Page:United States Statutes at Large Volume 82.djvu/392

 350

PUBLIC LAW 90-399-JULY 13, 1968

[82 STAT.

"(iii) that on the basis of new information before him, evaluated together with the evidence before him when the application was approved, the labeling of such animal feed, based on a fair evaluation of all material facts, is false or misleading in any particular and was not corrected within a reasonable time after receipt of written notice from the Secretary specifying the matter complained of. " (C) Xny order under paragraph (4) of this subsection shall state the findings upon which it is based. Recordkeeping. u^^>^ jj^ ^|-^g ^.^^^ ^f.^^^^ animal feed for which an approval of a,n application filed pursuant to this subsection is in effect— " (A) the applicant shall establish and maintain such records, and make such reports to the Secretary, or (at the option of the Secretary) to the appropriate person or persons holding an approved application filed under subsection (b), 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 paragraph (4) of this subsection. " (B) every person required under this subsection to maintain 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. Certification. " (n)(l) The Secretary, pursuant to regulations promulgated by him, shall provide for the certification of batches of a new animal drug composed wholly or partly of any kind of penicillin, streptomycm, chlortetracycline, chloramphenicol, or bacitracin, or any derivative thereof. A batch of any such drug shall be certified if an approval of an application filed pursuant to subsection (b) is effective with respect to such drug and such drug has the characteristics of identity and such batch has the characteristics of strength, quality, and purity upon the basis of which the application was approved, but shall not otherwise be certified. Prior to the effective date of such regulations the Secretary, in lieu of certification, shall issue a release for any batch which, in his judgment, may be released without risk as to the safety and efficacy of its use. Such release shall prescribe the date of its expiration and other conditions under which it shall cease to be effective as to such batch and as to portions thereof. "(2) Regulations providing for such certifications shall contain such provisions as are necessary to carry out the purposes of this subsection, including provisions prescribing— " (A) tests and methods of assay to determine compliance with applicable standards of identity and of strength, quality, and purity; " (B) effective periods for certificates, and other conditions under which they shall cease to be effective as to certified batches and as to portions thereof; " (C) administration and procedure; and " (D) such fees, specified m such regulations, as are necessary to provide, equip, and maintain an adequate certification service. Such regulations shall prescribe only such tests and methods of assay as will provide for certification or rejection wnthin the shortest time consistent with the purposes of this subsection.

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