Page:United States Statutes at Large Volume 122.djvu/3535

 12 2 STA T .35 12 PUBLIC LA W 11 0– 31 6— AU G .1 4, 200 8‘ ‘ SEC.740A . R EA UTHO R IZ ATIO N; RE P ORTIN G RE Q UIRE M ENTS. ‘ ‘ (a)PERFO R MANC E R E P OR T.—Begin ning w i thf i sc a ly ea r20 0 9, n o t later than 6 0 d ays after the end of each fiscal year d u ring which fees are collected under this p art, the S ecretary shall prepare and su bm it to the C ommittee on E nergy and Commerce of the H ouse of Representati v es and the Committee on Health, Education, L abor, and Pensions of the Senate a report concerning the progress of the F ood and D rug A dministration in achieving the goals identi - fied in the letters described in section 1 01(b) of the Animal Drug U ser Fee Amendments of 200 8 toward e x pediting the animal drug development process and the review of the new and supplemental animal drug applications and investigational animal drug submis- sions 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 administrative procedures adopted by the Food and Drug Administration 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) F IS CA L 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) 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 ATION.— ‘‘(1) CONSULTATION.—In developing recommendations to present to the Congress with respect to the goals, and plans for meeting the goals, for the process for the review of animal drug applications for the first 5 fiscal years after fiscal year 201 3, 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); Notice.F e d e ralR e g i s ter ,pub licatio n . Reco m menda - tions. W eb site. Ef fecti v e dates. 21USC379j– 13.

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