21 USC 379 - Definitions

Collapse to view only § 379g. Definitions

§ 379g. Definitions
§ 379h. Authority to assess and use drug fees
§ 379h-1. Fees relating to advisory review of prescription-drug television advertising
§ 379h-2. Reauthorization; reporting requirements

§ 379g. DefinitionsFor purposes of this subpart:

(1) The term “human drug application” means an application for—

(A) approval of a new drug submitted under section 355(b) of this title, or

(B) 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 September 1, 1992, 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 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 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 (B), of a large volume biological product intended for single dose injection for intravenous use or infusion.

(2) The term “supplement” means a request to the Secretary to approve a change in a human drug application which has been approved.

(3)

(A) The term “prescription drug product” means a specific strength or potency of a drug in final dosage form—

(i) for which a human drug application has been approved,

(ii) which may be dispensed only under prescription pursuant to section 353(b) of this title, and

(iii) 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).

(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 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, 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.

(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 379h(a)(2) of this title, 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.

(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 substantial further manufacturing (such as capsules, tablets, or lyophilized products before reconstitution).

(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. 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 262 of title 42 and for the release of lots of biologics under such section.

(E) Monitoring of research conducted in connection with the review of human drug applications.

(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 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).

(v) Carrying out section 355(k)(5) of this title (relating to adverse event reports and postmarket safety activities).

(7) 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—

(A) 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,

(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 379h of this title 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 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.

(9) The term “person” includes an affiliate thereof.

(10) 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.

(11) 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.

(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).

(June 25, 1938, ch. 675, § 735, as added Pub. L. 102–571, title I, § 103, Oct. 29, 1992, 106 Stat. 4491; amended Pub. L. 105–115, title I, §§ 102, 125(b)(2)(M), Nov. 21, 1997, 111 Stat. 2298, 2326; Pub. L. 107–188, title V, § 503, June 12, 2002, 116 Stat. 688; Pub. L. 110–85, title I, § 102, Sept. 27, 2007, 121 Stat. 825; Pub. L. 111–148, title VII, § 7002(f)(3)(A), Mar. 23, 2010, 124 Stat. 818; Pub. L. 112–144, title I, § 102, title IV, § 407, July 9, 2012, 126 Stat. 996, 1039; Pub. L. 117–180, div. F, title I, § 1002, Sept. 30, 2022, 136 Stat. 2140.)

§ 379h. Authority to assess and use drug fees

(a) Types of feesBeginning in fiscal year 2023, the Secretary shall assess and collect fees in accordance with this section as follows:

(1) Human drug application fee

(A) In generalEach person that submits, on or after September 1, 1992, a human drug application shall be subject to a fee as follows:

(i) A fee established under subsection (c)(6) for a human drug application for which clinical data (other than bioavailability or bioequivalence studies) with respect to safety or effectiveness are required for approval.

(ii) A fee established under subsection (c)(6) for a human drug application for which clinical data (other than bioavailability or bioequivalence studies) with respect to safety or effectiveness are not required for approval. Such fee shall be half of the amount of the fee established under clause (i).

(B) Payment

(D) Refund of fee if application refused for filing or withdrawn before filing

(E) Fees for applications previously refused for filing or withdrawn before filing

(F) Exception for designated orphan drug

(G) Refund of fee if application withdrawn

(H) Exception for skin-test diagnostic products

(2) Prescription drug program fee

(A) In general

(i) Payment of fees

(ii) Special rule for previously discontinued drug products

(B) Exception for certain prescription drug productsA prescription drug program fee shall not be assessed for a prescription drug product under subparagraph (A) if such product is—

(i) a large volume parenteral product (a sterile aqueous drug product packaged in a single-dose container with a volume greater than or equal to 100 mL, not including powders for reconstitution or pharmacy bulk packages) identified on the list compiled under section 355(j)(7) of this title;

(ii) pharmaceutically equivalent (as defined in section 314.3 of title 21, Code of Federal Regulations (or any successor regulation)) to another product on the list of products compiled under section 355(j)(7) of this title (not including the discontinued section of such list); or

(iii) a skin-test diagnostic product.

