Proposed Collection; Comment Request; Inventory and Evaluation of Clinical Networks

SUMMARY:

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on the proposed data collection projects, the National Heart, Lung, and Blood Institute (NHLBI), 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: 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 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, on management and governance, effectiveness in changing clinical practice, information 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:

There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

Request For Comments: Written comments and/or suggestions from the public and affected agencies should address one or more of the following points: (1) Whether the proposed collection is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

FOR FURTHER INFORMATION CONTACT:

To request more information on the proposed project or to obtain a copy of data collection plans and instruments, contact Dr. Paul Sorlie, Division of Epidemiology and Clinical Applications, NHLBI, NIH, II Rockledge Centre, 6701 Rockledge Drive, MSC #7934, Bethesda, MD, 20892-7934, or call non-toll-free number (301) 435-0707, or e-mail your request, including our address to: sorliep@nhlbi.nih.gov.

Comments Due Date: Comments regarding this information collected are best assured of having their full effect if received within 60-days of the date of this publication.