DTNH22-09-D-00135-TO8 - Section A OMB v1.3.1

DTNH22-09-D-00135-TO8 - Section A OMB v1.3.1.docx

Medical Review Guidelines and Medical Advisory Board Practices

OMB: 2127-0705

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TABLE OF CONTENTS


SUPPORTING STATEMENT


  1. JUSTIFICATION


A.1. Explain the circumstances that make the collection of information necessary. Identify any Legal or administrative requirements that necessitate the collection. Attach a copy of the appropriate section of each statute and regulation mandating or authorizing the collection of information.

a. Circumstances making the collection necessary

b. Statute authorizing the collection of information


A.2. Indicate how, by whom, and for what purpose the information is to be used. Except for a new collection, indicate the actual use the agency has made of the information received from the current collection.


A.3. Describe whether, and to what extent, the collection of information involves the use of automated, electronic, mechanical or other technological collection techniques or other information technology. Also describe any considerations of using information technology to reduce burden.


A.4. Describe efforts to identify duplication. Show specifically why any similar information, already available cannot be used or modified for use for the purposes described in Item 2 above.


A.5. If the collection of information involves small businesses or other small entities, describe the methods used to minimize burden.


A.6. Describe the consequences to Federal Program or policy activities if the collection is not collected or collected less frequently.


A.7. Explain any special circumstances that require the collection to be conducted in a manner inconsistent with the guidelines set forth in 5 CFR 1320.6.


A.8. Provide a copy of the FEDERAL REGISTER document soliciting comments on extending the collection of information, a summary of all public comments responding to the notice, and a description of the agency’s actions in response to the comments. Describe efforts to consult with persons outside the agency to obtain their views.


A.9. Explain any decisions to provide any payment or gift to respondents, other than remuneration of contractors or grantees.


A.10. Describe any assurance of confidentiality provided to respondents.


A.11. Provide additional justification for any questions of a sensitive nature, such as sexual behavior or attitudes, religious beliefs, and other matters that are commonly considered private.


A.12. Provide estimates of the hour burden of the collection of information on the respondents.


A.13. Provide an estimate of the total annual cost to the respondents or record keepers resulting from the collection of information.


A.14. Provide estimates of the annualized cost to the Federal Government


A.15. Explain the reasons for any program changes or adjustments in Items 13 or 14 of the OMB 83-I


A.16. For collection of information whose results will be published, outline plans for tabulation and publication.


A.17. If seeking approval to not display the expiration date for OMB approval of the information collection, explain the reasons that display would be inappropriate.


A.18. Explain each exception to the certification statement identified in Item 19, “Certification for Paperwork Reduction Act Submissions” of the OMB Form 83-I


Supporting Statement


  1. Justification


The National Highway Traffic Safety Administration (NHTSA) of the U.S. Department of Transportation (USDOT) is seeking approval from the Office of Management and Budget (OMB) to conduct a census survey of the medical review process in each of the 51 driver licensing agencies, to document the structures, guidelines, and processes used by the 51 driver licensing agencies in the United States


A.1. Explain the circumstances that make the collection of information necessary. Identify any Legal or administrative requirements that necessitate the collection. Attach a copy of the appropriate section of each statute and regulation mandating or authorizing the collection of information.


a. Circumstances making the collection necessary


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.


A 2008 estimate by the Federal Highway Administration reveals that there are more than 208 million licensed drivers in the United States, of whom about 15% are 65 years of age or older.1 The proportion of older drivers (age 65 and older) is anticipated to grow to more than one in five over the next 20 to 30 years as the population ages and as the current cohort of drivers continues driving longer than previous generations. In this context, Driver Medical Review practices will assume a more prominent role in the years and decades ahead as our population ages, and medical conditions and associated impairments in safe driving abilities that are more common among older people become more prevalent. It is in the interest both of society and of older individuals themselves – who are most likely to be seriously injured or killed in a crash, due to increased physical frailty – to ensure that effective guidelines and practices are in place to evaluate those referred to a State licensing agency on account of (age-related) changes in function known to impair driving performance. Drivers whose competency is in question, regardless of their age, may be reported or referred to the licensing agency by a number of sources, although these differ somewhat from State to State. Similarities and differences in Driver Medical Review practices across the United States were highlighted in Strategies for Medical Advisory Boards and Licensing Review 2.


