Page:United States Statutes at Large Volume 111 Part 3.djvu/271

 PUBLIC LAW 105-115—NOV. 21, 1997 111 STAT. 2359 551 and does not have a primary focus on new uses of drugs or devices that are marketed or under investigation by a manufacturer supporting the dissemination of information; and "(5) presents materials that are not false or misleading. "SEC. 553. ESTABLISHMENT OF LIST OF ARTICLES AND PUBLICA- TIONS DISSEMINATED AND LIST OF PROVIDERS THAT RECEIVED ARTICLES AND REFERENCE PUBLICATIONS. "(a) IN GENERAL. —^A manufacturer may disseminate information under section 551 on a new use only if the manufacturer prepares and submits to the Secretary biannually— "(1) a list containing the titles of the articles and reference publications relating to the new use of drugs or devices that were disseminated by the manufacturer to a person described in section 551(a) for the 6-month period preceding the date on which the manufacturer submits the list to the Secretary; and "(2) a list that identifies the categories of providers (as described in section 551(a)) that received the articles and ref- erence publications for the 6-month period described in paragraph (1). "(b) RECORDS.—A manufacturer that disseminates information under section 551 shall keep records that may be used by the manufacturer when, pursuant to section 555, such manufacturer is required to take corrective action and shall be made available to the Secretary, upon request, for purposes of ensuring or taking corrective action pursuant to such section. Such records, at the Secretary's discretion, may identify the recipient of information provided pursuant to section 551 or the categories of such recipients. "SEC. 554. REQUIREMENT REGARDING SUBMISSION OF SUPPLE- MENTAL APPLICATION FOR NEW USE; EXEMPTION FROM REQUIREMENT. "(a) IN GENERAL. —^A manufacturer may disseminate information under section 551 on a new use only if— "(1)(A) the manufacturer has submitted to the Secretary a supplemental application for such use; or "(B) the manufacturer meets the condition described in subsection (b) or (c) (relating to a certification that the manufacturer will submit such an application); or "(2) there is in effect for the manufacturer an exemption under subsection (d) from the requirement of paragraph (1). "(b) CERTIFICATION ON SUPPLEMENTAL APPLICATION; CONDITION IN CASE OF COMPLETED STUDIES. —For purposes of subsection (a)(1)(B), a manufacturer may disseminate information on a new use if the manufacturer has submitted to the Secretary an application containing a certification that— "(1) the studies needed for the submission of a supplemental application for the new use have been completed; and "(2) the supplemental application will be submitted to the Secretary not later than 6 months after the date of the initial dissemination of information under section 551. "(c) CERTIFICATION ON SUPPLEMENTAL APPLICATION; CONDITION IN CASE OF PLANNED STUDIES.— "(1) IN GENERAL.— For purposes of subsection (a)(1)(B), a manufacturer may disseminate information on a new use if— "(A) the manufacturer has submitted to the Secretary an application containing— 21 USC 360aaa-2. 21 USC 360aaa-3.

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