81 FR 44675 - Agency Information Collection Activities; New Information Collection Request: 391.41 CMV Driver Medication Form
DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety Administration Federal Register Volume 81, Issue 131 (July 8, 2016)
Federal Motor Carrier Safety Administration
Federal Register Volume 81, Issue 131 (July 8, 2016)
| Page Range | 44675-44680 | |
| FR Document | 2016-16199 |
[Federal Register Volume 81, Number 131 (Friday, July 8, 2016)] [Notices] [Pages 44675-44680] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-16199] ----------------------------------------------------------------------- DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration [Docket No. FMCSA-2015-0180] Agency Information Collection Activities; New Information Collection Request: 391.41 CMV Driver Medication Form AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice and request for comments. ----------------------------------------------------------------------- SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FMCSA announces its plan to submit the Information Collection Request (ICR) described below to the Office of Management and Budget (OMB) for its review and approval and invites public comment on the approval of a new Information Collection (IC) titled, 391.41 CMV Driver Medication Form. Comments received in response to this notice are sent to the OMB Desk Officer to address. This IC is voluntary and may be utilized by medical examiners (MEs) responsible for issuing Medical Examiner's Certificates (MECs) to commercial motor vehicle (CMV) drivers. MEs that choose to use this IC will do so in an effort to communicate with treating healthcare professionals who are responsible for prescribing certain medications, so that the ME fully understands the reasons the medications have been prescribed. The information obtained by the ME when utilizing this IC will assist the ME in determining if the driver is medically certified according to the physical qualifications standards outlined in 49 CFR 391.41 and to ensure that there are no disqualifying medical conditions or underlying medical conditions and [[Page 44676]] prescribed medications that could adversely affect their safe driving ability or cause incapacitation constituting a risk to the public. DATES: Please send your comments to this notice by August 8, 2016. OMB must receive your comments by this date to act quickly on the ICR. ADDRESSES: All comments should reference Federal Docket Management System (FDMS) Docket Number FMCSA-2015-0180. Interested persons are invited to submit written comments on the proposed IC to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be addressed to the attention of the Desk Officer, Department of Transportation/Federal Motor Carrier Safety Administration, and sent via electronic mail to [email protected], faxed to (202) 395-6974, or mailed to the Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW., Washington, DC 20503. FOR FURTHER INFORMATION CONTACT: Christine A. Hydock, Chief, Medical Programs Division, (202) 366-4001, [email protected], U.S. Department of Transportation, Federal Motor Carrier Safety Administration, 1200 New Jersey Avenue SE., Room W64-113, Washington, DC 20590-0001. SUPPLEMENTARY INFORMATION: Title: 391.41 CMV Driver Medication Form. OMB Control Number: 2126-00XX. Type of Request: New collection. Respondents: Prescribing healthcare professionals. Estimated Number of Respondents: 1,082,200 (total number of prescribing healthcare providers in the U.S.). Estimated Time per Response: 8 minutes. Expiration Date: N/A. This is a new ICR. Frequency of Response: Voluntary. Estimated Total Annual Burden: 144,293 hours [1,082,200 responses x 8 minutes to complete response/60 minutes = 144,293]. Background: The primary mission of FMCSA is to reduce crashes, injuries, and fatalities involving large trucks and buses. The Secretary of Transportation has delegated to FMCSA its responsibility under 49 U.S.C. 31136 and 31502 to prescribe regulations that ensure that CMVs are operated safely. As part of this mission, the Agency's Medical Programs Division works to ensure that CMV drivers engaged in interstate commerce operations are physically qualified and able to safely perform their work. Information used to determine and certify driver medical fitness must be collected in order for our highways to be safe. FMCSA is the Federal government agency authorized to require the collection of this information and the authorizing regulations are located at 49 CFR parts 390-399. FMCSA is required by statute to establish standards for the physical qualifications of drivers who operate CMVs in interstate commerce for non-excepted industries [49 U.S.C. 31136(a)(3) and 31502(b)]. The regulations discussing this collection are outlined in the Federal Motor Carrier Safety Regulations (FMCSRs) at 49 CFR part 390-399. FMCSRs at 49 CFR 391.41 set forth the physical qualification standards that interstate CMV drivers who are subject to part 391 must meet, with the exception of commercial driver's license/commercial learner's permit (CDL/CLP) drivers transporting migrant workers (who must meet the physical qualification standards set forth in 49 CFR 398.3). The FMCSRs covering driver physical qualification records are found at 49 CFR 391.43, which specify that a medical examination be performed on CMV drivers subject to part 391 who operate in interstate commerce. The results of the examination shall be recorded in accordance with the requirements set forth in that section. 49 CFR 391.41(b)(12) states that a person is physically qualified to drive a CMV if that person does not use any drug or substance identified in 21 CFR 1308.11 Schedule I, an amphetamine, a narcotic, or other habit-forming drug and does not use any non-Schedule I drug or substance that is identified in the other Schedules in 21 CFR part 1308 except when the use is prescribed by a licensed medical practitioner, as defined in Sec. 382.107, who is familiar with the driver's medical history and has advised the driver that the substance will not adversely affect the driver's ability to safely operate a CMV. In 2006, FMCSA's Medical Review Board (MRB) deliberated on the topic of the use of Schedule II medications. The MRB considered information provided in a 2006 FMCSA sponsored Evidence Report and a subsequent Medical Expert Panel (MEP) to examine the relationship between the licit use of Schedule II medications and the risk for a motor vehicle crash. In 2013, FMCSA tasked the MRB with updating the opinions and recommendations of the 2006 Evidence Report and MEP. On September 10, 2013, the MRB and Motor Carrier Safety Advisory Committee (MCSAC) met jointly to hear presentations on the licit use of Schedule II medications and their regulation, and on U.S. Department of Transportation drug and alcohol testing protocols. Subsequently, the committees engaged in a discussion on the issue as it applies to CMV drivers. On September 11, 2013, the MRB discussed the issue in greater detail as its task to present a report to the Agency relating to CMV drivers and Schedule II medication use and to develop a form for MEs on the National Registry of Certified Medical Examiners (National