Page:United States Statutes at Large Volume 111 Part 3.djvu/282

 Ill STAT. 2370 PUBLIC LAW 105-115—NOV. 21, 1997 Secretary 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. Federal Register, "(g) ANNUAL REPORT.—The Secretary shall annually prepare publication. 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.". SEC. 407. INFORMATION SYSTEM. (a) AMENDMENT. —Chapter VII (21 U.S.C. 371 et seq.) is amended by adding at the end the following: " SUBCHAPTER D—INFORMATION AND EDUCATION 21 USC 379k. "SEC. 741. INFORMATION SYSTEM. "The Secretary shall establish and maintain an information system to track the status and progress of each application or submission (including a petition, notification, or other similar form of request) submitted to the Food and Drug Administration requesting agency action.". 21 USC 379k (b) REPORT. — Not later than 1 year after the date of enactment note. of this Act, the Secretary of Health and Human Services shall submit a report to the Committee on Labor and Humsm Resources of the Senate and the Committee on Commerce of the House of Representatives on the status of the system to be established under

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