Title 21 — Food and Drugs
Part C · Chapter 9 — Federal Food, Drug, and Cosmetic Act
§ 379g. Definitions
Statutory text
For purposes of this subpart:
The term “human drug application” means an application for—
approval of a new drug submitted under section 355(b) of this title, or
licensure of a biological product under subsection (a) of section 262 of title 42.
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 , does not include an application with respect to an allergenic extract product licensed before , does not include an application with respect to a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before , does not include an application with respect to an in vitro diagnostic biologic product licensed under section 262 of title 42, does not include an application with respect to a large volume parenteral drug product approved before , does not include an application for a licensure of a biological product for further manufacturing use only, and does not include an application or supplement submitted by a State or Federal Government entity for a drug that is not distributed commercially. Such term does include an application for licensure, as described in subparagraph (B), of a large volume biological product intended for single dose injection for intravenous use or infusion.
The term “supplement” means a request to the Secretary to approve a change in a human drug application which has been approved.
The term “prescription drug product” means a specific strength or potency of a drug in final dosage form—
for which a human drug application has been approved,
which may be dispensed only under prescription pursuant to section 353(b) of this title, and
which is on the list of products described in section 355(j)(7)(A) of this title (not including the discontinued section of such list) or is on a list created and maintained by the Secretary of products approved under human drug applications under section 262 of title 42 (not including the discontinued section of such list).
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 , an allergenic extract product licensed before , a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before , or an in vitro diagnostic biologic product licensed under section 262 of title 42. Such term does not include a biological product that is licensed for further manufacturing use only, and does not include a drug that is not distributed commercially and is the subject of an application or supplement submitted by a State or Federal Government entity. Such term does include a large volume biological product intended for single dose injection for intravenous use or infusion.
If a written request to place a product in the discontinued section of either of the lists referenced in subparagraph (A)(iii) is submitted to the Secretary on behalf of an applicant, and the request identifies the date the product is, or will be, withdrawn from sale, then for purposes of assessing the prescription drug program fee under section 379h(a)(2) of this title, the Secretary shall consider such product to have been included in the discontinued section on the later of—
the date such request was received; or
if the product will be withdrawn from sale on a future date, such future date when the product is withdrawn from sale.
For purposes of this subparagraph, a product shall be considered withdrawn from sale once the applicant has ceased its own distribution of the product, whether or not the applicant has ordered recall of all previously distributed lots of the product, except that a routine, temporary interruption in supply shall not render a product withdrawn from sale.
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 substantial further manufacturing (such as capsules, tablets, or lyophilized products before reconstitution).
The term “prescription drug establishment” means a foreign or domestic place of business which is at one general physical location consisting of one or more buildings all of which are within five miles of each other and at which one or more prescription drug products are manufactured in final dosage form. For purposes of this paragraph, the term “manufactured” does not include packaging.
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:
The activities necessary for the review of human drug applications and supplements.
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.
The inspection of prescription drug establishments and other facilities undertaken as part of the Secretary’s review of pending human drug applications and supplements.
Activities necessary for the review of applications for licensure of establishments subject to section 262 of title 42 and for the release of lots of biologics under such section.
Monitoring of research conducted in connection with the review of human drug applications.
Postmarket safety activities with respect to drugs approved under human drug applications or supplements, including the following activities:
Collecting, developing, and reviewing safety information on approved drugs, including adverse event reports.
Developing and using improved adverse-event data-collection systems, including information technology systems.
Developing and using improved analytical tools to assess potential safety problems, including access to external data bases.
Implementing and enforcing section 355(o) of this title (relating to postapproval studies and clinical trials and labeling changes) and section 355(p) of this title (relating to risk evaluation and mitigation strategies).
Carrying out section 355(k)(5) of this title (relating to adverse event reports and postmarket safety activities).
The term “costs of resources allocated for the process for the review of human drug applications” means the expenses in connection with the process for the review of human drug applications for—
officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers, employees, and committees and to contracts with such contractors,
management of information, and the acquisition, maintenance, and repair of computer resources,
leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies, and
collecting fees under section 379h of this title and accounting for resources allocated for the review of human drug applications and supplements.
The term “adjustment factor” applicable to a fiscal year is the Consumer Price Index for all urban consumers (all items; United States city average) for October of the preceding fiscal year divided by such Index for October 1996.
The term “person” includes an affiliate thereof.
The term “active”, with respect to a commercial investigational new drug application, means such an application to which information was submitted during the relevant period.
The term “affiliate” means a business entity that has a relationship with a second business entity if, directly or indirectly—
one business entity controls, or has the power to control, the other business entity; or
a third party controls, or has power to control, both of the business entities.
The term “skin-test diagnostic product”—
means a product—
for prick, scratch, intradermal, or subcutaneous administration;
expected to produce a limited, local reaction at the site of administration (if positive), rather than a systemic effect;
not intended to be a preventive or therapeutic intervention; and
intended to detect an immediate- or delayed-type skin hypersensitivity reaction to aid in the diagnosis of—
an allergy to an antimicrobial agent;
an allergy that is not to an antimicrobial agent, if the diagnostic product was authorized for marketing prior to ; or
infection with fungal or mycobacterial pathogens; and
includes positive and negative controls required to interpret the results of a product described in subparagraph (A).
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.
Prescription Drug User Fee Act of 1992
Pub. L. 102–571 title I § 103 · 106 Stat. 4491
Enacted · 21 U.S.C. § 379g
June 25, 1938, ch. 675, § 735, as added Pub. L. 102–571, title I, § 103, Oct. 29, 1992, 106 Stat. 4491
Source evidence
Code source credit
June 25, 1938, ch. 675, § 735, as added Pub. L. 102–571, title I, § 103, Oct. 29, 1992, 106 Stat. 4491Enacted 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.”.Food and Drug Administration Modernization Act of 1997
Pub. L. 105–115 § 102(1) · 111 Stat. 2296
Struck · 21 U.S.C. § 379g(1)
Pub. L. 105–115, § 102(1), in closing provisions, struck out “and” before “does not include an application”
Substituted · 21 U.S.C. § 379g(1)