Registry) to send to treating clinicians of CMV drivers to expound on the use of these medications by driver applicants. On October 22, 2013, the MRB submitted their recommendations to FMCSA. A MEP convened to provide an updated opinion on Schedule II Opioids and Stimulants & CMV Crash Risk and Driver Performance. The FMCSA revised the task of the MRB instructing them to review an updated evidence report and the MEP opinion that was furnished subsequent to its deliberations on Schedule II Opioids and Stimulants & CMV Crash Risk and Driver Performance: Evidence Report and Systematic Review. FMCSA directed the MRB to consider this report's findings and confer with the MCSAC on this topic during a joint meeting in October 2014. The MRB met in public meetings on July 29-30, 2014, and developed Schedule II medication recommendations. The MRB presented these recommendations to the MCSAC in a joint public meeting on October 27, 2014, where they were deliberated by both committees. As a result, FMCSA's MRB and MCSAC provided joint recommendations related to the use of Schedule II medications by CMV drivers. Because there is moderate evidence to support the contention that the licit use of opioids increases the risk of motor vehicle crashes and impacts indirect measures of driver performance negatively, included was the recommendation that FMCSA develop a standardized medication questionnaire to assist the certified ME when reviewing prescription medications that have been disclosed during the history and physical examination for CMV driver certification. The two advisory groups recommended to FMCSA that the standardized CMV driver medication questionnaire be voluntary and include the following information and questions: 1. Questionnaire should be titled 391.41 CMV Driver Medication Questionnaire. 2. Questionnaire should request the following information: a. Identifying name and date of birth of the CMV driver. [[Page 44677]] b. Introductory paragraph stating purpose of the CMV Driver Medication Report. c. Statements of Sec. 391.41(b)(12) (Physical Qualifications of Drivers relating to driver use of scheduled substances) and The Driver's Role, as found in the Medical Examination Report form found at the end of 49 CFR 391.43 (Medical Examination; Certificate of Physical Examination). d. Name, state of licensure, signature, address and contact information of the prescribing healthcare provider, as well as the date the form was completed. e. Name, signature, date, address and contact information of the certified ME. 3. Report should include the following information: a. 1--List all medications and dosages that you have prescribed to the above named individual. b. 2--List any other medications and dosages that you are aware have been prescribed to the above named individual by another treating healthcare provider. c. 3--What medical conditions are being treated with these medications? d. 4--It is my medical opinion that, considering the mental and physical requirements of operating a CMV and with awareness of a CMV driver's role (consistent with The Driver's Role statement on page 2 of the form), I believe my patient: (a) Has no medication side effects from medication(s) that I prescribe that would adversely affect the ability to operate a CMV safely; and (2) has no medical condition(s) that I am treating with the above medication(s) that would adversely affect the ability to operate a CMV safely. The public interest in, and right to have, safe highways requires the assurance that drivers of CMVs can safely perform the increased physical and mental demands of their duties. FMCSA's medical standards provide this assurance by requiring drivers to be examined and medically certified as physically and mentally qualified to drive. The purpose for collecting this information is to assist the ME in determining if the driver is medically qualified under 49 CFR 391.41 and to ensure that there are no disqualifying medical conditions that could adversely affect their safe driving ability or cause incapacitation constituting a risk to the public. 49 CFR 391.41(b)(12) states that a person is physically qualified to drive a CMV if that person does not use any drug or substance identified in 21 CFR 1308.11 Schedule I, an amphetamine, a narcotic, or other habit-forming drug and does not use any non-Schedule I drug or substance that is identified in the other Schedules in 21 CFR part 1308 except when the use is prescribed by a licensed medical practitioner, as defined in Sec. 382.107, who is familiar with the driver's medical history and has advised the driver that the substance will not adversely affect the driver's ability to safely operate a CMV. The use of this IC is at the discretion of the ME to facilitate communication with treating healthcare professionals who are responsible for prescribing certain medications so that the ME fully understands the reasons the medications have been prescribed. This information will assist the ME in determining whether the underlying medical condition and the prescribed medication will impact the driver's safe operation of a CMV. Therefore, there is no required collection frequency. The 391.41 CMV Driver Medication Form will be available as a fillable PDF or may be downloaded from the FMCSA Web site. Prescribing healthcare providers will be able to fax or scan and email the report to the certified ME. Consistent with the OMB's commitment to minimizing respondents' recordkeeping and paperwork burdens and the increased use of secure electronic modes of communication, the Agency anticipates that approximately 50 percent of the 391.41 CMV Driver Medication Forms will be transmitted electronically. The information collected from the 391.41 CMV Driver Medication Form, will be used by the certified ME that requested the completion of the form and will become part of the CMV driver's medical record maintained by the certified ME. Therefore, the information will not be available to the public. The FMCSRs covering driver physical qualification records are found at 49 CFR 391.43, which specify that a medical examination be performed on CMV drivers subject to part 391 who operate in interstate commerce. The results of the examination shall be recorded in accordance with the requirements set forth in that section. MEs are required to maintain records of the CMV driver medical examinations they conduct. Disclaimer language is displayed at the end of the medical form to declare sensitive information on the form must be handled and maintained securely to prevent inadvertent disclosure. The language also states the form is for official use only, by authorized persons, and the form should be properly disposed of when no longer required. Discussion of Comments Received A. Overview of Comments In response to the Federal Register notice published on November 25, 2015, requesting public comment concerning the necessity of the proposed IC, the accuracy of the estimated burden, how the quality of collected information could be enhanced, and ways in which the burden could be minimized without reducing the quality of the collected information (80 FR 73871), FMCSA received 14 comments. The commenters included certified MEs, CMV drivers, training