Department of Health and Human Services October 18, 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is amending the biologics regulations by providing options to the existing requirement for the processing of live vaccines. FDA is amending the regulations due to advances in technology that will allow processing of live vaccines to be performed in multiproduct manufacturing areas. We are publishing this rule because the existing requirement regarding facilities and equipment for live vaccine processing is too prescriptive and is no longer necessary. We are taking this action as part of our continuing effort to reduce the burden of unnecessary regulations on industry and to revise outdated regulations without diminishing public health protection. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under our usual procedures for notice and comment in the event that we receive any significant adverse comments on the direct final rule. If we receive any significant adverse comments that warrant terminating the direct final rule, we will consider such comments on the proposed rule in developing the final rule.

The National Health and Nutrition Examination Survey (NHANES) is a program of periodic surveys conducted by the National Center for Health Statistics (NCHS) of the Centers for Disease Control and Prevention (CDC). Examination surveys conducted since 1960 by NCHS have provided national estimates of the health and nutritional status of the U.S. civilian noninstitutionalized population. To add to the extensive amount of information collected for the purpose of describing the health of the population, DNA specimens were collected during two NHANES surveys. DNA is available in the form of crude lysates of cell lines derived from approximately 7,157 participants enrolled in Phase II of NHANES III (1991-1994). In addition, DNA purified from whole blood is also available from approximately 7,900 participants enrolled in the 1999-2002 NHANES survey years. All specimens (NHANES III and NHANES 1999-2002 were sent to the Division of Laboratory Sciences (DLS) at the National Center for Environmental Health (NCEH) for processing. DNA samples from these specimens are being made available to the research community for genetic analyses. No funding is provided as part of this solicitation. NCHS will begin to accept proposals after the publication of this notice and will continue to accept proposals on an on-going basis. Proposals received within 60 days of the notice will complete review approximately 180 days after the notice is published. After this initial review of proposals, all proposal categories will be reviewed twice a year beginning January 1 and July 1 of each year. Unforeseen circumstances could result in a change to this schedule. Proposals will be reviewed by a technical panel and by an internal Secondary Review Committee of senior CDC scientists. The Secondary Review Committee will perform a programmatic review based on the results of the technical review panel and consider the scientific and technical results from the first level of review, important programmatic considerations such as program priorities, program relevance, and other criteria germane to this announcement and to CDC. Projects approved by both reviews will be submitted to the NCHS Ethics Review Board for final approval. Approved projects that do not obtain funding on their own will be canceled. A more complete description of this program follows.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry on Special Protocol Assessment'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The President's Council on Bioethics (Edmund D. Pellegrino, MD, Chairman) will hold its thirty-first meeting, at which it will continue (1) its inquiry into the ``crisis'' of the healing professions with expert presentations and Council discussions; and (2) its inquiry into the moral foundations of health care. Subjects discussed at past Council meetings (although not on the agenda for the November 2007 meeting) include: Therapeutic and reproductive cloning, assisted reproduction, reproductive genetics, neuroscience, aging retardation, organ transplantation, newborn screening, human dignity, 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 ResponsibilityL: The Regulation of New Biotechnologies (March 2004), Alternative Sources of Human Pluripotent Stem Cells: A White Paper (May 2005), and Taking Care: Ethical Caregiving in Our Aging Society (September 2005). Reports on (a) the bioethical significance of the concept of human dignity, (b) controversies in the determination of death, and (c) organ procurement, transplantation, and allocation are forthcoming.