Page:United States Statutes at Large Volume 111 Part 3.djvu/273

 PUBLIC LAW 105-115—NOV. 21, 1997 111 STAT. 2361 "(ii) the size of the population expected to benefit from approval of the supplemental application. "(B) The Secretary makes a determination that, for reasons defined by the Secretary, it would be unethical to conduct the studies necessary for the supplemental application. In making such determination, the Secretary shall consider (in addition to any other considerations the Secretary finds appropriate) whether the new use involved is the standard of medical care for a health condition. "(3) TIME FOR CONSIDERATION OF APPLICATION; DEEMED APPROVAL. — "(A) IN GENERAL.—The Secretary shall approve or deny an application under paragraph (1) for an exemption not later than 60 days after the receipt of the application. If the Secretary does not comply with the preceding sentence, the application is deemed to be approved. "(B) TERMINATION OF DEEMED APPROVAL.— If pursuant to a deemed approval under subparagraph (A) a manufacturer disseminates written information under section 551 on a new use, the Secretary may at any time terminate such approval and under section 555(b)(3) order the manufacturer to cease disseminating the information. "(e) REQUIREMENTS REGARDING APPLICATIONS. — Applications \under this section shall be submitted in the form and manner prescribed by the Secretary. 21 USC 360aaa-4. "SEC. 555. CORRECTIVE ACTIONS; CESSATION OF DISSEMINATION. "(a) POSTDISSEMINATION DATA REGARDING SAFETY AND EFFECTIVENESS. — "(1) CORRECTIVE ACTIONS.— With respect to data received by the Secretary after the dissemination of information under section 551 by a manufacturer has begun (whether received pursuant to paragraph (2) or otherwise), if the Secretary determines that the data indicate that the new use involved may not be effective or may present a significant risk to public health, the Secretary shall, after consultation with the manufacturer, take such action regarding the dissemination of the information as the Secretary determines to be appropriate for the protection of the public health, which may include ordering that the manufacturer cease the dissemination of the information. "(2) RESPONSIBILITIES OF MANUFACTURERS TO SUBMIT DATA. —After a manufacturer disseminates information under section 551, the manufacturer shall submit to the Secretary a notification of any additional knowledge of the manufacturer on clinical research or other data that relate to the safety or effectiveness of the new use involved. If the manufacturer is in possession of the data, the notification shall include the data. The Secretary shall by regulation establish the scope Regulations. of the responsibilities of manufacturers under this paragraph, including such limits on the responsibilities as the Secretary determines to be appropriate. "(b) CESSATION OF DISSEMINATION.— "(1) FAILURE OF MANUFACTURER TO COMPLY WITH REQUIRE- MENTS.— The Secretary may order a manufacturer to cease the dissemination of information pursuant to section 551 if

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