Based on the state of the knowledge in 20033, in most cases—in both States with and without a Medical Advisory Board (MAB)—when a licensing agency received a complaint or letter of concern regarding a driver’s ability to operate a motor vehicle safely, the agency began the reexamination process by sending the driver a medical form that needed to be completed by his or her treating physician and returned to the licensing agency. Based on the information obtained in the physician’s report and the State’s statutes governing medical fitness to drive, the driver’s operating privilege was either continued without restriction, continued with restriction, continued based on the results of a licensing agency testing (e.g., vision, knowledge, functional capacity, or road-test), or withdrawn. In the majority of States with a MAB, case review of the physician’s report and further orders for licensing agency road testing and license determinations can be completed by licensing agency staff.


Case reviews for fitness-to-drive determinations by the MAB in most States were generally reserved for the following types of cases: (1) the more complicated or unusual medical cases or those falling outside of the medical guidelines; (2) those where conflicting information was received in treating physician reports; and (3) for drivers who appealed a departmental licensing action. In only a few States did the MAB review all referred cases. The number of referrals received by the licensing departments per year in these States ranged from 300 to 13,000. The caseload reached as high as 38,000 per year for licensing agency case-reviewers when including periodic review cases. Because disposition of the majority of referrals to a licensing agency was performed by licensing agency case review staff (either administrative staff or medical professionals such as nurses), it is important in this project to document the structure and process of the licensing agency unit that performs case review of referred drivers both for States with MABs and for those without MABs.


For this project it is also important to document the structure and process of each State’s MAB, because differences exist in the composition and role the MAB plays across States. For example, in some States, the MAB works closely with the licensing agency to develop medical guidelines and standards to guide Medical Review by the licensing agency case review staff. Some also assist with development of referral forms and forms used to gather information from the drivers’ treating physicians. These activities generally occur in addition to individual case review, although there are some MABs that do not perform case review at all, and others that only review cases in which the driver is appealing a Departmental licensing determination. In addition, the two largest differences between the States that are suspected to influence referral outcomes and safety are (1) the depth and breadth of medical criteria in State statutes for determining fitness to drive (and continued licensure), and (2) the qualifications of the in-house staff that conduct case reviews. These differences are not necessarily related to whether the State has an MAB. There is great variability in the medical criteria used to make licensing determinations. Some jurisdictions rely solely on the treating physician’s opinion regarding fitness to drive, while others employ very specific medical and functional criteria for many medical conditions. Other jurisdictions have guidelines only for loss of consciousness/seizure disorders. Also, the staff that reviews the completed physicians’ reports vary from non-medical administrative staff in some jurisdictions to registered nurses in other jurisdictions, to non-medical administrative staff and a consulting/contract nurse or physician. In some jurisdictions, Medical Review staff are dedicated to Medical Review activities, while in others they may also have other licensing agency duties, serving as Hearing Officers or driver safety branch personnel with multifaceted responsibilities in addition to Medical Review duties.


This diversity of policies and practices calls for a study that documents strengths and limitations of the different approaches that have developed across the States to evaluate medical fitness to drive—specifically, to identify those most at risk due to age-related impairing conditions and to determine the most appropriate licensing actions to promote public health and preserve individual mobility. This project will critically examine the full range of referral sources, review practices, and associated licensing outcomes evidenced among all 51 U.S. jurisdictions to address this need, and update the state of the knowledge, which is over 10 years old. The information is of interest to State licensing agencies in updating their own guidelines, practices, and outreach to those who may refer drivers for medical review. It is of interest to NHTSA in promoting practices that maintain public safety while allowing for personal mobility.



