2013-23972. Submission for OMB Review; 30-day Comment Request; Quantification of Behavioral and Physiological Effects of Drugs Using a Mobile Scalable Device

SUMMARY:

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute on Drug Abuse (NIDA), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on March 29, 2013, Vol.78, No.61, pages 19273-19274, 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. The National Institute on Drug Abuse (NIDA), the National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

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, [e-mail] or by fax to 202-395-6974, Attention: NIH Desk Officer.

DATES:

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

FOR FURTHER INFORMATION CONTACT:

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. Steve Gust, National Institute on Drug Abuse, 6001 Executive Blvd., Bethesda, MD 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.

Proposed Collection: Quantification of Behavioral and Physiological Effects of Drugs Using a Mobile Scalable Device, 0925-New, National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH).

Need and Use of Information Collection: This study will examine the effectiveness of a mobile scalable device to detect the impairing effects of different drugs. The primary purpose of the data collected is to determine eligibility in a driving simulation study and to verify the effectiveness of the experimental manipulations. The findings will provide valuable information concerning the utility and effectiveness of mobile, smartphone/tablet-based neurocognitive assessment that can provide a multifactorial evaluation of cognitive functioning associated with impaired driving.

OMB approval is requested for 18 months. There are no costs to respondents other than their time. The total estimated annualized burden hours are 859.

Estimated Annualized Burden Hours

Form name	Type of respondent	Number of respondents	Number of responses per respondent	Average burden per response (in hours)	Per annual hour burden
Phone Screening	Adults	100	1	10/60	17
Consent Process, In-Person Screening Adderall	Adults			45/60	75
Consent Process, In-Person Screening Xanax	Adults	100		45/60	75
Consent Process, In-Person Screening Cannabis	Adults			45/60	75
Driving Survey	Adults		1	15/60	18
Realism Survey	Adults		1	3/60	4
Sleep and Intake Questionnaire	Adults		2	3/60	7
Stanford Sleepiness Scale	Adults	72	6	1/60	7
Wellness Survey	Adults		2	2/60	5
Dosing/Driving/Waiting	Adults		2	4	576

Dated: September 25, 2013.

Glenda J. Conroy,

Executive Officer (OM Director), NIDA, NIH.