I 
110TH CONGRESS 
2D SESSION 
H. R. 6432 
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 
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, 
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 spec-
ified, amendments made by this Act to a section or other 
provision of law are amendments to such section or other 
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provision of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 301 et seq.). 
(c) FINDING.—Congress finds that the fees author-
ized by the amendments made in this Act will be dedicated 
toward expediting the animal drug development process 
and the review of new and supplemental animal drug ap-
plications 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 Com-
mittee on Energy and Commerce of the House of Rep-
resentatives and the Chairman of the Committee on 
Health, Education, Labor, and Pensions of the Senate as 
set forth in the Congressional 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 
510’’ and inserting ‘‘that has not been withdrawn’’; 
(2) in paragraph (10), by striking ‘‘year being 
2003’’ and inserting ‘‘month being October 2002’’; 
(3) by redesignating paragraph (11) as para-
graph (12); and 
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(4) 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: ‘‘, 
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.— 
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(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 in fiscal year 2009, 
$4,320,000 in fiscal year 2010, $4,862,000 in 
fiscal year 2011, $5,442,000 in fiscal year 
2012, and $6,061,000 in 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 
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year 2012 exceeds the cumulative amount appro-
priated 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. 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 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 
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expediting the animal drug development process and the 
review of the new and supplemental animal drug applica-
tions 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 admin-
istrative procedures adopted by the Food and Drug Ad-
ministration 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. 
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‘‘(d) REAUTHORIZATION.— 
‘‘(1) 
CONSULTATION.—In 
developing 
rec-
ommendations to present to the Congress with re-
spect to the goals, and plans for meeting the goals, 
for the process for the review of animal drug appli-
cations 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— 
‘‘(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-
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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 month during negotiations 
with the regulated industry, the Secretary shall hold 
discussions with representatives of patient and con-
sumer advocacy groups to continue discussions of 
their views on the reauthorization and their sugges-
tions for changes to this part as expressed under 
paragraph (2). 
‘‘(4) 
PUBLIC
REVIEW
OF
RECOMMENDA-
TIONS.—After negotiations with the regulated indus-
try, the Secretary shall— 
‘‘(A) present the recommendations devel-
oped under paragraph (1) to the Congressional 
committees specified in such paragraph; 
‘‘(B) publish such recommendations in the 
Federal Register; 
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‘‘(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 recommenda-
tions; 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 rec-
ommendations under paragraph (4), a summary of 
the views and comments received under such para-
graph, and any changes made to the recommenda-
tions 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 
Secretary shall make publicly available, on the 
Internet Web site of the Food and Drug Ad-
ministration, minutes of all negotiation meet-
ings conducted under this subsection between 
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the Food and Drug Administration and the reg-
ulated 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. 5. PERIODIC DRUG EXPERIENCE REPORTS. 
(a) REPORTING PERIOD; SUBMISSION DATE.—With 
respect to periodic drug experience reports on antibiotic 
new animal drugs that are required under section 
514.80(b)(4) of title 21, Code of Federal Regulations, the 
Secretary of Health and Human Services (in this section 
referred to as the ‘‘Secretary’’) shall modify such section 
to provide that, in the case of each such report that is 
required on an annual basis— 
(1) the reporting period is the calendar year, 
beginning with calendar year 2008; and 
(2) the report on such a period is due not later 
than March 31 following the end of the period. 
(b) TRANSITIONAL PROVISION.— 
(1) IN
GENERAL.—With respect to periodic 
drug experience reports under section 514.80(b)(4) 
of title 21, Code of Federal Regulations, that, but 
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for the enactment of this Act, would be due during 
the transitional period, the Secretary shall ensure 
that implementation of this section does not result 
in— 
(A) excluding any portion of calendar year 
2007 from consideration; or 
(B) delaying the submission date so that a 
gap of more than 12 months occurs between the 
submission of such reports. 
(2) DEFINITION.—In this subsection, the term 
‘‘transitional period’’ means the period beginning on 
the effective date of the final regulation published 
pursuant to subsection (c) and ending on March 30, 
2009. 
(c) RULEMAKING PROCEDURE.—To carry out this 
section, the Secretary shall publish a final regulation not 
later than 60 days after the date of the enactment of this 
Act. For purposes of such rulemaking, good cause (as such 
term is used in section 553(b) of title 5, United States 
Code) shall be considered to exist. 
SEC. 6. 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 
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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 appli-
cations and supplemental animal drug applications (as de-
fined in such part as of such day) that on or after Sep-
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. 7. EFFECTIVE DATE. 
The amendments made by sections 2, 3, and 4 shall 
take effect on October 1, 2008, or the date of the enact-
ment of this Act, whichever is later, except that fees under 
part 4 of subchapter C of chapter VII of the Federal Food, 
Drug, and Cosmetic Act, as amended by this Act, shall 
be assessed for all animal drug applications and supple-
mental animal drug applications received on or after Octo-
ber 1, 2008, regardless of the date of the enactment of 
this Act. 
SEC. 8. SUNSET DATES. 
(a) AUTHORIZATION.—The amendments made by 
sections 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. 
Æ 
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