(b) Fee revenue amounts

(1) In generalFor each of the fiscal years 2023 through 2027, fees under subsection (a) shall, except as provided in subsections (c), (d), (f), and (g), be established to generate a total revenue amount under such subsection that is equal to the sum of—

(A) the annual base revenue for the fiscal year (as determined under paragraph (3));

(B) the dollar amount equal to the inflation adjustment for the fiscal year (as determined under subsection (c)(1));

(C) the dollar amount equal to the strategic hiring and retention adjustment for the fiscal year (as determined under subsection (c)(2));

(D) the dollar amount equal to the capacity planning adjustment for the fiscal year (as determined under subsection (c)(3));

(E) the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(4));

(F) the dollar amount equal to the additional direct cost adjustment for the fiscal year (as determined under subsection (c)(5)); and

(G) additional dollar amounts for each fiscal year as follows:

(i) $65,773,693 for fiscal year 2023.

(ii) $25,097,671 for fiscal year 2024.

(iii) $14,154,169 for fiscal year 2025.

(iv) $4,864,860 for fiscal year 2026.

(v) $1,314,620 for fiscal year 2027.

(2) Types of feesOf the total revenue amount determined for a fiscal year under paragraph (1)—

(A) 20 percent shall be derived from human drug application fees under subsection (a)(1); and

(B) 80 percent shall be derived from prescription drug program fees under subsection (a)(2).

(3) Annual base revenueFor purposes of paragraph (1), the dollar amount of the annual base revenue for a fiscal year shall be—

(A) for fiscal year 2023, $1,151,522,958; and

(B) for fiscal years 2024 through 2027, the dollar amount of the total revenue amount established under paragraph (1) for the previous fiscal year, not including any adjustments made under subsection (c)(4) or (c)(5).

(1) Inflation adjustment

(A) In generalFor purposes of subsection (b)(1)(B), the dollar amount of the inflation adjustment to the annual base revenue for each fiscal year shall be equal to the product of—

(i) such annual base revenue for the fiscal year under subsection (b)(1)(A); and

(ii) the inflation adjustment percentage under subparagraph (B).

(B) Inflation adjustment percentageThe inflation adjustment percentage under this subparagraph for a fiscal year is equal to the sum of—

(i) the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 years of the preceding 4 fiscal years, multiplied by the proportion of personnel compensation and benefits costs to total costs of the process for the review of human drug applications (as defined in section 379g(6) of this title) for the first 3 years of the preceding 4 fiscal years; and

(ii) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Arlington-Alexandria, DC–VA–MD–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of the process for the review of human drug applications (as defined in section 379g(6) of this title) for the first 3 years of the preceding 4 fiscal years.

(2) Strategic hiring and retention adjustmentFor each fiscal year, after the annual base revenue established in subsection (b)(1)(A) is adjusted for inflation in accordance with paragraph (1), the Secretary shall further increase the fee revenue and fees by the following amounts:

(A) For fiscal year 2023, $9,000,000.

(B) For each of fiscal years 2024 through 2027, $4,000,000.

(3) Capacity planning adjustment

(A) In general

(B) Methodology

(D) Publication in Federal Register

(4) Operating reserve adjustment

(A) IncreaseFor fiscal year 2023 and subsequent fiscal years, the Secretary shall, in addition to adjustments under paragraphs (1), (2), and (3), further increase the fee revenue and fees if such an adjustment is necessary to provide for operating reserves of carryover user fees for the process for the review of human drug applications for each fiscal year in at least the following amounts:

(i) For fiscal year 2023, at least 8 weeks of operating reserves.

(ii) For fiscal year 2024, at least 9 weeks of operating reserves.

(iii) For fiscal year 2025 and subsequent fiscal years, at least 10 weeks of operating reserves.