organizations, the American Trucking Associations (ATA), the Owner-Operator Independent Drivers Association (OOIDA), and the American College of Occupational and Environmental Medicine (ACOEM). The first area of comments involved the effectiveness of the 391.41 CMV Driver Medication Form. The second area of comments discussed the burden hours and costs. The final area of comments were issues that were considered outside the scope of this ICR and the optional use of the 391.41 CMV Driver Medication Form. These comments will be briefly summarized with an explanation as to why the issues raised are not within the scope of this notice. Five commenters expressed support for the ICR and two commenters explicitly opposed the ICR. The remaining seven neither supported nor opposed the ICR, but raised concerns or provided suggestions for changes to the optional form. The following sections provide details regarding specific issues raised by the commenters. B. Effectiveness of the 391.41 CMV Driver Medication Form ACOEM acknowledged that the current process used by MEs is clearly inadequate but also feels that the form falls far short of being able to adequately assess whether a driver will be impaired by medications or an underlying medical condition. They also stated that many healthcare providers do not fully understand the safety risks and responsibilities of the CMV driver and would rely on the patient's statement that the medication does not impair the driver's ability to safely operate a CMV. Therefore, they believe that the prescribing healthcare provider statements would not be reliable. ACOEM also believes that the form does not go far enough to address the use of opioids by drivers and the rapid increase in adverse effects of opioid use and suggests that FMCSA strive for a form that becomes the standard of [[Page 44678]] practice that requires the treating provider and the ME to be aware of medications and conditions, including opioid use. Others commented that some physicians have no problem stating that their patient is safe to drive a CMV while taking these medications leaving the ME that disagrees and is not willing to issue the driver a MEC with a driver that is angry based on the differing opinions. OOIDA stated that the form would be a direct challenge to the treating physician according to Sec. 391.41(b)(12)(ii) that states ``A person is physically qualified to drive a commercial motor vehicle if that person does not use any non-Schedule I drug or substance that is identified in the other Schedules in 21 CFR part 1308 except when the use is prescribed by a licensed medical practitioner, as defined in Sec. 392.107, who is familiar with the driver's medical history and has advised the driver that the substance will not adversely affect the driver's ability to safely operate a commercial vehicle.'' They believe that this form challenges the opinion of the driver's treating physician and puts it in the hands of a stranger with no knowledge of the driver's background and who is unfamiliar with the driver's medical history. FMCSA Response FMCSA is providing the 391.43 CMV Driver Medication Form at the request of MEs to be used at their discretion, and as a resource for assisting MEs in making medical certification determinations of interstate CMV drivers. Use of the form is voluntary and MEs may do so in an effort to communicate with treating healthcare providers who are responsible for prescribing certain medications, so that the ME fully understands the reasons the medications have been prescribed. Information about the driver's role was specifically added to the form to assist those healthcare providers that do not fully understand the safety risks and responsibilities of the CMV driver and in an effort to obtain reliable data. The form was specifically designed to address any medications that a driver is taking that may impair his/her ability to safety operate a CMV and was not intended to address only opioids. The information obtained by the ME when utilizing the optional 391.41 CMV Driver Medication Form will assist the ME in determining if the driver is medically qualified under 49 CFR 391.41 and to ensure that there are no disqualifying medical conditions or underlying medical conditions and prescribed medications that could adversely affect the driver's safe driving ability or cause incapacitation constituting a risk to the public. The decision to certify a driver is a discretionary decision that rests with the certifying ME. MEs may disqualify a driver who takes any medications or combination of medications and substances that may impair or interfere with safe driving practices. C. Burden Hours and Costs Several commenters expressed concern that prescribing healthcare providers would not respond in a timely manner or at all, and that delays would be costly to drivers and motor carriers. ATA stated that FMCSA should consider the impact of potential delays to driver recertification, because the form does not advise prescribing healthcare providers to complete and return the form to the requesting ME within a specific timeframe, nor does it require MEs to certify a driver who is medically qualified even in the absence of the completed form. They expressed concern that the lack of such language could result in unnecessary and costly delays that would penalize qualified drivers due to circumstances that are out of their control. ATA recommended that if a prescribing healthcare provider is unable to return the form to a ME in a timely manner, FMCSA should advise MEs to continue to use their own judgement and certify drivers in these circumstances if they find them to be medically qualified. Others commented that MEs will find the proposed form to be too restrictive and excessive explaining that although a full list of medications seems to be a good idea, it could significantly increase the effort required by the prescribing healthcare providers which is counterproductive to obtaining their assistance. Suggestions were made to ask the prescribing healthcare provider a single question such as is the driver taking any other medications that may be a risk to safe driving, to list only those medications that would negatively affect the ability of the driver to safely operate a CMV, or to only ask about medications that are of concern that the patient reported. Dr. Michael Megehee recommended including a statement that FMCSA guidelines require the ME to ask the prescribing healthcare provider for assistance in determining whether the driver is safe to operate a CMV and they meet the FMCSRs and that although the ME considers the opinions of treating physicians, the ME is responsible for making the final medical qualification determination. ATA stated that while this IC may be a useful tool to many MEs in determining whether a driver is medically qualified, in certain cases, it will not always be necessary. They believe that in most situations, the ME should be able to verify the accuracy of the information provided by the driver and the need for the medication based upon their training and experience in performing medical examinations and a robust conversation with the driver. They suggested that to avoid any unnecessary and costly