Department of Health and Human Services December 1, 2011 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) with the U.S. Department of Agriculture's (USDA) Agricultural and Marketing Service, Farm Service Agency, and Food Nutrition Service. The purpose of the MOU is to provide a framework for the parties to communicate and cooperate in the timely and full exchange of information to optimize controls essential to minimizing potential for the distribution or use of USDA foods which may be unsafe. For the purpose of this MOU, the term ``USDA foods'' will mean commodities procured by USDA for use in domestic nutrition assistance programs.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Generic Clearance for the Collection of Qualitative Feedback on FDA Service Delivery'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from manufacturers of pressure ulcer treatment medical devices, such as (but not limited to): Ultrasonic wound care systems, negative pressure therapy units, turning & positioning systems, special mattresses, mattress covers, pillows, cushions, etc. Scientific information is being solicited to inform our Pressure Ulcer Treatment Strategies: A Comparative Effectiveness Review, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on these devices will improve the quality of this comparative effectiveness review. AHRQ is requesting this scientific information and conducting this comparative effectiveness review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173.

The National Institutes of Health (NIH) has analyzed public comments received regarding adoption and implementation of the 8th Edition of the Guide for the Care and Use of Laboratory Animals (Guide) and has determined to adopt the 8th Edition of the Guide. (The comments, received by NIH from February 24 to May 24, 2011, may be viewed at https://grants.nih.gov/grants/olaw/2011guidecomments/web listing.htm.) In NIH's judgment, the 8th Edition of the Guide empowers continued advancement in the humane care and use of vertebrate animals in research, research training, and biological testing. Effective January 1, 2012, institutions that receive Public Health Service (PHS) support for animal activities must base their animal care and use programs on the 8th Edition of the Guide and must complete at least one semiannual program review and facilities inspection using the 8th Edition of the Guide as the basis for evaluation by December 31, 2012. It is not required that all necessary changes be completed by December 31, 2012, but rather that an evaluation must be conducted and a plan and schedule for implementation of the standards in the 8th Edition of the Guide must be developed by December 31, 2012. Institutions must verify to the Office of Laboratory Animal Welfare (OLAW), the organizational component of NIH that provides guidance and interpretation of the PHS Policy on Humane Care and Use of Laboratory Animals, that they have met the required schedule. This will be done through the Annual Report to OLAW covering the 2012 reporting period due January 31, 2013. In addition, institutions must document the implementation of the 8th Edition of the Guide in their next Animal Welfare Assurance renewal. OLAW has developed Position Statements located at https:// grants.nih.gov/grants/olaw/2011positionstatement.htm. The Position Statements clarify the ways in which NIH expects Assured institutions to implement the 8th Edition of the Guide by addressing the following concerns: cost of implementing the 8th Edition of the Guide; animal housing specifications; use of nonpharmaceutical-grade compounds; food and fluid restrictions; multiple surgical procedures; and application of the 8th Edition of the Guide to agricultural animals used in biomedical research. In addition, there is a summary of OLAW's position on performance standards and practice standards. The public is invited to submit comments on their understanding of the Position Statements for a period of 60 days from December 1, 2011, to January 29, 2012. In response, OLAW may further clarify the Position Statements.