Iwin: Navigating your Path to Well-Being (NIDA)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 4 Consent Form	Form and Instruction	New	Repair queued
Form 3 Follow up Outcome Assessments (6 and 9 months)	Form and Instruction	New	Repair queued
Form 2 Baseline Assessment	Form and Instruction	New	Repair queued
Form 1 Screening	Form and Instruction	New	Repair queued
30-day FRN 2016-12164.pdf	Supplementary Document	Uploaded 2016-05-24	Repair queued
Attachment2.IRB Approval.pdf	Supplementary Document	Uploaded 2016-05-23	Repair queued
Attachment 10 - Privacy Act Officer Memo.docx	Supplementary Document	Uploaded 2016-05-23	Repair queued
Attachment9. Sample Screen Shots.docx	Supplementary Document	Uploaded 2016-05-23	Repair queued
Attachment8.Certificate of Confidentiality.pdf	Supplementary Document	Uploaded 2016-05-23	Repair queued
Attachment 7.Reminder Messages.docx	Supplementary Document	Uploaded 2016-05-23	Repair queued
Attachment 6. 2016 Military Standard Pay (2).pdf	Supplementary Document	Uploaded 2016-05-23	Repair queued
Supporting Statement B.doc	Supporting Statement B	Uploaded 2016-05-23	Repair queued
Supporting Statement A.doc	Supporting Statement A	Uploaded 2016-05-23	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
221663	Consent Form	Form and Instruction	New
221662	Follow up Outcome Assessments (6 and 9 months)	Form and Instruction	New
221661	Baseline Assessment	Form and Instruction	New
221660	Screening	Form and Instruction	New

ICR Details

OMB Control No:	ICR Reference No: 201605-0925-004
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Iwin: Navigating your Path to Well-Being (NIDA)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Withdrawn	Conclusion Date: 02/02/2017
	Date Received in OIRA: 05/26/2016
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		12 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The primary aim of the project is to demonstrate the efficacy of the Individual Well-Being Navigator (Iwin) mobile application. The Iwin application provides three types of integrated interventions through each user’s smartphone: 1) stage-matched feedback on the participant’s risk behaviors; 2) daily in-app messaging determined by a series of algorithms that control the timing, content, and cadence of the messages; and 3) up to two prompts a week to complete stage-matched activities that foster behavior change. The overall design is a 2 group (treatment and control group) by 3 occasions with repeated measures across occasions. An estimated 1624 Military Personnel will need to be screened to arrive at an eligible sample of 812. Randomization of the eligible sample will occur at the individual level after the participant completes informed consent online. Those in the Control Group will complete online assessments at baseline, 6 and 9 months.

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Authorizing Statute(s): US Code: 42 USC sect 6A(III)(15) Name of Law: National Institute on Drug Abuse
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 10640	03/01/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 32764	05/24/2016
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

table that charts list of burden

IC Title	Form No.	Form Name
Consent Form	4	Consent Form
Screening	1	Screening
Baseline Assessment	2	Baseline Assessment
Follow up Outcome Assessments (6 and 9 months)	3	Follow-up Outcome Assessments(6 and 9 months)

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Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: New submission

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Annual Cost to Federal Government: $409,449

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 05/26/2016

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