29–006 

113TH CONGRESS REPORT " ! HOUSE OF REPRESENTATIVES 1st Session 113–188 

AMENDING THE FEDERAL FOOD, DRUG, AND COSMETIC 

ACT TO REAUTHORIZE USER FEE PROGRAMS RELATING 

TO NEW ANIMAL DRUGS 

AUGUST 2, 2013.—Committed to the Committee of the Whole House on the State 

of the Union and ordered to be printed 

Mr. UPTON, from the Committee on Energy and Commerce, 

submitted the following 

R E P O R T 

[To accompany H.R. 1407] 

[Including cost estimate of the Congressional Budget Office] 

The Committee on Energy and Commerce, to whom was referred 

the bill (H.R. 1407) to amend the Federal Food, Drug, and Cosmetic Act to reauthorize user fee programs relating to new animal 

drugs, having considered the same, report favorably thereon with 

amendments and recommend that the bill as amended do pass. 

CONTENTS 

Page 

Purpose and Summary ............................................................................................ 17 

Background and Need for Legislation .................................................................... 17 

Hearings ................................................................................................................... 18 

Committee Consideration ........................................................................................ 18 

Committee Votes ...................................................................................................... 19 

Committee Oversight Findings ............................................................................... 19 

Statement of General Performance Goals and Objectives .................................... 19 

New Budget Authority, Entitlement Authority, and Tax Expenditures ............. 19 

Earmarks, Limited Tax Benefits, and Limited Tariff Benefits ........................... 19 

Committee Cost Estimate ....................................................................................... 19 

Congressional Budget Office Estimate ................................................................... 19 

Federal Mandates Statement ................................................................................. 24 

Duplication of Federal Programs ............................................................................ 24 

Disclosure of Directed Rule Makings ..................................................................... 24 

Advisory Committee Statement .............................................................................. 24 

Applicability to Legislative Branch ........................................................................ 24 

Section-by-Section Analysis of the Legislation ...................................................... 24 

Changes in Existing Law Made by the Bill, as Reported ..................................... 25 

The amendments are as follows: 

Strike all after the enacting clause and insert the following: 


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SECTION 1. TABLE OF CONTENTS. 

Sec. 1. Table of Contents. 

TITLE I—ANIMAL DRUG USER FEE AMENDMENTS 

Sec. 101. Short title; finding. 

Sec. 102. Definitions. 

Sec. 103. Authority to assess and use animal drug fees. 

Sec. 104. Reauthorization; reporting requirements. 

Sec. 105. Savings clause. 

Sec. 106. Effective date. 

Sec. 107. Sunset dates. 

TITLE II—ANIMAL GENERIC DRUG USER FEE AMENDMENTS 

Sec. 201. Short title; finding. 

Sec. 202. Authority to assess and use generic new animal drug fees. 

Sec. 203. Reauthorization; reporting requirements. 

Sec. 204. Savings clause. 

Sec. 205. Effective date. 

Sec. 206. Sunset dates. 

TITLE I—ANIMAL DRUG USER FEE 

AMENDMENTS 

SEC. 101. SHORT TITLE; FINDING. 

(a) SHORT TITLE.—This title may be cited as the ‘‘Animal Drug User Fee Amendments of 2013’’. 

(b) FINDING.—Congress finds that the fees authorized by the amendments made 

in this title will be dedicated toward expediting the animal drug development process and the review of new and supplemental animal drug applications and investigational animal drug submissions as set forth in the goals identified, for purposes 

of part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic 

Act, in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Energy and Commerce of the House of Representatives 

and the Chairman of the Committee on Health, Education, Labor, and Pensions of 

the Senate as set forth in the Congressional Record. 

SEC. 102. DEFINITIONS. 

Section 739 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–11) is 

amended to read as follows: 

‘‘SEC. 739. DEFINITIONS. 

‘‘For purposes of this part: 

‘‘(1) The term ‘animal drug application’ means an application for approval of 

any new animal drug submitted under section 512(b)(1). Such term does not include either a new animal drug application submitted under section 512(b)(2) 

or a supplemental animal drug application. 

‘‘(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 section 512(c)(2) for which data with respect to safety or effectiveness are required. 

‘‘(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 section 

512(j) for a new animal drug intended to be the subject of an animal drug 

application or a supplemental animal drug application; or 

‘‘(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 


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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. 

‘‘(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 section 740 and accounting for resources allocated for the review of animal drug applications, supplemental animal drug 

applications, and investigational animal drug submissions. 

‘‘(10) The term ‘adjustment factor’ applicable to a fiscal year refers to the formula set forth in section 735(8) with the base or comparator month being October 2002. 

‘‘(11) The term ‘person’ includes an affiliate thereof. 

‘‘(12) The term ‘affiliate’ refers to the definition set forth in section 735(11).’’. 

SEC. 103. AUTHORITY TO ASSESS AND USE ANIMAL DRUG FEES. 

Section 740 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–12) is 

amended to read as follows: 

‘‘SEC. 740. 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: 


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‘‘(i) A fee established in subsection (c) for an animal drug application, 

except an animal drug application described in section 512(d)(4). 

‘‘(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 described in section 512(d)(4). 

‘‘(B) PAYMENT.—The fee required by subparagraph (A) shall be due upon 

submission of the animal drug application or supplemental animal drug application. 

‘‘(C) EXCEPTION FOR PREVIOUSLY FILED APPLICATION OR SUPPLEMENT.—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). 

‘‘(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 section 510; and 

‘‘(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 

section 510, or is submitted for relisting under section 510 if the animal 

drug product has been withdrawn from listing and relisted. After such fee 

is paid for that fiscal year, such fee shall be due each subsequent fiscal year 

that the product remains listed, 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.—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 section 510; and 

‘‘(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 


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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.— ‘‘(i) IN GENERAL.—An establishment shall be assessed only one fee per 

fiscal year under this section, subject to clause (ii). 

‘‘(ii) CERTAIN MANUFACTURERS.—If a single establishment manufactures both animal drug products and prescription drug products, as defined in section 735(3), such establishment shall be assessed both the 

animal drug establishment fee and the prescription drug establishment 

fee, as set forth in section 736(a)(2), within a single fiscal year. 

‘‘(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 2014, the fees required under subsection (a) shall be 

established to generate a total revenue amount of $23,600,000; and 

‘‘(B) for each of fiscal years 2015 through 2018, the fees required under 

subsection (a) shall be established to generate a total revenue amount of 

$21,600,000. 

‘‘(2) TYPES OF FEES.—Of the total revenue amount determined 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.—For fiscal year 2015 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 

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 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 

‘‘(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 less food and energy; annual index) for 


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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. 

The adjustment made each fiscal year under this paragraph shall be added on 

a compounded basis to the sum of all adjustments made each fiscal year after 

fiscal year 2014 under this paragraph. 

‘‘(3) WORKLOAD ADJUSTMENT.—For fiscal year 2015 and subsequent fiscal 

years, after the revenue amounts established in subsection (b) are adjusted for 

inflation in accordance with paragraph (2), the 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. With respect 

to such adjustment— 

‘‘(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). 

‘‘(4) FINAL YEAR ADJUSTMENT.—For fiscal year 2018, 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 2019. 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 2018. 

‘‘(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.— 

‘‘(1) IN GENERAL.—The Secretary shall grant a waiver from or a reduction of 

one or more fees assessed under subsection (a) where the Secretary finds that— 

‘‘(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 


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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. 

‘‘(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 section 739(5)(B) 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 animal drug application, supplemental animal drug application, or investigational animal drug submission 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 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 


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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 2014 

through 2018, there is authorized to be appropriated for fees under this section 

an amount equal to the total revenue amount determined under subsection (b) 

for the fiscal year, as adjusted or otherwise affected under subsection (c) and 

paragraph (4). 

‘‘(4) OFFSET OF OVERCOLLECTIONS; RECOVERY OF COLLECTION SHORTFALLS.— 

‘‘(A) OFFSET OF OVERCOLLECTIONS.—If the sum of the cumulative amount 

of fees collected under this section for fiscal years 2014 through 2016 and 

the amount of fees estimated to be collected under this section for fiscal 

year 2017 (including any increased fee collections attributable to subparagraph (B)), exceeds the cumulative amount appropriated pursuant to 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. 

‘‘(B) RECOVERY OF COLLECTION SHORTFALLS.— 

‘‘(i) FISCAL YEAR 2016.—For fiscal year 2016, 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 2014 falls below the amount of fees authorized for fiscal year 2014 under paragraph (3). 

‘‘(ii) FISCAL YEAR 2017.—For fiscal year 2017, 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 2015 falls below the amount of fees authorized for fiscal year 2015 under paragraph (3). 

‘‘(iii) FISCAL YEAR 2018.—For fiscal year 2018, the amount of fees otherwise authorized to be collected under this section (including any reduction in the authorized amount under subparagraph (A)), shall be increased by the cumulative amount, if any, by which the amount collected under this section and appropriated for fiscal years 2016 and 

2017 (including estimated collections for fiscal year 2017) falls below 

the cumulative amount of fees authorized under paragraph (3) for fiscal 

years 2016 and 2017. 

‘‘(h) COLLECTION OF UNPAID FEES.—In any case where the Secretary does not receive payment of a fee assessed under subsection (a) within 30 days after it is due, 

such fee shall be treated as a claim of the United States Government subject to subchapter II of chapter 37 of title 31, United States Code. 

‘‘(i) 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.’’. 

SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS. 

Section 740A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–13) is 

amended to read as follows: 


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‘‘SEC. 740A. REAUTHORIZATION; REPORTING REQUIREMENTS. 

‘‘(a) PERFORMANCE REPORT.—Beginning with fiscal year 2014, not later than 120 

days after the end of each fiscal year during which fees are collected under this 

part, 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 101(b) of the Animal Drug User Fee Amendments of 2013 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 2014, not later than 120 days 

after the end of each fiscal year during which fees are collected under this part, 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 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 2018, and for the reauthorization of this part 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 part, 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 part; 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 part 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, 2018, 

the Secretary shall transmit to Congress the revised recommendations under 

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graph, 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.’’. 

