Page:United States Statutes at Large Volume 110 Part 2.djvu/801

 PUBLIC LAW 104-180—AUG. 6, 1996 110 STAT. 1593 TITLE VI RELATED AGENCIES AND FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION SALARIES AND EXPENSES For necessary expenses of the Food and Drug Administration, including hire and purchase of passenger motor vehicles; for rental of special purpose space in the District of Columbia or elsewhere; and for miscellaneous and emergency expenses of enforcement activities, authorized and approved by the Secretary and to be accounted for solely on the Secretary's certificate, not to exceed $25,000; $907,499,000, of which not to exceed $87,528,000 in fees pursuant to section 736 of the Federal Food, Drug, and Cosmetic Act may be credited to this appropriation and remain available until expended: Provided, That fees derived from applications received during fiscal year 1997 shall be subject to the fiscal year 1997 limitation: Provided further. That none of these funds shall be used to develop, establish, or operate any program of user fees authorized by 31 U.SC. 9701. In addition, fees pursuant to section 354 of the Public Health Service Act may be credited to this accoxmt, to remain available until expended. In addition, fees pursuant to section 801 of the Federal Food, Drug, and Cosmetic Act may be credited to this account, to remain available until expended. GENERAL PROVISIONS SEC. 601. EFFECTIVE MEDICATION GUIDES. — 21 USC 353 note. (a) IN GENERAL.— Not later than 30 days after the date of enactment of this Act, the Secretary of the Department of Health and Human Services shall request that national organizations representing health care professionals, consumer organizations, voluntary health agencies, the pharmaceutical industry, drug wholesalers, patient drug information database companies, and other relevant parties collaborate to develop a long-range comprehensive action plan to achieve goals consistent with the goals of the proposed rule of the Food and Drug Administration on "Prescription Drug Product Labeling: Medication Guide Requirements" (60 Fed. Reg. 44182; relating to the provision of oral and written prescription information to consumers). (b) GOALS.—Goals consistent with the proposed rule described in subsection (a) are the distribution of useful written information to 75 percent of individuals receiving new precriptions by the year 2000 and to 95 percent by the year 2006. (c) PLAN. —The plan described in subsection (a) shall— (1) identify the plan goals; (2) assess the effectiveness of the current private-sector approaches used to provide oral and written prescription information to consumers; 29-194O-96 -26:QL3Part2

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