Page:United States Statutes at Large Volume 82.djvu/390

 348

PUBLIC LAW 90-399-JULY 13, 1968

[82 STAT.

cations of use pi'eseribed pursuant to subsection (i)), be considered 21 us^c 3^°2*^ adulterated within the meanin*^ of chiuse (1) of section 402(a). Recordkeeping. "(1)(1) l u the case of a u j new animal drug for which an approval of an application filed pursuant to subsection (b) is in effect, the applicant shall establish and maintain such records, and make such reports to the Secretary, of data relating to experience and other data or information, received or otherwise obtained by such applicant with respect to such drug, or with respect to animal feeds bearing or containing such drug, as the Secretary may by general regulation, or by order with respect to such application, prescribe on the basis of a finding that such records and reports are necessary in order to enable the Secretary to determine, or facilitate a determination, whether there is or may be ground for invoking subsection (e) or subsection (m)(4) of this section. Such regulation or order shall provide, where the Secretary deems it to be appropriate, for the examination, upon request, by the pereons to whom such regulation or order is applicable, of similar information received or otherwise obtained by the Secretary. "(2) Every person required under this subsection to maintain 7'ecords, and every person in charge or custody thereof, shall, upon request of an officer or employee designated by the Secretary, permit such officer oc employee at all reasonable times to have access to and copy and verify such records. '•(m)(1) Any person may file with the Secretary an application with respect to any intended use or uses of an animal feed bearing or containing a new animal drug. Such person shall submit to the Secretary as part of the application (A) a full statement of the composition of such animal feed, (B) an identification of the regulation or regulations (relating to the new animal drug or drugs to be used in such feed), published pursuant to subsection (i), on which he relies as a basis for approval of his application with respect to the use of such drug in such feed, (C) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such animal feed, (D) specimens of the labeling proposed to be used for such animal feed, and (E) if so requested by the Secretary, samples of such animal feed or components thereof. "(2) Within ninety days after the filing of an application pursuant to subsection (m)(1), or such additional period as may be agreed upon by the Secretary and the applicant, the Secretary shall either (A) issue an order approving the application if he then finds that none of the grounds for denying approval specified in paragraph (3) applies, or (B) give the applicant notice of an opportunity for a hearing before the Secretary under paragraph (8) on the question whether such application is approvable. The procedure governing such a hearing shall be the procedure set forth in the last two sentences of subsection (c). "(3) If the Secretary, after due notice to the applicant in accordance with paragraph (2) and giving him an opportunity for a hearing in accordance with such paragraph, finds, on the basis of information submitted to him as part of the application or on the basis of any other information before him— " (A) that there is not in effect a regulation under subsection (i) (identified in such application) on the basis of which such application may be approved; " (B) that such animal feed (including the proposed use of any new animal drue therein or thereon) does not conform to an applicable regulation published pursuant to subsection (i) referred to in the application, or that the purposes and conditions or indications of use prescribed, recommended, or suggested in the labeling of such feed do not conform to the applicable pur-

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