Department of Health and Human Services June 25, 2007 – Federal Register Recent Federal Regulation Documents

Pursuant to Section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold its thirteenth meeting. The meeting will be open to the public.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case: Diana Layman, University of Oklahoma Health Sciences Center: Based on the report of an investigation conducted by the University of Oklahoma Health Sciences Center (OUHSC) and additional analysis conducted by the Office of Research Integrity during its oversight review, the U.S. Public Health Service (PHS) found that Ms. Diana Layman, Tribal Efforts Against Lead (TEAL) phlebotomist, OUHSC, engaged in scientific misconduct in research supported by National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH), grant R01 ES008755. Specifically, Ms. Layman falsified research in the TEAL study by substituting or conspiring with another phlebotomist to substitute her blood or blood of another phlebotomist for blood samples of 10-15 child participants in the TEAL study. Ms. Layman has entered into a Voluntary Exclusion Agreement (Agreement) in which she has voluntarily agreed, for a period of three (3) years, beginning on May 30, 2007: (1) To exclude herself from any contracting or subcontracting with any agency of the United States Government and from eligibility or involvement in nonprocurement programs of the United States Government as defined in HHS' implementation of OMB Guidelines to Agencies on Governmentwide Debarment and Suspension at 2 CFR part 376, et seq.; and (2) To exclude herself from serving in any advisory capacity to PHS, including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant.

The Food and Drug Administration (FDA) is issuing a final rule regarding current good manufacturing practice (CGMP) for dietary supplements. The final rule establishes the minimum CGMPs necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure the quality of the dietary supplement. The final rule is one of many actions related to dietary supplements that we are taking to promote and protect the public health.