Part C—Fees
subpart 1—freedom of information fees
§379f. Recovery and retention of fees for freedom of information requests
(a) In general
The Secretary, acting through the Commissioner of Food and Drugs, may—
(1) set and charge fees, in accordance with
(2) retain all fees charged for such requests; and
(3) establish an accounting system and procedures to control receipts and expenditures of fees received under this section.
(b) Use of fees
The Secretary and the Commissioner of Food and Drugs shall not use fees received under this section for any purpose other than funding the processing of requests described in subsection (a)(1). Such fees shall not be used to reduce the amount of funds made to carry out other provisions of this chapter.
(c) Waiver of fees
Nothing in this section shall supersede the right of a requester to obtain a waiver of fees pursuant to
(June 25, 1938, ch. 675, §731, formerly §711, as added
Codification
Section was formerly classified to
subpart 2—fees relating to drugs
§379g. Definitions
For purposes of this subpart:
(1) The term "human drug application" means an application for—
(A) approval of a new drug submitted under
(B) licensure of a biological product under subsection (a) of
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
(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,
(B) which may be dispensed only under prescription pursuant to
(C) which is on the list of products described in
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
(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
(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
(v) Carrying out
(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
(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.
(June 25, 1938, ch. 675, §735, as added
Termination of Section
For termination of section by section 104(a) of
Amendments
2012—Par. (1)(B).
Par. (7).
2010—Par. (1)(B).
2007—
Par. (1).
Par. (1)(A).
Par. (1)(B), (C).
"(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
Par. (3)(C).
Par. (4).
Par. (6)(F).
Par. (8).
Pars. (9) to (11).
2002—Par. (1).
Par. (3).
Par. (3)(C).
Par. (6)(F).
Par. (8).
1997—Par. (1).
Par. (1)(B) to (D).
Par. (3).
Par. (4).
Par. (5).
"(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).
Par. (8)(A).
Par. (8)(B).
Par. (9).
Effective Date of 2017 Amendment
Effective Date of 2012 Amendment
Amendment by section 407 of
Effective and Termination Dates of 2007 Amendment
Effective and Termination Dates of 2002 Amendment
Amendment by
[
Effective and Termination Dates of 1997 Amendment
[
Termination Date
[
[
Savings Provision
Accountability and Reports
"(a)
"(1)
"(2)
"(b)
"(c)
Congressional Findings Concerning Fees Relating to Drugs
"(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
"(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
"(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
"(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
"(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
Annual Reports
"(a)
"(b)
"(a)
"(b)
"(c)
Animal Drug User Fee Study
§379h. Authority to assess and use drug fees
(a) Types of fees
Beginning in fiscal year 2018, the Secretary shall assess and collect fees in accordance with this section as follows:
(1) Human drug application fee
(A) In general
Each person that submits, on or after September 1, 1992, a human drug application shall be subject to a fee as follows:
(i) A fee established under subsection (c)(5) 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)(5) for a human drug application for which clinical data (other than bioavailability or bioequivalence studies) with respect to safety or effectiveness are not required for approval. Such fee shall be half of the amount of the fee established under clause (i).
(B) Payment
The fee required by subparagraph (A) shall be due upon submission of the application.
(C) Exception for previously filed application
If a human drug application was submitted by a person that paid the fee for such application, was accepted for filing, and was not approved or was withdrawn (without a waiver), the submission of a human drug application for the same product by the same person (or the person's licensee, assignee, or successor) shall not be subject to a fee under subparagraph (A).
(D) Refund of fee if application refused for filing or withdrawn before filing
The Secretary shall refund 75 percent of the fee paid under subparagraph (B) for any application which is refused for filing or withdrawn without a waiver before filing.
(E) Fees for applications previously refused for filing or withdrawn before filing
A human drug application that was submitted but was refused for filing, or was withdrawn before being accepted or refused for filing, shall be subject to the full fee under subparagraph (A) upon being resubmitted or filed over protest, unless the fee is waived or reduced under subsection (d).
(F) Exception for designated orphan drug
A human drug application for a prescription drug product that has been designated as a drug for a rare disease or condition pursuant to
(G) Refund of fee if application withdrawn
If an application is withdrawn after the application was filed, the Secretary may refund the fee or a portion of the fee if no substantial work was performed on the application after the application was filed. The Secretary shall have the sole discretion to refund a fee or a portion of the fee under this subparagraph. A determination by the Secretary concerning a refund under this paragraph shall not be reviewable.
(2) Prescription drug program fee
(A) In general
Except as provided in subparagraphs (B) and (C), each person who is named as the applicant in a human drug application, and who, after September 1, 1992, had pending before the Secretary a human drug application or supplement, shall pay the annual prescription drug program fee established for a fiscal year under subsection (c)(5) for each prescription drug product that is identified in such a human drug application approved as of October 1 of such fiscal year. Such fee shall be due on the later of the first business day on or after October 1 of each fiscal year or the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section. Such fee shall be paid only once for each product for a fiscal year in which the fee is payable.
(B) Exception for certain prescription drug products
A prescription drug program fee shall not be assessed for a prescription drug product under subparagraph (A) if such product is—
(i) identified on the list compiled under
(ii) the same product as another product that—
(I) was approved under an application filed under
(II) is not in the list of discontinued products compiled under
(iii) the same product as another product that was approved under an abbreviated application filed under
(iv) the same product as another product that was approved under an abbreviated new drug application pursuant to regulations in effect prior to the implementation of the Drug Price Competition and Patent Term Restoration Act of 1984.
(C) Limitation
A person who is named as the applicant in an approved human drug application shall not be assessed more than 5 prescription drug program fees for a fiscal year for prescription drug products identified in such approved human drug application.
(b) Fee revenue amounts
(1) In general
For each of the fiscal years 2018 through 2022, fees under subsection (a) shall, except as provided in subsections (c), (d), (f), and (g), be established to generate a total revenue amount under such subsection that is equal to the sum of—
(A) the annual base revenue for the fiscal year (as determined under paragraph (3));
(B) the dollar amount equal to the inflation adjustment for the fiscal year (as determined under subsection (c)(1));
(C) the dollar amount equal to the capacity planning adjustment for the fiscal year (as determined under subsection (c)(2));
(D) the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(3));
(E) the dollar amount equal to the additional direct cost adjustment for the fiscal year (as determined under subsection (c)(4)); and
(F) additional dollar amounts for each fiscal year as follows:
(i) $20,077,793 for fiscal year 2018.
(ii) $21,317,472 for fiscal year 2019.
(iii) $16,953,329 for fiscal year 2020.
(iv) $5,426,896 for fiscal year 2021.
(v) $2,769,609 for fiscal year 2022.
(2) Types of fees
Of the total revenue amount determined for a fiscal year under paragraph (1)—
(A) 20 percent shall be derived from human drug application fees under subsection (a)(1); and
(B) 80 percent shall be derived from prescription drug program fees under subsection (a)(2).
(3) Annual base revenue
For purposes of paragraph (1), the dollar amount of the annual base revenue for a fiscal year shall be—
(A) for fiscal year 2018, $878,590,000; and
(B) for fiscal years 2019 through 2022, the dollar amount of the total revenue amount established under paragraph (1) for the previous fiscal year, not including any adjustments made under subsection (c)(3) or (c)(4).
(c) Adjustments; annual fee setting
(1) Inflation adjustment
(A) In general
For purposes of subsection (b)(1)(B), the dollar amount of the inflation adjustment to the annual base revenue for each fiscal year shall be equal to the product of—
(i) such annual base revenue for the fiscal year under subsection (b)(1)(A); and
(ii) the inflation adjustment percentage under subparagraph (B).
(B) Inflation adjustment percentage
The inflation adjustment percentage under this subparagraph for a fiscal year is equal to the sum of—
(i) the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 years of the preceding 4 fiscal years, multiplied by the proportion of personnel compensation and benefits costs to total costs of the process for the review of human drug applications (as defined in
(ii) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of the process for the review of human drug applications (as defined in
(2) Capacity planning adjustment
(A) In general
For each fiscal year, after the annual base revenue established in subsection (b)(1)(A) is adjusted for inflation in accordance with paragraph (1), such revenue shall be adjusted further for such fiscal year, in accordance with this paragraph, to reflect changes in the resource capacity needs of the Secretary for the process for the review of human drug applications.
(B) Interim methodology
(i) In general
Until the capacity planning methodology described in subparagraph (C) is effective, the adjustment under this paragraph for a fiscal year shall be based on the product of—
(I) the annual base revenue for such year, as adjusted for inflation under paragraph (1); and
(II) the adjustment percentage under clause (ii).
(ii) Adjustment percentage
The adjustment percentage under this clause for a fiscal year is the weighted change in the 3-year average ending in the most recent year for which data are available, over the 3-year average ending in the previous year, for—
(I) the total number of human drug applications, efficacy supplements, and manufacturing supplements submitted to the Secretary;
(II) the total number of active commercial investigational new drug applications; and
(III) the total number of formal meetings scheduled by the Secretary, and written responses issued by the Secretary in lieu of such formal meetings, as identified in section I.H of the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017.
(C) Capacity planning methodology
(i) Development; evaluation and report
The Secretary shall obtain, through a contract with an independent accounting or consulting firm, a report evaluating options and recommendations for a new methodology to accurately assess changes in the resource and capacity needs of the process for the review of human drug applications. The capacity planning methodological options and recommendations presented in such report shall utilize and be informed by personnel time reporting data as an input. The report shall be published for public comment no later than the end of fiscal year 2020.
(ii) Establishment and implementation
After review of the report described in clause (i) and any public comments thereon, the Secretary shall establish a capacity planning methodology for purposes of this paragraph, which shall—
(I) replace the interim methodology under subparagraph (B);
(II) incorporate such approaches and attributes as the Secretary determines appropriate; and
(III) be effective beginning with the first fiscal year for which fees are set after such capacity planning methodology is established.
(D) Limitation
Under no circumstances shall an adjustment under this paragraph result in fee revenue for a fiscal year that is less than the sum of the amounts under subsections (b)(1)(A) (the annual base revenue for the fiscal year) and (b)(1)(B) (the dollar amount of the inflation adjustment for the fiscal year).
(E) Publication in Federal Register
The Secretary shall publish in the Federal Register notice under paragraph (5) of the fee revenue and fees resulting from the adjustment and the methodologies under this paragraph.
(3) Operating reserve adjustment
(A) Increase
For fiscal year 2018 and subsequent fiscal years, the Secretary may, in addition to adjustments under paragraphs (1) and (2), further increase the fee revenue and fees if such an adjustment is necessary to provide for not more than 14 weeks of operating reserves of carryover user fees for the process for the review of human drug applications.
(B) Decrease
If the Secretary has carryover balances for such process in excess of 14 weeks of such operating reserves, the Secretary shall decrease such fee revenue and fees to provide for not more than 14 weeks of such operating reserves.
(C) Notice of rationale
If an adjustment under subparagraph (A) or (B) is made, the rationale for the amount of the increase or decrease (as applicable) in fee revenue and fees shall be contained in the annual Federal Register notice under paragraph (5) establishing fee revenue and fees for the fiscal year involved.
(4) Additional direct cost adjustment
(A) In general
The Secretary shall, in addition to adjustments under paragraphs (1), (2), and (3), further increase the fee revenue and fees—
(i) for fiscal year 2018, by $8,730,000; and
(ii) for fiscal year 2019 and subsequent fiscal years, by the amount determined under subparagraph (B).
(B) Amount
The amount determined under this subparagraph is—
(i) $8,730,000, multiplied by
(ii) the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All Items; Annual Index) for the most recent year of available data, divided by such Index for 2016.
(5) Annual fee setting
The Secretary shall, not later than 60 days before the start of each fiscal year that begins after September 30, 2017—
(A) establish, for each such fiscal year, human drug application fees and prescription drug program fees under subsection (a), based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection; and
(B) publish such fee revenue and fees in the Federal Register.
(6) Limit
The total amount of fees charged, as adjusted under this subsection, for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of human drug applications.
(d) Fee waiver or reduction
(1) In general
The Secretary shall grant to a person who is named as the applicant in a human drug application a waiver from or a reduction of one or more fees assessed to that person under subsection (a) where the Secretary finds that—
(A) such waiver or reduction is necessary to protect the public health,
(B) the assessment of the fee would present a significant barrier to innovation because of limited resources available to such person or other circumstances, or
(C) the applicant involved is a small business submitting its first human drug application to the Secretary for review.
(2) Considerations
In determining whether to grant a waiver or reduction of a fee under paragraph (1), the Secretary shall consider only the circumstances and assets of the applicant involved and any affiliate of the applicant.
(3) Rules relating to small businesses
(A) "Small business" defined
In paragraph (1)(C), the term "small business" means an entity that has fewer than 500 employees, including employees of affiliates, and that does not have a drug product that has been approved under a human drug application and introduced or delivered for introduction into interstate commerce.
(B) Waiver of application fee
The Secretary shall waive under paragraph (1)(C) the application fee for the first human drug application that a small business or its affiliate submits to the Secretary for review. After a small business or its affiliate is granted such a waiver, the small business or its affiliate shall pay application fees for all subsequent human drug applications submitted to the Secretary for review in the same manner as an entity that does not qualify as a small business.
(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 such fees owed by such person have been paid.
(f) Limitations
(1) In general
Fees under subsection (a) shall be refunded for a fiscal year beginning after fiscal year 1997 unless appropriations for salaries and expenses of the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) are equal to or greater than the amount of appropriations for the salaries and expenses of the Food and Drug Administration for the fiscal year 1997 (excluding the amount of fees appropriated for such fiscal year) multiplied by the adjustment factor applicable to the fiscal year involved.
(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 prescription drug program fees at any time in such fiscal year notwithstanding the provisions of subsection (a) relating to the date fees are to be paid.
(3) Limitation
Beginning on October 1, 2023, the authorities under
(g) Crediting and availability of fees
(1) In general
Subject to paragraph (2)(C), fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the review of human drug applications.
(2) Collections and appropriation acts
(A) In general
The 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 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.
(B) Compliance
The Secretary shall be considered to have met the requirements of subparagraph (A)(ii) in any fiscal year if the costs funded by appropriations and allocated for the process for the review of human drug applications—
(i) are not more than 3 percent below the level specified in subparagraph (A)(ii); or
(ii)(I) are more than 3 percent below the level specified in subparagraph (A)(ii), and fees assessed for the fiscal year following the subsequent fiscal year are decreased by the amount in excess of 3 percent by which such costs fell below the level specified in such subparagraph; and
(II) such costs are not more than 5 percent below the level specified in such subparagraph.
(C) Provision for early payments
Payment of fees authorized under this section for a fiscal year, prior to the due date for such fees, may be accepted by the Secretary in accordance with authority provided in advance in a prior year appropriations Act.
(3) Authorization of appropriations
For each of the fiscal years 2018 through 2022, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount determined under subsection (b) for the fiscal year, as adjusted or otherwise affected under subsection (c).
(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
(i) Written requests for waivers, reductions, and refunds
To qualify for consideration for a waiver or reduction under subsection (d), or for a refund of any fee collected in accordance with subsection (a), a person shall submit to the Secretary a written request for such waiver, reduction, or refund not later than 180 days after such fee is due.
(j) Construction
This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employers, and advisory committees not engaged in the process of the review of human drug applications, be reduced to offset the number of officers, employees, and advisory committees so engaged.
(k) Orphan drugs
(1) Exemption
A drug designated under
(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 during the previous year.
(2) Evidence of qualification
An exemption under paragraph (1) applies with respect to a drug only if the applicant involved submits a certification that its gross annual revenues did not exceed $50,000,000 for the preceding 12 months before the exemption was requested.
(June 25, 1938, ch. 675, §736, as added
Termination of Section
For termination of section by section 104(a) of
References in Text
The Drug Price Competition and Patent Term Restoration Act of 1984, referred to in subsec. (a)(2)(B)(iv), is
Section 101(b) of the Prescription Drug User Fee Amendments of 2017, referred to in subsec. (c)(2)(B)(ii)(III), is section 101(b) of
Amendments
2017—Subsec. (a).
Subsec. (a)(1).
Subsec. (a)(1)(A)(i).
Subsec. (a)(1)(A)(ii).
Subsec. (a)(1)(C).
Subsec. (a)(1)(F).
Subsec. (a)(2).
Subsec. (a)(2)(A).
Subsec. (a)(2)(B).
Subsec. (a)(2)(C).
Subsec. (a)(3).
Subsec. (b).
Subsec. (c).
Subsec. (d)(1)(C), (D).
Subsec. (d)(3).
Subsec. (d)(3)(A).
Subsec. (d)(3)(B).
Subsec. (d)(4).
Subsec. (e).
Subsec. (f)(2).
Subsec. (f)(3).
Subsec. (g)(3).
Subsec. (g)(4).
Subsec. (k)(1).
2012—Subsec. (a).
Subsec. (a)(1)(A).
Subsec. (a)(2)(A).
Subsec. (a)(3)(A).
Subsec. (a)(3)(B).
Subsec. (b)(1).
Subsec. (b)(1)(A).
Subsec. (b)(1)(B), (C).
Subsec. (b)(3), (4).
Subsec. (c).
Subsec. (g)(1).
Subsec. (g)(2)(A)(i).
Subsec. (g)(2)(A)(ii).
Subsec. (g)(2)(C).
Subsec. (g)(3).
Subsec. (g)(4).
2007—Subsec. (a).
Subsec. (a)(1)(A).
Subsec. (a)(1)(D).
Subsec. (a)(1)(E) to (G).
Subsec. (a)(2)(A).
Subsec. (a)(2)(C).
Subsec. (a)(3)(A).
Subsec. (b).
Subsec. (c)(1).
Subsec. (c)(2).
Subsec. (c)(2)(A).
Subsec. (c)(2)(B).
Subsec. (c)(2)(C).
Subsec. (c)(3).
Subsec. (c)(4).
Subsec. (c)(5).
Subsec. (c)(6).
Subsec. (d)(1).
Subsec. (d)(2), (3).
Subsec. (d)(4).
Subsec. (d)(4)(A).
Subsec. (g)(1).
Subsec. (g)(3).
Subsec. (g)(4).
Subsec. (k).
2002—Subsec. (a).
Subsec. (a)(1)(A)(i).
Subsec. (a)(1)(A)(ii).
Subsec. (a)(1)(F), (G).
Subsec. (a)(2)(A).
Subsec. (a)(3)(A).
"(i) who is named as the applicant in a human drug application for a prescription drug product which has been submitted for listing under
"(ii) who, after September 1, 1992, had pending before the Secretary a human drug application or supplement,
shall pay for each such prescription drug product the annual fee established in subsection (b) of this section. Such fee shall be payable for the fiscal year in which the product is first submitted for listing under
Subsec. (a)(3)(B).
Subsec. (b).
Subsec. (c)(1).
Subsec. (c)(1)(A).
Subsec. (c)(1)(B).
Subsec. (c)(2) to (5).
Subsec. (d)(1)(C) to (E).
Subsec. (d)(3)(A), (B).
Subsec. (f).
Subsec. (f)(1).
Subsec. (g)(1).
Subsec. (g)(2).
Subsec. (g)(3)(A) to (E).
"(A) $106,800,000 for fiscal year 1998;
"(B) $109,200,000 for fiscal year 1999;
"(C) $109,200,000 for fiscal year 2000;
"(D) $114,000,000 for fiscal year 2001; and
"(E) $110,100,000 for fiscal year 2002,".
1997—Subsec. (a).
Subsec. (a)(1)(B).
"(i)
"(ii)
"(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
"(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."
Subsec. (a)(1)(D).
Subsec. (a)(1)(E) to (G).
Subsec. (a)(2).
"(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
"(B) after September 1, 1992, had pending before the Secretary a human drug application or supplement,
shall be subject to the annual fee established in subsection (b) of this section for each such establishment, payable on or before January 31 of each year."
Subsec. (a)(3)(A).
Subsec. (a)(3)(B).
Subsec. (b).
Subsec. (c).
Subsec. (c)(1).
Subsec. (c)(2).
Subsec. (c)(3).
Subsec. (d).
Subsec. (f)(1).
Subsec. (g)(1).
Subsec. (g)(2)(A).
Subsec. (g)(2)(B).
Subsec. (g)(3), (4).
"(A) $36,000,000 for fiscal year 1993,
"(B) $54,000,000 for fiscal year 1994,
"(C) $75,000,000 for fiscal year 1995,
"(D) $78,000,000 for fiscal year 1996, and
"(E) $84,000,000 for fiscal year 1997,
as adjusted to reflect increases in the total fee revenues made under subsection (c)(1) of this section."
Subsecs. (i), (j).
Effective Date of 2017 Amendment
Amendment by section 102 of
Effective Date of 2012 Amendment
Amendment by
Effective Date of 2007 Amendment
Amendment by
Effective Date of 2002 Amendment
Amendment by
Effective Date of 1997 Amendment
Amendment by
Termination Date
Section to terminate Oct. 1, 2022, see section 104(a) of
Special Rule for Waivers and Refunds
§379h–1. Fees relating to advisory review of prescription-drug television advertising
(a) Types of direct-to-consumer television advertisement review fees
Beginning 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
With respect to a proposed direct-to-consumer television advertisement (referred to in this section as a "DTC advertisement"), each person that on or after October 1, 2007, submits such an advertisement for advisory review by the Secretary prior to its initial public dissemination shall, except as provided in subparagraph (B), be subject to a fee established under subsection (c)(3).
(B) Exception for required submissions
A DTC advertisement that is required to be submitted to the Secretary prior to initial public dissemination is not subject to a fee under subparagraph (A) unless the sponsor designates the submission as a submission for advisory review.
(C) Notice to Secretary of number of advertisements
Not later than June 1 of each fiscal year, the Secretary shall publish a notice in the Federal Register requesting any person to notify the Secretary within 30 days of the number of DTC advertisements the person intends to submit for advisory review in the next fiscal year. Notwithstanding the preceding sentence, for fiscal year 2008, the Secretary shall publish such a notice in the Federal Register not later than 30 days after September 27, 2007.
(D) Payment
(i) In general
The fee required by subparagraph (A) (referred to in this section as "an advisory review fee") shall be due not later than October 1 of the fiscal year in which the DTC advertisement involved is intended to be submitted for advisory review, subject to subparagraph (F)(i). Notwithstanding the preceding sentence, the advisory review fee for any DTC advertisement that is intended to be submitted for advisory review during fiscal year 2008 shall be due not later than 120 days after September 27, 2007, or an earlier date as specified by the Secretary.
(ii) Effect of submission
Notification of the Secretary under subparagraph (C) of the number of DTC advertisements a person intends to submit for advisory review is a legally binding commitment by that person to pay the annual advisory review fee for that number of submissions on or before October 1 of the fiscal year in which the advertisement is intended to be submitted. Notwithstanding the preceding sentence, the commitment shall be a legally binding commitment by that person to pay the annual advisory review fee for that number of submissions for fiscal year 2008 by the date specified in clause (i).
(iii) Notice regarding carryover submissions
In making a notification under subparagraph (C), the person involved shall in addition notify the Secretary if under subparagraph (F)(i) the person intends to submit a DTC advertisement for which the advisory review fee has already been paid. If the person does not so notify the Secretary, each DTC advertisement submitted by the person for advisory review in the fiscal year involved shall be subject to the advisory review fee.
(E) Modification of advisory review fee
(i) Late payment
If a person has submitted a notification under subparagraph (C) with respect to a fiscal year and has not paid all advisory review fees due under subparagraph (D) not later than November 1 of such fiscal year (or, in the case of such a notification submitted with respect to fiscal year 2008, not later than 150 days after September 27, 2007, or an earlier date specified by the Secretary), the fees shall be regarded as late and an increase in the amount of fees applies in accordance with this clause, notwithstanding any other provision of this section. For such person, all advisory review fees for such fiscal year shall be due and payable 20 days before any direct-to-consumer advertisement is submitted to the Secretary for advisory review, and each such fee shall be equal to 150 percent of the fee that otherwise would have applied pursuant to subsection (c)(3).
(ii) Exceeding identified number of submissions
If a person submits a number of DTC advertisements for advisory review in a fiscal year that exceeds the number identified by the person under subparagraph (C), an increase in the amount of fees applies under this clause for each submission in excess of such number, notwithstanding any other provision of this section. For each such DTC advertisement, the advisory review fee shall be due and payable 20 days before the advertisement is submitted to the Secretary, and the fee shall be equal to 150 percent of the fee that otherwise would have applied pursuant to subsection (c)(3).
(F) Limits
(i) Submissions
For each advisory review fee paid by a person for a fiscal year, the person is entitled to acceptance for advisory review by the Secretary of one DTC advertisement and acceptance of one resubmission for advisory review of the same advertisement. The advertisement shall be submitted for review in the fiscal year for which the fee was assessed, except that a person may carry over not more than one paid advisory review submission to the next fiscal year. Resubmissions may be submitted without regard to the fiscal year of the initial advisory review submission.
(ii) No refunds
Except as provided by subsections (d)(4) and (f), fees paid under this section shall not be refunded.
(iii) No waivers, exemptions, or reductions
The Secretary shall not grant a waiver, exemption, or reduction of any fees due or payable under this section.
(iv) Right to advisory review not transferable
The right to an advisory review under this paragraph is not transferable, except to a successor in interest.
(2) Operating reserve fee
(A) In general
Each person that on or after October 1, 2007, is assessed an advisory review fee under paragraph (1) shall be subject to fee 1 established under subsection (d)(2) (referred to in this section as an "operating reserve fee") for the first fiscal year in which an advisory review fee is assessed to such person. The person is not subject to an operating reserve fee for any other fiscal year.
(B) Payment
Except 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.
(C) Late notice of submission
If, in the first fiscal year of a person's participation in the program under this section, that person submits any DTC advertisements for advisory review that are in excess of the number identified by that person in response to the Federal Register notice described in subsection (a)(1)(C), that person shall pay an operating reserve fee for each of those advisory reviews equal to the advisory review fee for each submission established under paragraph (1)(E)(ii). Fees required by this subparagraph shall be in addition to any fees required by subparagraph (A). Fees under this subparagraph shall be due 20 days before any DTC advertisement is submitted by such person to the Secretary for advisory review.