SEC. 105. SAVINGS CLAUSE. 

Notwithstanding the amendments made by this title, part 4 of subchapter C of 

chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–11 et seq.), 

as in effect on the day before the date of the enactment of this title, shall continue 

to be in effect with respect to animal drug applications and supplemental animal 

drug applications (as defined in such part as of such day) that on or after October 

1, 2008, but before October 1, 2013, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such 

part for a fiscal year prior to fiscal year 2014. 

SEC. 106. EFFECTIVE DATE. 

The amendments made by this title shall take effect on October 1, 2013, or the 

date of enactment of this title, whichever is later, except that fees under part 4 of 

subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, as amended by this title, shall be assessed for all animal drug applications and supplemental 

animal drug applications received on or after October 1, 2013, regardless of the date 

of the enactment of this title. 

SEC. 107. SUNSET DATES. 

(a) AUTHORIZATION.—Section 740 of the Federal Food, Drug, and Cosmetic Act (21 

U.S.C. 379j–12) shall cease to be effective October 1, 2018. 

(b) REPORTING REQUIREMENTS.—Section 740A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–13) shall cease to be effective January 31, 2019. 

(c) PREVIOUS SUNSET PROVISION.— 

(1) IN GENERAL.—Section 108 of the Animal Drug User Fee Amendments of 

2008 (Public Law 110–316) is repealed. 

(2) CONFORMING AMENDMENT.—Public Law 110–316 (122 Stat. 2509) is 

amended in the table of contents in section 1, by striking the item relating to 

section 108. 

(d) TECHNICAL CLARIFICATION.—Effective November 18, 2003, section 5 of the Animal Drug User Fee Act of 2003 (Public Law 108–130) is repealed. 

TITLE II—ANIMAL GENERIC DRUG USER FEE 

AMENDMENTS 

SECTION 201. SHORT TITLE; FINDING. 

(a) SHORT TITLE.—This title may be cited as the ‘‘Animal Generic Drug User Fee 

Amendments of 2013’’. 

(b) FINDING.—The fees authorized by this title will be dedicated 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 as set forth in the goals identified in the letters from the Secretary of Health 

and Human Services to the Chairman of the Committee on Energy and Commerce 

of the House of Representatives and the Chairman of the Committee on Health, 

Education, Labor, and Pensions of the Senate as set forth in the Congressional 

Record. 

SEC. 202. AUTHORITY TO ASSESS AND USE GENERIC NEW ANIMAL DRUG FEES. 

Section 741 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21) is 

amended to read as follows: 

‘‘SEC. 741. 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: 


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‘‘(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 for an animal drug described in section 512(d)(4) and submitted on or after October 1, 2013, 

shall be subject to a fee equal to 50 percent of the amount of the abbreviated application fee established in subsection (c). 

‘‘(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 section 510; and 

‘‘(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 section 510, or is submitted for relisting under section 510 if 

the generic new animal drug product has been withdrawn from listing and 

relisted. After such fee is paid for that fiscal year, such fee shall be due 

each subsequent fiscal year that the product remains listed, 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.—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: 


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‘‘(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 AMOUNTS.—Subject to subsections (c), (d), (f), and (g), the fees required 

under subsection (a) shall be established to generate fee revenue amounts as follows: 

‘‘(1) TOTAL FEE REVENUES FOR APPLICATION FEES.—The total fee revenues to 

be collected in abbreviated application fees under subsection (a)(1) shall be 

$1,832,000 for fiscal year 2014, $1,736,000 for fiscal year 2015, $1,857,000 for 

fiscal year 2016, $1,984,000 for fiscal year 2017, and $2,117,000 for fiscal year 

2018. 

‘‘(2) TOTAL FEE REVENUES FOR PRODUCT FEES.—The total fee revenues to be 

collected in generic new animal drug product fees under subsection (a)(2) shall 

be $2,748,000 for fiscal year 2014, $2,604,000 for fiscal year 2015, $2,786,000 

for fiscal year 2016, $2,976,000 for fiscal year 2017, and $3,175,000 for fiscal 

year 2018. 

‘‘(3) TOTAL FEE REVENUES FOR SPONSOR FEES.—The total fee revenues to be 

collected in generic new animal drug sponsor fees under subsection (a)(3) shall 

be $2,748,000 for fiscal year 2014, $2,604,000 for fiscal year 2015, $2,786,000 

for fiscal year 2016, $2,976,000 for fiscal year 2017, and $3,175,000 for fiscal 

year 2018. 

‘‘(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) WORKLOAD ADJUSTMENT.—The fee revenues shall be adjusted each fiscal 

year after fiscal year 2014 to reflect changes in review workload. With respect 

to such adjustment: 

‘‘(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). 

‘‘(3) FINAL YEAR ADJUSTMENT.—For fiscal year 2018, 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 2019. 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 2018. 

‘‘(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 abbreviated applications 

for generic new animal drugs. 

‘‘(d) FEE WAIVER OR REDUCTION.—The Secretary shall grant a waiver from or a 

reduction of 1 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. 

‘‘(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 


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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.—There are authorized to be appropriated for fees under this section— 

‘‘(A) $7,328,000 for fiscal year 2014; 

‘‘(B) $6,944,000 for fiscal year 2015; 


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‘‘(C) $7,429,000 for fiscal year 2016; 

‘‘(D) $7,936,000 for fiscal year 2017; and 

‘‘(E) $8,467,000 for fiscal year 2018; 

as adjusted to reflect adjustments in the total fee revenues made under this section and changes in the total amounts collected by abbreviated application fees, 

generic new animal drug sponsor fees, and generic new animal drug product 

fees. 

‘‘(4) 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 chapter 37 of title 31, United States Code. 

‘‘(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 section 742: 

‘‘(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 section 512(b)(2). Such term does not include a supplemental abbreviated application for a generic new animal drug. 

‘‘(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 

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gredient 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 section 

512(j) for a generic new animal drug intended to be the subject of an abbreviated application or a supplemental abbreviated application; or 

‘‘(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 section 735(11)). 

‘‘(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.’’. 

SEC. 203. REAUTHORIZATION; REPORTING REQUIREMENTS. 

Section 742 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–22) is 

amended to read as follows: 

‘‘SEC. 742. REAUTHORIZATION; REPORTING REQUIREMENTS. 

‘‘(a) PERFORMANCE REPORTS.—Beginning with fiscal year 2014, not later than 120 

days after the end of each fiscal year during which fees are collected under this 

part, 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 2013 toward 

expediting the generic new animal drug development process and the review of abVerDate Mar 15 2010 03:50 Aug 06, 2013 Jkt 029006 PO 00000 Frm 00015 Fmt 6659 Sfmt 6621 E:\HR\OC\HR188.XXX HR188

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breviated 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 2014, not later than 120 days 

after the end of each fiscal year during which fees are collected under this part, 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 2018, and for the reauthorization of this part 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 part, 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 part; 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 part 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, 2018, 

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 


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1Department of Health and Human Services, Food and Drug Administration, Fiscal Year 

2005. http://www.fda.gov/aboutfda/reportsmanualsforms/reports/budgetreports/2005fda 

budgetsummary/ucm112985.htm 

as well as significant controversies or differences of opinion during the negotiations and their resolution.’’. 

SEC. 204. SAVINGS CLAUSE. 

Notwithstanding the amendments made by this title, part 5 of subchapter C of 

chapter VII of the Federal Food, Drug, and Cosmetic Act, as in effect on the day 

before the date of enactment of this title, shall continue to be in effect with respect 

to abbreviated applications for a generic new animal drug and supplemental abbreviated applications for a generic new animal drug (as defined in such part as of such 

day) that on or after October 1, 2008, but before October 1, 2013, were accepted by 

the Food and Drug Administration for filing with respect to assessing and collecting 

any fee required by such part for a fiscal year prior to fiscal year 2014. 

SEC. 205. EFFECTIVE DATE. 

The amendments made by this title shall take effect on October 1, 2013, or the 

date of enactment of this title, whichever is later, except that fees under part 5 of 

subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, as amended by this title, shall be assessed for all abbreviated applications for a generic new 

animal drug and supplemental abbreviated applications for a generic new animal 

drug received on or after October 1, 2013, regardless of the date of enactment of 

this title. 

SEC. 206. SUNSET DATES. 

(a) AUTHORIZATION.—Section 741 of the Federal Food, Drug, and Cosmetic Act (21 

U.S.C. 379j–21) shall cease to be effective October 1, 2018. 

(b) REPORTING REQUIREMENTS.—Section 742 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–22) shall cease to be effective January 31, 2019. 

(c) PREVIOUS SUNSET PROVISION.— 

(1) IN GENERAL.—Section 204 of the Animal Generic Drug User Fee Act of 

2008 (Public Law 110–316) is repealed. 

(2) CONFORMING AMENDMENT.—Public Law 110–316 (122 Stat. 3509) is 

amended in the table of contents in section 1, by striking the item relating to 

section 204. 

Amend the title to read: 

A bill to amend the Federal Food, Drug, and Cosmetic Act to reauthorize user fee 

programs relating to new animal drugs and generic new animal drugs. 

PURPOSE AND SUMMARY

H.R. 1407, the ‘‘Animal Drug User Fee Amendments of 2013,’’ 

was introduced on April 9, 2013, by Rep. John Shimkus (R–IL) and 

subsequently referred to the Committee on Energy and Commerce 

Subcommittee on Health. 

This legislation would amend the Federal Food, Drug, and Cosmetic Act to reauthorize user fee programs relating to new and generic animal drugs. 

