PUBLIC LAW 110–316—AUG. 14, 2008 122 STAT. 3509 

Public Law 110–316 

110th Congress 

An Act 

To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the 

animal drug user fee program, to establish a program of fees relating to generic 

new animal drugs, to make certain technical corrections to the Food and Drug 

Administration Amendments Act of 2007, and for other purposes. 

Be it enacted by the Senate and House of Representatives of 

the United States of America in Congress assembled, 

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. 

Sec. 102. Definitions. 

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

Sec. 104. Reauthorization; reporting requirements. 

Sec. 105. Antimicrobial animal drug distribution reports. 

Sec. 106. Savings clause. 

Sec. 107. Effective date. 

Sec. 108. Sunset dates. 

TITLE II—ANIMAL GENERIC DRUG USER FEE 

Sec. 201. Short title; findings. 

Sec. 202. Fees relating to abbreviated applications for generic new animal drugs. 

Sec. 203. Accountability and reports. 

Sec. 204. Sunset dates. 

TITLE III—TECHNICAL CORRECTIONS TO FDAAA 

Sec. 301. Consideration of certain petitions. 

Sec. 302. Registry and results data bank. 

SEC. 2. 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—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’’. 

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

amendments made in this title will be dedicated toward expediting 

21 USC 379j–11 

note. 

21 USC 301 note. 

Animal Drug 

User Fee 

Amendments 

of 2008. 

Aug. 14, 2008 

[H.R. 6432] 


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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 (21 U.S.C. 379j–11) is amended— 

(1) in paragraph (6), by striking ‘‘, except for an approved 

application for which all subject products have been removed 

from listing under section 510’’ and inserting ‘‘that has not 

been withdrawn by the applicant and for which approval has 

not been withdrawn by the Secretary’’; 

(2) in paragraph (8)(H), by striking ‘‘but not such activities 

after an animal drug has been approved’’ and inserting ‘‘but 

not after such application has been approved’’; 

(3) in paragraph (10), by striking ‘‘year being 2003’’ and 

inserting ‘‘month being October 2002’’; 

(4) by redesignating paragraph (11) as paragraph (12); 

and 

(5) by inserting after paragraph (10) the following: 

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

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

(a) TYPES OF FEES.—Section 740(a) (21 U.S.C. 379j–12(a)) is 

amended— 

(1) in paragraph (1)(A)(i), by inserting after ‘‘for an animal 

drug application’’ the following: ‘‘, except an animal drug 

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

and 

(2) by amending paragraph (1)(A)(ii) to read as follows: 

‘‘(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— 

‘‘(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) FEE AMOUNTS.— (1) TOTAL FEE REVENUES FOR APPLICATION AND SUPPLEMENT

FEES.—Section 740(b)(1) (21 U.S.C. 379j–12(b)(1)) is amended— 

(A) by striking ‘‘and supplemental animal drug application fees’’ and inserting ‘‘and supplemental and other 

animal drug application fees’’; and 

(B) by striking ‘‘$1,250,000’’ and all that follows 

through the period at the end and inserting ‘‘$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.’’. 

(2) TOTAL FEE REVENUES FOR PRODUCT FEES.—Section 

740(b)(2) (21 U.S.C. 379j–12(b)(2)) is amended by striking 

‘‘$1,250,000’’ and all that follows through the period at the 

end and inserting ‘‘$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.’’. 

(3) TOTAL FEE REVENUES FOR ESTABLISHMENT FEES.—Section 740(b)(3) (21 U.S.C. 379j–12(b)(3)) is amended by striking 

‘‘$1,250,000’’ and all that follows through the period at the 

end and inserting ‘‘$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.’’. 

(4) TOTAL FEE REVENUES FOR SPONSOR FEES.—Section 

740(b)(4) (21 U.S.C. 379j–12(b)(4)) is amended by striking 

‘‘$1,250,000’’ and all that follows through the period at the 

end and inserting ‘‘$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.’’. 

