. 105–115, § 103(a)(1), substituted “Beginning in fiscal year 1998” for “Beginning in fiscal year 1993” in introductory provisions

   Source evidence

   Code amendment note
   Subsec. (a). Pub. L. 105–115, § 103(a)(1), substituted “Beginning in fiscal year 1998” for “Beginning in fiscal year 1993” in introductory provisions.

   Enacted provision · exact public law section
   (1) by striking “Beginning in fiscal year 1993” and inserting “Beginning in fiscal year 1998”;

3. 1997

   Food and Drug Administration Modernization Act of 1997

   Pub. L. 105–115 § 103(a)(2)(A) · 111 Stat. 2296

   Amended · 21 U.S.C. § 379h(a)(1)(B)

   Pub. L. 105–115, § 103(a)(2)(A), amended heading and text of subpar. (B) generally. Prior to amendment, text read as follows:

   Source evidence

   Code amendment note
   Subsec. (a)(1)(B). Pub. L. 105–115, § 103(a)(2)(A), amended heading and text of subpar. (B) generally. Prior to amendment, text read as follows:

   “(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.”

   Enacted provision · exact public law section
   (A) by striking subparagraph (B) and inserting the following: “(B) Payment.— The fee required by subparagraph (A) shall be due upon submission of the application or supplement.”;

4. 1997

   Food and Drug Administration Modernization Act of 1997

   Pub. L. 105–115 § 103(a)(2)(B) · 111 Stat. 2296

   1. Substituted · 21 U.S.C. § 379h(a)(1)(D)

      Pub. L. 105–115, § 103(a)(2)(B), substituted “refused” for “not accepted” in text

   2. Substituted · 21 U.S.C. § 379h(a)(1)(D)

      Pub. L. 105–115, § 103(a)(2)(B), substituted “75 percent” for “50 percent” in text

   3. Substituted · 21 U.S.C. § 379h(a)(1)(D)

      Pub. L. 105–115, § 103(a)(2)(B), substituted “subparagraph (B)” for “subparagraph (B)(i)” in text

   Source evidence

   Code amendment note
   Subsec. (a)(1)(D). Pub. L. 105–115, § 103(a)(2)(B), substituted “refused” for “not accepted” in heading and “75 percent” for “50 percent”, “subparagraph (B)” for “subparagraph (B)(i)”, and “refused” for “not accepted” in text.

   Enacted provision · exact public law section
   (B) in subparagraph (D)— (i) in the subparagraph heading, by striking “not accepted” and inserting “refused”; (ii) by striking “50 percent” and inserting “75 percent”; (iii) by striking “subparagraph (B)(i)” and inserting “subparagraph (B)”; and (iv) by striking “not accepted” and inserting “refused”; and

5. 1997

   Food and Drug Administration Modernization Act of 1997

   Pub. L. 105–115 § 103(a)(2)(C) · 111 Stat. 2296

   Added · 21 U.S.C. § 379h(a)(1)(E)(G)

   Pub. L. 105–115, § 103(a)(2)(C), added subpars. (E) to (G)

   Source evidence

   Code amendment note
   Subsec. (a)(1)(E) to (G). Pub. L. 105–115, § 103(a)(2)(C), added subpars. (E) to (G).

   Enacted provision · exact public law section
   (C) by adding at the end the following: “(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 526 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 526 as a drug for a rare disease or condition with regard to the indication proposed in such supplement. “(F) Exception for supplements for pediatric indications.— A supplement to a human drug application proposing to include a new indication for use in pediatric populations shall not be assessed a fee under subparagraph (A). “(G) 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 nave 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.”;

6. 1997

   Food and Drug Administration Modernization Act of 1997

   Pub. L. 105–115 § 103(a)(3) · 111 Stat. 2296

   Amended · 21 U.S.C. § 379h(a)(2)

   Pub. L. 105–115, § 103(a)(3), reenacted heading without change and amended text generally. Prior to amendment, text read as follows: “Each person that—

   Source evidence

   Code amendment note
   Subsec. (a)(2). Pub. L. 105–115, § 103(a)(3), reenacted heading without change and amended text generally. Prior to amendment, text read as follows: “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.”

   Enacted provision · exact public law section
   (3) by striking paragraph (2) and inserting the following: “(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) 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.”; and

7. 1997

   Food and Drug Administration Modernization Act of 1997

   Pub. L. 105–115 § 103(a)(4)(A) · 111 Stat. 2296

   1. Substituted · 21 U.S.C. § 379h(a)(3)(A)

      Pub. L. 105–115, § 103(a)(4)(A), substituted, in cl. (i), “has been submitted for listing” for “is listed”

   2. Substituted · 21 U.S.C. § 379h(a)(3)(A)

      Pub. L. 105–115, § 103(a)(4)(A), substituted, in cl. (i), “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.” for “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.”

   Source evidence

   Code amendment note
   Subsec. (a)(3)(A). Pub. L. 105–115, § 103(a)(4)(A), substituted, in cl. (i), “has been submitted for listing” for “is listed” and, in closing provisions, “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.” for “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.”

   Enacted provision · exact public law section
   (A) in subparagraph (A)— (i) in clause (i), by striking “is fisted” and inserting “has been submitted for listing”; and (ii) by striking “Such fee shall be payable” and all that follows through “section 510.” and inserting the following: “Such fee shall be payable for the fiscal year in which the product is first submitted for listing under section 510, or is submitted for relisting under section 510 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.”; and

8. 1997

   Food and Drug Administration Modernization Act of 1997

   Pub. L. 105–115 § 103(a)(4)(B) · 111 Stat. 2296

   Substituted · 21 U.S.C. § 379h(a)(3)(B)

   Pub. L. 105–115, § 103(a)(4)(B), substituted “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.” for “355(j) of this title.”

   Source evidence

   Code amendment note
   Subsec. (a)(3)(B). Pub. L. 105–115, § 103(a)(4)(B), substituted “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.” for “355(j) of this title.”.

   Enacted provision · exact public law section
   (B) in subparagraph (B), by striking “505(j).” and inserting the following: “505(j), under an abbreviated application filed under section 507 (as in effect on the day before the date of enactment of the Food and Drug Administration Modernization Act of 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.”.

9. 1997

   Food and Drug Administration Modernization Act of 1997

   Pub. L. 105–115 § 103(b) · 111 Stat. 2296

   Amended · 21 U.S.C. § 379h(b)

   Pub. L. 105–115, § 103(b), amended subsec. (b) generally. Prior to amendment, subsec. (b) related to fee amounts, including a schedule of fees in par. (1) and fee exceptions for certain small businesses in par. (2)

   Source evidence

   Code amendment note
   Subsec. (b). Pub. L. 105–115, § 103(b), amended subsec. (b) generally. Prior to amendment, subsec. (b) related to fee amounts, including a schedule of fees in par. (1) and fee exceptions for certain small businesses in par. (2).

   Enacted provision · exact public law section
   (b) Fee Amounts.— Section 736(b) (21 U.S.C. 379h(b)) is amended to read as follows: “(b) Fee Amounts.— Except as provided in subsections (c), (d), (f), and (g), the fees required under subsection (a) shall be determined and assessed as follows: “(1) Application and supplement fees.— “(A) Full fees.— The application fee under subsection (a)(1)(A)(i) 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) 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) 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) in a fiscal year shall be equal to the total fee revenues collected in establishment fees under subsection (a)(2) in that fiscal year.”.

10. 1997

    Food and Drug Administration Modernization Act of 1997

    Pub. L. 105–115 § 103(c)(1) · 111 Stat. 2296

    Substituted · 21 U.S.C. § 379h(c)

    Pub. L. 105–115, § 103(c)(1), substituted “Adjustments” for “Increases and adjustments” in heading

    Source evidence

    Code amendment note
    Subsec. (c). Pub. L. 105–115, § 103(c)(1), substituted “Adjustments” for “Increases and adjustments” in heading.

    Enacted provision · exact public law section
    (1) in the subsection heading, by striking “Increases and”;

11. 1997

    Food and Drug Administration Modernization Act of 1997

    Pub. L. 105–115 § 103(c)(2) · 111 Stat. 2296

    1. Substituted · 21 U.S.C. § 379h(c)(1)

       Pub. L. 105–115, § 103(c)(2), substituted “Inflation adjustment” for “Revenue increase” after “total percentage” in subpars. (A) and (B)

    2. Substituted · 21 U.S.C. § 379h(c)(1)

       Pub. L. 105–115, § 103(c)(2), substituted “The fees and total fee revenues established in subsection (b) shall be adjusted by the Secretary” for “The total fee revenues established by the schedule in subsection (b)(1) shall be increased by the Secretary” after “total percentage” in subpars. (A) and (B)

    3. Substituted · 21 U.S.C. § 379h(c)(1)

       Pub. L. 105–115, § 103(c)(2), substituted “change” for “increase” after “total percentage” in subpars. (A) and (B)

    4. Inserted · 21 U.S.C. § 379h(c)(1)

       Pub. L. 105–115, § 103(c)(2), inserted at end “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.”

    Source evidence

    Code amendment note
    Subsec. (c)(1). Pub. L. 105–115, § 103(c)(2), substituted “Inflation adjustment” for “Revenue increase” in heading, “The fees and total fee revenues established in subsection (b) shall be adjusted by the Secretary” for “The total fee revenues established by the schedule in subsection (b)(1) shall be increased by the Secretary” in introductory provisions, and “change” for “increase” after “total percentage” in subpars. (A) and (B), and inserted at end “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.”

    Enacted provision · exact public law section
    (2) in paragraph (1)— (A) by striking “(1) Revenue” and all that follows through “increased by the Secretary” and inserting the following: “(1) Inflation adjustment.—The fees and total fee revenues established in subsection (b) shall be adjusted by the Secretary”; (B) in subparagraph (A), by striking “increase” and inserting “change”; (C) in subparagraph (B), by striking “increase” and inserting “change”; and (D) by adding at the end the following flush sentence: “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.”;

12. 1997

    Food and Drug Administration Modernization Act of 1997

    Pub. L. 105–115 § 103(c)(3) · 111 Stat. 2296

    Substituted · 21 U.S.C. § 379h(c)(2)

    Pub. L. 105–115, § 103(c)(3), substituted “September 30, 1997, adjust the establishment and product fees described in subsection (b) 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) 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).” for “October 1, 1992, adjust the fees established by the schedule in subsection (b)(1) 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.”

    Source evidence

    Code amendment note
    Subsec. (c)(2). Pub. L. 105–115, § 103(c)(3), substituted “September 30, 1997, adjust the establishment and product fees described in subsection (b) 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) 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).” for “October 1, 1992, adjust the fees established by the schedule in subsection (b)(1) 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.”

    Enacted provision · exact public law section
    (3) in paragraph (2), by striking “October 1, 1992,” and all that follows through “such schedule.” and inserting the following: “September 30, 1997, adjust the establishment and product fees described in subsection (b) 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) 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).”; and

13. 1997

    Food and Drug Administration Modernization Act of 1997

    Pub. L. 105–115 § 103(c)(4) · 111 Stat. 2296

    Substituted · 21 U.S.C. § 379h(c)(3)

    Pub. L. 105–115, § 103(c)(4), substituted “this subsection” for “paragraph (2)”

    Source evidence

    Code amendment note
    Subsec. (c)(3). Pub. L. 105–115, § 103(c)(4), substituted “this subsection” for “paragraph (2)”.

    Enacted provision · exact public law section
    (4) in paragraph (3), by striking “paragraph (2)” and inserting “this subsection”.

14. 1997

    Food and Drug Administration Modernization Act of 1997

    Pub. L. 105–115 § 103(d) · 111 Stat. 2296

    1. Struck · 21 U.S.C. § 379h(d)

       Pub. L. 105–115, § 103(d), struck out introductory provisions which read “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—” and closing provisions which read “In making the finding in paragraph (3), the Secretary may use standard costs.”

    2. Inserted · 21 U.S.C. § 379h(d)

       Pub. L. 105–115, § 103(d), inserted designation, heading, and introductory provisions of par. (1)

    3. Redesignated · 21 U.S.C. § 379h(d)

       Pub. L. 105–115, § 103(d), redesignated former pars. (1) to (4) as subpars. (A) to (D), respectively, of par. (1)

    4. Added · 21 U.S.C. § 379h(d)

       Pub. L. 105–115, § 103(d), added pars. (1)(E), (2), and (3)

    Source evidence

    Code amendment note
    Subsec. (d). Pub. L. 105–115, § 103(d), struck out introductory provisions which read “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—” and closing provisions which read “In making the finding in paragraph (3), the Secretary may use standard costs.”, inserted designation, heading, and introductory provisions of par. (1), redesignated former pars. (1) to (4) as subpars. (A) to (D), respectively, of par. (1), and added pars. (1)(E), (2), and (3).

    Enacted provision · exact public law section
    (d) Fee Waiver or Reduction.— Section 736(d) (21 U.S.C. 379h(d)) is amended— (1) by redesignating paragraphs (1), (2), (3), and (4) as subparagraphs (A), (B), (C), and (D), respectively and indenting appropriately; (2) by striking “The Secretary shall grant a” and all that follows through “finds that—” and inserting the following: “(1) In general.— The Secretary shall grant a waiver from or a reduction of one or more fees assessed under subsection (a) where the Secretary finds that—”; (3) in subparagraph (C) (as so redesignated in paragraph (1)), by striking “, or” and inserting a comma; (4) in subparagraph (D) (as so redesignated in paragraph (1)), by striking the period and inserting “, or”; (5) by inserting after subparagraph (D) (as so redesignated in paragraph (1)) the following: “(E) the applicant involved is a small business submitting its first human drug application to the Secretary for review.”; and (6) by striking “In making the finding in paragraph (3),” and all that follows through “standard costs.” and inserting the following: “(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) Definition.— 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.”.

15. 1997

    Food and Drug Administration Modernization Act of 1997

    Pub. L. 105–115 § 103(e) · 111 Stat. 2296

    1. Substituted · 21 U.S.C. § 379h(f)(1)

       Pub. L. 105–115, § 103(e), substituted “fiscal year 1997” for “fiscal year 1993”

    2. Substituted · 21 U.S.C. § 379h(f)(1)

       Pub. L. 105–115, § 103(e), substituted “fiscal year 1997 (excluding the amount of fees appropriated for such fiscal year)” for “fiscal year 1992”

    Source evidence

    Code amendment note
    Subsec. (f)(1). Pub. L. 105–115, § 103(e), substituted “fiscal year 1997” for “fiscal year 1993” and “fiscal year 1997 (excluding the amount of fees appropriated for such fiscal year)” for “fiscal year 1992”.

    Enacted provision · exact public law section
    (e) Assessment of Fees.— Section 736(f)(1) (21 U.S.C. 379h(f)(1)) is amended— (1) by striking “fiscal year 1993” and inserting “fiscal year 1997”; and (2) by striking “fiscal year 1992” and inserting “fiscal year 1997 (excluding the amount of fees appropriated for such fiscal year)”.

16. 1997

    Food and Drug Administration Modernization Act of 1997

    Pub. L. 105–115 § 103(f)(1) · 111 Stat. 2296

    Inserted · 21 U.S.C. § 379h(g)(1)

    Pub. L. 105–115, § 103(f)(1), inserted at end “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.”

    Source evidence

    Code amendment note
    Subsec. (g)(1). Pub. L. 105–115, § 103(f)(1), inserted at end “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.”

    Enacted provision · exact public law section
    (1) in paragraph (1), by adding at the end the following: “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.”;

17. 1997

    Food and Drug Administration Modernization Act of 1997

    Pub. L. 105–115 § 103(f)(2)(A) · 111 Stat. 2296

    Substituted · 21 U.S.C. § 379h(g)(2)(A)

    Pub. L. 105–115, § 103(f)(2)(A), substituted “Acts, or otherwise made available for obligation,” for “Acts”

    Source evidence

    Code amendment note
    Subsec. (g)(2)(A). Pub. L. 105–115, § 103(f)(2)(A), substituted “Acts, or otherwise made available for obligation,” for “Acts”.

    Enacted provision · exact public law section
    (A) in subparagraph (A), by striking “Acts” and inserting “Acts, or otherwise made available for obligation,”; and

18. 1997

    Food and Drug Administration Modernization Act of 1997

    Pub. L. 105–115 § 103(f)(2)(B) · 111 Stat. 2296

    Substituted · 21 U.S.C. § 379h(g)(2)(B)

    Pub. L. 105–115, § 103(f)(2)(B), substituted “over such costs, excluding costs paid from fees collected under this section, for fiscal year 1997” for “over such costs for fiscal year 1992”

    Source evidence

    Code amendment note
    Subsec. (g)(2)(B). Pub. L. 105–115, § 103(f)(2)(B), substituted “over such costs, excluding costs paid from fees collected under this section, for fiscal year 1997” for “over such costs for fiscal year 1992”.

