Department of Health and Human Services May 14, 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collection of information contained in the guidance entitled ``Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions'' dated March 18, 2002.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. The proposed information collection was previously published in the Federal Register on January 22, 2007, in Volume 72, No. 13, pg. 2700, and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The NIH may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: Evaluation of User Satisfaction with NIH Internet Sites. Type of Information Collection Request: New. 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 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 WWW warrant on-going constituent and resource analysis. With survey information, the NIH is enabled to serve, and respond to, the ever-changing demand by the public. The `public' includes individuals (such as patients, educators, students, etc.) and interested communities (such as national or local organizations/institutions) and business. Survey information will augment current Web content, delivery, and design research that is used to understand 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 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 or/and work environments. Type of Respondents: Public users of the NIH Internet site, https://www.nih.gov, which may include organizations, medical researchers, physicians and other health care providers, librarians, students, as well as individuals of the general public. Estimated Number of Respondents: 104,000. Number of Respondents Per Respondent: 1. Average Burden Hours Per Response: 0.084. Burden Hours Requested: 8684. Total annualized cost to respondents is estimated at $130,260. There are also no capital costs, operating costs and/or maintenance costs to report.