Department of Health and Human Services August 18, 2010 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on reporting requirements in implementing the lists of U.S. firms/processors exporting shell eggs, dairy products, game meat, game meat products, animal casings, gelatin, and collagen to the European Community (the EC).

The Food and Drug Administration (FDA) has determined that DIASTAT (diazepam rectal gel) (DIASTAT), 5 milligrams (mg)/milliliter (mL), 10 mg/2 mL, 15 mg/3 mL, and 20 mg/4 mL, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for diazepam rectal gel, 5 mg/mL, 10 mg/2 mL, 15 mg/3 mL, and 20 mg/4 mL, if all other legal and regulatory requirements are met.

The Substance Abuse and Mental Health Services Administration's (SAMHSA's) mission is to reduce the impact of substance abuse and mental illness on America's communities. The Agency was established in 1992 and directed by Congress to target effective substance abuse and mental health services to the people most in need and to translate research in these areas more effectively and more rapidly into the general health care system. As part of this effort, SAMHSA has expanded and refined the agency's National Registry of Evidence-based Programs and Practices (NREPP). Two previous notices announcing these changes have been published in the Federal Register (70 FR 50381, Aug. 26, 2005; 71 FR 13133, March 14, 2006). Since 2006, SAMHSA has held three open submission periods during which interventions could be submitted for potential review and inclusion on the NREPP Web site (71 FR 37590, June 30, 2006; 72 FR 30814, June 4, 2007). This notice announces the open submission period for Federal Fiscal Year 2011, explains how submissions will be screened and selected, and provides guidance on the submission process for individuals and organizations seeking to have an intervention reviewed and listed on the NREPP Web site. Potential applicants should be aware that this notice includes new information relating to the eligibility of interventions and review process that supersedes guidance provided in earlier Federal Register notices.