BACKGROUND AND NEED FOR LEGISLATION

Title I of H.R. 1407 would reauthorize the Animal Drug User Fee 

Act. In 2003, Congress first enacted the Animal Drug User Fee Act 

(ADUFA) to help improve the Food and Drug Administration’s 

(FDA) review of new animal drugs. The program was modeled after 

the Prescription Drug User Fee Program for human drugs and authorized for five years (ADUFA I).1 Under the user fee authority 

of ADUFA I, FDA collected funds to help expedite the new animal 

drug approval process, reduce the application backlog, and improve 

communications with drug sponsors. In 2008, because of the success of the program, Congress reauthorized ADUFA for an addiVerDate Mar 15 2010 05:03 Aug 06, 2013 Jkt 029006 PO 00000 Frm 00017 Fmt 6659 Sfmt 6602 E:\HR\OC\HR188.XXX HR188

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2Proposed ADUFA III Provisions of the Federal Food, Drug, and Cosmetic Act. Page 6–7. 

3Proposed ADUFA III Provisions of the Federal Food, Drug, and Cosmetic Act. Page 6–7. 

tional five years (ADUFA II). Unless Congress reauthorizes these 

user fees, FDA cannot collect them after September 30, 2013. 

Following the process prescribed by statute, FDA and industry 

negotiated a proposed agreement (agreement) regarding the size 

and scope of the user fees for Fiscal Years (FY) 2014 to 2018. In 

February 2013, FDA sent its final legislative recommendations on 

the agreement to the Committee on Energy and Commerce. Under 

the agreement, industry would pay approximately $23,600,000 in 

FY 2014 ($21,600,000 plus $2,000,000 for one-time information 

technology funding), and similar amounts in the remaining four 

years based on inflation adjusters. The fee would be paid through 

application fees (20 percent), product fees (27 percent), sponsor fees 

(27 percent), and establishment fees (26 percent).2

Title II of H.R. 1407 would reauthorize the Animal Generic Drug 

User Fee Act (AGDUFA). The language of this title is identical to 

H.R. 1408, which was introduced by Rep. Gardner (R–CO) on April 

9, 2013. H.R 1408 was also the subject of the legislative hearing 

on April 9. 

In 2008, Congress authorized the AGDUFA program for five 

years in order to improve the review of abbreviated new animal 

drug applications (AGDUFA I). AGDUFA I enabled the agency to 

eliminate its application backlog and reduce review times. FDA 

cannot collect these user fees after September 30, 2013, unless they 

are reauthorized by Congress. 

Similar to ADUFA, FDA and industry negotiated an agreement 

regarding the size and scope of AGDUFA for FY 2014 to 2018, and 

FDA sent its final legislative recommendations on the AGDUFA 

agreement to the Committee in February 2013. Under the proposed 

AGDUFA agreement, the industry would pay $7,328,00 in FY 2014 

($6,478,000 plus $850,000 for one-time information technology 

funding), $6,944,00 in FY 2015, $7,429,000 in FY 2016, $7,936,000 

in FY 2017, and $8,467,000 in FY 2018. These fees would be paid 

through application fees (25 percent), product fees (37.5 percent), 

and sponsor fees (37.5 percent).3

HEARINGS

The Subcommittee on Health held a hearing on the reauthorization of Animal Drug User Fee Program and the Animal Generic 

Drug User Fee Program on April 9, 2013. The Subcommittee received testimony from: Dr. Bernadette Dunham, Director, Center 

for Veterinary Medicine, Food and Drug Administration; Dr. Richard A. Carnevale, Vice President, Regulatory, Scientific and International Affairs, Animal Health Institute; Dr. Mike Apley, Professor and Section Head, Production Medicine and Clinical Pharmacology, College of Veterinary Medicine, Kansas State University; 

and Dr. Lance B. Price, Professor, Department of Occupational and 

Environmental Health, George Washington University. 

COMMITTEE CONSIDERATION

On May 8, 2013, the Subcommittee on Health met in open markup session and approved H.R. 1407, Animal Drug User Fee AmendVerDate Mar 15 2010 03:50 Aug 06, 2013 Jkt 029006 PO 00000 Frm 00018 Fmt 6659 Sfmt 6602 E:\HR\OC\HR188.XXX HR188

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ments Act of 2013, for full Committee consideration, as amended, 

by a voice vote. 

On May 15, 2013, the full Committee met in open markup session and approved H.R. 1407 by voice vote. 

COMMITTEE VOTES

Clause 3(b) of rule XIII of the Rules of the House of Representatives requires the Committee to list the record votes on the motion 

to report legislation and amendments thereto. There were no 

record votes taken in connection with ordering H.R. 1407 reported. 

A motion by Mr. Upton to order H.R. 1407 reported to the House, 

as amended, was agreed to by a voice vote. 

COMMITTEE OVERSIGHT FINDINGS

Pursuant to clause 3(c)(1) of rule XIII of the Rules of the House 

of Representatives, the Committee made findings that are reflected 

in this report. 

STATEMENT OF GENERAL PERFORMANCE GOALS AND OBJECTIVES

H.R. 1407, Animal Drug User Fee Amendments Act of 2013, 

would reauthorize the Animal Drug User Fee Act and the Animal 

Drug User Fee Act through September 30, 2018. 

NEW BUDGET AUTHORITY, ENTITLEMENT AUTHORITY, AND TAX

EXPENDITURES

In compliance with clause 3(c)(2) of rule XIII of the Rules of the 

House of Representatives, the Committee finds that H.R. 1407, 

Animal Drug User Fee Amendments Act of 2013, would result in 

no new or increased budget authority, entitlement authority, or tax 

expenditures or revenues. 

EARMARK, LIMITED TAX BENEFITS, AND LIMITED TARIFF BENEFITS

In compliance with clause 9(e), 9(f), and 9(g) of rule XXI of the 

Rules of the House of Representatives, the Committee finds that 

H.R. 1407, Animal Drug User Fee Amendments Act of 2013, contains no earmarks, limited tax benefits, or limited tariff benefits. 

COMMITTEE COST ESTIMATE

The Committee adopts as its own the cost estimate prepared by 

the Director of the Congressional Budget Office pursuant to section 

402 of the Congressional Budget Act of 1974. 

CONGRESSIONAL BUDGET OFFICE ESTIMATE

Pursuant to clause 3(c)(3) of rule XIII of the Rules of the House 

of Representatives, the following is the cost estimate provided by 

the Congressional Budget Office pursuant to section 402 of the 

Congressional Budget Act of 1974: 


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U.S. CONGRESS, CONGRESSIONAL BUDGET OFFICE, Washington, DC, May 24, 2013. 

Hon. FRED UPTON, 

Chairman, Committee on Energy and Commerce, 

House of Representatives, Washington, DC. 

DEAR MR. CHAIRMAN: The Congressional Budget Office has prepared the enclosed cost estimate for H.R. 1407, the Animal Drug 

User Fee Amendments of 2013. 

If you wish further details on this estimate, we will be pleased 

to provide them. The CBO staff contact is Julia Christensen. 

Sincerely, 

DOUGLAS W. ELMENDORF. 

Enclosure. 

H.R. 1407—Animal Drug User Fee Amendments of 2013 

Summary: H.R. 1407 would authorize the collection and spending 

of fees by the Food and Drug Administration (FDA) for certain activities to expedite the development and marketing approval of 

drugs for use in animals. Fees would supplement appropriated 

funds to cover FDA’s costs associated with reviewing certain applications and investigational submissions for brand and generic animal drugs. Such fees could be collected and made available for obligation only to the extent and in the amounts provided in advance 

in appropriation acts. The legislation would extend through fiscal 

year 2018, and make several technical changes to, FDA’s existing 

fee programs for brand and generic animal drugs, which expire at 

the end of fiscal year 2013. 

CBO estimates that implementing H.R. 1407 would reduce discretionary outlays, on net, by $7 million over the 2014–2018 period, 

assuming appropriation actions consistent with the bill. 

Pay-as-you-go procedures do not apply to this legislation because 

it would not affect direct spending or revenues. 

H.R. 1407 contains no intergovernmental mandates as defined in 

the Unfunded Mandates Reform Act (UMRA). The bill would impose private-sector mandates, as defined in UMRA, because it 

would require manufacturers of drugs for use in animals to pay 

specified fees to FDA. CBO estimates that the direct cost of complying with these requirements would not exceed the annual 

threshold established by UMRA for private-sector mandates ($150 

million in 2013, adjusted annually for inflation). 

Estimated cost to the Federal Government: The estimated budgetary impact of H.R. 1407 is shown in the following table. The costs 

of this legislation fall within budget function 550 (health). 

By fiscal year, in millions of dollars— 

2014 2015 2016 2017 2018 2014– 

2018 

CHANGES IN SPENDING SUBJECT TO APPROPRIATION 

Title I: Fees Relating to Animal Drugs: 

Collections from Fees: 

Estimated Authorization Level .................................... ¥24 ¥22 ¥22 ¥23 ¥23 ¥114 

Estimated Outlays ...................................................... ¥24 ¥22 ¥22 ¥23 ¥23 ¥114 

Spending of Fees: 

Estimated Authorization Level .................................... 24 22 22 23 23 114 

Estimated Outlays ...................................................... 19 21 22 23 23 109 


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By fiscal year, in millions of dollars— 

2014 2015 2016 2017 2018 2014– 

2018 

Subtotal, Estimated Authorization Level ........... 0 0 0 0 0 0 

Subtotal, Estimated Outlays ............................. ¥5 ¥1 * * * ¥6 

Title II: Fees Relating to Generic Animal Drugs: 

Collections from Fees 

Estimated Authorization Level .................................... ¥7 ¥7 ¥7 ¥8 ¥8 ¥38 

Estimated Outlays ...................................................... ¥7 ¥7 ¥7 ¥8 ¥8 ¥38 

Spending of Fees 

Estimated Authorization Level .................................... 7 7 7 8 8 38 

Estimated Outlays ...................................................... 6 7 7 8 8 36 

Subtotal, Estimated Authorization Level ........... 0 0 0 0 0 0 

Subtotal, Estimated Outlays ............................. ¥1 * * * * ¥2 

Administrative Expenses: 

Estimated Authorization Level ............................................. * * * * * 1 

Estimated Outlays ............................................................... * * * * * 1 

Net Effect on Spending by the Food and Drug Administration: 

Estimated Authorization Level ............................................. * * * * * 1 

Estimated Outlays ............................................................... ¥6 ¥1 * * * ¥7 

Note: Components may not sum to totals because of rounding; * = between ¥$500,000 and $500,000. 

