S. 622 

One Hundred Thirteenth Congress 

of the 

United States of America 

AT THE FIRST SESSION 

Begun and held at the City of Washington on Thursday, 

the third day of January, two thousand and thirteen 

An Act 

To amend the Federal Food, Drug, and Cosmetic Act to reauthorize user fee programs 

relating to new animal drugs and generic new animal drugs. 

Be it enacted by the Senate and House of Representatives of 

the United States of America in Congress assembled, 

SECTION 1. SHORT TITLE. 

This Act may be cited as the ‘‘Animal Drug and Animal Generic 

Drug User Fee Reauthorization Act of 2013’’. 

SEC. 2. TABLE OF CONTENTS; REFERENCES IN ACT. 

(a) TABLE OF CONTENTS.—The table of contents of this Act 

is as follows: 

Sec. 1. Short title. 

Sec. 2. Table of contents; references in Act. 

TITLE I—FEES RELATING TO ANIMAL DRUGS 

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—FEES RELATING TO GENERIC ANIMAL DRUGS 

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. 

(b) REFERENCES IN ACT.—Except as otherwise specified, amendments made by this Act to a section or other provision of law 

are amendments to such section or other provision of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). 

TITLE I—FEES RELATING TO ANIMAL 

DRUGS 

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 
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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 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. 
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‘‘(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; 
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‘‘(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: 

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

drug application, except an animal drug application 

subject to the criteria set forth 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 subject to the 

criteria set forth 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. 
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‘‘(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 
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assessed a fee under paragraph (2) unless the animal drug 

establishment listed in the application does not engage 

in the manufacture of the animal drug product during 

the fiscal year. The fee under this paragraph for a fiscal 

year shall be due upon the later of— 

‘‘(i) the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under 

this section; or 

‘‘(ii) January 31 of each year. 

‘‘(C) LIMITATION.— ‘‘(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); 
S. 622—7 

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

business’ means an entity that has fewer than 500 

employees, including employees of affiliates. 

‘‘(B) WAIVER OF APPLICATION FEE.—The Secretary shall 

waive under paragraph (1)(E) the application fee for the 

first animal drug application that a small business or its 

affiliate submits to the Secretary for review. After a small 

business or its affiliate is granted such a waiver, the small 

business or its affiliate shall pay application fees for all 

subsequent animal drug applications and supplemental 

animal drug applications for which safety or effectiveness 

data are required in the same manner as an entity that 

does not qualify as a small business. 

‘‘(C) CERTIFICATION.—The Secretary shall require any 

person who applies for a waiver under paragraph (1)(E) 

to certify their qualification for the waiver. The Secretary 

shall periodically publish in the Federal Register a list 

of persons making such certifications. 

‘‘(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 
S. 622—10 

obligation only to the extent and in the amount provided in 

advance in appropriations Acts. Such fees are authorized to 

be appropriated to remain available until expended. Such sums 

as may be necessary may be transferred from the Food and 

Drug Administration salaries and expenses appropriation 

account without fiscal year limitation to such appropriation 

account for salary and expenses with such fiscal year limitation. 

The sums transferred shall be available solely for the process 

for the review of animal drug applications. 

‘‘(2) COLLECTIONS AND APPROPRIATION ACTS.— ‘‘(A) IN GENERAL.—The fees authorized by this section— 

‘‘(i) subject to subparagraph (C), shall be collected 

and available in each fiscal year in an amount not 

to exceed the amount specified in appropriation Acts, 

or otherwise made available for obligation for such 

fiscal year, and 

‘‘(ii) shall be available to defray increases in the 

costs of the resources allocated for the process for 

the review of animal drug applications (including 

increases in such costs for an additional number of 

full-time equivalent positions in the Department of 

Health and Human Services to be engaged in such 

process) over such costs, excluding costs paid from 

fees collected under this section, for fiscal year 2003 

multiplied by the adjustment factor. 

