Page:United States Statutes at Large Volume 122.djvu/3545

 12 2 STA T .35 22 PUBLIC LA W 11 0– 31 6— AU G .1 4, 200 8‘ ‘ (9)PERSON.—Thet e rm ‘ p er son’i n clud es a na f filiate thereof (as such term is defined in section 735 ( 1 1)). ‘‘(1 0 ) PRO C ESS F OR TH ERE VI E W OF AB BREVIATE D A P P L ICA - TIONS FOR G ENERIC NEW ANI M AL DR U GS.—The term ‘process for the re v ie w ofa b breviated applications for g eneric new animal drugs’ means the following activities of the S ecretar y with respect to the review of abbreviated applications , supple- mental abbreviated applications, and investigational submis- sions

‘‘( A ) The activities necessary for the review of abbre- viated applications, supplemental abbreviated applications, and investigational submissions. ‘‘( B ) The issuance of action letters which approve abbre- viated applications or supplemental abbreviated applica- tions or which set forth in detail the specific deficiencies in abbreviated applications, supplemental abbreviated applications, or investigational submissions and, where appropriate, the actions necessary to place such applica- tions, supplemental applications, or submissions in condi- tion for approval. ‘‘( C ) The inspection of generic new animal drug establishments and other facilities underta k en as part of the Secretary’s review of pending abbreviated applications, supplemental abbreviated applications, and investigational submissions. ‘‘( D ) M onitoring of research conducted in connection with the review of abbreviated applications, supplemental abbreviated applications, and investigational submissions. ‘‘( E ) The development of regulations and policy related to the review of abbreviated applications, supplemental abbreviated applications, and investigational submissions. ‘‘( F ) Development of standards for products sub j ect to review. ‘‘( G ) Meetings between the agency and the generic new animal drug sponsor. ‘‘( H ) R eview of advertising and labeling prior to approval of an abbreviated application or supplemental abbreviated application, but not after such application has been approved. ‘‘(11) SUPPLEMENTAL ABBREVIATED APPLICATION FOR GENERIC NEW ANIMAL DRUG.—The terms ‘supplemental abbre- viated application for a generic new animal drug’ and ‘supple- mental abbreviated application’ mean a re q uest to the Secretary to approve a change in an approved abbreviated application.’’. SEC.203 . A CC OUNT A BIL IT Y AN DR E P ORTS. Part 5 of subchapter C of chapter VI I of the Federal Food, Drug, and Cosmetic Act ( 2 1 U .S.C. 379f et seq.), as added by section 202, is amended by inserting after section 7 4 1 the following: ‘ ‘SEC. 74 2. REAUT H ORI Z ATION REPORTIN G RE Q UIRE M ENTS. ‘‘(a) PERFORMANCE REPORTS.—Beginning with fiscal year 2009, not later than 6 0 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, L abor, and Pensions of the Senate, and the Committee on Energy and Com- merce of the House of Representatives a report concerning the progress of the Food and Drug Administration in achieving the Ef f ectiv e da te .21USC379j– 22.

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