delays to drivers and carriers alike, FMCSA should emphasize to MEs that the form is strictly voluntary and not a de facto standard when performing medical examinations. They also suggested that the form be consistent with the newly revised MER Form, MCSA-5875 by limiting its inquiry into medications that the driver is currently prescribed and that the prescribing healthcare provider should only report those medications that they can confirm have been prescribed. They stated that asking for all prescribed medications imposes a burden on healthcare providers without any significant positive impact on safety and suggested asking healthcare providers to list those medications that a driver is currently prescribed and would negatively affect their ability to safely operate a CMV will dramatically limit the collection burden without diminishing the quality of the information being collected. OOIDA stated that there will be an increase in the number of inconsistencies in the medical certification process as MEs with no personal relationship with the driver attempt to evaluate a great deal of long-term medication usage. They stated that the proposed use of the 391.41 CMV Driver Medication Form invites second guessing of a primary physician by MEs who are empowered by an unreliable medical form and that it invites the ME to question every medication and dosage which has been previously prescribed. They feel that this IC will only increase problems drivers have already experienced with MDs, which have resulted in higher costs and lengthier delays for drivers. Ultimately, they stated that the IC will lead to higher costs and longer wait times for drivers as they complete the examination with a ME and that it is already a common occurrence for the ME to conduct excessive testing beyond what is required under the current medical examination form. OOIDA points out that the IC is not limited to Schedule II drugs and could include items with no perceptible link to the safe operation of a CMV and believes that requesting an unlimited amount of [[Page 44679]] information is not helpful to determining a driver's fitness to operate a CMV and that there is no need to require a listing of any prescribed drugs beyond those regulated by Sec. 382.213: Controlled substance use. FMCSA Response FMCSA does not believe that the form will add any time to the certification decision nor is it necessary to advise the ME to make a certification decision at any specified time after sending the 391.41 CMV Driver Medication Form to the prescribing healthcare provider. In addition, the Medical Examiner's Certification Integration final rule provides a determination pending category that allows the driver to continue to operate a CMV as long as the driver has an unexpired MEC, for a maximum of 45 days, if the ME needs additional information to make a certification decision making additional delays unlikely. As previously stated, the form was specifically designed to address any prescription medications that a driver is taking that may impair his/her ability to safely operate a CMV. Therefore, the Agency does not believe that the form is too restrictive or excessive nor will it significantly increase the effort required by the prescribing healthcare providers. Instead, the Agency believes that the form will be a useful resource for MEs in making a medical certification decision of drivers that are taking prescribed medications. Because the prescribing healthcare provider is not trained regarding the FMCSRs and may not be a certified ME, FMCSA does not believe that asking the prescribing healthcare provider a single question such as is the driver taking any other medications that may be a risk to safe driving, to list only those medications that would negatively affect the ability of the driver to safely operate a CMV, or to only ask about medications that are of concern that the patient reported would provide reliable information to assist the ME in making a medical certification decision. FMCSA is not requiring MEs to use the 391.41 CMV Driver Medication Form, use of the form is completely voluntary. Therefore, it would not be appropriate to add a statement that FMCSA is requiring MEs to ask the prescribing healthcare provider for assistance in determining whether the driver is safe to operate a CMV and that they meet the FMCSRs. The fact that the ME is responsible for making the final medical certification determination is stated on the form. FMCSA continues to emphasize that the 391.41 CMV Driver Medication Form is optional and may be used at the discretion of the ME as a resource for the ME to communicate with prescribing healthcare providers, enabling the ME to make a more informed medical certification determination. When used, this form will supplement the MER Form, MCSA-5875 by asking for all medications that the prescribing healthcare provider has prescribed and any other medications that they are aware have been prescribed by another treating healthcare provider, and was designed to address any prescription medications that a driver is taking that may impair his/her ability to safety operate a CMV. The Agency does not feel that asking for all medications prescribed on this optional form imposes a burden on healthcare providers without any significant positive impact on safety and that limiting the collection to only medications that a driver is currently prescribed that the prescribing healthcare provider feels would negatively affect their ability to safely operate a CMV would diminish the quality of the information being collected. Interstate CMV drivers are required to use a certified ME listed on the National Registry for their medical examination and certification. Therefore, in many cases the driver is going to a ME that they do not have a personal relationship with. The use of the optional 391.41 CMV Driver Medication Form does not change this fact nor does it have a negative impact. The 391.41 CMV Driver Medication Form is a tool to collect information that the MEs already collect at their discretion when performing driver examinations. This optional form will serve as a resource for the ME to use in communicating with prescribing healthcare providers, enabling the ME to make a more informed medical certification determination. The decision to certify a driver is a discretionary decision that continues to rest with the certifying ME. As previously stated, MEs may disqualify a driver who takes any medications or combination of medications and substances that may impair or interfere with safe driving practices. D. Issues Outside the Scope of This Notice A number of respondents submitted comments on topics that were outside the scope of what was proposed in this notice. This notice specifically requested comments related to the proposed IC and optional form to be used as an IC tool. 1. Schedule II Medication Use OOIDA disputed the fact that there is moderate evidence of increased risk due to Schedule II drug use and stated that the paucity of data shows that few CMV drivers have had problems with licit Schedule II drug use, or even prescription medications. They also stated that studies do not show that a significant number of CMV operators are crashing