[Federal Register Volume 69, Number 189 (Thursday, September 30, 2004)]
[Notices]
[Pages 58451-58452]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-21987]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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

SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of

[[Page 58452]]

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:

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                                                            Estimated number   Average burden    Estimated total
           Type of respondents            Estimated number  of responses per      hours per       annual burden
                                           of respondents      respondent         response       hours requested
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Clinical research network staff:
    Inventory Questionnaire (Tier 1)....             2,000                 1                 2             4,000
    In-depth Survey of Subsample of                    400                 1                 2               800
     Networks (Tier 2)..................
                                         -------------------
        Total...........................  ................  ................  ................             4,800
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    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: [email protected].
    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.

    Dated: September 27, 2004.
Peter Savage,
Director, DECA, NHLBI, National Institutes of Health.
[FR Doc. 04-21987 Filed 9-24-04; 8:45 am]
BILLING CODE 4140-01-M