‘‘(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— 
‘‘(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 
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‘‘(E) after consideration of such public 
views and comments, revise such recommenda-
tions as necessary. 
‘‘(5) TRANSMITTAL OF RECOMMENDATIONS.—Not 
later than January 15, 2018, 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 pre-
senting the recommendations developed under 
paragraphs (1) through (5) to Congress, the Sec-
retary 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 
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or differences of opinion during the negotiations 
and their resolution.’’. 
SEC. 204. SAVINGS CLAUSE. 
Notwithstanding the amendments made by this title, 
part 5 of subchapter C of chapter VII of the Federal Food, 
Drug, and Cosmetic Act, as in effect on the day before the 
date of enactment of this title, shall continue to be in effect 
with respect to abbreviated applications for a generic new 
animal drug and supplemental abbreviated applications for 
a generic new animal drug (as defined in such part as of 
such day) that on or after October 1, 2008, but before Octo-
ber 1, 2013, were accepted by the Food and Drug Adminis-
tration for filing with respect to assessing and collecting 
any fee required by such part for a fiscal year prior to fiscal 
year 2014. 
SEC. 205. EFFECTIVE DATE. 
The amendments made by this title shall take effect 
on October 1, 2013, or the date of enactment of this title, 
whichever is later, except that fees under part 5 of sub-
chapter C of chapter VII of the Federal Food, Drug, and 
Cosmetic Act, as amended by this title, shall be assessed for 
all abbreviated applications for a generic new animal drug 
and supplemental abbreviated applications for a generic 
new animal drug received on or after October 1, 2013, re-
gardless of the date of enactment of this title. 
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SEC. 206. SUNSET DATES. 
(a) AUTHORIZATION.—Section 741 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21) shall 
cease to be effective October 1, 2018. 
(b) REPORTING REQUIREMENTS.—Section 742 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 
22) shall cease to be effective January 31, 2019. 
(c) PREVIOUS SUNSET PROVISION.— 
(1) IN GENERAL.—Section 204 of the Animal Ge-
neric Drug User Fee Act of 2008 (Public Law 110– 
316) is repealed. 
(2) CONFORMING
AMENDMENT.—Public Law 
110–316 (122 Stat. 3509) is amended in the table of 
contents in section 1, by striking the item relating to 
section 204. 
Amend the title so as to read: ‘‘A bill to amend the 
Federal Food, Drug, and Cosmetic Act to reauthorize 
user fee programs relating to new animal drugs and ge-
neric new animal drugs.’’. 
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Union Calendar No. 135 
113TH CONGRESS 
1ST SESSION 
H. R. 1407 
[Report No. 113–188] 
A BILL 
To amend the Federal Food, Drug, and Cosmetic 
Act to reauthorize user fee programs relating to 
new animal drugs. 
AUGUST 2, 2013 
Reported with amendments, committed to the Committee 
of the Whole House on the State of the Union, and or-
dered to be printed 
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