(c) ADJUSTMENTS TO FEES.—Section 740(c) (21 U.S.C. 379j– 

12(c)) is amended— 

(1) by striking paragraph (1); 

(2) by redesignating paragraphs (2) through (5) as paragraphs (1) through (4), respectively; 

(3) in paragraph (1), as so redesignated— 

(A) in the matter preceding subparagraph (A), by 

striking ‘‘After the fee revenues are adjusted for inflation 

in accordance with paragraph (1), the fee revenues shall 

be further adjusted each fiscal year after fiscal year 2004’’ 

and inserting ‘‘The fee revenues shall be adjusted each 

fiscal year after fiscal year 2009’’; and 

(B) in subparagraph (B), by striking ‘‘, as adjusted 

for inflation under paragraph (1)’’; and 

(4) in paragraph (2), as so redesignated— 

(A) by striking ‘‘2008’’ each place it appears and 

inserting ‘‘2013’’; and 

(B) by striking ‘‘2009’’ and inserting ‘‘2014’’. 

(d) AUTHORIZATION OF APPROPRIATIONS.—Subparagraphs (A) 

through (E) of section 740(g)(3) (21 U.S.C. 379j–12(g)(3)) are 

amended to read as follows: 

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

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

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

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

‘‘(E) $24,244,000 for fiscal year 2013;’’. 

(e) OFFSET.—Section 740(g)(4) (21 U.S.C. 379j–12(g)(4)) is 

amended to read as follows: 

‘‘(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.’’. 

SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS. 

Part 4 of subchapter C of chapter VII (21 U.S.C. 379j–11 

et seq.) is amended by inserting after section 740 the following: 


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

‘‘(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. 

‘‘(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. 

‘‘(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 

2013, 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); 

Notice. 

Federal Register, 

publication. 

Recommendations. 

Web site. 

Effective dates. 

21 USC 379j–13. 


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‘‘(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, 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. 

‘‘(6) MINUTES OF NEGOTIATION MEETINGS.— 

‘‘(A) PUBLIC AVAILABILITY.—Before presenting the recommendations developed under paragraphs (1) through (5) 

to the Congress, the Secretary shall make publicly available, on the Internet Web site of the Food and Drug 

Administration, minutes of all negotiation meetings conducted under this subsection between the Food and Drug 

Administration and the 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. ANTIMICROBIAL ANIMAL DRUG DISTRIBUTION REPORTS. 

(a) REPORTS.—Section 512(l) (21 U.S.C. 360b(l)) is amended 

by adding at the end the following: 

‘‘(3)(A) In the case of each new animal drug described in paragraph (1) that contains an antimicrobial active ingredient, the 

sponsor of the drug shall submit an annual report to the Secretary 

on the amount of each antimicrobial active ingredient in the drug 

that is sold or distributed for use in food-producing animals, 

including information on any distributor-labeled product. 

‘‘(B) Each report under this paragraph shall specify the amount 

of each antimicrobial active ingredient— 

‘‘(i) by container size, strength, and dosage form; 

Web site. 

Deadline. 

Comments. 

Federal Register, 

publication. 

Deadlines. 

Web site. 


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‘‘(ii) by quantities distributed domestically and quantities 

exported; and 

‘‘(iii) by dosage form, including, for each such dosage form, 

a listing of the target animals, indications, and production 

classes that are specified on the approved label of the product. 

‘‘(C) Each report under this paragraph shall— 

‘‘(i) be submitted not later than March 31 each year; 

‘‘(ii) cover the period of the preceding calendar year; and 

‘‘(iii) include separate information for each month of such 

calendar year. 

‘‘(D) The Secretary may share information reported under this 

paragraph with the Antimicrobial Resistance Task Force established 

under section 319E of the Public Health Service Act. 

‘‘(E) The Secretary shall make summaries of the information 

reported under this paragraph publicly available, except that— 

‘‘(i) the summary data shall be reported by antimicrobial 

class, and no class with fewer than 3 distinct sponsors of 

approved applications shall be independently reported; and 

‘‘(ii) the data shall be reported in a manner consistent 

with protecting both national security and confidential business 

information.’’. 

(b) FIRST REPORT.—For each new animal drug that is subject 

to the reporting requirement under section 512(l)(3) of the Federal 

Food, Drug, and Cosmetic Act, as added by subsection (a), and 

for which an approval of an application filed pursuant to section 

512(b) or 571 of such Act is in effect on the date of the enactment 

of this title, the Secretary of Health and Human Services shall 

require the sponsor of the drug to submit the first report under 

such section 512(l)(3) for the drug not later than March 31, 2010. 

(c) SEPARATE REPORT.—The reports required under section 

512(l)(3) of the Federal Food, Drug, and Cosmetic Act, as added 

by subsection (a), shall be separate from periodic drug experience 

reports that are required under section 514.80(b)(4) of title 21, 

Code of Federal Regulations (as in effect on the date of the enactment of this title). 