    Enacted provision · exact public law section
    (B) in subparagraph (B), by striking “over such costs for fiscal year 1992” and inserting “over such costs, excluding costs paid from fees collected under this section, for fiscal year 1997”; and

19. 1997

    Food and Drug Administration Modernization Act of 1997

    Pub. L. 105–115 § 103(f)(3) · 111 Stat. 2296

    1. Added · 21 U.S.C. § 379h(g)(3); 21 U.S.C. § 379h(g)(4)

       Pub. L. 105–115, § 103(f)(3), added pars. (3) and (4)

    2. Struck · 21 U.S.C. § 379h(g)(3); 21 U.S.C. § 379h(g)(4)

       Pub. L. 105–115, § 103(f)(3), struck out heading and text of former par. (3). Text read as follows: “There are authorized to be appropriated for fees under this section—

    Source evidence

    Code amendment note
    Subsec. (g)(3), (4). Pub. L. 105–115, § 103(f)(3), added pars. (3) and (4) and struck out heading and text of former par. (3). Text read as follows: “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.”

    Enacted provision · exact public law section
    (3) by striking paragraph (3) and inserting the following: “(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 tees that would otherwise be authorized to be collected under this section pursuant to appropriation Acts for a subsequent fiscal year.”.

20. 1997

    Food and Drug Administration Modernization Act of 1997

    Pub. L. 105–115 § 103(g) · 111 Stat. 2296

    1. Added · 21 U.S.C. § 379h(i); 21 U.S.C. § 379h(j)

       Pub. L. 105–115, § 103(g), added subsec. (i)

    2. Redesignated · 21 U.S.C. § 379h(i); 21 U.S.C. § 379h(j)

       Pub. L. 105–115, § 103(g), redesignated former subsec. (i) as (j)

    Source evidence

    Code amendment note
    Subsecs. (i), (j). Pub. L. 105–115, § 103(g), added subsec. (i) and redesignated former subsec. (i) as (j).

    Enacted provision · exact public law section
    (g) Requirement for Written Requests for Waivers, Reductions, and Refunds.— Section 736 (21 U.S.C. 379h) is amended— (1) by redesignating subsection (i) as subsection (j); and (2) by inserting after subsection (h) the following: “(i) Written Requests for Waivers, Reductions, and Refunds.— To qualify for consideration for a waiver or reduction under subsection (d), or for a refund of any fee collected in accordance with subsection (a), 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.”.

21. 2002

    Best Pharmaceuticals for Children Act

    Pub. L. 107–109 § 5(a) · 115 Stat. 1408

    1. Redesignated · 21 U.S.C. § 379h(a)(1)(F); 21 U.S.C. § 379h(a)(1)(G)

       Pub. L. 107–109 redesignated subpar. (G) as (F)

    2. Struck · 21 U.S.C. § 379h(a)(1)(F); 21 U.S.C. § 379h(a)(1)(G)

       Pub. L. 107–109 struck out heading and text of former subpar. (F). Text read as follows: “A supplement to a human drug application proposing to include a new indication for use in pediatric populations shall not be assessed a fee under subparagraph (A).”

    Source evidence

    Code amendment note
    Subsec. (a)(1)(F), (G). Pub. L. 107–109 redesignated subpar. (G) as (F) and struck out heading and text of former subpar. (F). Text read as follows: “A supplement to a human drug application proposing to include a new indication for use in pediatric populations shall not be assessed a fee under subparagraph (A).”

    Enacted provision · exact public law section
    (a) Elimination of User Fee Waiver for Pediatric Supplements.— Section 736(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(a)(1)) is amended— (1) by striking subparagraph (F); and (2) by redesignating subparagraph (G) as subparagraph (F).

22. 2002

    Prescription Drug User Fee Amendments of 2002

    Pub. L. 107–188 § 504(a)(1) · 116 Stat. 594

    Substituted · 21 U.S.C. § 379h(a)

    Pub. L. 107–188, § 504(a)(1), substituted “fiscal year 2003” for “fiscal year 1998” in introductory provisions

    Source evidence

    Code amendment note
    Subsec. (a). Pub. L. 107–188, § 504(a)(1), substituted “fiscal year 2003” for “fiscal year 1998” in introductory provisions.

    Enacted provision · exact public law section
    (1) in the matter preceding paragraph (1), by striking “fiscal year 1998” and inserting “fiscal year 2003”;

23. 2002

    Prescription Drug User Fee Amendments of 2002

    Pub. L. 107–188 § 504(a)(2)(A) · 116 Stat. 594

    Substituted · 21 U.S.C. § 379h(a)(1)(A)(i)

    Pub. L. 107–188, § 504(a)(2)(A), substituted “under subsection (c)(4)” for “in subsection (b)”

    Source evidence

    Code amendment note
    Subsec. (a)(1)(A)(i). Pub. L. 107–188, § 504(a)(2)(A), substituted “under subsection (c)(4)” for “in subsection (b)”.

    Enacted provision · exact public law section
    (A) in each of clauses (i) and (ii), by striking “in subsection (b)” and inserting “under subsection (c)(4)”; and

24. 2002

    Prescription Drug User Fee Amendments of 2002

    Pub. L. 107–188 § 504(a)(2) · 116 Stat. 594

    1. Substituted · 21 U.S.C. § 379h(a)(1)(A)(ii)

       Pub. L. 107–188, § 504(a)(2), substituted “under subsection (c)(4)” for “in subsection (b)”

    2. Inserted · 21 U.S.C. § 379h(a)(1)(A)(ii)

       Pub. L. 107–188, § 504(a)(2), inserted “Such fee shall be half of the amount of the fee established under clause (i).” at end

    Source evidence

    Code amendment note
    Subsec. (a)(1)(A)(ii). Pub. L. 107–188, § 504(a)(2), substituted “under subsection (c)(4)” for “in subsection (b)” and inserted “Such fee shall be half of the amount of the fee established under clause (i).” at end.

    Enacted provision · exact public law section
    (2) in paragraph (1)(A)— (A) in each of clauses (i) and (ii), by striking “in subsection (b)” and inserting “under subsection (c)(4)”; and (B) in clause (ii), by adding at the end the following sentence: “Such fee shall be half of the amount of the fee established under clause (i).”;

25. 2002

    Prescription Drug User Fee Amendments of 2002

    Pub. L. 107–188 § 504(a)(3) · 116 Stat. 594

    1. Substituted · 21 U.S.C. § 379h(a)(2)(A)

       Pub. L. 107–188, § 504(a)(3), in concluding provisions, substituted “under subsection (c)(4)” for “in subsection (b)”

    2. Substituted · 21 U.S.C. § 379h(a)(2)(A)

       Pub. L. 107–188, § 504(a)(3), in concluding provisions, substituted “payable on or before October 1” for “payable on or before January 31”

    Source evidence

    Code amendment note
    Subsec. (a)(2)(A). Pub. L. 107–188, § 504(a)(3), in concluding provisions, substituted “under subsection (c)(4)” for “in subsection (b)” and “payable on or before October 1” for “payable on or before January 31”.

    Enacted provision · exact public law section
    (3) in paragraph (2)(A), in the matter after and below clause (ii)— (A) by striking “in subsection (b)” and inserting “under subsection (c)(4)”; and (B) by striking “payable on or before January 31” and inserting “payable on or before October 1”; and

26. 2002

    Prescription Drug User Fee Amendments of 2002

    Pub. L. 107–188 § 504(a)(4)(A) · 116 Stat. 594

    Amended · 21 U.S.C. § 379h(a)(3)(A)

    Pub. L. 107–188, § 504(a)(4)(A), amended heading and text of subpar. (A) generally. Prior to amendment, text read as follows: “Except as provided in subparagraph (B), each person—

    Source evidence

    Code amendment note
    Subsec. (a)(3)(A). Pub. L. 107–188, § 504(a)(4)(A), amended heading and text of subpar. (A) generally. Prior to amendment, text read as follows: “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.”

    Enacted provision · exact public law section
    (A) by amending subparagraph (A) to read as follows: “(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). 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.”; and

27. 2002

    Prescription Drug User Fee Amendments of 2002

    Pub. L. 107–188 § 504(a)(4)(B) · 116 Stat. 594

    Substituted · 21 U.S.C. § 379h(a)(3)(B)

    Pub. L. 107–188, § 504(a)(4)(B), substituted “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)” for “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)”

    Source evidence

    Code amendment note
    Subsec. (a)(3)(B). Pub. L. 107–188, § 504(a)(4)(B), substituted “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)” for “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)”.

    Enacted provision · exact public law section
    (B) in subparagraph (B), by striking “The listing” and all that follows through “filed under section 505(b)(2)” and inserting the following: “A prescription drug product shall not be assessed a fee under subparagraph (A) if such product is identified on the list compiled under section 505(j)(7)(A) 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 505(b)”.

28. 2002

    Prescription Drug User Fee Amendments of 2002

    Pub. L. 107–188 § 504(b) · 116 Stat. 594

    1. Amended · 21 U.S.C. § 379h(b)

       Pub. L. 107–188, § 504(b), amended heading and text of subsec. (b) generally

    2. Substituted · 21 U.S.C. § 379h(b)

       Pub. L. 107–188, § 504(b), substituting “Fee revenue amounts” for “Fee amounts” in heading

    3. Substituted · 21 U.S.C. § 379h(b)

       Pub. L. 107–188, § 504(b), substituting fee schedules for fiscal years 2003 to 2007 for fee provisions relating to fiscal years 1998 to 2002

    Source evidence

    Code amendment note
    Subsec. (b). Pub. L. 107–188, § 504(b), amended heading and text of subsec. (b) generally, substituting “Fee revenue amounts” for “Fee amounts” in heading and substituting fee schedules for fiscal years 2003 to 2007 for fee provisions relating to fiscal years 1998 to 2002.

    Enacted provision · exact public law section
    (b) Fee Amounts.—Section 736(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(b)) is amended to read as follows: “(b) Fee Revenue Amounts.—Except as provided in subsections (c), (d), (f), and (g), fees under subsection (a) 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 the date of the enactment of the Prescription Drug User Fee Amendments of 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.”.

29. 2002

    Prescription Drug User Fee Amendments of 2002

    Pub. L. 107–188 § 504(c)(1)(A) · 116 Stat. 594

    1. Substituted · 21 U.S.C. § 379h(c)(1)

       Pub. L. 107–188, § 504(c)(1)(A), (D), substituted “revenues” for “fees and total fee revenues” in concluding provisions

    2. Substituted · 21 U.S.C. § 379h(c)(1)

       Pub. L. 107–188, § 504(c)(1)(A), (D), substituted “fiscal year 2003” for “fiscal year 1997” in concluding provisions

    Source evidence

    Code amendment note
    Subsec. (c)(1). Pub. L. 107–188, § 504(c)(1)(A), (D), substituted “revenues” for “fees and total fee revenues” in introductory provisions and “fiscal year 2003” for “fiscal year 1997” in concluding provisions.

    Enacted provision · exact public law section
    (A) in the matter preceding subparagraph (A), by striking “fees and total fee revenues” and inserting “revenues”;

30. 2002

    Prescription Drug User Fee Amendments of 2002

    Pub. L. 107–188 § 504(c)(1)(B) · 116 Stat. 594

    1. Struck · 21 U.S.C. § 379h(c)(1)(A)

       Pub. L. 107–188, § 504(c)(1)(B), struck out “during the preceding fiscal year” before “in the Consumer Price Index”

    2. Substituted · 21 U.S.C. § 379h(c)(1)(A)

       Pub. L. 107–188, § 504(c)(1)(B), substituted “for the 12 month period ending June 30 preceding the fiscal year for which fees are being established, or” for “, or”

    Source evidence

    Code amendment note
    Subsec. (c)(1)(A). Pub. L. 107–188, § 504(c)(1)(B), struck out “during the preceding fiscal year” before “in the Consumer Price Index” and substituted “for the 12 month period ending June 30 preceding the fiscal year for which fees are being established, or” for “, or”.

    Enacted provision · exact public law section
    (B) in subparagraph (A)— (i) by striking “during the preceding fiscal year”; and (ii) by striking “, or” and inserting the following: “for the 12 month period ending June 30 preceding the fiscal year for which fees are being established, or”;

31. 2002

    Prescription Drug User Fee Amendments of 2002

    Pub. L. 107–188 § 504(c)(1)(C) · 116 Stat. 594

    Substituted · 21 U.S.C. § 379h(c)(1)(B)

    Pub. L. 107–188, § 504(c)(1)(C), substituted “for the previous fiscal year” for “for such fiscal year”

    Source evidence

    Code amendment note
    Subsec. (c)(1)(B). Pub. L. 107–188, § 504(c)(1)(C), substituted “for the previous fiscal year” for “for such fiscal year”.

    Enacted provision · exact public law section
    (C) in subparagraph (B), by striking “for such fiscal year” and inserting “for the previous fiscal year”; and

32. 2002

    Prescription Drug User Fee Amendments of 2002

    Pub. L. 107–188 § 504(c)(2) · 116 Stat. 594

    1. Added · 21 U.S.C. § 379h(c)(2)(5)

       Pub. L. 107–188, § 504(c)(2)–(4), added pars. (2) and (3)

    2. Redesignated · 21 U.S.C. § 379h(c)(2)(5)

       Pub. L. 107–188, § 504(c)(2)–(4), redesignated former pars. (2) and (3) as (4) and (5), respectively

    3. Amended · 21 U.S.C. § 379h(c)(2)(5)

       Pub. L. 107–188, § 504(c)(2)–(4), amended heading and text of par. (4) generally. Prior to amendment, text of par. (4) read as follows: “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.”

    Source evidence

    Code amendment note
    Subsec. (c)(2) to (5). Pub. L. 107–188, § 504(c)(2)–(4), added pars. (2) and (3), redesignated former pars. (2) and (3) as (4) and (5), respectively, and amended heading and text of par. (4) generally. Prior to amendment, text of par. (4) read as follows: “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.”

    Enacted provision · exact public law section
    (2) by redesignating paragraphs (2) and (3) as paragraphs (4) and (5), respectively;

33. 2002

    Prescription Drug User Fee Amendments of 2002

    Pub. L. 107–188 § 504(d)(1) · 116 Stat. 594

    1. Inserted · 21 U.S.C. § 379h(d)(1)(C)(E)

       Pub. L. 107–188, § 504(d)(1), inserted “or” at end of subpar. (C)

    2. Redesignated · 21 U.S.C. § 379h(d)(1)(C)(E)

       Pub. L. 107–188, § 504(d)(1), redesignated subpar. (E) as (D)

    3. Struck · 21 U.S.C. § 379h(d)(1)(C)(E)

       Pub. L. 107–188, § 504(d)(1), struck out former subpar. (D) which read as follows: “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”

    Source evidence

    Code amendment note
    Subsec. (d)(1)(C) to (E). Pub. L. 107–188, § 504(d)(1), inserted “or” at end of subpar. (C), redesignated subpar. (E) as (D), and struck out former subpar. (D) which read as follows: “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”.

    Enacted provision · exact public law section
    (1) in paragraph (1)— (A) in subparagraph (C), by inserting “or” after the comma at the end; (B) by striking subparagraph (D); and (C) by redesignating subparagraph (E) as subparagraph (D); and

34. 2002

    Prescription Drug User Fee Amendments of 2002

    Pub. L. 107–188 § 504(d)(2) · 116 Stat. 594

    Substituted · 21 U.S.C. § 379h(d)(3)(A); 21 U.S.C. § 379h(d)(3)(B)

    Pub. L. 107–188, § 504(d)(2), substituted “paragraph (1)(D)” for “paragraph (1)(E)”

    Source evidence

    Code amendment note
    Subsec. (d)(3)(A), (B). Pub. L. 107–188, § 504(d)(2), substituted “paragraph (1)(D)” for “paragraph (1)(E)”.

    Enacted provision · exact public law section
    (2) in paragraph (3), in each of subparagraphs (A) and (B), by striking “paragraph (1)(E)” each place such term appears and inserting “paragraph (1)(D)”.

35. 2002

    Prescription Drug User Fee Amendments of 2002

    Pub. L. 107–188 § 504(e)(1) · 116 Stat. 594

    Substituted · 21 U.S.C. § 379h(f)

    Pub. L. 107–188, § 504(e)(1), substituted “Limitations” for “Assessment of fees” in heading

    Source evidence

    Code amendment note
    Subsec. (f). Pub. L. 107–188, § 504(e)(1), substituted “Limitations” for “Assessment of fees” in heading.

    Enacted provision · exact public law section
    (1) in the heading for the subsection, by striking “Assessment of Fees.—” and inserting “Limitations.—”; and

36. 2002

    Prescription Drug User Fee Amendments of 2002

    Pub. L. 107–188 § 504(e)(2) · 116 Stat. 594

    1. Substituted · 21 U.S.C. § 379h(f)(1)

       Pub. L. 107–188, § 504(e)(2), substituted “In general” for “Limitation” in text

    2. Substituted · 21 U.S.C. § 379h(f)(1)

       Pub. L. 107–188, § 504(e)(2), substituted “Fees under subsection (a) shall be refunded for a fiscal year beginning” for “Fees may not be assessed under subsection (a) for a fiscal year beginning” in text

    Source evidence

    Code amendment note
    Subsec. (f)(1). Pub. L. 107–188, § 504(e)(2), substituted “In general” for “Limitation” in heading and “Fees under subsection (a) shall be refunded for a fiscal year beginning” for “Fees may not be assessed under subsection (a) for a fiscal year beginning” in text.

    Enacted provision · exact public law section
    (2) in paragraph (1), by striking the heading for the paragraph and all that follows through “fiscal year beginning” and inserting the following: “In general.—Fees under subsection (a) shall be refunded for a fiscal year beginning”.

