or supplemental abbreviated application, but 
not such activities after a generic new animal 
drug has been approved. 
‘‘(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 ap-
prove a change in an approved abbreviated applica-
tion.’’. 
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 sec-
tion 741 the following: 
‘‘SEC. 
742. 
REAUTHORIZATION; 
REPORTING 
REQUIRE-
MENTS. 
‘‘(a) PERFORMANCE REPORTS.—Beginning with fis-
cal 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 Com-
mittee 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 achiev-
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ing 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 develop-
ment process and the review of abbreviated applications 
for generic new animal drugs, supplemental abbreviated 
applications for generic new animal drugs, and investiga-
tional submissions for generic new animal 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 
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. 
‘‘(d) REAUTHORIZATION.— 
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‘‘(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 
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 Congress the revised recommenda-
tions under paragraph (4), a summary of the views 
and comments received under such paragraph, and 
any changes made to the recommendations in re-
sponse 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 
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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