(D) Late payment
(i) In general
Notwithstanding subparagraph (B), and subject to clause (ii), an operating reserve fee shall be regarded as late if the person required to pay the fee has not paid the complete operating reserve fee by—
(I) for fiscal year 2008, 150 days after September 27, 2007, or an earlier date specified by the Secretary; or
(II) in any subsequent year, November 1.
(ii) Complete payment
The complete operating reserve fee shall be due and payable 20 days before any DTC advertisement is submitted by such person to the Secretary for advisory review.
(iii) Amount
Notwithstanding any other provision of this section, an operating reserve fee that is regarded as late under this subparagraph shall be equal to 150 percent of the operating reserve fee that otherwise would have applied pursuant to subsection (d).
(b) Advisory review fee revenue amounts
Fees under subsection (a)(1) shall be established to generate revenue amounts of $6,250,000 for each of fiscal years 2008 through 2012, as adjusted pursuant to subsections (c) and (g)(4).
(c) Adjustments
(1) Inflation adjustment
Beginning 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
(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 adjustment
Beginning 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
Not later than August 1 of each fiscal year (or, with respect to fiscal year 2008, not later than 90 days after September 27, 2007), the Secretary shall establish for the next fiscal year the DTC advertisement advisory review fee under subsection (a)(1), based on the revenue amounts established under subsection (b), the adjustments provided under paragraphs (1) and (2), and the number of DTC advertisements identified pursuant to subsection (a)(1)(C), excluding allowable previously-paid carry over submissions. The annual advisory review fee shall be established by dividing the fee revenue for a fiscal year (as adjusted pursuant to this subsection) by the number of DTC advertisements so identified, excluding allowable previously-paid carry over submissions under subsection (a)(1)(F)(i).
(B) Fiscal year 2008 fee limit
Notwithstanding subsection (b) and the adjustments pursuant to this subsection, the fee established under subparagraph (A) for fiscal year 2008 may not be more than $83,000 per submission for advisory review.
(C) Annual fee limit
Notwithstanding subsection (b) and the adjustments pursuant to this subsection, the fee established under subparagraph (A) for a fiscal year after fiscal year 2008 may not be more than 50 percent more than the fee established for the prior fiscal year.
(D) Limit
The total amount of fees obligated for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process for the advisory review of prescription drug advertising.
(d) Operating reserves
(1) In general
The Secretary shall establish in the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation a Direct-to-Consumer Advisory Review Operating Reserve, of at least $6,250,000 in fiscal year 2008, to continue the program under this section in the event the fees collected in any subsequent fiscal year pursuant to subsection (a)(1) do not generate the fee revenue amount established for that fiscal year.
(2) Fee setting
The Secretary shall establish the operating reserve fee under subsection (a)(2)(A) for each person required to pay the fee by multiplying the number of DTC advertisements identified by that person pursuant to subsection (a)(1)(C) by the advisory review fee established pursuant to subsection (c)(3) for that fiscal year, except that in no case shall the operating reserve fee assessed be less than the operating reserve fee assessed if the person had first participated in the program under this section in fiscal year 2008.
(3) Use of operating reserve
The Secretary may use funds from the reserves only to the extent necessary in any fiscal year to make up the difference between the fee revenue amount established for that fiscal year under subsections (b) and (c) and the amount of fees actually collected for that fiscal year pursuant to subsection (a)(1), or to pay costs of ending the program under this section if it is terminated pursuant to subsection (f) or not reauthorized beyond fiscal year 2012.
(4) Refund of operating reserves
Within 120 days after the end of fiscal year 2012, or if the program under this section ends early pursuant to subsection (f), the Secretary, after setting aside sufficient operating reserve amounts to terminate the program under this section, shall refund all amounts remaining in the operating reserve on a pro rata basis to each person that paid an operating reserve fee assessment. In no event shall the refund to any person exceed the total amount of operating reserve fees paid by such person pursuant to subsection (a)(2).
(e) Effect of failure to pay fees
Notwithstanding any other requirement, a submission for advisory review of a DTC advertisement submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for review by the Secretary until all fees owed by such person under this section have been paid.
(f) Effect of inadequate funding of program
(1) Initial funding
If on November 1, 2007, or 120 days after September 27, 2007, whichever is later, the Secretary has not received at least $11,250,000 in advisory review fees and operating reserve fees combined, the program under this section shall not commence and all collected fees shall be refunded.
(2) Later fiscal years
Beginning in fiscal year 2009, if, on November 1 of the fiscal year, the combination of the operating reserves, annual fee revenues from that fiscal year, and unobligated fee revenues from prior fiscal years falls below $9,000,000, adjusted for inflation (as described in subsection (c)(1)), the program under this section shall terminate, and the Secretary shall notify all participants, retain any money from the unused advisory review fees and the operating reserves needed to terminate the program, and refund the remainder of the unused fees and operating reserves. To the extent required to terminate the program, the Secretary shall first use unobligated advisory review fee revenues from prior fiscal years, then the operating reserves, and finally, unused advisory review fees from the relevant fiscal year.
(g) Crediting and availability of fees
(1) In general
Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the advisory review of prescription drug advertising.
(2) Collections and appropriation acts
(A) In general
The fees authorized by this section—
(i) shall be retained in each fiscal year in an amount not to exceed the amount specified 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 employees
For 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
For each of the fiscal years 2008 through 2012, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount determined under subsection (b) for the fiscal year, as adjusted pursuant to subsection (c) and paragraph (4) of this subsection, plus amounts collected for the reserve fund under subsection (d).
(4) Offset
Any amount of fees collected for a fiscal year under this section that exceeds the amount of fees specified in appropriation Acts for such fiscal year shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be collected under this section pursuant to appropriation Acts for a subsequent fiscal year.
(h) Definitions
For 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
(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—
(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;
(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
Effective Date
Section effective Oct. 1, 2007, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2007, see section 107 of
1 So in original. Probably should be "the fee".
§379h–2. Reauthorization; reporting requirements
(a) Performance report
(1) In general
Beginning with fiscal year 2018, not 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) of the Prescription Drug User Fee Amendments of 2017 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; and
(viii) the number of breakthrough designations for a fiscal year for each review division.
(2) Inclusion
The report under this subsection for a fiscal year shall include information on all previous cohorts for which the Secretary has not given a complete response on all human drug applications and supplements in the cohort.
(3) Real time reporting
(A) In general
Not later than 30 calendar days after the end of the second quarter of fiscal year 2018, and not later than 30 calendar days after the end of each quarter of each fiscal year thereafter, the Secretary shall post the data described in subparagraph (B) on the internet website of the Food and Drug Administration for such quarter and on a cumulative basis for such fiscal year, and may remove duplicative data from the annual performance report under this subsection.
(B) Data
The 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) of the Prescription Drug User Fee Amendments of 2017.
(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) of the Prescription Drug User Fee Amendments of 2017.
(iii) The number of new drug applications and biological licensing applications approved.
(iv) The number of new drug applications and biological licensing applications filed.
(4) Rationale for PDUFA program changes
Beginning with fiscal year 2020, the Secretary shall include in the annual report under paragraph (1)—
(A) data, analysis, and discussion of the changes in the number of full-time equivalents hired as agreed upon in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017 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 drugs, including identifying drivers of such changes; and
(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.
(5) Analysis
For 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) of the Prescription Drug User Fee Amendments of 2017 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) of the Prescription Drug User Fee Amendments of 2017 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) of the Prescription Drug User Fee Amendments of 2017.
(b) Fiscal report
Beginning with fiscal year 2018, not 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 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 for such fiscal year.
(c) Corrective action report
Beginning with fiscal year 2018, for each fiscal year for which fees are collected under this part, 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
For each fiscal year, if the Secretary determines, based on the analysis under subsection (a)(5), that each of the goals identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017 for the applicable fiscal year have been met, the corrective action report shall include recommendations on ways in which the Secretary can improve and streamline the human drug application review process.
(2) Goals missed
For any of the goals identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017 for the applicable fiscal year that the Secretary determines to not have been met, the corrective action report shall include—
(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
Each fiscal year, as applicable and requested, representatives from the Centers with expertise in the review of human drugs shall meet with representatives from the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives to report on the contents described in the reports under this section.
(2) Participation in congressional hearing
Each fiscal year, as applicable and requested, representatives from the Food and Drug Administration shall participate in a public hearing before the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, to report on the contents described in the reports under this section. Such hearing shall occur not later than 120 days after the end of each fiscal year for which fees are collected under this part.
(e) Public availability
The Secretary shall make the reports required under subsections (a) and (b) available to the public on the Internet Web site of the Food and Drug Administration.
(f) Reauthorization
(1) Consultation
In developing recommendations to present to the Congress with respect to the goals, and plans for meeting the goals, for the process for the review of human drug applications for the first 5 fiscal years after fiscal year 2022, and for the reauthorization of this subpart for such fiscal years, the Secretary shall consult with—
(A) the Committee on Energy and Commerce of the House of Representatives;
(B) the Committee on Health, Education, Labor, and Pensions of the Senate;
(C) scientific and academic experts;
(D) health care professionals;
(E) representatives of patient and consumer advocacy groups; and
(F) the regulated industry.
(2) Prior public input
Prior 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
Not less frequently than once every month during negotiations with the regulated industry, the Secretary shall hold discussions with representatives of patient and consumer advocacy groups to continue discussions of their views on the reauthorization and their suggestions for changes to this subpart as expressed under paragraph (2).
(4) Public review of recommendations
After 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;
(C) provide for a period of 30 days for the public to provide written comments on such recommendations;
(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.
(5) Transmittal of recommendations
Not later than January 15, 2022, the Secretary shall transmit to the Congress the revised recommendations under paragraph (4), a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments.
(6) Minutes of negotiation meetings
(A) Public availability
Before presenting the recommendations developed under paragraphs (1) through (5) to the Congress, the Secretary shall make publicly available, on the public Web site of the Food and Drug Administration, minutes of all negotiation meetings conducted under this subsection between the Food and Drug Administration and the regulated industry.
(B) Content
The minutes described under subparagraph (A) shall summarize any substantive proposal made by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations and their resolution.
(June 25, 1938, ch. 675, §736B, as added
Termination of Section
For termination of section by section 104(b) of
References in Text
Section 101(b) of the Prescription Drug User Fee Amendments of 2017, referred to in subsecs. (a) and (c), is section 101(b) of
Amendments
2017—Subsec. (a)(1).
Subsec. (a)(1)(A).
Subsec. (a)(3), (4).
Subsec. (a)(5).
Subsec. (b).
Subsec. (c).
Subsec. (d).
Subsecs. (e), (f).
2012—Subsec. (a).
Subsec. (b).
Subsec. (d)(1), (5).
Effective Date of 2017 Amendment
Amendment by section 103 of
Effective Date of 2012 Amendment
Amendment by
Effective and Termination Dates
[
Section effective Oct. 1, 2007, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2007, see section 107 of
subpart 3—fees relating to devices
§379i. Definitions
For purposes of this subpart:
(1) The term "premarket application" means—
(A) an application for approval of a device submitted under
(B) a product development protocol described in
Such term does not include a supplement, a premarket report, or a premarket notification submission.
(2) The term "premarket report" means a report submitted under
(3) The term "premarket notification submission" means a report submitted under
(4)(A) The term "supplement", with respect to a panel-track supplement, a 180-day supplement, a real-time supplement, or an efficacy supplement, means a request to the Secretary to approve a change in a device for which—
(i) an application or report has been approved under
(ii) a notice of completion has become effective under
(B) The term "panel-track supplement" means a supplement to an approved premarket application or premarket report under
(C) The term "180-day supplement" means a supplement to an approved premarket application or premarket report under
(D) The term "real-time supplement" means a supplement to an approved premarket application or premarket report under
(E) The term "efficacy supplement" means a supplement to an approved premarket application under
(5) The term "30-day notice" means a notice under
(6) The term "request for classification information" means a request made under
(7) The term "annual fee", for periodic reporting concerning a class III device, means the annual fee associated with periodic reports required by a premarket application approval order.
(8) The term "de novo classification request" means a request made under
(9) The term "process for the review of device applications" means the following activities of the Secretary with respect to the review of premarket applications, premarket reports, supplements, and premarket notification submissions:
(A) The activities necessary for the review of premarket applications, premarket reports, supplements, and premarket notification submissions.
(B) The issuance of action letters that allow the marketing of devices or which set forth in detail the specific deficiencies in such applications, reports, supplements, or submissions and, where appropriate, the actions necessary to place them in condition for approval.
(C) The inspection of manufacturing establishments and other facilities undertaken as part of the Secretary's review of pending premarket applications, premarket reports, and supplements.
(D) Monitoring of research conducted in connection with the review of such applications, reports, supplements, and submissions.
(E) Review of device applications subject to
(F) The development of guidance, policy documents, or regulations to improve the process for the review of premarket applications, premarket reports, supplements, and premarket notification submissions.
(G) The development of voluntary test methods, consensus standards, or mandatory performance standards under
(H) The provision of technical assistance to device manufacturers in connection with the submission of such applications, reports, supplements, or submissions.
(I) Any activity undertaken under
(J) Evaluation of postmarket studies required as a condition of an approval of a premarket application or premarket report under
(K) Compiling, developing, and reviewing information on relevant devices to identify safety and effectiveness issues for devices subject to premarket applications, premarket reports, supplements, or premarket notification submissions.
(10) The term "costs of resources allocated for the process for the review of device applications" means the expenses in connection with the process for the review of device 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 and accounting for resources allocated for the review of premarket applications, premarket reports, supplements, submissions, and de novo classification requests.
(11) 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 2016.
(12) The term "person" includes an affiliate thereof.
(13) The term "affiliate" means a business entity that has a relationship with a second business entity (whether domestic or international) 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.
(14) The term "establishment subject to a registration fee" means an establishment that is registered (or is required to register) with the Secretary under
(June 25, 1938, ch. 675, §737, as added
Termination of Section
For termination of section by section 210(a) of
Amendments
2017—Par. (8).
Par. (9).
Par. (10).
Par. (11).
Pars. (12) to (14).
2016—Par. (5).
2012—Par. (9).
Par. (10).
Par. (13).
2007—
Pars. (5) to (9).
Par. (10).
Par. (11).
Par. (12).
Par. (13).
2004—
Par. (4)(B).
Par. (4)(D).
Par. (5)(J).
Par. (8).
Effective Date of 2017 Amendment
Effective Date of 2012 Amendment
Effective and Termination Dates of 2007 Amendment
Effective and Termination Dates
[
[
Savings Provision
Findings
"(1) prompt approval and clearance of safe and effective devices is critical to the improvement of the public health so that patients may enjoy the benefits of devices to diagnose, treat, and prevent 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 devices and the assurance of device safety and effectiveness so that statutorily mandated deadlines may be met; and
"(3) the fees authorized by this title [enacting this subpart and provisions set out as notes under this section and
Annual Reports
"(a)
"(1) the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 101(3) [set out as a note above] during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals, not later than 60 days after the end of each fiscal year during which fees are collected under this part [title I of
"(2) 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, not later than 120 days after the end of each fiscal year during which fees are collected under the medical device user-fee program established under the amendment made by section 102 [enacting this subpart].
"(b)
"(1) information on the number of different types of applications and notifications, and the total amount of fees paid for each such type of application or notification, from businesses with gross receipts or sales from $0 to $100,000,000, with such businesses categorized in $10,000,000 intervals; and
"(2) a certification by the Secretary that the amounts appropriated for salaries and expenses of the Food and Drug Administration for such fiscal year and obligated by the Secretary for the performance of any function relating to devices that is not for the process for the review of device applications, as defined in paragraph (5) [now (8)] of section 737 of the Federal Food, Drug, and Cosmetic Act (
Study
Consultation
"(a)
"(b)
§379j. Authority to assess and use device fees
(a) Types of fees
(1) In general
Beginning in fiscal year 2018, the Secretary shall assess and collect fees in accordance with this section.
(2) Premarket application, premarket report, supplement, and submission fee, and annual fee for periodic reporting concerning a class III device
(A) In general
Except as provided in subparagraph (B) and subsections (d) and (e), each person who submits any of the following, on or after October 1, 2017, shall be subject to a fee established under subsection (c) for the fiscal year involved in accordance with the following:
(i) A premarket application.
(ii) For a premarket report, a fee equal to the fee that applies under clause (i).
(iii) For a panel track supplement, a fee equal to 75 percent of the fee that applies under clause (i).
(iv) For a 180-day supplement, a fee equal to 15 percent of the fee that applies under clause (i).
(v) For a real-time supplement, a fee equal to 7 percent of the fee that applies under clause (i).
(vi) For a 30-day notice, a fee equal to 1.6 percent of the fee that applies under clause (i).
(vii) For an efficacy supplement, a fee equal to the fee that applies under clause (i).
(viii) For a premarket notification submission, a fee equal to 3.4 percent of the fee that applies under clause (i).
(ix) For a request for classification information, a fee equal to 1.35 percent of the fee that applies under clause (i).
(x) For periodic reporting concerning a class III device, an annual fee equal to 3.5 percent of the fee that applies under clause (i).
(xi) For a de novo classification request, a fee equal to 30 percent of the fee that applies under clause (i).
(B) Exceptions
(i) Humanitarian device exemption
An application under
(ii) Further manufacturing use
No fee shall be required under subparagraph (A) for the submission of a premarket application under
(iii) State or Federal Government sponsors
No fee shall be required under subparagraph (A) for a premarket application, premarket report, supplement, or premarket notification submission submitted by a State or Federal Government entity unless the device involved is to be distributed commercially.
(iv) Premarket notifications by third parties
No fee shall be required under subparagraph (A) for a premarket notification submission reviewed by an accredited person pursuant to
(v) Pediatric conditions of use
(I) In general
No fee shall be required under subparagraph (A) for a premarket application, premarket report, premarket notification submission, or de novo classification request if the proposed conditions of use for the device involved are solely for a pediatric population. No fee shall be required under such subparagraph for a supplement if the sole purpose of the supplement is to propose conditions of use for a pediatric population.
(II) Subsequent proposal of adult conditions of use
In the case of a person who submits a premarket application or premarket report for which, under subclause (I), a fee under subparagraph (A) is not required, any supplement to such application that proposes conditions of use for any adult population is subject to the fee that applies under such subparagraph for a premarket application.
(C) Payment
The fee required by subparagraph (A) shall be due upon submission of the premarket application, premarket report, supplement, premarket notification submission, 30-day notice, request for classification information, or periodic reporting concerning a class III device. Applicants submitting portions of applications pursuant to
(D) Refunds
(i) Application refused for filing
The Secretary shall refund 75 percent of the fee paid under subparagraph (A) for any application, report, or supplement that is refused for filing.
(ii) Application withdrawn before filing
The Secretary shall refund 75 percent of the fee paid under subparagraph (A) for any application, report, or supplement that is withdrawn prior to the filing decision of the Secretary.
(iii) Application withdrawn before first action
After receipt of a request for a refund of the fee paid under subparagraph (A) for a premarket application, premarket report, or supplement that is withdrawn after filing but before a first action, the Secretary may return some or all of the fee. The amount of refund, if any, shall be based on the level of effort already expended on the review of such application, report, or supplement.
(iv) Modular applications withdrawn before first action
The Secretary shall refund 75 percent of the application fee paid for an application submitted under
(v) Later withdrawn modular applications
If an application submitted under
(vi) Sole discretion to refund
The Secretary shall have sole discretion to refund a fee or portion of the fee under clause (iii) or (v). A determination by the Secretary concerning a refund under clause (iii) or (v) shall not be reviewable.
(3) Annual establishment registration fee
(A) In general
Except as provided in subparagraph (B), each establishment subject to a registration fee shall be subject to a fee for each initial or annual registration under
(B) Exception
No fee shall be required under subparagraph (A) for an establishment operated by a State or Federal governmental entity or an Indian tribe (as defined in the Indian Self Determination and Educational Assistance Act 1 [
(C) Payment
The fee required under subparagraph (A) shall be due once each fiscal year, upon the later of—
(i) the initial or annual registration (as applicable) of the establishment under
(ii) the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of fees for such year under this section.
(b) Fee Amounts
(1) In general
Subject to subsections (c), (d), (e), and (h), for each of fiscal years 2018 through 2022, fees under subsection (a) shall be derived from the base fee amounts specified in paragraph (2), to generate the total revenue amounts specified in paragraph (3).
(2) Base fee amounts specified
For purposes of paragraph (1), the base fee amounts specified in this paragraph are as follows:
Fee Type | Fiscal Year 2018 | Fiscal Year 2019 | Fiscal Year 2020 | Fiscal Year 2021 | Fiscal Year 2022 |
---|---|---|---|---|---|
Premarket Application | $294,000 | $300,000 | $310,000 | $328,000 | $329,000 |
Establishment Registration | $4,375 | $4,548 | $4,760 | $4,975 | $4,978 |
(3) Total revenue amounts specified
For purposes of paragraph (1), the total revenue amounts specified in this paragraph are as follows:
(A) $183,280,756 for fiscal year 2018.
(B) $190,654,875 for fiscal year 2019.
(C) $200,132,014 for fiscal year 2020.
(D) $211,748,789 for fiscal year 2021.
(E) $213,687,660 for fiscal year 2022.
(c) Annual fee setting; adjustments
(1) In general
The Secretary shall, 60 days before the start of each fiscal year after September 30, 2017, establish fees under subsection (a), based on amounts specified under subsection (b) and the adjustments provided under this subsection, and publish such fees, and the rationale for any adjustments to such fees, in the Federal Register.
(2) Inflation adjustments
(A) Adjustment to total revenue amounts
For fiscal year 2018 and each subsequent fiscal year, the Secretary shall adjust the total revenue amount specified in subsection (b)(3) for such fiscal year by multiplying such amount by the applicable inflation adjustment under subparagraph (B) for such year.
(B) Applicable inflation adjustment
The applicable inflation adjustment for fiscal year 2018 and each subsequent fiscal year is the product of—
(i) the base inflation adjustment under subparagraph (C) for such fiscal year; and
(ii) the product of the base inflation adjustment under subparagraph (C) for each of the fiscal years preceding such fiscal year, beginning with fiscal year 2016.
(C) Base inflation adjustment
(i) In general
Subject to further adjustment under clause (ii), the base inflation adjustment for a fiscal year is the sum of one plus—
(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 0.60; and
(II) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by 0.40.
(ii) Limitations
For purposes of subparagraph (B), if the base inflation adjustment for a fiscal year under clause (i)—
(I) is less than 1, such adjustment shall be considered to be equal to 1; or
(II) is greater than 1.04, such adjustment shall be considered to be equal to 1.04.
(D) Adjustment to base fee amounts
For each of fiscal years 2018 through 2022, the Secretary shall—
(i) adjust the base fee amounts specified in subsection (b)(2) for such fiscal year by multiplying such amounts by the applicable inflation adjustment under subparagraph (B) for such year; and
(ii) if the Secretary determines necessary, increase (in addition to the adjustment under clause (i)) such base fee amounts, on a uniform proportionate basis, to generate the total revenue amounts under subsection (b)(3), as adjusted for inflation under subparagraph (A).
(3) Volume-based adjustments to establishment registration base fees
For each of fiscal years 2018 through 2022, after the base fee amounts specified in subsection (b)(2) are adjusted under paragraph (2)(D), the base establishment registration fee amounts specified in such subsection shall be increased, as the Secretary estimates is necessary in order for total fee collections for such fiscal year to generate the total revenue amounts, as adjusted under paragraph (2).
(4) Limit
The total amount of fees charged, as adjusted under this subsection, for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of device applications.
(5) Supplement
(A) In general
The Secretary may use unobligated carryover balances from fees collected in previous fiscal years to ensure that sufficient fee revenues are available in that fiscal year, so long as the Secretary maintains unobligated carryover balances of not less than 1 month of operating reserves for the first month of the next fiscal year.
(B) Notice to Congress
Not later than 14 days before the Secretary anticipates the use of funds described in subparagraph (A), the Secretary shall provide notice to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives.
(d) Small businesses; fee waiver and fee reduction regarding premarket approval fees
(1) In general
The Secretary shall grant a waiver of the fee required under subsection (a) for one premarket application, or one premarket report, where the Secretary finds that the applicant involved is a small business submitting its first premarket application to the Secretary, or its first premarket report, respectively, for review. For the purposes of this paragraph, the term "small business" means an entity that reported $30,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates. In addition, for subsequent premarket applications, premarket reports, and supplements where the Secretary finds that the applicant involved is a small business, the fees specified in clauses (i) through (vii) and clauses (ix), (x), and (xi) of subsection (a)(2)(A) may be paid at a reduced rate in accordance with paragraph (2)(C).
(2) Rules relating to premarket approval fees
(A) Definition
For purposes of this paragraph, the term "small business" means an entity that reported $100,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates.
(B) Evidence of qualification
(i) In general
An applicant shall pay the higher fees established by the Secretary each year unless the applicant submits evidence that it qualifies for a waiver of the fee or the lower fee rate.
(ii) Firms submitting tax returns to the United States Internal Revenue Service
The applicant shall support its claim that it meets the definition under subparagraph (A) by submission of a copy of its most recent Federal income tax return for a taxable year, and a copy of such returns of its affiliates, which show an amount of gross sales or receipts that is less than the maximum established in subparagraph (A). The applicant, and each of such affiliates, shall certify that the information provided is a true and accurate copy of the actual tax forms they submitted to the Internal Revenue Service. If no tax forms are submitted for any affiliate, the applicant shall certify that the applicant has no affiliates.
(iii) Firms not submitting tax returns to the United States Internal Revenue Service
In the case of an applicant that has not previously submitted a Federal income tax return, the applicant and each of its affiliates shall demonstrate that it meets the definition under subparagraph (A) by submission of a signed certification, in such form as the Secretary may direct through a notice published in the Federal Register, that the applicant or affiliate meets the criteria for a small business and a certification, in English, from the national taxing authority of the country in which the applicant or, if applicable, affiliate is headquartered. The certification from such taxing authority shall bear the official seal of such taxing authority and shall provide the applicant's or affiliate's gross receipts or sales for the most recent year in both the local currency of such country and in United States dollars, the exchange rate used in converting such local currency to dollars, and the dates during which these receipts or sales were collected. The applicant shall also submit a statement signed by the head of the applicant's firm or by its chief financial officer that the applicant has submitted certifications for all of its affiliates, or that the applicant has no affiliates.
