Proposed Collection; Comment Request; Inventory and Evaluation of Clinical Research Networks, 24824-24825 [05-9393]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• National Institutes of Health

[Federal Register Volume 70, Number 90 (Wednesday, May 11, 2005)]
[Notices]
[Pages 24824-24825]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-9393]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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

[[Page 24825]]

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
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                                                             Number of     Frequency of    Average time     Annual hour     Hourly wage     Respondent
                  Type of  respondents                      respondents      response      per response       burden           rate            cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                       Core Survey
--------------------------------------------------------------------------------------------------------------------------------------------------------
Principal Investigator/Physician........................             240               1             .25              60         $470.00       $4,200.00
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                                                                    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 
(301) 435-0707, or e-mail your request, including your 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 30-days 
of the date of this publication.

    Dated: May 4, 2005.
Charles Mackay,
Chief, Project Clearance Liaison, National Institutes of Health.
[FR Doc. 05-9393 Filed 5-10-05; 8:45 am]
BILLING CODE 4140-01-M