DEFINITIONS.

SEC. 102. DEFINITIONS. Section 735 (21 U.S.C. 379g) is amended— (1) in the second sentence of paragraph (1)— (A) by striking “Service Act, and” and inserting “Service Act,”; and (B) by striking “September 1, 1992.” and inserting the following: “September 1, 1992, does not include an application for a licensure of a biological product for further manufacturing use only, and does not include an application or supplement submitted by a State or Federal Government entity for a drug that is not distributed commercially. Such term does include an application for licensure, as described in subparagraph (D), of a large volume biological product intended for single dose injection for intravenous use or infusion.”; (2) in the second sentence of paragraph (3)— (A) by striking “Service Act, and” and inserting “Service Act,”; and (B) by striking “September 1, 1992.” and inserting the following: “September 1, 1992, does not include a 111 STAT. 2299biological product that is licensed for further manufacturing use only, and does not include a drug that is not distributed commercially and is the subject of an application or supplement submitted by a State or Federal Government entity. Such term does include a large volume biological product intended for single dose injection for intravenous use or infusion.”; (3) in paragraph (4), by striking “without” and inserting “without substantial”; (4) by amending the first sentence of paragraph (5) to read as follows: “(5) The term ‘prescription drug establishment’ means a foreign or domestic place of business which is at one general physical location consisting of one or more buildings all of which are within five miles of each other and at which one or more prescription drug products are manufactured in final dosage form.”; (5) in paragraph (7)(A)— (A) by striking “employees under contract” and all that follows through “Administration,” the second time it occurs and inserting “contractors of the Food and Drug Administration,”; and (B) by striking “and committees,” and inserting “and committees and to contracts with such contractors,”; (6) in paragraph (8)— (A) in subparagraph (A)— (i) by striking “August of” and inserting “April of”; and (ii) by striking “August 1992” and inserting “April 1997”; and (B) in subparagraph (B)— (i) by striking “section 254(d)” and inserting “section 254(c)”; (ii) by striking “1992” and inserting “1997”; and (iii) by striking “102d Congress, 2d Session” and inserting “105th Congress, 1st Session”; and (7) by adding at the end the following: “(9) The term ‘affiliate’ means a business entity that has a relationship with a second business entity if, directly or indirectly— “(A) one business entity controls, or has the power to control, the other business entity; or “(B) a third party controls, or has power to control, both of the business entities.”.