Basis of estimate: For this estimate, CBO assumes that H.R. 

1407 will be enacted near the start of fiscal year 2014, that the full 

amounts authorized will be collected and appropriated for each 

year, and that outlays will follow historical patterns for the fee programs. Assuming appropriation actions that trigger the collection 

of fees and are consistent with other provisions of the bill, CBO estimates that implementing H.R. 1407 would reduce discretionary 

outlays, on net, by $7 million over the 2014–2018 period, mostly because the spending of authorized fees lags slightly behind their collection. 

Conditions for assessment and use of fees 

H.R. 1407 would authorize the collection and spending of fees by 

FDA for certain activities to expedite the development and marketing approval of drugs for use in animals for fiscal years 2014 

through 2018. Under current law, FDA administers two separate 

fee programs involving animal drugs: One program covers brandname animal drugs and the other program covers generic drugs for 

use in animals. Both fee programs will expire at the end of fiscal 

year 2013. 

Fees authorized by the bill could be collected and made available 

for obligation by FDA only to the extent and in the amounts provided in advance in appropriation acts. The legislation would also 

retain the existing statutory limitations that fees cannot be assessed in a given year unless appropriations for salaries and expenses of FDA (excluding the amount of user fees appropriated for 

such fiscal year) satisfy a maintenance-of-effort requirement. Fees 

could be assessed only if the amount appropriated in that year 

equals or exceeds the amount appropriated for 2003 increased by 

an adjustment factor that reflects the percentage increase in the 

consumer price index for all urban consumers. 

In addition, for each of the programs, fees could be collected and 

spent in a given year only if the cost of resources allocated to reviewing brand and generic animal drug applications (excluding 

fees) exceeds the amount that is 3 percent below the level allocated 


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for such activities in a base year inflated by an adjustment factor. 

This estimate assumes that such conditions would be met. 

Title I: Fees relating to animal drugs 

H.R. 1407 would authorize FDA to assess and spend certain fees 

from manufacturers of brand-name drugs for use in animals to help 

defray FDA’s costs of expediting the regulatory review process for 

such drugs through fiscal year 2018. For fiscal year 2012, FDA collected about $21 million in fees associated with brand-name animal 

drugs. 

Similar to the existing fee structure, four categories of fees would 

be authorized by title I of the bill: (1) animal drug application and 

supplement fees, (2) animal drug product fees, (3) animal drug establishment fees, and (4) animal drug sponsor fees. H.R. 1407 

would authorize the appropriation of specific aggregate amounts of 

collections for each fiscal year 2014 through 2018, subject to further adjustments defined by the legislation. Collections would be 

adjusted each year by an inflation factor to reflect changes in 

FDA’s operating costs. Collections could also be modified based on 

certain workload estimates, when applicable. (No such adjustments 

for workload have occurred over the last four years of the existing 

program, and we expect that they would not occur in the future.) 

For fiscal year 2018, the bill would authorize the collection of operating reserves for the beginning of fiscal year 2019, unless carryover balances for the fee program exceed three months of such reserves. CBO expects that the final-year adjustment for operating 

reserves would not be made. We estimate aggregate collections 

from fees for the brand animal drug program authorized by H.R. 

1407 would total $114 million over the 2014–2018 period. 

CBO estimates that authorizing the fee program for brand animal drugs through 2018 would reduce discretionary outlays, on net, 

by $6 million over the 2014–2018 period, assuming appropriation 

actions consistent with the bill. The estimated authorization levels 

for collections and spending offset each other exactly from 2014 

through 2018. However, spending of authorized fees lags somewhat 

behind their collection, thereby generating savings over the period. 

Title II: Fees relating to generic animal drugs 

H.R. 1407 would extend FDA’s authority to assess and spend fees 

from manufacturers of certain generic new drugs for use in animals 

that would help cover the costs of regulatory activities to expedite 

the development and approval for marketing such drugs through 

fiscal year 2018. (The term ‘‘generic new drug’’ refers to drugs that 

must gain marketing approval by FDA because they are not generally recognized as safe and effective for use in animals and are 

approved under an abbreviated review process.) Collections associated with FDA’s fee program for generic animal drugs totaled 

about $7 million for fiscal year 2012. 

Three categories of fees would be authorized by title II of the bill: 

(1) fees for abbreviated applications, (2) fees on generic new drug 

products for animals, and (3) fees on sponsors of generic new drugs 

for animals. The bill would authorize the appropriation of specific 

aggregate amounts of collections for each fiscal year 2014 through 

2018. Collections could be further adjusted each year based on certain workload estimates, when applicable. (No such adjustments for 


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workload have occurred over the last four years of the existing program, and we expect that they would not occur in the future.) For 

fiscal year 2018, the bill would authorize additional adjustments to 

collections under specific circumstances, including the assessment 

of up to three months of operating reserves for the beginning of fiscal year 2019, unless carryover balances for the fee program exceed 

three months of such reserves. CBO expects that the final-year adjustment for operating reserves would not be made. We estimate 

aggregate collections from fees for generic new animal drugs authorized by the bill would total $38 million over the 2014–2018 period. 

CBO estimates that authorizing the fee program for generic new 

animal drugs over the 2014–2018 period would reduce discretionary outlays, on net, by $2 million over that period, assuming 

appropriation actions consistent with the bill. Because FDA would 

have the authority to spend collections, the estimated negative 

budget authority resulting from collections would exactly offset the 

budget authority for spending in each fiscal year. However, spending of fees would lag behind the collections and thus generate net 

discretionary savings over the 2014–2018 period. 

Other administrative expenses 

Funding for certain administrative activities associated with the 

fee programs authorized by H.R. 1407 would not be fully covered 

by fees. The bill would require that FDA report annually to the 

Congress on its performance under the fee programs and on the fiscal status of the programs. The legislation would also require that 

FDA consult with the Congressional committees of jurisdiction and 

outside experts, including industry and consumer groups, and publish its recommendations concerning reauthorization of the fee programs. CBO estimates that such administrative activities associated with implementing H.R. 1407 that are not covered by fees 

would cost less than $500,000 annually. 

Pay-as-You-Go considerations: None. 

Estimated impact on state, local, and tribal governments: H.R. 

1407 contains no intergovernmental mandates as defined in UMRA 

and would impose no costs on state, local, or tribal governments. 

Estimated impact on the private sector: The imposition of application, product, establishment, and sponsor fees that private entities would pay to FDA would be considered a private-sector mandate as defined in UMRA. CBO estimates that the fees collected 

over the 2014–2018 period would total $153 million. Those 

amounts would not exceed the annual threshold specified in UMRA 

($150 million in 2013, adjusted annually for inflation) in any of the 

five years that the mandate would be effective. 

Previous CBO estimate: On March 20, 2013, CBO transmitted a 

cost estimate for S. 622, the Animal Drug and Animal Generic 

Drug User Fee Reauthorization Act of 2013, as reported by the 

Senate Committee on Health, Education, Labor, and Pensions on 

March 20, 2013. The text of the two pieces of legislation is nearly 

identical, and the CBO cost estimates are the same. 

Estimate prepared by: Federal Costs: Julia Christensen; Impact 

on State, Local, and Tribal Governments: Lisa Ramirez-Branum; 

Impact on the Private Sector: Alexia Diorio. 


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Estimate approved by: Holly Harvey, Deputy Assistant Director 

for Budget Analysis. 

FEDERAL MANDATES STATEMENT

The Committee adopts as its own the estimate of Federal mandates prepared by the Director of the Congressional Budget Office 

pursuant to section 423 of the Unfunded Mandates Reform Act. 

DUPLICATION OF FEDERAL PROGRAMS

No provision of H.R. 1407 establishes or reauthorizes a program 

of the Federal Government known to be duplicative of another Federal program, a program that was included in any report from the 

Government Accountability Office to Congress pursuant to section 

21 of Public Law 111–139, or a program related to a program identified in the most recent Catalog of Federal Domestic Assistance. 

DISCLOSURE OF DIRECTED RULE MAKINGS

The Committee estimates that enacting H.R. 1407 specifically directs to be completed zero specific rule makings within the meaning of 5 U.S.C. 551. 

ADVISORY COMMITTEE STATEMENT

No advisory committees within the meaning of section 5(b) of the 

Federal Advisory Committee Act were created by this legislation. 

APPLICABILITY TO LEGISLATIVE BRANCH

The Committee finds that the legislation does not relate to the 

terms and conditions of employment or access to public services or 

accommodations within the meaning of section 102(b)(3) of the Congressional Accountability Act. 

SECTION-BY-SECTION ANALYSIS OF THE LEGISLATION

TITLE I—ANIMAL DRUG USER FEE AMENDMENTS

Section 101. Short Title; Finding: This section provides the short 

title and finding. 

Section 102. Definitions: This section defines the terms ‘‘animal 

drug application,’’ ‘‘supplemental animal drug application,’’ ‘‘animal 

drug product,’’ ‘‘animal drug establishment,’’ ‘‘investigational animal drug submission,’’ ‘‘animal drug sponsor,’’ ‘‘final dosage form,’’ 

‘‘process for the review of animal drug applications,’’ ‘‘costs of resources allocated for the process for the review of animal drug applications,’’ ‘‘adjustment factor,’’ ‘‘person,’’ and ‘‘affiliate.’’ 

Section 103. Authority to Assess and Use Animal Drug Fees: This 

section establishes the fees due under this title of the bill. 