due to prescription medication use and that because insufficient data exists regarding the use of Schedule II drugs by CMV drivers should be an indication to the MRB and FMCSA that there are very few CMV drivers who have had problems with licit Schedule II drug usage. Dr. Kurt T. Hegmann stated that this form should not be adopted for opioids/Schedule II medications, because this form is not evidence- based, not validated, there is no objective test to figure out who is unsafe and will crash if using opioids/Schedule II medications, and the form will cause a false sense of security that both endorses narcotics- using truck drivers and a method to sign the form to approve them to drive under the influence, and is likely to inadvertently further increase fatalities. He also stated that the form appears to evade the FDA-supported advice on opioid prescription labels that uniformly warn against vehicle operation and suggested we adopt the 2006 MEP recommendation to eliminate the potential exception that a prescriber who thought someone could drive, would be allowed to drive on opioids. Dr. Hegamann believes that this form will not help the Agency meet its primary mission. Instead he states that individuals using opioids should not drive trucks and instead should be tapered and/or de-toxed and then resume driving off those medications. On the other hand, ACOEM, stated that the form does not go far enough to address the use of opioids by drivers and the rapid increase in adverse effects of opioid use. They pointed out that the original proposed version of this form goes back to the 2006 Schedule II Medication Panel and had significantly more content, which would have given the treating provider and the ME a clearer understanding of the impairment risks of the medications. They suggested any form incorporate some of the recommendations from the MRB and MCSAC joint Task 14-3: Schedule II Controlled Substances and CMV Drivers including the recommendation that a driver should not be medically qualified to operate a CMV while he/she is under treatment with narcotics or any narcotic derivative without exception. They go [[Page 44680]] on to explain that because the current exception remains in the FMCSRs (40 CFR 391.41(b)(12)(ii)), they recommend guidelines be provided to MEs regarding the use of narcotics. FMCSA Response Although optional use of the 391.41 CMV Driver Medication Form was introduced as a result of the MRB and MCSAC recommendations related to the use of Schedule II medications by CMV drivers, the recommendation was for FMCSA to develop a standardized form to assist the certified ME when reviewing prescription medications that have been disclosed during the history and physical examination for CMV driver certification. Therefore, the form was not designed to specifically address Schedule II medications. The form was designed to address any prescription medications that a driver is taking that may impair his/her ability to safety operate a CMV. FMCSA is not considering a change in the regulations or guidance that would prohibit or advise the ME regarding Schedule II medications at this time. Therefore, these comments are outside of the scope of this notice. 2. Qualifications of the ME Several commenters stated that a ME might not be qualified to make a medical qualification decision if the driver uses Schedule II medications, because of a lack of training in pharmacology. OOIDA stated that the personal physician is best equipped to review a driver's medical history and suggested that a personal physician be the one to review the driver's medical history and make the decision whether a medication will adversely affect the driver's ability to safely operate a CMV. Dr. Hegmann advocated for implementation of the MRB's recommendation that ME eligibility be limited to those medically trained (i.e., MD, DO, PA and NPs). He stated that the concept that these medically untrained examiners can make an informed judgment about driver impairment from narcotics, assess how opioids may interact with other medications, provide guidance to truck drivers, and judge fitness to drive is factually false. Dr. Hegmann feels that FMCSA does not rely on recommendations of the MRB and will selectively use whichever source of guidance is least restrictive which is directly contrary to the central, stated purpose of the Agency. FMCSA Response FMCSA responded to the question of who is qualified to be a ME in the National Registry of Certified Medical Examiners final rule (77 FR 24106, April 20, 2012), and is not considering a change to the regulation in 49 CFR 390.103, Eligibility requirements for medical examiner certification in this notice. Therefore, these comments are outside the scope of this notice. Public Comments Invited: FMCSA requests that you comment on any aspect of this information collection, including: (1) Whether the proposed collection is necessary for FMCSA to perform its functions, (2) the accuracy of the estimated burden, (3) ways for the FMCSA to enhance the quality, usefulness, and clarity of the collected information, and (4) ways that the burden could be minimized without reducing the quality of the collected information. Comments received in response to this notice are sent to the OMB Desk Officer to address. Issued under the authority delegated in 49 CFR 1.87 on: June 30, 2016. G. Kelly Regal, Associate Administrator, Office of Research and Information Technology. [FR Doc. 2016-16199 Filed 7-7-16; 8:45 am] BILLING CODE 4910-EX-P
![Federal Register / Vol. 81, No. 131 / Friday, July 8, 2016 / Notices 44675
evaluation according to the same the State and any drivers who receive a VI. Conclusion
procedures and testing criteria used by State-issued SPE certificate: The Agency does not intend its
FMCSA. If the driver passes the skill • Virginia must establish and decision to pressure other States to take
evaluation, the State issues the SPE maintain its own SPE program that is action to implement State-run SPE
certificate. Virginia maintains records of essentially identical to the current programs. Virginia is the first State to
applications, testing, and certificates FMCSA program. submit an application on behalf of its
issued, which are available, as required, • The State must maintain an drivers to provide an alternative to the
for periodic review by FMCSA. On application process modeled on the Federal SPE process. Other States are
behalf of CMV drivers licensed in the FMCSA process and submit information welcome to make similar applications if
Commonwealth of Virginia, the State concerning the application process to they believe it is appropriate to do so
requested renewal of the exemption FMCSA’s Medical Programs Division for and they have the resources to meet
from 49 CFR 391.49 concerning review, as required. terms and conditions comparable to
FMCSA’s SPE certificate process for • State personnel who conduct the those provided in this exemption.
drivers who have experienced an skill test must complete SPE training
impairment or loss of a limb. Issued on: June 29, 2016.
identical to that of FMCSA personnel
T.F. Scott Darling, III,
II. Basis for Renewing Exemption currently administering the Federal SPE
program. Acting Administrator.
