Page:United States Statutes at Large Volume 111 Part 3.djvu/210

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Ill STAT. 2298 PUBLIC LAW 105-115—NOV. 21, 1997 TITLE I—IMPROVING REGULATION OF DRUGS Subtitle A—Fees Relating to Drugs 21 USC 379g SEC. 101. FINDINGS. ^- Congress finds that^ (1) prompt approval of safe and effective new drugs and other therapies is critical to the improvement of the public health so that patients may enjoy the benefits provided by these therapies to treat and prevent illness and disease; (2) the public health will be served by making additional funds available for the purpose of augmenting the resources of the Food and Drug Administration that are devoted to the process for review of human drug applications.; (3) the provisions added by the Prescription Drug User Fee Act of 1992 have been successful in 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; and (4) the fees authorized by amendments made in this subtitle will be dedicated toward expediting the drug development process and the review of humsin 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 Commerce of the House of Representatives and the chairman of the Committee on Labor and Human Resources of the Senate, as set forth in the Congressional Record. 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