Section 104. Reauthorization; Reporting Requirements: This section requires FDA to submit a performance report and financial report within 120 days after the end of each FY. Both of these reports will be available on the FDA website. The section also establishes the process for the reauthorization of the user fee. 

Section 105. Savings Clause: Animal drug applications and supplemental animal drug applications submitted and accepted for filing by the FDA on or after October 1, 2008, but before October 1, 


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2013, and which are still pending as of the AGDUFA II enactment 

are subject to AGDUFA I fees. 

Section 106. Effective Date: This section establishes the effective 

date as the later of October 1, 2013, or the date of enactment. 

Section 107. Sunset Dates: This section provides that the title 

will cease to be effective on October 1, 2018. 

TITLE II—ANIMAL GENERIC DRUG USER FEE

Section 201. Short Title; Finding: This section provides the short 

title and finding. 

Section 202. Authority to Assess and Use Generic New Animal 

Drug Fees: This section establishes the animal generic drug fees 

under the bill. 

Section 203. Reauthorization; Reporting Requirements: This section requires the Secretary to submit a financial report and performance report within 120 days after the end of each fiscal year. 

Both of these reports will be available on the FDA’s website. The 

section also establishes the process for the reauthorization of the 

fee. 

Section 204. Savings Clause: Applications submitted and accepted for filing on or after October 1, 2008, but before October 1, 2013, 

and which are still pending as of the AGDUFA II enactment, are 

subject to AGDUFA I fees. 

Section 205. Effective Date: This section establishes the effective 

date as the later of October 1, 2013, or the date of enactment. 

Section 206. Sunset Dates: This section provides that the title 

will cease to be effective on October 1, 2018. 

CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED

In compliance with clause 3(e) of rule XIII of the Rules of the 

House of Representatives, changes in existing law made by the bill, 

as reported, are shown as follows (existing law proposed to be omitted is enclosed in black brackets, new matter is printed in italic, 

existing law in which no change is proposed is shown in roman): 

FEDERAL FOOD, DRUG, AND COSMETIC ACT 

* * * * * * * 

CHAPTER VII—GENERAL AUTHORITY 

* * * * * * * 

SUBCHAPTER C—FEES

* * * * * * * 

PART 4—FEES RELATING TO ANIMAL DRUGS 

øSEC. 739. DEFINITIONS. 

øFor purposes of this part: 

ø(1) The term ‘‘animal drug application’’ means an application for approval of any new animal drug submitted under section 512(b)(1). Such term does not include either a new animal 

drug application submitted under section 512(b)(2) or a supplemental animal drug application. 


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ø(2) The term ‘‘supplemental animal drug application’’ 

means— 

ø(A) a request to the Secretary to approve a change in 

an animal drug application which has been approved; or 

ø(B) a request to the Secretary to approve a change to 

an application approved under section 512(c)(2) for which 

data with respect to safety or effectiveness are required. 

ø(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. 

ø(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. 

ø(5) The term ‘‘investigational animal drug submission’’ 

means— 

ø(A) the filing of a claim for an investigational exemption under section 512(j) for a new animal drug intended 

to be the subject of an animal drug application or a supplemental animal drug application, or 

ø(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. 

ø(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. 

ø(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. 

ø(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: 

ø(A) The activities necessary for the review of animal 

drug applications, supplemental animal drug applications, 

and investigational animal drug submissions. 

ø(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 apVerDate Mar 15 2010 03:50 Aug 06, 2013 Jkt 029006 PO 00000 Frm 00026 Fmt 6659 Sfmt 6602 E:\HR\OC\HR188.XXX HR188

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plications, supplements or submissions in condition for approval. 

ø(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. 

ø(D) Monitoring of research conducted in connection 

with the review of animal drug applications, supplemental 

animal drug applications, and investigational animal drug 

submissions. 

ø(E) The development of regulations and policy related 

to the review of animal drug applications, supplemental 

animal drug applications, and investigational animal drug 

submissions. 

ø(F) Development of standards for products subject to review. 

ø(G) Meetings between the agency and the animal drug 

sponsor. 

ø(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. 

ø(9) The term ‘‘costs of resources allocated for the process for 

the review of animal drug applications’’ means the expenses incurred in connection with the process for the review of animal 

drug applications for— 

ø(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, 

ø(B) management of information, and the acquisition, 

maintenance, and repair of computer resources, 

ø(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 

ø(D) collecting fees under section 740 and accounting for 

resources allocated for the review of animal drug applications, supplemental animal drug applications, and investigational animal drug submissions. 

ø(10) The term ‘‘adjustment factor’’ applicable to a fiscal year 

refers to the formula set forth in section 735(8) with the base 

or comparator month being October 2002. 

ø(11) The term ‘‘person’’ includes an affiliate thereof. 

ø(12) The term ‘‘affiliate’’ refers to the definition set forth in 

section 735(11). 

øSEC. 740. AUTHORITY TO ASSESS AND USE ANIMAL DRUG FEES. 

ø(a) TYPES OF FEES.—Beginning in fiscal year 2004, the Secretary shall assess and collect fees in accordance with this section 

as follows: 


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ø(1) ANIMAL DRUG APPLICATION AND SUPPLEMENT FEE.— 

ø(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: 

ø(i) A fee established in subsection (b) for an animal 

drug application, except an animal drug application 

subject to the criteria set forth in section 512(d)(4); 

and 

ø(ii) A fee established in subsection (b), in an 

amount that is equal to 50 percent of the amount of 

the fee under clause (i), for— 

ø(I) a supplemental animal drug application for 

which safety or effectiveness data are required; 

and 

ø(II) an animal drug application subject to the 

criteria set forth in section 512(d)(4). 

ø(B) PAYMENT.—The fee required by subparagraph (A) 

shall be due upon submission of the animal drug application or supplemental animal drug application. 

ø(C) EXCEPTION FOR PREVIOUSLY FILED APPLICATION OR

SUPPLEMENT.—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). 

ø(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. 

ø(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. 

ø(2) ANIMAL DRUG PRODUCT FEE.—Each person— 

ø(A) 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 section 510, and 

ø(B) who, after September 1, 2003, had pending before 

the Secretary an animal drug application or supplemental 

animal drug application; 


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shall pay for each such animal drug product the annual fee established in subsection (b). Such fee shall be payable for the 

fiscal year in which the animal drug product is first submitted 

for listing under section 510, or is submitted for relisting under 

section 510 if the animal drug product has been withdrawn 

from listing and relisted. After such fee is paid for that fiscal 

year, such fee shall be payable on or before January 31 of each 

year. Such fee shall be paid only once for each animal drug 

product for a fiscal year in which the fee is payable. 

ø(3) ANIMAL DRUG ESTABLISHMENT FEE.—Each person— 

ø(A) who owns or operates, directly or through an affiliate, an animal drug establishment, and 

ø(B) 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 section 510, and 

ø(C) who, after September 1, 2003, had pending before 

the Secretary an animal drug application or supplemental 

animal drug application, 

shall be assessed an annual fee established in subsection (b) 

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. 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 

shall be paid on or before January 31 of each year. The establishment shall be assessed only one fee per fiscal year under 

this section: Provided, however, That where a single establishment manufactures both animal drug products and prescription drug products, as defined in section 735(3), such establishment shall be assessed both the animal drug establishment fee 

and the prescription drug establishment fee, as set forth in section 736(a)(2), within a single fiscal year. 

ø(4) ANIMAL DRUG SPONSOR FEE.—Each person— 

ø(A) who meets the definition of an animal drug sponsor 

within a fiscal year; and 

ø(B) 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 fee established under subsection 

(b). The fee shall be paid on or before January 31 of each year. 

Each animal drug sponsor shall pay only one such fee each fiscal year. 

ø(b) FEE AMOUNTS.—Except as provided in subsection (a)(1) and 

subsections (c), (d), (f), and (g), the fees required under subsection 

(a) shall be established to generate fee revenue amounts as follows: 

ø(1) TOTAL FEE REVENUES FOR APPLICATION AND SUPPLEMENT

FEES.—The total fee revenues to be collected in animal drug 

application fees under subsection (a)(1)(A)(i) and supplemental 

and other animal drug application fees under subsection 

(a)(1)(A)(ii) shall be $3,815,000 for fiscal year 2009, $4,320,000 


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for fiscal year 2010, $4,862,000 for fiscal year 2011, $5,442,000 

for fiscal year 2012, and $6,061,000 for fiscal year 2013. 

ø(2) TOTAL FEE REVENUES FOR PRODUCT FEES.—The total fee 

revenues to be collected in product fees under subsection (a)(2) 

shall be $3,815,000 for fiscal year 2009, $4,320,000 for fiscal 

year 2010, $4,862,000 for fiscal year 2011, $5,442,000 for fiscal 

year 2012, and $6,061,000 for fiscal year 2013. 

ø(3) TOTAL FEE REVENUES FOR ESTABLISHMENT FEES.—The 

total fee revenues to be collected in establishment fees under 

subsection (a)(3) shall be $3,815,000 for fiscal year 2009, 

$4,320,000 for fiscal year 2010, $4,862,000 for fiscal year 2011, 

$5,442,000 for fiscal year 2012, and $6,061,000 for fiscal year 

2013. 

ø(4) TOTAL FEE REVENUES FOR SPONSOR FEES.—The total fee 

revenues to be collected in sponsor fees under subsection (a)(4) 

shall be $3,815,000 for fiscal year 2009, $4,320,000 for fiscal 

year 2010, $4,862,000 for fiscal year 2011, $5,442,000 for fiscal 

year 2012, and $6,061,000 for fiscal year 2013. 

ø(c) ADJUSTMENTS.— 

ø(1) WORKLOAD ADJUSTMENT.—The fee revenues shall be adjusted each fiscal year after fiscal year 2009 to reflect changes 

in review workload. With respect to such adjustment: 

ø(A) This 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. The Secretary shall publish in the Federal Register the fees resulting from this adjustment and the supporting methodologies. 

