Department of Health and Human Services September 7, 2005 – Federal Register Recent Federal Regulation Documents
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Draft Guidance for Industry and Food and Drug Administration Staff: Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications.'' FDA is issuing this draft guidance to recommend an approach for determining whether a laboratory test may be performed by laboratories with a certificate of waiver under CLIA. This draft guidance replaces the previous draft guidance entitled ``Guidance for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Criteria for Waiver,'' March 1, 2001.
Draft Guidance for Industry on the Pediatric Research Equity Act; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``How to Comply with the Pediatric Research Equity Act.'' This draft guidance provides recommendations on how to interpret the requirements of the Pediatric Research Equity Act (PREA), which requires pediatric studies of certain drugs and biological products to ensure that those products that are likely to be commonly used in children or that represent a meaningful therapeutic benefit over existing treatments contain adequate pediatric labeling for approved indications.
Use of Materials Derived From Cattle in Human Food and Cosmetics
The Food and Drug Administration (FDA) is amending the interim final rule on use of materials derived from cattle in human food and cosmetics published in the Federal Register of July 14, 2004. In the July 14, 2004, interim final rule, FDA designated certain materials from cattle, including the entire small intestine, as ``prohibited cattle materials'' and banned the use of such materials in human food, including dietary supplements, and in cosmetics. FDA is taking this action in response to comments received on the interim final rule. Information was provided in comments that persuaded the agency that the distal ileum, one of three portions of the small intestine, could be consistently and effectively removed from the small intestine, such that the remainder of the small intestine, formerly a prohibited cattle material, could be used for human food or cosmetics. We (FDA) are also clarifying that milk and milk products, hide and hide-derived products, and tallow derivatives are not prohibited cattle materials. Comments also led the agency to reconsider the method cited in the interim final rule for determining insoluble impurities in tallow and to cite instead a method that is less costly to use and requires less specialized equipment. FDA issued the interim final rule to minimize human exposure to materials that scientific studies have demonstrated are highly likely to contain the bovine spongiform encephalopathy (BSE) agent in cattle infected with the disease. FDA believes that the amended provisions of the interim final rule provide the same level of protection from human exposure to the agent that causes BSE as the original provisions.
Public Health Assessments Completed
This notice announces those sites for which ATSDR has completed public health assessments during the period from April through June 2005. This list includes sites that are on or proposed for inclusion on the National Priorities List (NPL) and includes sites for which assessments were prepared in response to requests from the public.
Fees for Sanitation Inspections of Cruise Ships
This notice announces fees for vessel sanitation inspections for fiscal year 2006 (October 1, 2005, through September 30, 2006).
Medical Devices; Immunology and Microbiology Devices; Classification of the Endotoxin Assay; Technical Amendment
The Food and Drug Administration (FDA) published a final rule in the Federal Register of October 31, 2003 (68 FR 62007). The final rule classified the endotoxin assay into class II (special controls). The agency classified the device into class II (special controls) in order to provide reasonable assurance of safety and effectiveness of the device. FDA is amending the agency's regulations to redesignate the section number listed in the Code of Federal Regulations (CFR) from Sec. 866.3610 to Sec. 866.3210.
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