PRA-2126-0006 SS diabetes final rule updated 091918

Department of Transportation

Office of the Chief Information Officer

Supporting Statement

Medical Qualification Requirements

INTRODUCTION

This is to request the Office of Management and Budget’s (OMB) approval for the revision of the Information Collection Request (ICR) titled Medical Qualification Requirements, covered by OMB Control Number 2126-0006, which is currently due to expire on September 30, 2019. This revision is due to the Agency’s development of a final rule titled Qualifications of Drivers; Diabetes Standard (83 FR 47486, September 19, 2018) to revise its regulations to eliminate the blanket prohibition against insulin-dependent diabetic individuals’ operation of commercial motor vehicles (CMV) in interstate commerce. The purpose of the Qualifications of Drivers; Diabetes Standard final rule is to permit drivers with a stable insulin regimen and properly controlled insulin-treated diabetes mellitus (ITDM) to operate CMVs in interstate commerce. Currently, drivers with ITDM are prohibited from driving CMVs in interstate commerce unless they obtain an exemption from the Federal diabetes standard set forth in 49 CFR § 391.41(b)(3). The final rule enables an ITDM individual to obtain a Medical Examiner’s Certificate (MEC) from a certified medical examiner (ME) for up to a maximum of 12 months if the treating clinician¹ (TC), the healthcare professional who manages, and prescribes insulin for, the treatment of the individual’s diabetes, certifies to the certified ME that the individual maintains a stable insulin regimen and proper control of his or her ITDM, and the certified ME determines that the individual meets FMCSA’s physical qualification standards. The final rule eliminates the need for the Diabetes Exemption Program and, therefore, the related information collection. The final rule adds a new information collection requirement for the TC to complete a form, titled Insulin-Treated Diabetes Mellitus Assessment Form, MCSA-5870, that is provided to the certified ME. The addition of this requirement will add 654 annual burden hours and $60,417 annual salary costs. However, eliminating the Diabetes Exemption Program information collection results in 2,599 less annual burden hours and $77,749 less annual salary costs. Therefore, the diabetes standard as provided in the final rule will provide a total decrease of 1,945 in annual burden hours and $17,332 in salary costs.

Part A. Justification

1. CIRCUMSTANCES THAT MAKE THE COLLECTION OF INFORMATION NECESSARY

The Federal Motor Carrier Safety Administration’s (FMCSA) regulations require that CMV operators meet certain physical qualification standards to ensure these individuals are physically capable of operating large trucks and buses safely on the Nation’s public roadways. CMVs (trucks and buses) are longer, heavier, and more difficult to maneuver than automobiles. Not only does it take a skilled driver to operate them safely, it takes a physically and mentally fit driver to do so as well. 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. 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 parts 390-399.

IC-1: Physical Qualification Standards

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. The current provisions of 49 CFR §§ 391.51 and 398.3 require that a motor carrier retain the MEC in the driver’s qualification (DQ) file for 3 years. The certificate affirms that the driver is physically qualified to drive a CMV in interstate commerce.

IC-2: Resolution of Medical Conflict

If two MEs disagree about the medical certification of a driver, the requirements set forth in 49 CFR § 391.47 mandate that the applicant (driver or motor carrier) submit a copy of a report including results of all medical testing and the opinion of an impartial medical specialist in the field in which the medical conflict arose. The specialist should be one agreed to by the motor carrier and the driver. The purpose of the specialist is to provide a medical opinion, regarding the driver’s qualification status that can be mutually agreed upon by the driver and the motor carrier. If there is disagreement regarding the medical specialist’s opinion by either party, 49 CFR § 391.47 provides the procedure for submitting an application to FMCSA for resolution of the medical conflict.

