[Federal Register Volume 70, Number 90 (Wednesday, May 11, 2005)]
[Notices]
[Pages 24824-24825]
From the Federal Register Online via the Government Publishing 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
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Core Survey
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Principal Investigator/Physician........................ 240 1 .25 60 $470.00 $4,200.00
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Extended Surveys
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(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
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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:
[email protected].
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