(B) Decrease

(5) Additional direct cost adjustment

(A) IncreaseThe Secretary shall, in addition to adjustments under paragraphs (1), (2), (3), and (4), further increase the fee revenue and fees—

(i) for fiscal year 2023, by $44,386,150; and

(ii) for each of fiscal years 2024 through 2027, by the amount set forth in clauses (i) through (iv) of subparagraph (B), as applicable, multiplied by the Consumer Price Index for urban consumers (Washington-Arlington-Alexandria, DC–VA–MD–WV; Not Seasonally Adjusted; All Items; Annual Index) for the most recent year of available data, divided by such Index for 2021.

(B) Applicable amountsThe amounts referred to in subparagraph (A)(ii) are the following:

(i) For fiscal year 2024, $60,967,993.

(ii) For fiscal year 2025, $35,799,314.

(iii) For fiscal year 2026, $35,799, 314.

(iv) For fiscal year 2027, $35,799,314.

(6) Annual fee settingThe Secretary shall, not later than 60 days before the start of each fiscal year that begins after September 30, 2022—

(A) establish, for each such fiscal year, human drug application fees and prescription drug program fees under subsection (a), based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection; and

(B) publish such fee revenue and fees in the Federal Register.

(7) Limit

(d) Fee waiver or reduction

(1) In generalThe Secretary shall grant to a person who is named as the applicant in a human drug application a waiver from or a reduction of one or more fees assessed to that person under subsection (a) where the Secretary finds that—

(A) such waiver or reduction is necessary to protect the public health,

(B) the assessment of the fee would present a significant barrier to innovation because of limited resources available to such person or other circumstances, or

(2) Considerations

(3) Rules relating to small businesses

(A) “Small business” defined

(B) Waiver of application fee

(e) Effect of failure to pay fees

(f) Limitations

(1) In general

(2) Authority

(3) Limitation

(g) Crediting and availability of fees

(1) In general

(2) Collections and appropriation acts

(A) In generalThe fees authorized by this section—

(i) subject to subparagraph (C), shall be collected and available in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation, for such fiscal year, and

(ii) shall be available—(I) for fiscal year 2023, to defray increases in the costs of the resources allocated for the process for the review of human drug applications (including increases in such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process) over such costs, excluding costs paid from fees collected under this section, for fiscal year 1997 multiplied by the adjustment factor; and(II) for fiscal year 2024 and each subsequent fiscal year, to defray the costs of the resources allocated for the process for the review of human drug applications (including such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process), only if the sum of the amounts allocated by the Secretary for such costs, excluding costs paid from fees collected under this section, plus other costs for the maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, and other necessary materials and supplies in connection with the process for the review of human drug applications, is no less than the amount allocated for such costs, excluding any such costs paid from fees collected under this section, for fiscal year 1997, multiplied by the adjustment factor.

(B) ComplianceThe Secretary shall be considered to have met the requirements of subparagraph (A)(ii) in any fiscal year if the costs funded by appropriations and allocated as described in subclause (I) or (II) of such subparagraph, as applicable—

(i) are not more than 3 percent below the level specified in subparagraph (A)(ii); or

(ii)(I) are more than 3 percent below the level specified in subparagraph (A)(ii), and fees assessed for the fiscal year following the subsequent fiscal year are decreased by the amount in excess of 3 percent by which such costs fell below the level specified in such subparagraph; and(II) such costs are not more than 5 percent below the level specified in such subparagraph.

(3) Authorization of appropriations

(h) Collection of unpaid fees

(i) Written requests for waivers, reductions, exemptions, and returns; disputes concerning feesTo qualify for consideration for a waiver or reduction under subsection (d), an exemption under subsection (k), or the return of any fee paid under this section, including if the fee is claimed to have been paid in error, a person shall—

(1) not later than 180 days after such fee is due, submit to the Secretary a written request justifying such waiver, reduction, exemption, or return; and

(2) include in the request any legal authorities under which the request is made.