(C) Reduced fees
Where the Secretary finds that the applicant involved meets the definition under subparagraph (A), the fees established under subsection (c)(1) may be paid at a reduced rate of—
(i) 25 percent of the fee established under such subsection for a premarket application, a premarket report, a supplement, periodic reporting concerning a class III device, or a de novo classification request; and
(ii) 50 percent of the fee established under such subsection for a 30-day notice or a request for classification information.
(D) Request for fee waiver or reduction
An applicant seeking a fee waiver or reduction under this subsection shall submit supporting information to the Secretary at least 60 days before the fee is required pursuant to subsection (a). The decision of the Secretary regarding whether an entity qualifies for such a waiver or reduction is not reviewable.
(e) Small businesses; fee reduction regarding premarket notification submissions
(1) In general
For fiscal year 2008 and each subsequent fiscal year, where the Secretary finds that the applicant involved is a small business, the fee specified in subsection (a)(2)(A)(viii) may be paid at a reduced rate in accordance with paragraph (2)(C).
(2) Rules relating to premarket notification submissions
(A) Definition
For purposes of this subsection, the term "small business" means an entity that reported $100,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates.
(B) Evidence of qualification
(i) In general
An applicant shall pay the higher fees established by the Secretary each year unless the applicant submits evidence that it qualifies for the lower fee rate.
(ii) Firms submitting tax returns to the United States Internal Revenue Service
The applicant shall support its claim that it meets the definition under subparagraph (A) by submission of a copy of its most recent Federal income tax return for a taxable year, and a copy of such returns of its affiliates, which show an amount of gross sales or receipts that is less than the maximum established in subparagraph (A). The applicant, and each of such affiliates, shall certify that the information provided is a true and accurate copy of the actual tax forms they submitted to the Internal Revenue Service. If no tax forms are submitted for any affiliate, the applicant shall certify that the applicant has no affiliates.
(iii) Firms not submitting tax returns to the United States Internal Revenue Service
In the case of an applicant that has not previously submitted a Federal income tax return, the applicant and each of its affiliates shall demonstrate that it meets the definition under subparagraph (A) by submission of a signed certification, in such form as the Secretary may direct through a notice published in the Federal Register, that the applicant or affiliate meets the criteria for a small business and a certification, in English, from the national taxing authority of the country in which the applicant or, if applicable, affiliate is headquartered. The certification from such taxing authority shall bear the official seal of such taxing authority and shall provide the applicant's or affiliate's gross receipts or sales for the most recent year in both the local currency of such country and in United States dollars, the exchange rate used in converting such local currency to dollars, and the dates during which these receipts or sales were collected. The applicant shall also submit a statement signed by the head of the applicant's firm or by its chief financial officer that the applicant has submitted certifications for all of its affiliates, or that the applicant has no affiliates.
(C) Reduced fees
For fiscal year 2008 and each subsequent fiscal year, where the Secretary finds that the applicant involved meets the definition under subparagraph (A), the fee for a premarket notification submission may be paid at 25 percent of the fee that applies under subsection (a)(2)(A)(viii), and as established under subsection (c)(1).
(D) Request for reduction
An applicant seeking a fee reduction under this subsection shall submit supporting information to the Secretary at least 60 days before the fee is required pursuant to subsection (a). The decision of the Secretary regarding whether an entity qualifies for such a reduction is not reviewable.
(f) Effect of failure to pay fees
(1) No acceptance of submissions
A premarket application, premarket report, supplement, premarket notification submission, 30-day notice, request for classification information, periodic reporting concerning a class III device, or de novo classification request submitted by a person subject to fees under subsections (a)(2) and (a)(3) shall be considered incomplete and shall not be accepted by the Secretary until all such fees owed by such person have been paid.
(2) No registration
Registration information submitted under
(g) Conditions
(1) Performance goals; termination of program
With respect to the amount that, under the salaries and expenses account of the Food and Drug Administration, is appropriated for a fiscal year for devices and radiological products, fees may not be assessed under subsection (a) for the fiscal year, and the Secretary is not expected to meet any performance goals identified for the fiscal year, if—
(A) the amount so appropriated for the fiscal year, excluding the amount of fees appropriated for the fiscal year, is more than 1 percent less than $320,825,000 multiplied by the adjustment factor applicable to such fiscal year; or
(B) fees were not assessed under subsection (a) for the previous fiscal year.
(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 premarket applications, supplements, premarket reports, premarket notification submissions, 30-day notices, requests for classification information, periodic reporting concerning a class III device, and establishment registrations at any time in such fiscal year, notwithstanding the provisions of subsection (a) relating to the date fees are to be paid.
(3) Limitation
Beginning on October 1, 2023, the authorities under
(h) Crediting and availability of fees
(1) In general
Subject to paragraph (2)(C), fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriation Acts. Such fees are authorized to be appropriated to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the review of device applications.
(2) Collections and appropriation acts
(A) In general
The 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 to defray increases in the costs of the resources allocated for the process for the review of device 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 2009 multiplied by the adjustment factor.
(B) Compliance
(i) In general
The Secretary shall be considered to have met the requirements of subparagraph (A)(ii) in any fiscal year if the costs funded by appropriations and allocated for the process for the review of device applications—
(I) are not more than 3 percent below the level specified in subparagraph (A)(ii); or
(II)(aa) are more than 3 percent below the level specified in subparagraph (A)(ii), and fees assessed for a 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
(bb) such costs are not more than 5 percent below the level specified in such subparagraph.
(ii) More than 5 percent
To the extent such costs are more than 5 percent below the specified level in subparagraph (A)(ii), fees may not be collected under this section for that fiscal year.
(C) Provision for early payments
Payment of fees authorized under this section for a fiscal year, prior to the due date for such fees, may be accepted by the Secretary in accordance with authority provided in advance in a prior year appropriations Act.
(3) Authorizations of appropriations
For each of the fiscal years 2018 through 2022, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount specified under subsection (b)(3) for the fiscal year, as adjusted under subsection (c).
(i) 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
(j) Written requests for refunds
To qualify for consideration for a refund under subsection (a)(2)(D), a person shall submit to the Secretary a written request for such refund not later than 180 days after such fee is due.
(k) 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, employees, and advisory committees not engaged in the process of the review of device applications, be reduced to offset the number of officers, employees, and advisory committees so engaged.
(June 25, 1938, ch. 675, §738, as added
Termination of Section
For termination of section by section 210(a) of
References in Text
The Indian Self Determination and Educational Assistance Act, referred to in subsec. (a)(3)(B), probably means the Indian Self-Determination and Education Assistance Act,
Amendments
2017—Subsec. (a)(1).
Subsec. (a)(2)(A).
Subsec. (a)(2)(A)(viii).
Subsec. (a)(2)(A)(xi).
Subsec. (a)(2)(B)(v)(I).
Subsec. (a)(3)(A).
Subsec. (b).
Subsec. (c)(1).
Subsec. (c)(2)(A).
Subsec. (c)(2)(B).
"(i) for fiscal year 2014, the base inflation adjustment under subparagraph (C) for such fiscal year; and
"(ii) for fiscal year 2015 and each subsequent fiscal year, the product of—
"(I) the base inflation adjustment under subparagraph (C) for such fiscal year; and
"(II) the product of the base inflation adjustment under subparagraph (C) for each of the fiscal years preceding such fiscal year, beginning with fiscal year 2014."
Subsec. (c)(2)(C).
Subsec. (c)(2)(D).
Subsec. (c)(3).
Subsec. (d)(1).
Subsec. (d)(2)(C)(i).
Subsec. (e)(2)(C).
Subsec. (f).
Subsec. (f)(1).
Subsec. (g).
Subsec. (g)(1)(A).
Subsec. (h).
Subsec. (h)(3).
Subsec. (h)(4).
Subsecs. (i) to (l).
2012—Subsec. (a)(1).
Subsec. (a)(2)(A).
Subsec. (a)(2)(A)(viii).
Subsec. (a)(3)(A).
Subsec. (a)(3)(C).
Subsec. (b).
Subsec. (c).
Subsecs. (f) to (h).
Subsec. (h)(1)(A).
Subsec. (i).
Subsec. (i)(1).
Subsec. (i)(2)(A)(i).
Subsec. (i)(2)(A)(ii).
Subsec. (i)(2)(C).
Subsec. (i)(3).
Subsec. (i)(4).
Subsecs. (j) to (l).
2007—Subsec. (a)(1).
Subsec. (a)(2).
Subsec. (a)(2)(A)(iii).
Subsec. (a)(2)(A)(iv).
Subsec. (a)(2)(A)(v).
Subsec. (a)(2)(A)(vi), (vii).
Subsec. (a)(2)(A)(viii).
Subsec. (a)(2)(A)(ix), (x).
Subsec. (a)(2)(C).
Subsec. (a)(2)(D)(iii).
Subsec. (a)(2)(D)(iv) to (vi).
Subsec. (a)(3).
Subsec. (b).
Subsec. (c).
Subsec. (c)(1).
Subsec. (c)(2), (3).
Subsec. (c)(4).
Subsec. (d)(1).
Subsec. (d)(2)(A).
Subsec. (d)(2)(B).
Subsec. (d)(2)(B)(ii).
Subsec. (d)(2)(B)(iii).
Subsec. (d)(2)(C).
Subsec. (e)(1).
Subsec. (e)(2)(A).
Subsec. (e)(2)(B).
Subsec. (e)(2)(B)(ii).
Subsec. (e)(2)(B)(iii).
Subsec. (e)(2)(C).
Subsec. (f).
Subsec. (g)(1).
Subsec. (g)(2).
Subsec. (h)(3).
Subsec. (h)(4).
2005—Subsec. (a)(2)(A).
Subsec. (b).
Subsec. (c).
Subsec. (c)(1).
Subsec. (c)(2).
Subsec. (c)(3).
Subsec. (c)(4).
Subsec. (c)(5), (6).
Subsec. (d)(1).
Subsec. (d)(2)(A).
Subsec. (d)(2)(C).
Subsec. (e)(2)(A).
Subsec. (e)(2)(C).
Subsec. (g)(1)(B)(i).
"(I) $205,720,000 multiplied by the adjustment factor applicable to fiscal year 2003;
"(II) $205,720,000 multiplied by the adjustment factor applicable to fiscal year 2004; and
"(III) $205,720,000 multiplied by the adjustment factor applicable to fiscal year 2005."
Subsec. (g)(1)(B)(ii).
Subsec. (g)(1)(C).
Subsec. (g)(1)(C)(ii).
Subsec. (g)(1)(D)(i).
Subsec. (h)(3)(D), (E).
"(D) $32,615,000 for fiscal year 2006; and
"(E) $35,000,000 for fiscal year 2007,".
2004—
Subsec. (a).
Subsec. (a)(1)(A).
Subsec. (a)(1)(D)(i), (ii).
Subsec. (d)(1).
Subsec. (d)(2)(B).
Subsec. (e)(1).
Subsec. (e)(2)(B).
Subsec. (e)(2)(C).
Subsec. (f).
Subsec. (h)(2)(B).
Subsec. (j).
Effective Date of 2017 Amendment
Amendment by section 203 of
Effective Date of 2012 Amendment
Amendment by
Effective Date of 2007 Amendment
Amendment by
Effective and Termination Dates
Section ceases to be effective Oct. 1, 2022, see section 210(a) of
Section effective Oct. 26, 2002, except for certain premarket fees, see section 106 of
Fee Exemption for Certain Entities Submitting Premarket Reports
"(1) the premarket report is the first such report submitted to the Secretary by the person; and
"(2) before October 1, 2002, the person submitted a premarket application to the Secretary for the same device as the device for which the person is submitting the premarket report."
1 See References in Text note below.
§379j–1. Reauthorization; reporting requirements
(a) Reports
(1) Performance report
(A) In general
(i) General requirements
Beginning with fiscal year 2018, for each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives annual reports concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017 during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals.
(ii) Additional information
Beginning with fiscal year 2018, the annual report under this subparagraph shall include the progress of the Center for Devices and Radiological Health in achieving the goals, and future plans for meeting the goals, including—
(I) the number of premarket applications filed under
(II) the number of reports submitted under
(III) the number of expedited development and priority review designations under section 360e–3 1 of this title per fiscal year.
(iii) Real time reporting
(I) In general
Not later than 30 calendar days after the end of the second quarter of fiscal year 2018, and not later than 30 calendar days after the end of each quarter of each fiscal year thereafter, the Secretary shall post the data described in subclause (II) on the internet website of the Food and Drug Administration for such quarter and on a cumulative basis for such fiscal year, and may remove duplicative data from the annual report under this subparagraph.
(II) Data
The Secretary shall post the following data in accordance with subclause (I):
(aa) The number and titles of draft and final guidance on topics related to the process for the review of devices, and whether such guidances were issued as required by statute or pursuant to the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017; and
(bb) The number and titles of public meetings held on topics related to the process for the review of devices, and if such meetings were required by statute or pursuant to a commitment under the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017.
(iv) 2 Rationale for MDUFA program changes
Beginning with fiscal year 2020, the Secretary shall include in the annual report under paragraph (1)—
(I) data, analysis, and discussion of the changes in the number of full-time equivalents hired as agreed upon in the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017 and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Devices and Radiological Health, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner;
(II) data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of devices, including identifying drivers of such changes; and
(III) for each of the Center for Devices and Radiological Health, 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.
(iv) 2 Analysis
For each fiscal year, the Secretary shall include in the report under clause (i) an analysis of the following:
(I) The difference between the aggregate number of premarket applications filed under
(aa) the number of applications filed and reports submitted during one fiscal year for which a decision is not scheduled to be made until the following fiscal year; and
(bb) the aggregate number of applications for each fiscal year that did not meet the goals as identified by the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017 for the applicable fiscal year.
(II) Relevant data to determine whether the Center for Devices and Radiological Health has met performance enhancement goals identified by the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017 for the applicable fiscal year.
(III) The most common causes and trends for external or other circumstances affecting the ability of the Center for Devices and Radiological Health, the Office of Regulatory Affairs, or the Food and Drug Administration to meet review time and performance enhancement goals identified by the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017.
(B) Publication
With regard to information to be reported by the Food and Drug Administration to industry on a quarterly and annual basis pursuant to the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017, the Secretary shall make such information publicly available on the Internet Web site of the Food and Drug Administration not later than 60 days after the end of each quarter or 120 days after the end of each fiscal year, respectively, to which such information applies. This information shall include the status of the independent assessment identified in the letters described in such section 201(b).
(C) Updates
The Secretary shall include in each report under subparagraph (A) information on all previous cohorts for which the Secretary has not given a complete response on all device premarket applications and reports, supplements, and premarket notifications in the cohort.
(2) Corrective action report
Beginning with fiscal year 2018, for 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:
(A) Goals met
For each fiscal year, if the Secretary determines, based on the analysis under paragraph (1)(A)(iv), that each of the goals identified by the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017 for the applicable fiscal year have been met, the corrective action report shall include recommendations on ways in which the Secretary can improve and streamline the medical device application review process.
(B) Goals missed
For each of the goals identified by the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017 for the applicable fiscal year that the Secretary determines to not have been met, the corrective action report shall include—
(i) a justification for such determination;
(ii) a description of the types of circumstances, in the aggregate, under which applications or reports submitted under
(iii) a summary and any trends with regard to the circumstances for which a review goal was missed; and
(iv) the performance enhancement goals that were not achieved during the previous fiscal year and 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 3 fiscal year.
(3) Enhanced communication
(A) Communications with Congress
Each fiscal year, as applicable and requested, representatives from the Centers with expertise in the review of devices shall meet with representatives from the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives to report on the contents described in the reports under this section.
(B) Participation in congressional hearing
Each fiscal year, as applicable and requested, representatives from the Food and Drug Administration shall participate in a public hearing before the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, to report on the contents described in the reports under this section. Such hearing shall occur not later than 120 days after the end of each fiscal year for which fees are collected under this subpart.
(4) Fiscal report
For fiscal years 2018 through 2022, not later than 120 days after the end of each fiscal year during which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, 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.
(5) Public availability
The Secretary shall make the reports required under paragraphs (1) and (2) available to the public on the Internet Web site of the Food and Drug Administration.
(b) Reauthorization
(1) Consultation
In developing recommendations to present to Congress with respect to the goals, and plans for meeting the goals, for the process for the review of device applications for the first 5 fiscal years after fiscal year 2022, and for the reauthorization of this subpart for such fiscal years, the Secretary shall consult with—
(A) the Committee on Energy and Commerce of the House of Representatives;
(B) the Committee on Health, Education, Labor, and Pensions of the Senate;
(C) scientific and academic experts;
(D) health care professionals;
(E) representatives of patient and consumer advocacy groups; and
(F) the regulated industry.
(2) Prior public input
Prior 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)(1);
(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
Not less frequently than once every month during negotiations with the regulated industry, the Secretary shall hold discussions with representatives of patient and consumer advocacy groups to continue discussions of their views on the reauthorization and their suggestions for changes to this subpart as expressed under paragraph (2).
(4) Public review of recommendations
After 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;
(C) provide for a period of 30 days for the public to provide written comments on such recommendations;
(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.
(5) Transmittal of recommendations
Not later than January 15, 2022, the Secretary shall transmit to Congress the revised recommendations under paragraph (4), a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments.
(6) Minutes of negotiation meetings
(A) Public availability
Before presenting the recommendations developed under paragraphs (1) through (5) to the Congress, the Secretary shall make publicly available, on the public Web site of the Food and Drug Administration, minutes of all negotiation meetings conducted under this subsection between the Food and Drug Administration and the regulated industry.
(B) Content
The minutes described under subparagraph (A) shall summarize any substantive proposal made by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations and their resolution.
(June 25, 1938, ch. 675, §738A, as added
Termination of Section
For termination of section by section 210(b) of
References in Text
Section 201(b) of the Medical Device User Fee Amendments of 2017, referred to in subsec. (a)(1)(A), (B), (2), is section 201(b) of
Amendments
2017—Subsec. (a)(1)(A).
Subsec. (a)(1)(A)(i).
Subsec. (a)(1)(A)(iv).
Subsec. (a)(1)(B).
Subsec. (a)(2), (3).
Subsec. (a)(4).
Subsec. (a)(5).
Subsec. (b)(1).
Subsec. (b)(5).
2012—Subsec. (a)(1).
Subsec. (a)(2).
Subsec. (b)(1).
Subsec. (b)(5).
Effective Date of 2017 Amendment
Amendment by section 204 of
Effective Date of 2012 Amendment
Amendment by
Effective and Termination Dates
Section effective Oct. 1, 2007, except for certain premarket fees under this subpart, see section 216 of
1 See References in Text note below.
2 So in original. Two cls. (iv) have been enacted.
subpart 4—fees relating to animal drugs
§379j–11. Definitions
For purposes of this subpart:
(1)(A) The term "animal drug application" means—
(i) an application for approval of any new animal drug submitted under
(ii) an application for conditional approval of a new animal drug submitted under
(B) Such term does not include either a new animal drug application submitted under
(2) The term "supplemental animal drug application" means—
(A) a request to the Secretary to approve a change in an animal drug application which has been approved; or
(B) a request to the Secretary to approve a change to an application approved under
(3) The term "animal drug product" means each specific strength or potency of a particular active ingredient or ingredients in final dosage form marketed by a particular manufacturer or distributor, which is uniquely identified by the labeler code and product code portions of the national drug code, and for which an animal drug application or a supplemental animal drug application has been approved.
(4) The term "animal 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 5 miles of each other, at which one or more animal drug products are manufactured in final dosage form.
(5) The term "investigational animal drug submission" means—
(A) the filing of a claim for an investigational exemption under
(B) the submission of information for the purpose of enabling the Secretary to evaluate the safety or effectiveness of an animal drug application or supplemental animal drug application in the event of their filing.
(6) The term "animal drug sponsor" means either an applicant named in an animal drug application that has not been withdrawn by the applicant and for which approval has not been withdrawn by the Secretary, or a person who has submitted an investigational animal drug submission that has not been terminated or otherwise rendered inactive by the Secretary.
(7) The term "final dosage form" means, with respect to an animal drug product, a finished dosage form which is approved for administration to an animal without substantial further manufacturing. Such term includes animal drug products intended for mixing in animal feeds.
(8) The term "process for the review of animal drug applications" means the following activities of the Secretary with respect to the review of animal drug applications, supplemental animal drug applications, and investigational animal drug submissions:
(A) The activities necessary for the review of animal drug applications, supplemental animal drug applications, and investigational animal drug submissions.
(B) The issuance of action letters which approve animal drug applications or supplemental animal drug applications or which set forth in detail the specific deficiencies in animal drug applications, supplemental animal drug applications, or investigational animal drug submissions and, where appropriate, the actions necessary to place such applications, supplements or submissions in condition for approval.
(C) The inspection of animal drug establishments and other facilities undertaken as part of the Secretary's review of pending animal drug applications, supplemental animal drug applications, and investigational animal drug submissions.
(D) Monitoring of research conducted in connection with the review of animal drug applications, supplemental animal drug applications, and investigational animal drug submissions.
(E) The development of regulations and policy related to the review of animal drug applications, supplemental animal drug applications, and investigational animal drug submissions.
(F) Development of standards for products subject to review.
(G) Meetings between the agency and the animal drug sponsor.
(H) Review of advertising and labeling prior to approval of an animal drug application or supplemental animal drug application, but not after such application has been approved.
(I) The activities necessary for implementation of the United States and European Union Good Manufacturing Practice Mutual Inspection Agreement with respect to animal drug products subject to review, including implementation activities prior to and following product approval.
(9) The term "costs of resources allocated for the process for the review of animal drug applications" means the expenses in connection with the process for the review of animal drug applications for—
(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees consulted with respect to the review of specific animal drug applications, supplemental animal drug applications, or investigational animal drug submissions, and costs related to such officers, employees, committees, and contractors, including costs for travel, education, and recruitment and other personnel activities;
(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
(10) The term "adjustment factor" applicable to a fiscal year refers to the formula set forth in
(11) The term "person" includes an affiliate thereof.
(12) The term "affiliate" refers to the definition set forth in
(June 25, 1938, ch. 675, §739, as added
Amendments
2018—Par. (1).
Par. (8)(I).
2013—
2008—Par. (6).
Par. (8)(H).
Par. (10).
Pars. (11), (12).
2007—
Par. (11).
Effective Date of 2018 Amendment
Effective Date of 2013 Amendment
Effective and Termination Dates of 2008 Amendment
Effective Date of 2007 Amendment
Amendment by
Termination Date
Savings Provisions
Findings
"(1) Prompt approval of safe and effective new animal drugs is critical to the improvement of animal health and the public health.
"(2) Animal health and 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 new animal drug applications.
"(3) The fees authorized by this Act [enacting this subpart and provisions set out as notes under this section and
Accountability and Reports
"(a)
"(1)
"(2)
"(A) publish in the Federal Register recommendations under paragraph (1), after negotiations with the regulated industry;
"(B) present the recommendations to the Committees referred to in that paragraph;
"(C) hold a meeting at which the public may comment on the recommendations; and
"(D) provide for a period of 30 days for the public to provide written comments on the recommendations.
"(b)
"(c)
§379j–12. Authority to assess and use animal drug fees
(a) Types of fees
Beginning in fiscal year 2004, the Secretary shall assess and collect fees in accordance with this section as follows:
(1) Animal drug application and supplement fee
(A) In general
Each person that submits, on or after September 1, 2003, an animal drug application or a supplemental animal drug application shall be subject to a fee as follows:
(i) A fee established in subsection (c) for an animal drug application, except an animal drug application subject to the criteria set forth in
(ii) A fee established in subsection (c), in an amount that is equal to 50 percent of the amount of the fee under clause (i), for—
(I) a supplemental animal drug application for which safety or effectiveness data are required; and
(II) an animal drug application subject to the criteria set forth in
(B) Payment
The fee required by subparagraph (A) shall be due upon submission of the animal drug application or supplemental animal drug application.
(C) Exceptions for previously filed application or supplement
(i) If an animal drug application or a supplemental animal drug application 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 or refund), the submission of an animal drug application or a supplemental animal drug application for the same product by the same person (or the person's licensee, assignee, or successor) shall not be subject to a fee under subparagraph (A).
(ii) Beginning with fiscal year 2019, in the case of an animal drug application submitted by a person under
(D) Refund of fee if application refused for filing
The Secretary shall refund 75 percent of the fee paid under subparagraph (B) for any animal drug application or supplemental animal drug application which is refused for filing.
(E) Refund of fee if application withdrawn
If an animal drug application or a supplemental animal drug application is withdrawn after the application or supplement was filed, the Secretary may refund the fee or portion of the fee paid under subparagraph (B) if no substantial work was performed on the application or supplement after the application or supplement was filed. The Secretary shall have the sole discretion to refund the fee under this paragraph. A determination by the Secretary concerning a refund under this paragraph shall not be reviewable.
(2) Animal drug product fee
(A) In general
Each person—
(i) who is named as the applicant in an animal drug application or supplemental animal drug application for an animal drug product which has been submitted for listing under
(ii) who, after September 1, 2003, had pending before the Secretary an animal drug application or supplemental animal drug application,
shall pay for each such animal drug product the annual fee established in subsection (c).
(B) Payment; fee due date
Such fee shall be payable for the fiscal year in which the animal drug product is first submitted for listing under
(i) the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section; or
(ii) January 31 of each year.
(C) Limitation
Such fee shall be paid only once for each animal drug product for a fiscal year in which the fee is payable.
(3) Animal drug establishment fee
(A) In general
Each person—
(i) who owns or operates, directly or through an affiliate, an animal drug establishment;
(ii) who is named as the applicant in an animal drug application or supplemental animal drug application for an animal drug product which has been submitted for listing under
(iii) who, after September 1, 2003, had pending before the Secretary an animal drug application or supplemental animal drug application,
shall be assessed an annual establishment fee as established in subsection (c) for each animal drug establishment listed in its approved animal drug application as an establishment that manufactures the animal drug product named in the application.