37. 2002

    Prescription Drug User Fee Amendments of 2002

    Pub. L. 107–188 § 504(f)(1) · 116 Stat. 594

    Struck and inserted · 21 U.S.C. § 379h(g)(1)

    Pub. L. 107–188, § 504(f)(1), which directed the amendment of par. (1) by striking “Fees collected for a fiscal year” and all that follows through “fiscal year limitation.” and inserting “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.”, was not executed because the phrase “fiscal year limitation.” appeared in two places and because of the corrective amendment by Pub. L. 110–85, § 103(h)(1), which is effective as if included in Pub. L. 107–188, § 504. See 2007 Amendment note above and Effective Date of 2007 Amendment note below

    Source evidence

    Code amendment note
    Subsec. (g)(1). Pub. L. 107–188, § 504(f)(1), which directed the amendment of par. (1) by striking “Fees collected for a fiscal year” and all that follows through “fiscal year limitation.” and inserting “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.”, was not executed because the phrase “fiscal year limitation.” appeared in two places and because of the corrective amendment by Pub. L. 110–85, § 103(h)(1), which is effective as if included in Pub. L. 107–188, § 504. See 2007 Amendment note above and Effective Date of 2007 Amendment note below.

    Enacted provision · exact public law section
    (1) In general.— Section 736(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(g)(1)) is amended by striking “Fees collected for a fiscal year” and all that follows through “fiscal year limitation.” and inserting the following: “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.”.

38. 2002

    Prescription Drug User Fee Amendments of 2002

    Pub. L. 107–188 § 504(f)(2) · 116 Stat. 594

    1. Amended · 21 U.S.C. § 379h(g)(2)

       Pub. L. 107–188, § 504(f)(2), amended par. (2) by designating existing provisions as subpar. (A)

    2. Inserted · 21 U.S.C. § 379h(g)(2)

       Pub. L. 107–188, § 504(f)(2), inserting subpar. (A) heading

    3. Added · 21 U.S.C. § 379h(g)(2)

       Pub. L. 107–188, § 504(f)(2), adding subpar. (B)

    4. Redesignated · 21 U.S.C. § 379h(g)(2)

       Pub. L. 107–188, § 504(f)(2), redesignating former subpars. (A) and (B) as cls. (i) and (ii), respectively, of subpar. (A)

    5. Substituted · 21 U.S.C. § 379h(g)(2)

       Pub. L. 107–188, § 504(f)(2), substituting “shall be retained in each fiscal year in an amount not to exceed the amount specified” for “shall be collected in each fiscal year in an amount equal to the amount specified” in cl. (i), and realigning margin of cl. (ii)

    Source evidence

    Code amendment note
    Subsec. (g)(2). Pub. L. 107–188, § 504(f)(2), amended par. (2) by designating existing provisions as subpar. (A), inserting subpar. (A) heading, adding subpar. (B), redesignating former subpars. (A) and (B) as cls. (i) and (ii), respectively, of subpar. (A), substituting “shall be retained in each fiscal year in an amount not to exceed the amount specified” for “shall be collected in each fiscal year in an amount equal to the amount specified” in cl. (i), and realigning margin of cl. (ii).

    Enacted provision · exact public law section
    (2) Collections and appropriation acts.— Section 736(g)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(g)(2)) is amended— (A) by redesignating subparagraphs (A) and (B) as clauses (i) and (ii), respectively; (B) by striking “(2) Collections” and all that follows through “the amount specified” in clause (i) (as so redesignated) and inserting the following: “(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”; (C) by moving clause (ii) (as so redesignated) two ems to the right; and (D) by adding at the end the following subparagraph: “(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— “(i) are not more than 3 percent below the level specified in subparagraph (A)(ii); or “(ii) (I) are more than 3 percent below the level specified in subparagraph (A)(ii), and fees assessed for the fiscal year following the subsequent fiscal year are decreased by the amount in excess of 3 percent by which such costs fell below the level specified in such subparagraph; and “(II) such costs are not more than 5 percent below the level specified in such subparagraph.”.

39. 2002

    Prescription Drug User Fee Amendments of 2002

    Pub. L. 107–188 § 504(f)(3) · 116 Stat. 594

    1. Added · 21 U.S.C. § 379h(g)(3)(A)(E)

       Pub. L. 107–188, § 504(f)(3), added subpars. (A) to (E)

    2. Struck · 21 U.S.C. § 379h(g)(3)(A)(E)

       Pub. L. 107–188, § 504(f)(3), struck out former subpars. (A) to (E) which read as follows:

    Source evidence

    Code amendment note
    Subsec. (g)(3)(A) to (E). Pub. L. 107–188, § 504(f)(3), added subpars. (A) to (E) and struck out former subpars. (A) to (E) which read as follows:

    “(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,”.

    Enacted provision · exact public law section
    (3) Authorization of appropriations.—Section 736(g)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(g)(3)) is amended by striking subparagraphs (A) through (E) and inserting the following: “(A) $222,900,000 for fiscal year 2003; “(B) $231,000,000 for fiscal year 2004; “(C) $252,000,000 for fiscal year 2005; “(D) $259,300,000 for fiscal year 2006; and “(E) $259,300,000 for fiscal year 2007;”.

40. 2007

    Prescription Drug User Fee Amendments of 2007

    Pub. L. 110–85 § 103(a)(1) · 121 Stat. 823

    Substituted · 21 U.S.C. § 379h(a)

    Pub. L. 110–85, § 103(a)(1), substituted “2008” for “2003” in introductory provisions

    Source evidence

    Code amendment note
    Subsec. (a). Pub. L. 110–85, § 103(a)(1), substituted “2008” for “2003” in introductory provisions.

    Enacted provision · exact public law section
    (1) in the matter preceding paragraph (1), by striking “2003” and inserting “2008”;

41. 2007

    Prescription Drug User Fee Amendments of 2007

    Pub. L. 110–85 § 103(g) · 121 Stat. 823

    Substituted · 21 U.S.C. § 379h(a)(1)(A)

    Pub. L. 110–85, § 103(g), substituted “(c)(5)” for “(c)(4)” in cls. (i) and (ii)

    Source evidence

    Code amendment note
    Subsec. (a)(1)(A). Pub. L. 110–85, § 103(g), substituted “(c)(5)” for “(c)(4)” in cls. (i) and (ii).

    Enacted provision · exact public law section
    (g) Conforming Amendment.— Section 736(a) (21 U.S.C. 379h(a)) is amended in paragraphs (1)(A)(i), (1)(A)(ii), (2)(A), and (3)(A) by striking “(c)(4)” each place such term appears and inserting “(c)(5)”.

42. 2007

    Prescription Drug User Fee Amendments of 2007

    Pub. L. 110–85 § 103(a)(2)(A) · 121 Stat. 823

    Inserted · 21 U.S.C. § 379h(a)(1)(D)

    Pub. L. 110–85, § 103(a)(2)(A), inserted “or withdrawn before filing” after “refused for filing” in heading and “or withdrawn without a waiver before filing” before period at end of text

    Source evidence

    Code amendment note
    Subsec. (a)(1)(D). Pub. L. 110–85, § 103(a)(2)(A), inserted “or withdrawn before filing” after “refused for filing” in heading and “or withdrawn without a waiver before filing” before period at end of text.

    Enacted provision · exact public law section
    (A) in subparagraph (D)— (i) in the heading, by inserting “or withdrawn before filing” after “refused for filing”; and (ii) by inserting before the period at the end the following: “or withdrawn without a waiver before filing”;

43. 2007

    Prescription Drug User Fee Amendments of 2007

    Pub. L. 110–85 § 103(a)(2)(B) · 121 Stat. 823

    1. Added · 21 U.S.C. § 379h(a)(1)(E)(G)

       Pub. L. 110–85, § 103(a)(2)(B), (C), added subpar. (E)

    2. Redesignated · 21 U.S.C. § 379h(a)(1)(E)(G)

       Pub. L. 110–85, § 103(a)(2)(B), (C), redesignated former subpars. (E) and (F) as (F) and (G), respectively

    Source evidence

    Code amendment note
    Subsec. (a)(1)(E) to (G). Pub. L. 110–85, § 103(a)(2)(B), (C), added subpar. (E) and redesignated former subpars. (E) and (F) as (F) and (G), respectively.

    Enacted provision · exact public law section
    (B) by redesignating subparagraphs (E) and (F) as subparagraphs (F) and (G), respectively; and

44. 2007

    Prescription Drug User Fee Amendments of 2007

    Pub. L. 110–85 § 103(a)(3)(A) · 121 Stat. 823

    1. Substituted · 21 U.S.C. § 379h(a)(2)(A)

       Pub. L. 110–85, § 103(a)(3)(A), (g), substituted “subparagraphs (B) and (C)” for “subparagraph (B)” in concluding provisions

    2. Substituted · 21 U.S.C. § 379h(a)(2)(A)

       Pub. L. 110–85, § 103(a)(3)(A), (g), substituted “(c)(5)” for “(c)(4)” in concluding provisions

    Source evidence

    Code amendment note
    Subsec. (a)(2)(A). Pub. L. 110–85, § 103(a)(3)(A), (g), substituted “subparagraphs (B) and (C)” for “subparagraph (B)” in introductory provisions and “(c)(5)” for “(c)(4)” in concluding provisions.

    Enacted provision · exact public law section
    (A) in subparagraph (A), by striking “subparagraph (B)” and inserting “subparagraphs (B) and (C)”; and

45. 2007

    Prescription Drug User Fee Amendments of 2007

    Pub. L. 110–85 § 103(a)(3)(B) · 121 Stat. 823

    Added · 21 U.S.C. § 379h(a)(2)(C)

    Pub. L. 110–85, § 103(a)(3)(B), added subpar. (C)

    Source evidence

    Code amendment note
    Subsec. (a)(2)(C). Pub. L. 110–85, § 103(a)(3)(B), added subpar. (C).

    Enacted provision · exact public law section
    (B) by adding at the end the following: “(C) Special rules for positron emission tomography drugs.— “(i) In general.— Except as provided in clause (ii), each person who is named as the applicant in an approved human drug application for a positron emission tomography drug shall be subject under subparagraph (A) to one-sixth of an annual establishment fee with respect to each such establishment identified in the application as producing positron emission tomography drugs under the approved application. “(ii) Exception from annual establishment fee.— Each person who is named as the applicant in an application described in clause (i) shall not be assessed an annual establishment fee for a fiscal year if the person certifies to the Secretary, at a time specified by the Secretary and using procedures specified by the Secretary, that— “(I) the person is a not-for-profit medical center that has only 1 establishment for the production of positron emission tomography drugs; and “(II) at least 95 percent of the total number of doses of each positron emission tomography drug produced by such establishment during such fiscal year will be used within the medical center. “(iii) Definition.— For purposes of this subparagraph, the term ‘positron emission tomography drug’ has the meaning given to the term ‘compounded positron emission tomography drug’ in section 201(ii), except that paragraph (1)(B) of such section shall not apply.” .

46. 2007

    Prescription Drug User Fee Amendments of 2007

    Pub. L. 110–85 § 103(g) · 121 Stat. 823

    Substituted · 21 U.S.C. § 379h(a)(3)(A)

    Pub. L. 110–85, § 103(g), substituted “(c)(5)” for “(c)(4)”

    Source evidence

    Code amendment note
    Subsec. (a)(3)(A). Pub. L. 110–85, § 103(g), substituted “(c)(5)” for “(c)(4)”.

    Enacted provision · exact public law section
    (g) Conforming Amendment.— Section 736(a) (21 U.S.C. 379h(a)) is amended in paragraphs (1)(A)(i), (1)(A)(ii), (2)(A), and (3)(A) by striking “(c)(4)” each place such term appears and inserting “(c)(5)”.

47. 2007

    Prescription Drug User Fee Amendments of 2007

    Pub. L. 110–85 § 103(b) · 121 Stat. 823

    1. Amended · 21 U.S.C. § 379h(b)

       Pub. L. 110–85, § 103(b), amended subsec. (b) generally

    2. Substituted · 21 U.S.C. § 379h(b)

       Pub. L. 110–85, § 103(b), substituting provisions contained in pars. (1) to (4) relating to fee revenue amounts for fiscal years 2008 through 2012 for undesignated provisions relating to fee schedules for fiscal years 2003 to 2007

    Source evidence

    Code amendment note
    Subsec. (b). Pub. L. 110–85, § 103(b), amended subsec. (b) generally, substituting provisions contained in pars. (1) to (4) relating to fee revenue amounts for fiscal years 2008 through 2012 for undesignated provisions relating to fee schedules for fiscal years 2003 to 2007.

    Enacted provision · exact public law section
    (b) Fee Revenue Amounts.— Section 736(b) (21 U.S.C. 379h(b)) is amended to read as follows: “(b) Fee Revenue Amounts.— “(1) In general.— For each of the fiscal years 2008 through 2012, fees under subsection (a) shall, except as provided in subsections (c), (d), (f), and (g), be established to generate a total revenue amount under such subsection that is equal to the sum of— “(A) $392,783,000; and “(B) an amount equal to the modified workload adjustment factor for fiscal year 2007 (as determined under paragraph (3)). “(2) Types of fees.— Of the total revenue amount determined for a fiscal year under paragraph (1)— “(A) one-third shall be derived from fees under subsection (a)(1) (relating to human drug applications and supplements); “(B) one-third shall be derived from fees under subsection (a)(2) (relating to prescription drug establishments); and “(C) one-third shall be derived from fees under subsection (a)(3) (relating to prescription drug products). “(3) Modified workload adjustment factor for fiscal year 2007.— For purposes of paragraph (1)(B), the Secretary shall determine the modified workload adjustment factor by determining the dollar amount that results from applying the methodology that was in effect under subsection (c)(2) for fiscal year 2007 to the amount $354,893,000, except that, with respect to the portion of such determination that is based on the change in the total number of commercial investigational new drug applications, the Secretary shall count the number of such applications that were active during the most recent 12-month period for which data on such submissions is available. “(4) Additional fee revenues for drug safety.— “(A) In general.— For Applicability. each of the fiscal years 2008 through 2012, paragraph (1)(A) shall be applied by substituting the amount determined under subparagraph (B) for ‘$392,783,000’. “(B) Amount determined.— For each of the fiscal years 2008 through 2012, the amount determined under this subparagraph is the sum of— “(i) $392,783,000; plus “(ii) (I) for fiscal year 2008, $25,000,000; “(II) for fiscal year 2009, $35,000,000; “(III) for fiscal year 2010, $45,000,000; “(IV) for fiscal year 2011, $55,000,000; and “(V) for fiscal year 2012, $65,000,000.” .

48. 2007

    Prescription Drug User Fee Amendments of 2007

    Pub. L. 110–85 § 103(c)(1) · 121 Stat. 823

    1. Substituted · 21 U.S.C. § 379h(c)(1)

       Pub. L. 110–85, § 103(c)(1), amended par. (1) by substituting “For fiscal year 2009 and subsequent fiscal years, the revenues established in subsection (b)” for “The revenues established in subsection (b)” in introductory provisions

    2. Added · 21 U.S.C. § 379h(c)(1)

       Pub. L. 110–85, § 103(c)(1), adding subpar. (C)

    3. Substituted · 21 U.S.C. § 379h(c)(1)

       Pub. L. 110–85, § 103(c)(1), substituting “fiscal year 2008” for “fiscal year 2003” in concluding provisions

    Source evidence

    Code amendment note
    Subsec. (c)(1). Pub. L. 110–85, § 103(c)(1), amended par. (1) by substituting “For fiscal year 2009 and subsequent fiscal years, the revenues established in subsection (b)” for “The revenues established in subsection (b)” in introductory provisions, adding subpar. (C), and substituting “fiscal year 2008” for “fiscal year 2003” in concluding provisions.

    Enacted provision · exact public law section
    (1) Inflation adjustment.— Section 736(c)(1) (21 U.S.C. 379h(c)(1)) is amended— (A) in the matter preceding subparagraph (A), by striking “The revenues established in subsection (b)” and inserting “For fiscal year 2009 and subsequent fiscal years, the revenues established in subsection (b)”; (B) in subparagraph (A), by striking “or” at the end; (C) in subparagraph (B), by striking the period at the end and inserting “, or”; (D) by inserting after subparagraph (B) the following: “(C) the average annual 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 5 years of the preceding 6 fiscal years.” ; and (E) in the matter following subparagraph (C) (as added by subparagraph (D)), by striking “fiscal year 2003” and inserting “fiscal year 2008”.

49. 2007

    Prescription Drug User Fee Amendments of 2007

    Pub. L. 110–85 § 103(c)(2)(A) · 121 Stat. 823

    Substituted · 21 U.S.C. § 379h(c)(2)

    Pub. L. 110–85, § 103(c)(2)(A), substituted “For fiscal year 2009 and subsequent fiscal years,” for “Beginning with fiscal year 2004,” in introductory provisions

    Source evidence

    Code amendment note
    Subsec. (c)(2). Pub. L. 110–85, § 103(c)(2)(A), substituted “For fiscal year 2009 and subsequent fiscal years,” for “Beginning with fiscal year 2004,” in introductory provisions.