b. Statute authorizing the collection of information


Title 23, United States Code, Chapter 4, Section 403 Title 23, United States Code, Chapter 4, Section 403 (Attachment 1) gives the Secretary authorization to use funds appropriated to carry out this section to conduct research and development activities (23 U.S.C. § 403(b)(1)) with respect to driver characteristics (See 23 U.S.C. § 403(b)(1)(A)(i)) human behavioral factors and their effect on highway and traffic safety (See 23 U.S.C. § 403(b)(1) (B)), and the effects of State laws (See See 23 U.S.C. § 403(b)(1) (F)).


A.2. Indicate how, by whom, and for what purpose the information is to be used. Except for a new collection, indicate the actual use the agency has made of the information received from the current collection.


This is a new collection of information, incorporating elements from similar but less comprehensive collections conducted in 2003 and 2009. Respondent compliance is voluntary.


The data collected in the proposed survey will be summarized in a document that may serve as a reference for driver licensing agencies when updating their medical review procedures and guidelines. For example, upon learning that Maryland MVA and North Carolina DMV both employ nurses on their case review staff, Virginia DMV sought and gained permission and funding to hire nurses as case reviewers, and presently has 10 nurse case reviewers in their Medical Review Unit. Another example would be a licensing agency that wants to update its license renewal form to include more medical conditions or update the form that is used by treating physicians to collect a driver’s medical history will have easy access to forms used by other licensing agencies to collect this information. The comparative data will also serve as a resource for NHTSA Regional Administrators, characterizing their States’ practices, juxtaposed against those in other Regions, and in promoting best practices. It will also provide a comprehensive reference for researchers interested in State driver licensing policies and practices affecting medically and functionally at-risk drivers.


A.3. Describe whether, and to what extent, the collection of information involves the use of automated, electronic, mechanical or other technological collection techniques or other information technology. Also describe any consideration of using information technology to reduce burden.


To collect this information, The NHTSA Contractor will email a Microsoft Word document that may be completed electronically using checkboxes and short fill-ins where a non-standard response is checked. The NHTSA Contractor will follow up by telephone if responses need to be clarified. Alternately, at the respondent’s preference, the document may be printed and completed manually (pen and paper) and mailed back to The NHTSA Contractor via USPS. This approach minimizes the burden to respondents by allowing them to select the preferred method of responding. This method has been previously used and yielded a high response rate.



A.4. Describe efforts to identify duplication. Show specifically why any similar information, already available cannot be used or modified for use for the purposes described in Item 2 above.


The latest compilation of driver licensing policies and practices was conducted by AAAFTS in 2009, but the information is now 5 years old, and it contains less detail than the survey originally conducted by AAMVA in 2003, which is now 11 years old. Project staff are experts in this area with members of staff having been involved in both the 2003 and 2009 study. A search through the currently published literature and informal discussion with colleagues reveled no more recent data collections on this topic and that no other data collections of the same ilk in progress.


A.5. If the collection of information involves small businesses or other small entities, describe the methods used to minimize burden.


The information collection involves State employees of driver licensing agencies, not small businesses. The size of driver licensing agencies varies by State, and so the information collection may involve small entities. The mode of survey administration (emailed Word document) was selected as most convenient for licensing agencies. It involves technology commonly in use within licensing agencies, and allows agencies to select when they will respond so they can participate when it is convenient to their schedules.

NHTSA has worked to limit the number of questions being asked. While it is estimated that responding to the questions will take on average 5 hours, it is expected that this burden will be split among multiple people because no single source is likely to be in possession of the different types of information being requested.


A.6. Describe the consequence to Federal program or policy activities if the collection is not conducted or is conducted less frequently, as well as any technical or legal obstacles to reducing burden.


