Quantification of Behavioral and Physiological Effects of Drugs Using a Mobile Scalable Device

Forms and Documents

Document Name	Status
Form 10 Wellness Survey Screenshot Form	New
Form 9 Realism Survey - Screenshot Form	New
Form 8 Driving Survey -Screenshot Form	New
Form 11 Adults - Dosing/Driving/Waiting/ - (Intervention) Form and Instruction	New
Form 8 Adults- Stanford Sleepiness Scale Form	New
Form 7 Adults- Sleep and Intake Questionnaire Form	New
Form 4 Adults-Consent Process, In-Person Screening Cannabis Form	New
Form 3 Adults -Consent Process, In-Person Screening Xanax Form	New
Form 2 Adults - Consent Process, In-Person Screening Adderall Form	New
Form 1 Adults- Phone Screening Form and Instruction	New
HawkIRB_Study3.pdf Supplementary Document	2014-01-28
HawkIRB_Study2.pdf Supplementary Document	2014-01-28
HawkIRB_Study1.pdf Supplementary Document	2014-01-28
IRB approval-memo (34).doc Supplementary Document	2014-01-28
Supporting Sttmnt B MSD-REVISED 2.3.2014-.doc Supporting Statement B	2014-02-03
Attachment 6 Realism Survey.doc Supplementary Document	2013-10-24
Attachment 2 (MSD_DrivingSurvey).doc Supplementary Document	2013-10-24
Attachment 5 Wellness Survey.doc Supplementary Document	2013-10-24
Attachment 15 -Placeholder Approval Memo - Cannabis.doc Supplementary Document	2013-10-24
Attachment 14 MSD - Approval memo- Xanax.pdf Supplementary Document	2013-10-24
Attachment 13- Approval-memo- Adderal.pdf Supplementary Document	2013-10-24
Attachment 16- CoC_Applciation.pdf Supplementary Document	2013-10-24
Supporting_Sttmnt_A_MSD_08292013[1].doc Supporting Statement A	2013-10-25

IC Document Collections

IC ID	Document Title	Status
209134	Wellness Survey Screenshot Form	New
209133	Realism Survey - Screenshot Form	New
209132	Driving Survey -Screenshot Form	New
209131	Adults - Dosing/Driving/Waiting/ - (Intervention) Form and Instruction	New
209130	Adults- Stanford Sleepiness Scale Form	New
209129	Adults- Sleep and Intake Questionnaire Form	New
209128	Adults-Consent Process, In-Person Screening Cannabis Form	New
209127	Adults -Consent Process, In-Person Screening Xanax Form	New
209126	Adults - Consent Process, In-Person Screening Adderall Form	New
209125	Adults- Phone Screening Form and Instruction	New

ICR Details

OMB Control No: 0925-0692	ICR Reference No: 201310-0925-003
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No: 20716
Title: Quantification of Behavioral and Physiological Effects of Drugs Using a Mobile Scalable Device
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: Approved with change	Conclusion Date: 02/06/2014
	Date Received in OIRA: 10/30/2013
Terms of Clearance: If there is any change in the IRB protocol (or an updated clearance is obtained), that change must be submitted to OMB. Consistent with the current IRB terms of clearance, data collection cannot begin until a certificate of confidentiality is obtained.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/29/2016	18 Months From Approved
Responses	1,408	0	0
Time Burden (Hours)	859	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This ICR is to test the effectiveness of a mobile scalable device to detect the impairing effects of different drugs on driving data. Participant's cognitive functioning associated with impaired driving due to stimulant or depressant usage will be monitored in a laboratory setting. Participants will be exposed to one of three substances – Adderal, Xanax, or Cannabis – that are commonly used recreationally, and then "drive" in a simulator. The findings will enable evaluation of the reliability of the device and its algorithms in quantifying the effects of stimulant and depressant drug use, and will provide valuable information concerning the utility and effectiveness of mobile, Smartphone/tablet-based neurocognitive assessment. The device will enable a multifactorial evaluation of cognitive functioning associated with impaired driving. The tool will be applicable worldwide, and will facilitate epidemiological, comparative studies of drugged driving.

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Authorizing Statute(s): US Code: 42 USC USC285o Name of Law: null
  

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:
	78 FR 19273	03/29/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 60886	10/02/2013
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 10

IC Title	Form No.	Form Name
Adults - Dosing/Driving/Waiting/ - (Intervention)	11, 12, 13	Informed Consent- Adderall ,   Informed Consent - Xanax ,   Informed Consent - Cannabis
Driving Survey -Screenshot	8	Driving Survey Screenshot
Realism Survey - Screenshot	9	Realism Survey Screenshot
Wellness Survey Screenshot	10	Wellness Survey Screenshot
Adults- Phone Screening	1, 2	Adults- Phone Screening ,   Adults - Consent Process Adderall
Adults - Consent Process, In-Person Screening Adderall	2	Adults- Consent Process, In-Person Screening Adderall
Adults -Consent Process, In-Person Screening Xanax	3	Adults - Consent Process,in-Person Screening Xanax
Adults-Consent Process, In-Person Screening Cannabis	4	Adults - In-Person Screening Cannabis
Adults- Sleep and Intake Questionnaire	7	Adu;ts Sleep and Intake Questionnaire
Adults- Stanford Sleepiness Scale	8	Adults- Stanford Sleepiness Scale

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	1,408	0	0	1,408	0	0
Annual Time Burden (Hours)	859	0	0	859	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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: This is a new ICR.

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Annual Cost to Federal Government: $235,000

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? Yes

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: 10/30/2013

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