[Federal Register Volume 77, Number 101 (Thursday, May 24, 2012)]
[Notices]
[Pages 31027-31028]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-12656]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; Comment Request; Web-Based Assessment 
of the Clinical Studies Support Center (CSSC)

    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 to 
review and approve the information collection listed below. This 
proposed information collection was previously published in the Federal 
Register on March 12, 2011, Volume 77 No. 44, pages 14531-14533 and 
allowed 60-days for public comment. One comment was 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 current valid OMB control number.
    Proposed Collection: Title: Web-Based Assessment of the Clinical 
Studies Support Center (CSSC). Type of Information Collection Request: 
New. Need and Use of Information Collection: Over the past decade Data 
Safety Monitoring Boards (DSMBs), Observational Safety Monitoring 
Boards (OSMBs), and Protocol Review Committees (PRCs) have become an 
important quality standard in clinical trials and research involving 
human subjects. The National Heart, Lung, and Blood Institute (NHLBI) 
alone currently has approximately 60 active review Committees. These 
include DSMBs, OSMBs, and PRCs which are independent groups convened to 
review study protocols developed under NHLBI funded Clinical Trial 
Networks. These committees are composed of members with expertise in 
biostatistics, clinical trials, bioethics, and other specific 
scientific and research areas. The NHLBI is charged with ensuring the 
highest quality of each Institute-funded clinical research project and 
compliance with Department of Health and Human Services (DHHS)/National 
Institutes of Health (NIH)/NHLBI regulations regarding human subject 
protections and safety monitoring. To carry out this responsibility, 
the NHLBI program staff instituted a new methodology for supporting the 
administration of NHLBI-appointed Committees in 2009. The new 
methodology included the establishment of the Clinical Studies Support 
Center (CSSC) under the direction of Westat, Inc. The CSSC is a pilot 
program to support the operations of NHLBI's DSMBs, Observational 
OSMBs, and PRCs for the Division of Blood Diseases and Resources. 
Utilizing Executive Secretaries to support each NHLBI safety monitoring 
board, the CSSC is responsible for documenting standardized operating 
procedures related to the administration of monitoring committees and 
the support center in a CSSC Manual of Operations and Procedures (MOP); 
coordinating meeting space and logistics for in-person meetings, Web 
conferences, and teleconferences; managing distribution of adverse 
event notifications to DSMB chairs and members, new protocols, and 
proposed amendments; and providing Executive Secretaries who provide 
scientific and administrative support to document board recommendations 
related to the safety and efficacy of trial interventions and the 
quality and completeness of clinical research study data. To move 
forward with full knowledge of current Committee operations and to 
monitor the effect of newly established procedures, Westat is required, 
as part of this contract, to conduct an assessment of the efficiency 
and effectiveness of NHLBI CSSC committee operations. As part of this 
assessment, the NHLBI requires feedback and advice regarding the 
support provided by the CSSC for monitoring board operations. To this 
end, a Web-based questionnaire will be administered to Chairs and 
members of monitoring boards to learn about their opinions about 
specific CSSC activities and their satisfaction with the performance of 
CSSC staff.
    Frequency of Response: Once. Affected Public: Individuals. Type of 
Respondents: Monitoring board members. The annual reporting burden is a 
follows: Estimated Number of Respondents: 90; Estimated Number of 
Responses per Respondent: 1; Average Burden of Hours per Response: 0.33 
and Estimated Total Annual Burden Hours Requested: 30.36. The 
annualized cost to respondents is estimated at: $ 3.036 (based on $100 
per hour). There are no Capital Costs to report. There are no Operating 
or Maintenance Costs to report.

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                                                   Number of     Frequency of    Average time      Annual hour
              Type of respondents                 respondents      responses     per response        burden
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                                     Table A.12.1. ESTIMATES OF HOUR BURDEN
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D/OSMB Chairs.................................              10               1            0.33              3.3
D/OSMB Members................................              78               1            0.33             25.74

[[Page 31028]]

 
Members in two D/OSMB.........................               2               2            0.33              1.32
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    Total.....................................              90  ..............  ..............             30.36
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             Table 1-1 and 1-2--Estimate of Requested Burden Hours and Dollar Value of Burden Hours
 
                                     Number of     Frequency of    Average time     Hourly age      Respondent
       Type of respondents          respondents      response      per response        rate            cost
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                                  Table A.12-2. ANNUALIZED COST TO RESPONDENTS
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DSMB Chairs.....................              10               1             .33             100             330
DSMB Members....................              78               1             .33             100           2,574
Members in two D/OSMB...........               2               2             .33             100             132
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    Totals......................              90  ..............  ..............  ..............           3,036
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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) Evaluate 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) Evaluate 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) Enhance the 
quality, utility, and clarity of the information to be collected; and 
(4) 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, especially regarding 
the estimated public burden and associated response time, should be 
directed to the: Office of Management and Budget, Office of Regulatory 
Affairs, [email protected] or by fax to 202-395-6974, 
Attention: Desk Officer for NIH. To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
instruments, contact: Erin Smith, Contracting Officer Technical 
Representative, Room 9149, 6701 Rockledge Drive, Bethesda, MD 20892-
7950, or call 301-435-0050, or Email your request to 
[email protected].
    Comments Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 30-days 
of the date of this publication.

    Dated: May 1, 2012.
Keith Hoots,
Director, Division of Blood Diseases and Resources, National Heart, 
Lung, and Blood Institute, NIH.
    Dated: May 14, 2012.
Lynn Susulske,
NHLBI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2012-12656 Filed 5-23-12; 8:45 am]
BILLING CODE 4140-01-P