Page:United States Statutes at Large Volume 104 Part 6.djvu/135

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PUBLIC LAW 101-629—NOV. 28, 1990 104 STAT. 4525 the costs of research and development, fabrication, and distribution of the device. "(4) Devices granted an exemption under paragraph (2) may only be used— "(A) in facilities that have established, in accordance with regulations of the Secretary, a local institutional review committee to supervise clinical testing of devices in the facilities, and "(B) if, before the use of a device, an institutional review committee approves the use in the treatment or disignosis of a disease or condition referred to in paragraph (2)(A). "(5) An exemption under paragraph (2) shall be for a term of 18 months and may only be initially granted in the 5-year period beginning on the date regulations under paragraph (6) take effect. The Secretary may extend such an exemption for a period of 18 months if the Secretary is able to make the findings set forth in paragraph (2) and if the applicant supplies information demonstrating compliance with paragraph (3). An exemption may be extended more than once and may be extended after the expiration of such 5- year period. "(6) Within one year of the date of the enactment of this subsec- Regulations, tion, the Secretary shall issue regulations to implement this subsection.". (b) EFFECTIVE DATE.— Subsection (m) of section 520 of the Federal 21 USC 360j Food, Drug, and Cosmetic Act, as added by the amendment made by ^°^- subsection (a), shall take effect on the effective date of the regulations issued by the Secretary under paragraph (6) of such subsection. (c) REPORT.—Within 4 years after the issuance of regulations 21 USC 360j under section 520(m)(6) of the Federal Food, Drug, and Cosmetic Act, note. as added by the amendment made by subsection (a), the Secretary of Health and Human Services shall report to the Congress (1) on the types of devices exempted under such section, (2) an evaluation of the effects of such section, and (3) a recommendation on extension of the section. SEC. 15. ESTABLISHMENT OF THE OFFICE OF INTERNATIONAL RELATIONS. (a) OFFICE. — Title VIII is amended by adding at the end the following: "OFFICE OF INTERNATIONAL RELATIONS "SEC. 803. (a) There is established in the Department of Health 21 USC 383. and Human Services an Office of International Relations. "(h) In carrying out the functions of the office under subsection (a), the Secretary may enter into agreements with foreign countries to facilitate commerce in devices between the United States and such countries consistent with the requirements of this Act. In such agreements, the Secretary shall encourage the mutual recognition of— "(1) good manufacturing practice regulations promulgated under section 520(f), gind "(2) other regulations and testing protocols as the Secretary determines to be appropriate." (b) REPORT.— Not later than 2 years after the date of the enact- 21 USC 383 note, ment of this Act, the Secretary of Health and Human Services shall prepare and submit to the appropriate committees of Congress a