    Enacted provision · exact public law section
    (A) in the matter preceding subparagraph (A), by striking “Beginning with fiscal year 2004,” and inserting “For fiscal year 2009 and subsequent fiscal years,”;

50. 2007

    Prescription Drug User Fee Amendments of 2007

    Pub. L. 110–85 § 103(c)(2)(B) · 121 Stat. 823

    Substituted · 21 U.S.C. § 379h(c)(2)(A)

    Pub. L. 110–85, § 103(c)(2)(B), substituted “human drug applications (adjusted for changes in review activities, as described in the notice that the Secretary is required to publish in the Federal Register under this subparagraph), efficacy supplements, and manufacturing supplements submitted to the Secretary, and the change in the total number of active commercial investigational new drug applications (adjusted for changes in review activities, as so described) during the most recent 12-month period for which data on such submissions is available.” for “human drug applications, commercial investigational new drug applications, efficacy supplements, and manufacturing supplements submitted to the Secretary.” in first sentence

    Source evidence

    Code amendment note
    Subsec. (c)(2)(A). Pub. L. 110–85, § 103(c)(2)(B), substituted “human drug applications (adjusted for changes in review activities, as described in the notice that the Secretary is required to publish in the Federal Register under this subparagraph), efficacy supplements, and manufacturing supplements submitted to the Secretary, and the change in the total number of active commercial investigational new drug applications (adjusted for changes in review activities, as so described) during the most recent 12-month period for which data on such submissions is available.” for “human drug applications, commercial investigational new drug applications, efficacy supplements, and manufacturing supplements submitted to the Secretary.” in first sentence.

    Enacted provision · exact public law section
    (B) in subparagraph (A), in the first sentence— (i) by striking “human drug applications,” and inserting “human drug applications (adjusted for changes in review activities, as described in the notice that the Secretary is required to publish in the Federal Register under this subparagraph),”; (ii) by striking “commercial investigational new drug applications,”; and (iii) by inserting before the period the following: “, and the change in the total number of active commercial investigational new drug applications (adjusted for changes in review activities, as so described) during the most recent 12-month period for which data on such submissions is available”;

51. 2007

    Prescription Drug User Fee Amendments of 2007

    Pub. L. 110–85 § 103(c)(2)(C) · 121 Stat. 823

    Inserted · 21 U.S.C. § 379h(c)(2)(B)

    Pub. L. 110–85, § 103(c)(2)(C), inserted at end “Any adjustment for changes in review activities made in setting fees and revenue amounts for fiscal year 2009 may not result in the total workload adjustment being more than 2 percentage points higher than it would have been in the absence of the adjustment for changes in review activities.”

    Source evidence

    Code amendment note
    Subsec. (c)(2)(B). Pub. L. 110–85, § 103(c)(2)(C), inserted at end “Any adjustment for changes in review activities made in setting fees and revenue amounts for fiscal year 2009 may not result in the total workload adjustment being more than 2 percentage points higher than it would have been in the absence of the adjustment for changes in review activities.”

    Enacted provision · exact public law section
    (C) in subparagraph (B), by adding at the end the following: “Any adjustment for changes in review activities made in setting fees and revenue amounts for fiscal year 2009 may not result in the total workload adjustment being more than 2 percentage points higher than it would have been in the absence of the adjustment for changes in review activities.”; and

52. 2007

    Prescription Drug User Fee Amendments of 2007

    Pub. L. 110–85 § 103(c)(2)(D) · 121 Stat. 823

    Added · 21 U.S.C. § 379h(c)(2)(C)

    Pub. L. 110–85, § 103(c)(2)(D), added subpar. (C)

    Source evidence

    Code amendment note
    Subsec. (c)(2)(C). Pub. L. 110–85, § 103(c)(2)(D), added subpar. (C).

    Enacted provision · exact public law section
    (D) by adding at the end the following: “(C) The Contracts. Study. Secretary shall contract with an independent accounting firm to study the adjustment for changes in review activities applied in setting fees and revenue amounts for fiscal year 2009 and to make recommendations, if warranted, for future changes in the methodology for calculating the adjustment. Effective date. After review of the recommendations, the Secretary shall, if warranted, make appropriate changes to the methodology, and the changes shall be effective for each of the fiscal years 2010 through 2012. The Secretary shall not make any adjustment for changes in review activities for any fiscal year after 2009 unless such study has been completed.” .

53. 2007

    Prescription Drug User Fee Amendments of 2007

    Pub. L. 110–85 § 103(c)(3) · 121 Stat. 823

    Redesignated · 21 U.S.C. § 379h(c)(3)

    Pub. L. 110–85, § 103(c)(3), added par. (3). Former par. (3) redesignated (4)

    Source evidence

    Code amendment note
    Subsec. (c)(3). Pub. L. 110–85, § 103(c)(3), added par. (3). Former par. (3) redesignated (4).

    Enacted provision · exact public law section
    (3) Rent and rent-related cost adjustment.— Section 736(c) (21 U.S.C. 379h(c)) is amended— (A) by redesignating paragraphs (3), (4), and (5) as paragraphs (4), (5), and (6), respectively; and (B) by inserting after paragraph (2) the following: “(3) Rent and rent-related cost adjustment.— For fiscal year 2010 and each subsequent fiscal year, the Secretary shall, before making adjustments under paragraphs (1) and (2), decrease the fee revenue amount established in subsection (b) if actual costs paid for rent and rent-related expenses for the preceding fiscal year are less than estimates made for such year in fiscal year 2006. Any reduction made under this paragraph shall not exceed the amount by which such costs fall below the estimates made in fiscal year 2006 for such fiscal year, and shall not exceed $11,721,000 for any fiscal year.” .

54. 2007

    Prescription Drug User Fee Amendments of 2007

    Pub. L. 110–85 § 103(c)(3)(A) · 121 Stat. 823

    1. Redesignated · 21 U.S.C. § 379h(c)(4)

       Pub. L. 110–85, § 103(c)(3)(A), (4), redesignated par. (3) as (4)

    2. Redesignated · 21 U.S.C. § 379h(c)(4)

       Pub. L. 110–85, § 103(c)(3)(A), (4), amended it generally. Prior to amendment, text read as follows: “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.” Former par. (4) redesignated (5)

    Source evidence

    Code amendment note
    Subsec. (c)(4). Pub. L. 110–85, § 103(c)(3)(A), (4), redesignated par. (3) as (4) and amended it generally. Prior to amendment, text read as follows: “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.” Former par. (4) redesignated (5).

    Enacted provision · exact public law section
    (A) by redesignating paragraphs (3), (4), and (5) as paragraphs (4), (5), and (6), respectively; and

55. 2007

    Prescription Drug User Fee Amendments of 2007

    Pub. L. 110–85 § 103(c)(3)(A) · 121 Stat. 823

    1. Redesignated · 21 U.S.C. § 379h(c)(5)

       Pub. L. 110–85, § 103(c)(3)(A), (5), redesignated par. (4) as (5)

    2. Redesignated · 21 U.S.C. § 379h(c)(5)

       Pub. L. 110–85, § 103(c)(3)(A), (5), substituted “2007” for “2002”. Former par. (5) redesignated (6)

    Source evidence

    Code amendment note
    Subsec. (c)(5). Pub. L. 110–85, § 103(c)(3)(A), (5), redesignated par. (4) as (5) and substituted “2007” for “2002”. Former par. (5) redesignated (6).

    Enacted provision · exact public law section
    (A) by redesignating paragraphs (3), (4), and (5) as paragraphs (4), (5), and (6), respectively; and

56. 2007

    Prescription Drug User Fee Amendments of 2007

    Pub. L. 110–85 § 103(c)(3)(A) · 121 Stat. 823

    Redesignated · 21 U.S.C. § 379h(c)(6)

    Pub. L. 110–85, § 103(c)(3)(A), redesignated par. (5) as (6)

    Source evidence

    Code amendment note
    Subsec. (c)(6). Pub. L. 110–85, § 103(c)(3)(A), redesignated par. (5) as (6).

    Enacted provision · exact public law section
    (A) by redesignating paragraphs (3), (4), and (5) as paragraphs (4), (5), and (6), respectively; and

57. 2007

    Prescription Drug User Fee Amendments of 2007

    Pub. L. 110–85 § 103(d)(1) · 121 Stat. 823

    Inserted · 21 U.S.C. § 379h(d)(1)

    Pub. L. 110–85, § 103(d)(1), inserted “to a person who is named as the applicant in a human drug application” after “The Secretary shall grant” and “to that person” after “one or more fees assessed” in introductory provisions

    Source evidence

    Code amendment note
    Subsec. (d)(1). Pub. L. 110–85, § 103(d)(1), inserted “to a person who is named as the applicant in a human drug application” after “The Secretary shall grant” and “to that person” after “one or more fees assessed” in introductory provisions.

    Enacted provision · exact public law section
    (1) in paragraph (1), in the matter preceding subparagraph (A)— (A) by inserting after “The Secretary shall grant” the following: “to a person who is named as the applicant in a human drug application”; and (B) by inserting “to that person” after “one or more fees assessed”;

58. 2007

    Prescription Drug User Fee Amendments of 2007

    Pub. L. 110–85 § 103(d)(2) · 121 Stat. 823

    1. Added · 21 U.S.C. § 379h(d)(2); 21 U.S.C. § 379h(d)(3)

       Pub. L. 110–85, § 103(d)(2), (3), added par. (2)

    2. Redesignated · 21 U.S.C. § 379h(d)(2); 21 U.S.C. § 379h(d)(3)

       Pub. L. 110–85, § 103(d)(2), (3), redesignated former par. (2) as (3). Former par. (3) redesignated (4)

    Source evidence

    Code amendment note
    Subsec. (d)(2), (3). Pub. L. 110–85, § 103(d)(2), (3), added par. (2) and redesignated former par. (2) as (3). Former par. (3) redesignated (4).

    Enacted provision · exact public law section
    (2) by redesignating paragraphs (2) and (3) as paragraphs (3) and (4), respectively;

59. 2007

    Prescription Drug User Fee Amendments of 2007

    Pub. L. 110–85 § 103(d)(2) · 121 Stat. 823

    Redesignated · 21 U.S.C. § 379h(d)(4)

    Pub. L. 110–85, § 103(d)(2), redesignated par. (3) as (4)

    Source evidence

    Code amendment note
    Subsec. (d)(4). Pub. L. 110–85, § 103(d)(2), redesignated par. (3) as (4).

    Enacted provision · exact public law section
    (2) by redesignating paragraphs (2) and (3) as paragraphs (3) and (4), respectively;

60. 2007

    Prescription Drug User Fee Amendments of 2007

    Pub. L. 110–85 § 103(d)(4) · 121 Stat. 823

    Inserted · 21 U.S.C. § 379h(d)(4)(A)

    Pub. L. 110–85, § 103(d)(4), inserted before period at end “, 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”

    Source evidence

    Code amendment note
    Subsec. (d)(4)(A). Pub. L. 110–85, § 103(d)(4), inserted before period at end “, 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”.

    Enacted provision · exact public law section
    (4) in paragraph (4) (as redesignated by paragraph (2)), in subparagraph (A), by inserting before the period the following: “, 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”.

61. 2007

    Prescription Drug User Fee Amendments of 2007

    Pub. L. 110–85 § 103(h)(1) · 121 Stat. 823

    Substituted · 21 U.S.C. § 379h(g)(1)

    Pub. L. 110–85, § 103(h)(1), substituted “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.” for “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.”

    Source evidence

    Code amendment note
    Subsec. (g)(1). Pub. L. 110–85, § 103(h)(1), substituted “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.” for “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.”

    Enacted provision · exact public law section
    (1) Amendment.— Section 736(g)(1) (21 U.S.C. 379h(g)(1)) is amended by striking the first sentence and inserting the following: “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.”.

62. 2007

    Prescription Drug User Fee Amendments of 2007

    Pub. L. 110–85 § 103(e)(1) · 121 Stat. 823

    Amended · 21 U.S.C. § 379h(g)(3)

    Pub. L. 110–85, § 103(e)(1), amended par. (3) generally. Prior to amendment, par. (3) authorized appropriations for fiscal years 2003 to 2007

    Source evidence

    Code amendment note
    Subsec. (g)(3). Pub. L. 110–85, § 103(e)(1), amended par. (3) generally. Prior to amendment, par. (3) authorized appropriations for fiscal years 2003 to 2007.

    Enacted provision · exact public law section
    (1) Authorization of appropriations.— Section 736(g)(3) (21 U.S.C. 379h(g)(3)) is amended to read as follows: “(3) Authorization of appropriations.— For each of the fiscal years 2008 through 2012, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount determined under subsection (b) for the fiscal year, as adjusted or otherwise affected under subsection (c) and paragraph (4) of this subsection.” .

63. 2007

    Prescription Drug User Fee Amendments of 2007

    Pub. L. 110–85 § 103(e)(2) · 121 Stat. 823

    Amended · 21 U.S.C. § 379h(g)(4)

    Pub. L. 110–85, § 103(e)(2), reenacted heading without change and amended text generally. Prior to amendment, text read as follows: “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.”

    Source evidence

    Code amendment note
    Subsec. (g)(4). Pub. L. 110–85, § 103(e)(2), reenacted heading without change and amended text generally. Prior to amendment, text read as follows: “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.”

    Enacted provision · exact public law section
    (2) Offset.— Section 736(g)(4) (21 U.S.C. 379h(g)(4)) is amended to read as follows: “(4) Offset.— If the sum of the cumulative amount of fees collected under this section for the fiscal years 2008 through 2010 and the amount of fees estimated to be collected under this section for fiscal year 2011 exceeds the cumulative amount appropriated under paragraph (3) for the fiscal years 2008 through 2011, the excess 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 fiscal year 2012.” .

64. 2007

    Prescription Drug User Fee Amendments of 2007

    Pub. L. 110–85 § 103(f) · 121 Stat. 823

    Added · 21 U.S.C. § 379h(k)

    Pub. L. 110–85, § 103(f), added subsec. (k)

    Source evidence

    Code amendment note
    Subsec. (k). Pub. L. 110–85, § 103(f), added subsec. (k).

    Enacted provision · exact public law section
    (f) Exemption for Orphan Drugs.— Section 736 (21 U.S.C. 379h) is further amended by adding at the end the following: “(k) Orphan Drugs.— “(1) Exemption.— A drug designated under section 526 for a rare disease or condition and approved under section 505 or under section 351 of the Public Health Service Act shall be exempt from product and establishment fees under this section, if the drug meets all of the following conditions: “(A) The drug meets the public health requirements contained in this Act as such requirements are applied to requests for waivers for product and establishment fees. “(B) The drug is owned or licensed and is marketed by a company that had less than $50,000,000 in gross worldwide revenue during the previous year. “(2) Evidence of qualification.— An exemption under paragraph (1) applies with respect to a drug only if the applicant involved submits a certification that its gross annual revenues did not exceed $50,000,000 for the preceding 12 months before the exemption was requested.” .

65. 2012

    Prescription Drug User Fee Amendments of 2012

    Pub. L. 112–144 § 103(1)(A) · 126 Stat. 993

    Substituted · 21 U.S.C. § 379h(a)

    Pub. L. 112–144, § 103(1)(A), substituted “fiscal year 2013” for “fiscal year 2008” in introductory provisions

    Source evidence

    Code amendment note
    Subsec. (a). Pub. L. 112–144, § 103(1)(A), substituted “fiscal year 2013” for “fiscal year 2008” in introductory provisions.

    Enacted provision · exact public law section
    (A) in the matter preceding paragraph (1), by striking “fiscal year 2008” and inserting “fiscal year 2013”;

66. 2012

    Prescription Drug User Fee Amendments of 2012

    Pub. L. 112–144 § 103(1)(B) · 126 Stat. 993

    Substituted · 21 U.S.C. § 379h(a)(1)(A)

    Pub. L. 112–144, § 103(1)(B), substituted “(c)(4)” for “(c)(5)” in cls. (i) and (ii)

    Source evidence

    Code amendment note
    Subsec. (a)(1)(A). Pub. L. 112–144, § 103(1)(B), substituted “(c)(4)” for “(c)(5)” in cls. (i) and (ii).

    Enacted provision · exact public law section
    (B) in paragraph (1)(A)— (i) in clause (i), by striking “(c)(5)” and inserting “(c)(4)”; and (ii) in clause (ii), by striking “(c)(5)” and inserting “(c)(4)”;

67. 2012

    Prescription Drug User Fee Amendments of 2012

    Pub. L. 112–144 § 103(1)(C) · 126 Stat. 993

    1. Substituted · 21 U.S.C. § 379h(a)(2)(A)

       Pub. L. 112–144, § 103(1)(C), substituted “(c)(4)” for “(c)(5)” in concluding provisions

    2. Substituted · 21 U.S.C. § 379h(a)(2)(A)

       Pub. L. 112–144, § 103(1)(C), substituted “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” for “payable on or before October 1 of each year” in concluding provisions

    Source evidence

    Code amendment note
    Subsec. (a)(2)(A). Pub. L. 112–144, § 103(1)(C), substituted “(c)(4)” for “(c)(5)” and “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” for “payable on or before October 1 of each year” in concluding provisions.

