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.
PL 110-316 (H.R.6432), enacted 08/14/2008

122 STAT. 3509 
PUBLIC LAW 110–316—AUG. 14, 2008 
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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122 STAT. 3510 
PUBLIC LAW 110–316—AUG. 14, 2008 
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 applica-
tion 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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122 STAT. 3511 
PUBLIC LAW 110–316—AUG. 14, 2008 
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.—Sec-
tion 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 para-
graphs (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 appro-
priation account of the Food and Drug Administration as pro-
vided 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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122 STAT. 3512 
PUBLIC LAW 110–316—AUG. 14, 2008 
‘‘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 identi-
fied 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 submis-
sions 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 Administra-
tion. 
‘‘(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 sub-
section (a); 
Notice. 
Federal Register, 
publication. 
Recommenda- 
tions. 
Web site. 
Effective dates. 
21 USC 379j–13. 
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122 STAT. 3513 
PUBLIC LAW 110–316—AUG. 14, 2008 
‘‘(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 representa-
tives 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 negotia-
tions 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 Reg-
ister; 
‘‘(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 com-
ments, 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 rec-
ommendations developed under paragraphs (1) through (5) 
to the Congress, the Secretary shall make publicly avail-
able, on the Internet Web site of the Food and Drug 
Administration, minutes of all negotiation meetings con-
ducted under this subsection between the Food and Drug 
Administration and the regulated industry. 
‘‘(B) CONTENT.—The minutes described under subpara-
graph (A) shall summarize any substantive proposal made 
by any party to the negotiations as well as significant 
controversies or differences of opinion during the negotia-
tions 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 para-
graph (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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122 STAT. 3514 
PUBLIC LAW 110–316—AUG. 14, 2008 
‘‘(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 enact-
ment 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 amend-
ments 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 
information. 
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122 STAT. 3515 
PUBLIC LAW 110–316—AUG. 14, 2008 
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 sec-
tion 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 aug-
menting 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 Com-
mittee 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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122 STAT. 3516 
PUBLIC LAW 110–316—AUG. 14, 2008 
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 applica-
tion. 
‘‘(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 applica-
tion 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 per-
son— 
‘‘(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 investiga-
tional submission, 
shall be assessed an annual fee established under sub-
section (b). The fee shall be paid on or before January 
31 of each year. 
Deadline. 
Deadline. 
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122 STAT. 3517 
PUBLIC LAW 110–316—AUG. 14, 2008 
‘‘(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 sub-
section (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 Sec-
retary 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 investiga-
tional generic new animal drug protocol submissions sub-
mitted to the Secretary. The Secretary shall publish in 
the Federal Register the fees resulting from this adjust-
ment 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 estab-
lished 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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122 STAT. 3518 
PUBLIC LAW 110–316—AUG. 14, 2008 
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 oper-
ating 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 estab-
lished 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 applica-
tion 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 sub-
section (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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122 STAT. 3519 
PUBLIC LAW 110–316—AUG. 14, 2008 
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 trans-
ferred 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 avail-
able solely for the process for the review of abbreviated applica-
tions for generic new animal drugs. 
‘‘(2) COLLECTIONS AND APPROPRIATION ACTS.— 
‘‘(A) IN
GENERAL.—The fees authorized by this sec-
tion— 
‘‘(i) shall be retained in each fiscal year in an 
amount not to exceed the amount specified in appro-
priation Acts, or otherwise made available for obliga-
tion 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 equiva-
lent 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 adjust-
ment 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 appro-
priation account of the Food and Drug Administration as pro-
vided 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 sub-
section (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 accord-
ance 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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122 STAT. 3521 
PUBLIC LAW 110–316—AUG. 14, 2008 
‘‘(A) officers and employees of the Food and Drug 
Administration, contractors of the Food and Drug Adminis-
tration, 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 fix-
tures, 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 exemp-
tion 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 effective-
ness of a generic new animal drug in the event of the 
filing of an abbreviated application or supplemental abbre-
viated 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, supple-
mental abbreviated applications, and investigational submis-
sions: 
‘‘(A) The activities necessary for the review of abbre-
viated applications, supplemental abbreviated applications, 
and investigational submissions. 
‘‘(B) The issuance of action letters which approve abbre-
viated applications or supplemental abbreviated applica-
tions 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 applica-
tions, supplemental applications, or submissions in condi-
tion 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 abbre-
viated application for a generic new animal drug’ and ‘supple-
mental 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 Com-
merce 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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122 STAT. 3523 
PUBLIC LAW 110–316—AUG. 14, 2008 
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, supple-
mental 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 Administra-
tion. 
‘‘(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 sub-
section (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 representa-
tives of veterinary, patient, and consumer advocacy groups 
to continue discussions of their views on the reauthorization 
Deadlines. 
Web site. 
Notice. 
Federal Register, 
publication. 
Recommenda- 
tions. 
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 negotia-
tions 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 Reg-
ister; 
‘‘(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 com-
ments, 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 rec-
ommendations developed under paragraphs (1) through (5) 
to Congress, the Secretary shall make publicly available, 
on the Internet Web site of the Food and Drug Administra-
tion, 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 subpara-
graph (A) shall summarize any substantive proposal made 
by any party to the negotiations as well as significant 
controversies or differences of opinion during the negotia-
tions 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 sec-
tion 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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122 STAT. 3525 
PUBLIC LAW 110–316—AUG. 14, 2008 
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. 
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 ele-
ments:’’; 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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