Department of Health and Human Services February 14, 2008 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is amending certain regulations regarding generally recognized as safe (GRAS) substances to remove references to FDA development of food-grade specifications in cooperation with the National Academy of Sciences (NAS, now the National Academies). This action is editorial in nature and is intended to ensure the accuracy of the agency's regulations.

The President's Council on Bioethics (Edmund D. Pellegrino, MD, Chairman) will hold its thirty-second meeting, at which it will discuss and hear presentations on (1) newborn screening and (2) the problems of cost, access, and quality in American health care. The Council will also unveil its most recent publication, Human Dignity and Bioethics: Essays Commissioned by the President's Council on Bioethics. Subjects discussed at past Council meetings (although not on the agenda for the March 2008 meeting) include: therapeutic and reproductive cloning, assisted reproduction, reproductive genetics, neuroscience, aging retardation, organ transplantation, personalized medicine, and lifespan-extension. Publications issued by the Council to date include: Human Cloning and Human Dignity: An Ethical Inquiry (July 2002); Beyond Therapy: Biotechnology and the Pursuit of Happiness (October 2003); Being Human: Readings from the President's Council on Bioethics (December 2003); Monitoring Stem Cell Research (January 2004), Reproduction and Responsibility: The Regulation of New Biotechnologies (March 2004), Alternative Sources of Human Pluripotent Stem Cells: A White Paper (May 2005), Taking Care: Ethical Caregiving in Our Aging Society (September 2005), and Human Dignity and Bioethics: Essays Commissioned by the President's Council on Bioethics (March 2008). Reports on (a) controversies in the determination of death, and (b) organ procurement, transplantation, and allocation are forthcoming.

Pursuant to the Federal Technology Transfer Act of 1986 (FTTA, 15 U.S.C. 3710; and Executive Order 12591 of April 10, 1987, as amended, and in accordance with 35 U.S.C. 207 and 37 CFR Part 404, the National Institutes of Health (NIH) of the Public Health Service (PHS) of the Department of Health and Human Services (HHS) seeks a Cooperative Research and Development Agreement (CRADA) and/or license(s) with a pharmaceutical or biotechnology company to develop and commercialize amphipathic helical peptides potentially useful for the treatment and prevention of cardiovascular disease. The CRADA would have an expected duration of one (1) to five (5) years. The goals of the CRADA include the rapid publication of research results and timely commercialization of products, methods of treatment or prevention that may result from the research. The CRADA Collaborator will have an option to negotiate the terms of an exclusive or non-exclusive commercialization license to subject inventions arising under the CRADA defined by the CRADA Research Plan, subject to any pre-existing licenses already issued for other fields of use, and can apply for background licenses to the existing patent applications encompassed within HHS Reference Nos. E-114-2004/0-US-01 (United States Patent Application Serial No. 11/577,259), E-114-2004/0-AU-03 (Australian Patent Application Serial No. 2005295640), E-114-2004/0-CA-04 (Canadian Patent Application No. 2584048), E-114-2004/0-EP-05 (European Patent Application No. 05815961.7) and E-114-2004/0-JP-06 (Japanese Patent Application No. 2007-536912) titled: Multi-Domain Amphipathic Helical Peptides and Methods of Their Use.

In compliance with the requirement of Section 3506(c) (2) (A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH), will publish periodic summaries of proposed projects to the Office of Management and Budget (OMB) for review and approval.