Department of Health and Human Services May 11, 2005 – Federal Register Recent Federal Regulation Documents

The invention listed below is owned by an agency of the U.S. Government and is 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.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung and Blood Institute (NHLBI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on September 30, 2004, page 58451 and 58452 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 National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: Inventory and Evaluation of Clinical Research Networks. Type of Information Collection Request: NEW. Need and Use of Information Collection: This project is part of the NIH Roadmap to improve the speed and effectiveness of translating basic scientific discoveries into clinical products and practices that improve health care. The project, which is related to the Reengineering of the Clinical Research Enterprise, has been designed to enhance the efficiency and productivity of clinical research by promoting clinical research networks to rapidly conduct high quality clinical studies where multiple research questions can be addressed. Specifically, this study involves (1) developing an inventory and database of clinical research networks, (2) asking representatives from these networks to respond to an Inventory Questionnaire (Tier 1) that will allow us to update information we collected from public sources and gather additional information on network characteristics, and (3) conducting more in-depth surveys (Tier 2) with \1/3\ of the identified networks (Tier 2). Data will be used to characterize the selected networks in terms of network focus, management and governance, effectiveness in changing clinical practice, informatics infrastructure, and training and training infrastructure. Best practices will be identified and presented at a national leadership forum. Frequency of Response: Networks will be asked to respond to the Inventory Questionnaire (Tier 1) once. It is anticipated that 60% of the networks queried will actually meet the network eligibility criteria. A \1/3\ sample of the eligible networks will also be asked to complete an additional more in- depth survey (Tier 2). Affected Public: Staff at clinical research networks. Type of Respondents: Staff completing the surveys will include physicians, nurses, administrators, financial analysts, information technology professionals, and clerks. The annual reporting burden is as follows:

The Food and Drug Administration (FDA) is reopening until June 11, 2005, the comment period for the notice, published in the Federal Register of February 9, 2005 (70 FR 6888). In the notice, FDA announced the availability of a draft guidance entitled ``Q8 Pharmaceutical Development.'' FDA is reopening the comment period to provide additional time for public comment consistent with the time for comment provided by other ICH regulatory entities.