[Federal Register Volume 71, Number 86 (Thursday, May 4, 2006)]
[Notices]
[Pages 26381-26382]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-6710]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; Comment Request; CERTAS: A Researcher 
Configurable Self-Monitoring System

SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of 
the Paperwork Reduction Act of 1995, for opportunity for public comment 
proposed data collection projects, the National Cancer Institute (NCI) 
and 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: CERTAS: A Researcher Configurable Self-Monitoring System.
    Type of Information Collection Request: NEW.
    Need and Use of Information Collection: This study seeks to further 
our understanding of the usefulness and potential advantages of 
electronic self-monitoring of behavior-specifically diet and exercise 
behaviors associated with reduction of cancer risks. Logs, diaries, 
checklists and other self-monitoring tools are an ubiquitous part of 
nearly all cancer control research. The primary objective of this study 
trial is to compare paper-based self-monitoring to CERTAS self-
monitoring devices (wireless sync and local sync) in a range of cancer 
risk behaviors. The findings will provide valuable information 
regarding: (1) A comparison of the real time recording compliance of 
these methods, (2) the pre-post effects of each type of recording 
(paper versus electronic), and (3) the relative cost per valid recorded 
entry for the two methods.
    Frequency of Response: Daily.
    Affected Public: Individuals.
    Type of Respondents: Males and females 18 years of age or older who 
are: (1) Interested in improving their diet and exercise behaviors as 
they relate to cancer prevention, (2) proficient in utilizing a 
computer, and (3) generally healthy with no medical conditions which 
would require a special diet or preclude regular exercise. The present 
study includes pre-post tests and a four week comparative trial. The 
pre-post tests involve the completion of self-administered 
questionnaires on diet and physical activity as well as body 
measurements (i.e. height, weight, waist, hips). The pre-test visit 
will also include a review of the study information and informed 
consent. A usability interview of the self-monitoring method will 
conclude the post-test. The two office visits for the pre-post tests 
will take approximately one hour per visit. The four week comparative 
trial has a total of one-hundred and twelve possible responses (4 
responses per 28 days; about 8 minutes per day).
    The annual reporting burden is as follows:
    Estimated Number of Respondents: 200.
    Estimated Number of Responses per Respondent: 3.
    Average Burden Hours Per Response: 1.9, and
    Estimated Total Annual Burden Hours Requested: 1,148. There are no 
Capital Costs, Operating Costs, and/or Maintenance Costs to report.

                                            Estimates of Hour Burden
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                                                     Number of     Frequency of    Average time     Annual hour
                 Respondent type                    respondents      response      per  response      burden
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Male............................................              80               3          1.9134         459.264
Female..........................................             120               3          1.9134         688.896
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    Total.......................................             200  ..............  ..............        1,148.16
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                                          Hour Burden Estimates By Form
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                                                     Number of     Frequency of    Average time   Aggregate hour
                  Type of form                         items         response        per form         burden
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GSEL............................................              28               2           .5              1.0
Physical Activity...............................               3               2           .0835            .167
Self-Monitoring.................................              15               1          3.7408           3.740

[[Page 26382]]

 
*Additional Pre-test Items......................  ..............               1           .4175            .417
**Additional Post-test Items....................  ..............               1           .4175            .417
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............           5.74
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*Includes study briefing, demographics, consent form, body measurements.
**Includes body measurements and usability interview.

    Request for Comments: Written comments and/or suggestions from the 
public and affected agencies are invited on 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, electric, 
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 the data collection plans and 
instruments, contact Dr. Jami Obermayer, Principal Investigator, PICS, 
Inc., 12007 Sunrise Valley Drive, Suite 480 Reston, Virginia 20191 at 
(703) 758-1798 or e-mail your request, including your address to 
[email protected].
    Commments Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 60-days 
of the date of this publication.

    Dated: April 27, 2006.
Rachelle Ragland-Greene,
National Institutes of Health, NCI Project Clearance Liaison.
 [FR Doc. E6-6710 Filed 5-3-06; 8:45 am]
BILLING CODE 4101-01-P