(j) Construction

(k) Orphan drugs

(1) ExemptionA drug designated under section 360bb of this title for a rare disease or condition and approved under section 355 of this title or under section 262 of title 42 shall be exempt from prescription drug program fees under this section, if the drug meets all of the following conditions:

(A) The drug meets the public health requirements contained in this chapter as such requirements are applied to requests for waivers for prescription drug program fees.

(B) The drug is owned or licensed and is marketed by a company that had less than $50,000,000 in gross worldwide revenue as determined under paragraph (2).

(2) Evidence of qualificationAn exemption under paragraph (1) applies with respect to a drug only if the applicant involved submits a certification that the applicant’s gross annual revenues did not exceed $50,000,000 for the last calendar year ending prior to the fiscal year for which the exemption is requested. Such certification shall be supported by—

(A) tax returns submitted to the United States Internal Revenue Service; or

(B) as necessary, other appropriate financial information.

(June 25, 1938, ch. 675, § 736, as added Pub. L. 102–571, title I, § 103, Oct. 29, 1992, 106 Stat. 4494; amended Pub. L. 105–115, title I, § 103(a)–(g), Nov. 21, 1997, 111 Stat. 2299–2304; Pub. L. 107–109, § 5(a), Jan. 4, 2002, 115 Stat. 1413; Pub. L. 107–188, title V, § 504, June 12, 2002, 116 Stat. 689; Pub. L. 110–85, title I, § 103(a)–(h)(1), Sept. 27, 2007, 121 Stat. 826–832; Pub. L. 112–144, title I, § 103, July 9, 2012, 126 Stat. 996; Pub. L. 115–52, title I, § 102(a)(1), (b)–(h), title IX, § 905(b)(1), Aug. 18, 2017, 131 Stat. 1007–1012, 1090; Pub. L. 117–180, div. F, title I, § 1003, Sept. 30, 2022, 136 Stat. 2142; Pub. L. 117–328, div. FF, title III, § 3625(a), Dec. 29, 2022, 136 Stat. 5880.)

§ 379h–1. Fees relating to advisory review of prescription-drug television advertising

(a) Types of direct-to-consumer television advertisement review feesBeginning in fiscal year 2008, the Secretary shall assess and collect fees in accordance with this section as follows:

(1) Advisory review fee

(A) In general

(B) Exception for required submissions

(D) Payment

(i) In general

(ii) Effect of submission

(iii) Notice regarding carryover submissions

(E) Modification of advisory review fee

(i) Late payment

(ii) Exceeding identified number of submissions

(F) Limits

(i) Submissions

(ii) No refunds

(iii) No waivers, exemptions, or reductions

(iv) Right to advisory review not transferable

(2) Operating reserve fee

(A) In general

(B) PaymentExcept as provided in subparagraph (C), the operating reserve fee shall be due no later than—

(i) October 1 of the first fiscal year in which the person is required to pay an advisory review fee under paragraph (1); or

(ii) for fiscal year 2008, 120 days after September 27, 2007, or an earlier date specified by the Secretary.

(D) Late payment

(i) In generalNotwithstanding subparagraph (B), and subject to clause (ii), an operating reserve fee shall be regarded as late if the person required to pay the fee has not paid the complete operating reserve fee by—(I) for fiscal year 2008, 150 days after September 27, 2007, or an earlier date specified by the Secretary; or(II) in any subsequent year, November 1.

(ii) Complete payment

(iii) Amount

(b) Advisory review fee revenue amounts

(1) Inflation adjustmentBeginning with fiscal year 2009, the revenues established in subsection (b) shall be adjusted by the Secretary by notice, published in the Federal Register, for a fiscal year to reflect the greater of—

(A) the total percentage change that occurred in the Consumer Price Index for all urban consumers (all items; U.S. city average), for the 12-month period ending June 30 preceding the fiscal year for which fees are being established;

(B) the total percentage change for the previous fiscal year in basic pay under the General Schedule in accordance with section 5332 of title 5, as adjusted by any locality-based comparability payment pursuant to section 5304 of such title for Federal employees stationed in the District of Columbia; or

(C) the average annual change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 5 fiscal years of the previous 6 fiscal years.

