Page:United States Statutes at Large Volume 118.djvu/930

 118 STAT. 900 PUBLIC LAW 108–282—AUG. 2, 2004 ‘‘(3) such other information as may be prescribed by the Secretary in the index listing. ‘‘(i)(1) In the case of any new animal drug for which an index listing pursuant to subsection (a) is in effect, the person who has an index listing 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 person 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 listing, 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 deter mination, whether there is or may be ground for invoking subsection (f). Such regulation or order shall provide, where the Secretary deems it to be appropriate, for the examination, upon request, by the persons to whom such regulation or order is applicable, of similar information received or otherwise obtained by the Sec retary. ‘‘(2) 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. ‘‘(j)(1) Safety and effectiveness data and information which has been submitted in support of a request for a new animal drug to be indexed under this section and which has not been previously disclosed to the public shall be made available to the public, upon request, unless extraordinary circumstances are shown— ‘‘(A) if no work is being or will be undertaken to have the drug indexed in accordance with the request, ‘‘(B) if the Secretary has determined that such drug cannot be indexed and all legal appeals have been exhausted, ‘‘(C) if the indexing of such drug is terminated and all legal appeals have been exhausted, or ‘‘(D) if the Secretary has determined that such drug is not a new animal drug. ‘‘(2) Any request for data and information pursuant to para graph (1) shall include a verified statement by the person making the request that any data or information received under such para graph shall not be disclosed by such person to any other person— ‘‘(A) for the purpose of, or as part of a plan, scheme, or device for, obtaining the right to make, use, or market, or making, using, or marketing, outside the United States, the drug identified in the request for indexing; and ‘‘(B) without obtaining from any person to whom the data and information are disclosed an identical verified statement, a copy of which is to be provided by such person to the Sec retary, which meets the requirements of this paragraph. ‘‘SEC. 573. DESIGNATED NEW ANIMAL DRUGS FOR MINOR USE OR MINOR SPECIES. ‘‘(a) DESIGNATION.— ‘‘(1) The manufacturer or the sponsor of a new animal drug for a minor use or use in a minor species may request that the Secretary declare that drug a ‘designated new animal drug’. A request for designation of a new animal drug shall 21 USC 360ccc–2. Records. Reports.

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