Be it enacted by the Senate and House of Representa-
tives 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 amend-
ments 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 author-
ized by the amendments made in this title will be dedi-
cated toward expediting the animal drug development 
process and the review of new and supplemental animal 
drug applications and investigational animal drug submis-
sions 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 prod-
ucts 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510’’ and inserting ‘‘that has not been withdrawn by 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withdrawn by the Secretary’’; 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 ap-
proved’’ and inserting ‘‘but not after such applica-
tion has been approved’’;
(3) in paragraph (10), by striking ‘‘year being 
2003’’ and inserting ‘‘month being October 2002’’; 
(4) by redesignating paragraph (11) as para-
graph (12); and 
(5) by inserting after paragraph (10) the fol-
lowing: 
‘‘(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 cri-
teria 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 per-
cent of the amount of the fee under clause 
(i), for— 
‘‘(I) a supplemental animal drug 
application for which safety or effec-
tiveness data are required; and
‘‘(II) an animal drug application 
subject to the criteria set forth in sec-
tion 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 sup-
plemental and other animal drug application 
fees’’; and 
(B) by striking ‘‘$1,250,000’’ and all that 
follows through the period at the end and in-
serting ‘‘$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 for fiscal year 2010, $4,862,000 for fis-
cal year 2011, $5,442,000 for fiscal year 2012, and 
$6,061,000 for fiscal year 2013.’’.
(3) TOTAL
FEE
REVENUES
FOR
ESTABLISH-
MENT 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 fis-
cal 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 fis-
cal 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 ad-
justed for inflation in accordance with para-