Page:United States Statutes at Large Volume 111 Part 3.djvu/244

 Ill STAT. 2332 PUBLIC LAW 105-115—NOV. 21, 1997 (A) the performance of the sponsors referred to in such section in fulfilling the agreements with respect to the conduct of postmarketing studies described in such section of such Act; and (B) the timeliness of the Secretary's review of the postmarketing studies; and (3) any legislative recommendations respecting the postmarketing studies. SEC. 131. NOTIFICATION OF DISCONTINUANCE OF A LIFE SAVING PRODUCT. (a) IN GENERAL.— Chapter V, as amended by section 130, is further amended by inserting after section 506B the following: 21 USC 356c. "SEC. 506C. DISCONTINUANCE OF A LIFE SAVING PRODUCT. "(a) IN GENERAL.— ^A manufacturer that is the sole manufacturer of a drug— "(1) that is— "(A) life-supporting; "(B) life-sustaining; or "(C) intended for use in the prevention of a debilitating disease or condition; "(2) for which an application has been approved under section 505(b) or 505(j); and "(3) that is not a product that was originally derived from human tissue and was replaced by a recombinant product, shall notify the Secretary of a discontinuance of the manufacture of the drug at least 6 months prior to the date of the discontinuance. "(b) REDUCTION IN NOTIFICATION PERIOD. —The notification period required under subsection (a) for a manufacturer may be reduced if the manufacturer certifies to the Secretary that good cause exists for the reduction, such as a situation in which— "(1) a public health problem may result from continuation of the manufacturing for the 6-month period; "(2) a biomaterials shortage prevents the continuation of the manufacturing for the 6-month period; "(3) a liability problem may exist for the manufacturer if the manufacturing is continued for the 6-month period; "(4) continuation of the manufacturing for the 6-month period may cause substantial economic hardship for the manufacturer; "(5) the manufacturer has filed for bankruptcy under chapter 7 or 11 of title 11, United States Code; or "(6) the manufacturer can continue the distribution of the drug involved for 6 months. "(c) DISTRIBUTION. —To the maximum extent practicable, the Secretary shall distribute information on the discontinuation of the drugs described in subsection (a) to appropriate physician and patient organizations.". TITLE II—IMPROVING REGULATION OF DEVICES SEC. 201. INVESTIGATIONAL DEVICE EXEMPTIONS. (a) IN GENERAL.—Section 520(g) (21 U.S.C. 360j(g)) is amended by adding at the end the following:

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