ø(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). 

ø(2) FINAL YEAR ADJUSTMENT.—For fiscal year 2013, the Secretary may further increase the fees 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 2014. 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 2013. 

ø(3) 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 


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subsection (b) and the adjustments provided under this subsection. 

ø(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 animal drug applications. 

ø(d) FEE WAIVER OR REDUCTION.— 

ø(1) IN GENERAL.—The Secretary shall grant a waiver from 

or a reduction of 1 or more fees assessed under subsection (a) 

where the Secretary finds that— 

ø(A) the assessment of the fee would present a significant barrier to innovation because of limited resources 

available to such person or other circumstances, 

ø(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, 

ø(C) the animal drug application or supplemental animal 

drug application is intended solely to provide for use of the 

animal drug in— 

ø(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 

ø(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)), 

ø(D) the animal drug application or supplemental animal drug application is intended solely to provide for a 

minor use or minor species indication, or 

ø(E) the sponsor involved is a small business submitting 

its first animal drug application to the Secretary for review. 

ø(2) USE OF STANDARD COSTS.—In making the finding in 

paragraph (1)(B), the Secretary may use standard costs. 

ø(3) RULES FOR SMALL BUSINESSES.— 

ø(A) DEFINITION.—In paragraph (1)(E), the term ‘‘small 

business’’ means an entity that has fewer than 500 employees, including employees of affiliates. 

ø(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. 

ø(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. 


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ø(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 section 739(5)(B) 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 animal drug application, supplemental animal drug application or investigational animal drug submission 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. 

ø(f) ASSESSMENT OF FEES.— ø(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. 

ø(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. 

ø(g) CREDITING AND AVAILABILITY OF FEES.— ø(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 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. 

ø(2) COLLECTIONS AND APPROPRIATION ACTS.— 

ø(A) IN GENERAL.—The fees authorized by this section— 

ø(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 

ø(ii) shall only be collected and available to defray 

increases in the costs of the resources allocated for the 


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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. 

ø(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— 

ø(i) are not more than 3 percent below the level 

specified in subparagraph (A)(ii); or 

ø(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 

ø(II) such costs are not more than 5 percent below 

the level specified in subparagraph (A)(ii). 

ø(3) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated for fees under this section— 

ø(A) $15,260,000 for fiscal year 2009; 

ø(B) $17,280,000 for fiscal year 2010; 

ø(C) $19,448,000 for fiscal year 2011; 

ø(D) $21,768,000 for fiscal year 2012; and 

ø(E) $24,244,000 for fiscal year 2013; 

as adjusted to reflect adjustments in the total fee revenues 

made under this section and changes in the total amounts collected by animal drug application fees, supplemental animal 

drug application fees, animal drug sponsor fees, animal drug 

establishment fees, and animal drug product fees. 

ø(4) OFFSET.—If the sum of the cumulative amount of fees 

collected under this section for fiscal years 2009 through 2011 

and the amount of fees estimated to be collected under this 

section for fiscal year 2012 exceeds the cumulative amount appropriated under paragraph (3) for the fiscal years 2009 

through 2012, 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 2013. 

ø(h) COLLECTION OF UNPAID FEES.—In any case where the Secretary does not receive payment of a fee assessed under subsection 

(a) within 30 days after it is due, such fee shall be treated as a 

claim of the United States Government subject to subchapter II of 

chapter 37 of title 31, United States Code. 

ø(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 


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written request for such waiver, reduction, or refund not later than 

180 days after such fee is due. 

ø(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. 

ø(k) ABBREVIATED NEW ANIMAL DRUG APPLICATIONS.—The Secretary shall— 

ø(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 

ø(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. 

øSEC. 740A. REAUTHORIZATION; REPORTING REQUIREMENTS. 

ø(a) PERFORMANCE REPORT.—Beginning with fiscal year 2009, 

not later than 60 days after the end of each fiscal year during 

which fees are collected under this part, 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 101(b) of the Animal Drug 

User Fee Amendments of 2008 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. 

ø(b) FISCAL REPORT.—Beginning with fiscal year 2009, not later 

than 120 days after the end of each fiscal year during which fees 

are collected under this part, 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 during such fiscal year for which the report is made. 

ø(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. 

ø(d) REAUTHORIZATION.— 

ø(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 2013, 

and for the reauthorization of this part for such fiscal years, 

the Secretary shall consult with— 


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ø(A) the Committee on Energy and Commerce of the 

House of Representatives; 

ø(B) the Committee on Health, Education, Labor, and 

Pensions of the Senate; 

ø(C) scientific and academic experts; 

ø(D) veterinary professionals; 

ø(E) representatives of patient and consumer advocacy 

groups; and 

ø(F) the regulated industry. 

ø(2) PRIOR PUBLIC INPUT.—Prior to beginning negotiations 

with the regulated industry on the reauthorization of this part, 

the Secretary shall— 

ø(A) publish a notice in the Federal Register requesting 

public input on the reauthorization; 

ø(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); 

ø(C) provide a period of 30 days after the public meeting 

to obtain written comments from the public suggesting 

changes to this part; and 

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

ø(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 part as expressed under 

paragraph (2). 

ø(4) PUBLIC REVIEW OF RECOMMENDATIONS.—After negotiations with the regulated industry, the Secretary shall— 

ø(A) present the recommendations developed under 

paragraph (1) to the Congressional committees specified in 

such paragraph; 

ø(B) publish such recommendations in the Federal Register; 

ø(C) provide for a period of 30 days for the public to provide written comments on such recommendations; 

ø(D) hold a meeting at which the public may present its 

views on such recommendations; and 

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

ø(5) TRANSMITTAL OF RECOMMENDATIONS.—Not later than 

January 15, 2013, 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. 

ø(6) MINUTES OF NEGOTIATION MEETINGS.— ø(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 conVerDate Mar 15 2010 03:50 Aug 06, 2013 Jkt 029006 PO 00000 Frm 00035 Fmt 6659 Sfmt 6602 E:\HR\OC\HR188.XXX HR188

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ducted under this subsection between the Food and Drug 

Administration and the regulated industry. 

ø(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.¿ 

SEC. 739. DEFINITIONS. 

For purposes of this part: 

(1) The term ‘‘animal drug application’’ means an application 

for approval of any new animal drug submitted under section 

512(b)(1). Such term does not include either a new animal drug 

application submitted under section 512(b)(2) or a supplemental 

animal drug application. 

(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 section 512(c)(2) for which data 

with respect to safety or effectiveness are required. 

(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 section 512(j) for a new animal drug intended to be 

the subject of an animal drug application or a supplemental animal drug application; or 

(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. 


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(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. 

(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 


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(D) collecting fees under section 740 and accounting for 

resources allocated for the review of animal drug applications, supplemental animal drug applications, and investigational animal drug submissions. 

(10) The term ‘‘adjustment factor’’ applicable to a fiscal year 

refers to the formula set forth in section 735(8) with the base 

or comparator month being October 2002. 

(11) The term ‘‘person’’ includes an affiliate thereof. 

(12) The term ‘‘affiliate’’ refers to the definition set forth in 

section 735(11). 

SEC. 740. 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 

described in section 512(d)(4). 

(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 described in section 512(d)(4). 

(B) PAYMENT.—The fee required by subparagraph (A) 

shall be due upon submission of the animal drug application or supplemental animal drug application. 

(C) EXCEPTION FOR PREVIOUSLY FILED APPLICATION OR

SUPPLEMENT.—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). 

(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 


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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 section 510; and 

(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 section 510, or is submitted for 

relisting under section 510 if the animal drug product has 

been withdrawn from listing and relisted. After such fee is 

paid for that fiscal year, such fee shall be due each subsequent fiscal year that the product remains listed, 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.—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 section 510; and 

(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 


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and obligation of fees for such fiscal year under this 

section; or 

(ii) January 31 of each year. 

(C) LIMITATION.— (i) IN GENERAL.—An establishment shall be assessed 

only one fee per fiscal year under this section, subject 

to clause (ii). 

(ii) CERTAIN MANUFACTURERS.—If a single establishment manufactures both animal drug products and 

prescription drug products, as defined in section 

735(3), such establishment shall be assessed both the 

animal drug establishment fee and the prescription 

drug establishment fee, as set forth in section 736(a)(2), 

within a single fiscal year. 

(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 2014, the fees required under subsection (a) shall be established to generate a total revenue 

amount of $23,600,000; and 

(B) for each of fiscal years 2015 through 2018, the fees 

required under subsection (a) shall be established to generate a total revenue amount of $21,600,000. 

(2) TYPES OF FEES.—Of the total revenue amount determined 

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 SepVerDate Mar 15 2010 03:50 Aug 06, 2013 Jkt 029006 PO 00000 Frm 00040 Fmt 6659 Sfmt 6603 E:\HR\OC\HR188.XXX HR188

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tember 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.—For fiscal year 2015 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 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 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 

(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 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. 

The adjustment made each fiscal year under this paragraph 

shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2014 under this 

paragraph. 

(3) WORKLOAD ADJUSTMENT.—For fiscal year 2015 and subsequent fiscal years, after the revenue amounts established in subsection (b) are adjusted for inflation in accordance with paragraph (2), the 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. With respect to such adjustment— 

(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 


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revenues for that fiscal year established in subsection (b), 

as adjusted for inflation under paragraph (2). 

(4) FINAL YEAR ADJUSTMENT.—For fiscal year 2018, 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 2019. 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 2018. 

(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.— (1) IN GENERAL.—The Secretary shall grant a waiver from or 

a reduction of one or more fees assessed under subsection (a) 

where the Secretary finds that— 

(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 


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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. 

(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 section 739(5)(B) 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 animal drug application, supplemental animal drug application, or investigational animal drug submission 

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 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 salVerDate Mar 15 2010 03:50 Aug 06, 2013 Jkt 029006 PO 00000 Frm 00043 Fmt 6659 Sfmt 6603 E:\HR\OC\HR188.XXX HR188

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ary 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 2014 through 2018, there is authorized to be appropriated for fees under this section an amount equal to the total 

revenue amount determined under subsection (b) for the fiscal 

year, as adjusted or otherwise affected under subsection (c) and 

paragraph (4). 

