Page:United States Statutes at Large Volume 121.djvu/980

 PUBLIC LAW 110–85—SEPT. 27, 2007

121 STAT. 959

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(1) redesignating paragraphs (1), (2), (3), (4), and (5) as subparagraphs (A), (B), (C), (D), and (E), respectively; (2) striking ‘‘(l) Safety and’’ and inserting ‘‘(l)(1) Safety and’’; and (3) adding at the end the following: ‘‘(2) ACTION PACKAGE FOR APPROVAL.— ‘‘(A) ACTION PACKAGE.—The Secretary shall publish the action package for approval of an application under subsection (b) or section 351 of the Public Health Service Act on the Internet Web site of the Food and Drug Administration— ‘‘(i) not later than 30 days after the date of approval of such application for a drug no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under this section or section 351 of the Public Health Service Act; and ‘‘(ii) not later than 30 days after the third request for such action package for approval received under section 552 of title 5, United States Code, for any other drug. ‘‘(B) IMMEDIATE PUBLICATION OF SUMMARY REVIEW.—Notwithstanding subparagraph (A), the Secretary shall publish, on the Internet Web site of the Food and Drug Administration, the materials described in subparagraph (C)(iv) not later than 48 hours after the date of approval of the drug, except where such materials require redaction by the Secretary. ‘‘(C) CONTENTS.—An action package for approval of an application under subparagraph (A) shall be dated and shall include the following: ‘‘(i) Documents generated by the Food and Drug Administration related to review of the application. ‘‘(ii) Documents pertaining to the format and content of the application generated during drug development. ‘‘(iii) Labeling submitted by the applicant. ‘‘(iv) A summary review that documents conclusions from all reviewing disciplines about the drug, noting any critical issues and disagreements with the applicant and within the review team and how they were resolved, recommendations for action, and an explanation of any nonconcurrence with review conclusions. ‘‘(v) The Division Director and Office Director’s decision document which includes— ‘‘(I) a brief statement of concurrence with the summary review; ‘‘(II) a separate review or addendum to the review if disagreeing with the summary review; and ‘‘(III) a separate review or addendum to the review to add further analysis. ‘‘(vi) Identification by name of each officer or employee of the Food and Drug Administration who— ‘‘(I) participated in the decision to approve the application; and ‘‘(II) consents to have his or her name included in the package. ‘‘(D) REVIEW.—A scientific review of an application is considered the work of the reviewer and shall not be altered by management or the reviewer once final.

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Publication. Web site. Deadlines.

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