DEFINITIONS.

SEC. 102. DEFINITIONS. Section 735 (21 U.S.C. 379g) is amended—(1) in the matter before paragraph (1), by striking “For purposes of this subchapter” and inserting “For purposes of this part”;(2) in paragraph (1)—(A) in subparagraph (A), by striking “505(b)(1),” and inserting “505(b), or”;(B) by striking subparagraph (B);(C) by redesignating subparagraph (C) as subparagraph (B); and121 STAT. 826(D) in the matter following subparagraph (B), as so redesignated, by striking “subparagraph (C)” and inserting “subparagraph (B)”;(3) in paragraph (3)(C)—(A) by striking “505(j)(7)(A)” and inserting “505(j)(7)(A) (not including the discontinued section of such list)”; and(B) by inserting before the period “(not including the discontinued section of such list)”;(4) in paragraph (4), by inserting before the period at the end the following: “(such as capsules, tablets, or lyophilized products before reconstitution)”;(5) by amending paragraph (6)(F) to read as follows:“(F) Postmarket safety activities with respect to drugs approved under human drug applications or supplements, including the following activities:“(i) Collecting, developing, and reviewing safety information on approved drugs, including adverse event reports.“(ii) Developing and using improved adverse-event data-collection systems, including information technology systems.“(iii) Developing and using improved analytical tools to assess potential safety problems, including access to external data bases.“(iv) Implementing and enforcing section 505(o) (relating to postapproval studies and clinical trials and labeling changes) and section 505(p) (relating to risk evaluation and mitigation strategies).“(v) Carrying out section 505(k)(5) (relating to adverse event reports and postmarket safety activities).”;(6) in paragraph (8)—(A) by striking “April of the preceding fiscal year” and inserting “October of the preceding fiscal year”; and(B) by striking “April 1997” and inserting “October 1996”;(7) by redesignating paragraph (9) as paragraph (11); and(8) by inserting after paragraph (8) the following paragraphs:“(9) The term ‘person’ includes an affiliate thereof.“(10) The term ‘active’, with respect to a commercial investigational new drug application, means such an application to which information was submitted during the relevant period.”.