(B) Payment; fee due date
The annual establishment fee shall be assessed in each fiscal year in which the animal drug product named in the application is assessed a fee under paragraph (2) unless the animal drug establishment listed in the application does not engage in the manufacture of the animal drug product during the fiscal year. The fee under this paragraph for a fiscal year shall be due upon the later of—
(i) the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section; or
(ii) January 31 of each year.
(C) Limitation
An establishment shall be assessed only one fee per fiscal year under this section.
(4) Animal drug sponsor fee
(A) In general
Each person—
(i) who meets the definition of an animal drug sponsor within a fiscal year; and
(ii) who, after September 1, 2003, had pending before the Secretary an animal drug application, a supplemental animal drug application, or an investigational animal drug submission,
shall be assessed an annual sponsor fee as established under subsection (c).
(B) Payment; fee due date
The fee under this paragraph for a fiscal year shall be due upon the later of—
(i) the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section; or
(ii) January 31 of each year.
(C) Limitation
Each animal drug sponsor shall pay only one such fee each fiscal year.
(b) Fee revenue amounts
(1) In general
Subject to subsections (c), (d), (f), and (g)—
(A) for fiscal year 2019, the fees required under subsection (a) shall be established to generate a total revenue amount of $30,331,240; and
(B) for each of fiscal years 2020 through 2023, the fees required under subsection (a) shall be established to generate a total revenue amount of $29,931,240.
(2) Types of fees
Of the total revenue amount established for a fiscal year under paragraph (1)—
(A) 20 percent shall be derived from fees under subsection (a)(1) (relating to animal drug applications and supplements);
(B) 27 percent shall be derived from fees under subsection (a)(2) (relating to animal drug products);
(C) 26 percent shall be derived from fees under subsection (a)(3) (relating to animal drug establishments); and
(D) 27 percent shall be derived from fees under subsection (a)(4) (relating to animal drug sponsors).
(c) Annual fee setting; adjustments
(1) Annual fee setting
The Secretary shall establish, 60 days before the start of each fiscal year beginning after September 30, 2003, for that fiscal year, animal drug application fees, supplemental animal drug application fees, animal drug sponsor fees, animal drug establishment fees, and animal drug product fees based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection.
(2) Inflation adjustment
(A) For fiscal year 2020 and subsequent fiscal years, the revenue amounts established in subsection (b) shall be adjusted by the Secretary by notice, published in the Federal Register, for a fiscal year, by multiplying such revenue amounts by an amount equal to the sum of—
(i) one;
(ii) 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 of the preceding 4 fiscal years for which data are available, multiplied by the average proportion of personnel compensation and benefits costs to total Food and Drug Administration costs for the first 3 years of the preceding 4 fiscal years for which data are available; and
(iii) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; not seasonally adjusted; all items less food and energy; annual index) for the first 3 years of the preceding 4 years for which data are available multiplied by the average proportion of all costs other than personnel compensation and benefits costs to total Food and Drug Administration costs for the first 3 years of the preceding 4 fiscal years for which data are available.
(B)
(3) Workload adjustments
(A) In general
For fiscal year 2020 and subsequent fiscal years, after the fee revenue amounts established under subsection (b) are adjusted for inflation in accordance with paragraph (2), the fee revenue amounts shall be further adjusted for such fiscal year to reflect changes in the workload of the Secretary for the process for the review of animal drug applications, subject to subparagraphs (B) and (C). With respect to such adjustment—
(i) such adjustment shall be determined by the Secretary based on a weighted average of the change in the total number of animal drug applications, supplemental animal drug applications for which data with respect to safety or effectiveness are required, manufacturing supplemental animal drug applications, investigational animal drug study submissions, and investigational animal drug protocol submissions submitted to the Secretary; and
(ii) the Secretary shall publish in the Federal Register the fees resulting from such adjustment and the supporting methodologies.
(B) Reduction of workload-based increase by amount of certain excess collections
For each of fiscal years 2021 through 2023, if application of the workload adjustment under subparagraph (A) increases the fee revenue amounts otherwise established for the fiscal year under subsection (b), as adjusted for inflation under paragraph (2), such fee revenue increase shall be reduced by the amount of any excess collections, as described in subsection (g)(4), for the second preceding fiscal year, up to the amount of such fee revenue increase.
(C) Rule of application
Under no circumstances shall the workload adjustments under this paragraph result in fee revenues for a fiscal year that are less than the fee revenues for that fiscal year established under subsection (b), as adjusted for inflation under paragraph (2).
(4) Final year adjustment
For fiscal year 2023, the Secretary may, in addition to other adjustments under this subsection, further increase the fees under this section, if such an adjustment is necessary, to provide for up to 3 months of operating reserves of carryover user fees for the process for the review of animal drug applications for the first 3 months of fiscal year 2024. If the Food and Drug Administration has carryover balances for the process for the review of animal drug applications in excess of 3 months of such operating reserves, then this adjustment will not be made. If this adjustment is necessary, then the rationale for the amount of the increase shall be contained in the annual notice setting fees for fiscal year 2023.
(5) Limit
The total amount of fees charged, as adjusted under this subsection, for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of animal drug applications.
(d) Fee waiver or reduction; exemptions from fees
(1) Waiver or reduction
The Secretary shall grant a waiver from or a reduction of one or more fees assessed under subsection (a) where the Secretary finds that—
(A) the assessment of the fee would present a significant barrier to innovation because of limited resources available to such person or other circumstances;
(B) 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 animal drug applications for such person;
(C) the animal drug application or supplemental animal drug application is intended solely to provide for use of the animal drug in—
(i) a Type B medicated feed (as defined in section 558.3(b)(3) of title 21, Code of Federal Regulations (or any successor regulation)) intended for use in the manufacture of Type C free-choice medicated feeds; or
(ii) a Type C free-choice medicated feed (as defined in section 558.3(b)(4) of title 21, Code of Federal Regulations (or any successor regulation));
(D) the animal drug application or supplemental animal drug application is intended solely to provide for a minor use or minor species indication; or
(E) the sponsor involved is a small business submitting its first animal drug application to the Secretary for review.
(2) Use of standard costs
In making the finding in paragraph (1)(B), the Secretary may use standard costs.
(3) Rules for small businesses
(A) Definition
In paragraph (1)(E), the term "small business" means an entity that has fewer than 500 employees, including employees of affiliates.
(B) Waiver of application fee
The Secretary shall waive under paragraph (1)(E) the application fee for the first animal drug application that a small business or its affiliate submits to the Secretary for review. After a small business or its affiliate is granted such a waiver, the small business or its affiliate shall pay application fees for all subsequent animal drug applications and supplemental animal drug applications for which safety or effectiveness data are required in the same manner as an entity that does not qualify as a small business.
(C) Certification
The Secretary shall require any person who applies for a waiver under paragraph (1)(E) to certify their qualification for the waiver. The Secretary shall periodically publish in the Federal Register a list of persons making such certifications.
(4) Exemptions from fees
(A) Certain labeling supplements to add number of approved application
Fees under this section shall not apply with respect to any person who—
(i) not later than September 30, 2023, submits a supplemental animal drug application relating to a new animal drug application approved under
(ii) otherwise would be subject to fees under this section solely on the basis of such supplemental application.
(B) Certain animal drug applications
Fees under paragraphs (2), (3), and (4) of subsection (a) shall not apply with respect to any person who is the named applicant or sponsor of an animal drug application, supplemental animal drug application, or investigational animal drug submission if such application or submission involves the intentional genomic alteration of an animal that is intended to produce a drug, device, or biological product subject to fees under
(e) Effect of failure to pay fees
An animal drug application or supplemental animal drug application 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. An investigational animal drug submission under
(f) Assessment of fees
(1) Limitation
Fees may not be assessed under subsection (a) for a fiscal year beginning after fiscal year 2003 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 2003 (excluding the amount of fees appropriated for such fiscal year) multiplied by the adjustment factor applicable to the fiscal year involved.
(2) Authority
If the Secretary does not assess fees under subsection (a) 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 animal drug applications, supplemental animal drug applications, investigational animal drug submissions, animal drug sponsors, animal drug establishments and animal 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
Subject to paragraph (2)(C), fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to be appropriated to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salary and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the review of animal drug applications.
(2) Collections and appropriation Acts
(A) In general
The 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 to defray increases in the costs of the resources allocated for the process for the review of animal 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 2003 multiplied by the adjustment factor.
(B) Compliance
The Secretary shall be considered to have met the requirements of subparagraph (A)(ii) in any fiscal year if the costs funded by appropriations and allocated for the process for the review of animal drug applications—
(i) are not more than 3 percent below the level specified in subparagraph (A)(ii); or
(ii)(I) are more than 3 percent below the level specified in subparagraph (A)(ii), and fees assessed for the fiscal year following the subsequent fiscal year are decreased by the amount in excess of 3 percent by which such costs fell below the level specified in subparagraph (A)(ii); and
(II) such costs are not more than 5 percent below the level specified in subparagraph (A)(ii).
(C) Provision for early payments
Payment of fees authorized under this section for a fiscal year, prior to the due date for such fees, may be accepted by the Secretary in accordance with authority provided in advance in a prior year appropriations Act.
(3) Authorization of appropriations
For each of the fiscal years 2019 through 2023, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount established under subsection (b) for the fiscal year, as adjusted or otherwise affected under subsection (c) and paragraph (5).
(4) Excess collections
If the sum total of fees collected under this section for a fiscal year exceeds the amount of fees authorized to be appropriated for such year under paragraph (3), the excess collections shall be credited to the appropriations account of the Food and Drug Administration as provided in paragraph (1).
(5) Recovery of collection shortfalls
(A) In general
Subject to subparagraph (B)—
(i) for fiscal year 2021, the amount of fees otherwise authorized to be collected under this section shall be increased by the amount, if any, by which the amount collected under this section and appropriated for fiscal year 2019 falls below the amount of fees authorized for fiscal year 2019 under paragraph (3);
(ii) for fiscal year 2022, the amount of fees otherwise authorized to be collected under this section shall be increased by the amount, if any, by which the amount collected under this section and appropriated for fiscal year 2020 falls below the amount of fees authorized for fiscal year 2020 under paragraph (3); and
(iii) for fiscal year 2023, the amount of fees otherwise authorized to be collected under this section shall be increased by the cumulative amount, if any, by which the amount collected under this section and appropriated for fiscal years 2021 and 2022 (including estimated collections for fiscal year 2022) falls below the cumulative amount of fees authorized for such fiscal years under paragraph (3).
(B) Reduction of shortfall-based fee increase by prior year excess collections
(i) In general
Subject to clause (ii), the Secretary shall, in such manner as the Secretary determines appropriate, reduce any fee increase otherwise applicable for a fiscal year under subparagraph (A) by the amount of any excess collections under this section for preceding fiscal years (after fiscal year 2018).
(ii) Workload-based fee accounting
In applying clause (i), the Secretary shall account for the reduction of workload-based fee revenue increases by excess collections under subsection (c)(3)(B), in such manner as needed to provide that no portion of any excess collections described in clause (i) is applied for purposes of reducing fee increases under both such subsection (c)(3)(B) and this paragraph.
(C) Rule of application
Under no circumstances shall adjustments under this paragraph result in fee revenues for a fiscal year that are less than the fee revenues for that fiscal year established in subsection (b), as adjusted or otherwise affected under subsection (c).
(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
(i) Written requests for waivers, reductions, and refunds
To qualify for consideration for a waiver or reduction under subsection (d), or for a refund of any fee collected in accordance with subsection (a), a person shall submit to the Secretary a written request for such waiver, reduction, or refund not later than 180 days after such fee is due.
(j) Construction
This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employees, and advisory committees not engaged in the process of the review of animal drug applications, be reduced to offset the number of officers, employees, and advisory committees so engaged.
(k) Abbreviated new animal drug applications
The Secretary shall—
(1) to the extent practicable, segregate the review of abbreviated new animal drug applications from the process for the review of animal drug applications; and
(2) adopt other administrative procedures to ensure that review times of abbreviated new animal drug applications do not increase from their current level due to activities under the user fee program.
(June 25, 1938, ch. 675, §740, as added
Termination of Section
For termination of section by section 107(a) of
Amendments
2018—Subsec. (a)(1)(C).
Subsec. (b)(1)(A).
Subsec. (b)(1)(B).
Subsec. (b)(2).
Subsec. (c)(2).
Subsec. (c)(3).
"(A) such adjustment shall be determined by the Secretary based on a weighted average of the change in the total number of animal drug applications, supplemental animal drug applications for which data with respect to safety or effectiveness are required, manufacturing supplemental animal drug applications, investigational animal drug study submissions, and investigational animal drug protocol submissions submitted to the Secretary;
"(B) the Secretary shall publish in the Federal Register the fees resulting from such adjustment and the supporting methodologies; and
"(C) under no circumstances shall such adjustment result in fee revenues for a fiscal year that are less than the fee revenues for that fiscal year established in subsection (b), as adjusted for inflation under paragraph (2)."
Subsec. (c)(4).
Subsec. (d).
Subsec. (d)(1).
Subsec. (d)(4).
Subsec. (g)(3).
Subsec. (g)(4), (5).
2017—Subsec. (a)(3)(C).
"(i)
"(ii)
2013—
2008—Subsec. (a)(1)(A)(i).
Subsec. (a)(1)(A)(ii).
Subsec. (b)(1).
Subsec. (b)(2).
Subsec. (b)(3).
Subsec. (b)(4).
Subsec. (c)(1).
Subsec. (c)(2).
Subsec. (c)(3) to (5).
Subsec. (g)(3)(A) to (E).
"(A) $5,000,000 for fiscal year 2004;
"(B) $8,000,000 for fiscal year 2005;
"(C) $10,000,000 for fiscal year 2006;
"(D) $10,000,000 for fiscal year 2007; and
"(E) $10,000,000 for fiscal year 2008;".
Subsec. (g)(4).
Effective Date of 2018 Amendment
Amendment by
Effective Date of 2017 Amendment
Amendment by
Effective Date of 2013 Amendment
Amendment by
Effective Date of 2008 Amendment
Amendment by
Termination Date
§379j–13. Reauthorization; reporting requirements
(a) Performance report
Beginning with fiscal year 2019, not later than 120 days after the end of each fiscal year during which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 101(b) of the Animal Drug User Fee Amendments of 2018 toward expediting the animal drug development process and the review of the new and supplemental animal drug applications and investigational animal drug submissions during such fiscal year, the future plans of the Food and Drug Administration for meeting the goals, the review times for abbreviated new animal drug applications, and the administrative procedures adopted by the Food and Drug Administration to ensure that review times for abbreviated new animal drug applications are not increased from their current level due to activities under the user fee program.
(b) Fiscal report
Beginning with fiscal year 2019, not later than 120 days after the end of each fiscal year during which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives 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.
(c) Public availability
The Secretary shall make the reports required under subsections (a) and (b) available to the public on the Internet Web site of the Food and Drug Administration.
(d) Reauthorization
(1) Consultation
In developing recommendations to present to the Congress with respect to the goals, and plans for meeting the goals, for the process for the review of animal drug applications for the first 5 fiscal years after fiscal year 2023, and for the reauthorization of this subpart for such fiscal years, the Secretary shall consult with—
(A) the Committee on Health, Education, Labor, and Pensions of the Senate;
(B) the Committee on Energy and Commerce of the House of Representatives;
(C) scientific and academic experts;
(D) veterinary professionals;
(E) representatives of patient and consumer advocacy groups; and
(F) the regulated industry.
(2) Prior public input
Prior 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
Not less frequently than once every 4 months during negotiations with the regulated industry, the Secretary shall hold discussions with representatives of veterinary, patient, and consumer advocacy groups to continue discussions of their views on the reauthorization and their suggestions for changes to this subpart as expressed under paragraph (2).
(4) Public review of recommendations
After 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;
(C) provide for a period of 30 days for the public to provide written comments on such recommendations;
(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.
(5) Transmittal of recommendations
Not later than January 15, 2023, the Secretary shall transmit to Congress the revised recommendations under paragraph (4) 1 a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments.
(6) Minutes of negotiation meetings
(A) Public availability
Before presenting the recommendations developed under paragraphs (1) through (5) to Congress, the Secretary shall make publicly available, on the Internet Web site of the Food and Drug Administration, minutes of all negotiation meetings conducted under this subsection between the Food and Drug Administration and the regulated industry.
(B) Content
The minutes described under subparagraph (A) shall summarize any substantive proposal made by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations and their resolution.
(June 25, 1938, ch. 675, §740A, as added
Termination of Section
For termination of section by section 107(b) of
References in Text
Section 101(b) of the Animal Drug User Fee Amendments of 2018, referred to in subsec. (a), is section 101(b) of
Amendments
2018—Subsec. (a).
Subsec. (b).
Subsec. (d)(1), (5).
2013—
Effective Date of 2018 Amendment
Amendment by
Effective Date of 2013 Amendment
Amendment by
Effective and Termination Dates
Section effective Oct. 1, 2008, with fees under this subpart to be assessed for all animal drug applications and supplemental animal drug applications received on or after Oct. 1, 2008, see section 107 of
1 So in original. Probably should be followed by a comma.
subpart 5—fees relating to generic new animal drugs
Termination of Subpart
For termination of subpart by section 206(a), (b) of
§379j–21. Authority to assess and use generic new animal drug fees
(a) Types of fees
Beginning with respect to fiscal year 2009, the Secretary shall assess and collect fees in accordance with this section as follows:
(1) Abbreviated application fee
(A) In general
Each person that submits, on or after July 1, 2008, an abbreviated application for a generic new animal drug shall be subject to a fee as established in subsection (c) for such an application.
(B) Payment
The fee required by subparagraph (A) shall be due upon submission of the abbreviated application.
(C) Exceptions
(i) Previously filed application
If an abbreviated application was submitted by a person that paid the fee for such application, was accepted for filing, and was not approved or was withdrawn (without a waiver or refund), the submission of an abbreviated application for the same product by the same person (or the person's licensee, assignee, or successor) shall not be subject to a fee under subparagraph (A).
(ii) Certain abbreviated applications involving combination animal drugs
An abbreviated application which is subject to the criteria in
(D) Refund of fee if application refused for filing
The Secretary shall refund 75 percent of the fee paid under subparagraph (B) for any abbreviated application which is refused for filing.
(E) Refund of fee if application withdrawn
If an abbreviated application is withdrawn after the application was filed, the Secretary may refund the fee or portion of the fee paid under subparagraph (B) if no substantial work was performed on the application after the application was filed. The Secretary shall have the sole discretion to refund the fee under this subparagraph. A determination by the Secretary concerning a refund under this subparagraph shall not be reviewable.
(2) Generic new animal drug product fee
(A) In general
Each person—
(i) who is named as the applicant in an abbreviated application or supplemental abbreviated application for a generic new animal drug product which has been submitted for listing under
(ii) who, after September 1, 2008, had pending before the Secretary an abbreviated application or supplemental abbreviated application,
shall pay for each such generic new animal drug product the annual fee established in subsection (c).
(B) Payment; fee due date
Such fee shall be payable for the fiscal year in which the generic new animal drug product is first submitted for listing under
(i) the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section; or
(ii) January 31 of each year.
(C) Limitation
Such fee shall be paid only once for each generic new animal drug product for a fiscal year in which the fee is payable.
(3) Generic new animal drug sponsor fee
(A) In general
Each person—
(i) who meets the definition of a generic new animal drug sponsor within a fiscal year; and
(ii) who, after September 1, 2008, had pending before the Secretary an abbreviated application, a supplemental abbreviated application, or an investigational submission,
shall be assessed an annual generic new animal drug sponsor fee as established under subsection (c).
(B) Payment; fee due date
Such fee shall be due each fiscal year upon the later of—
(i) the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section; or
(ii) January 31 of each year.
(C) Amount of fee
Each generic new animal drug sponsor shall pay only 1 such fee each fiscal year, as follows:
(i) 100 percent of the amount of the generic new animal drug sponsor fee published for that fiscal year under subsection (c) for an applicant with more than 6 approved abbreviated applications.
(ii) 75 percent of the amount of the generic new animal drug sponsor fee published for that fiscal year under subsection (c) for an applicant with more than 1 and fewer than 7 approved abbreviated applications.
(iii) 50 percent of the amount of the generic new animal drug sponsor fee published for that fiscal year under subsection (c) for an applicant with 1 or fewer approved abbreviated applications.
(b) Fee revenue amounts
(1) In general
Subject to subsections (c), (d), (f), and (g), for each of fiscal years 2019 through 2023, the fees required under subsection (a) shall be established to generate a total revenue amount of $18,336,340.
(2) Types of fees
Of the total revenue amount established for a fiscal year under paragraph (1)—
(A) 25 percent shall be derived from fees under subsection (a)(1) (relating to abbreviated applications for a generic new animal drug);
(B) 37.5 percent shall be derived from fees under subsection (a)(2) (relating to generic new animal drug products); and
(C) 37.5 percent shall be derived from fees under subsection (a)(3) (relating to generic new animal drug sponsors).
(c) Annual fee setting; adjustments
(1) Annual fee setting
The Secretary shall establish, 60 days before the start of each fiscal year beginning after September 30, 2008, for that fiscal year, abbreviated application fees, generic new animal drug sponsor fees, and generic new animal drug product fees, based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection.
(2) Inflation adjustment
(A) In general
For fiscal year 2020 and subsequent fiscal years, the revenue amounts established under subsection (b) shall be adjusted by the Secretary by notice, published in the Federal Register, for a fiscal year, by multiplying such revenue amounts by an amount equal to the sum of—
(i) one;
(ii) 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 of the preceding 4 fiscal years for which data are available, multiplied by the average proportion of personnel compensation and benefits costs to total Food and Drug Administration costs for the first 3 of the preceding 4 fiscal years for which data are available; and
(iii) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; not seasonally adjusted; all items less food and energy; annual index) for the first 3 of the preceding 4 years for which data are available multiplied by the average proportion of all costs other than personnel compensation and benefits costs to total Food and Drug Administration costs for the first 3 of the preceding 4 fiscal years for which data are available.
(B) Compounded basis
The adjustment made each fiscal year after fiscal year 2020 under this paragraph shall be applied on a compounded basis to the revenue amount calculated under this paragraph for the most recent previous fiscal year.
(3) Workload adjustments
(A) In general
For fiscal year 2020 and subsequent fiscal years, after the fee revenue amounts established under subsection (b) are adjusted for inflation in accordance with paragraph (2), the fee revenue amounts shall be further adjusted for each such fiscal year to reflect changes in the workload of the Secretary for the process for the review of abbreviated applications for generic new animal drugs, subject to subparagraphs (B) and (C). With respect to such adjustment—
(i) this adjustment shall be determined by the Secretary based on a weighted average of the change in the total number of abbreviated applications for generic new animal drugs, manufacturing supplemental abbreviated applications for generic new animal drugs, investigational generic new animal drug study submissions, and investigational generic new animal drug protocol submissions submitted to the Secretary; and
(ii) the Secretary shall publish in the Federal Register the fees resulting from this adjustment and the supporting methodologies.
(B) Reduction of workload-based increase by amount of certain excess collections
For each of fiscal years 2021 through 2023, if application of the workload adjustment under subparagraph (A) increases the fee revenue amounts otherwise established for the fiscal year under subsection (b), as adjusted for inflation under paragraph (2), such fee revenue increase shall be reduced by the amount of any excess collections, as described in subsection (g)(4), for the second preceding fiscal year, up to the amount of such fee revenue increase.
(C) Rule of application
Under no circumstances shall workload adjustments under this paragraph result in fee revenues for a fiscal year that are less than the fee revenues for that fiscal year established under subsection (b), as adjusted for inflation under paragraph (2).
(4) Final year adjustment
For fiscal year 2023, the Secretary may, in addition to other adjustments under this subsection, further increase the fees under this section, if such an adjustment is necessary, to provide for up to 3 months of operating reserves of carryover user fees for the process for the review of abbreviated applications for generic new animal drugs for the first 3 months of fiscal year 2024. If the Food and Drug Administration has carryover balances for the process for the review of abbreviated applications for generic new animal drugs in excess of 3 months of such operating reserves, then this adjustment shall not be made. If this adjustment is necessary, then the rationale for the amount of the increase shall be contained in the annual notice setting fees for fiscal year 2023.
(5) Limit
The total amount of fees charged, as adjusted under this subsection, for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of abbreviated applications for generic new animal drugs.
(d) Fee waiver or reduction; exemption from fees
(1) Fee waiver or reduction
The Secretary shall grant a waiver from or a reduction of one or more fees assessed under subsection (a) where the Secretary finds that the generic new animal drug is intended solely to provide for a minor use or minor species indication.
(2) Exemption from fees
Fees under this section shall not apply with respect to any person who—
(A) not later than September 30, 2023, submits a supplemental abbreviated application for a generic new animal drug approved under
(B) otherwise would be subject to fees under this section solely on the basis of such supplemental abbreviated application.
(e) Effect of failure to pay fees
An abbreviated application for a generic new animal drug 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. An investigational submission for a generic new animal drug that is submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for review by the Secretary until all fees owed by such person have been paid. The Secretary may discontinue review of any abbreviated application for a generic new animal drug, supplemental abbreviated application for a generic new animal drug, or investigational submission for a generic new animal drug from a person if such person has not submitted for payment all fees owed under this section by 30 days after the date upon which they are due.
(f) Assessment of fees
(1) Limitation
Fees may not be assessed under subsection (a) for a fiscal year beginning after fiscal year 2008 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 2003 (excluding the amount of fees appropriated for such fiscal year) multiplied by the adjustment factor applicable to the fiscal year involved.
(2) Authority
If the Secretary does not assess fees under subsection (a) 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 abbreviated applications, generic new animal drug sponsors, and generic new animal 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
Subject to paragraph (2)(C), fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to be appropriated to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salary and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the review of abbreviated applications for generic new animal drugs.
(2) Collections and appropriation Acts
(A) In general
The 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 to defray increases in the costs of the resources allocated for the process for the review of abbreviated applications for generic new animal drugs (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 2008 multiplied by the adjustment factor.
(B) Compliance
The Secretary shall be considered to have met the requirements of subparagraph (A)(ii) in any fiscal year if the costs funded by appropriations and allocated for the process for the review of abbreviated applications for generic new animal drugs—
(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 subparagraph (A)(ii); and
(II) such costs are not more than 5 percent below the level specified in subparagraph (A)(ii).