SEC. 106. SAVINGS CLAUSE. 

Notwithstanding section 5 of the Animal Drug User Fee Act 

of 2003 (21 U.S.C. 379j–11 note), and 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 September 

1, 2003, but before October 1, 2008, 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 2009. 

SEC. 107. EFFECTIVE DATE. 

The amendments made by sections 102, 103, and 104 shall 

take effect on October 1, 2008, and 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 such date, regardless of the date of the enactment 

of this title. 

21 USC 379j–11 

note. 

21 USC 379j–11 

note. 

21 USC 360b 

note. 

Public 

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SEC. 108. SUNSET DATES. 

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

and 103 cease to be effective October 1, 2013. 

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

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’’. 

(b) FINDINGS.—Congress finds as follows: 

(1) Prompt approval of abbreviated applications for safe 

and effective generic new animal drugs will reduce animal 

healthcare costs and promote the well-being of animal health 

and the public health. 

(2) Animal health and the public health will be served 

by making additional funds available for the purpose of augmenting the resources of the Food and Drug Administration 

that are devoted to the process for the review of abbreviated 

applications for the approval of generic new animal drugs. 

(3) The fees authorized by this title 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. FEES RELATING TO ABBREVIATED APPLICATIONS FOR 

GENERIC NEW ANIMAL DRUGS. 

(a) REDESIGNATION.—Chapter VII (21 U.S.C. 371 et seq.) is 

amended by redesignating sections 741, 742, and 746 as sections 

745, 746, and 749, respectively. 

(b) AUTHORITY TO ASSESS AND USE GENERIC NEW ANIMAL

DRUG FEES.—Subchapter C of chapter VII of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 379f et seq.) is amended by 

adding at the end the following: 

‘‘PART 5—FEES RELATING TO GENERIC NEW 

ANIMAL DRUGS 

‘‘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 

Effective date. 

21 USC 379j–21. 

21 USC 379k, 

379l, and 379o. 

21 USC 379j–21 

note. 

21 USC 301 note. 

Animal Generic 

Drug User Fee 

Act of 2008. 

21 USC 379j–11 

note. 


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new animal drug shall be subject to a fee as established 

in subsection (b) for such an application. 

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

shall be due upon submission of the abbreviated application. 

‘‘(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). 

‘‘(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.—Each person— 

‘‘(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 

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

31 of each year. 

Deadline. 

Deadline. 


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‘‘(B) 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)(3) 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)(3) 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)(3) for an applicant with 1 or fewer 

approved abbreviated applications. 

‘‘(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: 

‘‘(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. 

‘‘(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. 

‘‘(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. 

‘‘(c) ADJUSTMENTS.— 

‘‘(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: 

‘‘(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). 

‘‘(2) FINAL YEAR ADJUSTMENT.—For fiscal year 2013, the 

Secretary may further increase the fees to provide for up to 

Federal Register, 

publication. 


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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. 

‘‘(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. 

‘‘(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 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 

Deadline. 

Effective date. 


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PUBLIC LAW 110–316—AUG. 14, 2008 122 STAT. 3519 

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.—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) shall be retained in each fiscal year in an 

amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation for such fiscal year; and 

‘‘(ii) shall 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. 

‘‘(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). 

‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—There are 

authorized to be appropriated for fees under this section— 

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

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

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

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

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


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122 STAT. 3520 PUBLIC LAW 110–316—AUG. 14, 2008 

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 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. 

‘‘(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 incurred in 

connection with the process for the review of abbreviated 

applications for generic new animal drugs for— 

Deadline. 

Deadline. 


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PUBLIC LAW 110–316—AUG. 14, 2008 122 STAT. 3521 

‘‘(A) officers and employees of the Food and Drug 

Administration, contractors of the Food and Drug Administration, advisory committees consulted with respect to the 

review of specific abbreviated applications, supplemental 

abbreviated applications, or investigational submissions, 

and costs related to such officers, employees, committees, 

and contractors, including costs for travel, education, and 

recruitment and other personnel activities; 

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

maintenance, and repair of computer resources; 

‘‘(C) leasing, maintenance, renovation, and repair of 

facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary 

materials and supplies; and 

‘‘(D) collecting fees under this section and accounting 

for resources allocated for the review of abbreviated 

applications, supplemental abbreviated applications, and 

investigational submissions. 

