2013-30851. Reports, Forms, and Record Keeping Requirements

AGENCY:

National Highway Traffic Safety Administration (NHTSA), DOT.

ACTION:

Request for public comment on proposed collection of information.

SUMMARY:

Before a Federal agency can collect certain information from the public, it must receive approval from the Office of Management and Budget (OMB). Under procedures established by the Paperwork Reduction Act of 1995, before seeking OMB approval, Federal agencies must solicit public comment on proposed collections of information, including extensions and reinstatements of previously approved collections.

This document describes the collection of information for which NHTSA intends to seek OMB approval.

DATES:

Comments must be received on or before February 24, 2014.

ADDRESSES:

You may submit comments identified by DOT Docket ID Number NHTSA-2013-0122 using any of the following methods:

Electronic submissions: Go to http://www.regulations.gov. Follow the on-line instructions for submitting comments.

Mail: Docket Management Facility, M-30, U.S. Department of Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor, Room W12-140, Washington, DC 20590.

Hand Delivery: West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. Fax: [phone].

Instructions: Each submission must include the Agency name and the Docket number for this Notice. Note that all comments received will be posted without change to http://www.regulations.gov including any personal information provided.

FOR FURTHER INFORMATION CONTACT:

Dr. Kathy Sifrit, Contracting Officer's Technical Representative, Office of Behavioral Safety Research (NTI-132), National Highway Traffic Safety Administration, 1200 New Jersey Avenue SE., W46-472, Washington, DC 20590. Dr. Sifrit's phone number is [phone] and her email address is [e-mail].

SUPPLEMENTARY INFORMATION:

Under the Paperwork Reduction Act of 1995, before an agency submits a proposed collection of information to OMB for approval, it must publish a document in the Federal Register providing a 60-day comment period and otherwise consult with members of the public and affected agencies concerning each proposed collection of information. The OMB has promulgated regulations describing what must be included in such a document. Under OMB's regulations (at 5 CFR 1320.8(d)), an agency must ask for public comment on the following: (i) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (ii) 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; (iii) how to enhance the quality, utility, and clarity of the information to be collected; and (iv) how 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, e.g., permitting electronic submission of responses. In compliance with these requirements, NHTSA asks public comment on the following proposed collection of information:

Mild Cognitive Impairment and Driving Performance

Type of Request—New information collection requirement.

OMB Clearance Number—None.

Form Number—NHTSA Form 1240.

Requested Expiration Date of Approval—3 years from date of approval.

Summary of the Collection of Information—The National Highway Traffic Safety Administration (NHTSA) proposes to collect information from licensed older drivers about their driving habits in order to determine whether they are eligible to participate in a study of the effects of mild cognitive impairment on driving performance. Study participation will be voluntary and solicited through driver rehabilitation specialist (DRS) referrals of drivers suspected of having some degree of cognitive impairment by the State of Virginia Department of Motor Vehicle (VA DMV). A comparison group of drivers matched on age and sex who have not been diagnosed with cognitive impairment will also be recruited, either by contacting individuals who participated in other studies and gave their consent to be contacted about future research opportunities or by posting notices describing the research opportunity at Area Agency on Aging Senior Centers. People interested in in participating will contact a designated staff member through a toll-free number to enroll. During a brief telephone pre-screening, a project assistant will explain inclusion and exclusion criteria for study participation. Candidate participants who meet these criteria will be enrolled in the study.

A project assistant will make appointments to visit each enrollee to explain the study, answer questions about study participation and obtain his/her signature on the informed consent agreement. The remaining data for this study will be collected through both clinical and on-road evaluations by the DRS. At the completion of each on-road performance evaluation, an in-vehicle data collection system will be installed in the subject's own car to obtain driving exposure information. The in-vehicle system will include a device to collect the vehicle's Global Positioning System coordinates and a companion device to capture an image of the driver to confirm that the driver for each trip is the study participant.

The Government may decide to fund an optional task to collect additional data. This Optional Task, if funded, would be conducted thorough monthly telephone interviews with a subset of the same drivers. In addition, a second set of clinical, driving exposure, and performance data would be collected one year after the initial set was collected, for the subset of participants in the Optional Task.

Description of the Need for the Information and Proposed Use of the Information—NHTSA was established to reduce the number of deaths, injuries, and economic losses resulting from motor vehicle crashes on the Nation's highways. As part of this statutory mandate, NHTSA is authorized to conduct research as a foundation for the development of motor vehicle standards and traffic safety programs.

Older adults comprise an increasing proportion of the (driving) population and there is reason for concern about the consequences of early stage dementia and mild cognitive impairment (MCI) and driver performance and safety, as these conditions become markedly more prevalent with advancing age. The objective in this project is to document differences in driving performance and exposure between participants with MCI and a comparison group of drivers. Analyses of these data will provide information about the relationship between scores on clinical measurements of cognitive impairment and multiple levels of driving performance and exposure among older adults. The improved understanding of changes in driving behaviors associated with MCI will help physicians, driving rehabilitation specialists, and others who provide guidance to older adults regarding driving safety to know when to recommend driving cessation. The findings from this study also will help clinicians to identify and intervene when a client with dementia begins to exhibit potentially risky driving behaviors. NHTSA will use the information to inform recommendations to health care providers and to the public regarding when the progression of a disease or condition causing cognitive impairment results in the need to transition from driving, with the ultimate goal of reducing injuries and loss of life on the highway.

Description of the Likely Respondents (Including Estimated Number, and Proposed Frequency of Response to the Collection of Information)— Respondents will include individuals who have been identified by the VA DMV's medical referral and review practices as potentially cognitively impaired, have been required to obtain a DRS evaluation to retain their driving licenses, and have been diagnosed with mild cognitive impairment (MCI). Control respondents will include participants matched for age and sex who do not suffer from clinically diagnosed cognitive impairment. It is estimated that 90 telephone conversations will be conducted with respondents to descriptive solicitations, to yield 60 participants; this assumes that up to half of those initially indicating interest will ultimately not meet inclusion criteria or be uninterested in participating.

Estimate of the Total Annual Reporting and Record Keeping Burden Resulting from the Collection of Information— The 90 telephone conversations will average 10 minutes in length including introduction, qualifying questions, potential participant questions, logistical questions, and conclusion. The total estimated annual burden will be 15 hours. Participants will incur no costs from the data collection and participants will incur no record keeping burden and no record keeping cost from the information collection. If the Optional Task is funded, we assume a subset of 50% of the original sample would participate. These participants will be contacted by phone once a month for the period of one year. The resulting 12 contacts (approximately 10 minutes in length) of an estimated 50% of the original sample (30 participants) will result in a total estimated annual burden of 60 hours.

Authority: 44 U.S.C. 3506(c)(2)(A).

Issued on December 20, 2013.

Jeff Michael,

Associate Administrator, Research and Program Development.