‘‘(11) SUPPLEMENTAL
ABBREVIATED
APPLICA-
TION FOR GENERIC NEW ANIMAL DRUG.—The terms 
‘supplemental abbreviated application for a generic 
new animal drug’ and ‘supplemental abbreviated ap-
plication’ mean a request to the Secretary to approve 
a change in an approved abbreviated application.’’. 
SEC. 4. 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 3, is amended by inserting after section 
741 the following: 
‘‘SEC. 
742. 
REAUTHORIZATION; 
REPORTING 
REQUIRE-
MENTS. 
‘‘(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 Commerce of the House of 
Representatives a report concerning the progress of the Food 
and Drug Administration in achieving the goals identified 
in the letters described in section 2(3) of the Animal Generic 
Drug User Fee Act of 2008 toward expediting the generic 
new animal drug development process and the review of ab-
breviated applications for generic new animal drugs, sup-
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PWALKER on PROD1PC71 with BILLS
plemental abbreviated applications for generic new animal 
drugs, and investigational submissions for generic new ani-
mal 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 au-
thority 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. 
‘‘(d) REAUTHORIZATION.— 
‘‘(1) 
CONSULTATION.—In 
developing 
rec-
ommendations 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 
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PWALKER on PROD1PC71 with BILLS
this part for such fiscal years, the Secretary shall con-
sult 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-
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 
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PWALKER on PROD1PC71 with BILLS
‘‘(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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PWALKER on PROD1PC71 with BILLS
‘‘(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 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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