Department of Health and Human Services January 30, 2008 – Federal Register Recent Federal Regulation Documents
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Guidance for Industry and Food and Drug Administration Staff; Clinical Laboratory Improvement Amendments of 1988: Recommendations for Clinical Laboratory Improvement Amendments of 1988: Waiver Applications for Manufacturers of In Vitro Diagnostic Devices; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices.'' FDA is issuing this guidance to recommend approaches for determining whether a laboratory test may be performed by laboratories with a certificate of waiver under CLIA.
Proposed Collection; Comment Request; Case-Cohort Study of Cancer and Related Disorders Among Benzene-Exposed Workers in China (OMB No. 0925-0454)
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
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