Page:United States Statutes at Large Volume 111 Part 3.djvu/243

 PUBLIC LAW 105-115—NOV. 21, 1997 111 STAT. 2331 (2) in subsection (b), by striking "to carry out this section" and inserting ", and for fiscal years 1998 through 2002 $3,000,000 for each fiscal year, to carry out this section". SEC. 129. REGULATIONS FOR SUNSCREEN PRODUCTS. 21 USC 393 note. Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services shall issue regulations for over-the-counter sunscreen products for the prevention or treatment of sunburn. SEC. 130. REPORTS OF POSTMARKETING APPROVAL STUDIES. (a) IN GENERAL.— Chapter V, as amended by section 116, is further amended by inserting after section 506A the following: "SEC. 506B. REPORTS OF POSTMARKETING STUDIES. 21 USC 356b. "(a) SUBMISSION.— "(1) IN GENERAL.—^A sponsor of a drug that has entered into an agreement with the Secretary to conduct a postmarketing study of a drug shall submit to the Secretary, within 1 year after the approved of such drug and annually thereafter until the study is completed or terminated, a report of the progress of the study or the reasons for the failure of the sponsor to conduct the study. The report shall be submitted in such form as is prescribed by the Secretary in regulations issued by the Secretary. "(2) AGREEMENTS PRIOR TO EFFECTIVE DATE. —Any agreement entered into between the Secretary and a sponsor of a drug, prior to the date of enactment of the Food and Drug Administration Modernization Act of 1997, to conduct a postmarketing study of a drug shall be subject to the requirements of paragraph (1). An initial report for such an agreement shall be submitted within 6 months after the date of the issuance of the regulations under paragraph (1). "(b) CONSIDERATION OF INFORMATION AS PUBLIC INFORMA- TION.—Any information pertaining to a report described in subsection (a) shall be considered to be public information to the extent that the information is necessary— "(1) to identify the sponsor; and "(2) to establish the status of a study described in subsection (a) and the reasons, if any, for any failure to carry out the study. "(c) STATUS OF STUDIES AND REPORTS.— The Secretary shall Federal Register, annuEdly develop and publish in the Federal Register a report publication. that provides information on the status of the postmarketing studies— "(1) that sponsors have entered into agreements to conduct; and "(2) for which reports have been submitted under subsection (a)(1). ". (b) REPORT TO CONGRESSIONAL COMMITTEES. —Not later than 21 USC 356b October 1, 2001, the Secretary shall prepare and submit to the note. Committee on Labor and Human Resources of the Senate and the Committee on Commerce of the House of Representatives a report containing— (1) a summary of the reports submitted under section 506B of the Federal Food, Drug, and Cosmetic Act; (2) an evaluation of—