(C) Provision for early payments
Payment of fees authorized under this section for a fiscal year, prior to the due date for such fees, may be accepted by the Secretary in accordance with authority provided in advance in a prior year appropriations Act.
(3) Authorization of appropriations
For each of the fiscal years 2019 through 2023, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount established under subsection (b) for the fiscal year, as adjusted or otherwise affected under subsection (c).
(4) 1 Excess collections
If the sum total of fees collected under this section for a fiscal year exceeds the amount of fees authorized to be appropriated for such year under paragraph (3), the excess collections shall be credited to the appropriations account of the Food and Drug Administration as provided in paragraph (1).
(4) 1 Offset
If the sum of the cumulative amount of fees collected under this section for the fiscal years 2014 through 2016 and the amount of fees estimated to be collected under this section for fiscal year 2017 exceeds the cumulative amount appropriated under paragraph (3) for the fiscal years 2014 through 2017, the excess amount shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation Acts for fiscal year 2018.
(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
(i) Written requests for waivers, reductions, and refunds
To qualify for consideration for a waiver or reduction under subsection (d), or for a refund of any fee collected in accordance with subsection (a), a person shall submit to the Secretary a written request for such waiver, reduction, or refund not later than 180 days after such fee is due.
(j) Construction
This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employees, and advisory committees not engaged in the process of the review of abbreviated applications for generic new animal drugs, be reduced to offset the number of officers, employees, and advisory committees so engaged.
(k) Definitions
In this section and
(1) Abbreviated application for a generic new animal drug
The terms "abbreviated application for a generic new animal drug" and "abbreviated application" mean an abbreviated application for the approval of any generic new animal drug submitted under
(2) Adjustment factor
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—
(A) for purposes of subsection (f)(1), such Index for October 2002; and
(B) for purposes of subsection (g)(2)(A)(ii), such Index for October 2007.
(3) Costs of resources allocated for the process for the review of abbreviated applications for generic new animal drugs
The term "costs of resources allocated for the process for the review of abbreviated applications for generic new animal drugs" means the expenses in connection with the process for the review of abbreviated applications for generic new animal drugs for—
(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees consulted with respect to the review of specific abbreviated applications, supplemental abbreviated applications, or investigational submissions, and costs related to such officers, employees, committees, and contractors, including costs for travel, education, and recruitment and other personnel activities;
(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 this section and accounting for resources allocated for the review of abbreviated applications, supplemental abbreviated applications, and investigational submissions.
(4) Final dosage form
The term "final dosage form" means, with respect to a generic new animal drug product, a finished dosage form which is approved for administration to an animal without substantial further manufacturing. Such term includes generic new animal drug products intended for mixing in animal feeds.
(5) Generic new animal drug
The term "generic new animal drug" means a new animal drug that is the subject of an abbreviated application.
(6) Generic new animal drug product
The term "generic new animal drug product" means each specific strength or potency of a particular active ingredient or ingredients in final dosage form marketed by a particular manufacturer or distributor, which is uniquely identified by the labeler code and product code portions of the national drug code, and for which an abbreviated application for a generic new animal drug or a supplemental abbreviated application has been approved.
(7) Generic new animal drug sponsor
The term "generic new animal drug sponsor" means either an applicant named in an abbreviated application for a generic new animal drug that has not been withdrawn by the applicant and for which approval has not been withdrawn by the Secretary, or a person who has submitted an investigational submission for a generic new animal drug that has not been terminated or otherwise rendered inactive by the Secretary.
(8) Investigational submission for a generic new animal drug
The terms "investigational submission for a generic new animal drug" and "investigational submission" mean—
(A) the filing of a claim for an investigational exemption under
(B) the submission of information for the purpose of enabling the Secretary to evaluate the safety or effectiveness of a generic new animal drug in the event of the filing of an abbreviated application or supplemental abbreviated application for such drug.
(9) Person
The term "person" includes an affiliate thereof (as such term is defined in
(10) Process for the review of abbreviated applications for generic new animal drugs
The term "process for the review of abbreviated applications for generic new animal drugs" means the following activities of the Secretary with respect to the review of abbreviated applications, supplemental abbreviated applications, and investigational submissions:
(A) The activities necessary for the review of abbreviated applications, supplemental abbreviated applications, and investigational submissions.
(B) The issuance of action letters which approve abbreviated applications or supplemental abbreviated applications or which set forth in detail the specific deficiencies in abbreviated applications, supplemental abbreviated applications, or investigational submissions and, where appropriate, the actions necessary to place such applications, supplemental applications, or submissions in condition for approval.
(C) The inspection of generic new animal drug establishments and other facilities undertaken as part of the Secretary's review of pending abbreviated applications, supplemental abbreviated applications, and investigational submissions.
(D) Monitoring of research conducted in connection with the review of abbreviated applications, supplemental abbreviated applications, and investigational submissions.
(E) The development of regulations and policy related to the review of abbreviated applications, supplemental abbreviated applications, and investigational submissions.
(F) Development of standards for products subject to review.
(G) Meetings between the agency and the generic new animal drug sponsor.
(H) Review of advertising and labeling prior to approval of an abbreviated application or supplemental abbreviated application, but not after such application has been approved.
(11) Supplemental abbreviated application for generic new animal drug
The terms "supplemental abbreviated application for a generic new animal drug" and "supplemental abbreviated application" mean a request to the Secretary to approve a change in an approved abbreviated application.
(June 25, 1938, ch. 675, §741, as added
Termination of Section
For termination of section by section 206(a) of
Prior Provisions
A prior section 741 of act June 25, 1938, was renumbered section 745 and is classified to
Amendments
2018—Subsec. (b).
Subsec. (c)(2).
Subsec. (c)(3).
"(A) This adjustment shall be determined by the Secretary based on a weighted average of the change in the total number of abbreviated applications for generic new animal drugs, manufacturing supplemental abbreviated applications for generic new animal drugs, investigational generic new animal drug study submissions, and investigational generic new animal drug protocol submissions submitted to the Secretary. The Secretary shall publish in the Federal Register the fees resulting from this adjustment and the supporting methodologies.
"(B) Under no circumstances shall this workload adjustment result in fee revenues for a fiscal year that are less than the fee revenues for that fiscal year established in subsection (b)."
Former par. (3) redesignated (4).
Subsec. (c)(4).
Subsec. (c)(5).
Subsec. (d).
Subsec. (g)(3), (4).
2013—
Effective Date of 2018 Amendment
Effective Date of 2013 Amendment
Termination Date
Savings Provisions
Findings
"(1) Prompt approval of abbreviated applications for safe and effective generic new animal drugs will reduce animal healthcare costs and promote the well-being of animal health and the public health.
"(2) Animal health and 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 abbreviated applications for the approval of generic new animal drugs.
"(3) The fees authorized by this title [see Short Title of 2008 Amendment note set out under
1 So in original. Two pars. (4) have been enacted.
§379j–22. Reauthorization; reporting requirements
(a) Performance reports
Beginning with fiscal year 2019, not later than 120 days after the end of each fiscal year during which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Energy and Commerce of the House of Representatives a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 201(b) of the Animal Generic Drug User Fee Amendments of 2018 toward expediting the generic new animal drug development process and the review of abbreviated applications for generic new animal drugs, supplemental abbreviated applications for generic new animal drugs, and investigational submissions for generic new animal drugs during such fiscal year.
(b) Fiscal report
Beginning with fiscal year 2019, not later than 120 days after the end of each fiscal year during which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Health, Education, Labor and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives 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.
(c) Public availability
The Secretary shall make the reports required under subsections (a) and (b) available to the public on the Internet Web site of the Food and Drug Administration.
(d) Reauthorization
(1) Consultation
In developing recommendations to present to Congress with respect to the goals, and plans for meeting the goals, for the process for the review of abbreviated applications for generic new animal drugs for the first 5 fiscal years after fiscal year 2023, and for the reauthorization of this subpart for such fiscal years, the Secretary shall consult with—
(A) the Committee on Energy and Commerce of the House of Representatives;
(B) the Committee on Health, Education, Labor, and Pensions of the Senate;
(C) scientific and academic experts;
(D) veterinary professionals;
(E) representatives of patient and consumer advocacy groups; and
(F) the regulated industry.
(2) Prior public input
Prior 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
Not less frequently than once every 4 months during negotiations with the regulated industry, the Secretary shall hold discussions with representatives of veterinary, patient, and consumer advocacy groups to continue discussions of their views on the reauthorization and their suggestions for changes to this subpart as expressed under paragraph (2).
(4) Public review of recommendations
After 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;
(C) provide for a period of 30 days for the public to provide written comments on such recommendations;
(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.
(5) Transmittal of recommendations
Not later than January 15, 2023, the Secretary shall transmit to Congress the revised recommendations under paragraph (4), a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments.
(6) Minutes of negotiation meetings
(A) Public availability
Before presenting the recommendations developed under paragraphs (1) through (5) to Congress, the Secretary shall make publicly available, on the Internet Web site of the Food and Drug Administration, minutes of all negotiation meetings conducted under this subsection between the Food and Drug Administration and the regulated industry.
(B) Content
The minutes described under subparagraph (A) shall summarize any substantive proposal made by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations and their resolution.
(June 25, 1938, ch. 675, §742, as added
Termination of Section
For termination of section by section 206(b) of
References in Text
Section 201(b) of the Animal Generic Drug User Fee Amendments of 2018, referred to in subsec. (a), is section 201(b) of
Prior Provisions
A prior section 742 of act June 25, 1938, was renumbered section 746 and is classified to
Amendments
2018—Subsec. (a).
Subsec. (b).
Subsec. (d)(1), (5).
2013—
Effective Date of 2018 Amendment
Amendment by
Effective Date of 2013 Amendment
Amendment by
Termination Date
subpart 6—fees related to food
§379j–31. Authority to collect and use fees
(a) In general
(1) Purpose and authority
For fiscal year 2010 and each subsequent fiscal year, the Secretary shall, in accordance with this section, assess and collect fees from—
(A) the responsible party for each domestic facility (as defined in
(B) the responsible party for a domestic facility (as defined in
(C) each importer participating in the voluntary qualified importer program under
(D) each importer subject to a reinspection in such fiscal year, to cover reinspection-related costs for such year.
(2) Definitions
For purposes of this section—
(A) the term "reinspection" means—
(i) with respect to domestic facilities (as defined in
(ii) with respect to importers, 1 or more examinations conducted under
(B) the term "reinspection-related costs" means all expenses, including administrative expenses, incurred in connection with—
(i) arranging, conducting, and evaluating the results of reinspections; and
(ii) assessing and collecting reinspection fees under this section; and
(C) the term "responsible party" has the meaning given such term in
(b) Establishment of fees
(1) In general
Subject to subsections (c) and (d), the Secretary shall establish the fees to be collected under this section for each fiscal year specified in subsection (a)(1), based on the methodology described under paragraph (2), and shall publish such fees in a Federal Register notice not later than 60 days before the start of each such year.
(2) Fee methodology
(A) Fees
Fees amounts established for collection—
(i) under subparagraph (A) of subsection (a)(1) for a fiscal year shall be based on the Secretary's estimate of 100 percent of the costs of the reinspection-related activities (including by type or level of reinspection activity, as the Secretary determines applicable) described in such subparagraph (A) for such year;
(ii) under subparagraph (B) of subsection (a)(1) for a fiscal year shall be based on the Secretary's estimate of 100 percent of the costs of the activities described in such subparagraph (B) for such year;
(iii) under subparagraph (C) of subsection (a)(1) for a fiscal year shall be based on the Secretary's estimate of 100 percent of the costs of the activities described in such subparagraph (C) for such year; and
(iv) under subparagraph (D) of subsection (a)(1) for a fiscal year shall be based on the Secretary's estimate of 100 percent of the costs of the activities described in such subparagraph (D) for such year.
(B) Other considerations
(i) Voluntary qualified importer program
In establishing the fee amounts under subparagraph (A)(iii) for a fiscal year, the Secretary shall provide for the number of importers who have submitted to the Secretary a notice under
(II) 1 Recoupment
In establishing the fee amounts under subparagraph (A)(iii) for the first 5 fiscal years after January 4, 2011, the Secretary shall include in such fee a reasonable surcharge that provides a recoupment of the costs expended by the Secretary to establish and implement the first year of the program under
(ii) Crediting of fees
In establishing the fee amounts under subparagraph (A) for a fiscal year, the Secretary shall provide for the crediting of fees from the previous year to the next year if the Secretary overestimated the amount of fees needed to carry out such activities, and consider the need to account for any adjustment of fees and such other factors as the Secretary determines appropriate.
(iii) Published guidelines
Not later than 180 days after January 4, 2011, the Secretary shall publish in the Federal Register a proposed set of guidelines in consideration of the burden of fee amounts on small business. Such consideration may include reduced fee amounts for small businesses. The Secretary shall provide for a period of public comment on such guidelines. The Secretary shall adjust the fee schedule for small businesses subject to such fees only through notice and comment rulemaking.
(3) Use of fees
The Secretary shall make all of the fees collected pursuant to clause 2 (i), (ii), (iii), and (iv) of paragraph (2)(A) available solely to pay for the costs referred to in such clause (i), (ii), (iii), and (iv) of paragraph (2)(A), respectively.
(c) Limitations
(1) In general
Fees under subsection (a) shall be refunded for a fiscal year beginning after fiscal year 2010 unless the amount of the total appropriations for food safety activities at the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) is equal to or greater than the amount of appropriations for food safety activities at the Food and Drug Administration for fiscal year 2009 (excluding the amount of fees appropriated for such fiscal year), multiplied by the adjustment factor under paragraph (3).
(2) Authority
If—
(A) the Secretary does not assess fees under subsection (a) for a portion of a fiscal year because paragraph (1) applies; and
(B) at a later date in such fiscal year, such paragraph (1) ceases to apply,
the Secretary may assess and collect such fees under subsection (a), without any modification to the rate of such fees, notwithstanding the provisions of subsection (a) relating to the date fees are to be paid.
(3) Adjustment factor
(A) In general
The adjustment factor described in paragraph (1) shall be the total percentage change that occurred in the Consumer Price Index for all urban consumers (all items; United States city average) for the 12-month period ending June 30 preceding the fiscal year, but in no case shall such adjustment factor be negative.
(B) Compounded basis
The adjustment under subparagraph (A) made each fiscal year shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2009.
(4) Limitation on amount of certain fees
(A) In general
Notwithstanding any other provision of this section and subject to subparagraph (B), the Secretary may not collect fees in a fiscal year such that the amount collected—
(i) under subparagraph (B) of subsection (a)(1) exceeds $20,000,000; and
(ii) under subparagraphs (A) and (D) of subsection (a)(1) exceeds $25,000,000 combined.
(B) Exception
If a domestic facility (as defined in
(d) Crediting and availability of fees
Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the purpose of paying the operating expenses of the Food and Drug Administration employees and contractors performing activities associated with these food safety fees.
(e) Collection of fees
(1) In general
The Secretary shall specify in the Federal Register notice described in subsection (b)(1) the time and manner in which fees assessed under this section shall be collected.
(2) Collection of unpaid fees
In any case where the Secretary does not receive payment of a fee assessed under this section within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to provisions of subchapter II of
(f) Annual report to Congress
Not later than 120 days after each fiscal year for which fees are assessed under this section, the Secretary shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, to include a description of fees assessed and collected for each such year and a summary description of the entities paying such fees and the types of business in which such entities engage.
(g) Authorization of appropriations
For fiscal year 2010 and each fiscal year thereafter, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount determined under subsection (b) for the fiscal year, as adjusted or otherwise affected under the other provisions of this section.
(June 25, 1938, ch. 675, §743, as added
Construction
Nothing in this section to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see
1 So in original. No subcl. (I) has been enacted.
2 So in original. Probably should be "clauses".
subpart 7—fees relating to generic drugs
§379j–41. Definitions
For purposes of this subpart:
(1) The term "abbreviated new drug application"—
(A) means an application submitted under
(B) does not include an application—
(i) for a positron emission tomography drug; or
(ii) submitted by a State or Federal governmental entity for a drug that is not distributed commercially.
(2) The term "active pharmaceutical ingredient" means—
(A) a substance, or a mixture when the substance is unstable or cannot be transported on its own, intended—
(i) to be used as a component of a drug; and
(ii) to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the human body; or
(B) a substance intended for final crystallization, purification, or salt formation, or any combination of those activities, to become a substance or mixture described in subparagraph (A).
(3) The term "adjustment factor" means a factor applicable to a fiscal year that 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 2011.
(4) 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.
(5) The term "contract manufacturing organization facility" means a manufacturing facility of a finished dosage form of a drug approved pursuant to an abbreviated new drug application, where such manufacturing facility is not identified in an approved abbreviated new drug application held by the owner of such facility or an affiliate of such owner or facility.
(6)(A) The term "facility"—
(i) means a business or other entity—
(I) under one management, either direct or indirect; and
(II) at one geographic location or address engaged in manufacturing or processing an active pharmaceutical ingredient or a finished dosage form; and
(ii) does not include a business or other entity whose only manufacturing or processing activities are one or more of the following: repackaging, relabeling, or testing.
(B) For purposes of subparagraph (A), separate buildings within close proximity are considered to be at one geographic location or address if the activities in them are—
(i) closely related to the same business enterprise;
(ii) under the supervision of the same local management; and
(iii) capable of being inspected by the Food and Drug Administration during a single inspection.
(C) If a business or other entity would meet the definition of a facility under this paragraph but for being under multiple management, the business or other entity is deemed to constitute multiple facilities, one per management entity, for purposes of this paragraph.
(7) The term "finished dosage form" means—
(A) a drug product in the form in which it will be administered to a patient, such as a tablet, capsule, solution, or topical application;
(B) a drug product in a form in which reconstitution is necessary prior to administration to a patient, such as oral suspensions or lyophilized powders; or
(C) any combination of an active pharmaceutical ingredient with another component of a drug product for purposes of production of a drug product described in subparagraph (A) or (B).
(8) The term "generic drug submission" means an abbreviated new drug application, an amendment to an abbreviated new drug application, or a prior approval supplement to an abbreviated new drug application.
(9) The term "human generic drug activities" means the following activities of the Secretary associated with generic drugs and inspection of facilities associated with generic drugs:
(A) The activities necessary for the review of generic drug submissions, including review of drug master files referenced in such submissions.
(B) The issuance of—
(i) approval letters which approve abbreviated new drug applications or supplements to such applications; or
(ii) complete response letters 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 issuance of letters related to Type II active pharmaceutical drug master files which—
(i) set forth in detail the specific deficiencies in such submissions, and where appropriate, the actions necessary to resolve those deficiencies; or
(ii) document that no deficiencies need to be addressed.
(D) Inspections related to generic drugs.
(E) Monitoring of research conducted in connection with the review of generic drug submissions and drug master files.
(F) Postmarket safety activities with respect to drugs approved under abbreviated new 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
(v) Carrying out
(G) Regulatory science activities related to generic drugs.
(10) The term "positron emission tomography drug" has the meaning given to the term "compounded positron emission tomography drug" in
(11) The term "prior approval supplement" means a request to the Secretary to approve a change in the drug substance, drug product, production process, quality controls, equipment, or facilities covered by an approved abbreviated new drug application when that change has a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of the drug product as these factors may relate to the safety or effectiveness of the drug product.
(12) The term "resources allocated for human generic drug activities" means the expenses 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 and employees 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 subsection (a) and accounting for resources allocated for the review of abbreviated new drug applications and supplements and inspection related to generic drugs.
(13) The term "Type II active pharmaceutical ingredient drug master file" means a submission of information to the Secretary by a person that intends to authorize the Food and Drug Administration to reference the information to support approval of a generic drug submission without the submitter having to disclose the information to the generic drug submission applicant.
(June 25, 1938, ch. 675, §744A, as added
Termination of Section
For termination of section by section 305(a) of
References in Text
The Drug Price Competition and Patent Term Restoration Act of 1984, referred to in par. (1)(A), is
Amendments
2017—Par. (1)(B).
Pars. (5) to (13).
Effective Date of 2017 Amendment
Effective and Termination Dates
[
Savings Clause
Finding of 2017 Amendment
Finding of 2012 Amendment
§379j–42. Authority to assess and use human generic drug fees
(a) Types of fees
Beginning in fiscal year 2018, the Secretary shall assess and collect fees in accordance with this section as follows:
(1) One-time backlog fee for abbreviated new drug applications pending on October 1, 2012
(A) In general
Each person that owns an abbreviated new drug application that is pending on October 1, 2012, and that has not received a tentative approval prior to that date, shall be subject to a fee for each such application, as calculated under subparagraph (B).
(B) Method of fee amount calculation
The amount of each one-time backlog fee shall be calculated by dividing $50,000,000 by the total number of abbreviated new drug applications pending on October 1, 2012, that have not received a tentative approval as of that date.
(C) Notice
Not later than October 31, 2012, the Secretary shall publish in the Federal Register a notice announcing the amount of the fee required by subparagraph (A).
(D) Fee due date
The fee required by subparagraph (A) shall be due no later than 30 calendar days after the date of the publication of the notice specified in subparagraph (C).
(E) Sunset
This paragraph shall cease to be effective October 1, 2022.
(2) Drug master file fee
(A) In general
Each person that owns a Type II active pharmaceutical ingredient drug master file that is referenced on or after October 1, 2012, in a generic drug submission by any initial letter of authorization shall be subject to a drug master file fee.
(B) One-time payment
If a person has paid a drug master file fee for a Type II active pharmaceutical ingredient drug master file, the person shall not be required to pay a subsequent drug master file fee when that Type II active pharmaceutical ingredient drug master file is subsequently referenced in generic drug submissions.
(C) Notice
Not later than 60 days before the start of each of fiscal years 2018 through 2022, the Secretary shall publish in the Federal Register the amount of the drug master file fee established by this paragraph for such fiscal year.
(D) Availability for reference
(i) In general
Subject to subsection (g)(2)(C), for a generic drug submission to reference a Type II active pharmaceutical ingredient drug master file, the drug master file must be deemed available for reference by the Secretary.
(ii) Conditions
A drug master file shall be deemed available for reference by the Secretary if—
(I) the person that owns a Type II active pharmaceutical ingredient drug master file has paid the fee required under subparagraph (A) within 20 calendar days after the applicable due date under subparagraph (E); and
(II) the drug master file has not failed an initial completeness assessment by the Secretary, in accordance with criteria to be published by the Secretary.
(iii) List
The Secretary shall make publicly available on the Internet Web site of the Food and Drug Administration a list of the drug master file numbers that correspond to drug master files that have successfully undergone an initial completeness assessment, in accordance with criteria to be published by the Secretary, and are available for reference.
(E) Fee due date
(i) In general
Subject to clause (ii), a drug master file fee shall be due on the earlier of—
(I) the date on which the first generic drug submission is submitted that references the associated Type II active pharmaceutical ingredient drug master file; or
(II) the date on which the drug master file holder requests the initial completeness assessment.
(ii) Limitation
No fee shall be due under subparagraph (A) for a fiscal year until the later of—
(I) 30 calendar days after publication of the notice provided for in subparagraph (C); or
(II) 30 calendar days after the date of enactment of an appropriations Act providing for the collection and obligation of fees for such year under this section.
(3) Abbreviated new drug application filing fee
(A) In general
Each applicant that submits, on or after October 1, 2012, an abbreviated new drug application shall be subject to a fee for each such submission in the amount established under subsection (d).
(B) Notice
Not later than 60 days before the start of each of fiscal years 2018 through 2022, the Secretary shall publish in the Federal Register the amount of the fees under subparagraph (A) for such fiscal year.
(C) Fee due date
The fees required by subparagraphs (A) and (F) shall be due no later than the date of submission of the abbreviated new drug application or prior approval supplement for which such fee applies.
(D) Refund of fee if abbreviated new drug application is not considered to have been received, is withdrawn prior to being received, or is no longer received
(i) Applications not considered to have been received and applications withdrawn prior to being received
The Secretary shall refund 75 percent of the fee paid under subparagraph (A) for any abbreviated new drug application that the Secretary considers not to have been received within the meaning of
(ii) Applications no longer received
The Secretary shall refund 100 percent of the fee paid under subparagraph (A) for any abbreviated new drug application if the Secretary initially receives the application under
(E) Fee for an application the Secretary considers not to have been received, or that has been withdrawn
An abbreviated new drug application that was submitted on or after October 1, 2012, and that the Secretary considers not to have been received, or that has been withdrawn, shall, upon resubmission of the application or a subsequent new submission following the applicant's withdrawal of the application, be subject to a full fee under subparagraph (A).
(F) Additional fee for active pharmaceutical ingredient information not included by reference to Type II active pharmaceutical ingredient drug master file
An applicant that submits a generic drug submission on or after October 1, 2017, shall pay a fee, in the amount determined under subsection (d)(2), in addition to the fee required under subparagraph (A), if—
(i) such submission contains information concerning the manufacture of an active pharmaceutical ingredient at a facility by means other than reference by a letter of authorization to a Type II active pharmaceutical drug master file; and
(ii) a fee in the amount equal to the drug master file fee established in paragraph (2) has not been previously paid with respect to such information.
(4) Generic drug facility fee and active pharmaceutical ingredient facility fee
(A) In general
Facilities identified in at least one generic drug submission that is approved to produce a finished dosage form of a human generic drug or an active pharmaceutical ingredient contained in a human generic drug shall be subject to fees as follows:
(i) Generic drug facility
Each person that owns a facility which is identified in at least one generic drug submission that is approved to produce one or more finished dosage forms of a human generic drug shall be assessed an annual fee for each such facility.
(ii) Active pharmaceutical ingredient facility
Each person that owns a facility which is identified in at least one generic drug submission in which the facility is approved to produce one or more active pharmaceutical ingredients or in a Type II active pharmaceutical ingredient drug master file referenced in at least one such generic drug submission, shall be assessed an annual fee for each such facility.
(iii) Facilities producing both active pharmaceutical ingredients and finished dosage forms
Each person that owns a facility identified in at least one generic drug submission that is approved to produce both one or more finished dosage forms subject to clause (i) and one or more active pharmaceutical ingredients subject to clause (ii) shall be subject only to the fee attributable to the manufacture of the finished dosage forms for that facility.