    Enacted provision · exact public law section
    (C) in the matter following clause (ii) in paragraph (2)(A)— (i) by striking “(c)(5)” and inserting “(c)(4)”; and (ii) by striking “payable on or before October 1 of each year” and inserting “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”;

68. 2012

    Prescription Drug User Fee Amendments of 2012

    Pub. L. 112–144 § 103(1)(D)(i) · 126 Stat. 993

    1. Substituted · 21 U.S.C. § 379h(a)(3)(A)

       Pub. L. 112–144, § 103(1)(D)(i), substituted “subsection (c)(4)” for “subsection (c)(5)”

    2. Substituted · 21 U.S.C. § 379h(a)(3)(A)

       Pub. L. 112–144, § 103(1)(D)(i), substituted “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.” for “payable on or before October 1 of each year.”

    Source evidence

    Code amendment note
    Subsec. (a)(3)(A). Pub. L. 112–144, § 103(1)(D)(i), substituted “subsection (c)(4)” for “subsection (c)(5)” and “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.” for “payable on or before October 1 of each year.”

    Enacted provision · exact public law section
    (i) in subparagraph (A)— (I) by striking “subsection (c)(5)” and inserting “subsection (c)(4)”; and (II) by striking “payable on or before October 1 of each year.” and inserting “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.”; and

69. 2012

    Prescription Drug User Fee Amendments of 2012

    Pub. L. 112–144 § 103(1)(D)(ii) · 126 Stat. 993

    Amended · 21 U.S.C. § 379h(a)(3)(B)

    Pub. L. 112–144, § 103(1)(D)(ii), amended subpar. (B) generally. Prior to amendment, text read as follows: “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.”

    Source evidence

    Code amendment note
    Subsec. (a)(3)(B). Pub. L. 112–144, § 103(1)(D)(ii), amended subpar. (B) generally. Prior to amendment, text read as follows: “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.”

    Enacted provision · exact public law section
    (ii) by amending subparagraph (B) to read as follows: “(B) Exception.— A prescription drug product shall not be assessed a fee under subparagraph (A) if such product is— “(i) identified on the list compiled under section 505(j)(7) with a potency described in terms of per 100 mL; “(ii) the same product as another product that— “(I) was approved under an application filed under section 505(b) or 505(j); and “(II) is not in the list of discontinued products compiled under section 505(j)(7); “(iii) the same product as another product that was approved under an abbreviated application filed under section 507 (as in effect on the day before the date of enactment of the Food and Drug Administration Modernization Act of 1997); or “(iv) the same product as another product that was approved 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.” ;

70. 2012

    Prescription Drug User Fee Amendments of 2012

    Pub. L. 112–144 § 103(2)(A)(i) · 126 Stat. 993

    Substituted · 21 U.S.C. § 379h(b)(1)

    Pub. L. 112–144, § 103(2)(A)(i), substituted “fiscal years 2013 through 2017” for “fiscal years 2008 through 2012” in introductory provisions

    Source evidence

    Code amendment note
    Subsec. (b)(1). Pub. L. 112–144, § 103(2)(A)(i), substituted “fiscal years 2013 through 2017” for “fiscal years 2008 through 2012” in introductory provisions.

    Enacted provision · exact public law section
    (i) in the matter preceding subparagraph (A), by striking “fiscal years 2008 through 2012” and inserting “fiscal years 2013 through 2017”;

71. 2012

    Prescription Drug User Fee Amendments of 2012

    Pub. L. 112–144 § 103(2)(A)(ii) · 126 Stat. 993

    Substituted · 21 U.S.C. § 379h(b)(1)(A)

    Pub. L. 112–144, § 103(2)(A)(ii), substituted “$693,099,000;” for “$392,783,000; and”

    Source evidence

    Code amendment note
    Subsec. (b)(1)(A). Pub. L. 112–144, § 103(2)(A)(ii), substituted “$693,099,000;” for “$392,783,000; and”.

    Enacted provision · exact public law section
    (ii) in subparagraph (A), by striking “$392,783,000; and” and inserting “$693,099,000;”; and

72. 2012

    Prescription Drug User Fee Amendments of 2012

    Pub. L. 112–144 § 103(2)(A)(iii) · 126 Stat. 993

    1. Added · 21 U.S.C. § 379h(b)(1)(B); 21 U.S.C. § 379h(b)(1)(C)

       Pub. L. 112–144, § 103(2)(A)(iii), added subpars. (B) and (C)

    2. Struck · 21 U.S.C. § 379h(b)(1)(B); 21 U.S.C. § 379h(b)(1)(C)

       Pub. L. 112–144, § 103(2)(A)(iii), struck out former subpar. (B) which read as follows: “an amount equal to the modified workload adjustment factor for fiscal year 2007 (as determined under paragraph (3)).”

    Source evidence

    Code amendment note
    Subsec. (b)(1)(B), (C). Pub. L. 112–144, § 103(2)(A)(iii), added subpars. (B) and (C) and struck out former subpar. (B) which read as follows: “an amount equal to the modified workload adjustment factor for fiscal year 2007 (as determined under paragraph (3)).”

    Enacted provision · exact public law section
    (iii) by striking subparagraph (B) and inserting the following: “(B) the dollar amount equal to the inflation adjustment for fiscal year 2013 (as determined under paragraph (3)(A)); and “(C) the dollar amount equal to the workload adjustment for fiscal year 2013 (as determined under paragraph (3)(B)).” ; and

73. 2012

    Prescription Drug User Fee Amendments of 2012

    Pub. L. 112–144 § 103(2)(B) · 126 Stat. 993

    1. Added · 21 U.S.C. § 379h(b)(3); 21 U.S.C. § 379h(b)(4)

       Pub. L. 112–144, § 103(2)(B), added par. (3)

    2. Struck · 21 U.S.C. § 379h(b)(3); 21 U.S.C. § 379h(b)(4)

       Pub. L. 112–144, § 103(2)(B), struck out former pars. (3) and (4) which related to the modified workload adjustment factor for fiscal year 2007 and additional fee revenues for drug safety for fiscal years 2008 through 2012, respectively

    Source evidence

    Code amendment note
    Subsec. (b)(3), (4). Pub. L. 112–144, § 103(2)(B), added par. (3) and struck out former pars. (3) and (4) which related to the modified workload adjustment factor for fiscal year 2007 and additional fee revenues for drug safety for fiscal years 2008 through 2012, respectively.

    Enacted provision · exact public law section
    (B) by striking paragraphs (3) and (4) and inserting the following: “(3) Fiscal year 2013 inflation and workload adjustments.— For purposes of paragraph (1), the dollar amount of the inflation and workload adjustments for fiscal year 2013 shall be determined as follows: “(A) Inflation adjustment.— The inflation adjustment for fiscal year 2013 shall be the sum of— “(i) $652,709,000 multiplied by the result of an inflation adjustment calculation determined using the methodology described in subsection (c)(1)(B); and “(ii) $652,709,000 multiplied by the result of an inflation adjustment calculation determined using the methodology described in subsection (c)(1)(C). “(B) Workload adjustment.— Subject to subparagraph (C), the workload adjustment for fiscal 2013 shall be— “(i) $652,709,000 plus the amount of the inflation adjustment calculated under subparagraph (A); multiplied by “(ii) the amount (if any) by which a percentage workload adjustment for fiscal year 2013, as determined using the methodology described in subsection (c)(2)(A), would exceed the percentage workload adjustment (as so determined) for fiscal year 2012, if both such adjustment percentages were calculated using the 5-year base period consisting of fiscal years 2003 through 2007. “(C) Limitation.— Under no circumstances shall the adjustment under subparagraph (B) result in fee revenues for fiscal year 2013 that are less than the sum of the amount under paragraph (1)(A) and the amount under paragraph (1)(B).” ;

74. 2012

    Prescription Drug User Fee Amendments of 2012

    Pub. L. 112–144 § 103(3) · 126 Stat. 993

    1. Added · 21 U.S.C. § 379h(c)

       Pub. L. 112–144, § 103(3), added subsec. (c)

    2. Struck · 21 U.S.C. § 379h(c)

       Pub. L. 112–144, § 103(3), struck out former subsec. (c) which related to inflation adjustment for fiscal year 2009 and subsequent fiscal years, workload adjustment for fiscal year 2009 and subsequent fiscal years, rent and rent-related cost adjustment for fiscal year 2010 and each subsequent fiscal year, final year adjustment for fiscal year 2012, annual fee setting for each fiscal year that began after Sept. 30, 2007, and the limit on the total amount of fees charged for a fiscal year

    Source evidence

    Code amendment note
    Subsec. (c). Pub. L. 112–144, § 103(3), added subsec. (c) and struck out former subsec. (c) which related to inflation adjustment for fiscal year 2009 and subsequent fiscal years, workload adjustment for fiscal year 2009 and subsequent fiscal years, rent and rent-related cost adjustment for fiscal year 2010 and each subsequent fiscal year, final year adjustment for fiscal year 2012, annual fee setting for each fiscal year that began after Sept. 30, 2007, and the limit on the total amount of fees charged for a fiscal year.

    Enacted provision · exact public law section
    (3) by striking subsection (c) and inserting the following: “(c) Adjustments.— “(1) Inflation adjustment.— Notice. Federal Register, publication. For fiscal year 2014 and subsequent fiscal years, the revenues established in subsection (b) shall be adjusted by the Secretary by notice, published in the Federal Register, for a fiscal year by the amount equal to the sum of— “(A) one; “(B) 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 735(6)) for the first 3 years of the preceding 4 fiscal years, and “(C) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–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 735(6)) for the first 3 years of the preceding 4 fiscal years. The adjustment made each fiscal year under this paragraph shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2013 under this paragraph. “(2) Workload adjustment.— For fiscal year 2014 and subsequent fiscal years, after the fee revenues established in subsection (b) 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) Determination. Time period. The adjustment shall be determined by the Secretary based on a weighted average of the change in the total number of human drug applications (adjusted for changes in review activities, as described in the notice that the Secretary is required to publish in the Federal Register under this subparagraph), efficacy supplements, and manufacturing supplements submitted to the Secretary, and the change in the total number of active commercial investigational new drug applications (adjusted for changes in review activities, as so described) during the most recent 12-month period for which data on such submissions is available. Federal Register, publication. The Secretary shall publish in the Federal Register the fee revenues and fees resulting from the adjustment and the supporting methodologies. “(B) Under no circumstances shall the adjustment result in fee revenues for a fiscal year that are less than the sum of the amount under subsection (b)(1)(A) and the amount under subsection (b)(1)(B), as adjusted for inflation under paragraph (1). “(C) Contracts. Reviews. Deadlines. The Secretary shall contract with an independent accounting or consulting firm to periodically review the adequacy of the adjustment and publish the results of those reviews. The first review shall be conducted and published by the end of fiscal year 2013 (to examine the performance of the adjustment since fiscal year 2009), and the second review shall be conducted and published by the end of fiscal year 2015 (to examine the continued performance of the adjustment). Reports. The reports shall evaluate whether the adjustment reasonably represents actual changes in workload volume and complexity and present options to discontinue, retain, or modify any elements of the adjustment. Publication. Public comments. The reports shall be published for public comment. After review of the reports and receipt of public comments, the Secretary shall, if warranted, adopt appropriate changes to the methodology. Effective date. If the Secretary adopts changes to the methodology based on the first report, the changes shall be effective for the first fiscal year for which fees are set after the Secretary adopts such changes and each subsequent fiscal year. “(3) Final year adjustment.— For fiscal year 2017, the Secretary may, in addition to adjustments under this paragraph and paragraphs (1) and (2), further increase the fee revenues and fees established in subsection (b) if such an adjustment is necessary to provide for not more than 3 months of operating reserves of carryover user fees for the process for the review of human drug applications for the first 3 months of fiscal year 2018. 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 2017. If the Secretary has carryover balances for such process in excess of 3 months of such operating reserves, the adjustment under this paragraph shall not be made. “(4) Annual fee setting.— Deadline. The Secretary shall, not later than 60 days before the start of each fiscal year that begins after September 30, 2012, establish, for the next fiscal year, application, product, and establishment fees under subsection (a), based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection. “(5) 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.” ; and

75. 2012

    Prescription Drug User Fee Amendments of 2012

    Pub. L. 112–144 § 103(4)(A) · 126 Stat. 993

    Substituted · 21 U.S.C. § 379h(g)(1)

    Pub. L. 112–144, § 103(4)(A), substituted “Subject to paragraph (2)(C), fees authorized” for “Fees authorized”

    Source evidence

    Code amendment note
    Subsec. (g)(1). Pub. L. 112–144, § 103(4)(A), substituted “Subject to paragraph (2)(C), fees authorized” for “Fees authorized”.

    Enacted provision · exact public law section
    (A) in paragraph (1), by striking “Fees authorized” and inserting “Subject to paragraph (2)(C), fees authorized”;

76. 2012

    Prescription Drug User Fee Amendments of 2012

    Pub. L. 112–144 § 103(4)(B)(i) · 126 Stat. 993

    Substituted · 21 U.S.C. § 379h(g)(2)(A)(i)

    Pub. L. 112–144, § 103(4)(B)(i), substituted “subject to subparagraph (C), shall be collected and available” for “shall be retained”

    Source evidence

    Code amendment note
    Subsec. (g)(2)(A)(i). Pub. L. 112–144, § 103(4)(B)(i), substituted “subject to subparagraph (C), shall be collected and available” for “shall be retained”.

    Enacted provision · exact public law section
    (i) in subparagraph (A)(i), by striking “shall be retained” and inserting “subject to subparagraph (C), shall be collected and available”;

77. 2012

    Prescription Drug User Fee Amendments of 2012

    Pub. L. 112–144 § 103(4)(B)(ii) · 126 Stat. 993

    Substituted · 21 U.S.C. § 379h(g)(2)(A)(ii)

    Pub. L. 112–144, § 103(4)(B)(ii), substituted “shall be available” for “shall only be collected and available”

    Source evidence

    Code amendment note
    Subsec. (g)(2)(A)(ii). Pub. L. 112–144, § 103(4)(B)(ii), substituted “shall be available” for “shall only be collected and available”.

    Enacted provision · exact public law section
    (ii) in subparagraph (A)(ii), by striking “shall only be collected and available” and inserting “shall be available”; and

78. 2012

    Prescription Drug User Fee Amendments of 2012

    Pub. L. 112–144 § 103(4)(B)(iii) · 126 Stat. 993

    Added · 21 U.S.C. § 379h(g)(2)(C)

    Pub. L. 112–144, § 103(4)(B)(iii), added subpar. (C)

    Source evidence

    Code amendment note
    Subsec. (g)(2)(C). Pub. L. 112–144, § 103(4)(B)(iii), added subpar. (C).

    Enacted provision · exact public law section
    (iii) by adding at the end the following new subparagraph: “(C) Provision for early payments.— Payment of fees authorized under this section for a fiscal year, prior to the due date for such fees, may be accepted by the Secretary in accordance with authority provided in advance in a prior year appropriations Act.” ;

79. 2012

    Prescription Drug User Fee Amendments of 2012

    Pub. L. 112–144 § 103(4)(C) · 126 Stat. 993

    Substituted · 21 U.S.C. § 379h(g)(3)

    Pub. L. 112–144, § 103(4)(C), substituted “fiscal years 2013 through 2017” for “fiscal years 2008 through 2012”

    Source evidence

    Code amendment note
    Subsec. (g)(3). Pub. L. 112–144, § 103(4)(C), substituted “fiscal years 2013 through 2017” for “fiscal years 2008 through 2012”.

    Enacted provision · exact public law section
    (C) in paragraph (3), by striking “fiscal years 2008 through 2012” and inserting “fiscal years 2013 through 2017”; and

80. 2012

    Prescription Drug User Fee Amendments of 2012

    Pub. L. 112–144 § 103(4)(D) · 126 Stat. 993

    1. Substituted · 21 U.S.C. § 379h(g)(4)

       Pub. L. 112–144, § 103(4)(D), substituted “fiscal years 2013 through 2015” for “fiscal years 2008 through 2010”

    2. Substituted · 21 U.S.C. § 379h(g)(4)

       Pub. L. 112–144, § 103(4)(D), substituted “fiscal year 2016” for “fiscal year 2011”

    3. Substituted · 21 U.S.C. § 379h(g)(4)

       Pub. L. 112–144, § 103(4)(D), substituted “fiscal years 2013 through 2016” for “fiscal years 2008 through 2011”

    4. Substituted · 21 U.S.C. § 379h(g)(4)

       Pub. L. 112–144, § 103(4)(D), substituted “fiscal year 2017” for “fiscal year 2012”

    Source evidence

    Code amendment note
    Subsec. (g)(4). Pub. L. 112–144, § 103(4)(D), substituted “fiscal years 2013 through 2015” for “fiscal years 2008 through 2010”, “fiscal year 2016” for “fiscal year 2011”, “fiscal years 2013 through 2016” for “fiscal years 2008 through 2011”, and “fiscal year 2017” for “fiscal year 2012”.

    Enacted provision · exact public law section
    (D) in paragraph (4)— (i) by striking “fiscal years 2008 through 2010” and inserting “fiscal years 2013 through 2015”; (ii) by striking “fiscal year 2011” and inserting “fiscal year 2016”; (iii) by striking “fiscal years 2008 through 2011” and inserting “fiscal years 2013 through 2016”; and (iv) by striking “fiscal year 2012” and inserting “fiscal year 2017”.