Pub. L. 105–115, § 102(1), in closing provisions, substituted “September 1, 1992, does not include an application for a licensure of a biological product for further manufacturing use only, and does not include an application or supplement submitted by a State or Federal Government entity for a drug that is not distributed commercially. Such term does include an application for licensure, as described in subparagraph (D), of a large volume biological product intended for single dose injection for intravenous use or infusion” for “September 1, 1992” before period at end
Source evidence
Code amendment note
Par. (1). Pub. L. 105–115, § 102(1), in closing provisions, struck out “and” before “does not include an application” and substituted “September 1, 1992, does not include an application for a licensure of a biological product for further manufacturing use only, and does not include an application or supplement submitted by a State or Federal Government entity for a drug that is not distributed commercially. Such term does include an application for licensure, as described in subparagraph (D), of a large volume biological product intended for single dose injection for intravenous use or infusion” for “September 1, 1992” before period at end.Enacted provision · exact public law section
(1) in the second sentence of paragraph (1)— (A) by striking “Service Act, and” and inserting “Service Act,”; and (B) by striking “September 1, 1992.” and inserting the following: “September 1, 1992, does not include an application for a licensure of a biological product for further manufacturing use only, and does not include an application or supplement submitted by a State or Federal Government entity for a drug that is not distributed commercially. Such term does include an application for licensure, as described in subparagraph (D), of a large volume biological product intended for single dose injection for intravenous use or infusion.”;Food and Drug Administration Modernization Act of 1997
Pub. L. 105–115 § 125(b)(2)(M) · 111 Stat. 2296
Inserted · 21 U.S.C. § 379g(1)(B)(D)
Pub. L. 105–115, § 125(b)(2)(M), inserted “or” at end of subpar. (B)
Redesignated · 21 U.S.C. § 379g(1)(B)(D)
Pub. L. 105–115, § 125(b)(2)(M), redesignated subpar. (D) as (C)
Struck · 21 U.S.C. § 379g(1)(B)(D)
Pub. L. 105–115, § 125(b)(2)(M), struck out former subpar. (C) which read as follows: “initial certification or initial approval of an antibiotic drug under section 357 of this title, or”
Source evidence
Code amendment note
Par. (1)(B) to (D). Pub. L. 105–115, § 125(b)(2)(M), inserted “or” at end of subpar. (B), redesignated subpar. (D) as (C), and struck out former subpar. (C) which read as follows: “initial certification or initial approval of an antibiotic drug under section 357 of this title, or”.Enacted provision · exact public law section
(M) Section 735(1) (21 U.S.C. 379g(1)(C)) is amended by inserting “or” at the end of subparagraph (B), by striking subparagraph (C), and by redesignating subparagraph (D) as subparagraph (C).Food and Drug Administration Modernization Act of 1997
Pub. L. 105–115 § 102(2) · 111 Stat. 2296
Struck · 21 U.S.C. § 379g(3)
Pub. L. 105–115, § 102(2), in closing provisions, struck out “and” before “does not include a large volume parenteral drug”
Substituted · 21 U.S.C. § 379g(3)
Pub. L. 105–115, § 102(2), in closing provisions, substituted “September 1, 1992, does not include a biological product that is licensed for further manufacturing use only, and does not include a drug that is not distributed commercially and is the subject of an application or supplement submitted by a State or Federal Government entity. Such term does include a large volume biological product intended for single dose injection for intravenous use or infusion” for “September 1, 1992” before period at end
Source evidence
Code amendment note
Par. (3). Pub. L. 105–115, § 102(2), in closing provisions, struck out “and” before “does not include a large volume parenteral drug” and substituted “September 1, 1992, does not include a biological product that is licensed for further manufacturing use only, and does not include a drug that is not distributed commercially and is the subject of an application or supplement submitted by a State or Federal Government entity. Such term does include a large volume biological product intended for single dose injection for intravenous use or infusion” for “September 1, 1992” before period at end.Enacted provision · exact public law section
(2) in the second sentence of paragraph (3)— (A) by striking “Service Act, and” and inserting “Service Act,”; and (B) by striking “September 1, 1992.” and inserting the following: “September 1, 1992, does not include a biological product that is licensed for further manufacturing use only, and does not include a drug that is not distributed commercially and is the subject of an application or supplement submitted by a State or Federal Government entity. Such term does include a large volume biological product intended for single dose injection for intravenous use or infusion.”;Food and Drug Administration Modernization Act of 1997
Pub. L. 105–115 § 102(3) · 111 Stat. 2296
Substituted · 21 U.S.C. § 379g(4)
Pub. L. 105–115, § 102(3), substituted “without substantial further manufacturing” for “without further manufacturing”
Source evidence
Code amendment note
Par. (4). Pub. L. 105–115, § 102(3), substituted “without substantial further manufacturing” for “without further manufacturing”.Enacted provision · exact public law section
(3) in paragraph (4), by striking “without” and inserting “without substantial”;Food and Drug Administration Modernization Act of 1997
Pub. L. 105–115 § 102(4) · 111 Stat. 2296
Amended · 21 U.S.C. § 379g(5)
Pub. L. 105–115, § 102(4), amended first sentence generally. Prior to amendment, first sentence read as follows: “The term ‘prescription drug establishment’ means a foreign or domestic place of business which is—
Source evidence
Code amendment note
Par. (5). Pub. L. 105–115, § 102(4), amended first sentence generally. Prior to amendment, first sentence read as follows: “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.”
Enacted provision · exact public law section
(4) by amending the first sentence of paragraph (5) to read as follows: “(5) The term ‘prescription drug establishment’ means a foreign or domestic place of business which is at one general physical location consisting of one or more buildings all of which are within five miles of each other and at which one or more prescription drug products are manufactured in final dosage form.”;Food and Drug Administration Modernization Act of 1997
Pub. L. 105–115 § 102(5) · 111 Stat. 2296
Substituted · 21 U.S.C. § 379g(7)(A)
Pub. L. 105–115, § 102(5), substituted “contractors of the Food and Drug Administration,” for “employees under contract with the Food and Drug Administration who work in facilities owned or leased for the Food and Drug Administration,”
Substituted · 21 U.S.C. § 379g(7)(A)
Pub. L. 105–115, § 102(5), substituted “and committees and to contracts with such contractors,” for “and committees,”
Source evidence
Code amendment note
Par. (7)(A). Pub. L. 105–115, § 102(5), substituted “contractors of the Food and Drug Administration,” for “employees under contract with the Food and Drug Administration who work in facilities owned or leased for the Food and Drug Administration,” and “and committees and to contracts with such contractors,” for “and committees,”.Enacted provision · exact public law section
(5) in paragraph (7)(A)— (A) by striking “employees under contract” and all that follows through “Administration,” the second time it occurs and inserting “contractors of the Food and Drug Administration,”; and (B) by striking “and committees,” and inserting “and committees and to contracts with such contractors,”;Food and Drug Administration Modernization Act of 1997
Pub. L. 105–115 § 102(6)(A) · 111 Stat. 2296
Substituted · 21 U.S.C. § 379g(8)(A)
Pub. L. 105–115, § 102(6)(A), substituted “April of the preceding fiscal year” for “August of the preceding fiscal year”
Substituted · 21 U.S.C. § 379g(8)(A)
Pub. L. 105–115, § 102(6)(A), substituted “April 1997” for “August 1992”
Source evidence
Code amendment note
Par. (8)(A). Pub. L. 105–115, § 102(6)(A), substituted “April of the preceding fiscal year” for “August of the preceding fiscal year” and “April 1997” for “August 1992”.Enacted provision · exact public law section
(A) in subparagraph (A)— (i) by striking “August of” and inserting “April of”; and (ii) by striking “August 1992” and inserting “April 1997”; andFood and Drug Administration Modernization Act of 1997
Pub. L. 105–115 § 102(6)(B) · 111 Stat. 2296
Substituted · 21 U.S.C. § 379g(8)(B)
Pub. L. 105–115, § 102(6)(B), substituted “section 254(c)” for “section 254(d)”
Substituted · 21 U.S.C. § 379g(8)(B)
Pub. L. 105–115, § 102(6)(B), substituted “fiscal year 1997” for “fiscal year 1992”
