Page:United States Statutes at Large Volume 110 Part 5.djvu/86

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110 STAT. 3160 PUBLIC LAW 104-250—OCT. 9, 1996 "(B) every person required under this subsection to meiintain records, and every person in charge or custody thereof, shall, upon request of an officer or employee designated by the Secretary, permit such officer or employee at all reasonable times to have access to and copy and verify such records. "(6) To the extent consistent with the public health, the Secretary may promulgate regulations for exempting from the operation of this subsection facihties that manufacture, process, pack, or hold animal feeds bearing or containing new animal drugs.". 21 USC 360b (c) TRANSITIONAL PROVISION.—A person engaged in the manunote. facture of animal feeds bearing or containing new animal drugs who holds at least one approved medicated feed application for an animal feed bearing or containing new animal drugs, the manufacture of which was not otherwise exempt from the requirement for an approved medicated feed application on the date of the enactment of this Act, shall be deemed to hold a license for the manufacturing site identified in the approved medicated feed application. The revocation of license provisions of section 512(m)(4) of the Federal Food, Drug, and Cosmetic Act, as simended by tiiis Act, shall apply to such ucenses. Such license shall expire within 18 months from the date of enactment of this Act unless the person submits to the Secretary a completed license application for the manufacturing site accompanied by a copy of an approved medicated feed application for such site, which license application shall be deemed to be approved upon receipt by the Secretary. Approved October 9, 1996. LEGISLATIVE HISTORY—H.R. 2508 (S. 773): HOUSE REPORTS: No. 104-823 (Comm. on Commerce). CONGRESSIONAL RECORD, Vol. 142 (1996): Sept. 24, considered and passed House. S. 773 considered and passed Senate. Sept. 25, H.R. 2508 considered and passed Senate.