The Agency’s decision regarding this • The skill evaluation and scoring for [FR Doc. 2016–16197 Filed 7–7–16; 8:45 am]
exemption is based on the fact that the SPE must be done using the same BILLING CODE 4910–EX–P
Virginia’s SPE program is essentially procedures and testing criteria used by
identical to the current FMCSA FMCSA.
program. Virginia continues to adhere to • Virginia must maintain records of DEPARTMENT OF TRANSPORTATION
the application process modeled on the applications, testing, and certificates
FMCSA process. State personnel who Federal Motor Carrier Safety
issued for periodic review by FMCSA. Administration
conduct the skill evaluation complete • Virginia must submit a monthly
the same training as FMCSA personnel report to FMCSA listing the names and [Docket No. FMCSA–2015–0180]
conducting the test and follow the same license number of each driver tested by
procedures and testing criteria used by the State and the result of the test (pass Agency Information Collection
FMCSA. FMCSA has conducted ongoing or fail). Activities; New Information Collection
monitoring and onsite SPE program • Each driver who receives a State- Request: 391.41 CMV Driver
reviews and Virginia continues to issued SPE must carry a copy of the Medication Form
maintain records of applications, certificate when driving for presentation AGENCY: Federal Motor Carrier Safety
testing, and certificates issued for to authorized Federal, State, or local law Administration (FMCSA), DOT.
periodic review by FMCSA. At the time enforcement officials. ACTION: Notice and request for
Virginia DMV submitted its request for
IV. Preemption of State Laws and comments.
exemption renewal to the Agency, it had
issued 13 new and 25 renewal SPE Regulations SUMMARY: In accordance with the
certificates. Based upon FMCSA’s An exemption granted under the Paperwork Reduction Act of 1995,
analyses of the applications and the authority of 49 U.S.C. 31315(b) FMCSA announces its plan to submit
program as a whole, FMCSA has preempts State laws and regulations that the Information Collection Request (ICR)
determined that no safety vulnerabilities conflict with or are inconsistent with described below to the Office of
are associated with Virginia’s renewal the exemption. The decision to grant Management and Budget (OMB) for its
request. The renewal of the exemption Virginia’s request amounts to automatic review and approval and invites public
is granted. Federal ratification of the State issued comment on the approval of a new
Consequently, FMCSA has concluded SPE certificate and therefore prohibits Information Collection (IC) titled,
that renewing the exemption allows the other jurisdictions from requiring a 391.41 CMV Driver Medication Form.
Virginia SPE program to achieve the separate FMCSA-issued SPE. The State- Comments received in response to this
level of safety required by 49 U.S.C. issued certificate must be treated as if it notice are sent to the OMB Desk Officer
31315. had been issued by FMCSA. Virginia- to address. This IC is voluntary and may
If a Virginia-licensed driver would licensed drivers who receive the State- be utilized by medical examiners (MEs)
prefer not to opt for the streamlined SPE issued SPE are allowed to operate CMVs responsible for issuing Medical
process, the driver may still apply for an in interstate commerce anywhere in the Examiner’s Certificates (MECs) to
FMCSA-issued SPE. However, FMCSA United States. commercial motor vehicle (CMV)
may still exercise its discretion and call drivers. MEs that choose to use this IC
upon Virginia DMV to provide V. Request for Comments will do so in an effort to communicate
assistance in conducting the road Interested parties possessing with treating healthcare professionals
evaluation needed to complete an SPE information that would otherwise show who are responsible for prescribing
application, depending on the volume that granting this exemption is not certain medications, so that the ME fully
of applications. achieving the statutory level of safety understands the reasons the
should immediately notify FMCSA. The medications have been prescribed. The
asabaliauskas on DSK3SPTVN1PROD with NOTICES
III. Terms and Conditions
Agency will evaluate any adverse information obtained by the ME when
The FMCSA grants the renewal of the evidence summited, and if safety is utilizing this IC will assist the ME in
exemption to allow the Virginia DMV to being compromised or if continuation of determining if the driver is medically
conduct SPE’s on drivers who have exemption would not be consistent with certified according to the physical
experienced an impairment or loss of a the goals and objectives of 49 U.S.C. qualifications standards outlined in 49
limb and are licensed in the 31136(e) and 31315, FMCSA will take CFR 391.41 and to ensure that there are
Commonwealth of Virginia. The immediate steps to revoked the Virginia no disqualifying medical conditions or
following terms and conditions apply to DMV exemption. underlying medical conditions and
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![44676 Federal Register / Vol. 81, No. 131 / Friday, July 8, 2016 / Notices
prescribed medications that could Information used to determine and regulation, and on U.S. Department of
adversely affect their safe driving ability certify driver medical fitness must be Transportation drug and alcohol testing
or cause incapacitation constituting a collected in order for our highways to be protocols. Subsequently, the committees
risk to the public. safe. FMCSA is the Federal government engaged in a discussion on the issue as
DATES: Please send your comments to agency authorized to require the it applies to CMV drivers. On September
this notice by August 8, 2016. OMB collection of this information and the 11, 2013, the MRB discussed the issue
must receive your comments by this authorizing regulations are located at 49 in greater detail as its task to present a
date to act quickly on the ICR. CFR parts 390–399. FMCSA is required report to the Agency relating to CMV
ADDRESSES: All comments should
by statute to establish standards for the drivers and Schedule II medication use