(B) Amount
The amount of fees established under subparagraph (A) shall be established under subsection (d).
(C) Notice
Within the timeframe specified in subsection (d)(1), the Secretary shall publish in the Federal Register the amount of the fees under subparagraph (A) for such fiscal year.
(D) Fee due date
For each of fiscal years 2018 through 2022, the fees under subparagraph (A) for such fiscal year shall be due on the later of—
(i) the first business day on or after October 1 of each such year; or
(ii) the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such year under this section for such year.
(5) Generic drug applicant program fee
(A) In general
A generic drug applicant program fee shall be assessed annually as described in subsection (b)(2)(E).
(B) Amount
The amount of fees established under subparagraph (A) shall be established under subsection (d).
(C) Notice
Within the timeframe specified in subsection (d)(1), the Secretary shall publish in the Federal Register the amount of the fees under subparagraph (A) for such fiscal year.
(D) Fee due date
For each of fiscal years 2018 through 2022, the fees under subparagraph (A) for such fiscal year shall be due on the later of—
(i) the first business day on or after October 1 of each such fiscal year; or
(ii) the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section for such fiscal year.
(6) Date of submission
For purposes of this chapter, a generic drug submission or Type II pharmaceutical master file is deemed to be "submitted" to the Food and Drug Administration—
(A) if it is submitted via a Food and Drug Administration electronic gateway, on the day when transmission to that electronic gateway is completed, except that a submission or master file that arrives on a weekend, Federal holiday, or day when the Food and Drug Administration office that will review that submission is not otherwise open for business shall be deemed to be submitted on the next day when that office is open for business; or
(B) if it is submitted in physical media form, on the day it arrives at the appropriate designated document room of the Food and Drug Administration.
(b) Fee revenue amounts
(1) In general
(A) Fiscal year 2018
For fiscal year 2018, fees under subsection (a) shall be established to generate a total estimated revenue amount under such subsection of $493,600,000.
(B) Fiscal years 2019 through 2022
For each of the fiscal years 2019 through 2022, fees under paragraphs (2) through (5) of subsection (a) shall be established to generate a total estimated revenue amount under such subsection that is equal to $493,600,000, as adjusted pursuant to subsection (c).
(2) Types of fees
In establishing fees under paragraph (1) to generate the revenue amounts specified in such paragraph for a fiscal year, such fees shall be derived from the fees under paragraphs (2) through (5) of subsection (a) as follows:
(A) Five percent shall be derived from fees under subsection (a)(2) (relating to drug master files).
(B) Thirty-three percent shall be derived from fees under subsection (a)(3) (relating to abbreviated new drug applications).
(C) Twenty percent shall be derived from fees under subsection (a)(4)(A)(i) (relating to generic drug facilities). The amount of the fee for a contract manufacturing organization facility shall be equal to one-third the amount of the fee for a facility that is not a contract manufacturing organization facility. The amount of the fee for a facility located outside the United States and its territories and possessions shall be $15,000 higher than the amount of the fee for a facility located in the United States and its territories and possessions.
(D) Seven percent shall be derived from fees under subsection (a)(4)(A)(ii) (relating to active pharmaceutical ingredient facilities). The amount of the fee for a facility located outside the United States and its territories and possessions shall be $15,000 higher than the amount of the fee for a facility located in the United States, including its territories and possessions.
(E)(i) Thirty-five percent shall be derived from fees under subsection (a)(5) (relating to generic drug applicant program fees). For purposes of this subparagraph, if a person has affiliates, a single program fee shall be assessed with respect to that person, including its affiliates, and may be paid by that person or any one of its affiliates. The Secretary shall determine the fees as follows:
(I) If a person (including its affiliates) owns at least one but not more than 5 approved abbreviated new drug applications on the due date for the fee under this subsection, the person (including its affiliates) shall be assessed a small business generic drug applicant program fee equal to one-tenth of the large size operation generic drug applicant program fee.
(II) If a person (including its affiliates) owns at least 6 but not more than 19 approved abbreviated new drug applications on the due date for the fee under this subsection, the person (including its affiliates) shall be assessed a medium size operation generic drug applicant program fee equal to two-fifths of the large size operation generic drug applicant program fee.
(III) If a person (including its affiliates) owns 20 or more approved abbreviated new drug applications on the due date for the fee under this subsection, the person (including its affiliates) shall be assessed a large size operation generic drug applicant program fee.
(ii) For purposes of this subparagraph, an abbreviated new drug application shall be deemed not to be approved if the applicant has submitted a written request for withdrawal of approval of such abbreviated new drug application by April 1 of the previous fiscal year.
(c) Adjustments
(1) Inflation adjustment
For fiscal year 2019 and subsequent fiscal years, the revenues established in subsection (b) shall be adjusted by the Secretary by notice, published in the Federal Register, for a fiscal year, to equal the product of the total revenues established in such notice for the prior fiscal year multiplied by an amount equal to the sum of—
(A) one;
(B) the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 years of the preceding 4 fiscal years multiplied by the proportion of personnel compensation and benefits costs to total costs of human generic drug activities for the first 3 years of the preceding 4 fiscal years; and
(C) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of human generic drug activities for the first 3 years of the preceding 4 fiscal years.
(2) Final year adjustment
For fiscal year 2022, the Secretary may, in addition to adjustments under paragraph (1), further increase the fee revenues and fees established in subsection (b) if such an adjustment is necessary to provide for not more than 3 months of operating reserves of carryover user fees for human generic drug activities for the first 3 months of fiscal year 2023. If such an adjustment is necessary, the rationale for the amount of the increase shall be contained in the annual notice establishing fee revenues and fees for fiscal year 2022. If the Secretary has carryover balances for such activities in excess of 3 months of such operating reserves, the adjustment under this subparagraph shall not be made.
(d) Annual fee setting
(1) Fiscal years 2018 through 2022
Not more than 60 days before the first day of each of fiscal years 2018 through 2022, the Secretary shall establish the fees described in paragraphs (2) through (5) of subsection (a), based on the revenue amounts established under subsection (b) and the adjustments provided under subsection (c).
(2) Fee for active pharmaceutical ingredient information not included by reference to Type II active pharmaceutical ingredient drug master file
In establishing the fee under paragraph (1), the amount of the fee under subsection (a)(3)(F) shall be determined by multiplying—
(A) the sum of—
(i) the total number of such active pharmaceutical ingredients in such submission; and
(ii) for each such ingredient that is manufactured at more than one such facility, the total number of such additional facilities; and
(B) the amount equal to the drug master file fee established in subsection (a)(2) for such submission.
(e) Limitations
(1) In general
The total amount of fees charged, as adjusted under subsection (c), for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for human generic drug activities.
(2) Leasing and necessary equipment
Beginning on October 1, 2023, the authorities under section 379j–41(11)(C) 1 of this title shall include only leasing and necessary scientific equipment.
(f) Identification of facilities
(1) Required submission of facility identification
Each person that owns a facility described in subsection (a)(4)(A) or a site or organization required to be identified by paragraph (3) shall submit to the Secretary the information required under this subsection each year. Such information shall, for each fiscal year, be submitted, updated, or reconfirmed on or before June 1 of the previous fiscal year.
(2) Information required to be submitted
At a minimum, the submission required by paragraph (1) shall include for each such facility—
(A) identification of a facility identified in an approved or pending generic drug submission;
(B) whether the facility manufactures active pharmaceutical ingredients or finished dosage forms, or both;
(C) whether or not the facility is located within the United States and its territories and possessions;
(D) whether the facility manufactures positron emission tomography drugs solely, or in addition to other drugs;
(E) whether the facility manufactures drugs that are not generic drugs; and
(F) whether the facility is a contract manufacturing organization facility.
(3) Certain sites and organizations
(A) In general
Any person that owns or operates a site or organization described in subparagraph (B) shall submit to the Secretary information concerning the ownership, name, and address of the site or organization.
(B) Sites and organizations
A site or organization is described in this subparagraph if it is identified in a generic drug submission and is—
(i) a site in which a bioanalytical study is conducted;
(ii) a clinical research organization;
(iii) a contract analytical testing site; or
(iv) a contract repackager site.
(C) Notice
The Secretary may, by notice published in the Federal Register, specify the means and format for submission of the information under subparagraph (A) and may specify, as necessary for purposes of this section, any additional information to be submitted.
(D) Inspection authority
The Secretary's inspection authority under
(g) Effect of failure to pay fees
(1) Generic drug backlog fee
Failure to pay the fee under subsection (a)(1) shall result in the Secretary placing the person that owns the abbreviated new drug application subject to that fee on a publicly available arrears list, such that no new abbreviated new drug applications or supplement submitted on or after October 1, 2012, from that person, or any affiliate of that person, will be received within the meaning of
(2) Drug master file fee
(A) Failure to pay the fee under subsection (a)(2) within 20 calendar days after the applicable due date under subparagraph (E) of such subsection (as described in subsection (a)(2)(D)(ii)(I)) shall result in the Type II active pharmaceutical ingredient drug master file not being deemed available for reference.
(B)(i) Any generic drug submission submitted on or after October 1, 2012, that references, by a letter of authorization, a Type II active pharmaceutical ingredient drug master file that has not been deemed available for reference shall not be received within the meaning of
(ii) The condition specified in this clause is that the fee established under subsection (a)(2) has been paid within 20 calendar days of the Secretary providing the notification to the sponsor of the abbreviated new drug application or supplement of the failure of the owner of the Type II active pharmaceutical ingredient drug master file to pay the drug master file fee as specified in subparagraph (C).
(C)(i) If an abbreviated new drug application or supplement to an abbreviated new drug application references a Type II active pharmaceutical ingredient drug master file for which a fee under subsection (a)(2)(A) has not been paid by the applicable date under subsection (a)(2)(E), the Secretary shall notify the sponsor of the abbreviated new drug application or supplement of the failure of the owner of the Type II active pharmaceutical ingredient drug master file to pay the applicable fee.
(ii) If such fee is not paid within 20 calendar days of the Secretary providing the notification, the abbreviated new drug application or supplement to an abbreviated new drug application shall not be received within the meaning of
(3) Abbreviated new drug application fee and prior approval supplement fee
Failure to pay a fee under subparagraph (A) or (F) of subsection (a)(3) within 20 calendar days of the applicable due date under subparagraph (C) of such subsection shall result in the abbreviated new drug application or the prior approval supplement to an abbreviated new drug application not being received within the meaning of
(4) Generic drug facility fee and active pharmaceutical ingredient facility fee
(A) In general
Failure to pay the fee under subsection (a)(4) within 20 calendar days of the due date as specified in subparagraph (D) of such subsection shall result in the following:
(i) The Secretary shall place the facility on a publicly available arrears list, such that no new abbreviated new drug application or supplement submitted on or after October 1, 2012, from the person that is responsible for paying such fee, or any affiliate of that person, will be received within the meaning of
(ii) Any new generic drug submission submitted on or after October 1, 2012, that references such a facility shall not be received, within the meaning of
(iii) All drugs or active pharmaceutical ingredients manufactured in such a facility or containing an ingredient manufactured in such a facility shall be deemed misbranded under
(B) Application of penalties
The penalties under this paragraph shall apply until the fee established by subsection (a)(4) is paid or the facility is removed from all generic drug submissions that refer to the facility.
(C) Nonreceival for nonpayment
(i) Notice
If an abbreviated new drug application or supplement to an abbreviated new drug application submitted on or after October 1, 2012, references a facility for which a facility fee has not been paid by the applicable date under subsection (a)(4)(C), the Secretary shall notify the sponsor of the generic drug submission of the failure of the owner of the facility to pay the facility fee.
(ii) Nonreceival
If the facility fee is not paid within 20 calendar days of the Secretary providing the notification under clause (i), the abbreviated new drug application or supplement to an abbreviated new drug application shall not be received within the meaning of
(5) Generic drug applicant program fee
(A) In general
A person who fails to pay a fee as required under subsection (a)(5) by the date that is 20 calendar days after the due date, as specified in subparagraph (D) of such subsection, shall be subject to the following:
(i) The Secretary shall place the person on a publicly available arrears list.
(ii) Any abbreviated new drug application submitted by the generic drug applicant or an affiliate of such applicant shall not be received, within the meaning of
(iii) All drugs marketed pursuant to any abbreviated new drug application held by such applicant or an affiliate of such applicant shall be deemed misbranded under
(B) Application of penalties
The penalties under subparagraph (A) shall apply until the fee required under subsection (a)(5) is paid.
(h) Limitations
(1) In general
Fees under subsection (a) shall be refunded for a fiscal year beginning after fiscal year 2012, 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 fiscal year 2009 (excluding the amount of fees appropriated for such fiscal year) multiplied by the adjustment factor (as defined in
(2) Authority
If the Secretary does not assess fees under subsection (a) during any portion of a fiscal year 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, at any time in such fiscal year notwithstanding the provisions of subsection (a) relating to the date fees are to be paid.
(i) Crediting and availability of fees
(1) In general
Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts, subject to paragraph (2). Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for human generic drug activities.
(2) Collections and appropriation Acts
(A) In general
The 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 for a fiscal year beginning after fiscal year 2012 to defray the costs of human generic drug activities (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 activities), only if the Secretary allocates for such purpose an amount for such fiscal year (excluding amounts from fees collected under this section) no less than $97,000,000 multiplied by the adjustment factor defined in
(B) Compliance
The Secretary shall be considered to have met the requirements of subparagraph (A)(ii) in any fiscal year if the costs funded by appropriations and allocated for human generic activities are not more than 10 percent below the level specified in such subparagraph.
(C) Provision for early payments
Payment of fees authorized under this section for a fiscal year, prior to the due date for such fees, may be accepted by the Secretary in accordance with authority provided in advance in a prior year appropriations Act.
(3) Authorization of appropriations
For each of the fiscal years 2018 through 2022, there is authorized to be appropriated for fees under this section an amount equivalent to the total revenue amount determined under subsection (b) for the fiscal year, as adjusted under subsection (c), if applicable, or as otherwise affected under paragraph (2) of this subsection.
(j) Collection of unpaid fees
In any case where the Secretary does not receive payment of a fee assessed under subsection (a) within 30 calendar days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of
(k) 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, employees, and advisory committees not engaged in human generic drug activities, be reduced to offset the number of officers, employees, and advisory committees so engaged.
(l) Positron emission tomography drugs
(1) Exemption from fees
Submission of an application for a positron emission tomography drug or active pharmaceutical ingredient for a positron emission tomography drug shall not require the payment of any fee under this section. Facilities that solely produce positron emission tomography drugs shall not be required to pay a facility fee as established in subsection (a)(4).
(2) Identification requirement
Facilities that produce positron emission tomography drugs or active pharmaceutical ingredients of such drugs are required to be identified pursuant to subsection (f).
(m) Disputes concerning fees
To qualify for the return of a fee claimed to have been paid in error under this section, a person shall submit to the Secretary a written request justifying such return within 180 calendar days after such fee was paid.
(n) Substantially complete applications
An abbreviated new drug application that is not considered to be received within the meaning of
(o) Information on abbreviated new drug applications owned by applicants and their affiliates
(1) In general
By April 1 of each year, each person that owns an abbreviated new drug application, or a designated affiliate of such person, shall submit, on behalf of the person and the affiliates of such person, to the Secretary a list of—
(A) all approved abbreviated new drug applications owned by such person; and
(B) if any affiliate of such person also owns an abbreviated new drug application, all affiliates that own any such abbreviated new drug application and all approved abbreviated new drug applications owned by any such affiliate.
(2) Format and method
The Secretary shall specify in guidance the format and method for submission of lists under this subsection.
(June 25, 1938, ch. 675, §744B, as added
Termination of Section
For termination of section by section 305(a) of
References in Text
Section 379j–41(11)(C), referred to in subsec. (e)(2), was redesignated section 379j–41(12)(C) by
Amendments
2017—Subsec. (a).
Subsec. (a)(1)(E).
Subsec. (a)(2)(C).
Subsec. (a)(2)(E)(i).
Subsec. (a)(2)(E)(ii)(I).
Subsec. (a)(3).
Subsec. (a)(3)(A).
Subsec. (a)(3)(B), (C).
Subsec. (a)(3)(D).
Subsec. (a)(3)(E).
Subsec. (a)(3)(F).
Subsec. (a)(4)(A).
Subsec. (a)(4)(A)(i).
Subsec. (a)(4)(A)(ii).
Subsec. (a)(4)(A)(iii).
Subsec. (a)(4)(C), (D).
Subsec. (a)(5), (6).
Subsec. (b)(1)(A).
"(i) $50,000,000 shall be generated by the one-time backlog fee for generic drug applications pending on October 1, 2012, established in subsection (a)(1); and
"(ii) $249,000,000 shall be generated by the fees under paragraphs (2) through (4) of subsection (a)."
Subsec. (b)(1)(B).
Subsec. (b)(2).
Subsec. (b)(2)(A).
Subsec. (b)(2)(B), (C).
"(B) Twenty-four percent shall be derived from fees under subsection (a)(3) (relating to abbreviated new drug applications and supplements). The amount of a fee for a prior approval supplement shall be half the amount of the fee for an abbreviated new drug application.
"(C) Fifty-six percent shall be derived from fees under subsection (a)(4)(A)(i) (relating to generic drug facilities). The amount of the fee for a facility located outside the United States and its territories and possessions shall be not less than $15,000 and not more than $30,000 higher than the amount of the fee for a facility located in the United States and its territories and possessions, as determined by the Secretary on the basis of data concerning the difference in cost between inspections of facilities located in the United States, including its territories and possessions, and those located outside of the United States and its territories and possessions."
Subsec. (b)(2)(D).
Subsec. (b)(2)(E).
Subsec. (c)(1).
Subsec. (c)(2).
Subsec. (d)(1).
Subsec. (d)(2), (3).
Subsec. (e).
Subsec. (f)(1).
"(A) for fiscal year 2013, be submitted not later than 60 days after the publication of the notice under paragraph (1); and
"(B) for each subsequent fiscal year, be submitted, updated, or reconfirmed on or before June 1 of the previous year."
Subsec. (f)(2).
Subsec. (f)(2)(A).
Subsec. (f)(2)(F).
Subsec. (f)(3), (4).
Subsec. (g)(1).
Subsec. (g)(2)(C)(ii).
Subsec. (g)(5).
Subsec. (h)(2).
Subsec. (i)(2)(A)(i).
Subsec. (i)(2)(C).
Subsec (i)(2)(D).
Subsec. (i)(3).
Subsec. (o).
2012—Subsec. (a).
Subsec. (i)(2)(C).
Effective Date of 2017 Amendment
Amendment by section 303 of
Effective and Termination Dates
Section ceases to be effective Oct. 1, 2022, see section 305(a) of
Section effective Oct. 1, 2012, with fees under this section and
Fees Authorized for Fiscal Year 2013
"(1) Notwithstanding section 744B(a)(2)(E)(ii) of the Federal Food, Drug, and Cosmetic Act (
"(2) Notwithstanding section 744B(a)(3)(C)(ii) of such Act, the fee authorized under section 744B(a)(3) of such Act for fiscal year 2013 shall be due on the later of—
"(A) the date of submission of the abbreviated new drug application or prior approval supplement for which such fee applies; or
"(B) 30 calendar days after publication of the notice referred to in section 744B(a)(3)(B)(i) of such Act.
"(3) Notwithstanding section 744B(a)(4)(D)(i) of such Act, the fee authorized under section 744B(a)(4) of such Act for fiscal year 2013 shall be due not later than 45 days after the publication of the notice under section 744B(a)(4)(C)(i) of such Act."
1 See References in Text note below.
§379j–43. Reauthorization; reporting requirements
(a) Performance report
(1) General requirements
Beginning with fiscal year 2018, not 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 the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2017 during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals.
(2) Real time reporting
(A) In general
Not later than 30 calendar days after the end of the second quarter of fiscal year 2018, and not later than 30 calendar days after the end of each quarter of each fiscal year thereafter, the Secretary shall post the data described in subparagraph (B) on the internet website of the Food and Drug Administration, and may remove duplicative data from the annual report under this subsection.
(B) Data
The 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 human generic drug activities and whether such guidances were issued as required by statute or pursuant to a commitment under the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2017.
(ii) The number and titles of public meetings held on topics related to human generic drug activities and whether such meetings were required by statute or pursuant to a commitment under the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2017.
(3) Rationale for GDUFA program changes
Beginning with fiscal year 2020, the Secretary shall include in the annual report under paragraph (1)—
(A) data, analysis, and discussion of the changes in the number of full-time equivalents hired as agreed upon in the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2017 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 human generic drug activities, including identifying drivers of such changes; and
(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.
(4) Analysis
For each fiscal year, the Secretary shall include in the report an analysis of the following:
(A) The difference between the aggregate number of abbreviated new drug applications filed and the aggregate number of approvals or aggregate number of complete response letters issued by the agency, 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; and
(ii) the aggregate number of applications for each fiscal year that did not meet the goals identified by the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2017 for the applicable fiscal year.
(B) Relevant data to determine whether the Food and Drug Administration has met the performance enhancement goals identified by the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2017 for the applicable fiscal year.
(C) The most common causes and trends for external or other circumstances that affected the ability of the Secretary to meet review time and performance enhancement goals identified by the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2017.
(b) Fiscal report
Beginning with fiscal year 2018, not 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 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 for such fiscal year.
(c) Corrective action report
Beginning with fiscal year 2018, for 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
For each fiscal year, if the Secretary determines, based on the analysis under subsection (a)(4), that each of the goals identified by the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2017 for the applicable fiscal year have been met, the corrective action report shall include recommendations on ways in which the Secretary can improve and streamline the abbreviated new drug application review process.
(2) Goals missed
For each of the goals identified by the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2017 for the applicable fiscal year that the Secretary determines to not have been met, the corrective action report shall include—
(A) a detailed justification for such determination and a description, as applicable, of the types of circumstances and trends under which abbreviated new drug applications missed the review goal times but were approved during the first cycle review, or review goals were missed; and
(B) with respect to performance enhancement goals that were not achieved, a detailed 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 1 fiscal year.
(d) Enhanced communication
(1) Communications with Congress
Each fiscal year, as applicable and requested, representatives from the Centers with expertise in the review of human drugs shall meet with representatives from the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives to report on the contents described in the reports under this section.
(2) Participation in congressional hearing
Each fiscal year, as applicable and requested, representatives from the Food and Drug Administration shall participate in a public hearing before the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, to report on the contents described in the reports under this section. Such hearing shall occur not later than 120 days after the end of each fiscal year for which fees are collected under this subpart.
(e) Public availability
The Secretary shall make the reports required under subsections (a) and (b) available to the public on the Internet Web site of the Food and Drug Administration.
(f) Reauthorization
(1) Consultation
In developing recommendations to present to the Congress with respect to the goals, and plans for meeting the goals, for human generic drug activities for the first 5 fiscal years after fiscal year 2022, and for the reauthorization of this subpart for such fiscal years, the Secretary shall consult with—
(A) the Committee on Energy and Commerce of the House of Representatives;
(B) the Committee on Health, Education, Labor, and Pensions of the Senate;
(C) scientific and academic experts;
(D) health care professionals;
(E) representatives of patient and consumer advocacy groups; and
(F) the generic drug industry.
(2) Prior public input
Prior to beginning negotiations with the generic drug 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
Not less frequently than once every month during negotiations with the generic drug industry, the Secretary shall hold discussions with representatives of patient and consumer advocacy groups to continue discussions of their views on the reauthorization and their suggestions for changes to this subpart as expressed under paragraph (2).
(4) Public review of recommendations
After negotiations with the generic drug 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;
(C) provide for a period of 30 days for the public to provide written comments on such recommendations;
(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.
(5) Transmittal of recommendations
Not later than January 15, 2022, the Secretary shall transmit to the Congress the revised recommendations under paragraph (4), a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments.
(6) Minutes of negotiation meetings
(A) Public availability
Before presenting the recommendations developed under paragraphs (1) through (5) to the Congress, the Secretary shall make publicly available, on the Internet Web site of the Food and Drug Administration, minutes of all negotiation meetings conducted under this subsection between the Food and Drug Administration and the generic drug industry.
(B) Content
The minutes described under subparagraph (A) shall summarize any substantive proposal made by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations and their resolution.
(June 25, 1938, ch. 675, §744C, as added
Termination of Section
For termination of section by section 305(b) of
References in Text
Section 301(b) of the Generic Drug User Fee Amendments of 2017, referred to in subsecs. (a) and (c), is section 301(b) of
Amendments
2017—Subsec. (a).
Subsec. (a)(4).
Subsec. (b).
Subsecs. (c) to (e).
Subsec. (f).
Effective Date of 2017 Amendment
Amendment by section 304 of
Effective and Termination Dates
[
Section effective Oct. 1, 2012, see section 305 of
subpart 8—fees relating to biosimilar biological products
§379j–51. Definitions
For purposes of this subpart:
(1) The term "adjustment factor" applicable to a fiscal year is the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items) for October of the preceding fiscal year divided by such Index for October 2011.
(2) 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.
(3) The term "biosimilar biological product" means a specific strength of a biological product in final dosage form for which a biosimilar biological product application has been approved.
(4)(A) Subject to subparagraph (B), the term "biosimilar biological product application" means an application for licensure of a biological product under
(B) Such term does not include—
(i) a supplement to such an application;
(ii) an application filed under
(iii) an application filed under
(I) whole blood or a blood component for transfusion;
(II) an allergenic extract product;
(III) an in vitro diagnostic biological product; or
(IV) a biological product for further manufacturing use only; or
(iv) an application for licensure under
(5) The term "biosimilar biological product development meeting" means any meeting, other than a biosimilar initial advisory meeting, regarding the content of a development program, including a proposed design for, or data from, a study intended to support a biosimilar biological product application.
(6) The term "biosimilar biological product development program" means the program under this subpart for expediting the process for the review of submissions in connection with biosimilar biological product development.
(7)(A) The term "biosimilar biological product establishment" means a foreign or domestic place of business—
(i) that is at one general physical location consisting of one or more buildings, all of which are within 5 miles of each other; and
(ii) at which one or more biosimilar biological products are manufactured in final dosage form.
(B) For purposes of subparagraph (A)(ii), the term "manufactured" does not include packaging.
