FOOD AND DRUG ADMINISTRATION MISSION AND ANNUAL REPORT.

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 are 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 of enactment of the Food and Drug Administration Modernization 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 111 STAT. 2370Secretary shall review the plan biannually and shall revise the plan as necessary, in consultation with such persons. “(2) Objectives of agency plan.—The plan required by paragraph (1) shall establish objectives and mechanisms to achieve such objectives, including objectives related to— “(A) maximizing the availability and clarity of information about the process for review of applications and submissions (including petitions, notifications, and any other similar forms of request) made under this Act; “(B) maximizing the availability and clarity of information for consumers and patients concerning new products; “(C) implementing inspection and postmarket monitoring provisions of this Act; “(D) ensuring access to the scientific and technical expertise needed by the Secretary to meet obligations described in paragraph (1); “(E) establishing mechanisms, by July 1, 1999, for meeting the time periods specified in this Act for the review of all applications and submissions described in subparagraph (A) and submitted after the date of enactment of the Food and Drug Administration Modernization Act of 1997; and “(F) eliminating backlogs in the review of applications and submissions described in subparagraph (A), by January 1, 2000. “(g) Annual Report.—The Secretary shall annually prepare and publish in the Federal Register and solicit public comment on a report that— “(1) provides detailed statistical information on the performance of the Secretary under the plan described in subsection (f); “(2) compares such performance of the Secretary with the objectives of the plan and with the statutory obligations of the Secretary; and “(3) identifies any regulatory policy that has a significant negative impact on compliance with any objective of the plan or any statutory obligation and sets forth any proposed revision to any such regulatory policy.”.