81. 2017

    Prescription Drug User Fee Amendments of 2017

    Pub. L. 115–52 § 102(a)(1)(A) · 131 Stat. 1005

    Substituted · 21 U.S.C. § 379h(a)

    Pub. L. 115–52, § 102(a)(1)(A), substituted “fiscal year 2018” for “fiscal year 2013” in introductory provisions

    Source evidence

    Code amendment note
    Subsec. (a). Pub. L. 115–52, § 102(a)(1)(A), substituted “fiscal year 2018” for “fiscal year 2013” in introductory provisions.

    Enacted provision · exact public law section
    (A) in the matter preceding paragraph (1), by striking “fiscal year 2013” and inserting “fiscal year 2018”;

82. 2017

    Prescription Drug User Fee Amendments of 2017

    Pub. L. 115–52 § 102(a)(1)(B) · 131 Stat. 1005

    1. Struck · 21 U.S.C. § 379h(a)(1)

       Pub. L. 115–52, § 102(a)(1)(B), (C), struck out “and supplement” before “fee” in heading

    2. Struck · 21 U.S.C. § 379h(a)(1)

       Pub. L. 115–52, § 102(a)(1)(B), (C), struck out “or a supplement” and “or supplement” wherever appearing in text

    Source evidence

    Code amendment note
    Subsec. (a)(1). Pub. L. 115–52, § 102(a)(1)(B), (C), struck out “and supplement” before “fee” in heading and struck out “or a supplement” and “or supplement” wherever appearing in text.

    Enacted provision · exact public law section
    (B) in the heading of paragraph (1), by striking “and supplement”;

83. 2017

    Prescription Drug User Fee Amendments of 2017

    Pub. L. 115–52 § 102(a)(1)(D)(i) · 131 Stat. 1005

    Substituted · 21 U.S.C. § 379h(a)(1)(A)(i)

    Pub. L. 115–52, § 102(a)(1)(D)(i), substituted “(c)(5)” for “(c)(4)”

    Source evidence

    Code amendment note
    Subsec. (a)(1)(A)(i). Pub. L. 115–52, § 102(a)(1)(D)(i), substituted “(c)(5)” for “(c)(4)”.

    Enacted provision · exact public law section
    (i) in clause (i), by striking “(c)(4)” and inserting “(c)(5)”; and

84. 2017

    Prescription Drug User Fee Amendments of 2017

    Pub. L. 115–52 § 102(a)(1)(C) · 131 Stat. 1005

    Substituted · 21 U.S.C. § 379h(a)(1)(A)(ii)

    Pub. L. 115–52, § 102(a)(1)(C), (D)(ii), substituted “A fee established under subsection (c)(5) 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.” for “A fee established under subsection (c)(4) for a human drug application for which clinical data with respect to safety or effectiveness are not required for which clinical data (other than bioavailability or bioequivalence studies) with respect to safety or effectiveness are required.”

    Source evidence

    Code amendment note
    Subsec. (a)(1)(A)(ii). Pub. L. 115–52, § 102(a)(1)(C), (D)(ii), substituted “A fee established under subsection (c)(5) 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.” for “A fee established under subsection (c)(4) for a human drug application for which clinical data with respect to safety or effectiveness are not required for which clinical data (other than bioavailability or bioequivalence studies) with respect to safety or effectiveness are required.”

    Enacted provision · exact public law section
    (C) in paragraph (1), by striking “or a supplement” and “or supplement” each place either appears;

85. 2017

    Prescription Drug User Fee Amendments of 2017

    Pub. L. 115–52 § 102(a)(1)(E) · 131 Stat. 1005

    Struck · 21 U.S.C. § 379h(a)(1)(C)

    Pub. L. 115–52, § 102(a)(1)(E), struck out “or supplement” after “application” in heading

    Source evidence

    Code amendment note
    Subsec. (a)(1)(C). Pub. L. 115–52, § 102(a)(1)(E), struck out “or supplement” after “application” in heading.

    Enacted provision · exact public law section
    (E) in the heading of paragraph (1)(C), by striking “or supplement”;

86. 2017

    Prescription Drug User Fee Amendments of 2017

    Pub. L. 115–52 § 102(a)(1)(F) · 131 Stat. 1005

    Struck · 21 U.S.C. § 379h(a)(1)(F)

    Pub. L. 115–52, § 102(a)(1)(F), struck out “or indication” after “drug” in heading and “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.” in text

    Source evidence

    Code amendment note
    Subsec. (a)(1)(F). Pub. L. 115–52, § 102(a)(1)(F), struck out “or indication” after “drug” in heading and “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.” in text.

    Enacted provision · exact public law section
    (F) in paragraph (1)(F)— (i) in the heading, by striking “or indication”; and (ii) by striking the second sentence;

87. 2017

    Prescription Drug User Fee Amendments of 2017

    Pub. L. 115–52 § 102(a)(1)(G) · 131 Stat. 1005

    1. Redesignated · 21 U.S.C. § 379h(a)(2)

       Pub. L. 115–52, § 102(a)(1)(G)–(I), redesignated par. (3) as (2)

    2. Substituted · 21 U.S.C. § 379h(a)(2)

       Pub. L. 115–52, § 102(a)(1)(G)–(I), substituted “Prescription drug program fee” for “Prescription drug product fee” in heading

    3. Struck · 21 U.S.C. § 379h(a)(2)

       Pub. L. 115–52, § 102(a)(1)(G)–(I), struck out former par. (2) which related to prescription drug establishment fee

    Source evidence

    Code amendment note
    Subsec. (a)(2). Pub. L. 115–52, § 102(a)(1)(G)–(I), redesignated par. (3) as (2), substituted “Prescription drug program fee” for “Prescription drug product fee” in heading, and struck out former par. (2) which related to prescription drug establishment fee.

    Enacted provision · exact public law section
    (G) by striking paragraph (2) (relating to a prescription drug establishment fee);

88. 2017

    Prescription Drug User Fee Amendments of 2017

    Pub. L. 115–52 § 102(a)(1)(J) · 131 Stat. 1005

    Substituted · 21 U.S.C. § 379h(a)(2)(A)

    Pub. L. 115–52, § 102(a)(1)(J), substituted “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)(5) for each prescription drug product that is identified in such a human drug application approved as of October 1 of such fiscal year.” for “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).”

    Source evidence

    Code amendment note
    Subsec. (a)(2)(A). Pub. L. 115–52, § 102(a)(1)(J), substituted “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)(5) for each prescription drug product that is identified in such a human drug application approved as of October 1 of such fiscal year.” for “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).”

    Enacted provision · exact public law section
    (J) in subparagraph (A) of such paragraph (2), by amending the first sentence to read as follows: “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)(5) for each prescription drug product that is identified in such a human drug application approved as of October 1 of such fiscal year.”;

89. 2017

    Prescription Drug User Fee Amendments of 2017

    Pub. L. 115–52 § 102(a)(1)(K) · 131 Stat. 1005

    1. Inserted · 21 U.S.C. § 379h(a)(2)(B)

       Pub. L. 115–52, § 102(a)(1)(K), inserted “for certain prescription drug products” after “Exception” in heading

    2. Substituted · 21 U.S.C. § 379h(a)(2)(B)

       Pub. L. 115–52, § 102(a)(1)(K), substituted “A prescription drug program fee shall not be assessed for a prescription drug product” for “A prescription drug product shall not be assessed a fee” in introductory provisions

    Source evidence

    Code amendment note
    Subsec. (a)(2)(B). Pub. L. 115–52, § 102(a)(1)(K), inserted “for certain prescription drug products” after “Exception” in heading and substituted “A prescription drug program fee shall not be assessed for a prescription drug product” for “A prescription drug product shall not be assessed a fee” in introductory provisions.

    Enacted provision · exact public law section
    (K) in subparagraph (B) of such paragraph (2)— (i) in the heading of subparagraph (B), by inserting after “Exception” the following: “for certain prescription drug products”; and (ii) by striking “A prescription drug product shall not be assessed a fee” and inserting “A prescription drug program fee shall not be assessed for a prescription drug product”; and

90. 2017

    Prescription Drug User Fee Amendments of 2017

    Pub. L. 115–52 § 102(a)(1)(L) · 131 Stat. 1005

    Added · 21 U.S.C. § 379h(a)(2)(C)

    Pub. L. 115–52, § 102(a)(1)(L), added subpar. (C)

    Source evidence

    Code amendment note
    Subsec. (a)(2)(C). Pub. L. 115–52, § 102(a)(1)(L), added subpar. (C).

    Enacted provision · exact public law section
    (L) by adding at the end of such paragraph (2) the following: “(C) Limitation.— 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.” .

91. 2017

    Prescription Drug User Fee Amendments of 2017

    Pub. L. 115–52 § 102(a)(1)(H) · 131 Stat. 1005

    Redesignated · 21 U.S.C. § 379h(a)(3)

    Pub. L. 115–52, § 102(a)(1)(H), redesignated par. (3) as (2)

    Source evidence

    Code amendment note
    Subsec. (a)(3). Pub. L. 115–52, § 102(a)(1)(H), redesignated par. (3) as (2).

    Enacted provision · exact public law section
    (H) by redesignating paragraph (3) as paragraph (2);

92. 2017

    Prescription Drug User Fee Amendments of 2017

    Pub. L. 115–52 § 102(b) · 131 Stat. 1005

    Amended · 21 U.S.C. § 379h(b)

    Pub. L. 115–52, § 102(b), amended subsec. (b) generally. Prior to amendment, subsec. (b) related to fee revenue amounts for fiscal years 2013 through 2017

    Source evidence

    Code amendment note
    Subsec. (b). Pub. L. 115–52, § 102(b), amended subsec. (b) generally. Prior to amendment, subsec. (b) related to fee revenue amounts for fiscal years 2013 through 2017.

    Enacted provision · exact public law section
    (b) Fee Revenue Amounts.— Subsection (b) of section 736 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h) is amended to read as follows: “(b) Fee Revenue Amounts.— “(1) In general.— For each of the fiscal years 2018 through 2022, fees under subsection (a) shall, except as provided in subsections (c), (d), (f), and (g), be established to generate a total revenue amount under such subsection that is equal to the sum of— “(A) the annual base revenue for the fiscal year (as determined under paragraph (3)); “(B) the dollar amount equal to the inflation adjustment for the fiscal year (as determined under subsection (c)(1)); “(C) the dollar amount equal to the capacity planning adjustment for the fiscal year (as determined under subsection (c)(2)); “(D) the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(3)); “(E) the dollar amount equal to the additional direct cost adjustment for the fiscal year (as determined under subsection (c)(4)); and “(F) additional dollar amounts for each fiscal year as follows: “(i) $20,077,793 for fiscal year 2018. “(ii) $21,317,472 for fiscal year 2019. “(iii) $16,953,329 for fiscal year 2020. “(iv) $5,426,896 for fiscal year 2021. “(v) $2,769,609 for fiscal year 2022. “(2) Types of fees.— Of the total revenue amount determined for a fiscal year under paragraph (1)— “(A) 20 percent shall be derived from human drug application fees under subsection (a)(1); and “(B) 80 percent shall be derived from prescription drug program fees under subsection (a)(2). “(3) Annual base revenue.— For purposes of paragraph (1), the dollar amount of the annual base revenue for a fiscal year shall be— “(A) for fiscal year 2018, $878,590,000; and “(B) for fiscal years 2019 through 2022, the dollar amount of the total revenue amount established under paragraph (1) for the previous fiscal year, not including any adjustments made under subsection (c)(3) or (c)(4).” .

93. 2017

    Prescription Drug User Fee Amendments of 2017

    Pub. L. 115–52 § 102(c) · 131 Stat. 1005

    Amended · 21 U.S.C. § 379h(c)

    Pub. L. 115–52, § 102(c), amended subsec. (c) generally. Prior to amendment, subsec. (c) related to adjustment of revenues for inflation and changes in workload, final year adjustment, setting of annual fee, and limit on total amount of fees charged

    Source evidence

    Code amendment note
    Subsec. (c). Pub. L. 115–52, § 102(c), amended subsec. (c) generally. Prior to amendment, subsec. (c) related to adjustment of revenues for inflation and changes in workload, final year adjustment, setting of annual fee, and limit on total amount of fees charged.

    Enacted provision · exact public law section
    (c) Adjustments; Annual Fee Setting.— Subsection (c) of section 736 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h) is amended to read as follows: “(c) Adjustments; Annual Fee Setting.— “(1) Inflation adjustment.— “(A) In general.— For purposes of subsection (b)(1)(B), the dollar amount of the inflation adjustment to the annual base revenue for each fiscal year shall be equal to the product of— “(i) such annual base revenue for the fiscal year under subsection (b)(1)(A); and “(ii) the inflation adjustment percentage under subparagraph (B). “(B) Inflation adjustment percentage.— The inflation adjustment percentage under this subparagraph for a fiscal year is equal to the sum of— “(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 735(6)) for the first 3 years of the preceding 4 fiscal years; and “(ii) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–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 735(6)) for the first 3 years of the preceding 4 fiscal years. “(2) Capacity planning adjustment.— “(A) In general.— For each fiscal year, after the annual base revenue established in subsection (b)(1)(A) is adjusted for inflation in accordance with paragraph (1), 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. “(B) Interim methodology.— “(i) In general.— Until the capacity planning methodology described in subparagraph (C) is effective, the adjustment under this paragraph for a fiscal year shall be based on the product of— “(I) the annual base revenue for such year, as adjusted for inflation under paragraph (1); and “(II) the adjustment percentage under clause (ii). “(ii) Adjustment percentage.— The adjustment percentage under this clause for a fiscal year is the weighted change in the 3-year average ending in the most recent year for which data are available, over the 3-year average ending in the previous year, for— “(I) the total number of human drug applications, efficacy supplements, and manufacturing supplements submitted to the Secretary; “(II) the total number of active commercial investigational new drug applications; and “(III) the total number of formal meetings scheduled by the Secretary, and written responses issued by the Secretary in lieu of such formal meetings, as identified in section I.H of the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017. “(C) Capacity planning methodology.— “(i) Development; evaluation and report.— The Secretary shall obtain, through a contract with an independent accounting or consulting firm, a report evaluating options and recommendations for a new methodology to accurately assess changes in the resource and capacity needs of the process for the review of human drug applications. The capacity planning methodological options and recommendations presented in such report shall utilize and be informed by personnel time reporting data as an input. Publication. Public information. Deadline. The report shall be published for public comment no later than the end of fiscal year 2020. “(ii) Establishment and implementation.— After review of the report described in clause (i) and any public comments thereon, the Secretary shall establish a capacity planning methodology for purposes of this paragraph, which shall— “(I) replace the interim methodology under subparagraph (B); “(II) incorporate such approaches and attributes as the Secretary determines appropriate; and “(III) be effective beginning with the first fiscal year for which fees are set after such capacity planning methodology is established. “(D) Limitation.— Under no circumstances shall an adjustment under this paragraph result in fee revenue for a fiscal year that is less than the sum of the amounts under subsections (b)(1)(A) (the annual base revenue for the fiscal year) and (b)(1)(B) (the dollar amount of the inflation adjustment for the fiscal year). “(E) Publication in federal register.— The Secretary shall publish in the Federal Register notice under paragraph (5) of the fee revenue and fees resulting from the adjustment and the methodologies under this paragraph. “(3) Operating reserve adjustment.— “(A) Increase.— For fiscal year 2018 and subsequent fiscal years, the Secretary may, in addition to adjustments under paragraphs (1) and (2), further increase the fee revenue and fees if such an adjustment is necessary to provide for not more than 14 weeks of operating reserves of carryover user fees for the process for the review of human drug applications. “(B) Decrease.— If the Secretary has carryover balances for such process in excess of 14 weeks of such operating reserves, the Secretary shall decrease such fee revenue and fees to provide for not more than 14 weeks of such operating reserves. “(C) Notice of rationale.— If an adjustment under subparagraph (A) or (B) is made, the rationale for the amount of the increase or decrease (as applicable) in fee revenue and fees shall be contained in the annual Federal Register notice under paragraph (5) establishing fee revenue and fees for the fiscal year involved. “(4) Additional direct cost adjustment.— “(A) In general.— The Secretary shall, in addition to adjustments under paragraphs (1), (2), and (3), further increase the fee revenue and fees— “(i) for fiscal year 2018, by $8,730,000; and “(ii) for fiscal year 2019 and subsequent fiscal years, by the amount determined under subparagraph (B). “(B) Amount.— The amount determined under this subparagraph is— “(i) $8,730,000, multiplied by “(ii) the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All Items; Annual Index) for the most recent year of available data, divided by such Index for 2016. “(5) Annual fee setting.— The Secretary shall, not later than 60 days before the start of each fiscal year that begins after September 30, 2017— “(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 “(B) publish such fee revenue and fees in the Federal Register. “(6) 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.” .

94. 2017

    Prescription Drug User Fee Amendments of 2017

    Pub. L. 115–52 § 102(d)(1) · 131 Stat. 1005

    1. Redesignated · 21 U.S.C. § 379h(d)(1)(C); 21 U.S.C. § 379h(d)(1)(D)

       Pub. L. 115–52, § 102(d)(1), redesignated subpar. (D) as (C)

    2. Struck · 21 U.S.C. § 379h(d)(1)(C); 21 U.S.C. § 379h(d)(1)(D)

       Pub. L. 115–52, § 102(d)(1), struck out former subpar. (C) which read as follows: “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”

    Source evidence

    Code amendment note
    Subsec. (d)(1)(C), (D). Pub. L. 115–52, § 102(d)(1), redesignated subpar. (D) as (C) and struck out former subpar. (C) which read as follows: “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”.

