Page:United States Statutes at Large Volume 111 Part 3.djvu/281

 PUBLIC LAW 105-115 —NOV. 21, 1997 111 STAT. 2369 "(3) The Secretary, acting through the Commissioner, shall maintain electronically and update and publish periodically in the Federal Register a list of guidance documents. All such documents shall be made available to the public. "(4) The Secretary shall ensure that an effective appeals mechanism is in place to address complaints that the Food and Drug Administration is not developing and using guidance documents in accordance with this subsection. "(5) Not later than July 1, 2000, the Secretary after evaluating Regulations, the effectiveness of the Good Guidance Practices document, published in the Federal Register at 62 Fed. Reg. 8961, shall promulgate a regulation consistent with this subsection specifying the policies and procedures of the Food and Drug Administration for the development, issuance, and use of guidcmce documents.". SEC. 406. FOOD AND DRUG ADMINISTRATION MISSION AND ANNUAL REPORT. (a) MISSION. —Section 903 (21 U.S.C. 393) is amended— (1) by redesignating subsections (b) and (c) as subsections (d) and (e), respectively; and (2) by inserting after subsection (a) the following: " (b) MISSION. — The Administration shall— "(1) promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner; "(2) with respect to such products, protect the public health by ensuring that— "(A) foods Eire safe, wholesome, sanitary, and properly labeled; "(B) human and veterinary drugs are safe and effective; "(C) there is reasonable assurance of the safety and effectiveness of devices intended for human use; "(D) cosmetics are safe and properly labeled; and "(E) public health and safety are protected from electronic product radiation; "(3) participate through appropriate processes with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements; and "(4) as determined to be appropriate by the Secretary, carry out paragraphs (1) through (3) in consultation with experts in science, medicine, and public health, and in cooperation with consumers, users, manufacturers, importers, packers, distributors, and retailers of regulated products.". (b) ANNUAL REPORT. —Section 903 (21 U.S.C. 393), as amended by subsection (a), is further amended by adding at the end the following: "(f) AGENCY PLAN FOR STATUTORY COMPLIANCE.— "(1) IN GENERAL.—Not later than 1 year after the date Federal Register, of enactment of the Food and Drug Administration Modemiza- publication. tion Act of 1997, the Secretary, after consultation with appropriate scientific and academic experts, health care professionals, representatives of patient and consumer advocacy groups, and the regulated industry, shall develop and publish in the Federal Register a plan bringing the Secretary into compliance with each of the obligations of the Secretary under this Act. The

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