Department of Health and Human Services November 3, 2008 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for emergency processing under the Paperwork Reduction Act of 1995 (the PRA). The proposed collection of information concerns the burden hours required for the Animal Generic Drug User Fee Cover Sheet, Form FDA 3728 and the timeframe requirement under the Animal Generic Drug User Fee Act of 2008 (AGDUFA) (21 U.S.C. 379j-21) for implementing the new user fee cover sheet Form FDA 3728.

This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award approximately $625,000 (total costs) per year for up to five years to the Community Anti-Drug Coalitions of America (CADCA). This is not a formal request for applications. Assistance will be provided only to the Community Anti-Drug Coalitions of America (CADCA) based on the receipt of a satisfactory application that is approved by an independent review group. Funding Opportunity Title: SP-09-004. Catalog Of Federal Domestic Assistance (CFDA) Number: 93.243. Authority: Sections 509, 516 and 520A of the Public Health Service Act, as amended. Justification: Only the Community Anti-Drug Coalitions of America (CADCA) is eligible to apply. The Substance Abuse and Mental Health Services Administration (SAMHSA) is seeking to award a single source grant to the Community Anti-Drug Coalitions of America (CADCA) to leverage existing resources and conference support to expand SAMHSA's scope and capacity to provide training and technical assistance to a large number of community leaders across the country who are committed to substance abuse prevention, substance abuse/addiction treatment and recovery support, and substance abuse/addiction-related mental health issues. The Community Anti-Drug Coalitions of America (CADCA) is uniquely qualified to carry out the activities of this program because the purpose of the program is to partner with a national organization that has special expertise and unique broad, national-level experience in working with community anti-drug coalitions. CADCA is the only national organization that annually provides training and technical assistance through a national leadership conference for thousands of members of community coalitions dedicated to preventing substance abuse. CADCA currently is the sole organization that plays a major role in helping to strengthen and develop the nation's prevention infrastructure of anti-drug coalitions in support of on-going activities funded by SAMHSA's priority grant programs including: the Substance Abuse Prevention and Treatment Block Grant, the Strategic Prevention Framework State Incentive Grant, and the Drug Free Communities Support Program. CADCA is the only identified organization that currently meets this experience level and national reach to over 5,000 identified anti- drug coalitions across the country. CADCA has long been recognized in communities as well as States throughout the nation as the national voice for the advocacy and technical support of anti-drug coalitions. As such, it is uniquely qualified and positioned to carry out the requirements of this announcement. Contact: Shelly Hara, Substance Abuse and Mental Health Services Administration, 1 Choke Cherry Road, Room 8-1081, Rockville, MD 20857; telephone: (240) 276-2321; E-mail: shelly.hara@samhsa.hhs.gov.

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 the information collection contained in the guidance for industry on formal dispute resolution.