The adjustment made each fiscal year by this subsection shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2008 under this subsection.

(2) Workload adjustmentBeginning with fiscal year 2009, after the fee revenues established in subsection (b) are adjusted for a fiscal year for inflation in accordance with paragraph (1), the fee revenues shall be adjusted further for such fiscal year to reflect changes in the workload of the Secretary with respect to the submission of DTC advertisements for advisory review prior to initial dissemination. With respect to such adjustment:

(A) The adjustment shall be determined by the Secretary based upon the number of DTC advertisements identified pursuant to subsection (a)(1)(C) for the upcoming fiscal year, excluding allowable previously paid carry over submissions. The adjustment shall be determined by multiplying the number of such advertisements projected for that fiscal year that exceeds 150 by $27,600 (adjusted each year beginning with fiscal year 2009 for inflation in accordance with paragraph (1)). The Secretary shall publish in the Federal Register the fee revenues and fees resulting from the adjustment and the supporting methodologies.

(B) Under no circumstances shall the adjustment result in fee revenues for a fiscal year that are less than the fee revenues established for the prior fiscal year.

(3) Annual fee setting for advisory review

(A) In general

(B) Fiscal year 2008 fee limit

(D) Limit

(d) Operating reserves

(1) In general

(2) Fee setting

(3) Use of operating reserve

(4) Refund of operating reserves

(e) Effect of failure to pay fees

(f) Effect of inadequate funding of program

(1) Initial funding

(2) Later fiscal years

(g) Crediting and availability of fees

(1) In general

(2) Collections and appropriation acts

(A) In generalThe fees authorized by this section—

(i) shall be retained in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation for such fiscal year; and

(ii) shall be available for obligation only if the amounts appropriated as budget authority for such fiscal year are sufficient to support a number of full-time equivalent review employees that is not fewer than the number of such employees supported in fiscal year 2007.

(B) Review employeesFor purposes of subparagraph (A)(ii), the term “full-time equivalent review employees” means the total combined number of full-time equivalent employees in—

(i) the Center for Drug Evaluation and Research, Division of Drug Marketing, Advertising, and Communications, Food and Drug Administration; and

(ii) the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, Food and Drug Administration.

(3) Authorization of appropriations

(4) Offset

(h) DefinitionsFor purposes of this section:

(1) The term “advisory review” means reviewing and providing advisory comments on DTC advertisements regarding compliance of a proposed advertisement with the requirements of this chapter prior to its initial public dissemination.

(2) The term “advisory review fee” has the meaning indicated for such term in subsection (a)(1)(D).

(3) The term “carry over submission” means a submission for an advisory review for which a fee was paid in one fiscal year that is submitted for review in the following fiscal year.

(4) The term “direct-to-consumer television advertisement” means an advertisement for a prescription drug product (as defined in section 379g(3) of this title) intended to be displayed on any television channel for less than 3 minutes.

(5) The term “DTC advertisement” has the meaning indicated for such term in subsection (a)(1)(A).

(6) The term “operating reserve fee” has the meaning indicated for such term in subsection (a)(2)(A).

(7) The term “person” includes an individual, partnership, corporation, and association, and any affiliate thereof or successor in interest.

(8) The term “process for the advisory review of prescription drug advertising” means the activities necessary to review and provide advisory comments on DTC advertisements prior to public dissemination and, to the extent the Secretary has additional staff resources available under the program under this section that are not necessary for the advisory review of DTC advertisements, the activities necessary to review and provide advisory comments on other proposed advertisements and promotional material prior to public dissemination.

