Page:United States Statutes at Large Volume 118.djvu/926

 118 STAT. 896 PUBLIC LAW 108–282—AUG. 2, 2004 approval issued under this section is no longer in effect unless the Secretary grants an extension of an additional 180 day period so that the Secretary can complete review of the application. The decision to grant an extension is committed to the discretion of the Secretary and not subject to judicial review. ‘‘(i) The decision of the Secretary under subsection (c), (d), or (e) of this section refusing or withdrawing conditional approval of an application shall constitute final agency action subject to judicial review. ‘‘(j) In this section and section 572, the term ‘transgenic animal’ means an animal whose genome contains a nucleotide sequence that has been intentionally modified in vitro, and the progeny of such an animal; Provided that the term ‘transgenic animal’ does not include an animal of which the nucleotide sequence of the genome has been modified solely by selective breeding. ‘‘SEC. 572. INDEX OF LEGALLY MARKETED UNAPPROVED NEW ANIMAL DRUGS FOR MINOR SPECIES. ‘‘(a)(1) The Secretary shall establish an index limited to— ‘‘(A) new animal drugs intended for use in a minor species for which there is a reasonable certainty that the animal or edible products from the animal will not be consumed by humans or food producing animals; and ‘‘(B) new animal drugs intended for use only in a hatchery, tank, pond, or other similar contained man made structure in an early, non food life stage of a food producing minor spe cies, where safety for humans is demonstrated in accordance with the standard of section 512(d) (including, for an anti microbial new animal drug, with respect to antimicrobial resist ance). ‘‘(2) The index shall not include a new animal drug that is contained in or a product of a transgenic animal. ‘‘(b) Any person intending to file a request under this section shall be entitled to one or more conferences to discuss the require ments for indexing a new animal drug. ‘‘(c)(1) Any person may submit a request to the Secretary for a determination whether a new animal drug may be eligible for inclusion in the index. Such a request shall include— ‘‘(A) information regarding the need for the new animal drug, the species for which the new animal drug is intended, the proposed intended use and conditions of use, and antici pated annual distribution; ‘‘(B) information to support the conclusion that the proposed use meets the conditions of subparagraph (A) or (B) of sub section (a)(1) of this section; ‘‘(C) information regarding the components and composition of the new animal drug; ‘‘(D) a description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such new animal drug; ‘‘(E) an environmental assessment that meets the require ments of the National Environmental Policy Act of 1969, as amended, and as defined in 21 CFR Part 25, as it appears on the date of enactment of this provision and amended there after or information to support a categorical exclusion from the requirement to prepare an environmental assessment; 21 USC 360ccc–1.

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