Some of the core values of NHTSA are service and leadership. The core value of service is fulfilled in part by providing resources critical to motor vehicle and highway safety through products and technical information. The core value of leadership is fulfilled in part by serving as a catalyst for addressing safety issues that affect the highway safety community. One important highway safety need in an aging society is to improve the efficiency and effectiveness of medical review practices. In order to address this need, NHTSA requires current and accurate information about the state of practice across all jurisdictions. This will permit analyses that compare and contrast programs and practices so that the Agency can serve the States and lead the discussion about potential enhancements. Without such evidence that the practices recommended by NHTSA are working in other States, some licensing agencies may be reluctant to adopt changes to their practices that would improve identifying, assessing, and rendering licensing decisions on medically at-risk drivers in their State.

Ultimately, a failure to conduct research on the processes used to evaluate medically-at-risk drivers is likely to result in a failure to reduce the number of traffic and pedestrian fatalities and injuries on our nation’s highways.

A.7. Explain any special circumstances that require the collection to be conducted in a manner inconsistent with the guidelines set forth in 5 CFR 1320.6.


No special circumstances require the collection to be conducted in a manner inconsistent with the guidelines in 5 CFR 1320.6. There is no regular reporting requirement, the requested (not required) turnaround time is in excess of 30 days, the respondents return only a single copy of the document, no record retention requirements exists, the census is not statistical, there is no pledge of confidentiality, the respondents are not required to respond nor are they asked to submit any confidential information.



A.8. Provide a copy of the FEDERAL REGISTER document soliciting comments on extending the collection of information, a summary of all public comments responding to the notice, and a description of the agency’s actions in response to the comments. Describe efforts to consult with persons outside the agency to obtain their views.


FEDERAL REGISTER NOTICE: A copy of the Federal Register Notice which notified the public of NHTSA’s intent to conduct this information collection, and provided a 60-day comment period, was published on October 30, 2013 (Federal Register/Vol. 78, No. 210/pp. 65038-65040 (Attachment 2). No comments were entered into the NHTSA docket in response to the 60-day Federal Register Notice


A copy of a second Federal Register Notice (Federal Register/Vol. 79, No. 20/pp. 5018-5019), which announced that this information collection request will be forwarded to OMB, was published January 30, 2014 (Attachment 3).


Experts from similar previous efforts are on the study staff and have developed the current questionnaire. Our partners at AAMVA, an organization which represents those who are likely respondents, have reviewed the questionnaire and provided feedback which we have incorporated into the document. AAMVA has agreed to co-sign a cover letter with NHTSA in support of the questionnaire. All parties are satisfied with the form of the document, the clarity of instructions, and reporting format of the data elements. All parties also believe that in many cases the requested data will be available.


A.9. Explain any decision to provide any payment or gift to respondents, other than remuneration of contractors or grantees.


No payment or gift will be provided to respondents.


A.10. Describe any assurance of confidentiality provided to respondents


No assurance or pledge of confidentiality will be provided. Respondents names will be mentioned in a report appendix. Although responses may be quantitatively or qualitatively summarized for the purposes of narrative clarity, microdata may be included in the final report where useful and will not be subject to any disclosure-limitation procedures.


A.11. Provide additional justification for any questions of a sensitive nature, such as sexual behavior or attitudes, religious beliefs, and other matters that are commonly considered private.


This survey contains no questions of a sensitive nature, as it deals strictly with state licensing agency medical review guidelines and procedures. No individual driver information is being collected in this survey.



A.12. Provide estimates of the hour burden of the collection of information on the respondents.


Information collection will be conducted by emailed survey, followed up by telephone to clarify responses as needed. Survey completion time is estimated to be 2.5 hours, and narrative editing another 2.5 hours. Thus, total time is estimated to be 5 hours. This includes all participant time including: the time required to respond to all of the applicable 63 questions in NHTSA Form 1228, narrative editing, staffer time required to send out all applicable emails, and, if necessary, any time that may be needed to ask questions of or respond to the NHTSA Contractor’s questions. However, based on previous experience, actual time to complete an individual survey may be between one hour to eight hours. The variance in actual time to completion is a consequence of differences between States in regards to the extent that the requested information is readily available. Therefore, our estimate of total time burden is:



51 States (includes DC) x 5 hours = 255 hours


There will be no regular collection of this data, therefore there is no annualized cost estimate. All time estimates are based on experience from similar previous surveys.


