Department of Health and Human Services March 6, 2007 – Federal Register Recent Federal Regulation Documents
Results 1 - 7 of 7
Secretary's Advisory Committee on Human Research Protections
Pursuant to section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP), will hold its twelfth meeting. The meeting will be open to the public.
Dandruff, Seborrheic Dermatitis, and Psoriasis Drug Products Containing Coal Tar and Menthol for Over-the-Counter Human Use; Amendment to the Monograph
The Food and Drug Administration (FDA) is issuing a final rule amending the final monograph (FM) for over-the-counter (OTC) dandruff, seborrheic dermatitis, and psoriasis drug products to include the combination of 1.8 percent coal tar solution and 1.5 percent menthol in a shampoo drug product to control dandruff. FDA did not receive any comments or data in response to its previously proposed rule to include this combination. This final rule is part of FDA's ongoing review of OTC drug products.
Guidance for Industry on Orally Inhaled and Intranasal Corticosteroids: Evaluation of the Effects on Growth in Children; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Orally Inhaled and Intranasal Corticosteroids: Evaluation of the Effects on Growth in Children.'' This guidance provides recommendations regarding the design, conduct, and evaluation of clinical trials to assess the effects of orally inhaled and intranasal corticosteroids on growth in children. For this class of drug products, measurement of growth is considered a sensitive surrogate of, and an important sentinel for, the potential to cause systemic effects. Growth studies designed and carried out following the recommendations in this guidance can provide adequate and well-controlled data that are consistent among drug products and can be included in product labeling. This guidance finalizes the draft guidance published on November 6, 2001.
Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory's certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// workplace.samhsa.gov and https://www.drugfreeworkplace.gov.
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