Page:United States Statutes at Large Volume 111 Part 3.djvu/227

 PUBLIC LAW 105-115—NOV. 21, 1997 111 STAT. 2315 for a manufacturing change shall contain such information as the Secretary determines to be appropriate, which shall include the information developed under subsection (b) by the holder in validating the effects of the change. "(B) AUTHORITY FOR DISTRIBUTION.— In the case of a manufacturing change to which paragraph (1)(B) applies: "(i) The holder involved may commence distribution of the drug involved 30 days after the Secretary receives the supplemental application under such paragraph, unless the Secretary notifies the holder within such 30-day period that prior approval of the application is required before distribution may be commenced, "(ii) The Secretary may designate a category of such changes for the purpose of providing that, in the case of a change that is in such category, the holder involved may commence distribution of the drug involved upon the receipt by the Secretary of a supplemental application for the change. "(iii) If the Secretary disapproves the supplemental application, the Secretary may order the manufacturer to cease the distribution of the drugs that have been made with the manufacturing change.", (b) TRANSITION RULE. —The amendment made by subsection 21 USC 356a (a) takes effect upon the effective date of regulations promulgated note. by the Secretary of Health and Human Services to implement such amendment, or upon the expiration of the 24-month period beginning on the date of the enactment of this Act, whichever occurs first. SEC. 117. STREAMLINING CLINICAL RESEARCH ON DRUGS. Section 505(i) (21 U.S.C. 355(i)) is amended— (1) by redesignating paragraphs (1) through (3) as subparagraphs (A) through (C), respectively; (2) by inserting "(1)" after "(i)"; (3) by striking the last two sentences; and (4) by inserting after paragraph (1) (as designated by paragraph (2) of this section) the following new paragraphs: "(2) Subject to paragraph (3), a clinical investigation of a new drug may begin 30 days after the Secretary has received from the manufacturer or sponsor of the investigation a submission containing such information about the drug and the clinical investigation, including— "(A) information on design of the investigation and adequate reports of basic information, certified by the applicant to be accurate reports, necessary to assess the safety of the drug for use in clinical investigation; and "(B) adequate information on the chemistry and manufacturing of the drug, controls available for the drug, and primary data tabulations from animal or human studies. "(3)(A) At any time, the Secretary may prohibit the sponsor of an investigation from conducting the investigation (referred to in this paragraph as a 'clinical hold') if the Secretary makes a determination described in subparagraph (B). The Secretary shall specify the basis for the clinical hold, including the specific information available to the Secretary which served as the basis for such clinical hold, and confirm such determination in writing.

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