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

ICR 201310-0925-003

OMB: 0925-0692

Federal Form Document

ICR Details
0925-0692 201310-0925-003
Historical Active
HHS/NIH 20716
Quantification of Behavioral and Physiological Effects of Drugs Using a Mobile Scalable Device
New collection (Request for a new OMB Control Number)   No
Regular
Approved with change 02/06/2014
Retrieve Notice of Action (NOA) 10/30/2013
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
02/29/2016 18 Months From Approved
1,408 0 0
859 0 0
0 0 0

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.

US Code: 42 USC USC285o Name of Law: null
  
None

Not associated with rulemaking

  78 FR 19273 03/29/2013
78 FR 60886 10/02/2013
No

  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
Yes
Miscellaneous Actions
No
This is a new ICR.

$235,000
Yes Part B of Supporting Statement
Yes
No
No
No
Uncollected
Mikia Currie 3014350941

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
10/30/2013


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