Substituted · 21 U.S.C. § 379g(8)(B)
Pub. L. 105–115, § 102(6)(B), substituted “105th Congress, 1st Session” for “102d Congress, 2d Session”
Source evidence
Code amendment note
Par. (8)(B). Pub. L. 105–115, § 102(6)(B), substituted “section 254(c)” for “section 254(d)”, “fiscal year 1997” for “fiscal year 1992”, and “105th Congress, 1st Session” for “102d Congress, 2d Session”.Enacted provision · exact public law section
(B) in subparagraph (B)— (i) by striking “section 254(d)” and inserting “section 254(c)”; (ii) by striking “1992” and inserting “1997”; and (iii) by striking “102d Congress, 2d Session” and inserting “105th Congress, 1st Session”; andFood and Drug Administration Modernization Act of 1997
Pub. L. 105–115 § 102(7) · 111 Stat. 2296
Added · 21 U.S.C. § 379g(9)
Pub. L. 105–115, § 102(7), added par. (9)
Source evidence
Code amendment note
Par. (9). Pub. L. 105–115, § 102(7), added par. (9).Enacted provision · exact public law section
(7) by adding at the end the following: “(9) The term ‘affiliate’ means a business entity that has a relationship with a second business entity if, directly or indirectly— “(A) one business entity controls, or has the power to control, the other business entity; or “(B) a third party controls, or has power to control, both of the business entities.”.Prescription Drug User Fee Amendments of 2002
Pub. L. 107–188 § 503(1) · 116 Stat. 594
Substituted · 21 U.S.C. § 379g(1)
Pub. L. 107–188, § 503(1), substituted “licensure, as described in subparagraph (C)” for “licensure, as described in subparagraph (D)” in concluding provisions
Source evidence
Code amendment note
Par. (1). Pub. L. 107–188, § 503(1), substituted “licensure, as described in subparagraph (C)” for “licensure, as described in subparagraph (D)” in concluding provisions.Enacted provision · exact public law section
(1) in paragraph (1), in the matter after and below subparagraph (C), by striking “licensure, as described in subparagraph (D)” and inserting “licensure, as described in subparagraph (C)”;Prescription Drug User Fee Amendments of 2002
Pub. L. 107–188 § 503(2)(D) · 116 Stat. 594
Substituted · 21 U.S.C. § 379g(3)
Pub. L. 107–188, § 503(2)(D), which directed the amendment of concluding provisions of par. (3) by striking “section 262 of title 42” and all that follows through “biological product” and inserting “section 262 of title 42. Such term does not include a biological product”, was executed by striking language ending with “biological product” the first time appearing, thereby making the substitution for “section 262 of title 42, does not include a large volume parenteral drug product approved before September 1, 1992, does not include a biological product”, to reflect the probable intent of Congress
Source evidence
Code amendment note
Par. (3). Pub. L. 107–188, § 503(2)(D), which directed the amendment of concluding provisions of par. (3) by striking “section 262 of title 42” and all that follows through “biological product” and inserting “section 262 of title 42. Such term does not include a biological product”, was executed by striking language ending with “biological product” the first time appearing, thereby making the substitution for “section 262 of title 42, does not include a large volume parenteral drug product approved before September 1, 1992, does not include a biological product”, to reflect the probable intent of Congress.Enacted provision · exact public law section
(D) in the matter after and below subparagraph (C) (as added by subparagraph (C) of this paragraph), by striking “Service Act,” and all that follows through “biological product” and inserting the following: “Service Act. Such term does not include a biological product”;Prescription Drug User Fee Amendments of 2002
Pub. L. 107–188 § 503(2)(A) · 116 Stat. 594
Added · 21 U.S.C. § 379g(3)(C)
Pub. L. 107–188, § 503(2)(A)–(C), added subpar. (C)
Source evidence
Code amendment note
Par. (3)(C). Pub. L. 107–188, § 503(2)(A)–(C), added subpar. (C).Enacted provision · exact public law section
(A) in subparagraph (A), by striking “and” at the end;Prescription Drug User Fee Amendments of 2002
Pub. L. 107–188 § 503(3) · 116 Stat. 594
Added · 21 U.S.C. § 379g(6)(F)
Pub. L. 107–188, § 503(3), added subpar. (F)
Source evidence
Code amendment note
Par. (6)(F). Pub. L. 107–188, § 503(3), added subpar. (F).Enacted provision · exact public law section
(3) in paragraph (6), by adding at the end the following subparagraph: “(F) In the case of drugs approved after October 1, 2002, under human drug applications or supplements: collecting, developing, and reviewing safety information on the drugs, including adverse event reports, during a period of time after approval of such applications or supplements, not to exceed three years.”; andPrescription Drug User Fee Amendments of 2002
Pub. L. 107–188 § 503(4) · 116 Stat. 594
Struck · 21 U.S.C. § 379g(8)
Pub. L. 107–188, § 503(4), struck out designations of subpars. (A) and (B) and text of subpar. (B) and concluding provisions
Substituted · 21 U.S.C. § 379g(8)
Pub. L. 107–188, § 503(4), substituting definition of “adjustment factor” as the Consumer Price Index for definition of Index as the lower of the Consumer Price Index or the total of discretionary budget authority provided for programs in the domestic category for the immediately preceding fiscal year divided by such budget authority for fiscal year 1997
Source evidence
Code amendment note
Par. (8). Pub. L. 107–188, § 503(4), struck out designations of subpars. (A) and (B) and text of subpar. (B) and concluding provisions, substituting definition of “adjustment factor” as the Consumer Price Index for definition of Index as the lower of the Consumer Price Index or the total of discretionary budget authority provided for programs in the domestic category for the immediately preceding fiscal year divided by such budget authority for fiscal year 1997.Enacted provision · exact public law section
(4) in paragraph (8)— (A) by striking the matter after and below subparagraph (B); (B) by striking subparagraph (B); (C) by striking “is the lower of” and all that follows through “Consumer Price Index” and inserting “is the Consumer Price Index”; and (D) by striking “1997, or” and inserting “1997.”.Prescription Drug User Fee Amendments of 2007
Pub. L. 110–85 § 102(1) · 121 Stat. 823
Substituted · 21 U.S.C. § 379g
Pub. L. 110–85, § 102(1), in introductory provisions, substituted “For purposes of this subpart” for “For purposes of this part”
Source evidence
Code amendment note
Pub. L. 110–85, § 102(1), in introductory provisions, substituted “For purposes of this subpart” for “For purposes of this part”.Enacted provision · exact public law section
(1) in the matter before paragraph (1), by striking “For purposes of this subchapter” and inserting “For purposes of this part”;Prescription Drug User Fee Amendments of 2007
Pub. L. 110–85 § 102(2)(D) · 121 Stat. 823
Substituted · 21 U.S.C. § 379g(1)
Pub. L. 110–85, § 102(2)(D), substituted “subparagraph (B)” for “subparagraph (C)” in concluding provisions
Source evidence
Code amendment note
Par. (1). Pub. L. 110–85, § 102(2)(D), substituted “subparagraph (B)” for “subparagraph (C)” in concluding provisions.Enacted provision · exact public law section
(D) in the matter following subparagraph (B), as so redesignated, by striking “subparagraph (C)” and inserting “subparagraph (B)”;Prescription Drug User Fee Amendments of 2007
Pub. L. 110–85 § 102(2)(A) · 121 Stat. 823
Substituted · 21 U.S.C. § 379g(1)(A)
Pub. L. 110–85, § 102(2)(A), substituted “355(b) of this title, or” for “355(b)(1) of this title,”
Source evidence
Code amendment note
Par. (1)(A). Pub. L. 110–85, § 102(2)(A), substituted “355(b) of this title, or” for “355(b)(1) of this title,”.Enacted provision · exact public law section
(A) in subparagraph (A), by striking “505(b)(1),” and inserting “505(b), or”;Prescription Drug User Fee Amendments of 2007
Pub. L. 110–85 § 102(2)(B) · 121 Stat. 823
Redesignated · 21 U.S.C. § 379g(1)(B); 21 U.S.C. § 379g(1)(C)
Pub. L. 110–85, § 102(2)(B), (C), redesignated subpar. (C) as (B)
Struck · 21 U.S.C. § 379g(1)(B); 21 U.S.C. § 379g(1)(C)
Pub. L. 110–85, § 102(2)(B), (C), struck out former subpar. (B) which read as follows: “approval of a new drug submitted under section 355(b)(2) of this title after September 30, 1992, which requests approval of—
Source evidence
Code amendment note
Par. (1)(B), (C). Pub. L. 110–85, § 102(2)(B), (C), redesignated subpar. (C) as (B) and struck out former subpar. (B) which read as follows: “approval of a new drug submitted under section 355(b)(2) of this title 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 355(b) of this title, or”.
