Department of Health and Human Services January 22, 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry and Food and Drug Administration Staff on Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle'' 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 twenty-eighth meeting, at which it will (1) Consider and discuss policy proposals in organ procurement, allocation, and transplantation; (2) hear presentations on and discuss issues in clinical applications of advancements in genetics, as well as genetics policy and ethics; and (3) discuss contributions to a pending Council report and volume on the bioethical significance of the concept of human dignity. All agenda items are continuations of previous Council discussions. Subjects discussed at past Council meetings (although not on the agenda for the February 2007 meeting) include: therapeutic and reproductive cloning, assisted reproduction, reproductive genetics, neuroscience, aging retardation, 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), and Taking Care: Ethical Caregiving in Our Aging Society (September 2005).

In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Evaluation of User Satisfaction with NIH Internet Sites. Type of Information Collection Request: Renewal. Need and Use of Information Collection: Executive Order 12862 directs agencies that provide significant services directly to the public to survey customers to determine the kind and quality of services they want and their level of satisfaction with existing services. With this submission, the NIH Office of Communications and Public Liaison seeks to obtain OMB's generic approval to conduct online customer satisfaction surveys. Since the late 1980's, the NIH has seized the opportunity to disseminate information and materials via the Internet. Today, rapid technological changes of the World Wide Web warrant on- going constitute nt and resource analysis. With survey data, the NIH is enabled to serve, and respond to, the ever-changing demand by the public. The `public' includes individuals (such as patients, health professionals, educators, and scientists), interested communities (such as national or local organizations/institutions) and businesses. Survey information will augment current Web content, delivery, and design research that is used to understand the needs of the Web user, and more specifically, the NIH user community. Primary objectives are to: (1) Classify NIH Internet users; (2) summarize and better understand customer needs; and (3) quantify the effectiveness/efficiency of current tools and delivery. Overall, the Institutes, Centers, and Offices of the NIH will use the survey results to identify strengths and weaknesses in current Internet strategies. Findings will help to: (1) Understand the user community and how to better serve Internet users; (2) discover areas requiring improvement in either content or delivery; (3) realize how to align Web offerings with identified user need(s); and (4) explore methods to offer and deliver information with efficacy and equity. Frequency of Response: On occasion [As needed on an on-going and potentially concurrent basis (by Institute, Center, or Office)]. Affected Public: Users of the Internet. Primarily, this is an individual at their place(s) of access including, but not limited to, home and/or work environments. Type of Respondents: Public users of the NIH Internet site, www.nih.gov, which may include organizations; medical researchers; physicians and other health care provides; librarians; students; and the general public. Estimated Number of Respondents: 104,000. Number of Responses Per Respondent: 1. Average Burden Hours Per Response: 0.0835. Burden Hours Request: 8684. Total annualized cost to respondents is estimated at $130,260. There are no capital costs, operating costs and/or maintenance costs to report.