05-9393. Proposed Collection; Comment Request; Inventory and Evaluation of Clinical Research Networks

Summary: 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:

Estimates of Hour Burden and Annualized Cost to Respondents

Type of respondents	Number of respondents	Frequency of response	Average time per response	Annual hour burden	Hourly wage rate	Respondent cost
Core Survey
Principal Investigator/Physician	240	1	.25	60	$470.00	$4,200.00
Extended Surveys
(1) Funding!:
Financial Managers	100	1	.75	75	38.00	2,850.00
(2) Focus! Scientific Productivity, Management, and Governance:
Principal Investigator! Physician	100	1	1.25	125	70.00	8,750.00
(3) Network Operations and Training:
Study Coordinator! Registered Nurse	100	1	1.25	125	25.00	3,125.00
(4) Recruitment and Retention:
Study Coordinator! Registered Nurse	100	1	.50	50	25.00	1,250.00
(5) Information Technology (IT) and Data Management:
Network and Database Administrators	100	1	1.0	100	29.00	2,900.00

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 of information 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.

Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice should be directed to the Office of Management and Budget, Office of Regulatory Affairs, New Executive Office Building, Room 10235, Washington, DC 20502, Attention: NIH Desk Officer. 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 [phone], or e-mail your request, including your address to: [e-mail].

Comments Due Date: Comments regarding this information collected are best assured of having their full effect if received within 30-days of the date of this publication.

Dated: May 4, 2005.

Charles Mackay,

Chief, Project Clearance Liaison, National Institutes of Health.