Enacted provision · exact public law section
(B) by striking subparagraph (B);Prescription Drug User Fee Amendments of 2007
Pub. L. 110–85 § 102(3) · 121 Stat. 823
Substituted · 21 U.S.C. § 379g(3)(C)
Pub. L. 110–85, § 102(3), substituted “355(j)(7)(A) of this title (not including the discontinued section of such list)” for “355(j)(7)(A) of this title”
Inserted · 21 U.S.C. § 379g(3)(C)
Pub. L. 110–85, § 102(3), inserted “(not including the discontinued section of such list)” before period at end
Source evidence
Code amendment note
Par. (3)(C). Pub. L. 110–85, § 102(3), substituted “355(j)(7)(A) of this title (not including the discontinued section of such list)” for “355(j)(7)(A) of this title” and inserted “(not including the discontinued section of such list)” before period at end.Enacted provision · exact public law section
(3) in paragraph (3)(C)— (A) by striking “505(j)(7)(A)” and inserting “505(j)(7)(A) (not including the discontinued section of such list)”; and (B) by inserting before the period “(not including the discontinued section of such list)”;Prescription Drug User Fee Amendments of 2007
Pub. L. 110–85 § 102(4) · 121 Stat. 823
Inserted · 21 U.S.C. § 379g(4)
Pub. L. 110–85, § 102(4), inserted “(such as capsules, tablets, or lyophilized products before reconstitution)” before period at end
Source evidence
Code amendment note
Par. (4). Pub. L. 110–85, § 102(4), inserted “(such as capsules, tablets, or lyophilized products before reconstitution)” before period at end.Enacted provision · exact public law section
(4) in paragraph (4), by inserting before the period at the end the following: “(such as capsules, tablets, or lyophilized products before reconstitution)”;Prescription Drug User Fee Amendments of 2007
Pub. L. 110–85 § 102(5) · 121 Stat. 823
Amended · 21 U.S.C. § 379g(6)(F)
Pub. L. 110–85, § 102(5), amended subpar. (F) generally. Prior to amendment, subpar. (F) read as follows: “In the case of drugs approved after October 1, 2002, under human drug applications or supplements: collecting, developing, and reviewing safety information on the drugs, including adverse event reports, during a period of time after approval of such applications or supplements, not to exceed three years.”
Source evidence
Code amendment note
Par. (6)(F). Pub. L. 110–85, § 102(5), amended subpar. (F) generally. Prior to amendment, subpar. (F) read as follows: “In the case of drugs approved after October 1, 2002, under human drug applications or supplements: collecting, developing, and reviewing safety information on the drugs, including adverse event reports, during a period of time after approval of such applications or supplements, not to exceed three years.”Enacted provision · exact public law section
(5) by amending paragraph (6)(F) to read as follows: “(F) Postmarket safety activities with respect to drugs approved under human drug applications or supplements, including the following activities: “(i) Collecting, developing, and reviewing safety information on approved drugs, including adverse event reports. “(ii) Developing and using improved adverse-event data-collection systems, including information technology systems. “(iii) Developing and using improved analytical tools to assess potential safety problems, including access to external data bases. “(iv) Implementing and enforcing section 505(o) (relating to postapproval studies and clinical trials and labeling changes) and section 505(p) (relating to risk evaluation and mitigation strategies). “(v) Carrying out section 505(k)(5) (relating to adverse event reports and postmarket safety activities).” ;Prescription Drug User Fee Amendments of 2007
Pub. L. 110–85 § 102(6) · 121 Stat. 823
Substituted · 21 U.S.C. § 379g(8)
Pub. L. 110–85, § 102(6), substituted “October of the preceding fiscal year” for “April of the preceding fiscal year”
Substituted · 21 U.S.C. § 379g(8)
Pub. L. 110–85, § 102(6), substituted “October 1996” for “April 1997”
Source evidence
Code amendment note
Par. (8). Pub. L. 110–85, § 102(6), substituted “October of the preceding fiscal year” for “April of the preceding fiscal year” and “October 1996” for “April 1997”.Enacted provision · exact public law section
(6) in paragraph (8)— (A) by striking “April of the preceding fiscal year” and inserting “October of the preceding fiscal year”; and (B) by striking “April 1997” and inserting “October 1996”;Prescription Drug User Fee Amendments of 2007
Pub. L. 110–85 § 102(7) · 121 Stat. 823
Added · 21 U.S.C. § 379g(9)(11)
Pub. L. 110–85, § 102(7), (8), added pars. (9) and (10)
Redesignated · 21 U.S.C. § 379g(9)(11)
Pub. L. 110–85, § 102(7), (8), redesignated former par. (9) as (11)
Source evidence
Code amendment note
Pars. (9) to (11). Pub. L. 110–85, § 102(7), (8), added pars. (9) and (10) and redesignated former par. (9) as (11).Enacted provision · exact public law section
(7) by redesignating paragraph (9) as paragraph (11); andBiologics Price Competition and Innovation Act of 2009
Pub. L. 111–148 title VII § 7002(f)(3)(A) · 124 Stat. 119
Substituted · 21 U.S.C. § 379g(1)(B)
Pub. L. 111–148 substituted “subsection (a) or (k) of section 262 of title 42” for “section 262 of title 42”
Source evidence
Code amendment note
Par. (1)(B). Pub. L. 111–148 substituted “subsection (a) or (k) of section 262 of title 42” for “section 262 of title 42”.Enacted provision · exact public law section
(A) Application of the prescription drug user fee provisions.— Section 735(1)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g(1)(B)) is amended by striking “section 351” and inserting “subsection (a) or (k) of section 351”.Biosimilar User Fee Act of 2012
Pub. L. 112–144 § 407 · 126 Stat. 993
Struck · 21 U.S.C. § 379g(1)(B)
Pub. L. 112–144, § 407, struck out “or (k)” after “subsection (a)”
Source evidence
Code amendment note
Par. (1)(B). Pub. L. 112–144, § 407, struck out “or (k)” after “subsection (a)”.Enacted provision · exact public law section
SEC. 407. CONFORMING AMENDMENT. Section 735(1)(B) (21 U.S.C. 379g(1)(B)) is amended by striking “or (k)”.Prescription Drug User Fee Amendments of 2012
Pub. L. 112–144 § 102 · 126 Stat. 993
Substituted · 21 U.S.C. § 379g(7)
Pub. L. 112–144, § 102, substituted “expenses in connection with” for “expenses incurred in connection with”
Source evidence
Code amendment note
Par. (7). Pub. L. 112–144, § 102, substituted “expenses in connection with” for “expenses incurred in connection with”.Enacted provision · exact public law section
SEC. 102. DEFINITIONS. Section 735(7) (21 U.S.C. 379g) is amended by striking “expenses incurred in connection with” and inserting “expenses in connection with”.Prescription Drug User Fee Amendments of 2022
Pub. L. 117–180 § 1002(a) · 136 Stat. 2114
Substituted · 21 U.S.C. § 379g(1)
Pub. L. 117–180, § 1002(a), substituted “does not include an application with respect to an allergenic extract product licensed before October 1, 2022, does not include an application with respect to a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before October 1, 2022, does not include an application with respect to” for “an allergenic extract product, or” in concluding provisions
Source evidence
Code amendment note
Par. (1). Pub. L. 117–180, § 1002(a), substituted “does not include an application with respect to an allergenic extract product licensed before October 1, 2022, does not include an application with respect to a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before October 1, 2022, does not include an application with respect to” for “an allergenic extract product, or” in concluding provisions.Enacted provision · exact public law section
(a) Human Drug Application.— Section 735(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g(1)) is amended, in the matter following subparagraph (B), by striking “an allergenic extract product, or” and inserting “does not include an application with respect to an allergenic extract product licensed before October 1, 2022, does not include an application with respect to a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before October 1, 2022, does not include an application with respect to”.Effective date note
Pub. L. 117–180, div. F, title I, § 1006, Sept. 30, 2022, 136 Stat. 2147, provided that: “The amendments made by this title [amending this section and sections 379h and 379h–2 of this title and repealing provisions set out as notes under this section and section 379h–2 of this title] shall take effect on October 1, 2022, or the date of the enactment of this Act [Sept. 30, 2022], whichever is later, except that fees under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.) shall be assessed for all human drug applications received on or after October 1, 2022, regardless of the date of the enactment of this Act.”Prescription Drug User Fee Amendments of 2022
