344
PUBLIC LAW 90-399-JULY 13, 1968
[82 STAT.
"(8) A new nnimjil drug or an animal feed bearing or containing a new animal drug shall not be deemed unsafe for the purj^oses oi Ante, p. 343. scc'tion 501(a)(5) Or (6) if such article is for investigational use and conforms to the terms of an exemption in effect with respect thereto under section 512(j). "(b) Any person may file with the Secretary an application with respect to any intended use or uses of a new animal drug. Such person .shall submit to the Secretary as a part of the application (1) full reports of investigations which have been made to show" whether or not such drug is safe and effective for use; (2) a full list of the articles used as components of such drug; (3) a full statement of the composition of such drug; (4) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug; (5) such samples of such drug and of the articles used as components thereof, of any animal feed for use in or on which such drug is intended, and of the edible portions or products (before or after slaughter) of animals to which such drug (directly or in or on animal feed) is intended to be administered, as the Secretary may require; (6) specimens of the labeling proposed to be used for such drug, or in case such drug is intended for use in animal feed, I>roposed labeling appropriate for such use, and specimens of the labeling for the drug to be manufactured, packed, or distributed by the applicant; (7) a description of practicable methods for determining the quantity, if any, of such drug in or on food, and any substance formed in or on food, because of its use; and (8) the proposed tolerance or withdrawal period or other use restrictions for such drug if any tolerance or withdrawal period or other use restrictions are required in order to assure that the proposed use of such drug will be safe. hearkT'*""'*^ ^°' "(^) Within one hundred and eighty days after the filing of an application pursuant to subsection (b), or such additional period as may be agreed upon by the Secretary and the applicant, the Secretary shall either (1) issue an order approving the application if he then finds that none of the grounds for denying approval specified in subsection (d) applies, or (2) give the applicant notice of an opportunity for a hearing before the Secretary under subsection (d) on the question whether such application is approvable. If the applicant elects to accept the opportunity for a hearing by written request within thirty days after such notice, such hearing shall commence not more than ninety days after the expiration of such thirty days unless the Secretary and the applicant otherwise agree. Any such hearing shall thereafter be conducted on an expedited basis and the Secretary's order thereon shall be issued within ninety days after the date fixed by the Secretary for filing final briefs. " (d)(1) If the Secretary finds, after due notice to the applicant in accordance with subsection (c) and giving him an opportunity for a hearing, in accordance with said subsection, that— " (A) the investigations, reports of which are required to be submitted to the Secretary pursuant to subsection (b), do not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof; " (B) the results of such tests show that such drug is unsafe for use under such conditions or do not show that such drug is safe for use under such conditions; " (C) the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug are inadequate to preserve its identity, strength, quality, and pvirity; " (D) upon the basis of the information submitted to him as
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