‘‘(4) FINAL DOSAGE FORM.—The term ‘final dosage form’ 

means, with respect to a generic new animal drug product, 

a finished dosage form which is approved for administration 

to an animal without substantial further manufacturing. Such 

term includes generic new animal drug products intended for 

mixing in animal feeds. 

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

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

of an abbreviated application. 

‘‘(6) GENERIC NEW ANIMAL DRUG PRODUCT.—The term 

‘generic new animal drug product’ means each specific strength 

or potency of a particular active ingredient or ingredients in 

final dosage form marketed by a particular manufacturer or 

distributor, which is uniquely identified by the labeler code 

and product code portions of the national drug code, and for 

which an abbreviated application for a generic new animal 

drug or a supplemental abbreviated application has been 

approved. 

‘‘(7) GENERIC NEW ANIMAL DRUG SPONSOR.—The term 

‘generic new animal drug sponsor’ means either an applicant 

named in an abbreviated application for a generic new animal 

drug that has not been withdrawn by the applicant and for 

which approval has not been withdrawn by the Secretary, or 

a person who has submitted an investigational submission for 

a generic new animal drug that has not been terminated or 

otherwise rendered inactive by the Secretary. 

‘‘(8) INVESTIGATIONAL SUBMISSION FOR A GENERIC NEW

ANIMAL DRUG.—The terms ‘investigational submission for a 

generic new animal drug’ and ‘investigational submission’ 

mean— 

‘‘(A) the filing of a claim for an investigational exemption under 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. 


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122 STAT. 3522 PUBLIC LAW 110–316—AUG. 14, 2008 

‘‘(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 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: 

‘‘(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. ACCOUNTABILITY AND REPORTS. 

Part 5 of subchapter C of chapter VII of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 379f et seq.), as added by 

section 202, is amended by inserting after section 741 the following: 

‘‘SEC. 742. REAUTHORIZATION; REPORTING REQUIREMENTS. 

‘‘(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 

Effective date. 

21 USC 379j–22. 


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PUBLIC LAW 110–316—AUG. 14, 2008 122 STAT. 3523 

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. 

‘‘(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. 

‘‘(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 2013, 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 

Deadlines. 

Web site. 

Notice. 

Federal Register, 

publication. 

Recommendations. 

Web site. 

Effective date. 


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122 STAT. 3524 PUBLIC LAW 110–316—AUG. 14, 2008 

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, 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. 

‘‘(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. SUNSET DATES. 

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

shall cease to be effective October 1, 2013. 

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

TITLE III—TECHNICAL CORRECTIONS 

TO FDAAA 

SEC. 301. CONSIDERATION OF CERTAIN PETITIONS. 

Subparagraph (A) of section 505(q)(1) (21 U.S.C. 355(q)(1)) is 

amended by adding at the end the following: 

‘‘Consideration of the petition shall be separate and apart 

from review and approval of any application.’’. 

SEC. 302. REGISTRY AND RESULTS DATA BANK. 

Paragraph (3) of section 402(j) of the Public Health Service 

Act (42 U.S.C. 282(j)) is amended— 

(1) in the matter preceding clause (i) in subparagraph 

(C), by striking ‘‘the following elements’’ and all that follows 

through ‘‘520(m) of such Act:’’ and inserting ‘‘for each applicable 

21 USC 379j–22 

note. 

21 USC 379j–21 

note. 

Web site. 

Deadline. 

Federal Register, 

publication. 


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PUBLIC LAW 110–316—AUG. 14, 2008 122 STAT. 3525 

LEGISLATIVE HISTORY—H.R. 6432: 

HOUSE REPORTS: No. 110–804 (Comm. on Energy and Commerce). 

CONGRESSIONAL RECORD, Vol. 154 (2008): 

July 30, considered and passed House. 

Aug. 1, considered and passed Senate. 

Æ 

clinical trial for a drug that is approved under section 505 

of the Federal Food, Drug, and Cosmetic Act or licensed under 

section 351 of this Act or a device that is cleared under section 

510(k) of the Federal Food, Drug, and Cosmetic Act or approved 

under section 515 or 520(m) of such Act, the following elements:’’; and 

(2) in clauses (i) and (iii) of subparagraph (I), by striking 

the term ‘‘drugs described in subparagraph (C)’’ each place 

such term appears and inserting ‘‘applicable clinical trials 

described in subparagraph (C)’’. 

Approved August 14, 2008. 


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