Pub. L. 117–180 § 1002(b) · 136 Stat. 2114
Substituted · 21 U.S.C. § 379g(3)
Pub. L. 117–180, § 1002(b), substituted “(3)(A) The term” for “(3) The term”
Redesignated · 21 U.S.C. § 379g(3)
Pub. L. 117–180, § 1002(b), redesignated former subpars. (A) to (C) as cls. (i) to (iii), respectively, of subpar. (A)
Amended · 21 U.S.C. § 379g(3)
Pub. L. 117–180, § 1002(b), designated concluding provisions as subpar. (B)
Substituted · 21 U.S.C. § 379g(3)
Pub. L. 117–180, § 1002(b), substituted “an allergenic extract product licensed before October 1, 2022, a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before October 1, 2022,” for “an allergenic extract product,”
Added · 21 U.S.C. § 379g(3)
Pub. L. 117–180, § 1002(b), added subpar. (C)
Source evidence
Code amendment note
Par. (3). Pub. L. 117–180, § 1002(b), substituted “(3)(A) The term” for “(3) The term”, redesignated former subpars. (A) to (C) as cls. (i) to (iii), respectively, of subpar. (A), designated concluding provisions as subpar. (B) and substituted “an allergenic extract product licensed before October 1, 2022, a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before October 1, 2022,” for “an allergenic extract product,”, and added subpar. (C).Enacted provision · exact public law section
(b) Prescription Drug Product.— Section 735(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g(3)) is amended— (1) by redesignating subparagraphs (A), (B), and (C) as clauses (i), (ii), and (iii), respectively; (2) by striking “(3) The term” and inserting “(3)(A) The term”; (3) by striking “Such term does not include whole blood” and inserting the following: “(B) Such term does not include whole blood” ; (4) by striking “an allergenic extract product,” and inserting “an allergenic extract product licensed before October 1, 2022, a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before October 1, 2022,” ; and (5) by adding at the end the following: “(C) (i) If a written request to place a product in the discontinued section of either of the lists referenced in subparagraph (A)(iii) is submitted to the Secretary on behalf of an applicant, and the request identifies the date the product is, or will be, withdrawn from sale, then for purposes of assessing the prescription drug program fee under section 736(a)(2), the Secretary shall consider such product to have been included in the discontinued section on the later of— “(I) the date such request was received; or “(II) if the product will be withdrawn from sale on a future date, such future date when the product is withdrawn from sale. “(ii) For purposes of this subparagraph, a product shall be considered withdrawn from sale once the applicant has ceased its own distribution of the product, whether or not the applicant has ordered recall of all previously distributed lots of the product, except that a routine, temporary interruption in supply shall not render a product withdrawn from sale.” .Effective date note
Pub. L. 117–180, div. F, title I, § 1006, Sept. 30, 2022, 136 Stat. 2147, provided that: “The amendments made by this title [amending this section and sections 379h and 379h–2 of this title and repealing provisions set out as notes under this section and section 379h–2 of this title] shall take effect on October 1, 2022, or the date of the enactment of this Act [Sept. 30, 2022], whichever is later, except that fees under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.) shall be assessed for all human drug applications received on or after October 1, 2022, regardless of the date of the enactment of this Act.”Prescription Drug User Fee Amendments of 2022
Pub. L. 117–180 § 1002(c) · 136 Stat. 2114
Added · 21 U.S.C. § 379g(12)
Pub. L. 117–180, § 1002(c), added par. (12)
Source evidence
Code amendment note
Par. (12). Pub. L. 117–180, § 1002(c), added par. (12).Enacted provision · exact public law section
(c) Skin-Test Diagnostic Product.— Section 735 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g) is amended by adding at the end the following: “(12) The term ‘skin-test diagnostic product’— “(A) means a product— “(i) for prick, scratch, intradermal, or subcutaneous administration; “(ii) expected to produce a limited, local reaction at the site of administration (if positive), rather than a systemic effect; “(iii) not intended to be a preventive or therapeutic intervention; and “(iv) intended to detect an immediate- or delayed-type skin hypersensitivity reaction to aid in the diagnosis of— “(I) an allergy to an antimicrobial agent; “(II) an allergy that is not to an antimicrobial agent, if the diagnostic product was authorized for marketing prior to October 1, 2022; or “(III) infection with fungal or mycobacterial pathogens; and “(B) includes positive and negative controls required to interpret the results of a product described in subparagraph (A).” .Effective date note
Pub. L. 117–180, div. F, title I, § 1006, Sept. 30, 2022, 136 Stat. 2147, provided that: “The amendments made by this title [amending this section and sections 379h and 379h–2 of this title and repealing provisions set out as notes under this section and section 379h–2 of this title] shall take effect on October 1, 2022, or the date of the enactment of this Act [Sept. 30, 2022], whichever is later, except that fees under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.) shall be assessed for all human drug applications received on or after October 1, 2022, regardless of the date of the enactment of this Act.”
47 of 47 references resolved to an enrolled provision
Notes
Termination of Section
For termination of section by section 1005(a) of Pub. L. 117–180, see Termination Date note below.
Editorial Notes
Amendments1997–2022 · 6 rounds
2022
Par. (1). Pub. L. 117–180, § 1002(a), substituted “does not include an application with respect to an allergenic extract product licensed before , does not include an application with respect to a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before , does not include an application with respect to” for “an allergenic extract product, or” in concluding provisions.
Par. (3). Pub. L. 117–180, § 1002(b), substituted “(3)(A) The term” for “(3) The term”, redesignated former subpars. (A) to (C) as cls. (i) to (iii), respectively, of subpar. (A), designated concluding provisions as subpar. (B) and substituted “an allergenic extract product licensed before , a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before ,” for “an allergenic extract product,”, and added subpar. (C).
Par. (12). Pub. L. 117–180, § 1002(c), added par. (12).
2012
Par. (1)(B). Pub. L. 112–144, § 407, struck out “or (k)” after “subsection (a)”.
Par. (7). Pub. L. 112–144, § 102, substituted “expenses in connection with” for “expenses incurred in connection with”.
2010
Par. (1)(B). Pub. L. 111–148 substituted “subsection (a) or (k) of section 262 of title 42” for “section 262 of title 42”.
2007
Pub. L. 110–85, § 102(1), in introductory provisions, substituted “For purposes of this subpart” for “For purposes of this part”.
Par. (1). Pub. L. 110–85, § 102(2)(D), substituted “subparagraph (B)” for “subparagraph (C)” in concluding provisions.
Par. (1)(A). Pub. L. 110–85, § 102(2)(A), substituted “355(b) of this title, or” for “355(b)(1) of this title,”.
Par. (1)(B), (C). Pub. L. 110–85, § 102(2)(B), (C), redesignated subpar. (C) as (B) and struck out former subpar. (B) which read as follows: “approval of a new drug submitted under section 355(b)(2) of this title after , 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 355(b) of this title, or”.
Par. (3)(C). Pub. L. 110–85, § 102(3), substituted “355(j)(7)(A) of this title (not including the discontinued section of such list)” for “355(j)(7)(A) of this title” and inserted “(not including the discontinued section of such list)” before period at end.
Par. (4). Pub. L. 110–85, § 102(4), inserted “(such as capsules, tablets, or lyophilized products before reconstitution)” before period at end.
Par. (6)(F). Pub. L. 110–85, § 102(5), amended subpar. (F) generally. Prior to amendment, subpar. (F) read as follows: “In the case of drugs approved after , under human drug applications or supplements: collecting, developing, and reviewing safety information on the drugs, including adverse event reports, during a period of time after approval of such applications or supplements, not to exceed three years.”
Par. (8). Pub. L. 110–85, § 102(6), substituted “October of the preceding fiscal year” for “April of the preceding fiscal year” and “October 1996” for “April 1997”.
Pars. (9) to (11). Pub. L. 110–85, § 102(7), (8), added pars. (9) and (10) and redesignated former par. (9) as (11).