(9) The term “resources allocated for the process for the advisory review of prescription drug advertising” means the expenses incurred in connection with the process for the advisory review of prescription drug advertising for—

(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;

(D) collection of fees under this section and accounting for resources allocated for the advisory review of prescription drug advertising; and

(E) terminating the program under this section pursuant to subsection (f)(2) if that becomes necessary.

(10) The term “resubmission” means a subsequent submission for advisory review of a direct-to-consumer television advertisement that has been revised in response to the Secretary’s comments on an original submission. A resubmission may not introduce significant new concepts or creative themes into the television advertisement.

(11) The term “submission for advisory review” means an original submission of a direct-to-consumer television advertisement for which the sponsor voluntarily requests advisory comments before the advertisement is publicly disseminated.

(June 25, 1938, ch. 675, § 736A, as added Pub. L. 110–85, title I, § 104, Sept. 27, 2007, 121 Stat. 832.)

§ 379h–2. Reauthorization; reporting requirements

(a) Performance report

(1) In generalNot later than 120 days after the end of each fiscal year for which fees are collected under this subpart, the Secretary 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 concerning—

(A) the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 101(b) 1

1 See References in Text note below.

of the Prescription Drug User Fee Amendments of 2022 during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals, including the status of the independent assessment described in such letters; and

(B) the progress of the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research in achieving the goals, and future plans for meeting the goals, including, for each review division—

(i) the number of original standard new drug applications and biologics license applications filed per fiscal year for each review division;

(ii) the number of original priority new drug applications and biologics license applications filed per fiscal year for each review division;

(iii) the number of standard efficacy supplements filed per fiscal year for each review division;

(iv) the number of priority efficacy supplements filed per fiscal year for each review division;

(v) the number of applications filed for review under accelerated approval per fiscal year for each review division;

(vi) the number of applications filed for review as fast track products per fiscal year for each review division;

(vii) the number of applications filed for orphan-designated products per fiscal year for each review division;

(viii) the number of breakthrough designations for a fiscal year for each review division; and

(ix) the number of investigational new drug applications submitted per fiscal year, including for each review division.

Nothing in subparagraph (B) shall be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5.

(2) Inclusion

(3) Real time reporting

(A) In general

(B) DataThe Secretary shall post the following data in accordance with subparagraph (A):

(i) The number and titles of draft and final guidance on topics related to the process for the review of human drug applications, and whether such guidances were issued as required by statute or pursuant to a commitment under the letters described in section 101(b) 1 of the Prescription Drug User Fee Amendments of 2022.

(ii) The number and titles of public meetings held on topics related to the process for the review of human drug applications, and whether such meetings were required by statute or pursuant to a commitment under the letters described in section 101(b) 1 of the Prescription Drug User Fee Amendments of 2022.

(iii) The number of new drug applications and biological licensing applications approved.

(iv) The number of new drug applications and biological licensing applications filed.

(v) For fiscal years 2023 and 2024, of the meeting requests from sponsors for which the Secretary has determined that a face-to-face meeting is appropriate, the number of face-to-face meetings requested by sponsors to be conducted in person (in such manner as the Secretary shall prescribe on the website of the Food and Drug Administration), and the number of such in-person meetings granted by the Secretary, with both such numbers disaggregated by the relevant agency center.

(4) Rationale for PDUFA program changesThe Secretary shall include in the annual report under paragraph (1)—

(A) data, analysis, and discussion of the changes in the number of individuals hired as agreed upon in the letters described in section 1001(b) of the Prescription Drug User Fee Amendments of 2022 and the number of remaining vacancies, the number of full-time equivalents funded by fees collected pursuant to section 379h of this title, and the number of full-time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner;

(B) data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of human drug applications, including identifying—

(i) drivers of such changes; and

(ii) changes in the average total cost per full-time equivalent in the prescription drug review program;

(C) for each of the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner, the number of employees for whom time reporting is required and the number of employees for whom time reporting is not required; and

(D) data, analysis, and discussion of the changes in the average full-time equivalent hours required to complete review of each type of human drug application.