reference Federal Docket Management physical qualifications of drivers who and to develop a form for MEs on the
System (FDMS) Docket Number operate CMVs in interstate commerce National Registry of Certified Medical
FMCSA–2015–0180. Interested persons for non-excepted industries [49 U.S.C. Examiners (National Registry) to send to
are invited to submit written comments 31136(a)(3) and 31502(b)]. The treating clinicians of CMV drivers to
on the proposed IC to the Office of regulations discussing this collection expound on the use of these
Information and Regulatory Affairs, are outlined in the Federal Motor medications by driver applicants. On
Office of Management and Budget. Carrier Safety Regulations (FMCSRs) at October 22, 2013, the MRB submitted
49 CFR part 390–399. FMCSRs at 49 their recommendations to FMCSA. A
Comments should be addressed to the
CFR 391.41 set forth the physical MEP convened to provide an updated
attention of the Desk Officer,
qualification standards that interstate opinion on Schedule II Opioids and
Department of Transportation/Federal
CMV drivers who are subject to part 391 Stimulants & CMV Crash Risk and
Motor Carrier Safety Administration,
must meet, with the exception of Driver Performance. The FMCSA
and sent via electronic mail to oira_
commercial driver’s license/commercial revised the task of the MRB instructing
submission@omb.eop.gov, faxed to (202)
learner’s permit (CDL/CLP) drivers them to review an updated evidence
395–6974, or mailed to the Office of
transporting migrant workers (who must report and the MEP opinion that was
Information and Regulatory Affairs,
meet the physical qualification furnished subsequent to its
Office of Management and Budget,
standards set forth in 49 CFR 398.3). deliberations on Schedule II Opioids
Docket Library, Room 10102, 725 17th The FMCSRs covering driver physical
Street NW., Washington, DC 20503. and Stimulants & CMV Crash Risk and
qualification records are found at 49 Driver Performance: Evidence Report
FOR FURTHER INFORMATION CONTACT: CFR 391.43, which specify that a and Systematic Review. FMCSA
Christine A. Hydock, Chief, Medical medical examination be performed on directed the MRB to consider this
Programs Division, (202) 366–4001, CMV drivers subject to part 391 who report’s findings and confer with the
fmcsamedical@dot.gov, U.S. Department operate in interstate commerce. The MCSAC on this topic during a joint
of Transportation, Federal Motor Carrier results of the examination shall be meeting in October 2014. The MRB met
Safety Administration, 1200 New Jersey recorded in accordance with the in public meetings on July 29–30, 2014,
Avenue SE., Room W64–113, requirements set forth in that section. and developed Schedule II medication
Washington, DC 20590–0001. 49 CFR 391.41(b)(12) states that a recommendations. The MRB presented
SUPPLEMENTARY INFORMATION: person is physically qualified to drive a these recommendations to the MCSAC
Title: 391.41 CMV Driver Medication CMV if that person does not use any in a joint public meeting on October 27,
Form. drug or substance identified in 21 CFR 2014, where they were deliberated by
OMB Control Number: 2126–00XX. 1308.11 Schedule I, an amphetamine, a
both committees. As a result, FMCSA’s
Type of Request: New collection. narcotic, or other habit-forming drug
Respondents: Prescribing healthcare MRB and MCSAC provided joint
and does not use any non-Schedule I
professionals. recommendations related to the use of
drug or substance that is identified in
Estimated Number of Respondents: Schedule II medications by CMV
the other Schedules in 21 CFR part 1308
1,082,200 (total number of prescribing drivers. Because there is moderate
except when the use is prescribed by a
healthcare providers in the U.S.). evidence to support the contention that
licensed medical practitioner, as
Estimated Time per Response: 8 the licit use of opioids increases the risk
defined in § 382.107, who is familiar
minutes. of motor vehicle crashes and impacts
with the driver’s medical history and
Expiration Date: N/A. This is a new indirect measures of driver performance
has advised the driver that the
ICR. substance will not adversely affect the negatively, included was the
Frequency of Response: Voluntary. driver’s ability to safely operate a CMV. recommendation that FMCSA develop a
Estimated Total Annual Burden: In 2006, FMCSA’s Medical Review standardized medication questionnaire
144,293 hours [1,082,200 responses × 8 Board (MRB) deliberated on the topic of to assist the certified ME when
minutes to complete response/60 the use of Schedule II medications. The reviewing prescription medications that
minutes = 144,293]. MRB considered information provided have been disclosed during the history
Background: The primary mission of in a 2006 FMCSA sponsored Evidence and physical examination for CMV
FMCSA is to reduce crashes, injuries, Report and a subsequent Medical Expert driver certification. The two advisory
and fatalities involving large trucks and Panel (MEP) to examine the relationship groups recommended to FMCSA that
buses. The Secretary of Transportation between the licit use of Schedule II the standardized CMV driver
has delegated to FMCSA its medications and the risk for a motor medication questionnaire be voluntary
responsibility under 49 U.S.C. 31136 vehicle crash. In 2013, FMCSA tasked and include the following information
asabaliauskas on DSK3SPTVN1PROD with NOTICES
and 31502 to prescribe regulations that the MRB with updating the opinions and questions:
ensure that CMVs are operated safely. and recommendations of the 2006 1. Questionnaire should be titled
As part of this mission, the Agency’s Evidence Report and MEP. 391.41 CMV Driver Medication
Medical Programs Division works to On September 10, 2013, the MRB and Questionnaire.
ensure that CMV drivers engaged in Motor Carrier Safety Advisory 2. Questionnaire should request the
interstate commerce operations are Committee (MCSAC) met jointly to hear following information:
physically qualified and able to safely presentations on the licit use of a. Identifying name and date of birth
perform their work. Schedule II medications and their of the CMV driver.
