Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations for 2003: Agricultural programsU.S. Government Printing Office, 2002 - United States |
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Page 3
... user fees , for the FDA in the next fiscal year . Our budget seeks re- sources to maintain our counterterrorism efforts , fully fund the pro- posed pay increase for our employees , expand our efforts in patient safety and generic drugs ...
... user fees , for the FDA in the next fiscal year . Our budget seeks re- sources to maintain our counterterrorism efforts , fully fund the pro- posed pay increase for our employees , expand our efforts in patient safety and generic drugs ...
Page 35
... user fees ; to improve the ability to assure the safety of regulated products ; to inspect and investigate domestic and foreign manufacturers ; and , to participate in harmonization efforts with countries to establish global standards ...
... user fees ; to improve the ability to assure the safety of regulated products ; to inspect and investigate domestic and foreign manufacturers ; and , to participate in harmonization efforts with countries to establish global standards ...
Page 43
... fees than estimated due to a reduced number of new drug applications and an increased proportion of submissions ... user fee functions it carries out in conjunction with PDUFA . The Agency will continue to work with industry 39 43.
... fees than estimated due to a reduced number of new drug applications and an increased proportion of submissions ... user fee functions it carries out in conjunction with PDUFA . The Agency will continue to work with industry 39 43.
Page 58
... user fees that are imposed , actual program increases , as I read it , are less than 1 percent over last year . I am having a little trouble seeing how you are going to be able to do your job . I just had a neighbor who unfortunately ...
... user fees that are imposed , actual program increases , as I read it , are less than 1 percent over last year . I am having a little trouble seeing how you are going to be able to do your job . I just had a neighbor who unfortunately ...
Page 98
... user fees , the FDA's major user fee legisla- tion supporting the review of new drugs is in effect only for the current year and reauthorization is in the works for the budget year . Could you clarify for the committee what assumptions ...
... user fees , the FDA's major user fee legisla- tion supporting the review of new drugs is in effect only for the current year and reauthorization is in the works for the budget year . Could you clarify for the committee what assumptions ...
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Common terms and phrases
90 percent act on 90 activities additional adverse events Agency Agency's Animal Drugs antimicrobial appropriate approved assessment associated bioterrorism blood Bonilla Bovine Spongiform Encephalopathy breast implant budget CFSAN clinical Committee compliance conduct consumers contamination costs Counter Terrorism CRAWFORD database dietary supplements disease domestic drug applications Drugs and Feeds electronic ensure establishments Estimate evaluate facilities Farm Credit Farm Credit System FDA's Federal fiscal Food and Drug food safety foodborne illness funding guidance HACCP Human Drugs implementation import increase industry inspections issues KAPTUR labeling laboratory Listeria monocytogenes loans mammography manufacturing medical devices medical products million monitoring MQSA Office pathogens patients PDUFA pediatric percent FY Performance Goals premarket proposed protect public health regulations regulatory request requirements Response Review and act risk Salmonella standards submissions surveillance System terrorist Undeclared color User Fees vaccines
Popular passages
Page 620 - October 31, 1977) provides that none of the funds appropriated or otherwise made available by this Act to the...
Page 438 - ... payment for publication of technical and Informational materials in professional and trade Journals...
Page 1193 - The four regulatory agencies that issued today's stateaents are the Office of the Comptroller of the Currency (OCC) , the Federal Deposit Insurance Corporation (FDIC), the Federal Reserve Board (FRB...
Page 1188 - Act of 1993 (GPRA) seeks to improve the effectiveness, efficiency, and accountability of federal programs by requiring federal agencies to set goals for program performance and to report on annual performance compared with the goals.
Page 21 - A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.
Page 388 - II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Page 326 - Available from National Technical Information Service, Springfield, VA 22151. ious requirements of the Environmental Protection Agency (EPA), the Nuclear Regulatory Commission (NRC), and other Federal and State agencies. The ultimate objective of these models is general prediction of the chemical concentrations to which organisms, including man, may be exposed following short or long-term releases of the chemical to the environment. Due to differences in intended uses, the models range in...
Page 306 - ... (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,...
Page 260 - I would be happy to provide that information for the record. (The information follows...
Page 301 - Section 736 (g) (2) (B), states that fees: shall only be collected and available to defray increases in the costs of the resources allocated for the process for the review of human drug applications (including increases in such costs for an additional number of fulltime equivalent positions...