Page:United States Statutes at Large Volume 122.djvu/3546

 12 2 STA T .35 23 PUBLIC LA W 11 0– 31 6— AU G .1 4, 200 8goalsident i f iedint h e lette r s des c ri b ed in section 201(3) of the A ni m al G eneric D r u g U ser F ee Act of 200 8 to w ard e xp editing the generic new animal drug de v elopment process and the review of abbreviated applications for generic new animal drugs , supple - mental abbreviated applications for generic new animal drugs, and investigational submissions for generic new animal drugs during such fiscal y ear .‘ ‘(b) F ISCALREPORT . —B eginning with fiscal year 200 9, not later than 120 days after the end of each fiscal year during which fees are collected under this part, the S ecretary shall prepare and submit to C ommittee on H ealth, E ducation, L abor, and P ensions 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) P UB LIC A V AILABILIT Y .— T he Secretary shall ma k e the reports re q uired under subsections (a) and (b) available to the public on the I nternet W eb site of the Food and Drug Administra- tion. ‘‘(d) REAUT H ORI Z ATIO N .— ‘‘(1) CONSULTATION.—In developing recommendations 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 reauthori z ation of this part for such fiscal years, the Secretary shall consult with— ‘‘(A) the Committee on Energy and Commerce 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 consumer advocacy groups; and ‘‘(F) the regulated industry. ‘‘(2) PRIOR PUBLIC INPUT.—Prior to beginning negotiations with the regulated industry on the reauthorization of this part, the Secretary shall— ‘‘(A) publish a notice in the Federal Register requesting public input on the reauthorization; ‘‘(B) hold a public meeting at which the public may present its views on the reauthorization, including specific suggestions for changes to the goals referred to in sub- section (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) PERIO D IC CONSULTATION.— N ot less frequently than once every 4 months during negotiations with the regulated industry, the Secretary shall hold discussions with representa- tives of veterinary, patient, and consumer advocacy groups to continue discussions of their views on the reauthorization Deadlin e s.W e b si t e. No ti c e. F ede r al R e g ister ,pu blication. Reco m menda - tions. Web site. Ef fecti v e date.

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