E6-11559. Submission for OMB Review; Comment Request; CERTAS: A Researcher Configurable Self-Monitoring System

SUMMARY:

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute, the National Institutes of Health 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 April 27, 2006 page 26381 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.

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 a 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 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;

Estimated Total Annual Burden Hours Requested: 1,148;

Estimated Annualized Cost to Respondents: $18,368.00.

There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.

Estimate Hours of Burden

Type of respondents	Number of respondents	Frequency of response	Average time per response	Annual hour burden
Male	80	3	1.9134	459.264
Female	120	3	1.9134	688.896
Total	200			1148.16

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.

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, New Executive Office Building, Room 10235, Washington, DC 20503, Attention: Desk Officer for NIH. To request more information on the proposal 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: [e-mail].

Comments Due Date: Comments regarding this information collection are best assured of having their full effect is received within 30 days of the date of this publication.

Dated: July 12, 2006.

Rachelle Ragland-Greene,

NCI Project Clearance Liaison, National Institutes of Health.