DEFINITIONS.

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 116 STAT. 689 of time after approval of such applications or supplements, not to exceed three years.”; and (4) in paragraph (8)— (A) by striking the matter after and below subparagraph (B); (B) by striking subparagraph (B); (C) by striking “is the lower of” and all that follows through “Consumer Price Index” and inserting “is the Consumer Price Index”; and (D) by striking “1997, or” and inserting “1997.”.