2002
Par. (1). Pub. L. 107–188, § 503(1), substituted “licensure, as described in subparagraph (C)” for “licensure, as described in subparagraph (D)” in concluding provisions.
Par. (3). Pub. L. 107–188, § 503(2)(D), which directed the amendment of concluding provisions of par. (3) by striking “section 262 of title 42” and all that follows through “biological product” and inserting “section 262 of title 42. Such term does not include a biological product”, was executed by striking language ending with “biological product” the first time appearing, thereby making the substitution for “section 262 of title 42, does not include a large volume parenteral drug product approved before , does not include a biological product”, to reflect the probable intent of Congress.
Par. (3)(C). Pub. L. 107–188, § 503(2)(A)–(C), added subpar. (C).
Par. (6)(F). Pub. L. 107–188, § 503(3), added subpar. (F).
Par. (8). Pub. L. 107–188, § 503(4), struck out designations of subpars. (A) and (B) and text of subpar. (B) and concluding provisions, substituting definition of “adjustment factor” as the Consumer Price Index for definition of Index as the lower of the Consumer Price Index or the total of discretionary budget authority provided for programs in the domestic category for the immediately preceding fiscal year divided by such budget authority for fiscal year 1997.
1997
Par. (1). Pub. L. 105–115, § 102(1), in closing provisions, struck out “and” before “does not include an application” and substituted “, does not include an application for a licensure of a biological product for further manufacturing use only, and does not include an application or supplement submitted by a State or Federal Government entity for a drug that is not distributed commercially. Such term does include an application for licensure, as described in subparagraph (D), of a large volume biological product intended for single dose injection for intravenous use or infusion” for “” before period at end.
Par. (1)(B) to (D). Pub. L. 105–115, § 125(b)(2)(M), inserted “or” at end of subpar. (B), redesignated subpar. (D) as (C), and struck out former subpar. (C) which read as follows: “initial certification or initial approval of an antibiotic drug under section 357 of this title, or”.
Par. (3). Pub. L. 105–115, § 102(2), in closing provisions, struck out “and” before “does not include a large volume parenteral drug” and substituted “, does not include a biological product that is licensed for further manufacturing use only, and does not include a drug that is not distributed commercially and is the subject of an application or supplement submitted by a State or Federal Government entity. Such term does include a large volume biological product intended for single dose injection for intravenous use or infusion” for “” before period at end.
Par. (4). Pub. L. 105–115, § 102(3), substituted “without substantial further manufacturing” for “without further manufacturing”.
Par. (5). Pub. L. 105–115, § 102(4), amended first sentence generally. Prior to amendment, first sentence read as follows: “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.”
Par. (7)(A). Pub. L. 105–115, § 102(5), substituted “contractors of the Food and Drug Administration,” for “employees under contract with the Food and Drug Administration who work in facilities owned or leased for the Food and Drug Administration,” and “and committees and to contracts with such contractors,” for “and committees,”.
Par. (8)(A). Pub. L. 105–115, § 102(6)(A), substituted “April of the preceding fiscal year” for “August of the preceding fiscal year” and “April 1997” for “August 1992”.
Par. (8)(B). Pub. L. 105–115, § 102(6)(B), substituted “section 254(c)” for “section 254(d)”, “fiscal year 1997” for “fiscal year 1992”, and “105th Congress, 1st Session” for “102d Congress, 2d Session”.
Par. (9). Pub. L. 105–115, § 102(7), added par. (9).
Statutory Notes and Related Subsidiaries
Effective Date of 2022 Amendment
Pub. L. 117–180, div. F, title I, § 1006, , 136 Stat. 2147, provided that: “The amendments made by this title [amending this section and sections 379h and 379h–2 of this title and repealing provisions set out as notes under this section and section 379h–2 of this title] shall take effect on , or the date of the enactment of this Act [], whichever is later, except that fees under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.) shall be assessed for all human drug applications received on or after , regardless of the date of the enactment of this Act.”
Effective Date of 2017 Amendment
Pub. L. 115–52, title I, § 105, , 131 Stat. 1012, provided that: “The amendments made by this title [see section 101(a) of Pub. L. 115–52, set out as a Short Title of 2017 Amendment note under section 301 of this title] shall take effect on , or the date of the enactment of this Act [], whichever is later, except that fees under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379g et seq.] shall be assessed for all human drug applications received on or after , regardless of the date of the enactment of this Act.”
Effective Date of 2012 Amendment
Pub. L. 112–144, title I, § 106, , 126 Stat. 1002, provided that: “The amendments made by this title [amending this section and sections 379h and 379h–2 of this title and repealing provisions set out as notes under this section and section 379h–2 of this title] shall take effect on , or the date of the enactment of this Act [], whichever is later, except that fees under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart] shall be assessed for all human drug applications received on or after , regardless of the date of the enactment of this Act.”
Amendment by section 407 of Pub. L. 112–144 effective , see section 405 of Pub. L. 112–144, set out as a note under section 379j–51 of this title.
Effective and Termination Dates of 2007 Amendment
Pub. L. 110–85, title I, § 106(a), , 121 Stat. 842, which provided that the amendments made by sections 102, 103, and 104 of Pub. L. 110–85 (enacting section 379h–1 of this title and amending this section and section 379h of this title) would cease to be effective , was repealed by Pub. L. 112–144, title I, § 105(c)(1), , 126 Stat. 1001.
Pub. L. 110–85, title I, § 107, , 121 Stat. 842, provided that: “The amendments made by this title [enacting sections 379h–1 and 379h–2 of this title and amending this section and sections 379h and 379j–11 of this title] shall take effect on , or the date of the enactment of this Act [], whichever is later, except that fees under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart] shall be assessed for all human drug applications received on or after , regardless of the date of the enactment of this Act.”
Effective and Termination Dates of 2002 Amendment
Amendment by Pub. L. 107–188 effective , see section 508 of Pub. L. 107–188, set out as an Effective Date of 2002 Amendment note under section 356b of this title.
Pub. L. 107–188, title V, § 509, , 116 Stat. 694, which provided that the amendments made by sections 503 and 504 of Pub. L. 107–188 (amending this section and section 379h of this title) would cease to be effective , and the amendment by section 505 of Pub. L. 107–188 (enacting provisions set out as a note below) would cease to be effective 120 days after , was repealed by Pub. L. 112–144, title I, § 105(d)(1)(A), , 126 Stat. 1001.
[Pub. L. 112–144, title I, § 105(d)(1), , 126 Stat. 1001, provided that the repeal of section 509 of Pub. L. 107–188, formerly set out above, is effective .]
Effective and Termination Dates of 1997 Amendment
Pub. L. 105–115, title I, § 106, , 111 Stat. 2305, provided that: “The amendments made by this subtitle [subtitle A (§§ 101–107) of title I of Pub. L. 105–115, amending this section and section 379h of this title] shall take effect .”
Pub. L. 105–115, title I, § 107, , 111 Stat. 2305, which provided that the amendments by sections 102 and 103 of Pub. L. 105–115 (amending this section and section 379h of this title) would cease to be effective , and the amendment by section 104 (enacting provisions set out as a note below) would cease to be effective 120 days after , was repealed by Pub. L. 112–144, title I, § 105(d)(2)(A), , 126 Stat. 1001.
[Pub. L. 112–144, title I, § 105(d)(2), , 126 Stat. 1001, provided that the repeal of section 107 of Pub. L. 105–115, formerly set out above, is effective .]
Termination Date
Pub. L. 117–180, div. F, title I, § 1005(a), , 136 Stat. 2147, provided that: “Sections 735 and 736 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g; 379h) shall cease to be effective .”
Pub. L. 115–52, title I, § 104(a), , 131 Stat. 1012, which provided that this section and section 379h of this title would cease to be effective , was repealed by Pub. L. 117–180, div. F, title I, § 1005(c), , 136 Stat. 2147.
