Page:United States Statutes at Large Volume 111 Part 3.djvu/279

 PUBLIC LAW 105-115—NOV. 21, 1997 111 STAT. 2367 voluntary health associations, and other appropriate persons about the availability of an investigational drug or investigational device under expanded access protocols submitted under this subsection. The information provided by the Secretary, in accordance with the preceding sentence, shall be the same type of information that is required by section 402(j)(3) of the Public Health Service Act. "(d) TERMINATION. —The Secretary may, at any time, with respect to a sponsor, physician, manufacturer, or distributor described in this section, terminate expanded access provided under this section for an investigational drug or investigational device if the requirements under this section are no longer met. "(e) DEFINITIONS.—In this section, the terms 'investigational drug*, 'investigational device', 'treatment investigational new drug application', and 'treatment investigational device exemption' shall have the meanings given the terms in regulations prescribed by the Secretary.". SEC. 403. APPROVAL OF SUPPLEMENTAL APPLICATIONS FOR 21 USC 371 note. APPROVED PRODUCTS. (a) STANDARDS.— Not later than 180 days after the date of enactment of this Act, the Secretary of Health and Human Services shall publish in the Federal Register standards for the prompt review of supplemental applications submitted for approved articles under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or section 351 of the Public Health Service Act (42 U.S.C. 262). (b) GUIDANCE TO INDUSTRY.—Not later than 180 days after the date of enactment of this Act, the Secretary shall issue final guidances to clarify the requirements for, and facilitate the submission of data to support, the approval of supplemental applications for the approved articles described in subsection (a). The guidances shall— (1) clarify circumstances in which published matter may be the basis for approval of a supplemental application; (2) specify data requirements that will avoid duplication of previously submitted data by recognizing the availability of data previously submitted in support of an original application; and (3) define supplemental applications that are eligible for priority review. (c) RESPONSIBILITIES OF CENTERS.— The Secretary shall designate an individual in each center within the Food and Drug Administration (except the Center for Food Safety and Applied Nutrition) to be responsible for— (1) encouraging the prompt review of supplemental applications for approved articles; and (2) working with sponsors to facilitate the development and submission of data to support supplemental applications. (d) COLLABORATION. — The Secretary shall implement programs and policies that will foster collaboration between the Food and Drug Administration, the National Institutes of Health, professional medical and scientific societies, and other persons, to identify published and unpublished studies that may support a supplemental application, and to encourage sponsors to make supplemental applications or conduct further research in support of a supplemental application based, in whole or in part, on such studies.

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