(8) The term "biosimilar initial advisory meeting"—
(A) means a meeting, if requested, that is limited to—
(i) a general discussion regarding whether licensure under
(ii) if so, general advice on the expected content of the development program; and
(B) does not include any meeting that involves substantive review of summary data or full study reports.
(9) The term "costs of resources allocated for the process for the review of biosimilar biological product applications" means the expenses in connection with the process for the review of biosimilar biological product 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
(10) The term "final dosage form" means, with respect to a biosimilar biological product, a finished dosage form which is approved for administration to a patient without substantial further manufacturing (such as lyophilized products before reconstitution).
(11) The term "financial hold"—
(A) means an order issued by the Secretary to prohibit the sponsor of a clinical investigation from continuing the investigation if the Secretary determines that the investigation is intended to support a biosimilar biological product application and the sponsor has failed to pay any fee for the product required under subparagraph (A), (B), or (D) of
(B) does not mean that any of the bases for a "clinical hold" under
(12) The term "person" includes an affiliate of such person.
(13) The term "process for the review of biosimilar biological product applications" means the following activities of the Secretary with respect to the review of submissions in connection with biosimilar biological product development, biosimilar biological product applications, and supplements:
(A) The activities necessary for the review of submissions in connection with biosimilar biological product development, biosimilar biological product applications, and supplements.
(B) Actions related to submissions in connection with biosimilar biological product development, the issuance of action letters which approve biosimilar biological product 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 biosimilar biological product establishments and other facilities undertaken as part of the Secretary's review of pending biosimilar biological product applications and supplements.
(D) Activities necessary for the release of lots of biosimilar biological products under
(E) Monitoring of research conducted in connection with the review of biosimilar biological product applications.
(F) Postmarket safety activities with respect to biologics approved under biosimilar biological product applications or supplements, including the following activities:
(i) Collecting, developing, and reviewing safety information on biosimilar biological products, 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
(v) Carrying out
(14) The term "supplement" means a request to the Secretary to approve a change in a biosimilar biological product application which has been approved, including a supplement requesting that the Secretary determine that the biosimilar biological product meets the standards for interchangeability described in
(June 25, 1938, ch. 675, §744G, as added
Termination of Section
For termination of section by section 405(a) of
Amendments
2017—Par. (1).
Par. (3).
Effective Date of 2017 Amendment
Effective and Termination Dates
[
"(a)
"(1) October 1, 2012; or
"(2) the date of the enactment of this title [July 9, 2012].
"(b)
Savings
Finding of 2017 Amendment
Finding of 2012 Amendment
§379j–52. Authority to assess and use biosimilar biological product fees
(a) Types of fees
Beginning in fiscal year 2018, the Secretary shall assess and collect fees in accordance with this section as follows:
(1) Biosimilar biological product development program fees
(A) Initial biosimilar biological product development fee
(i) In general
Each person that submits to the Secretary a meeting request described under clause (ii) or a clinical protocol for an investigational new drug protocol described under clause (iii) shall pay for the product named in the meeting request or the investigational new drug application the initial biosimilar biological product development fee established under subsection (c)(5).
(ii) Meeting request
The meeting request described in this clause is a request for a biosimilar biological product development meeting for a product.
(iii) Clinical protocol for IND
A clinical protocol for an investigational new drug protocol described in this clause is a clinical protocol consistent with the provisions of
(iv) Due date
The initial biosimilar biological product development fee shall be due by the earlier of the following:
(I) Not later than 5 days after the Secretary grants a request for a biosimilar biological product development meeting.
(II) The date of submission of an investigational new drug application describing an investigation that the Secretary determines is intended to support a biosimilar biological product application.
(v) Transition rule
Each person that has submitted an investigational new drug application prior to July 9, 2012, shall pay the initial biosimilar biological product development fee by the earlier of the following:
(I) Not later than 60 days after July 9, 2012, if the Secretary determines that the investigational new drug application describes an investigation that is intended to support a biosimilar biological product application.
(II) Not later than 5 days after the Secretary grants a request for a biosimilar biological product development meeting.
(B) Annual biosimilar biological product development fee
(i) In general
A person that pays an initial biosimilar biological product development fee for a product shall pay for such product, beginning in the fiscal year following the fiscal year in which the initial biosimilar biological product development fee was paid, an annual fee established under subsection (c)(5) for the biosimilar biological product development program (referred to in this section as "annual biosimilar biological product development fee").
(ii) Due date
The annual biosimilar biological product development fee for each fiscal year will be due on the later of—
(I) the first business day on or after October 1 of each such year; or
(II) the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such year under this section.
(iii) Exception
The annual biosimilar biological product development fee for each fiscal year will be due on the date specified in clause (ii), unless the person has—
(I) submitted a marketing application for the biological product that was accepted for filing; or
(II) discontinued participation in the biosimilar biological product development program for the product under subparagraph (C).
(iv) Refund
If a person submits a marketing application for a biosimilar biological product before October 1 of a fiscal year and such application is accepted for filing on or after October 1 of such fiscal year, the person may request a refund equal to the annual biosimilar biological product development fee paid by the person for the product for such fiscal year. To qualify for consideration for a refund under this clause, a person shall submit to the Secretary a written request for such refund not later than 180 days after the marketing application is accepted for filing.
(C) Discontinuation of fee obligation
A person may discontinue participation in the biosimilar biological product development program for a product, effective October 1 of a fiscal year, by, not later than August 1 of the preceding fiscal year—
(i) if no investigational new drug application concerning the product has been submitted, submitting to the Secretary a written declaration that the person has no present intention of further developing the product as a biosimilar biological product; or
(ii) if an investigational new drug application concerning the product has been submitted, withdrawing the investigational new drug application in accordance with part 312 of title 21, Code of Federal Regulations (or any successor regulations).
(D) Reactivation fee
(i) In general
A person that has discontinued participation in the biosimilar biological product development program for a product under subparagraph (C) shall, if the person seeks to resume participation in such program, pay a fee (referred to in this section as "reactivation fee") by the earlier of the following:
(I) Not later than 5 days after the Secretary grants a request by such person for a biosimilar biological product development meeting for the product (after the date on which such participation was discontinued).
(II) Upon the date of submission (after the date on which such participation was discontinued) by such person of an investigational new drug application describing an investigation that the Secretary determines is intended to support a biosimilar biological product application for that product.
(ii) Application of annual fee
A person that pays a reactivation fee for a product shall pay for such product, beginning in the next fiscal year, the annual biosimilar biological product development fee under subparagraph (B).
(E) Effect of failure to pay fees
(i) No biosimilar biological product development meetings
If a person has failed to pay an initial or annual biosimilar biological product development fee as required under subparagraph (A) or (B), or a reactivation fee as required under subparagraph (D), the Secretary shall not provide a biosimilar biological product development meeting relating to the product for which fees are owed.
(ii) No receipt of investigational new drug applications
Except in extraordinary circumstances, the Secretary shall not consider an investigational new drug application to have been received under
(I) the Secretary determines that the investigation is intended to support a biosimilar biological product application; and
(II) the sponsor has failed to pay an initial or annual biosimilar biological product development fee for the product as required under subparagraph (A) or (B), or a reactivation fee as required under subparagraph (D).
(iii) Financial hold
Notwithstanding
(I) the Secretary determines that the investigation is intended to support a biosimilar biological product application; and
(II) the sponsor has failed to pay an initial or annual biosimilar biological product development fee for the product as required under subparagraph (A) or (B), or a reactivation fee for the product as required under subparagraph (D).
(iv) No acceptance of biosimilar biological product applications or supplements
If a person has failed to pay an initial or annual biosimilar biological product development fee as required under subparagraph (A) or (B), or a reactivation fee as required under subparagraph (D), any biosimilar biological product application or supplement submitted by that person shall be considered incomplete and shall not be accepted for filing by the Secretary until all such fees owed by such person have been paid.
(F) Limits regarding fees
(i) Refunds
Except as provided in subparagraph (B)(iv), the Secretary shall not refund any initial or annual biosimilar biological product development fee paid under subparagraph (A) or (B), or any reactivation fee paid under subparagraph (D).
(ii) No waivers, exemptions, or reductions
The Secretary shall not grant a waiver, exemption, or reduction of any initial or annual biosimilar biological product development fee due or payable under subparagraph (A) or (B), or any reactivation fee due or payable under subparagraph (D).
(2) Biosimilar biological product application fee
(A) In general
Each person that submits, on or after October 1, 2017, a biosimilar biological product application shall be subject to the following fees:
(i) A fee established under subsection (c)(5) for a biosimilar biological product application for which clinical data (other than comparative bioavailability studies) with respect to safety or effectiveness are required for approval.
(ii) A fee established under subsection (c)(5) for a biosimilar biological product application for which clinical data (other than comparative bioavailability studies) with respect to safety or effectiveness are not required for approval. Such fee shall be equal to half of the amount of the fee described in clause (i).
(B) Rule of applicability; treatment of certain previously paid fees
Any person who pays a fee under subparagraph (A), (B), or (D) of paragraph (1) for a product before October 1, 2017, but submits a biosimilar biological product application for that product after such date, shall—
(i) be subject to any biosimilar biological product application fees that may be assessed at the time when such biosimilar biological product application is submitted; and
(ii) be entitled to no reduction of such application fees based on the amount of fees paid for that product before October 1, 2017, under such subparagraph (A), (B), or (D).
(C) Payment due date
Any fee required by subparagraph (A) shall be due upon submission of the application for which such fee applies.
(D) Exception for previously filed application
If a biosimilar biological product application was submitted by a person that paid the fee for such application, was accepted for filing, and was not approved or was withdrawn (without a waiver), the submission of a biosimilar biological product application for the same product by the same person (or the person's licensee, assignee, or successor) shall not be subject to a fee under subparagraph (A).
(E) Refund of application fee if application refused for filing or withdrawn before filing
The Secretary shall refund 75 percent of the fee paid under this paragraph for any application which is refused for filing or withdrawn without a waiver before filing.
(F) Fees for applications previously refused for filing or withdrawn before filing
A biosimilar biological product application that was submitted but was refused for filing, or was withdrawn before being accepted or refused for filing, shall be subject to the full fee under subparagraph (A) upon being resubmitted or filed over protest, unless the fee is waived under subsection (d).
(3) Biosimilar biological product program fee
(A) In general
Each person who is named as the applicant in a biosimilar biological product application shall pay the annual biosimilar biological product program fee established for a fiscal year under subsection (c)(5) for each biosimilar biological product that—
(i) is identified in such a biosimilar biological product application approved as of October 1 of such fiscal year; and
(ii) as of October 1 of such fiscal year, does not appear on a list, developed and maintained by the Secretary, of discontinued biosimilar biological products.
(B) Due date
The biosimilar biological product program fee for a fiscal year shall be due on the later of—
(i) the first business day on or after October 1 of each such year; or
(ii) the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such year under this section.
(C) One fee per product per year
The biosimilar biological product program fee shall be paid only once for each product for each fiscal year.
(D) Limitation
A person who is named as the applicant in a biosimilar biological product application shall not be assessed more than 5 biosimilar biological product program fees for a fiscal year for biosimilar biological products identified in such biosimilar biological product application.
(4) Biosimilar biological product fee
(A) In general
Each person who is named as the applicant in a biosimilar biological product application shall pay for each such biosimilar biological product the annual fee established under subsection (c)(5).
(B) Due date
The biosimilar biological product fee for a fiscal year shall be due on the later of—
(i) the first business day on or after October 1 of each such year; or
(ii) the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such year under this section.
(C) One fee per product per year
The biosimilar biological product fee shall be paid only once for each product for each fiscal year.
(b) Fee revenue amounts
(1) Fiscal year 2018
For fiscal year 2018, fees under subsection (a) shall be established to generate a total revenue amount equal to the sum of—
(A) $45,000,000; and
(B) the dollar amount equal to the fiscal year 2018 adjustment (as determined under subsection (c)(4)).
(2) Subsequent fiscal years
For each of the fiscal years 2019 through 2022, fees under subsection (a) shall, except as provided in subsection (c), be established to generate a total revenue amount equal to the sum of—
(A) the annual base revenue for the fiscal year (as determined under paragraph (4));
(B) the dollar amount equal to the inflation adjustment for the fiscal year (as determined under subsection (c)(1));
(C) the dollar amount equal to the capacity planning adjustment for the fiscal year (as determined under subsection (c)(2)); and
(D) the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(3)).
(3) Allocation of revenue amount among fees; limitations on fee amounts
(A) Allocation
The Secretary shall determine the percentage of the total revenue amount for a fiscal year to be derived from, respectively—
(i) initial and annual biosimilar biological product development fees and reactivation fees under subsection (a)(1);
(ii) biosimilar biological product application fees under subsection (a)(2); and
(iii) biosimilar biological product program fees under subsection (a)(3).
(B) Limitations on fee amounts
Until the first fiscal year for which the capacity planning adjustment under subsection (c)(2) is effective, the amount of any fee under subsection (a) for a fiscal year after fiscal year 2018 shall not exceed 125 percent of the amount of such fee for fiscal year 2018.
(C) Biosimilar biological product development fees
The initial biosimilar biological product development fee under subsection (a)(1)(A) for a fiscal year shall be equal to the annual biosimilar biological product development fee under subsection (a)(1)(B) for that fiscal year.
(D) Reactivation fee
The reactivation fee under subsection (a)(1)(D) for a fiscal year shall be equal to twice the amount of the annual biosimilar biological product development fee under subsection (a)(1)(B) for that fiscal year.
(4) Annual base revenue
For purposes of paragraph (2), the dollar amount of the annual base revenue for a fiscal year shall be the dollar amount of the total revenue amount for the previous fiscal year, excluding any adjustments to such revenue amount under subsection (c)(3).
(c) Adjustments; annual fee setting
(1) Inflation adjustment
(A) In general
For purposes of subsection (b)(2)(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); and
(ii) the inflation adjustment percentage under subparagraph (B).
(B) Inflation adjustment percentage
The inflation adjustment percentage under this subparagraph for a fiscal year is equal to the sum of—
(i) the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 years of the preceding 4 fiscal years, multiplied by the proportion of personnel compensation and benefits costs to total costs of the process for the review of biosimilar biological product applications (as defined in
(ii) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of the process for the review of biosimilar biological product applications (as defined in
(2) Capacity planning adjustment
(A) In general
Beginning with the fiscal year described in subparagraph (B)(ii)(II), the Secretary shall, in addition to the adjustment under paragraph (1), further increase the fee revenue and fees under this section for a fiscal year to reflect changes in the resource capacity needs of the Secretary for the process for the review of biosimilar biological product applications.
(B) Capacity planning methodology
(i) Development; evaluation and report
The Secretary shall obtain, through a contract with an independent accounting or consulting firm, a report evaluating options and recommendations for a new methodology to accurately assess changes in the resource and capacity needs of the process for the review of biosimilar biological product applications. The capacity planning methodological options and recommendations presented in such report shall utilize and be informed by personnel time reporting data as an input. The report shall be published for public comment not later than September 30, 2020.
(ii) Establishment and implementation
After review of the report described in clause (i) and receipt and review of public comments thereon, the Secretary shall establish a capacity planning methodology for purposes of this paragraph, which shall—
(I) incorporate such approaches and attributes as the Secretary determines appropriate; and
(II) be effective beginning with the first fiscal year for which fees are set after such capacity planning methodology is established.
(C) Limitation
Under no circumstances shall an adjustment under this paragraph result in fee revenue for a fiscal year that is less than the sum of the amounts under subsections (b)(2)(A) (the annual base revenue for the fiscal year) and (b)(2)(B) (the dollar amount of the inflation adjustment for the fiscal year).
(D) Publication in Federal Register
The Secretary shall publish in the Federal Register notice under paragraph (5) the fee revenue and fees resulting from the adjustment and the methodologies under this paragraph.
(3) Operating reserve adjustment
(A) Interim application; fee reduction
Until the first fiscal year for which the capacity planning adjustment under paragraph (2) is effective, the Secretary may, in addition to the adjustment under paragraph (1), reduce the fee revenue and fees under this section for a fiscal year as the Secretary determines appropriate for long-term financial planning purposes.
(B) General application and methodology
Beginning with the first fiscal year for which the capacity planning adjustment under paragraph (2) is effective, the Secretary may, in addition to the adjustments under paragraphs (1) and (2)—
(i) reduce the fee revenue and fees under this section as the Secretary determines appropriate for long-term financial planning purposes; or
(ii) increase the fee revenue and fees under this section if such an adjustment is necessary to provide for not more than 21 weeks of operating reserves of carryover user fees for the process for the review of biosimilar biological product applications.
(C) Federal Register notice
If an adjustment under subparagraph (A) or (B) is made, the rationale for the amount of the increase or decrease (as applicable) in fee revenue and fees shall be contained in the annual Federal Register notice under paragraph (5)(B) establishing fee revenue and fees for the fiscal year involved.
(4) Fiscal year 2018 adjustment
(A) In general
For fiscal year 2018, the Secretary shall adjust the fee revenue and fees under this section in such amount (if any) as needed to reflect an updated assessment of the workload for the process for the review of biosimilar biological product applications.
(B) Methodology
The Secretary shall publish under paragraph (5)(B) a description of the methodology used to calculate the fiscal year 2018 adjustment under this paragraph in the Federal Register notice establishing fee revenue and fees for fiscal year 2018.
(C) Limitation
No adjustment under this paragraph shall result in an increase in fee revenue and fees under this section in excess of $9,000,000.
(5) Annual fee setting
For fiscal year 2018 and each subsequent fiscal year, the Secretary shall, not later than 60 days before the start of each such fiscal year—
(A) establish, for the fiscal year, initial and annual biosimilar biological product development fees and reactivation fees under subsection (a)(1), biosimilar biological product application fees under subsection (a)(2), and biosimilar biological product program fees under subsection (a)(3), based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection; and
(B) publish such fee revenue and fees in the Federal Register.
(6) Limit
The total amount of fees assessed for a fiscal year under this section may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of biosimilar biological product applications.
(d) Application fee waiver for small business
(1) Waiver of application fee
The Secretary shall grant to a person who is named in a biosimilar biological product application a waiver from the application fee assessed to that person under subsection (a)(2)(A) for the first biosimilar biological product application that a small business or its affiliate submits to the Secretary for review. After a small business or its affiliate is granted such a waiver, the small business or its affiliate shall pay application fees for all subsequent biosimilar biological product applications submitted to the Secretary for review in the same manner as an entity that is not a small business.
(2) Considerations
In determining whether to grant a waiver of a fee under paragraph (1), the Secretary shall consider only the circumstances and assets of the applicant involved and any affiliate of the applicant.
(3) Small business defined
In this subsection, the term "small business" means an entity that has fewer than 500 employees, including employees of affiliates, and does not have a drug product that has been approved under a human drug application (as defined in
(e) Effect of failure to pay fees
A biosimilar biological product application or supplement submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for filing by the Secretary until all such fees owed by such person have been paid.
(f) Crediting and availability of fees
(1) In general
Subject to paragraph (2), fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the review of biosimilar biological product applications.
(2) Collections and appropriation Acts
(A) In general
Subject to subparagraphs (C) and (D), the fees authorized by this section 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.
(B) Use of fees and limitations
(i) In general
The fees authorized by this section shall be available for a fiscal year beginning after fiscal year 2012 to defray the costs of the process for the review of biosimilar biological product 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 Secretary allocates for such purpose an amount for such fiscal year (excluding amounts from fees collected under this section) no less than $20,000,000, multiplied by the adjustment factor applicable to the fiscal year involved.
(ii) Leasing and necessary equipment
Beginning on October 1, 2023, the authorities under
(C) Compliance
The Secretary shall be considered to have met the requirements of subparagraph (B) in any fiscal year if the costs described in such subparagraph are not more than 15 percent below the level specified in such subparagraph.
(D) Provision for early payments
Payment of fees authorized under this section for a fiscal year, prior to the due date for such fees, may be accepted by the Secretary in accordance with authority provided in advance in a prior year appropriations Act.
(3) Authorization of appropriations
For each of fiscal years 2018 through 2022, there is authorized to be appropriated for fees under this section an amount equivalent to the total amount of fees assessed for such fiscal year under this section.
(g) 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
(h) Written requests for waivers and refunds
To qualify for consideration for a waiver under subsection (d), or for a refund of any fee collected in accordance with subsection (a)(2)(A), a person shall submit to the Secretary a written request for such waiver or refund not later than 180 days after such fee is due.
(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 biosimilar biological product applications, be reduced to offset the number of officers, employees, and advisory committees so engaged.
(June 25, 1938, ch. 675, §744H, as added
Termination of Section
For termination of section by section 405(a) of
Amendments
2020—Subsec. (f)(2)(B).
2017—Subsec. (a).
Subsec. (a)(1).
Subsec. (a)(1)(A)(i).
Subsec. (a)(1)(B)(i).
Subsec. (a)(1)(B)(ii).
Subsec. (a)(1)(B)(iii).
Subsec. (a)(1)(B)(iv).
Subsec. (a)(1)(C).
Subsec. (a)(1)(D)(i).
Subsec. (a)(1)(D)(i)(I).
Subsec. (a)(1)(D)(i)(II).
Subsec. (a)(1)(E).
Subsec. (a)(1)(F).
Subsec. (a)(1)(F)(i).
Subsec. (a)(2).
Subsec. (a)(2)(A), (B).
Subsec. (a)(2)(C).
Subsec. (a)(2)(D).
Subsec. (a)(2)(E).
Subsec. (a)(2)(F).
Subsec. (a)(3).
Subsec. (a)(4)(A).
Subsec. (b).
Subsec. (c).
Subsec. (d).
Subsec. (d)(1).
Subsec. (e).
Subsec. (f).
Subsec. (f)(2)(B).
Subsec. (f)(2)(C).
Subsec. (f)(2)(D).
Subsec. (f)(3).
Subsec. (g).
Subsec. (h).
Subsec. (i).
2016—Subsec. (a)(1)(A)(v).
Subsec. (a)(2)(B).
Effective Date of 2020 Amendment
Effective Date of 2017 Amendment
Amendment by section 403 of
Effective and Termination Dates
Section ceases to be effective Oct. 1, 2022, see section 405(a) of
Section effective Oct. 1, 2012, with fees under this subpart to be assessed for all biosimilar biological product applications received on or after Oct. 1, 2012, see section 405 of
§379j–53. Reauthorization; reporting requirements
(a) Performance report
(1) General requirements
Beginning with fiscal year 2018, not 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 the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 401(b) of the Biosimilar User Fee Amendments of 2017 during such fiscal year and the future plans of the Food and Drug Administration for meeting such goals. The report for a fiscal year shall include information on all previous cohorts for which the Secretary has not given a complete response on all biosimilar biological product applications and supplements in the cohort.
(2) Additional information
Beginning with fiscal year 2018, the report under this subsection shall include the progress of the Food and Drug Administration in achieving the goals, and future plans for meeting the goals, including—
(A) information on all previous cohorts for which the Secretary has not given a complete response on all biosimilar biological product applications and supplements in the cohort;
(B) the number of original biosimilar biological product applications filed per fiscal year, and the number of approvals issued by the agency for such applications; and
(C) the number of resubmitted original biosimilar biological product applications filed per fiscal year and the number of approvals 1 letters issued by the agency for such applications.
(3) Real time reporting
(A) In general
Not later than 30 calendar days after the end of the second quarter of fiscal year 2018, and not later than 30 calendar days after the end of each quarter of each fiscal year thereafter, the Secretary shall post the data described in subparagraph (B) for such quarter and on a cumulative basis for the fiscal year on the internet website of the Food and Drug Administration, and may remove duplicative data from the annual report under this subsection.
(B) Data
The 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 biosimilars, and whether such guidances were required by statute or pursuant to a commitment under the letters described in section 401(b) of the Biosimilar User Fee Amendments of 2017.
(ii) The number and titles of public meetings held on topics related to the process for the review of biosimilars, and whether such meetings were required by statute or pursuant to a commitment under the letters described in section 401(b) of the Biosimilar User Fee Amendments of 2017.
(4) Rationale for BSUFA program changes
Beginning with fiscal year 2020, the Secretary shall include in the annual report under paragraph (1)—
(A) data, analysis, and discussion of the changes in the number of full-time equivalents hired as agreed upon in the letters described in section 401(b) of the Biosimilar User Fee Amendments of 2017 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 biosimilar biological product applications, including identifying drivers of such changes; and
(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.
(5) Analysis
For each fiscal year, the Secretary shall include in the report an analysis of the following:
(A) The difference between the aggregate number of biosimilar biological product applications and supplements filed and the aggregate number of approvals issued by the agency, 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; and
(ii) the aggregate number of applications for each fiscal year that did not meet the goals identified by the letters described in section 401(b) of the Biosimilar User Fee Amendments of 2017 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 the performance enhancement goals identified by the letters described in section 401(b) of the Biosimilar User Fee Amendments of 2017 for the applicable fiscal year.
(C) The most common causes and trends for external or other circumstances affecting the ability of the Secretary to meet review time and performance enhancement goals identified by the letters described in section 401(b) of the Biosimilar User Fee Amendments of 2017.
(b) Fiscal report
Not later than 120 days after the end of fiscal year 2018 and each subsequent 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 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 for such fiscal year.
(c) Corrective action report
Beginning with fiscal year 2018, and for 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 Committee on Appropriations of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and Committee on Appropriations of the Senate. The report shall include the following information, as applicable:
(1) Goals met
For each fiscal year, if the Secretary determines, based on the analysis under subsection (a)(5), that each of the goals identified by the letters described in section 401(b) of the Biosimilar User Fee Amendments of 2017 for the applicable fiscal year have been met, the corrective action report shall include recommendations on ways in which the Secretary can improve and streamline the biosimilar biological product application review process.
(2) Goals missed
For each of the goals identified by the letters described in section 401(b) of the Biosimilar User Fee Amendments of 2017 for the applicable fiscal year that the Secretary determines to not have been met, the corrective action report shall include—
(A) a justification for such determination and a description of the types of circumstances and trends, as applicable, under which biosimilar biological product applications missed the review goal times but were approved during the first cycle review, or 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 1 fiscal year.
