Department of Health and Human Services May 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.

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.

The Food and Drug Administration (FDA) is reopening until July 11, 2005, the comment period on the questions raised and issues addressed in the notice of public meeting, published in the Federal Register of October 5, 2004 (69 FR 59569), on the use of certain radioactive drugs for research purposes without an investigational new drug application (IND) under the conditions set forth in FDA regulations. We are taking this action in response to requests to extend the comment period and to allow additional time to review agency guidance on a related matter.

The Administration on Developmental Disabilities (ADD) in the Administration for Children and Families (ACF), U.S. Department of Health and Human Services (DHHS) announces the availability of fiscal year 2005 funds to award grants to support the expansion of the National Network of University Centers for Excellence in Developmental Disabilities Education, Research, and Service (UCEDDs). The Developmental Disabilities Assistance and Bill of Rights Act of 2000 (Pub. L. 106-402) section 152(d) (42 U.S.C. 15062) authorizes the expansion of the National Network of UCEDDs, ``* * * for States or populations that are unserved or underserved by Centers due to such factors as (1) population; (2) a high concentration of rural or urban areas; or (3) a high concentration of unserved or underserved populations.'' Applicants should have expertise in addressing the health disparities and education issues of ethnic and racial minority groups. This funding opportunity will support the administration and operation of up to three new UCEDDs that are interdisciplinary education, research, and public service units of universities, or public or not- for-profit entities associated with universities that engage in core functions (e.g., provision of interdisciplinary pre-service preparation and continuing education of students and fellows; provision of community services, including training and/or technical assistance; conduct of research; and dissemination of information) addressing, directly or indirectly, one or more of the areas of emphasis (e.g., quality assurance, education and early intervention, child care, health, employment, housing, transportation, recreation, and other services available or offered to individuals in a community, including formal and informal community supports, that affect their quality of life). This program announcement contains instructions for the submission of the fiscal year 2005 grant applications for core funding.