Page:United States Statutes at Large Volume 111 Part 3.djvu/285

 «^<(fS>fr^ PUBLIC LAW 105-115 —NOV. 21, 1997 111 STAT. 2373 (3) by inserting after clause (ii) the following: "(iii) ensure that such regulation conforms, to the extent practicable, with internationaly recognized steindgirds defining quality systems, or parts of the standards, for medical devices.". (b) HARMONIZATION EFFORTS.— Section 803 (21 U.S.C. 383) is amended by adding at the end the following: "(c)(1) The Secretary shall support the Office of the United States Trade Representative, in consultation with the Secretary of Commerce, in meetings with representatives of other countries to discuss methods and approaches to reduce the burden of regulation and harmonize regulatory requirements if the Secretary determines that such harmonization continues consumer protections consistent with the purposes of this Act. "(2) The Secretary shall support the Office of the United States Trade Representative, in consultation with the Secretary of Commerce, in efforts to move toward the acceptance of mutual recognition agreements relating to the regulation of drugs, biological products, devices, foods, food additives, and color additives, and the regulation of good manufacturing practices, between the European Union and the United States. "(3) The Secretary shall regularly participate in meetings with representatives of other foreign governments to discuss and reach agreement on methods and approaches to harmonize regulatory requirements. "(4) The Secretary shall, not later than 180 days after the date of enactment of the Food and Drug Administration Modernization Act of 1997, make public a plan that establishes a framework for achieving mutual recognition of good manufacturing practices inspections. "(5) Paragraphs (1) through (4) shall not apply with respect to products defined in section 201(ff).". SEC. 4H. ENVIRONMENTAL IMPACT REVIEW. Chapter VII (21 U.S.C. 371 et seq.), as amended by section 407, is further amended by adding at the end the following: "SUBCHAPTER E—ENVIRONMENTAL IMPACT REVIEW "SEC. 746. ENVIRONMENTAL IMPACT. 21 USC 379O. "Notwithstanding any other provision of law, an environmental impact statement prepared in accordance with the regulations published in part 25 of title 21, Code of Federal Regulations (as in effect on August 31, 1997) in connection with an action carried out under (or a recommendation or report relating to) this Act, shall be considered to meet the requirements for a detailed statement under section 102(2)(C) of the National Environmental Policy Act of 1969 (42 U.S.C. 4332(2)(C)).". SEC. 412. NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS AND COSMETICS. (a) NONPRESCRIPTION DRUGS. — Chapter VII (21 U.S.C. 371 et seq.), as amended by section 411, is further amended by adding at the end the following:

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