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![44680 Federal Register / Vol. 81, No. 131 / Friday, July 8, 2016 / Notices
on to explain that because the current FMCSA Response FOR FURTHER INFORMATION CONTACT:
exception remains in the FMCSRs (40 FMCSA responded to the question of Christine A. Hydock, Chief, Medical
CFR 391.41(b)(12)(ii)), they recommend who is qualified to be a ME in the Programs Division, (202) 366–4001,
guidelines be provided to MEs regarding National Registry of Certified Medical fmcsamedical@dot.gov, FMCSA,
the use of narcotics. Examiners final rule (77 FR 24106, April Department of Transportation, 1200
20, 2012), and is not considering a New Jersey Avenue SE., Room W64–
FMCSA Response 113, Washington, DC 20590–0001.
change to the regulation in 49 CFR
Although optional use of the 391.41 390.103, Eligibility requirements for Office hours are 8:30 a.m. to 5 p.m., e.t.,
medical examiner certification in this Monday through Friday, except Federal
CMV Driver Medication Form was
notice. Therefore, these comments are holidays. If you have questions
introduced as a result of the MRB and
outside the scope of this notice. regarding viewing or submitting
MCSAC recommendations related to the
Public Comments Invited: FMCSA material to the docket, contact Docket
use of Schedule II medications by CMV
requests that you comment on any Services, telephone (202) 366–9826.
drivers, the recommendation was for
aspect of this information collection, SUPPLEMENTARY INFORMATION:
FMCSA to develop a standardized form
to assist the certified ME when including: (1) Whether the proposed I. Electronic Access
reviewing prescription medications that collection is necessary for FMCSA to
perform its functions, (2) the accuracy of You may see all the comments online
have been disclosed during the history through the Federal Document
and physical examination for CMV the estimated burden, (3) ways for the
FMCSA to enhance the quality, Management System (FDMS) at http://
driver certification. Therefore, the form www.regulations.gov.
was not designed to specifically address usefulness, and clarity of the collected
Docket: For access to the docket to
Schedule II medications. The form was information, and (4) ways that the
read background documents or
designed to address any prescription burden could be minimized without
comments, go to http://
medications that a driver is taking that reducing the quality of the collected
www.regulations.gov and/or Room
may impair his/her ability to safety information. Comments received in
W12–140 on the ground level of the
operate a CMV. FMCSA is not response to this notice are sent to the
West Building, 1200 New Jersey Avenue
considering a change in the regulations OMB Desk Officer to address.
SE., Washington, DC, between 9 a.m.
or guidance that would prohibit or Issued under the authority delegated in 49 and 5 p.m., Monday through Friday,
advise the ME regarding Schedule II CFR 1.87 on: June 30, 2016. except Federal holidays.
medications at this time. Therefore, G. Kelly Regal, Privacy Act: In accordance with 5
these comments are outside of the scope Associate Administrator, Office of Research U.S.C. 553(c), DOT solicits comments
of this notice. and Information Technology. from the public to better inform its
[FR Doc. 2016–16199 Filed 7–7–16; 8:45 am] rulemaking process. DOT posts these
2. Qualifications of the ME BILLING CODE 4910–EX–P comments, without edit, including any
personal information the commenter
Several commenters stated that a ME
provides, to www.regulations.gov, as
might not be qualified to make a
DEPARTMENT OF TRANSPORTATION described in the system of records
medical qualification decision if the
notice (DOT/ALL–14 FDMS), which can
driver uses Schedule II medications, Federal Motor Carrier Safety be reviewed at www.dot.gov/privacy.
because of a lack of training in Administration
pharmacology. II. Background
[Docket No. FMCSA–2015–0345]
OOIDA stated that the personal On December 21, 2015, FMCSA
physician is best equipped to review a Qualification of Drivers; Exemption published a notice of receipt of
driver’s medical history and suggested Applications; Vision exemption applications from certain
that a personal physician be the one to individuals, and requested comments
review the driver’s medical history and AGENCY: Federal Motor Carrier Safety from the public (80 FR 79414). That
make the decision whether a medication Administration (FMCSA), DOT. notice listed 19 applicants’ case
will adversely affect the driver’s ability ACTION: Notice of final disposition. histories. The 19 individuals applied for
to safely operate a CMV. exemptions from the vision requirement
SUMMARY: FMCSA announces its in 49 CFR 391.41(b)(10), for drivers who
Dr. Hegmann advocated for decision to exempt 19 individuals from operate CMVs in interstate commerce.
implementation of the MRB’s the vision requirement in the Federal Under 49 U.S.C. 31136(e) and 31315,
recommendation that ME eligibility be Motor Carrier Safety Regulations FMCSA may grant an exemption for a 2-
limited to those medically trained (i.e., (FMCSRs). They are unable to meet the year period if it finds ‘‘such exemption
MD, DO, PA and NPs). He stated that vision requirement in one eye for would likely achieve a level of safety
the concept that these medically various reasons. The exemptions will that is equivalent to or greater than the
untrained examiners can make an enable these individuals to operate level that would be achieved absent
informed judgment about driver commercial motor vehicles (CMVs) in such exemption.’’ The statute also
impairment from narcotics, assess how interstate commerce without meeting allows the Agency to renew exemptions
opioids may interact with other the prescribed vision requirement in at the end of the 2-year period.
medications, provide guidance to truck one eye. The Agency has concluded that
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Accordingly, FMCSA has evaluated the
drivers, and judge fitness to drive is granting these exemptions will provide 19 applications on their merits and
factually false. Dr. Hegmann feels that a level of safety that is equivalent to or made a determination to grant
FMCSA does not rely on greater than the level of safety exemptions to each of them.
recommendations of the MRB and will maintained without the exemptions for
selectively use whichever source of these CMV drivers. III. Vision and Driving Experience of
guidance is least restrictive which is DATES: The exemptions were granted the Applicants
directly contrary to the central, stated January 21, 2016. The exemptions The vision requirement in the
purpose of the Agency. expire on January 21, 2018. FMCSRs provides:
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Document Created: 2016-07-08 00:17:27
Document Modified: 2016-07-08 00:17:27
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice and request for comments. | |
| Dates | Please send your comments to this notice by August 8, 2016. OMB must receive your comments by this date to act quickly on the ICR. | |
| Contact | Christine A. Hydock, Chief, Medical Programs Division, (202) 366-4001, [email protected], U.S. Department of Transportation, Federal Motor Carrier Safety Administration, 1200 New Jersey Avenue SE., Room W64-113, Washington, DC 20590-0001. | |
| FR Citation | 81 FR 44675 |
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