(4) OFFSET OF OVERCOLLECTIONS; RECOVERY OF COLLECTION

SHORTFALLS.— 

(A) OFFSET OF OVERCOLLECTIONS.—If the sum of the cumulative amount of fees collected under this section for fiscal years 2014 through 2016 and the amount of fees estimated to be collected under this section for fiscal year 2017 

(including any increased fee collections attributable to subparagraph (B)), exceeds the cumulative amount appropriated pursuant to paragraph (3) for the fiscal years 2014 

through 2017, the excess amount shall be credited to the 


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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. 

(B) RECOVERY OF COLLECTION SHORTFALLS.— 

(i) FISCAL YEAR 2016.—For fiscal year 2016, 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 2014 falls below the 

amount of fees authorized for fiscal year 2014 under 

paragraph (3). 

(ii) FISCAL YEAR 2017.—For fiscal year 2017, 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 2015 falls below the 

amount of fees authorized for fiscal year 2015 under 

paragraph (3). 

(iii) FISCAL YEAR 2018.—For fiscal year 2018, the 

amount of fees otherwise authorized to be collected 

under this section (including any reduction in the authorized amount under subparagraph (A)), shall be increased by the cumulative amount, if any, by which the 

amount collected under this section and appropriated 

for fiscal years 2016 and 2017 (including estimated 

collections for fiscal year 2017) falls below the cumulative amount of fees authorized under paragraph (3) 

for fiscal years 2016 and 2017. 

(h) COLLECTION OF UNPAID FEES.—In any case where the Secretary does not receive payment of a fee assessed under subsection 

(a) within 30 days after it is due, such fee shall be treated as a 

claim of the United States Government subject to subchapter II of 

chapter 37 of title 31, United States Code. 

(i) 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 


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increase from their current level due to activities under the user 

fee program. 

SEC. 740A. REAUTHORIZATION; REPORTING REQUIREMENTS. 

(a) PERFORMANCE REPORT.—Beginning with fiscal year 2014, not 

later than 120 days after the end of each fiscal year during which 

fees are collected under this part, 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 101(b) of the Animal Drug User Fee 

Amendments of 2013 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 2014, not later 

than 120 days after the end of each fiscal year during which fees 

are collected under this part, 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 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 2018, 

and for the reauthorization of this part 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 part, 

the Secretary shall— 

(A) publish a notice in the Federal Register requesting 

public input on the reauthorization; 


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(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 part; 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 part 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, 2018, 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. 


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PART 5—FEES RELATING TO GENERIC NEW 

ANIMAL DRUGS 

øSEC. 741. AUTHORITY TO ASSESS AND USE GENERIC NEW ANIMAL 

DRUG FEES. 

ø(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: 

ø(1) ABBREVIATED APPLICATION FEE.— 

ø(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 (b) for such an application. 

ø(B) PAYMENT.—The fee required by subparagraph (A) 

shall be due upon submission of the abbreviated application. 

ø(C) EXCEPTION FOR 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). 

ø(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. 

ø(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. 

ø(2) GENERIC NEW ANIMAL DRUG PRODUCT FEE.—Each person— 

ø(A) 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 section 510, and 

ø(B) 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 (b). Such fee shall be payable for the fiscal year in which the generic new animal drug 

product is first submitted for listing under section 510, or is 

submitted for relisting under section 510 if the generic new 

animal drug product has been withdrawn from listing and relisted. After such fee is paid for that fiscal year, such fee shall 

be payable on or before January 31 of each year. Such fee shall 


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be paid only once for each generic new animal drug product for 

a fiscal year in which the fee is payable. 

ø(3) GENERIC NEW ANIMAL DRUG SPONSOR FEE.— 

ø(A) IN GENERAL.—Each person— 

ø(i) who meets the definition of a generic new animal drug sponsor within a fiscal year, and 

ø(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 fee established under subsection (b). The fee shall be paid on or before January 31 

of each year. 

ø(B) AMOUNT OF FEE.—Each generic new animal drug 

sponsor shall pay only 1 such fee each fiscal year, as follows: 

ø(i) 100 percent of the amount of the generic new 

animal drug sponsor fee published for that fiscal year 

under subsection (c)(3) for an applicant with more 

than 6 approved abbreviated applications. 

ø(ii) 75 percent of the amount of the generic new 

animal drug sponsor fee published for that fiscal year 

under subsection (c)(3) for an applicant with more 

than 1 and fewer than 7 approved abbreviated applications. 

ø(iii) 50 percent of the amount of the generic new 

animal drug sponsor fee published for that fiscal year 

under subsection (c)(3) for an applicant with 1 or 

fewer approved abbreviated applications. 

ø(b) FEE AMOUNTS.—Except as provided in subsection (a)(1) and 

subsections (c), (d), (f), and (g), the fees required under subsection 

(a) shall be established to generate fee revenue amounts as follows: 

ø(1) TOTAL FEE REVENUES FOR APPLICATION FEES.—The total 

fee revenues to be collected in abbreviated application fees 

under subsection (a)(1) shall be $1,449,000 for fiscal year 2009, 

$1,532,000 for fiscal year 2010, $1,619,000 for fiscal year 2011, 

$1,712,000 for fiscal year 2012, and $1,809,000 for fiscal year 

2013. 

ø(2) TOTAL FEE REVENUES FOR PRODUCT FEES.—The total fee 

revenues to be collected in generic new animal drug product 

fees under subsection (a)(2) shall be $1,691,000 for fiscal year 

2009, $1,787,000 for fiscal year 2010, $1,889,000 for fiscal year 

2011, $1,997,000 for fiscal year 2012, and $2,111,000 for fiscal 

year 2013. 

ø(3) TOTAL FEE REVENUES FOR SPONSOR FEES.—The total fee 

revenues to be collected in generic new animal drug sponsor 

fees under subsection (a)(3) shall be $1,691,000 for fiscal year 

2009, $1,787,000 for fiscal year 2010, $1,889,000 for fiscal year 

2011, $1,997,000 for fiscal year 2012, and $2,111,000 for fiscal 

year 2013. 

ø(c) ADJUSTMENTS.— 

ø(1) WORKLOAD ADJUSTMENT.—The fee revenues shall be adjusted each fiscal year after fiscal year 2009 to reflect changes 

in review workload. With respect to such adjustment: 


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ø(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. 

ø(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). 

ø(2) FINAL YEAR ADJUSTMENT.—For fiscal year 2013, the Secretary may further increase the fees 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 2014. 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 2013. 

ø(3) 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. 

ø(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 abbreviated applications for generic 

new animal drugs. 

ø(d) FEE WAIVER OR REDUCTION.—The Secretary shall grant a 

waiver from or a reduction of 1 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. 

ø(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 


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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. 

ø(f) ASSESSMENT OF FEES.— 

ø(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. 

ø(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. 

ø(g) CREDITING AND AVAILABILITY OF FEES.— 

ø(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 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. 

ø(2) COLLECTIONS AND APPROPRIATION ACTS.— 

ø(A) IN GENERAL.—The fees authorized by this section— 

ø(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 

ø(ii) shall only be collected and 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. 

ø(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 alloVerDate Mar 15 2010 03:50 Aug 06, 2013 Jkt 029006 PO 00000 Frm 00051 Fmt 6659 Sfmt 6601 E:\HR\OC\HR188.XXX HR188

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cated for the process for the review of abbreviated applications for generic new animal drugs— 

ø(i) are not more than 3 percent below the level 

specified in subparagraph (A)(ii); or 

ø(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 

ø(II) such costs are not more than 5 percent below 

the level specified in subparagraph (A)(ii). 

ø(3) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated for fees under this section— 

ø(A) $4,831,000 for fiscal year 2009; 

ø(B) $5,106,000 for fiscal year 2010; 

ø(C) $5,397,000 for fiscal year 2011; 

ø(D) $5,706,000 for fiscal year 2012; and 

ø(E) $6,031,000 for fiscal year 2013; 

as adjusted to reflect adjustments in the total fee revenues 

made under this section and changes in the total amounts collected by abbreviated application fees, generic new animal 

drug sponsor fees, and generic new animal drug product fees. 

ø(4) OFFSET.—If the sum of the cumulative amount of fees 

collected under this section for the fiscal years 2009 through 

2011 and the amount of fees estimated to be collected under 

this section for fiscal year 2012 exceeds the cumulative amount 

appropriated under paragraph (3) for the fiscal years 2009 

through 2012, 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 2013. 

ø(h) COLLECTION OF UNPAID FEES.—In any case where the Secretary does not receive payment of a fee assessed under subsection 

(a) within 30 days after it is due, such fee shall be treated as a 

claim of the United States Government subject to subchapter II of 

chapter 37 of title 31, United States Code. 

ø(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. 

ø(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. 

ø(k) DEFINITIONS.—In this section and section 742: 

ø(1) ABBREVIATED APPLICATION FOR A GENERIC NEW ANIMAL

DRUG.—The terms ‘‘abbreviated application for a generic new 


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animal drug’’ and ‘‘abbreviated application’’ mean an abbreviated application for the approval of any generic new animal 

drug submitted under section 512(b)(2). Such term does not include a supplemental abbreviated application for a generic new 

animal drug. 

ø(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— 

ø(A) for purposes of subsection (f)(1), such Index for October 2002; and 

ø(B) for purposes of subsection (g)(2)(A)(ii), such Index 

for October 2007. 

ø(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 incurred in connection 

with the process for the review of abbreviated applications for 

generic new animal drugs for— 

ø(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; 

ø(B) management of information, and the acquisition, 

maintenance, and repair of computer resources; 

ø(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 

ø(D) collecting fees under this section and accounting for 

resources allocated for the review of abbreviated applications, supplemental abbreviated applications, and investigational submissions. 

