Page:United States Statutes at Large Volume 111 Part 3.djvu/262

 Ill STAT. 2350 PUBLIC LAW 105-115—NOV. 21, 1997 SEC. 217. CLARIFICATION OF THE NUMBER OF REQUIRED CLINICAL INVESTIGATIONS FOR APPROVAL. Section 513(a)(3)(A) (21 U.S.C. 360c(a)(3)(A)) is amended by striking "clinical investigations" and inserting "1 or more clinical investigations". TITLE III—IMPROVING REGULATION OF FOOD SEC. 301. FLEXIBILITY FOR REGULATIONS REGARDING CLAIMS. Section 403(r) (21 U.S.C. 343(r)) is amended by adding at the end the following: "(7) The Secretary may make proposed regulations issued under this paragraph effective upon publication pending consideration of public comment and publication of a final regulation if the Secretary determines that such action is necessary— "(A) to enable the Secretary to review and act promptly on petitions the Secretary determines provide for information necessary to— "(i) enable consumers to develop and maintain healthy dietary practices; "(ii) enable consumers to be informed promptly and effectively of important new knowledge regarding nutritional and health benefits of food; or "(iii) ensure that scientifically sound nutritional and health information is provided to consumers as soon as possible; or "(B) to enable the Secretary to act promptly to ban or modify a claim under this paragraph. Such proposed regulations shall be deemed final agency action for purposes of judicial review. ". SEC. 302. PETITIONS FOR CLAIMS. Section 403(r)(4)(A)(i) (21 U.S.C. 343(r)(4)(A)(i)) is amended— (1) by adding after the second sentence the following: "If the Secretary does not act within such 100 days, the petition shall be deemed to be denied unless an extension is mutually agreed upon by the Secretary and the petitioner."; (2) in the fourth sentence (as, amended by paragraph (1)) by inserting immediately before the comma the following: "or the petition is deemed to be denied"; and (3) by adding at the end the following: "If the Secretary does not act within such 90 days, the petition shall be deemed to be denied unless an extension is mutually agreed upon by the Secretary and the petitioner. If the Secretary issues a proposed regulation, the rulemaking shall be completed within 540 days of the date the petition is received by the Secretary. If the Secretary does not issue a regulation within such 540 days, the Secretary shall provide the Committee on Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate the reasons action on the regulation did not occur within such 540 days.". SEC. 303. HEALTH CLAIMS FOR FOOD PRODUCTS. Section 403(r)(3) (21 U.S.C. 343(r)(3)) is amended by adding at the end thereof the following:

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