Page:United States Statutes at Large Volume 104 Part 6.djvu/123

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PUBLIC LAW 101-629—NOV. 28, 1990 104 STAT. 4513 regulations, the Secretary shall minimize the administrative burdens on device user facilities consistent with the need to assure adequate information. (c) EFFECTIVE DATE.— Section 519(b) of the Federal Food, Drug, and 21 USC 360i Cosmetic Act, as added by the amendment made by subsection (a), ^°*^- shall take effect— (1) upon the effective date of regulations promulgated under subsection (b), or (2) upon the expiration of 12 months from the date of the enactment of this Act, whichever occurs first. (d) EDUCATION AND INFORMATION.— During the 18-month period 21 USC 360i beginning on the date of the enactment of this Act, the Secretary of ^°^' Health and Human Services shall inform device user facilities (as defined in section 519(b)(5)(A) of the Federal Food, Drug, and Cosmetic Act) and manufacturers and distributors of devices respecting the requirements of section 519(b) of such Act. Additionally, the Secretary, to the extent practicable, shall provide persons subject to the requirements of such section assistance in the form of publications regarding such requirements. (e) STUDY.— Not more than 36 months after the date of the enact- 21 USC 360i ment of this Act, the Comptroller General of the United States shall "°*®- conduct a study of— (1) the compliance by device user facilities (as defined in section 519(b)(5)(A) of the Federal Food, Drug, and Cosmetic Act) with the requirements of section 519(b) of such Act, (2) the actions taken by the manufacturers of devices in response to reports made to them under such section, (3) the cost effectiveness of such requirements and their implementation, and (4) any recommendations for improvements to such requirements. The Comptroller General shall complete the study and submit a report on the study not later than 45 months from the date of the enactment of this Act. The report shall be submitted to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate and to the Secretary of Health and Human Services, if) REPORT TO CONGRESS. —Not later than 36 months after the date 21 USC 360i of enactment of this Act, the Secretary of Health and Human "°^- Services shall prepare and submit to the appropriate committees of Congress a report that contains an evaluation of the requirements of section 519(b) of the Federal Food, Drug, and Cosmetic Act. In preparing the report, the Secretary shall consult with individuals and organizations with an interest in health care and consumer issues. At a minimum, the report shall contain— (1) an evaluation of the safety benefits of the requirements, (2) an evaluation of the burdens placed on the Food and Drug Administration and on device user facilities by the requirements, (3) an evaluation of the cost-effectiveness of the requirements, and (4) recommendations for legislative reform. SEC. 3. REPORTS. (a) DISTRIBUTOR REPORTS.—