ø(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. 

ø(5) GENERIC NEW ANIMAL DRUG.—The term ‘‘generic new 

animal drug’’ means a new animal drug that is the subject of 

an abbreviated application. 

ø(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 


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drug or a supplemental abbreviated application has been approved. 

ø(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. 

ø(8) INVESTIGATIONAL SUBMISSION FOR A GENERIC NEW ANI- MAL DRUG.—The terms ‘‘investigational submission for a generic new animal drug’’ and ‘‘investigational submission’’ 

mean— 

ø(A) the filing of a claim for an investigational exemption under section 512(j) for a generic new animal drug intended to be the subject of an abbreviated application or 

a supplemental abbreviated application; or 

ø(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. 

ø(9) PERSON.—The term ‘‘person’’ includes an affiliate thereof 

(as such term is defined in section 735(11)). 

ø(10) PROCESS FOR THE REVIEW OF ABBREVIATED APPLICA- TIONS 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: 

ø(A) The activities necessary for the review of abbreviated applications, supplemental abbreviated applications, 

and investigational submissions. 

ø(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. 

ø(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. 

ø(D) Monitoring of research conducted in connection 

with the review of abbreviated applications, supplemental 

abbreviated applications, and investigational submissions. 

ø(E) The development of regulations and policy related 

to the review of abbreviated applications, supplemental abbreviated applications, and investigational submissions. 

ø(F) Development of standards for products subject to review. 


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ø(G) Meetings between the agency and the generic new 

animal drug sponsor. 

ø(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. 

ø(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. 

øSEC. 742. REAUTHORIZATION; REPORTING REQUIREMENTS. 

ø(a) PERFORMANCE REPORTS.—Beginning with fiscal year 2009, 

not later than 60 days after the end of each fiscal year during 

which fees are collected under this part, 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(3) of the Animal Generic Drug User Fee Act of 2008 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. 

ø(b) FISCAL REPORT.—Beginning with fiscal year 2009, not later 

than 120 days after the end of each fiscal year during which fees 

are collected under this part, the Secretary shall prepare and submit to 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. 

ø(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. 

ø(d) REAUTHORIZATION.— 

ø(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 2013, and for the reauthorization of this 

part for such fiscal years, the Secretary shall consult with— 

ø(A) the Committee on Energy and Commerce of the 

House of Representatives; 

ø(B) the Committee on Health, Education, Labor, and 

Pensions of the Senate; 

ø(C) scientific and academic experts; 

ø(D) veterinary professionals; 

ø(E) representatives of patient and consumer advocacy 

groups; and 

ø(F) the regulated industry. 


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ø(2) PRIOR PUBLIC INPUT.—Prior to beginning negotiations 

with the regulated industry on the reauthorization of this part, 

the Secretary shall— 

ø(A) publish a notice in the Federal Register requesting 

public input on the reauthorization; 

ø(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); 

ø(C) provide a period of 30 days after the public meeting 

to obtain written comments from the public suggesting 

changes to this part; and 

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

ø(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 part as expressed under 

paragraph (2). 

ø(4) PUBLIC REVIEW OF RECOMMENDATIONS.—After negotiations with the regulated industry, the Secretary shall— 

ø(A) present the recommendations developed under 

paragraph (1) to the congressional committees specified in 

such paragraph; 

ø(B) publish such recommendations in the Federal Register; 

ø(C) provide for a period of 30 days for the public to provide written comments on such recommendations; 

ø(D) hold a meeting at which the public may present its 

views on such recommendations; and 

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

ø(5) TRANSMITTAL OF RECOMMENDATIONS.—Not later than 

January 15, 2013, 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. 

ø(6) MINUTES OF NEGOTIATION MEETINGS.— 

ø(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. 

ø(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.¿ 


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SEC. 741. 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 for an animal drug described in section 512(d)(4) 

and submitted on or after October 1, 2013, shall be 

subject to a fee equal to 50 percent of the amount of the 

abbreviated application fee established in subsection 

(c). 

(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 section 510; and 

(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 


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product is first submitted for listing under section 510, or 

is submitted for relisting under section 510 if the generic 

new animal drug product has been withdrawn from listing 

and relisted. After such fee is paid for that fiscal year, such 

fee shall be due each subsequent fiscal year that the product remains listed, 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.—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 AMOUNTS.—Subject to subsections (c), (d), (f), and (g), the 

fees required under subsection (a) shall be established to generate 

fee revenue amounts as follows: 

(1) TOTAL FEE REVENUES FOR APPLICATION FEES.—The total 

fee revenues to be collected in abbreviated application fees 

under subsection (a)(1) shall be $1,832,000 for fiscal year 2014, 

$1,736,000 for fiscal year 2015, $1,857,000 for fiscal year 2016, 

$1,984,000 for fiscal year 2017, and $2,117,000 for fiscal year 

2018. 


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(2) TOTAL FEE REVENUES FOR PRODUCT FEES.—The total fee 

revenues to be collected in generic new animal drug product fees 

under subsection (a)(2) shall be $2,748,000 for fiscal year 2014, 

$2,604,000 for fiscal year 2015, $2,786,000 for fiscal year 2016, 

$2,976,000 for fiscal year 2017, and $3,175,000 for fiscal year 

2018. 

(3) TOTAL FEE REVENUES FOR SPONSOR FEES.—The total fee 

revenues to be collected in generic new animal drug sponsor fees 

under subsection (a)(3) shall be $2,748,000 for fiscal year 2014, 

$2,604,000 for fiscal year 2015, $2,786,000 for fiscal year 2016, 

$2,976,000 for fiscal year 2017, and $3,175,000 for fiscal year 

2018. 

(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) WORKLOAD ADJUSTMENT.—The fee revenues shall be adjusted each fiscal year after fiscal year 2014 to reflect changes 

in review workload. With respect to such adjustment: 

(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). 

(3) FINAL YEAR ADJUSTMENT.—For fiscal year 2018, 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 2019. 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 2018. 

(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 abbreviated applications for generic new 

animal drugs. 


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(d) FEE WAIVER OR REDUCTION.—The Secretary shall grant a 

waiver from or a reduction of 1 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. 

(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— 


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(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.—There are authorized to be appropriated for fees under this section— (A) $7,328,000 for fiscal year 2014; 

(B) $6,944,000 for fiscal year 2015; 

(C) $7,429,000 for fiscal year 2016; 

(D) $7,936,000 for fiscal year 2017; and 

(E) $8,467,000 for fiscal year 2018; 

as adjusted to reflect adjustments in the total fee revenues made 

under this section and changes in the total amounts collected 

by abbreviated application fees, generic new animal drug sponsor fees, and generic new animal drug product fees. 

(4) 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. 


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(h) COLLECTION OF UNPAID FEES.—In any case where the Secretary does not receive payment of a fee assessed under subsection 

(a) within 30 days after it is due, such fee shall be treated as a 

claim of the United States Government subject to subchapter II of 

chapter 37 of title 31, United States Code. 

(i) 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 section 742: 

(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 section 512(b)(2). Such term does not include a supplemental abbreviated application for a generic new 

animal drug. 

(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 


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(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 section 512(j) for a generic new animal drug intended to be the subject of an abbreviated application or a 

supplemental abbreviated application; or 

(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 section 735(11)). 

(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 


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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. 

SEC. 742. REAUTHORIZATION; REPORTING REQUIREMENTS. 

(a) PERFORMANCE REPORTS.—Beginning with fiscal year 2014, 

not later than 120 days after the end of each fiscal year during 

which fees are collected under this part, 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 2013 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 2014, not later 

than 120 days after the end of each fiscal year during which fees 

are collected under this part, 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. 


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(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 2018, and for the reauthorization of this 

part 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 part, 

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 part; 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 part 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, 2018, the Secretary shall transmit to Congress the 

revised recommendations under paragraph (4), a summary of 


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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. 

* * * * * * * 

PUBLIC LAW 110–316 

* * * * * * * 

SECTION 1. TABLE OF CONTENTS 

The table of contents of this Act is as follows: 

Sec. 1. Table of contents. 

Sec. 2. References in Act. 

TITLE I—ANIMAL DRUG USER FEE AMENDMENTS 

Sec. 101. Short title; finding. 

* * * * * * * 

øSec. 108. Sunset dates.¿ 

* * * * * * * 

øSec. 204. Sunset dates.¿ 

* * * * * * * 

TITLE I—ANIMAL DRUG USER FEE 

AMENDMENTS 

SEC. 101. SHORT TITLE; FINDING 

(a) SHORT TITLE.—This title may be cited as the ‘‘Animal Drug 

User Fee Amendments of 2008’’. 

* * * * * * * 

øSEC. 108. SUNSET DATES. 

ø(a) AUTHORIZATION.—The amendments made by sections 102 

and 103 cease to be effective October 1, 2013. 

ø(b) REPORTING REQUIREMENTS.—The amendment made by section 104 ceases to be effective January 31, 2014.¿ 

* * * * * * * 


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TITLE II—ANIMAL GENERIC DRUG USER 

FEE 

SEC. 201. SHORT TITLE; FINDINGS 

(a) SHORT TITLE.—This title may be cited as the ‘‘Animal Generic 

Drug User Fee Act of 2008’’. 

* * * * * * * 

øSEC. 204. SUNSET DATES 

ø(a) AUTHORIZATION.—The amendments made by section 202 

shall cease to be effective October 1, 2013. 

ø(b) REPORTING REQUIREMENTS.—The amendment made by section 203 shall cease to be effective January 31, 2014.¿ 

* * * * * * * 

SECTION 5 OF THE ANIMAL DRUG USER FEE ACT OF 

2003 

* * * * * * * 

øSEC. 5. SUNSET. 

øThe amendments made by section 3 shall not be in effect after 

October 1, 2008, and section 4 shall not be in effect after 120 days 

after such date.¿ 

Æ 


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