Page:United States Statutes at Large Volume 110 Part 2.djvu/802

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110 STAT. 1594 PUBLIC LAW 104-180—AUG. 6, 1996 Guidelines. (3) develop guidelines for providing effective oral and written prescription information consistent with the findings of any such assessment; (4) contain elements necessary to ensure the transmittal of useful information to the consuming public, including being scientifically accurate, non-promotional in tone and content, sufficiently specific and comprehensive as to adequately inform consumers about the use of the product, and in an understandable, legible format that is readily comprehensible and not confusing to consumers expected to use the product. (5) develop a mechanism to assess periodically the quality of the or£d and written prescription information and the frequency with which the information is provided to consumers; and (6) provide for compliance with relevant State board regulations. (d) LIMITATION ON THE AUTHORITY OF THE SECRETARY.—The Secretary of the Department of Health and Human Services shall have no authority to implement the proposed rule described in subsection (a), or to develop any similar regulation, policy statement, or other guideline specifying a uniform content or format for written information voluntarily provided to consumers about prescription drugs if, (1) not later than 120 days after the date of enactment of this Act, the national organizations described in subsection (a) develop and submit to the Secretary for Health and Human Services a comprehensive, long-range action plan (as described in subsection (a)) which shall be acceptable to the Secretary of Health and Human Services; (2) the aforementioned plan is submitted to the Secretary of Health and Human Services for review and acceptance: Provided, That the Secretary shall give due consideration to the submitted plan and that any such acceptance shall not be arbitrarily withheld; and (3) the implementation of (a) a plan accepted by the Secretary commences within 30 days of the Secretary's acceptance of such plan, or (b) the plan submitted to the Secretary commences within 60 days of the submission of such plan if the Secretary fails to take any action on the plan within 30 days of the submission of the plan. The Secretary shall accept, reject or suggest modifications to the plan submitted within 30 days of its submission. The Secretary may confer with and assist private parties in the development of the plan described in subsections (a) and (b). (e) SECRETARY REVIEW. —Not later than January 1, 2001, the Secretary of the Department of Health and Human Services shall review the status of private-sector initiatives designed to achieve the goals of the plan described in subsection (a), and if svch goals are not achieved, the limitation in subsection (d) shall not apply, and the Secretary shall seek public comment on other initiatives that may be carried out to meet such goals. SEC. 602. Section 3 of the Saccharin Study and Labeling Act (21 U.S.C 348 note) is amended by striking out "May 1, 1997" and inserting in lieu thereof "May 1, 2002". SEC. 603. AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND COSMETIC ACT.— (a) IMPORTS FOR EXPORT.— Section 801(d)(3) of the Federal 21 USC 381. Food, Drug, and Cosmetic Act is amended—