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The Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research. [1]
As a work of the U.S. federal government, the image is in the public domain. Public domain Public domain false false This file is a work of the Centers for Disease Control and Prevention , part of the United States Department of Health and Human Services , taken or made as part of an employee's official duties.
[1] [2] [3] Phlebotomy licensure advocates claim that the licensure would enhance the quality of personnel, while the laboratory industry opposes phlebotomy licensure as an unnecessary cost. [ 4 ] [ 5 ] [ 6 ] Phlebotomy is not without risk, and more challenging patients increase the chance of complications. [ 7 ]
The federal funds received are then expended to perform the specific activity (e.g., purchase good or service or for payroll). However, laws and regulations require recipients to request funds only when it is immediately needed, and recipients must try to minimize the amount of time between the receipts of funds to the actual disbursement. [9]
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"About Code of Federal Regulations". Government Publishing Office. 9 March 2017. "A Research Guide to the Federal Register and the Code of Federal Regulations". Law Librarians' Society of Washington, D.C. July 21, 2012. "Report to Congress on the Costs and Benefits of Federal Regulations". Office of Management and Budget. September 30, 1997.
The FDA requires nonclinical laboratory studies on new drugs, food additives, and chemicals to assess their safety and potential effectiveness in humans in compliance with 21 CFR Part 58, Good Laboratory Practice for Nonclinical Studies under the Federal Food Drug and Cosmetic Act and Public Health Service Act. [16]
The Significant New Alternatives Policy (also known as Section 612 of the Clean Air Act or SNAP, promulgated at 40 CFR part 82 Subpart G) is a program of the EPA to determine acceptable chemical substitutes, and establish which are prohibited or regulated by the EPA. [1]