IB 
Union Calendar No. 520 
110TH CONGRESS 
2D SESSION 
H. R. 6432 
[Report No. 110–804] 
To amend the Federal Food, Drug, and Cosmetic Act to revise and extend 
the animal drug user fee program, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JULY 8, 2008 
Mr. PALLONE (for himself, Mr. DINGELL, Mr. BARTON of Texas, Mr. DEAL 
of Georgia, and Mr. TOWNS) introduced the following bill; which was re-
ferred to the Committee on Energy and Commerce 
JULY 30, 2008 
Additional sponsor: Ms. DEGETTE 
JULY 30, 2008 
Reported with an amendment, committed to the Committee of the Whole 
House on the State of the Union, and ordered to be printed 
[Strike out all after the enacting clause and insert the part printed in italic] 
[For text of introduced bill, see copy of bill as introduced on July 8, 2008] 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
revise and extend the animal drug user fee program, 
and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE; REFERENCES; FINDING. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Animal Drug User Fee Amendments of 2008’’. 
(b) REFERENCES IN ACT.—Except as otherwise speci-
fied, 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.). 
(c) FINDING.—Congress finds that the fees authorized 
by the amendments made in this Act will be dedicated to-
ward expediting the animal drug development process and 
the review of new and supplemental animal drug applica-
tions and investigational animal drug submissions as set 
forth in the goals identified, for purposes of part 4 of sub-
chapter 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 Con-
gressional Record. 
SEC. 2. 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 
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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 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 para-
graph (12); and 
(5) by inserting after paragraph (10) the fol-
lowing: 
‘‘(11) The term ‘person’ includes an affiliate 
thereof.’’. 
SEC. 3. 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: ‘‘, ex-
cept 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: 
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‘‘(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 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 insert-
ing ‘‘$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)) 
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is amended by striking ‘‘$1,250,000’’ and all that fol-
lows 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.’’. 
(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 fol-
lows 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 fol-
lows 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); 
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(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-
graph (1), the fee revenues shall be further ad-
justed 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 ap-
pears and inserting ‘‘2013’’; and 
(B) by striking ‘‘2009’’ and inserting 
‘‘2014’’. 
(d) AUTHORIZATION OF APPROPRIATIONS.—Subpara-
graphs (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;’’. 
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(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 esti-
mated 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 ap-
propriation account of the Food and Drug Adminis-
tration as provided in paragraph (1), and shall be 
subtracted from the amount of fees that would other-
wise be authorized to be collected under this section 
pursuant to appropriation Acts for fiscal year 2013.’’. 
SEC. 4. 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: 
‘‘SEC. 740A. REAUTHORIZATION; REPORTING REQUIRE-
MENTS. 
‘‘(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 
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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 1(c) of the Animal Drug 
User Fee Amendments of 2008 toward expediting the ani-
mal drug development process and the review of the new 
and supplemental animal drug applications and investiga-
tional animal drug submissions during such fiscal year, the 
future plans of the Food and Drug Administration for meet-
ing 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 applica-
tions are not increased from their current level due to ac-
tivities 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 author-
ity for such fees during such fiscal year and the use, by 
the Food and Drug Administration, of the fees collected dur-
ing such fiscal year for which the report is made. 
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‘‘(c) PUBLIC AVAILABILITY.—The Secretary shall make 
the reports required under subsections (a) and (b) available 
to the public on the Internet Web site of the Food and Drug 
Administration. 
‘‘(d) REAUTHORIZATION.— 
‘‘(1) 
CONSULTATION.—In 
developing 
rec-
ommendations 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 Com-
merce 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 con-
sumer advocacy groups; and 
‘‘(F) the regulated industry. 
‘‘(2) PRIOR PUBLIC INPUT.—Prior to beginning 
negotiations with the regulated industry on the reau-
thorization of this part, the Secretary shall— 
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‘‘(A) publish a notice in the Federal Reg-
ister requesting public input on the reauthoriza-
tion; 
‘‘(B) hold a public meeting at which the 
public may present its views on the reauthoriza-
tion, 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 fre-
quently 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 discus-
sions 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— 
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‘‘(A) present the recommendations developed 
under paragraph (1) to the Congressional com-
mittees 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 rec-
ommendations; 
‘‘(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 recommenda-
tions 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 pre-
senting the recommendations developed under 
paragraphs (1) through (5) to the Congress, the 
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Secretary shall make publicly available, on the 
Internet Web site of the Food and Drug Admin-
istration, minutes of all negotiation meetings 
conducted under this subsection between the Food 
and Drug Administration and the regulated in-
dustry. 
‘‘(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. 5. ANTIMICROBIAL ANIMAL DRUG DISTRIBUTION RE-
PORTS. 
(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 in-
gredient, 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— 
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‘‘(i) by container size, strength, and dosage form; 
‘‘(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, indica-
tions, 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 infor-
mation reported under this paragraph publicly available, 
except that— 
‘‘(i) the summary data shall be reported by anti-
microbial class, and no class with fewer than 3 dis-
tinct sponsors of approved applications shall be inde-
pendently reported; and 
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‘‘(ii) the data shall be reported in a manner con-
sistent 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 Act, 
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 peri-
odic 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 Act). 
SEC. 6. DESTRUCTION OF COUNTERFEIT ANIMAL DRUGS 
OFFERED FOR IMPORT. 
Section 801(a) (21 U.S.C. 381(a)) is amended— 
(1) in the third sentence, by inserting ‘‘or (4) 
such article is a counterfeit drug intended for use for 
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animals other than man,’’ before ‘‘then such article 
shall be refused admission’’; and 
(2) by striking ‘‘Clause (2) of the third sentence 
of this paragraph’’ and inserting ‘‘Notwithstanding 
the preceding sentence, the Secretary of the Treasury 
shall cause the destruction of any such article refused 
admission if (1) the article is a drug intended for use 
for animals other than man, the article appears to be 
adulterated, misbranded, or in violation of section 
505, and the article has a value less than $2,000 or 
such amount as the Secretary of Health and Human 
Services may determine by regulation; or (2) the arti-
cle appears to be a counterfeit drug intended for use 
for animals other than man. Clause (2) of the third 
sentence of this subsection’’. 
SEC. 7. SAVINGS CLAUSE. 
Notwithstanding section 5 of the Animal Drug User 
Fee Act of 2003 (21 U.S.C. 379j–11 note), and notwith-
standing the amendments made by this Act, part 4 of sub-
chapter 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 Act, shall 
continue to be in effect with respect to animal drug applica-
tions and supplemental animal drug applications (as de-
fined in such part as of such day) that on or after Sep-
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tember 1, 2003, but before October 1, 2008, were accepted 
by the Food and Drug Administration for filing with re-
spect to assessing and collecting any fee required by such 
part for a fiscal year prior to fiscal year 2009. 
SEC. 8. EFFECTIVE DATE. 
The amendments made by sections 2, 3, and 4 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 Act, 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 Act. 
SEC. 9. SUNSET DATES. 
(a) AUTHORIZATION.—The amendments made by sec-
tions 2 and 3 cease to be effective October 1, 2013. 
(b) REPORTING REQUIREMENTS.—The amendment 
made by section 4 ceases to be effective January 31, 2014. 
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Union Calendar No. 520 
110TH CONGRESS 
2D SESSION 
H. R. 6432 
[Report No. 110–804] 
A BILL 
To amend the Federal Food, Drug, and Cosmetic 
Act to revise and extend the animal drug user fee 
program, and for other purposes. 
JULY 30, 2008 
Reported with an amendment, committed to the Com-
mittee of the Whole House on the State of the Union, 
and ordered to be printed 
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