Page:United States Statutes at Large Volume 122.djvu/3544

 12 2 STA T .35 21 PUBLIC LA W 11 0– 31 6— AU G .1 4, 200 8‘ ‘ (A)of f icersand e mpl o y ees of th e F ood and D r ug Administration , contractors of the Food and Drug Adminis - tration, ad v isory committees consulted w ith respect to the review of specific a b breviated applications, supplemental abbreviated applications, or investigational submissions, and costs related to such officers, employees, committees, and contractors, including costs for travel, education, and recruitment and other personnel activities ‘‘( B ) management of information, and the ac q uisition, maintenance, and repair of computer resources; ‘‘( C ) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fi x - tures, furniture, scientific equipment, and other necessary materials and supplies; and ‘‘(D) collecting fees under this section and accounting for resources allocated for the review of abbreviated applications, supplemental abbreviated applications, and investigational submissions . ‘‘( 4 )F INALDOS A GEF O RM . —T he term ‘final dosage form ’ means, with respect to a generic new animal drug product, a finished dosage form which is approved for administration to an animal without substantial further manufacturing. S uch term includes generic new animal drug products intended for mixing in animal feeds. ‘‘( 5 ) G ENERI C NE W ANIMAL DR U G.—The term ‘generic new animal drug’ means a new animal drug that is the sub j ect of an abbreviated application. ‘‘( 6 ) GENERIC NEW ANIMAL DRUG P RODUC T .—The term ‘generic new animal drug product’ means each specific strength or potency of a particular active ingredient or ingredients in final dosage form mar k eted by a particular manufacturer or distributor, which is uniquely identified by the labeler code and product code portions of the national drug code, and for which an abbreviated application for a generic new animal drug or a supplemental abbreviated application has been approved. ‘‘( 7 ) GENERIC NEW ANIMAL DRUG SPONSOR.—The term ‘generic new animal drug sponsor’ means either an applicant named in an abbreviated application for a generic new animal drug that has not been withdrawn by the applicant and for which approval has not been withdrawn by the Secretary, or a person who has submitted an investigational submission for a generic new animal drug that has not been terminated or otherwise rendered inactive by the Secretary. ‘‘( 8 ) I N V ESTIGATIONAL SU B MISSION FOR A GENERIC NEW ANIMAL DRUG.—The terms ‘investigational submission for a generic new animal drug’ and ‘investigational submission’ mean— ‘‘(A) the filing of a claim for an investigational exemp- tion under section 5 12 (j) for a generic new animal drug intended to be the subject of an abbreviated application or a supplemental abbreviated application; or ‘‘(B) the submission of information for the purpose of enabling the Secretary to evaluate the safety or effective- ness of a generic new animal drug in the event of the filing of an abbreviated application or supplemental abbre- viated application for such drug.

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