Page:United States Statutes at Large Volume 121.djvu/959

 121 STAT. 938

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Establishment.

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PUBLIC LAW 110–85—SEPT. 27, 2007 use a different, comparable aspect of the elements to assure safe use, if the Secretary determines that— ‘‘(i) the burden of creating a single, shared system outweighs the benefit of a single, system, taking into consideration the impact on health care providers, patients, the applicant for the abbreviated new drug application, and the holder of the reference drug product; or ‘‘(ii) an aspect of the elements to assure safe use for the applicable listed drug is claimed by a patent that has not expired or is a method or process that, as a trade secret, is entitled to protection, and the applicant for the abbreviated new drug application certifies that it has sought a license for use of an aspect of the elements to assure safe use for the applicable listed drug and that it was unable to obtain a license. A certification under clause (ii) shall include a description of the efforts made by the applicant for the abbreviated new drug application to obtain a license. In a case described in clause (ii), the Secretary may seek to negotiate a voluntary agreement with the owner of the patent, method, or process for a license under which the applicant for such abbreviated new drug application may use an aspect of the elements to assure safe use, if required under subsection (f) for the applicable listed drug, that is claimed by a patent that has not expired or is a method or process that as a trade secret is entitled to protection. ‘‘(2) ACTION BY SECRETARY.—For an applicable listed drug for which a drug is approved under section 505(j), the Secretary— ‘‘(A) shall undertake any communication plan to health care providers required under subsection (e)(3) for the applicable listed drug; and ‘‘(B) shall inform the responsible person for the drug that is so approved if the risk evaluation and mitigation strategy for the applicable listed drug is modified. ‘‘(j) DRUG SAFETY OVERSIGHT BOARD.— ‘‘(1) IN GENERAL.—There is established a Drug Safety Oversight Board. ‘‘(2) COMPOSITION; MEETINGS.—The Drug Safety Oversight Board shall— ‘‘(A) be composed of scientists and health care practitioners appointed by the Secretary, each of whom is an employee of the Federal Government; ‘‘(B) include representatives from offices throughout the Food and Drug Administration, including the offices responsible for postapproval safety of drugs; ‘‘(C) include at least 1 representative each from the National Institutes of Health and the Department of Health and Human Services (other than the Food and Drug Administration); ‘‘(D) include such representatives as the Secretary shall designate from other appropriate agencies that wish to provide representatives; and ‘‘(E) meet at least monthly to provide oversight and advice to the Secretary on the management of important drug safety issues.’’.

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