A.13. Provide an estimate of the total annual cost to the respondents or record keepers resulting from the collection of information.


Survey respondents will incur no costs from the data collection and will incur no record keeping burden and no record keeping cost from the information collection


A.14. Provide estimates of the annualized cost to the Federal Government.


This is not an annual collection of data. Data collection costs to the Federal Government are based on the contractor's estimate of level of effort required to develop the survey, assist with OMB review, collect and enter data, and prepare the report with State narratives and appendix tables. These activities are estimated at a one-time cost of $61,504.



A.15. Explain the reasons for any program changes or adjustments in Items 13 or 14 of the OMB 83-I.


This is a one-time request that will create a program change of adding an additional 255 burden hours to NHTSA’s overall total. This request does not produce any repeating annual reporting, record-keeping burden, or cost burden.

A.16. For collection of information whose results will be published, outline plans for tabulation and publication.


NHTSA will summarize the survey results in a report to be disseminated to the licensing agencies, State highway safety offices, and other interested parties. The edited narratives returned by respondents will be presented in the body of the report, in alphabetical order by State. Information obtained through the survey will be provided as tables in an appendix to the report with some cross-tabulations involving key medical review characteristics. Selected results may also be inserted in other published NHTSA materials. All published NHTSA materials would be posted on its Website. No complex analytical techniques will be used. Data collection is expected to begin within three weeks of OMB approval. It is anticipated that data collection will be completed by September of 2014. The final report is expected to be completed by 03/25/2015 and published by the end of 2015.


A.17. If seeking approval to not display the expiration date for OMB approval of the information collection, explain the reasons that display would be inappropriate.


NHTSA will display the expiration date for OMB approval.


A.18. Explain each exception to the certification statement identified in Item 19, “Certification for Paperwork Reduction Act Submissions” of the OMB Form 83-I.


No exceptions to the certification are made.


References

Information Collection Activities: Submission for the Office of Management and Budget (OMB) Review; Request for Comment, Fed Reg. 78(210), 65038-65040 (proposed 2013).

Information Collection Activities: Submission for the Office of Management and Budget (OMB) Review; Request for Comment, Fed Reg. 79(20), 5018-5019 (proposed 2014).

Lococo, K. (2003). Summary of medical advisory board practices in the United States. Retrieved from: http://www.mdsupport.org/drivingsummary.pdf

Moving Ahead for Progress in the 21st Century Act of 2012, 23 U.S.C. § 403 et seq. (Government Printing Office, 2012).

OMB. (2003, September 17). To the Heads of Executive Agencies and Establishments. Circular A-4. Retrieved from: http://www.whitehouse.gov/sites/default/files/omb/assets/regulatory_matters_pdf/a-4.pdf.

Stutts, J. & Wilkins, J. (2009). Driver licensing policies and practices: Gearing up for an aging population. AAA Foundation for Traffic Safety. Retrieved from: http://lpp.seniordrivers.org/lpp/pdf/DriverLicensePoliciesReport.pdf

1 http://www.fhwa.dot.gov/policyinformation/statistics/2008/dl22.cfm

2 Lococo, K. and Staplin, L.  (2005).  Strategies for Medical Advisory Boards and Licensing Review.  U.S.DOT/NHTSA Publication No. DOT HS 809 874. Washington, D.C.  www.nhtsa.dot.gov/people/injury/research/MedicalAdvisory/index.html.


3 Lococo, K. (2003). Summary of medical advisory board practices in the United States. Task Report Prepared under NHTSA Contract No. DTNH22-02-P-05111. Retrieved from: http://www.mdsupport.org/drivingsummary.pdf


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