E8-23742. Reports, Forms, and Record Keeping Requirements

AGENCY:

National Highway Traffic Safety Administration (NHTSA), DOT.

ACTION:

Notice of 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 one collection of information for which NHTSA intends to seek OMB approval.

DATES:

Comments must be received on or before December 8, 2008.

ADDRESSES:

Comments should refer to the docket number and be submitted to: U.S. Department of Transportation, Docket Management Facility, West Building, 1200 New Jersey Ave., SE., Room W12-140, Washington, DC 20590. Docket hours are 9 a.m. to 5 p.m., Monday through Friday, except Federal holidays. You may call the docket at 202-647-5527. You may also submit comments electronically at http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT:

Ms. Amy Berning, Contracting Officer's Technical Representative, Office of Behavioral Safety Research (NTI-131), National Highway Traffic Safety Administration, 1200 New Jersey Ave, SE., Washington, DC 20590. Ms. Berning's phone number is 202-366-5587 and the 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:

Estimate of Crash Risk of Impaired Driving

Type of Request—New information collection requirement.

OMB Clearance Number—None.

Form Number—This collection of information uses no standard forms.

Requested Expiration Date of Approval—June 30, 2011.

Summary of the Collection of Information—NHTSA proposes to conduct a case-control study to assess the crash risk of alcohol-positive, drug-positive, and alcohol plus drug-positive drivers. Case-control studies are studies designed to identify factors that may contribute to a condition of interest (in this case crash involvement) by comparing a group of individuals who show the condition of interest (e.g., a motor vehicle crash) with a group who do not (e.g., drivers not involved in a crash). Case-control studies are an epidemiologically proven alternative to designs such as randomized controlled trials that cannot be used to evaluate injury-related outcomes. A key element of the case-control design is the matching of cases (e.g., crash-involved drivers) with controls (non-crashes-involved drivers) by exposure conditions (e.g., day of the week, time of the day, same street, same spot, same driving direction, etc.) and then assessing the increased or decreased risk attributable to other measured factors, such as alcohol and other drugs. Data collection would take place for at least one year in one community. Researchers would conduct 2,500 surveys with crash-involved drivers and 5,000 non-crash involved drivers. Crashes occurring within the selected site's boundaries that meet the study design criteria (e.g., tow-away, injury crashes, and fatal crashes) and that are not on limited access highways (e.g., interstate roadways) will be eligible for inclusion in the study. The research team will consist of a data collector (who is also a licensed phlebotomist) and an on-duty law enforcement officer. The police department dispatcher will notify that officer of all crashes that are called in and the team will respond to crashes reported during the shift. The team will use a sampling procedure to determine which crashes to attend. The team's police officer will then make contact with the on-scene investigating officer and then will briefly introduce the data collector to the driver(s). The data collector will then ask the driver (or drivers) to participate in a voluntary, confidential, research survey.

The survey includes questions about alcohol and drug use and impaired driving, a Blood Alcohol Concentration (BAC) breath test, collection of an oral fluid specimen, and collection of a blood sample. The results of the breath and biological samples will not be known to the researchers on site. Breath alcohol test results will be downloaded and analyzed later. Biological samples will be analyzed later at a central laboratory by a trained toxicologist.

Drivers must be at least age 16 to participate (18 years to provide a blood sample), speak English, not be in emotional or physical distress, not be driving a commercial vehicle, and be able to understand that they are being asked to voluntarily participate in a confidential research study and that participation will have no effect on their status with the police, courts, hospital, insurance companies, or department of motor vehicles. For those potential participants who are transported to a hospital, researchers will collaborate with the emergency departments to collect study data from those who are capable and able to voluntarily agree to participate in the study. Similar data will be collected on fatally injured drivers through the Medical Examiner's Office. The human subject protections procedures of each hospital will be followed as well as procedures of the Federal Office of Human Research Protections. For those potential participants who are arrested, the data collector will approach the driver after all processing by the police is complete.

The team will randomly select control-case drivers matched to crash cases. Cases will be matched in terms of roadway location, direction of travel, day of week, and time of driving. A road sign will indicate “Voluntary Survey Ahead.” The team's police officer will flag down the first available vehicle after the data collector indicates that he/she is ready to commence data collection. The data collector will invite the driver to participate in a voluntary confidential research survey and explain the details of the data collection. The same survey questions as noted above will be used. There will be two completed control cases (surveys) for each crash included in the study, for a total of 5,000 control cases.

Description of the Need for the Information and Proposed Use of the Information—The National Highway Traffic Safety Administration's (NHTSA) mission is to save lives, prevent injuries, and reduce healthcare and other economic costs associated with motor vehicle crashes. The agency's goal is to reduce the rate of fatalities in .08+ BAC crashes per 100 million vehicle miles traveled to 0.45 in 2011 (the rate in 2006 was .50). NHTSA also has the responsibility to reduce drug-involved driving. Little is known about the actual crash risk associated with drivers having consumed psychoactive drugs other than alcohol, alone and in combination with alcohol. This study would significantly add to the body of knowledge about that important issue, providing critical data on the crash risk of alcohol-positive and drug-positive drivers on the road. The results of the study will be used by NHTSA to help guide policy development and countermeasure programs intended to reduce the risk on our highways presented by impaired drivers.

Description of the Likely Respondents (Including Estimated Number, and Proposed Frequency of Response to the Collection of Information)—Under this proposed effort, the Contractor would conduct a pilot test of approximately 100 cases of the survey procedures and then spend approximately one year collecting 2,500 crash cases and 5,000 randomly selected control cases in one community.

Estimate of the Total Annual Reporting and Record Keeping Burden Resulting from the Collection of Information—NHTSA estimates that participants will spend an average of 20 minutes each to complete the survey, for a total of 2,508 hours for the 100 pilot case respondents and 7,500 study respondents. The respondents would not incur any reporting cost or record keeping burden from the data collection.

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

Issued on October 8, 2008.

Jeff Michael,

Acting Associate Administrator, Research and Program Development.