‘‘(B) COMPLIANCE.—The Secretary shall be considered 

to have met the requirements of subparagraph (A)(ii) in 

any fiscal year if the costs funded by appropriations and 

allocated for the process for the review of animal drug 

applications— 

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

specified in subparagraph (A)(ii); or 

‘‘(ii)(I) are more than 3 percent below the level 

specified in subparagraph (A)(ii), and fees assessed 

for the fiscal year following the subsequent fiscal year 

are decreased by the amount in excess of 3 percent 

by which such costs fell below the level specified in 

subparagraph (A)(ii); and 

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

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

‘‘(C) PROVISION FOR EARLY PAYMENTS.—Payment of fees 

authorized under this section for a fiscal year, prior to 

the due date for such fees, may be accepted by the Secretary 

in accordance with authority provided in advance in a 

prior year appropriations Act. 

‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—For each of the 

fiscal years 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 COLLEC- TION 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 
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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 
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‘‘(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: 

‘‘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 Health, Education, Labor, and 

Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report concerning the 

progress of the Food and Drug Administration in achieving the 

goals identified in the letters described in section 101(b) of the 

Animal Drug User Fee Amendments of 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 Health, Education, Labor, and Pensions 

of the Senate and the Committee on Energy and Commerce of 

the House of Representatives a report on the implementation of 

the authority for such fees during such fiscal year and the use, 

by the Food and Drug Administration, of the fees collected during 

such fiscal year for which the report is made. 

‘‘(c) PUBLIC AVAILABILITY.—The Secretary shall make the 

reports required under subsections (a) and (b) available to the 

public on the Internet Web site of the Food and Drug Administration. 

‘‘(d) REAUTHORIZATION.— 

‘‘(1) CONSULTATION.—In developing recommendations to 

present to the Congress with respect to the goals, and plans 

for meeting the goals, for the process for the review of animal 

drug applications for the first 5 fiscal years after fiscal year 

2018, and for the reauthorization of this part for such fiscal 

years, the Secretary shall consult with— 

‘‘(A) the Committee on Health, Education, Labor, and 

Pensions of the Senate; 

‘‘(B) the Committee on Energy and Commerce of the 

House of Representatives; 

‘‘(C) scientific and academic experts; 

‘‘(D) veterinary professionals; 

‘‘(E) representatives of patient and consumer advocacy 

groups; and 

‘‘(F) the regulated industry. 
S. 622—13 

‘‘(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 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 
S. 622—14 

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 Act, 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 Act. 

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.—The Animal Drug User Fee 

Amendments of 2008 (Public Law 110–316) 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—FEES RELATING TO GENERIC 

ANIMAL DRUGS 

SEC. 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. 
S. 622—15 

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: 

‘‘(1) ABBREVIATED APPLICATION FEE.— 

‘‘(A) IN GENERAL.—Each person that submits, on or 

after July 1, 2008, an abbreviated application for a generic 

new animal drug shall be subject to a fee as established 

in subsection (c) for such an application. 

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

shall be due upon submission of the abbreviated application. 

‘‘(C) EXCEPTIONS.— 

‘‘(i) PREVIOUSLY FILED APPLICATION.—If an abbreviated application was submitted by a person that 

paid the fee for such application, was accepted for 

filing, and was not approved or was withdrawn (without a waiver or refund), the submission of an abbreviated application for the same product by the same 

person (or the person’s licensee, assignee, or successor) 

shall not be subject to a fee under subparagraph (A). 

‘‘(ii) CERTAIN ABBREVIATED APPLICATIONS

INVOLVING COMBINATION ANIMAL DRUGS.—An abbreviated application which is subject to the criteria in 

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, 
S. 622—16 

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: 

‘‘(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, 
S. 622—17 

$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 
S. 622—18 

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 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.— 
S. 622—19 

‘‘(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; 

‘‘(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. 
S. 622—20 

‘‘(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 
S. 622—21 

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 abbreviated applications, supplemental abbreviated 
S. 622—22 

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 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 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. 
S. 622—23 

‘‘(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 
S. 622—24 

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.’’. 

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 Act, 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 Act. 

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.—The Animal Generic Drug 

User Fee Act of 2008 (Public Law 110–316) is amended in 
S. 622—25 

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

to section 204. 

Speaker of the House of Representatives. 

Vice President of the United States and

President of the Senate.