PUBLIC LAW 102-571—(Xrr. 29, 1992 106 STAT. 4491 Public Law 102-571 102d Congress An Act To amend the Federal Food, Drug, and Cosmetic Act to authorize human drug Q^^ 29 1992 application, prescription drug establishment, and prescription drug product fees ' and for other purposes. ' tH.R. 6181] Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, TITLE I—USER FEES or^tTs^r Fee Act of SEC. 101. SHORT TITLE AND REFERENCE. 21^USC 301 (a) SHORT TITLE.—This title may be cited as the "Prescription note. Drug User Fee Act of 1992". (b) REFERENCE. — Whenever in this title an amendment or repeal is expressed in terms of an amendment to, or repeal of, a section or other provision, the reference shall be consiaered to be made to a section or other provision of the Federal Food, Drug, and Cosmetic Act. SEC. 102. FINDINGS. 21 USC 379g The Congress finds that— (1) prompt approval of safe and effective new drugs is critical to the improvement of the public health so that patients may enjoy the benefits provided by these therapies to treat ana 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; and (3) the fees authorized by this title will be dedicated toward expediting the review of human drug applications as set forth in the goals identified in the letters of September 14, 1992, and September 21, 1992, from the Commissioner of Food and Drugs to the Chairman of the Energy and Commerce Committee of the House of Representatives and the Chairman of the Labor and Human Resources Committee of the Senate, as set forth at 138 Cong. Rec. H9099-H9100 (daily ed. September 22, 1992). SEC. 103. FEES RELATING TO DRUGS. Chapter VII, as amended by section 106, is amended by adding at the end of subchapter C the following:
- PART 2—FEES RELATING TO DRUGS
"SEC. 735. DEFINITIONS. 21 USC 379g. "For purposes of this subchapter: (1) The term liimian orug application' means an application for—
�
