Page:United States Statutes at Large Volume 110 Part 5.djvu/83

 PUBLIC LAW 104-250—OCT. 9, 1996 110 STAT. 3157 SEC. 6. FEED MILL LICENSES. (a) SECTION 512(a). —Paragraphs (1) and (2) of section 512(a) (21 U.S.C. 360b(a)) are amended to read as follows: "(a)(1) A new animal drug shall, with respect to any particular use or intended use of such drug, be deemed unsafe for the purposes of section 501(a)(5) and section 402(a)(2)(D) unless — "(A) there is in effect an approval of an application filed pursuant to subsection (b) with respect to such use or intended use of such drug, and "(B) such drug, its labeling, and such use conform to such approved application. A new animal drug shall also be deemed unsafe for such purposes in the event of removal from the establishment of a memufacturer, packer, or distributor of such drug for use in the manufacture of animal feed in any State unless at the time of such removal such manufacturer, packer, or distributor has an unrevoked written statement from the consignee of such drug, or notice from the Secretary, to the effect that, with respect to the use of such drug in animal feed, such consignee (i) holds a license issued under subsection (m) and has in its possession current approved labeling for such drug in animal feed; or (ii) will, if the consignee is not a user of the drug, ship such drug only to a holder of a license issued under subsection (m). "(2) An animal feed bearing or containing a new animal drug shall, with respect to any particular use or intended use of such animal feed be deemed imsafe for the purposes of section 501(a)(6) unless— "(A) there is in effect an approval of an application filed pursuant to subsection (b) with respect to such drug, as used in such animal feed, "(B) such animal feed is manufactured at a site for which there is in effect a license issued pursuant to subsection (m)(l) to manufacture such animal feed, and "(C) such animal feed and its labeling, distribution, holding, and use conform to the conditions and indications of use published pursuant to subsection (i).". (b) SECTION 512(m). —Section 512(m) (21 U.S.C. 360b(m)) is amended to read as follows: "(m)(l) Any person may file with the Secretary an application for a license to manufacture animal feeds bearing or containing new animal drugs. Such person shall submit to the Secretary as part of the application (A) a fiili statement of the business name and address of the specific facility at which the manufacturing is to take place and the facility's registration number, (B) the name and signature of the responsible individual or individuals for that facility, (C) a certification that the animal feeds bearing or containing new animal drugs are manufactured and labeled in accordance with the applicable regulations published pursuant to subsection (i), and (D) a certification that the methods used in, and the facilities and controls used for, manufacturing, processing, packaging, and holding such animal feeds are in conformity with current good manufacturing practice as described in section 501(a)(2)(B). "(2) Within 90 days after the filing of an application pursuant to paragraph (1), or such additional period as may be agreed upon by the Secretary and the applicant, the Secretary shall (A) issue an order approving the application if the Secretary then finds

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