Page:United States Statutes at Large Volume 82.djvu/389

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[82 STAT. 347]
[82 STAT. 347]
PUBLIC LAW 90-000—MMMM. DD, 1968

82

STAT. ]

PUBLIC LAW 90-399-JULY 13, 1968

347

and was not corrected within a reasonable time after receipt of written notice from the Secretary specifying the matter complained of. "(3) Any order under this subsection shall state the findings upon which it is based. "(f) Whenever the Secretary finds that the facts so require, he shall revoke any previous order under subsection (d), (e), or (m) refusing, withdrawing, or suspending approval of an application and shall approve such application or reinstate such approval, as may be appropriate. " (g) Orders of the Secretary issued under this section (other than orders issuing, amending, or repealing regulations) shall be served (1) in person by any officer or employee of the department designated by the Secretary or (2) by mailing the order by registered mail or by certified mail addressed to the applicant or respondent at his last known address in the records of the Secretary. " (h) An appeal may be taken by the applicant from an order of the Secretary refusing or withdrawing approval of an application filed under subsection (b) or (m) of this section. The provisions of subsection (h) of section 505 of this Act shall govern any such appeal. 52 Stat. 1052; "(i) When a new animal drug application filed pursuant to sub- '^^ ^*^'- 784, 785. section (b) is approved, the Secretary shall by notice, which upon Publication in publication shall be effective as a regulation, publish in the Federal Federal Register. Register the name and address of the applicant and the conditions and indications of use of the new animal drug covered by such application, including any tolerance and withdrawal period or other use restrictions and, if such new animal drug is intended for use in animal feed, appropriate purposes and conditions of use (including special labeling requirements) applicable to any animal feed for use in which such drug is approved, and such other information, upon the basis of which such application was approved, as the Secretary deems necessary to assure the safe and effective use of such drug. Upon withdrawal of approval of such new animal drug application or upon its suspension, the Secretary shall forthwith revoke or suspend, as the case may be, the regulation published pursuant to this subsection (i) insofar as it is based on the approval of such application. " (j) To the extent consistent with the public health, the Secretary Exemptions shall promulgate regulations for exempting from the operation of this section new animal drugs, and animal feeds bearing or containing new animal drugs, intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of animal drugs. Such regulations may, in the discretion of the Secretary, among other conditions relating to the protection of the public health, provide for conditioning such exemption upon the establishment and maintenance of such records, and the making of such reports to the Secretary, by the manufacturer or the sponsor of the investigation of such article, of data (including but not limited to analytical reports by investigators) obtained as a result of such investigational use of such article, as the Secretary finds will enable him to evaluate the safety and effectiveness of such article in the event of the filing of an application pursuant to this section. Such regulations, among other things, shall set forth the conditions (if any) upon which animals treated with such articles, and any products of such animals (before or after slaughter), may be marketed for food use. " (k) While approval of an application for a new animal drug is effective, a food shall not, by reason of bearing or containing such drug or any substance formed in or on the food because of its use in accordance with such application (including the conditions and indi-