Page:United States Statutes at Large Volume 122.djvu/3537

 12 2 STA T .35 1 4PUBLIC LA W 11 0– 31 6— AU G .14 , 200 8‘ ‘ (i i )byquant iti esd ist r ibuted d om esti c a l ly and quantities e xp orted and ‘‘(iii) by dosa g e f orm , including, for eac h such dosage form, a listing of the target animals, indications, and production classes that are specified on the appro v ed label of the product . ‘‘( C ) E ach report under this paragraph shall — ‘‘(i) be submitted not later than M arch 31 each year; ‘‘(ii) cover the period of the preceding calendar year; and ‘‘(iii) include separate information for each month of such calendar year. ‘‘( D ) T he S ecretary may share information reported under this paragraph w ith the A ntimicrobial R esistance Tas kF orce established under section 31 9 Eofthe P ublic H ealth Service Act. ‘‘(E) The Secretary shall make summaries of the information reported under this paragraph publicly available, except that— ‘‘(i) the summary data shall be reported by antimicrobial class, and no class with fewer than 3 distinct sponsors of approved applications shall be independently reported; and ‘‘(ii) the data shall be reported in a manner consistent with protecting both national security and confidential business information. ’ ’. (b) F IRST R EPO RT.—For each new animal drug that is sub j ect to the reporting requirement under section 5 1 2 (l)(3) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), and for which an approval of an application filed pursuant to section 512(b) or 5 7 1 of such Act is in effect on the date of the enactment of this title, the Secretary of Health and Human Services shall require the sponsor of the drug to submit the first report under such section 512(l)(3) for the drug not later than March 31, 2 0 10. (c) SEP A RATE REPORT.—The reports required under section 512(l)(3) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), shall be separate from periodic drug experience reports that are required under section 51 4 . 8 0(b)(4) of title 21, Code of Federal Regulations (as in effect on the date of the enact - ment of this title). SEC.106 .S AVING SC L A U SE. N otwithstanding section 5 of the Animal Drug U ser Fee Act of 2003 (21 U.S.C. 379j – 11 note), and notwithstanding the amend- ments made by this title, part 4 of subchapter C of chapter VI I of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 11 et seq.), as in effect on the day before the date of the enactment of this title, shall continue to be in effect with respect to animal drug applications and supplemental animal drug applications (as defined in such part as of such day) that on or after September 1, 2003, but before O ctober 1, 2008, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2009. SEC. 10 7 .E F FEC T IVE D ATE. The amendments made by sections 102, 103, and 104 shall take effect on October 1, 2008, and fees under part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, as amended by this title, shall be assessed for all animal drug applications and supplemental animal drug applications received on or after such date, regardless of the date of the enactment of this title. 21USC379j– 11 note. 21 USC 379j–11 note. 21USC3 60b note. Pu b lic in f o rma tion.

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