Page:United States Statutes at Large Volume 106 Part 5.djvu/855

 PUBLIC LAW 102-571—OCT. 29, 1992 106 STAT. 4493 respect to the review of human drug applications and supplements: drug applications and supplements. "(B) The issuance of action letters which approve human drug applications or which set forth in detail the specific deficiencies in such applications and, where appropriate, the actions necessary to place such applications in condition for approval. "(C) The inspection of prescription drug establishments and other facilities undertaken as part of the Secretary's review of pending human drug applications and supplements. "(D) Activities necessary for the review of applications for licensure of establishments subject to section 351 of the Public Health Service Act and for the release of lots of biologies under such section. "(E) Monitoring of research conducted in connection with the review of hirnian drug applications. "(7) The term 'costs of resources allocated for the process for the review of human drug applications' means the expenses incurred in connection with the process for the review of human drug applications for— "(A) officers and employees of the Food and Drug Administration, employees under contract with the Food and Drug Administration who work in facilities owned or leased for the Food and Drug Administration, advisory committees, and costs related to such officers, employees, and committees, "(B) management of information, and the acquisition, maintenance, and repair of computer resources, "(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, fumitiu'e, scientific equipment, and other necessary materials and supplies, and "(D) collecting fees under section 736 and accounting for resources allocated for the review of human drug applications and supplements. "(8) The term 'adjustment factor' applicable to a fiscal year is the lower of— "(A) the Consumer Price Index for all urban consumers (all items; United States city average) for August of the preceding fiscal year divided by such Index for August 1992, or "(B) the total of discretionary budget authority provided for programs in the domestic category for the immediately preceding fiscal year (as reported in the Office of Management and Budget sequestration preview report, if available, required under section 254(d) of the Balanced Budget and Emergency Deficit Control Act of 1985) divided by such budget authority for fiscal year 1992 (as reported in the Office of Management and Budget final sequestration report submitted after the end of the 102d Congress, 2d Session).
 * (6) The term 'process for the review of human drug applications' means the following activities of the Secretary with
 * (A) The activities necessary for the review of human

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