Page:United States Statutes at Large Volume 111 Part 3.djvu/222

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Ill STAT. 2310 PUBLIC LAW 105-115—NOV. 21, 1997 appropriate, at least 30 days prior to dissemination of the materials. " (3) EXPEDITED WITHDRAWAL OF APPROVAL.—The Secretary may withdraw approval of a fast track product using expedited procedures (as prescribed by the Secretary in regulations which shall include an opportunity for an informal hearing) if— "(A) the sponsor fails to conduct any required postapproval study of the fast track drug with due diligence; "(B) a post-approval study of the fast track product fails to verify clinical benefit of the product; "(C) other evidence demonstrates that the fast track product is not safe or effective under the conditions of use; or "(D) the sponsor disseminates false or misleading promotional materials with respect to the product. "(c) REVIEW OF INCOMPLETE APPLICATIONS FOR APPROVAL OF A FAST TRACK PRODUCT.— "(1) IN GENERAL.— If the Secretary determines, after preliminary evaluation of clinical data submitted by the sponsor, that a fast track product may be effective, the Secretary shall evaluate for filing, and may commence review of portions of, an application for the approval of the product before the sponsor submits a complete application. The Secretary shall commence such review only if the applicant— "(A) provides a schedule for submission of information necessary to make the application complete; and "(B) pays any fee that may be required under section 736. "(2) EXCEPTION. —Any time period for review of human drug applications that has been agreed to by the Secretary and that has been set forth in goals identified in letters of the Secretary (relating to the use of fees collected under section 736 to expedite the drug development process and the review of human drug applications) shall not apply to an application submitted under paragraph (1) until the date on which the application is complete. "(d) AWARENESS EFFORTS. — The Secretary shall— "(1) develop and disseminate to physicians, patient organizations, pharmaceutical and biotechnology companies, and other appropriate persons a description of the provisions of this section applicable to fast track products; and "(2) establish a program to encourage the development of surrogate endpoints that are reasonably likely to predict clinical benefit for serious or life-threatening conditions for which there exist significant unmet medical needs.". 21 USC 356 note. (b) GUIDANCE.— Within 1 year after the date of enactment of this Act, the Secretary of Health and Human Services shall issue guidance for fast track products (as defined in section 506(a)(1) of the Federal Food, Drug, and Cosmetic Act) that describes the policies and procedures that pertain to section 506 of such Act. SEC. 113. INFORMATION PROGRAM ON CLINICAL TRIALS FOR SERI- OUS OR LIFE-THREATENING DISEASES. (a) IN GENERAL. —Section 402 of the Public Health Service Act (42 U.S.C. 282) is amended— (1) by redesignating subsections (j) and (k) as subsections (k) and (1), respectively; and