(d) Enhanced communication
(1) Communications with Congress
Each fiscal year, as applicable and requested, representatives from the Centers with expertise in the review of human drugs shall meet with representatives from the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives to report on the contents described in the reports under this section.
(2) Participation in congressional hearing
Each fiscal year, as applicable and requested, representatives from the Food and Drug Administration shall participate in a public hearing before the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, to report on the contents described in the reports under this section. Such hearing shall occur not later than 120 days after the end of each fiscal year for which fees are collected under this subpart.
(e) Public availability
The Secretary shall make the reports required under subsections (a) and (b) available to the public on the Internet Web site of the Food and Drug Administration.
(f) Reauthorization
(1) Consultation
In developing recommendations to present to the Congress with respect to the goals described in subsection (a), and plans for meeting the goals, for the process for the review of biosimilar biological product applications for the first 5 fiscal years after fiscal year 2022, and for the reauthorization of this subpart for such fiscal years, the Secretary shall consult with—
(A) the Committee on Energy and Commerce of the House of Representatives;
(B) the Committee on Health, Education, Labor, and Pensions of the Senate;
(C) scientific and academic experts;
(D) health care professionals;
(E) representatives of patient and consumer advocacy groups; and
(F) the regulated industry.
(2) Public review of recommendations
After 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;
(C) provide for a period of 30 days for the public to provide written comments on such recommendations;
(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.
(3) Transmittal of recommendations
Not later than January 15, 2022, the Secretary shall transmit to the Congress the revised recommendations under paragraph (2), a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments.
(June 25, 1938, ch. 675, §744I, as added
Termination of Section
For termination of section by section 405(b) of
References in Text
Section 401(b) of the Biosimilar User Fee Amendments of 2017, referred to in subsecs. (a) and (c), is section 401(b) of
Codification
Amendments made by section 904(d)(2) of
Amendments
2017—Subsec. (a).
Subsec. (a)(5).
Subsec. (b).
Subsec. (c).
Subsecs. (d), (e).
Subsec. (f).
Effective Date of 2017 Amendment
Amendment by section 404 of
Effective and Termination Dates
[
Section effective Oct. 1, 2012, see section 405 of
subpart 9—fees relating to outsourcing facilities
§379j–61. Definitions
In this subpart:
(1) The term "affiliate" has the meaning given such term in
(2) The term "gross annual sales" means the total worldwide gross annual sales, in United States dollars, for an outsourcing facility, including the sales of all the affiliates of the outsourcing facility.
(3) The term "outsourcing facility" has the meaning given to such term in
(4) The term "reinspection" means, with respect to an outsourcing facility, 1 or more inspections conducted under
(June 25, 1938, ch. 675, §744J, as added
§379j–62. Authority to assess and use outsourcing facility fees
(a) Establishment and reinspection fees
(1) In general
For fiscal year 2015 and each subsequent fiscal year, the Secretary shall, in accordance with this subsection, assess and collect—
(A) an annual establishment fee from each outsourcing facility; and
(B) a reinspection fee from each outsourcing facility subject to a reinspection in such fiscal year.
(2) Multiple reinspections
An outsourcing facility subject to multiple reinspections in a fiscal year shall be subject to a reinspection fee for each reinspection.
(b) Establishment and reinspection fee setting
The Secretary shall—
(1) establish the amount of the establishment fee and reinspection fee to be collected under this section for each fiscal year based on the methodology described in subsection (c); and
(2) publish such fee amounts in a Federal Register notice not later than 60 calendar days before the start of each such year.
(c) Amount of establishment fee and reinspection fee
(1) In general
For each outsourcing facility in a fiscal year—
(A) except as provided in paragraph (4), the amount of the annual establishment fee under subsection (b) shall be equal to the sum of—
(i) $15,000, multiplied by the inflation adjustment factor described in paragraph (2); plus
(ii) the small business adjustment factor described in paragraph (3); and
(B) the amount of any reinspection fee (if applicable) under subsection (b) shall be equal to $15,000, multiplied by the inflation adjustment factor described in paragraph (2).
(2) Inflation adjustment factor
(A) In general
For fiscal year 2015 and subsequent fiscal years, the fee amounts established in paragraph (1) shall be adjusted by the Secretary by notice, published in the Federal Register, for a fiscal year by the amount equal to the sum of—
(i) 1;
(ii) 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 an average full-time equivalent position of the Food and Drug Administration for the first 3 years of the preceding 4 fiscal years; plus
(iii) the average annual percent change that occurred in the Consumer Price Index for urban consumers (U.S. City Average; 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 an average full-time equivalent position of the Food and Drug Administration for the first 3 years of the preceding 4 fiscal years.
(B) Compounded basis
The adjustment made each fiscal year under subparagraph (A) shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2014 under subparagraph (A).
(3) Small business adjustment factor
The small business adjustment factor described in this paragraph shall be an amount established by the Secretary for each fiscal year based on the Secretary's estimate of—
(A) the number of small businesses that will pay a reduced establishment fee for such fiscal year; and
(B) the adjustment to the establishment fee necessary to achieve total fees equaling the total fees that the Secretary would have collected if no entity qualified for the small business exception in paragraph (4).
(4) Exception for small businesses
(A) In general
In the case of an outsourcing facility with gross annual sales of $1,000,000 or less in the 12 months ending April 1 of the fiscal year immediately preceding the fiscal year in which the fees under this section are assessed, the amount of the establishment fee under subsection (b) for a fiscal year shall be equal to \1/3\ of the amount calculated under paragraph (1)(A)(i) for such fiscal year.
(B) Application
To qualify for the exception under this paragraph, a small business shall submit to the Secretary a written request for such exception, in a format specified by the Secretary in guidance, certifying its gross annual sales for the 12 months ending April 1 of the fiscal year immediately preceding the fiscal year in which fees under this subsection are assessed. Any such application shall be submitted to the Secretary not later than April 30 of such immediately preceding fiscal year.
(5) Crediting of fees
In establishing the small business adjustment factor under paragraph (3) for a fiscal year, the Secretary shall—
(A) provide for the crediting of fees from the previous year to the next year if the Secretary overestimated the amount of the small business adjustment factor for such previous fiscal year; and
(B) consider the need to account for any adjustment of fees and such other factors as the Secretary determines appropriate.
(d) Use of fees
The Secretary shall make all of the fees collected pursuant to subparagraphs (A) and (B) of subsection (a)(1) available solely to pay for the costs of oversight of outsourcing facilities.
(e) Supplement not supplant
Funds received by the Secretary pursuant to this section shall be used to supplement and not supplant any other Federal funds available to carry out the activities described in this section.
(f) Crediting and availability of fees
Fees authorized under this section shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the purpose of paying the costs of oversight of outsourcing facilities.
(g) Collection of fees
(1) Establishment fee
An outsourcing facility shall remit the establishment fee due under this section in a fiscal year when submitting a registration pursuant to
(2) Reinspection fee
The Secretary shall specify in the Federal Register notice described in subsection (b)(2) the manner in which reinspection fees assessed under this section shall be collected and the timeline for payment of such fees. Such a fee shall be collected after the Secretary has conducted a reinspection of the outsourcing facility involved.
(3) Effect of failure to pay fees
(A) Registration
An outsourcing facility shall not be considered registered under
(B) Misbranding
All drugs manufactured, prepared, propagated, compounded, or processed by an outsourcing facility for which any establishment fee or reinspection fee has not been paid, as required by this section, shall be deemed misbranded under
(4) Collection of unpaid fees
In any case where the Secretary does not receive payment of a fee assessed under this section within 30 calendar days after it is due, such fee shall be treated as a claim of the United States Government subject to provisions of subchapter II of
(h) Annual report to Congress
Not later than 120 calendar days after each fiscal year in which fees are assessed and collected under this section, the Secretary shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, to include a description of fees assessed and collected for such year, a summary description of entities paying the fees, a description of the hiring and placement of new staff, a description of the use of fee resources to support inspecting outsourcing facilities, and the number of inspections and reinspections of such facilities performed each year.
(i) Authorization of appropriations
For fiscal year 2014 and each subsequent fiscal year, there is authorized to be appropriated for fees under this section an amount equivalent to the total amount of fees assessed for such fiscal year under this section.
(June 25, 1938, ch. 675, §744K, as added
subpart 10—fees relating to over-the-counter drugs
§379j–71. Definitions
In this subpart:
(1) 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.
(2) The term "contract manufacturing organization facility" means an OTC monograph drug facility where neither the owner of such manufacturing facility nor any affiliate of such owner or facility sells the OTC monograph drug produced at such facility directly to wholesalers, retailers, or consumers in the United States.
(3) The term "costs of resources allocated for OTC monograph drug activities" means the expenses in connection with OTC monograph drug activities 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 costs related 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
(4) The term "FDA establishment identifier" is the unique number automatically generated by Food and Drug Administration's Field Accomplishments and Compliance Tracking System (FACTS) (or any successor system).
(5) The term "OTC monograph drug" means a nonprescription drug without an approved new drug application which is governed by the provisions of
(6) The term "OTC monograph drug activities" means activities of the Secretary associated with OTC monograph drugs and inspection of facilities associated with such products, including the following activities:
(A) The activities necessary for review and evaluation of OTC monographs and OTC monograph order requests, including—
(i) orders proposing or finalizing applicable conditions of use for OTC monograph drugs;
(ii) orders affecting status regarding general recognition of safety and effectiveness of an OTC monograph ingredient or combination of ingredients under specified conditions of use;
(iii) all OTC monograph drug development and review activities, including intra-agency collaboration;
(iv) regulation and policy development activities related to OTC monograph drugs;
(v) development of product standards for products subject to review and evaluation;
(vi) meetings referred to in
(vii) review of labeling prior to issuance of orders related to OTC monograph drugs or conditions of use; and
(viii) regulatory science activities related to OTC monograph drugs.
(B) Inspections related to OTC monograph drugs.
(C) Monitoring of clinical and other research conducted in connection with OTC monograph drugs.
(D) Safety activities with respect to OTC monograph drugs, including—
(i) collecting, developing, and reviewing safety information on OTC monograph drugs, including adverse event reports;
(ii) developing and using improved adverse event data-collection systems, including information technology systems; and
(iii) developing and using improved analytical tools to assess potential safety risks, including access to external databases.
(E) Other activities necessary for implementation of
(7) The term "OTC monograph order request" means a request for an order submitted under
(8) The term "Tier 1 OTC monograph order request" means any OTC monograph order request not determined to be a Tier 2 OTC monograph order request.
(9)(A) The term "Tier 2 OTC monograph order request" means, subject to subparagraph (B), an OTC monograph order request for—
(i) the reordering of existing information in the drug facts label of an OTC monograph drug;
(ii) the addition of information to the other information section of the drug facts label of an OTC monograph drug, as limited by section 201.66(c)(7) of title 21, Code of Federal Regulations (or any successor regulations);
(iii) modification to the directions for use section of the drug facts label of an OTC monograph drug, if such changes conform to changes made pursuant to
(iv) the standardization of the concentration or dose of a specific finalized ingredient within a particular finalized monograph;
(v) a change to ingredient nomenclature to align with nomenclature of a standards-setting organization; or
(vi) addition of an interchangeable term in accordance with section 330.1 of title 21, Code of Federal Regulations (or any successor regulations).
(B) The Secretary may, based on program implementation experience or other factors found appropriate by the Secretary, characterize any OTC monograph order request as a Tier 2 OTC monograph order request (including recharacterizing a request from Tier 1 to Tier 2) and publish such determination in a proposed order issued pursuant to
(10)(A) The term "OTC monograph drug facility" means a foreign or domestic business or other entity that—
(i) is—
(I) under one management, either direct or indirect; and
(II) at one geographic location or address engaged in manufacturing or processing the finished dosage form of an OTC monograph drug;
(ii) includes a finished dosage form manufacturer facility in a contractual relationship with the sponsor of one or more OTC monograph drugs to manufacture or process such drugs; and
(iii) does not include a business or other entity whose only manufacturing or processing activities are one or more of the following: production of clinical research supplies, testing, or placement of outer packaging on packages containing multiple products, for such purposes as creating multipacks, when each monograph drug product contained within the overpackaging is already in a final packaged form prior to placement in the outer overpackaging.
(B) For purposes of subparagraph (A)(i)(II), separate buildings or locations within close proximity are considered to be at one geographic location or address if the activities conducted in such buildings or locations are—
(i) closely related to the same business enterprise;
(ii) under the supervision of the same local management; and
(iii) under a single FDA establishment identifier and capable of being inspected by the Food and Drug Administration during a single inspection.
(C) If a business or other entity would meet criteria specified in subparagraph (A), but for being under multiple management, the business or other entity is deemed to constitute multiple facilities, one per management entity, for purposes of this paragraph.
(11) The term "OTC monograph drug meeting" means any meeting regarding the content of a proposed OTC monograph order request.
(12) The term "person" includes an affiliate of a person.
(13) The terms "requestor" and "sponsor" have the meanings given such terms in
(June 25, 1938, ch. 675, §744L, as added
Finding
§379j–72. Authority to assess and use OTC monograph fees
(a) Types of fees
Beginning with fiscal year 2021, the Secretary shall assess and collect fees in accordance with this section as follows:
(1) Facility fee
(A) In general
Each person that owns a facility identified as an OTC monograph drug facility on December 31 of the fiscal year or at any time during the preceding 12-month period shall be assessed an annual fee for each such facility as determined under subsection (c).
(B) Exceptions
(i) Facilities that cease activities
A fee shall not be assessed under subparagraph (A) if the identified OTC monograph drug facility—
(I) has ceased all activities related to OTC monograph drugs prior to December 31 of the year immediately preceding the applicable fiscal year; and
(II) has updated its registration to reflect such change under the requirements for drug establishment registration set forth in
(ii) Contract manufacturing organizations
The amount of the fee for a contract manufacturing organization facility shall be equal to two-thirds of the amount of the fee for an OTC monograph drug facility that is not a contract manufacturing organization facility.
(C) Amount
The amount of fees established under subparagraph (A) shall be established under subsection (c).
(D) Due date
(i) For first program year
For fiscal year 2021, the facility fees required under subparagraph (A) shall be due on the later of—
(I) the first business day of July of 2020; or
(II) 45 calendar days after publication of the Federal Register notice provided for under subsection (c)(4)(A).
(ii) Subsequent fiscal years
For each fiscal year after fiscal year 2021, the facility fees required under subparagraph (A) shall be due on the later of—
(I) the first business day of June of such year; or
(II) the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees under this section for such year.
(2) OTC monograph order request fee
(A) In general
Each person that submits an OTC monograph order request shall be subject to a fee for an OTC monograph order request. The amount of such fee shall be—
(i) for a Tier 1 OTC monograph order request, $500,000, adjusted for inflation for the fiscal year (as determined under subsection (c)(1)(B)); and
(ii) for a Tier 2 OTC monograph order request, $100,000, adjusted for inflation for the fiscal year (as determined under subsection (c)(1)(B)).
(B) Due date
The OTC monograph order request fees required under subparagraph (A) shall be due on the date of submission of the OTC monograph order request.
(C) Exception for certain safety changes
A person who is named as the requestor in an OTC monograph order shall not be subject to a fee under subparagraph (A) if the Secretary finds that the OTC monograph order request seeks to change the drug facts labeling of an OTC monograph drug in a way that would add to or strengthen—
(i) a contraindication, warning, or precaution;
(ii) a statement about risk associated with misuse or abuse; or
(iii) an instruction about dosage and administration that is intended to increase the safe use of the OTC monograph drug.
(D) Refund of fee if order request is recategorized as a Tier 2 OTC monograph order request
If the Secretary determines that an OTC monograph request initially characterized as Tier 1 shall be re-characterized as a Tier 2 OTC monograph order request, and the requestor has paid a Tier 1 fee in accordance with subparagraph (A)(i), the Secretary shall refund the requestor the difference between the Tier 1 and Tier 2 fees determined under subparagraphs (A)(i) and (A)(ii), respectively.
(E) Refund of fee if order request refused for filing or withdrawn before filing
The Secretary shall refund 75 percent of the fee paid under subparagraph (B) for any order request which is refused for filing or was withdrawn before being accepted or refused for filing.
(F) Fees for order requests previously refused for filing or withdrawn before filing
An OTC monograph order request that was submitted but was refused for filing, or was withdrawn before being accepted or refused for filing, shall be subject to the full fee under subparagraph (A) upon being resubmitted or filed over protest.
(G) Refund of fee if order request withdrawn
If an order request is withdrawn after the order request was filed, the Secretary may refund the fee or a portion of the fee if no substantial work was performed on the order request after the application was filed. The Secretary shall have the sole discretion to refund a fee or a portion of the fee under this subparagraph. A determination by the Secretary concerning a refund under this subparagraph shall not be reviewable.
(3) Refunds
(A) In general
Other than refunds provided pursuant to any of subparagraphs (D) through (G) of paragraph (2), the Secretary shall not refund any fee paid under paragraph (1) except as provided in subparagraph (B).
(B) Disputes concerning fees
To qualify for the return of a fee claimed to have been paid in error under paragraph (1) or (2), a person shall submit to the Secretary a written request justifying such return within 180 calendar days after such fee was paid.
(4) Notice
Within the timeframe specified in subsection (c), the Secretary shall publish in the Federal Register the amount of the fees under paragraph (1) for such fiscal year.
(b) Fee revenue amounts
(1) Fiscal year 2021
For fiscal year 2021, fees under subsection (a)(1) shall be established to generate a total facility fee revenue amount equal to the sum of—
(A) the annual base revenue for fiscal year 2021 (as determined under paragraph (3));
(B) the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(2)); and
(C) additional direct cost adjustments (as determined under subsection (c)(3)).
(2) Subsequent fiscal years
For each of the fiscal years 2022 through 2025, fees under subsection (a)(1) shall be established to generate a total facility fee revenue amount 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 operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(2));
(D) additional direct cost adjustments (as determined under subsection (c)(3)); and
(E) additional dollar amounts for each fiscal year as follows:
(i) $7,000,000 for fiscal year 2022.
(ii) $6,000,000 for fiscal year 2023.
(iii) $7,000,000 for fiscal year 2024.
(iv) $3,000,000 for fiscal year 2025.
(3) Annual base revenue
For purposes of paragraphs (1)(A) and (2)(A), the dollar amount of the annual base revenue for a fiscal year shall be—
(A) for fiscal year 2021, $8,000,000; and
(B) for fiscal years 2022 through 2025, the dollar amount of the total revenue amount established under this subsection for the previous fiscal year, not including any adjustments made under subsection (c)(2) or (c)(3).
(c) Adjustments; annual fee setting
(1) Inflation adjustment
(A) In general
For purposes of subsection (b)(2)(B), the dollar amount of the inflation adjustment to the annual base revenue for fiscal year 2022 and each subsequent fiscal year shall be equal to the product of—
(i) such annual base revenue for the fiscal year under subsection (b)(2); and
(ii) the inflation adjustment percentage under subparagraph (C).
(B) OTC monograph order request fees
For purposes of subsection (a)(2), the dollar amount of the inflation adjustment to the fee for OTC monograph order requests for fiscal year 2022 and each subsequent fiscal year shall be equal to the product of—
(i) the applicable fee under subsection (a)(2) for the preceding fiscal year; and
(ii) the inflation adjustment percentage under subparagraph (C).
(C) Inflation adjustment percentage
The inflation adjustment percentage under this subparagraph for a fiscal year is equal to—
(i) for each of fiscal years 2022 and 2023, the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data; and
(ii) for each of fiscal years 2024 and 2025, 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 OTC monograph drug activities for the first 3 years of the preceding 4 fiscal years; and
(II) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of OTC monograph drug activities for the first 3 years of the preceding 4 fiscal years.
(2) Operating reserve adjustment
(A) In general
For fiscal year 2021 and subsequent fiscal years, for purposes of subsections (b)(1)(B) and (b)(2)(C), the Secretary may, in addition to adjustments under paragraph (1), further increase the fee revenue and fees if such an adjustment is necessary to provide operating reserves of carryover user fees for OTC monograph drug activities for not more than the number of weeks specified in subparagraph (B).
(B) Number of weeks
The number of weeks specified in this subparagraph is—
(i) 3 weeks for fiscal year 2021;
(ii) 7 weeks for fiscal year 2022;
(iii) 10 weeks for fiscal year 2023;
(iv) 10 weeks for fiscal year 2024; and
(v) 10 weeks for fiscal year 2025.
(C) Decrease
If the Secretary has carryover balances for such process in excess of 10 weeks of the operating reserves referred to in subparagraph (A), the Secretary shall decrease the fee revenue and fees referred to in such subparagraph to provide for not more than 10 weeks of such operating reserves.
(D) Rationale for adjustment
If an adjustment under this paragraph is made, the rationale for the amount of the increase or decrease (as applicable) in fee revenue and fees shall be contained in the annual Federal Register notice under paragraph (4) establishing fee revenue and fees for the fiscal year involved.
(3) Additional direct cost adjustment
The Secretary shall, in addition to adjustments under paragraphs (1) and (2), further increase the fee revenue and fees for purposes of subsection (b)(2)(D) by an amount equal to—
(A) $14,000,000 for fiscal year 2021;
(B) $7,000,000 for fiscal year 2022;
(C) $4,000,000 for fiscal year 2023;
(D) $3,000,000 for fiscal year 2024; and
(E) $3,000,000 for fiscal year 2025.
(4) Annual fee setting
(A) Fiscal year 2021
The Secretary shall, not later than the second Monday in May of 2020—
(i) establish OTC monograph drug facility fees for fiscal year 2021 under subsection (a), based on the revenue amount for such year under subsection (b) and the adjustments provided under this subsection; and
(ii) publish fee revenue, facility fees, and OTC monograph order requests in the Federal Register.
(B) Subsequent fiscal years
The Secretary shall, for each fiscal year that begins after September 30, 2021, not later than the second Monday in March that precedes such fiscal year—
(i) establish for such fiscal year, based on the revenue amounts under subsection (b) and the adjustments provided under this subsection—
(I) OTC monograph drug facility fees under subsection (a)(1); and
(II) OTC monograph order request fees under subsection (a)(2); and
(ii) publish such fee revenue amounts, facility fees, and OTC monograph order request fees in the Federal Register.
(d) Identification of facilities
Each person that owns an OTC monograph drug facility shall submit to the Secretary the information required under this subsection each year. Such information shall, for each fiscal year—
(1) be submitted as part of the requirements for drug establishment registration set forth in
(2) include for each such facility, at a minimum, identification of the facility's business operation as that of an OTC monograph drug facility.
(e) Effect of failure to pay fees
(1) OTC monograph drug facility fee
(A) In general
Failure to pay the fee under subsection (a)(1) within 20 calendar days of the due date as specified in subparagraph (D) of such subsection shall result in the following:
(i) The Secretary shall place the facility on a publicly available arrears list.
(ii) All OTC monograph drugs manufactured in such a facility or containing an ingredient manufactured in such a facility shall be deemed misbranded under
(B) Application of penalties
The penalties under this paragraph shall apply until the fee established by subsection (a)(1) is paid.
(2) Order requests
An OTC monograph order request 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 under this section have been paid.
(3) Meetings
A person subject to fees under this section shall be considered ineligible for OTC monograph drug meetings until all such fees owed by such person have been paid.
(f) Crediting and availability of fees
(1) In general
Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for OTC monograph drug activities.
(2) Collections and appropriation Acts
(A) In general
Subject to subparagraph (C), the fees authorized by this section 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.
(B) Use of fees and limitation
The fees authorized by this section shall be available to defray increases in the costs of the resources allocated for OTC monograph drug activities (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 activities), only if the Secretary allocates for such purpose an amount for such fiscal year (excluding amounts from fees collected under this section) no less than $12,000,000, multiplied by the adjustment factor applicable to the fiscal year involved under subsection (c)(1).
(C) Compliance
The Secretary shall be considered to have met the requirements of subparagraph (B) in any fiscal year if the costs funded by appropriations and allocated for OTC monograph drug activities are not more than 15 percent below the level specified in such subparagraph.
(D) Provision for early payments in subsequent years
Payment of fees authorized under this section for a fiscal year (after fiscal year 2021), prior to the due date for such fees, may be accepted by the Secretary in accordance with authority provided in advance in a prior year appropriations Act.
(3) Authorization of appropriations
For each of the fiscal years 2021 through 2025, there is authorized to be appropriated for fees under this section an amount equal to the total amount of fees assessed for such fiscal year under this section.
(g) Collection of unpaid fees
In any case where the Secretary does not receive payment of a fee assessed under subsection (a) within 30 calendar days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of
(h) 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 OTC monograph drug activities, be reduced to offset the number of officers, employees, and advisory committees so engaged.
(June 25, 1938, ch. 675, §744M, as added
§379j–73. Reauthorization; reporting requirements
(a) Performance report
Beginning with fiscal year 2021, and not later than 120 calendar days after the end of each fiscal year thereafter 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 the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 3861(b) 1 of the CARES Act during such fiscal year and the future plans of the Food and Drug Administration for meeting such goals.
(b) Fiscal report
Not later than 120 calendar days after the end of fiscal year 2021 and each subsequent 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 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 for such fiscal year.
(c) Public availability
The Secretary shall make the reports required under subsections (a) and (b) available to the public on the internet website of the Food and Drug Administration.
(d) Reauthorization
(1) Consultation
In developing recommendations to present to the Congress with respect to the goals described in subsection (a), and plans for meeting the goals, for OTC monograph drug activities for the first 5 fiscal years after fiscal year 2025, and for the reauthorization of this subpart for such fiscal years, the Secretary shall consult with—
(A) the Committee on Energy and Commerce of the House of Representatives;
(B) the Committee on Health, Education, Labor, and Pensions of the Senate;
(C) scientific and academic experts;
(D) health care professionals;
(E) representatives of patient and consumer advocacy groups; and
(F) the regulated industry.
(2) Public review of recommendations
After 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;
(C) provide for a period of 30 calendar days for the public to provide written comments on such recommendations;
(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.
(3) Transmittal of recommendations
Not later than January 15, 2025, the Secretary shall transmit to the Congress the revised recommendations under paragraph (2), a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments.
(June 25, 1938, ch. 675, §744N, as added
References in Text
Section 3861(b) of the CARES Act, referred to in subsec. (a), probably means section 3861 of