(5) AnalysisFor each fiscal year, the Secretary shall include in the report under paragraph (1) an analysis of the following:

(A) The difference between the aggregate number of human drug applications filed and the aggregate number of approvals, accounting for—

(i) such applications filed during one fiscal year for which a decision is not scheduled to be made until the following fiscal year;

(ii) the aggregate number of applications for each fiscal year that did not meet the goals identified in the letters described in section 101(b) 1 of the Prescription Drug User Fee Amendments of 2022 for the applicable fiscal year.

(B) Relevant data to determine whether the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research have met performance enhancement goals identified in the letters described in section 101(b) 1 of the Prescription Drug User Fee Amendments of 2022 for the applicable fiscal year.

(C) The most common causes and trends of external or other circumstances affecting the ability of the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, Office of Regulatory Affairs, and the Food and Drug Administration to meet the review time and performance enhancement goals identified in the letters described in section 101(b) 1 of the Prescription Drug User Fee Amendments of 2022.

(b) Fiscal report

(c) Corrective action reportFor each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit a corrective action report to the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate. The report shall include the following information, as applicable:

(1) Goals met

(2) Goals missed

(A) a detailed justification for such determination and a description, as applicable, of the types of circumstances and trends under which human drug applications that missed the review goal time were approved during the first cycle review, or application review goals were missed; and

(B) with respect to performance enhancement goals that were not achieved, a description of efforts the Food and Drug Administration has put in place for the fiscal year in which the report is submitted to improve the ability of such agency to meet each such goal for the such fiscal year.

(d) Enhanced communication

(1) Communications with Congress

(2) Participation in congressional hearing

(e) Public availability

(f) Reauthorization

(1) ConsultationIn developing recommendations to present to the Congress with respect to the goals, and plans for meeting the goals, for the process for the review of human drug applications for the first 5 fiscal years after fiscal year 2027, and for the reauthorization of this subpart for such fiscal years, the Secretary shall consult with—

(A) the Committee on Energy and Commerce of the House of Representatives;

(B) the Committee on Health, Education, Labor, and Pensions of the Senate;

(D) health care professionals;

(E) representatives of patient and consumer advocacy groups; and

(F) the regulated industry.

(2) Prior public inputPrior to beginning negotiations with the regulated industry on the reauthorization of this subpart, the Secretary shall—

(A) publish a notice in the Federal Register requesting public input on the reauthorization;

(B) hold a public meeting at which the public may present its views on the reauthorization, including specific suggestions for changes to the goals referred to in subsection (a);

(C) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to this subpart; and

(D) publish the comments on the Food and Drug Administration’s Internet Web site.

(3) Periodic consultation

(4) Updates to Congress

(5) Public review of recommendationsAfter negotiations with the regulated industry, the Secretary shall—

(A) present the recommendations developed under paragraph (1) to the Congressional committees specified in such paragraph;

(B) publish such recommendations in the Federal Register;

(D) hold a meeting at which the public may present its views on such recommendations; and

(E) after consideration of such public views and comments, revise such recommendations as necessary.

(6) Transmittal of recommendations

(7) Minutes of negotiation meetings

(A) Public availability

(B) Content

(June 25, 1938, ch. 675, § 736B, as added Pub. L. 110–85, title I, § 105, Sept. 27, 2007, 121 Stat. 840; amended Pub. L. 112–144, title I, § 104, July 9, 2012, 126 Stat. 1000; Pub. L. 115–52, title I, § 103, title IX, §§ 903(a), 904(a), Aug. 18, 2017, 131 Stat. 1012, 1077, 1082; Pub. L. 117–180, div. F, title I, § 1004, Sept. 30, 2022, 136 Stat. 2146; Pub. L. 117–328, div. FF, title III, § 3626(a), Dec. 29, 2022, 136 Stat. 5883.)