[Pub. L. 117–180, div. F, title I, § 1005(c), , 136 Stat. 2147, provided that the repeal of section 104(a) of Pub. L. 115–52, formerly set out above, is effective .]
Pub. L. 112–144, title I, § 105(a), , 126 Stat. 1001, which provided that this section and section 379h of this title would cease to be effective , was repealed by Pub. L. 115–52, title I, § 104(c), , 131 Stat. 1012.
[Pub. L. 115–52, title I, § 104(c), , 131 Stat. 1012, provided that the repeal of section 105(a) of Pub. L. 112–144, formerly set out above, is effective .]
Pub. L. 102–571, title I, § 105, , 106 Stat. 4498, which provided that the amendment by section 103 of Pub. L. 102–571 (enacting this subpart) would not be in effect after , and the amendment by section 104 of Pub. L. 102–571 (enacting provisions set out as a note below) would not be in effect after 120 days after , was repealed by Pub. L. 112–144, title I, § 105(d)(3), , 126 Stat. 1002.
[Pub. L. 112–144, title I, § 105(d)(3), , 126 Stat. 1002, provided that the repeal of section 105 of Pub. L. 102–571, formerly set out above, is effective .]
Savings Provision
Pub. L. 117–180, div. F, title I, § 1007, , 136 Stat. 2147, provided that: “Notwithstanding the amendments made by this title [amending this section and section 379h and 379h–2 of this title and repealing provisions set out as notes under this section and section 379h–2 of this title], part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.), as in effect on the day before the date of the enactment of this title [], shall continue to be in effect with respect to human drug applications and supplements (as defined in such part as of such day) that were accepted by the Food and Drug Administration for filing on or after , but before , with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2023.”
Pub. L. 115–52, title I, § 106, , 131 Stat. 1013, provided that: “Notwithstanding the amendments made by this title [see section 101(a) of Pub. L. 115–52, set out as a Short Title of 2017 Amendment note under section 301 of this title], part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379g et seq.], as in effect on the day before the date of the enactment of this title [], shall continue to be in effect with respect to human drug applications and supplements (as defined in such part as of such day) that on or after , but before , were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2018.”
Pub. L. 112–144, title I, § 107, , 126 Stat. 1002, provided that: “Notwithstanding the amendments made by this title [amending this section and section 379h and 379h–2 of this title and repealing provisions set out as notes under this section and section 379h–2 of this title], part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], as in effect on the day before the date of the enactment of this title [], shall continue to be in effect with respect to human drug applications and supplements (as defined in such part as of such day) that on or after , but before , were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2012.”
Pub. L. 112–144, title IV, § 406, , 126 Stat. 1039, provided that: “Notwithstanding the amendments made by this title [enacting sections 379j–51 to 379j–53 of this title and amending this section and section 379d–4 of this title], part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], as in effect on the day before the date of the enactment of this title [], shall continue to be in effect with respect to human drug applications and supplements (as defined in such part as of such day) that were accepted by the Food and Drug Administration for filing on or after , but before , with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2013.”
Pub. L. 110–85, title I, § 108, , 121 Stat. 842, provided that: “Notwithstanding section 509 of the Prescription Drug User Fee Amendments of 2002 [Pub. L. 107–188] ([former] 21 U.S.C. 379g note), and notwithstanding the amendments made by this title [enacting sections 379h–1 and 379h–2 of this title and amending this section and sections 379h and 379j–11 of this title], part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], as in effect on the day before the date of the enactment of this title [], shall continue to be in effect with respect to human drug applications and supplements (as defined in such part as of such day) that on or after , but before , were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2008.”
Pub. L. 107–188, title V, § 507, , 116 Stat. 694, provided that: “Notwithstanding section 107 of the Food and Drug Administration Modernization Act of 1997 [section 107 of Pub. L. 105–115, formerly set out as an Effective and Termination Dates of 1997 Amendment note above], and notwithstanding the amendments made by this subtitle [subtitle A (§§ 501–509) of title V of Pub. L. 107–188, amending this section and sections 356b and 379h of this title], part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], as in effect on the day before the date of the enactment of this Act [], continues to be in effect with respect to human drug applications and supplements (as defined in such part as of such day) that, on or after , but before , were accepted by the Food and Drug Administration for filing and with respect to assessing and collecting any fee required by such Act for a fiscal year prior to fiscal year 2003.”
Pub. L. 105–115, title I, § 105, , 111 Stat. 2305, provided that: “Notwithstanding section 105 of the Prescription Drug User Fee Act of 1992 [section 105 of Pub. L. 102–571, formerly set out as a Termination Date note above], the Secretary shall retain the authority to assess and collect any fee required by part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart] for a human drug application or supplement accepted for filing prior to , and to assess and collect any product or establishment fee required by such Act for a fiscal year prior to fiscal year 1998.”
Accountability and Reports
Pub. L. 107–188, title V, § 505, , 116 Stat. 692, provided that:
“(a) Public Accountability.—
“(1) Consultation.—
In developing recommendations to the Congress for the goals and plans for meeting the goals for the process for the review of human drug applications for the fiscal years after fiscal year 2007, and for the reauthorization of sections 735 and 736 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379g, 379h], the Secretary of Health and Human Services (referred to in this section as the ‘Secretary’) shall consult with the Committee on Energy and Commerce of the House of Representatives, the Committee on Health, Education, Labor, and Pensions of the Senate, appropriate scientific and academic experts, health care professionals, representatives of patient and consumer advocacy groups, and the regulated industry.
“(2) Recommendations.—
The Secretary shall publish in the Federal Register recommendations under paragraph (1), after negotiations with the regulated industry; shall present such recommendations to the congressional committees specified in such paragraph; shall hold a meeting at which the public may present its views on such recommendations; and shall provide for a period of 30 days for the public to provide written comments on such recommendations.
“(b) Performance Report.—
Beginning with fiscal year 2003, not later than 60 days after the end of each fiscal year during which fees are collected under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.), the Secretary of Health and Human Services shall prepare and submit to the President, the Committee on Energy and Commerce of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions of the Senate a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 502(4) [section 502(4) of Pub. L. 107–188, set out below] during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals.
“(c) Fiscal Report.—
Beginning with fiscal year 2003, not later than 120 days after the end of each fiscal year during which fees are collected under the part described in subsection (b), the Secretary of Health and Human Services shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions of the Senate, a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected during such fiscal year for which the report is made.”
Congressional Findings Concerning Fees Relating to Drugs
Pub. L. 117–180, div. F, title I, § 1001(b), , 136 Stat. 2140, provided that: “Congress finds that the fees authorized by the amendments made by this title [amending this section and sections 379h and 379h–2 of this title and repealing provisions set out as notes under this section and section 379h–2 of this title] will be dedicated toward expediting the drug development process and the process for the review of human drug applications, including postmarket drug safety activities, as set forth in the goals identified for purposes of part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.), in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record.”
Pub. L. 115–52, title I, § 101(b), , 131 Stat. 1006, provided that: “The Congress finds that the fees authorized by the amendments made in this title [see section 101(a) of Pub. L. 115–52, set out as a Short Title of 2017 Amendment note under section 301 of this title] will be dedicated toward expediting the drug development process and the process for the review of human drug applications, including postmarket drug safety activities, as set forth in the goals identified for purposes of part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379g et seq.], in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record.”
Pub. L. 112–144, title I, § 101(b), , 126 Stat. 996, provided that: “The Congress finds that the fees authorized by the amendments made in this title [amending this section and sections 379h and 379h–2 of this title and repealing provisions set out as notes under this section and section 379h–2 of this title] will be dedicated toward expediting the drug development process and the process for the review of human drug applications, including postmarket drug safety activities, as set forth in the goals identified for purposes of part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record.”
