2016-04364. Proposed Collection; 60-Day Comment Request; iWin: Navigating Your Path to Well-Being

Summary: In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute on Drug Abuse (NIDA), 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.

Written comments and/or suggestions from the public and affected agencies are invited to 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.

To Submit Comments And For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Dr. Belinda Sims, Health Scientist, DESPR, PRB, NIDA, NIH, 6001 Executive Boulevard, Room 5153, Bethesda, Maryland 20892, or call non-toll-free number [phone], or Email your request, including your address to: [e-mail]. Formal requests for additional plans and instruments must be requested in writing.

Comment 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.

Proposed Collection: iWin: Navigating your Path to Well-Being, 0925-NEW, National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH).

Need and Use of Information Collection: The overarching objective of this proposal is to conduct a randomized trial to evaluate the effectiveness of the Individual Well-Being Navigator (iWin) mobile application, a substance abuse prevention and well-being enhancement program designed specifically for military personnel. This mobile application provides an innovative, tailored mobile application using best practices in behavior change science and innovative technology to assist military personnel in preventing substance abuse and enhancing well-being by providing them with the most appropriate intervention content at the right time. It integrates Trans-theoretical Model of Behavior Change based tailoring, SMS messaging, stage of change matched activities, and engaging game-like features in a cutting edge multiple behavior change program. The first year of this project will focus on the completion of development and beta testing of the app. In year 2, the efficacy of the iWin program will be determined by tests of statistical significance indicating that participants in the Treatment condition had lower scores on an index of substance use and other behavioral risks than the control group at 6 and 9 month follow-up. The overall design is a 2 group (treatment and control group) by 3 Occasions with repeated measures across occasions. Once shown to be effective, the iWin program will assist organizations that serve military personnel to meet the directives of both the Department of Defense and the Chairman of the Joint Chiefs of Staff indicating that prevention programs be evidence based, evaluated by the specified populations and address full Total Force Fitness paradigm rather than a single behavior.

OMB approval is requested for 1 year. There are no costs to respondents other than their time. The total estimated annualized burden hours are 1,557.

Estimated Annualized Burden Hours

Form name	Type of respondent	Number of respondents	Number of responses per respondent	Average burden per response ( in hours)	Total annual burden hour
Screening	Military Personnel	1,624	1	10/60	271
Baseline	Military Personnel	812	1	30/60	406
Follow-up Outcome Assessments (6 and 9 month)	Military Personnel	812	2	30/60	812
Consent Form	Military Personnel	821	1	5/60	68

Dated: February 19, 2016.

Genevieve R. deAlmeida,

Project Clearance Liaison, NIDA, NIH.