    Enacted provision · exact public law section
    (1) in paragraph (1)— (A) by inserting “or” at the end of subparagraph (B); (B) by striking subparagraph (C); and (C) by redesignating subparagraph (D) as subparagraph (C);

95. 2017

    Prescription Drug User Fee Amendments of 2017

    Pub. L. 115–52 § 102(d)(2) · 131 Stat. 1005

    1. Redesignated · 21 U.S.C. § 379h(d)(3)

       Pub. L. 115–52, § 102(d)(2), (3), redesignated par. (4) as (3)

    2. Struck · 21 U.S.C. § 379h(d)(3)

       Pub. L. 115–52, § 102(d)(2), (3), struck out former par. (3). Text read as follows: “In making the finding in paragraph (1)(C), the Secretary may use standard costs.”

    Source evidence

    Code amendment note
    Subsec. (d)(3). Pub. L. 115–52, § 102(d)(2), (3), redesignated par. (4) as (3) and struck out former par. (3). Text read as follows: “In making the finding in paragraph (1)(C), the Secretary may use standard costs.”

    Enacted provision · exact public law section
    (2) by striking paragraph (3) (relating to use of standard costs);

96. 2017

    Prescription Drug User Fee Amendments of 2017

    Pub. L. 115–52 § 102(d)(4)(A) · 131 Stat. 1005

    Substituted · 21 U.S.C. § 379h(d)(3)(A)

    Pub. L. 115–52, § 102(d)(4)(A), substituted “paragraph (1)(C)” for “paragraph (1)(D)”

    Source evidence

    Code amendment note
    Subsec. (d)(3)(A). Pub. L. 115–52, § 102(d)(4)(A), substituted “paragraph (1)(C)” for “paragraph (1)(D)”.

    Enacted provision · exact public law section
    (A) in subparagraphs (A) and (B), by striking “paragraph (1)(D)” and inserting “paragraph (1)(C)”; and

97. 2017

    Prescription Drug User Fee Amendments of 2017

    Pub. L. 115–52 § 102(d)(4) · 131 Stat. 1005

    1. Substituted · 21 U.S.C. § 379h(d)(3)(B)

       Pub. L. 115–52, § 102(d)(4), substituted “paragraph (1)(C)” for “paragraph (1)(D)”

    2. Struck · 21 U.S.C. § 379h(d)(3)(B)

       Pub. L. 115–52, § 102(d)(4), struck out cl. (i) designation before “application fees”

    3. Substituted · 21 U.S.C. § 379h(d)(3)(B)

       Pub. L. 115–52, § 102(d)(4), substituted a period for “; and” after “qualify as a small business”

    4. Struck · 21 U.S.C. § 379h(d)(3)(B)

       Pub. L. 115–52, § 102(d)(4), struck out cl. (ii), which read as follows: “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.”

    Source evidence

    Code amendment note
    Subsec. (d)(3)(B). Pub. L. 115–52, § 102(d)(4), substituted “paragraph (1)(C)” for “paragraph (1)(D)”, struck out cl. (i) designation before “application fees”, substituted a period for “; and” after “qualify as a small business”, and struck out cl. (ii), which read as follows: “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.”

    Enacted provision · exact public law section
    (4) in paragraph (3), as so redesignated— (A) in subparagraphs (A) and (B), by striking “paragraph (1)(D)” and inserting “paragraph (1)(C)”; and (B) in subparagraph (B)— (i) by striking clause (ii); (ii) by striking “shall pay” through “(i) application fees” and inserting “shall pay application fees”; and (iii) by striking “; and” at the end and inserting a period.

98. 2017

    Prescription Drug User Fee Amendments of 2017

    Pub. L. 115–52 § 102(d)(3) · 131 Stat. 1005

    Redesignated · 21 U.S.C. § 379h(d)(4)

    Pub. L. 115–52, § 102(d)(3), redesignated par. (4) as (3)

    Source evidence

    Code amendment note
    Subsec. (d)(4). Pub. L. 115–52, § 102(d)(3), redesignated par. (4) as (3).

    Enacted provision · exact public law section
    (3) by redesignating paragraph (4) as paragraph (3); and

99. 2017

    Prescription Drug User Fee Amendments of 2017

    Pub. L. 115–52 § 102(e) · 131 Stat. 1005

    Substituted · 21 U.S.C. § 379h(e)

    Pub. L. 115–52, § 102(e), substituted “all such fees” for “all fees”

    Source evidence

    Code amendment note
    Subsec. (e). Pub. L. 115–52, § 102(e), substituted “all such fees” for “all fees”.

    Enacted provision · exact public law section
    (e) Effect of Failure To Pay Fees.— Section 736(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(e)) is amended by striking “all fees” and inserting “all such fees”.

100. 2017

     Prescription Drug User Fee Amendments of 2017

     Pub. L. 115–52 § 102(f) · 131 Stat. 1005

     Substituted · 21 U.S.C. § 379h(f)(2)

     Pub. L. 115–52, § 102(f), substituted “prescription drug program fees” for “supplements, prescription drug establishments, and prescription drug products”

     Source evidence

     Code amendment note
     Subsec. (f)(2). Pub. L. 115–52, § 102(f), substituted “prescription drug program fees” for “supplements, prescription drug establishments, and prescription drug products”.

     Enacted provision · exact public law section
     (f) Limitations.— Section 736(f)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(f)(2)) is amended by striking “supplements, prescription drug establishments, and prescription drug products” and inserting “prescription drug program fees”.

101. 2017

     FDA Reauthorization Act of 2017

     Pub. L. 115–52 § 905(b)(1) · 131 Stat. 1005

     Added · 21 U.S.C. § 379h(f)(3)

     Pub. L. 115–52, § 905(b)(1), added par. (3)

     Source evidence

     Code amendment note
     Subsec. (f)(3). Pub. L. 115–52, § 905(b)(1), added par. (3).

     Enacted provision · exact public law section
     (1) PDUFA.— Section 736(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(f)) is amended by adding at the end the following: “(3) Limitation.— Beginning on October 1, 2023, the authorities under section 735(7)(C) shall include only expenditures for leasing and necessary scientific equipment.” .

102. 2017

     Prescription Drug User Fee Amendments of 2017

     Pub. L. 115–52 § 102(g)(1) · 131 Stat. 1005

     1. Substituted · 21 U.S.C. § 379h(g)(3)

        Pub. L. 115–52, § 102(g)(1), substituted “2018 through 2022” for “2013 through 2017”

     2. Struck · 21 U.S.C. § 379h(g)(3)

        Pub. L. 115–52, § 102(g)(1), struck out “and paragraph (4) of this subsection” after “subsection (c)”

     Source evidence

     Code amendment note
     Subsec. (g)(3). Pub. L. 115–52, § 102(g)(1), substituted “2018 through 2022” for “2013 through 2017” and struck out “and paragraph (4) of this subsection” after “subsection (c)”.

     Enacted provision · exact public law section
     (1) in paragraph (3)— (A) by striking “2013 through 2017” and inserting “2018 through 2022”; and (B) by striking “and paragraph (4) of this subsection”; and

103. 2017

     Prescription Drug User Fee Amendments of 2017

     Pub. L. 115–52 § 102(g)(2) · 131 Stat. 1005

     Struck · 21 U.S.C. § 379h(g)(4)

     Pub. L. 115–52, § 102(g)(2), struck out par. (4). Prior to amendment, text read as follows: “If the sum of the cumulative amount of fees collected under this section for the fiscal years 2013 through 2015 and the amount of fees estimated to be collected under this section for fiscal year 2016 exceeds the cumulative amount appropriated under paragraph (3) for the fiscal years 2013 through 2016, the excess 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 fiscal year 2017.”

     Source evidence

     Code amendment note
     Subsec. (g)(4). Pub. L. 115–52, § 102(g)(2), struck out par. (4). Prior to amendment, text read as follows: “If the sum of the cumulative amount of fees collected under this section for the fiscal years 2013 through 2015 and the amount of fees estimated to be collected under this section for fiscal year 2016 exceeds the cumulative amount appropriated under paragraph (3) for the fiscal years 2013 through 2016, the excess 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 fiscal year 2017.”

     Enacted provision · exact public law section
     (2) by striking paragraph (4).

104. 2017

     Prescription Drug User Fee Amendments of 2017

     Pub. L. 115–52 § 102(h) · 131 Stat. 1005

     Substituted · 21 U.S.C. § 379h(k)(1)

     Pub. L. 115–52, § 102(h), substituted “prescription drug program fees” for “product and establishment fees” in two places

     Source evidence

     Code amendment note
     Subsec. (k)(1). Pub. L. 115–52, § 102(h), substituted “prescription drug program fees” for “product and establishment fees” in two places.

     Enacted provision · exact public law section
     (h) Orphan Drugs.— Section 736(k) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(k)) is amended by striking “product and establishment fees” each place it appears and inserting “prescription drug program fees”.

105. 2022

     Prescription Drug User Fee Amendments of 2022

     Pub. L. 117–180 § 1003(a)(1)(A) · 136 Stat. 2114

     Substituted · 21 U.S.C. § 379h(a)

     Pub. L. 117–180, § 1003(a)(1)(A), substituted “fiscal year 2023” for “fiscal year 2018” in introductory provisions

     Source evidence

     Code amendment note
     Subsec. (a). Pub. L. 117–180, § 1003(a)(1)(A), substituted “fiscal year 2023” for “fiscal year 2018” in introductory provisions.

     Enacted provision · exact public law section
     (A) in the matter preceding paragraph (1), by striking “fiscal year 2018” and inserting “fiscal year 2023”;

     Effective date note
     Amendment by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2022, see section 1006 of Pub. L. 117–180, set out as a note under section 379g of this title.

106. 2022

     Prescription Drug User Fee Amendments of 2022

     Pub. L. 117–180 § 1003(a)(1)(B) · 136 Stat. 2114

     Substituted · 21 U.S.C. § 379h(a)(1)(A)

     Pub. L. 117–180, § 1003(a)(1)(B), substituted “(c)(6)” for “(c)(5)” in cls. (i) and (ii)

     Source evidence

     Code amendment note
     Subsec. (a)(1)(A). Pub. L. 117–180, § 1003(a)(1)(B), substituted “(c)(6)” for “(c)(5)” in cls. (i) and (ii).

     Enacted provision · exact public law section
     (B) in paragraph (1)(A), by striking “(c)(5)” each place it appears and inserting “(c)(6)”;

     Effective date note
     Amendment by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2022, see section 1006 of Pub. L. 117–180, set out as a note under section 379g of this title.

107. 2022

     Prescription Drug User Fee Amendments of 2022

     Pub. L. 117–180 § 1003(a)(1)(C) · 136 Stat. 2114

     Inserted · 21 U.S.C. § 379h(a)(1)(C)

     Pub. L. 117–180, § 1003(a)(1)(C), inserted “prior to approval” after “or was withdrawn”

     Source evidence

     Code amendment note
     Subsec. (a)(1)(C). Pub. L. 117–180, § 1003(a)(1)(C), inserted “prior to approval” after “or was withdrawn”.

     Enacted provision · exact public law section
     (C) in paragraph (1)(C), by inserting “prior to approval” after “or was withdrawn”; and

     Effective date note
     Amendment by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2022, see section 1006 of Pub. L. 117–180, set out as a note under section 379g of this title.

108. 2022

     Prescription Drug User Fee Amendments of 2022

     Pub. L. 117–180 § 1003(a)(1)(D) · 136 Stat. 2114

     Added · 21 U.S.C. § 379h(a)(1)(H)

     Pub. L. 117–180, § 1003(a)(1)(D), added subpar. (H)

     Source evidence

     Code amendment note
     Subsec. (a)(1)(H). Pub. L. 117–180, § 1003(a)(1)(D), added subpar. (H).

     Enacted provision · exact public law section
     (D) in paragraph (1), by adding at the end the following: “(H) Exception for skin-test diagnostic products.— A human drug application for a skin-test diagnostic product shall not be subject to a fee under subparagraph (A).” .

     Effective date note
     Amendment by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2022, see section 1006 of Pub. L. 117–180, set out as a note under section 379g of this title.

109. 2022

     Prescription Drug User Fee Amendments of 2022

     Pub. L. 117–180 § 1003(a)(2)(A) · 136 Stat. 2114

     1. Amended · 21 U.S.C. § 379h(a)(2)(A)

        Pub. L. 117–180, § 1003(a)(2)(A), designated existing provisions as cl. (i)

     2. Inserted · 21 U.S.C. § 379h(a)(2)(A)

        Pub. L. 117–180, § 1003(a)(2)(A), inserted heading

     3. Substituted · 21 U.S.C. § 379h(a)(2)(A)

        Pub. L. 117–180, § 1003(a)(2)(A), substituted “subsection (c)(6)” for “subsection (c)(5)”

     4. Added · 21 U.S.C. § 379h(a)(2)(A)

        Pub. L. 117–180, § 1003(a)(2)(A), added cl. (ii)

     Source evidence

     Code amendment note
     Subsec. (a)(2)(A). Pub. L. 117–180, § 1003(a)(2)(A), designated existing provisions as cl. (i) and inserted heading, substituted “subsection (c)(6)” for “subsection (c)(5)”, and added cl. (ii).

     Enacted provision · exact public law section
     (A) in subparagraph (A)— (i) by striking “Except as provided in subparagraphs (B) and (C)” and inserting the following: “(i) Payment of fees.— Except as provided in subparagraphs (B) and (C)” ; (ii) by striking “subsection (c)(5)” and inserting “subsection (c)(6)”; and (iii) by adding at the end the following: “(ii) Special rule for previously discontinued drug products.— 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 735(3)(A)(iii), 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. Deadline. 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.” ; and

     Effective date note
     Amendment by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2022, see section 1006 of Pub. L. 117–180, set out as a note under section 379g of this title.

110. 2022

     Prescription Drug User Fee Amendments of 2022

     Pub. L. 117–180 § 1003(a)(2)(B) · 136 Stat. 2114

     Amended · 21 U.S.C. § 379h(a)(2)(B)

     Pub. L. 117–180, § 1003(a)(2)(B), amended subpar. (B) generally. Prior to amendment, text read as follows: “A prescription drug program fee shall not be assessed for a prescription drug product under subparagraph (A) if such product is—

     Source evidence

     Code amendment note
     Subsec. (a)(2)(B). Pub. L. 117–180, § 1003(a)(2)(B), amended subpar. (B) generally. Prior to amendment, text read as follows: “A prescription drug program fee shall not be assessed for a prescription drug product under subparagraph (A) if such product is—

     “(i) identified on the list compiled under section 355(j)(7) of this title with a potency described in terms of per 100 mL; “(ii) the same product as another product that— “(I) was approved under an application filed under section 355(b) or 355(j) of this title; and “(II) is not in the list of discontinued products compiled under section 355(j)(7) of this title; “(iii) the same product as another product that was approved under an abbreviated application filed under section 357 of this title (as in effect on the day before November 21, 1997); or “(iv) the same product as another product that was approved 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.”

     Enacted provision · exact public law section
     (B) by amending subparagraph (B) to read as follows: “(B) Exception for certain prescription drug products.— 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 505(j)(7); “(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 505(j)(7) (not including the discontinued section of such list); or “(iii) a skin-test diagnostic product.” .

     Effective date note
     Amendment by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2022, see section 1006 of Pub. L. 117–180, set out as a note under section 379g of this title.

111. 2022

     Prescription Drug User Fee Amendments of 2022

     Pub. L. 117–180 § 1003(b)(1) · 136 Stat. 2114

     Amended · 21 U.S.C. § 379h(b)(1)

     Pub. L. 117–180, § 1003(b)(1), amended par. (1) generally. Prior to amendment, par. (1) related to fees for fiscal years 2018 through 2022

     Source evidence

     Code amendment note
     Subsec. (b)(1). Pub. L. 117–180, § 1003(b)(1), amended par. (1) generally. Prior to amendment, par. (1) related to fees for fiscal years 2018 through 2022.

     Enacted provision · exact public law section
     (1) In general.— Paragraph (1) of section 736(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(b)) is amended to read as follows: “(1) In general.— For each of the fiscal years 2023 through 2027, fees under subsection (a) shall, except as provided in subsections (c), (d), (f), and (g), be established to generate a total revenue amount under such subsection that is equal to the sum of— “(A) the annual base revenue for the fiscal year (as determined under paragraph (3)); “(B) the dollar amount equal to the inflation adjustment for the fiscal year (as determined under subsection (c)(1)); “(C) the dollar amount equal to the strategic hiring and retention adjustment for the fiscal year (as determined under subsection (c)(2)); “(D) the dollar amount equal to the capacity planning adjustment for the fiscal year (as determined under subsection (c)(3)); “(E) the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(4)); “(F) the dollar amount equal to the additional direct cost adjustment for the fiscal year (as determined under subsection (c)(5)); and “(G) additional dollar amounts for each fiscal year as follows: “(i) $65,773,693 for fiscal year 2023. “(ii) $25,097,671 for fiscal year 2024. “(iii) $14,154,169 for fiscal year 2025. “(iv) $4,864,860 for fiscal year 2026. “(v) $1,314,620 for fiscal year 2027.” .

     Effective date note
     Amendment by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2022, see section 1006 of Pub. L. 117–180, set out as a note under section 379g of this title.

