Department of Health and Human Services August 8, 2006 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Phibro Animal Health. The supplemental NADA provides for the approval of the dihydrate salt of oxytetracycline in their Type A medicated article used in aquaculture feed, a change of oxytetracycline concentration in the Type A medicated article, and the addition of an indication for control of gaffkemia in lobsters.

The Office of Disease Prevention and Health Promotion (ODPHP)/ Office of Public Health and Science (OPHS), announces that up to $250,000 in fiscal year (FY) 2006 funds is available for a cooperative agreement with the Arkansas Center for Health Improvement (ACHI) for a project entitled, ``From BMI to Student Body Mass Improvement: Healthy Achievement Through Awareness and Actiona Detailed Evaluation of the Arkansas School BMI Project.'' Working in collaboration with the ACHI, administratively housed unit in the University of Arkansas for Medical Sciences (501C3 organization) and serves as the primary health policy development source for the Arkansas Department of Health and Human Services, the initiative seeks to gain information about programs that have established school based-body mass index assessments of school age children. The goals of this evaluation project are to identify key elements for the translation of BMI information as a public health intervention for positive behavioral change among families, children and adolescents to improve nutrition and increase physical activity. The project will design and pilot test a detailed evaluation protocol to assess the specific benefits and effectiveness of the Arkansas School BMI Assessment Project, building on the findings from the ACHI ReportThe 2005 Arkansas Assessment of Childhood and Adolescent Obesity; and The Year Two Evaluation of Arkansas Act 1220 conducted by the University of Arkansas for Medical Sciences' College of Public Health with support from The Robert Wood Johnson Foundation. The evaluation protocol will specially address: The effectiveness and acceptability of the BMI assessment by teachers, students, families, and physicians; The essential information and care systems to support follow-up and follow-through for prevention and interventions; The students, families, and schools knowledge, attitudes, and adoption of healthier nutrition and physical activity choices; and, The changes in the individual BMI and the childhood population overweight and obesity rates. The purpose of this project is to assess the principles and outcomes of a statewide community-based intervention program incorporating various scientific methods and behavioral approaches. At a time when overweight and obesity are dramatically increasing, initiatives like the Arkansas School Body Mass Index (BMI) Assessment Project will evaluate the diverse populations that are at higher than average risk of developing excessive weight, especially children in urban/rural areas with a high prevalence of minority individuals. This program promotes several focus areas of the Healthy People 2010 including: Maternal, Infant, and Child Health; Nutrition and Overweight; Physical Activity and Educational and Community-Based Programs Health Communication. The project will be approved for up to a one-year period for a total of $250,000 (including indirect costs). Funding for the cooperative agreement is contingent upon the availability of funds.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria.'' 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 describes a procedure to facilitate acceptance by regulatory authorities of pharmacopoeial test methods (referred to in the draft guidance as analytical procedures and/or acceptance criteria (APAC)) for use in the three ICH regions. The draft guidance is intended to facilitate regulatory acceptance of these proposed test methods and their interchangeability with test methods contained in the local regional pharmacopoeias, thus avoiding redundant testing and different acceptance criteria in favor of a common testing strategy in each ICH regulatory region. Elsewhere in this issue of theFederal Register, FDA is announcing the availability of a draft guidance entitled ``Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria; Annex 1: Residue on Ignition/Sulphated Ash General.''

As required by section 101 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), this final rule creates an exception to the physician self-referral prohibition in section 1877 of the Social Security Act (the Act) for certain arrangements in which a physician receives compensation in the form of items or services (not including cash or cash equivalents) (``nonmonetary remuneration'') that is necessary and used solely to receive and transmit electronic prescription information. In addition, using our separate legal authority under section 1877(b)(4) of the Act, this rule creates a separate regulatory exception for certain arrangements involving the provision of nonmonetary remuneration in the form of electronic health records software or information technology and training services necessary and used predominantly to create, maintain, transmit, or receive electronic health records. These exceptions are consistent with the President's goal of achieving widespread adoption of interoperable electronic health records to improve the quality and efficiency of health care while maintaining the levels of security and privacy that consumers expect.