Department of Health and Human Services January 22, 2009 – Federal Register Recent Federal Regulation Documents

HRSA will provide 2 additional years of support in the absence of competition for one cohort of grants under the Leadership Education in Neurodevelopmental and Other Related Disabilities (LEND) MCH Training Program. HRSA will extend the project period to June 30, 2011, for the cohort of the LEND program expected to compete in fiscal year (FY) 2009, which would correspond to the sunset of the Combating Autism Act. Currently, there are 34 LEND grants split into two cohorts (17 each) with different end dates; one group is scheduled to compete in FY 2009 (Cohort A), and the other in FY 2011 (Cohort B). HRSA will non- competitively extend with funds the 5-year project periods for those LEND grantees ending on June 30, 2009, for 2 additional budget periods at the same level of support for the same scope of activities which they received in FY 2008.

Late in 2001, the U.S. Congress addressed the need for support of analytical methods and reference materials development related to dietary supplements. The Congressional appropriation language supported an increased ODS budget for several topics, including analytical methods and reference materials. The Senate language called for: ``ODS to allocate sufficient funds to speed up an ongoing collaborative effort to develop and disseminate validated analytical methods and reference materials for the most commonly used botanicals and other dietary supplements.'' On February 8, 2002, ODS held a public meeting to solicit comments to assist ODS in designing an overall strategy for implementing the Congressional mandate to foster development and validation of analytical methods and reference materials for dietary supplements. In Fiscal Years 2004 and 2005, Congress again used similar language supporting the Analytical Methods and Reference Materials Program in the ODS appropriations. On September 10, 2007, ODS held a Stakeholders' Meeting to review the progress that had been made by the Analytical Methods and Reference Materials Program since its inception in 2002 and to receive comments on future programmatic directions. As a follow-up to the recommendations from the Stakeholders' Meeting, a Vitamin Methodology Workshop was held in July 2008. This workshop sought to evaluate the state of analytical methodology on vitamins suitable for dietary supplements and to identify gaps in the analytical science for the purpose of meeting future methods needs of stakeholders. Results of the Vitamin Methodology Workshop include an executive summary of the outcome of the workshop (in preparation) as well as recognition of a need for a Dietary Supplement Element Methodology Workshop. The purpose of this upcoming workshop is to evaluate the state of analytical methods for nutrient and non-nutrient minerals (including toxic elements) in dietary supplement products and to identify gaps in methodology, with a view toward designing a research program to fill the unmet methods needs of stakeholders. The desired outcomes of this meeting are to provide an overview of the status of analytical methodology for elements, to discuss analytical method purpose statements, to discuss the definition and evaluation of a method's purpose, as well as its fitness for purpose. The sponsor of this meeting is the NIH Office of Dietary Supplements.

The Food and Drug Administration (FDA) is announcing the availability of Compliance Policy Guide Sec. 540.370Fish and Fishery ProductsDecomposition (the CPG). The CPG provides guidance for FDA staff on decomposition in fish and fishery products.