Pub. L. 110–85, title I, § 101(c), , 121 Stat. 825, provided that: “The Congress finds that the fees authorized by the amendments made in this title [enacting sections 379h–1 and 379h–2 of this title and amending this section and sections 379h and 379j–11 of this title] will be dedicated toward expediting the drug development process and the process for the review of human drug applications, including postmarket drug safety activities, as set forth in the goals identified for purposes of part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record.”
Pub. L. 107–188, title V, § 502, , 116 Stat. 687, provided that:
“The Congress finds that—
“(1) prompt approval of safe and effective new drugs and other therapies is critical to the improvement of the public health so that patients may enjoy the benefits provided by these therapies to treat and prevent illness and disease;
“(2) the public health will be served by making additional funds available for the purpose of augmenting the resources of the Food and Drug Administration that are devoted to the process for the review of human drug applications and the assurance of drug safety;
“(3) the provisions added by the Prescription Drug User Fee Act of 1992 [see section 101(a) of Pub. L. 102–571, set out as a Short Title of 1992 Amendment note under section 301 of this title], as amended by the Food and Drug Administration Modernization Act of 1997 [see Short Title of 1997 Amendment note set out under section 301 of this title], have been successful in substantially reducing review times for human drug applications and should be—
“(A) reauthorized for an additional 5 years, with certain technical improvements; and
“(B) carried out by the Food and Drug Administration with new commitments to implement more ambitious and comprehensive improvements in regulatory processes of the Food and Drug Administration, including—
“(i) strengthening and improving the review and monitoring of drug safety;
“(ii) considering greater interaction between the agency and sponsors during the review of drugs and biologics intended to treat serious diseases and life-threatening diseases; and
“(iii) developing principles for improving first-cycle reviews; and
“(4) the fees authorized by amendments made in this subtitle [subtitle A (§§ 501–509) of title V of Pub. L. 107–188, amending this section and sections 356b and 379h of this title] will be dedicated towards expediting the drug development process and the process for the review of human drug applications as set forth in the goals identified for purposes of part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], in the letters from the Secretary of Health and Human Services to the chairman of the Committee on Energy and Commerce of the House of Representatives and the chairman of the Committee on Health, Education, Labor and Pensions of the Senate, as set forth in the Congressional Record.”
Pub. L. 105–115, title I, § 101, , 111 Stat. 2298, provided that:
“Congress finds that—
“(1) prompt approval of safe and effective new drugs and other therapies is critical to the improvement of the public health so that patients may enjoy the benefits provided by these therapies to treat and prevent illness and disease;
“(2) the public health will be served by making additional funds available for the purpose of augmenting the resources of the Food and Drug Administration that are devoted to the process for review of human drug applications;
“(3) the provisions added by the Prescription Drug User Fee Act of 1992 [see section 101(a) of Pub. L. 102–571, set out as a Short Title of 1992 Amendment note under section 301 of this title] have been successful in substantially reducing review times for human drug applications and should be—
“(A) reauthorized for an additional 5 years, with certain technical improvements; and
“(B) carried out by the Food and Drug Administration with new commitments to implement more ambitious and comprehensive improvements in regulatory processes of the Food and Drug Administration; and
“(4) the fees authorized by amendments made in this subtitle [subtitle A (§§ 101–107) of title I of Pub. L. 105–115, amending this section and section 379h of this title] will be dedicated toward expediting the drug development process and the review of human drug applications as set forth in the goals identified, for purposes of part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], in the letters from the Secretary of Health and Human Services to the chairman of the Committee on Commerce of the House of Representatives and the chairman of the Committee on Labor and Human Resources [now Committee on Health, Education, Labor, and Pensions] of the Senate, as set forth in the Congressional Record.”
Pub. L. 102–571, title I, § 102, , 106 Stat. 4491, provided that:
“The Congress finds that—
“(1) prompt approval of safe and effective new drugs is critical to the improvement of the public health so that patients may enjoy the benefits provided by these therapies to treat and prevent illness and disease;
“(2) the public health will be served by making additional funds available for the purpose of augmenting the resources of the Food and Drug Administration that are devoted to the process for review of human drug applications; and
“(3) the fees authorized by this title [see Short Title of 1992 Amendment note, set out under section 301 of this title] will be dedicated toward expediting the review of human drug applications as set forth in the goals identified in the letters of , and , from the Commissioner of Food and Drugs to the Chairman of the Energy and Commerce Committee of the House of Representatives and the Chairman of the Labor and Human Resources Committee of the Senate, as set forth at 138 Cong. Rec. H9099–H9100 (daily ed. ) [Cong. Rec., vol. 138, pt. 18, p. 26928, ].”
Annual Reports
Pub. L. 105–115, title I, § 104, , 111 Stat. 2304, provided that:
“(a) Performance Report.—
Beginning with fiscal year 1998, not later than 60 days after the end of each fiscal year during which fees are collected under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.), the Secretary of Health and Human Services shall prepare and submit to the Committee on Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 101(4) [section 101(4) of Pub. L. 105–115, set out above] during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals.
“(b) Fiscal Report.—
Beginning with fiscal year 1998, not later than 120 days after the end of each fiscal year during which fees are collected under the part described in subsection (a), the Secretary of Health and Human Services shall prepare and submit to the Committee on Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected during such fiscal year for which the report is made.”
Pub. L. 102–571, title I, § 104, , 106 Stat. 4498, provided that:
“(a) First Report.—
Within 60 days after the end of each fiscal year during which fees are collected under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], the Secretary of Health and Human Services shall submit a report stating the Food and Drug Administration’s progress in achieving the goals identified in section 102(3) of this Act [set out as a note above] during such fiscal year and that agency’s future plans for meeting such goals.
“(b) Second Report.—
Within 120 days after the end of each fiscal year during which such fees are collected, the Secretary of Health and Human Services shall submit a report on the implementation of the authority for such fees during such fiscal year and on the use the Food and Drug Administration made of the fees collected during such fiscal year for which the report is made.
“(c) Committees.—
The reports described in subsections (a) and (b) shall be submitted to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate.”
Animal Drug User Fee Study
Pub. L. 102–571, title I, § 108, , 106 Stat. 4500, directed Secretary, in consultation with manufacturers of animal drug products and other interested persons, to undertake study to evaluate whether, and under what conditions, to impose user fees to supplement appropriated funds in order to improve process of reviewing applications (including abbreviated and supplemental applications) for new animal drugs under section 360b of this title, and further provided for submission of study to Congress no later than .
Credits
1938–2022 · 7 acts
- 1938June 25, 1938, ch. 675, § 735, as added Pub. L. 102–571, title I, § 103, , 106 Stat. 4491
- 1997amended Pub. L. 105–115, title I, §§ 102, 125(b)(2)(M), , 111 Stat. 2298, 2326
- 2002Pub. L. 107–188, title V, § 503, , 116 Stat. 688
- 2007Pub. L. 110–85, title I, § 102, , 121 Stat. 825
- 2010Pub. L. 111–148, title VII, § 7002(f)(3)(A), , 124 Stat. 818
- 2012Pub. L. 112–144, title I, § 102, title IV, § 407, , 126 Stat. 996, 1039
- 2022Pub. L. 117–180, div. F, title I, § 1002, , 136 Stat. 2140.
Show as published
(June 25, 1938, ch. 675, § 735, as added Pub. L. 102–571, title I, § 103, , 106 Stat. 4491; amended Pub. L. 105–115, title I, §§ 102, 125(b)(2)(M), , 111 Stat. 2298, 2326; Pub. L. 107–188, title V, § 503, , 116 Stat. 688; Pub. L. 110–85, title I, § 102, , 121 Stat. 825; Pub. L. 111–148, title VII, § 7002(f)(3)(A), , 124 Stat. 818; Pub. L. 112–144, title I, § 102, title IV, § 407, , 126 Stat. 996, 1039; Pub. L. 117–180, div. F, title I, § 1002, , 136 Stat. 2140.)