Page:United States Statutes at Large Volume 111 Part 3.djvu/276

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Ill STAT. 2364 PUBLIC LAW 105-115—NOV. 21, 1997 21 USC 360aaa note. 21 USC 360aaa note. 21 USC 360aaa note. 21 USC 360aaa note. (as defined in section 556(5)) from requiring authorization from the entity to disseminate an ari;icle pubhshed by such entity or charging fees for the purchase of reprints of pubhshed articles from such entity.". (b) PROHIBITED ACT. — Section 301 (21 U.S.C. 331), as amended by section 210, is amended by adding at the end the following: "(z) The dissemination of information in violation of section 551. ". (c) REGULATIONS.— Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services shall promulgate regulations to implement the amendments made by this section. (d) EFFECTIVE DATE.—The amendments made by this section shall take effect 1 year after the date of enactment of this Act, or upon the Secretary's issuance of final regulations pursuant to subsection (c), whichever is sooner. (e) SUNSET.—The amendments made by this section cease to be effective September 30, 2006, or 7 years after the date on which the Secretary promulgates the regulations described in subsection (c), whichever is later. (f) STUDIES AND REPORTS.— (1) GENERAL ACCOUNTING OFFICE.— (A) IN GENERAL.— The Comptroller General of the United States shall conduct a study to determine the impact of subchapter D of chapter V of the Federal Food, Drug, and Cosmetic Act, as added by this section, on the resources of the Department of Health and Human Services. (B) REPORT. — Not later than January 1, 2002, the Comptroller General of the United States shall prepare and submit to the Committee on Labor and Human Resources of the Senate and the Committee on Commerce of the House of Representatives a report of the results of the study. (2) DEPARTMENT OF HEALTH AND HUMAN SERVICES.— (A) IN GENERAL.—In order to assist Congress in determining whether the provisions of such subchapter should be extended beyond the termination date specified in subsection (e), the Secretary of Health and Human Services shall, in accordance with subparagraph (B), arrange for the conduct of a study of the scientific issues raised as a result of the enactment of such subchapter including issues relating to— (i) the effectiveness of such subchapter with respect to the provision of useful scientific information to health care practitioners; (ii) the quality of the information being disseminated pursuant to the provisions of such subchapter; (iii) the quality and usefulness of the information provided, in accordance with such subchapter, by the Secretary or by the manufacturer at the request of the Secretary; and (iv) the impact of such subchapter on research in the area of new uses, indications, or dosages, particularly the impact on pediatric indications and rare diseases. (3) PROCEDURE FOR STUDY. —