Page:United States Statutes at Large Volume 116 Part 1.djvu/714

 116 STAT. 688 PUBLIC LAW 107-188-JUNE 12, 2002 substantially reducing review times for human drug applications and should be— (A) reauthorized for an additional 5 years, with certain technical improvements; and (B) carried out by the Food and Drug Administration with new commitments to implement more ambitious and comprehensive improvements in regulatory processes of the Food and Drug Administration, including— (i) strengthening and improving the review and monitoring of drug safety; (ii) considering greater interaction between the agency and sponsors during the review of drugs and biologies intended to treat serious diseases and lifethreatening diseases; and (iii) developing principles for improving first-cycle reviews; and (4) the fees authorized by amendments made in this subtitle will be dedicated towards expediting the drug development process and the process for the review of human drug applications as set forth in the goals identified for purposes of part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the letters from the Secretary of Health and Human Services to the chairman of the Committee on Energy and Commerce of the House of Representatives and the chairman of the Committee on Health, Education, Labor and Pensions of the Senate, as set forth in the Congressional Record. SEC. 503. DEFINITIONS. Section 735 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g) is amended— (1) in paragraph (1), in the matter after and below subparagraph (C), by striking "licensure, as described in subparagraph (D)" and inserting "licensure, as described in subparagraph (C)"; (2) in paragraph (3)— (A) in subparagraph (A), by striking "and" at the end; (B) in subparagraph (B), by striking the period and inserting ", and"; (C) by inserting after subparagraph (B) the following subparagraph: "(C) which is on the list of products described in section 505(j)(7)(A) or is on a list created and maintained by the Secretary of products approved under human drug applications under section 351 of the Public Health Service Act."; and (D) in the matter after and below subparagraph (C) (as added by subparagraph (C) of this paragraph), by striking "Service Act," and all that follows through "biological product" and inserting the following: "Service Act. Such term does not include a biological product"; (3) in paragraph (6), by adding at the end the following subparagraph: "(F) In the case of drugs approved after October 1, 2002, under human drug applications or supplements: collecting, developing, and reviewing safety information on the drugs, including adverse event reports, during a period

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