Department of Health and Human Services March 26, 2008 – Federal Register Recent Federal Regulation Documents

This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award approximately $500,000 (total costs) per year for up to three years to the American Society of Addiction Medicine (ASAM). This is not a formal request for applications. Assistance will be provided only to the American Society of Addiction Medicine (ASAM) based on the receipt of a satisfactory application that is approved by an independent review group. Funding Opportunity Title: TI-08-014. Catalog of Federal Domestic Assistance (CFDA) Number: 93.243. Authority: Section 509 of the Public Health Service Act, as amended. Justification: Only the American Society of Addiction Medicine (ASAM) is eligible to apply. The Substance Abuse and Mental Health Services Administration (SAMHSA) is seeking to award a single source grant to the American Society of Addiction Medicine (ASAM) to establish a national mentoring network offering support (clinical updates, evidence-based outcomes and training) free of charge to physicians and other medical professionals in the appropriate use of methadone for the treatment of chronic pain and opioid addiction. SAMHSA is responsible for certifying over 1,000 Opioid Treatment Programs (OTPs) that use methadone and buprenorphine in the treatment of opioid addiction. This initiative will help address the nation's rise in methadone-associated deaths that has been spurred by misuse/abuse and fatal drug interactions involving methadone. According to the National Center for Health Statistics (NCHS), methadone poisoning deaths nationwide increased 390% from 786 deaths in 1999 to 3,849 deaths in 2004, and on going data indicate that the number of deaths in many states continued to increase in 2005 and 2006. Thus, prompt and direct implementation of this cooperative agreement is necessary to help ensure public health and safety. To address this healthcare crisis in a timely manner, eligibility for the cooperative agreement is limited to ASAM to establish a national mentoring network and to carry out the dissemination of information and education as it relates to methadone use in the treatment of opioid addiction and chronic pain. ASAM presently provides a parallel service under a SAMHSA cooperative agreement to operate a Physician Clinical Support System (PCSS) to assist physicians with issues related to office-based treatment of opioid dependence with buprenorphine. As a result, ASAM is in the unique position to have the infrastructure and capacity in place to expeditiously meet the specific and unique needs outlined in this announcement. In addition, ASAM has demonstrated in the past (through the PCSS project) the capability to implement and achieve the goals of this program.

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 requirements for appeals of science-based decisions above the division level at the Center for Veterinary Medicine (CVM).

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 procedure by which a manufacturer or distributor of dietary supplements or of a new dietary ingredient is to submit to FDA information upon which the manufacturer or distributor has based its conclusion that a dietary supplement containing a new dietary ingredient will reasonably be expected to be safe.

The Food and Drug Administration is correcting a notice that appeared in the Federal Register of February 29, 2008 (73 FR 11095). The document announced that a temporary permit has been issued to Florida's Natural Growers, to market test a product designated as ``Frozen Concentrate for Lemonade 3+1 Ratio.'' The document was published with an incorrect value for the Brix (measure of concentration of sugars in juice). This document corrects the error.

The Food and Drug Administration (FDA) is amending its regulations to change the fax number to which food facility registration forms under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) can be sent. This action is editorial in nature and is intended to improve the accuracy of the agency's regulations.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance updates and combines information from two ICH guidances, ``S2A Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals'' and ``S2B Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals.'' The draft guidance is intended to help facilitate drug development programs, ensure patient safety, and reduce animal usage.