112. 2022

     Prescription Drug User Fee Amendments of 2022

     Pub. L. 117–180 § 1003(b)(2) · 136 Stat. 2114

     Amended · 21 U.S.C. § 379h(b)(3)

     Pub. L. 117–180, § 1003(b)(2), amended par. (3) generally. Prior to amendment, par. (3) related to annual base revenue for fiscal years 2018 through 2022

     Source evidence

     Code amendment note
     Subsec. (b)(3). Pub. L. 117–180, § 1003(b)(2), amended par. (3) generally. Prior to amendment, par. (3) related to annual base revenue for fiscal years 2018 through 2022.

     Enacted provision · exact public law section
     (2) Annual base revenue.— Paragraph (3) of section 736(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(b)) is amended to read as follows: “(3) Annual base revenue.— For purposes of paragraph (1), the dollar amount of the annual base revenue for a fiscal year shall be— “(A) for fiscal year 2023, $1,151,522,958; and “(B) for fiscal years 2024 through 2027, the dollar amount of the total revenue amount established under paragraph (1) for the previous fiscal year, not including any adjustments made under subsection (c)(4) or (c)(5).” .

     Effective date note
     Amendment by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2022, see section 1006 of Pub. L. 117–180, set out as a note under section 379g of this title.

113. 2022

     Prescription Drug User Fee Amendments of 2022

     Pub. L. 117–180 § 1003(c)(1) · 136 Stat. 2114

     Substituted · 21 U.S.C. § 379h(c)(1)(B)(ii)

     Pub. L. 117–180, § 1003(c)(1), substituted “Washington-Arlington-Alexandria, DC–VA–MD–WV” for “Washington-Baltimore, DC–MD–VA–WV”

     Source evidence

     Code amendment note
     Subsec. (c)(1)(B)(ii). Pub. L. 117–180, § 1003(c)(1), substituted “Washington-Arlington-Alexandria, DC–VA–MD–WV” for “Washington-Baltimore, DC–MD–VA–WV”.

     Enacted provision · exact public law section
     (1) Inflation adjustment.— Section 736(c)(1)(B)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(c)(1)(B)(ii)) is amended by striking “Washington-Baltimore, DC–MD–VA–WV” and inserting “Washington-Arlington-Alexandria, DC–VA–MD–WV”.

     Effective date note
     Amendment by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2022, see section 1006 of Pub. L. 117–180, set out as a note under section 379g of this title.

114. 2022

     Prescription Drug User Fee Amendments of 2022

     Pub. L. 117–180 § 1003(c)(2)(B) · 136 Stat. 2114

     Redesignated · 21 U.S.C. § 379h(c)(2)

     Pub. L. 117–180, § 1003(c)(2)(B), added par. (2). Former par. (2) redesignated (3)

     Source evidence

     Code amendment note
     Subsec. (c)(2). Pub. L. 117–180, § 1003(c)(2)(B), added par. (2). Former par. (2) redesignated (3).

     Enacted provision · exact public law section
     (B) by inserting after paragraph (1) the following: “(2) Strategic hiring and retention adjustment.— For each fiscal year, after the annual base revenue established in subsection (b)(1)(A) is adjusted for inflation in accordance with paragraph (1), the Secretary shall further increase the fee revenue and fees by the following amounts: “(A) For fiscal year 2023, $9,000,000. “(B) For each of fiscal years 2024 through 2027, $4,000,000.” .

     Effective date note
     Amendment by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2022, see section 1006 of Pub. L. 117–180, set out as a note under section 379g of this title.

115. 2022

     Prescription Drug User Fee Amendments of 2022

     Pub. L. 117–180 § 1003(c)(2)(A) · 136 Stat. 2114

     1. Redesignated · 21 U.S.C. § 379h(c)(3)

        Pub. L. 117–180, § 1003(c)(2)(A), (3), redesignated par. (2) as (3)

     2. Redesignated · 21 U.S.C. § 379h(c)(3)

        Pub. L. 117–180, § 1003(c)(2)(A), (3), amended it generally. Prior to amendment, par. related to establishment of a capacity planning methodology and interim methodology. Former par. (3) redesignated (4)

     Source evidence

     Code amendment note
     Subsec. (c)(3). Pub. L. 117–180, § 1003(c)(2)(A), (3), redesignated par. (2) as (3) and amended it generally. Prior to amendment, par. related to establishment of a capacity planning methodology and interim methodology. Former par. (3) redesignated (4).

     Enacted provision · exact public law section
     (A) by redesignating paragraphs (2) through (6) as paragraphs (3) through (7), respectively; and

     Effective date note
     Amendment by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2022, see section 1006 of Pub. L. 117–180, set out as a note under section 379g of this title.

116. 2022

     Prescription Drug User Fee Amendments of 2022

     Pub. L. 117–180 § 1003(c)(2)(A) · 136 Stat. 2114

     Redesignated · 21 U.S.C. § 379h(c)(4)

     Pub. L. 117–180, § 1003(c)(2)(A), redesignated par. (3) as (4). Former par. (4) redesignated (5)

     Source evidence

     Code amendment note
     Subsec. (c)(4). Pub. L. 117–180, § 1003(c)(2)(A), redesignated par. (3) as (4). Former par. (4) redesignated (5).

     Enacted provision · exact public law section
     (A) by redesignating paragraphs (2) through (6) as paragraphs (3) through (7), respectively; and

     Effective date note
     Amendment by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2022, see section 1006 of Pub. L. 117–180, set out as a note under section 379g of this title.

117. 2022

     Prescription Drug User Fee Amendments of 2022

     Pub. L. 117–180 § 1003(c)(4)(A) · 136 Stat. 2114

     Amended · 21 U.S.C. § 379h(c)(4)(A)

     Pub. L. 117–180, § 1003(c)(4)(A), amended subpar. (A) generally. Prior to amendment, text read as follows: “For fiscal year 2018 and subsequent fiscal years, the Secretary may, in addition to adjustments under paragraphs (1) and (2), further increase the fee revenue and fees if such an adjustment is necessary to provide for not more than 14 weeks of operating reserves of carryover user fees for the process for the review of human drug applications.”

     Source evidence

     Code amendment note
     Subsec. (c)(4)(A). Pub. L. 117–180, § 1003(c)(4)(A), amended subpar. (A) generally. Prior to amendment, text read as follows: “For fiscal year 2018 and subsequent fiscal years, the Secretary may, in addition to adjustments under paragraphs (1) and (2), further increase the fee revenue and fees if such an adjustment is necessary to provide for not more than 14 weeks of operating reserves of carryover user fees for the process for the review of human drug applications.”

     Enacted provision · exact public law section
     (A) by amending subparagraph (A) to read as follows: “(A) Increase.— 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.” ; and

     Effective date note
     Amendment by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2022, see section 1006 of Pub. L. 117–180, set out as a note under section 379g of this title.

118. 2022

     Prescription Drug User Fee Amendments of 2022

     Pub. L. 117–180 § 1003(c)(4)(B) · 136 Stat. 2114

     Substituted · 21 U.S.C. § 379h(c)(4)(C)

     Pub. L. 117–180, § 1003(c)(4)(B), substituted “paragraph (6)” for “paragraph (5)”

     Source evidence

     Code amendment note
     Subsec. (c)(4)(C). Pub. L. 117–180, § 1003(c)(4)(B), substituted “paragraph (6)” for “paragraph (5)”.

     Enacted provision · exact public law section
     (B) in subparagraph (C), by striking “paragraph (5)” and inserting “paragraph (6)”.

     Effective date note
     Amendment by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2022, see section 1006 of Pub. L. 117–180, set out as a note under section 379g of this title.

119. 2022

     Prescription Drug User Fee Amendments of 2022

     Pub. L. 117–180 § 1003(c)(2)(A) · 136 Stat. 2114

     1. Redesignated · 21 U.S.C. § 379h(c)(5)

        Pub. L. 117–180, § 1003(c)(2)(A), (5), redesignated par. (4) as (5)

     2. Redesignated · 21 U.S.C. § 379h(c)(5)

        Pub. L. 117–180, § 1003(c)(2)(A), (5), amended it generally. Prior to amendment, par. related to additional direct cost adjustment for fiscal years 2018, 2019, and subsequent fiscal years. Former par. (5) redesignated (6)

     Source evidence

     Code amendment note
     Subsec. (c)(5). Pub. L. 117–180, § 1003(c)(2)(A), (5), redesignated par. (4) as (5) and amended it generally. Prior to amendment, par. related to additional direct cost adjustment for fiscal years 2018, 2019, and subsequent fiscal years. Former par. (5) redesignated (6).

     Enacted provision · exact public law section
     (A) by redesignating paragraphs (2) through (6) as paragraphs (3) through (7), respectively; and

     Effective date note
     Amendment by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2022, see section 1006 of Pub. L. 117–180, set out as a note under section 379g of this title.

120. 2022

     Prescription Drug User Fee Amendments of 2022

     Pub. L. 117–180 § 1003(c)(2)(A) · 136 Stat. 2114

     1. Redesignated · 21 U.S.C. § 379h(c)(6)

        Pub. L. 117–180, § 1003(c)(2)(A), (6), redesignated par. (5) as (6)

     2. Redesignated · 21 U.S.C. § 379h(c)(6)

        Pub. L. 117–180, § 1003(c)(2)(A), (6), substituted “September 30, 2022” for “September 30, 2017” in introductory provisions. Former par. (6) redesignated (7)

     Source evidence

     Code amendment note
     Subsec. (c)(6). Pub. L. 117–180, § 1003(c)(2)(A), (6), redesignated par. (5) as (6) and substituted “September 30, 2022” for “September 30, 2017” in introductory provisions. Former par. (6) redesignated (7).

     Enacted provision · exact public law section
     (A) by redesignating paragraphs (2) through (6) as paragraphs (3) through (7), respectively; and

     Effective date note
     Amendment by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2022, see section 1006 of Pub. L. 117–180, set out as a note under section 379g of this title.

121. 2022

     Prescription Drug User Fee Amendments of 2022

     Pub. L. 117–180 § 1003(c)(2)(A) · 136 Stat. 2114

     Redesignated · 21 U.S.C. § 379h(c)(7)

     Pub. L. 117–180, § 1003(c)(2)(A), redesignated par. (6) as (7)

     Source evidence

     Code amendment note
     Subsec. (c)(7). Pub. L. 117–180, § 1003(c)(2)(A), redesignated par. (6) as (7).

     Enacted provision · exact public law section
     (A) by redesignating paragraphs (2) through (6) as paragraphs (3) through (7), respectively; and

     Effective date note
     Amendment by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2022, see section 1006 of Pub. L. 117–180, set out as a note under section 379g of this title.

122. 2022

     Prescription Drug User Fee Amendments of 2022

     Pub. L. 117–180 § 1003(d) · 136 Stat. 2114

     Substituted · 21 U.S.C. § 379h(g)(3)

     Pub. L. 117–180, § 1003(d), substituted “fiscal years 2023 through 2027” for “fiscal years 2018 through 2022”

     Source evidence

     Code amendment note
     Subsec. (g)(3). Pub. L. 117–180, § 1003(d), substituted “fiscal years 2023 through 2027” for “fiscal years 2018 through 2022”.

     Enacted provision · exact public law section
     (d) Crediting and Availability of Fees.— Section 736(g)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(g)(3)) is amended by striking “fiscal years 2018 through 2022” and inserting “fiscal years 2023 through 2027”.

     Effective date note
     Amendment by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2022, see section 1006 of Pub. L. 117–180, set out as a note under section 379g of this title.

123. 2022

     Prescription Drug User Fee Amendments of 2022

     Pub. L. 117–180 § 1003(e) · 136 Stat. 2114

     Amended · 21 U.S.C. § 379h(i)

     Pub. L. 117–180, § 1003(e), amended subsec. (i) generally. Prior to amendment, text read as follows: “To qualify for consideration for a waiver or reduction under subsection (d), or for a refund of any fee collected in accordance with subsection (a), 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.”

     Source evidence

     Code amendment note
     Subsec. (i). Pub. L. 117–180, § 1003(e), amended subsec. (i) generally. Prior to amendment, text read as follows: “To qualify for consideration for a waiver or reduction under subsection (d), or for a refund of any fee collected in accordance with subsection (a), 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.”

     Enacted provision · exact public law section
     (e) Written Requests for Waivers, Reductions, Exemptions, and Returns; Disputes Concerning Fees.— Section 736(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(i)) is amended to read as follows: “(i) Written Requests for Waivers, Reductions, Exemptions, and Returns; Disputes Concerning Fees.— 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.” .

     Effective date note
     Amendment by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2022, see section 1006 of Pub. L. 117–180, set out as a note under section 379g of this title.

124. 2022

     Prescription Drug User Fee Amendments of 2022

     Pub. L. 117–180 § 1003(f)(1) · 136 Stat. 2114

     Substituted · 21 U.S.C. § 379h(k)(1)(B)

     Pub. L. 117–180, § 1003(f)(1), substituted “as determined under paragraph (2)” for “during the previous year”

     Source evidence

     Code amendment note
     Subsec. (k)(1)(B). Pub. L. 117–180, § 1003(f)(1), substituted “as determined under paragraph (2)” for “during the previous year”.

     Enacted provision · exact public law section
     (1) in paragraph (1)(B), by striking “during the previous year” and inserting “as determined under paragraph (2)”; and

     Effective date note
     Amendment by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2022, see section 1006 of Pub. L. 117–180, set out as a note under section 379g of this title.

125. 2022

     Prescription Drug User Fee Amendments of 2022

     Pub. L. 117–180 § 1003(f)(2) · 136 Stat. 2114

     Amended · 21 U.S.C. § 379h(k)(2)

     Pub. L. 117–180, § 1003(f)(2), amended par. (2) generally. Prior to amendment, text read as follows: “An exemption under paragraph (1) applies with respect to a drug only if the applicant involved submits a certification that its gross annual revenues did not exceed $50,000,000 for the preceding 12 months before the exemption was requested.”

     Source evidence

     Code amendment note
     Subsec. (k)(2). Pub. L. 117–180, § 1003(f)(2), amended par. (2) generally. Prior to amendment, text read as follows: “An exemption under paragraph (1) applies with respect to a drug only if the applicant involved submits a certification that its gross annual revenues did not exceed $50,000,000 for the preceding 12 months before the exemption was requested.”

     Enacted provision · exact public law section
     (2) by amending paragraph (2) to read as follows: “(2) Evidence of qualification.— An exemption under paragraph (1) applies with respect to a drug only if the applicant involved submits a certification that the applicant’s gross annual revenues did not exceed $50,000,000 for the last calendar year ending prior to the fiscal year for which the exemption is requested. Such certification shall be supported by— “(A) tax returns submitted to the United States Internal Revenue Service; or “(B) as necessary, other appropriate financial information.” .

     Effective date note
     Amendment by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2022, see section 1006 of Pub. L. 117–180, set out as a note under section 379g of this title.

126. 2022

     Food and Drug Omnibus Reform Act of 2022

     Pub. L. 117–328 § 3625(a)(1) · 136 Stat. 4459

     1. Substituted · 21 U.S.C. § 379h(g)(2)(A)(ii)

        Pub. L. 117–328, § 3625(a)(1), substituted “shall be available—” for “shall be available to defray”

     2. Amended · 21 U.S.C. § 379h(g)(2)(A)(ii)

        Pub. L. 117–328, § 3625(a)(1), designated remainder of existing provisions as subcl. (I)

     3. Inserted · 21 U.S.C. § 379h(g)(2)(A)(ii)

        Pub. L. 117–328, § 3625(a)(1), inserted “for fiscal year 2023, to defray” before “increases in the costs”

     4. Added · 21 U.S.C. § 379h(g)(2)(A)(ii)

        Pub. L. 117–328, § 3625(a)(1), added subcl. (II)

     Source evidence

     Code amendment note
     Subsec. (g)(2)(A)(ii). Pub. L. 117–328, § 3625(a)(1), substituted “shall be available—” for “shall be available to defray”, designated remainder of existing provisions as subcl. (I), inserted “for fiscal year 2023, to defray” before “increases in the costs”, and added subcl. (II).

     Enacted provision · exact public law section
     (1) in subparagraph (A)(ii)— (A) by striking “shall be available to defray” and inserting the following: “shall be available— “(I) for fiscal year 2023, to defray” ; (B) by striking the period and inserting “; and”; and (C) by adding at the end the following: “(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.” ; and

127. 2022

     Food and Drug Omnibus Reform Act of 2022

     Pub. L. 117–328 § 3625(a)(2) · 136 Stat. 4459

     Substituted · 21 U.S.C. § 379h(g)(2)(B)

     Pub. L. 117–328, § 3625(a)(2), substituted “as described in subclause (I) or (II) of such subparagraph, as applicable” for “for the process for the review of human drug applications” in introductory provisions

     Source evidence

     Code amendment note
     Subsec. (g)(2)(B). Pub. L. 117–328, § 3625(a)(2), substituted “as described in subclause (I) or (II) of such subparagraph, as applicable” for “for the process for the review of human drug applications” in introductory provisions.

     Enacted provision · exact public law section
     (2) in subparagraph (B), by striking “for the process for the review of human drug applications” and inserting “as described in subclause (I) or (II) of such subparagraph, as applicable”.

191 of 191 references resolved to an enrolled provision