Page:United States Statutes at Large Volume 111 Part 3.djvu/284

 Ill STAT. 2372 PUBLIC LAW 105-115—NOV. 21, 1997 of one or more centers to carry out the activities specified in subsection (b), "(b) REQUIRED ACTIVITIES. —The activities referred to in subsection (a) are the following: "(1) The conduct of state-of-the-art clinical and laboratory research for the following purposes: "(A) To increase awareness of— "(i) new uses of drugs, biological products, and devices; "(ii) ways to improve the effective use of drugs, biological products, and devices; and "(iii) risks of new uses and risks of combinations of drugs and biological products. "(B) To provide objective clinical information to the following individuals and entities: "(i) Health care practitioners or other providers of health care goods or services. "(ii) Pharmacy benefit managers, "(iii) Health maintenance organizations or other managed health care organizations. "(iv) Health care insurers or governmental agencies. "(v) Consumers. "(C) To improve the quality of health care while reducing the cost of health care through— "(i) the appropriate use of drugs, biological products, or devices; and "(ii) the prevention of adverse effects of drugs, biological products, and devices and the consequences of such effects, such as unnecessary hospitalizations. "(2) The conduct of research on the comparative effectiveness and safety of drugs, biological products, and devices. "(3) Such other activities as the Secretary determines to be appropriate, except that the grant may not be expended to assist the Secretary in the review of new drugs. "(c) APPLICATION FOR GRANT.—^A grant under subsection (a) may be made only if an application for the grant is submitted to the Secretary and the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section. "(d) PEER REVIEW.— ^A grant under subsection (a) may be made only if the application for the grant has undergone appropriate technical and scientific peer review. "(e) AUTHORIZATION OF APPROPRIATIONS. — For the purpose of carrying out this section, there are authorized to be appropriated $2,000,000 for fiscal year 1998, and $3,000,000 for each of fiscal years 1999 through 2002. ". SEC. 410. MUTUAL RECOGNITION AGREEMENTS AND GLOBAL HARMONIZATION. (a) GOOD MANUFACTURING PRACTICE REQUIREMENTS.— Section 520(f)(1)(B) (21 U.S.C. 360j(f)(l)(B)) is amended— (1) in clause (i), by striking ", and" at the end and inserting a semicolon; (2) in clause (ii), by striking the period and inserting "; and"; and