IC-3: Medical Exemptions

FMCSA may, on a case by case basis, grant a medical exemption from a physical qualification standard set forth in 49 CFR § 391.41, if the Agency determines the exemption is in the interest of the public and would likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved by complying with the regulation. Without an exemption, individuals who do not meet the requirements in 49 CFR § 391.41 would not be qualified to operate a CMV in interstate commerce. The Agency currently has two established exemption programs which are the diabetes exemption program and the vision exemption program. These two exemption programs outline specific criteria that applicants must meet prior to approval of an exemption from the vision and diabetes standards set forth in 49 CFR § 391.41. Although not established programs, due to numerous requests, in 2013, the Agency began granting exemptions from the Agency’s physical qualifications standard concerning the hearing standard for interstate drivers and the regulatory requirement that interstate CMV drivers have ‘‘no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause loss of consciousness or any loss of ability to control a CMV.’’ 49 CFR 381.310 establishes the procedures that persons must follow to request exemptions from the FMCSRs.

IC-3a: Diabetes Exemptions

On September 3, 2003, FMCSA announced in a Final Notice of Disposition titled, Qualification of Drivers; Exemption Applications; Diabetes, (68 FR 52441), that it will issue exemptions to CMV drivers with insulin-treated diabetes mellitus (ITDM) from the Federal diabetes standard set forth in 49 CFR § 391.41(b)(3). An exemption is granted only to those applicants who meet specific conditions and comply with all the requirements of the exemption. Exemptions are valid for up to 2 years and require renewal after the end of that period.

On November 8, 2005, FMCSA announced in a Notice of Revised Final Disposition titled, Eligibility Criteria and Applications; Diabetes, (70 FR 67777), its decision to revise the terms and conditions of its previous decision to issue exemptions to CMV drivers with ITDM from the Federal diabetes standard in the FMCSRs. This action was in response to section 4129 of the Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users (SAFETEA-LU), Public Law 109-59, 119 Stat. 1144 (August 10, 2005) (at Attachment H), which required FMCSA within 90 days of the statute’s enactment to modify its exemption program to allow individuals who use insulin to treat diabetes mellitus to operate CMVs in interstate commerce. While these individuals no longer had to demonstrate safe driving experience operating a CMV while using insulin, other requirements were implemented by section 4129. Under the current Diabetes Exemption Program, each applicant is required to provide the following: certain vital statistics, an endocrinologist evaluation, an evaluation by an ophthalmologist or optometrist, a current Medical Examination Report (MER) from a ME, a readable photocopy of a current driver’s license and a current motor vehicle record (MVR). The Agency must ensure that granting the exemption will likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved by complying with the regulations.

IC-3b: Vision Exemptions

Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may exempt a CMV driver from application of the vision standards if it finds “such exemption would likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved absent such exemption.” In July 1992, the Agency first published the criteria for the Vision Waiver Program, which listed the conditions and reporting standards that CMV drivers approved for participation would need to meet (Qualification of Drivers; Vision Waivers, 57 FR 31458, July 16, 1992). The current Vision Exemption Program was established in 1998, following the enactment of amendments to the statutes governing exemptions made by § 4007 of the Transportation Equity Act for the 21^st Century (TEA-21), Public Law 105-178, 112 Stat. 107, 401 (June 9, 1998). Applications are now handled in accordance with 49 CFR part 381 subpart C. Individuals may apply for an exemption for up to 2 years from specified provisions of the FMCSRs, including physical qualification standards specified under 49 CFR § 391.41(b) (see 49 CFR 381.300(c)). Vision exemptions are considered under the procedures established in 49 CFR part 381 subpart C, on a case-by-case basis upon application by CMV drivers who do not meet the vision standards of 49 CFR 391.41(b)(10). The Agency provided an example format of the information that can be submitted by an applicant for a vision exemption. The template outlines all information and documents the applicant should include to be considered for an exemption and the criteria for approval.

On December 18, 2013, FMCSA published in a Notice; request for comments titled, Physical Qualification of Drivers; Standards; Changes to Vision Exemption Program Criteria, (78 FR 76590), proposing to change the eligibility requirements for the Agency’s Vision Exemption Program. The Agency has determined that the proposed changes in the eligibility criteria and conditions for the Vision Exemption Program will continue to ensure a level of safety that is equivalent to, or greater than, the level of safety maintained under the existing criteria. However, one of the Agency’s purposes for publishing this notice was to acquire feedback from all interested persons to ensure that the Agency has all of the information necessary to make a sound decision when making changes to the Vision Exemption Program criteria.

IC-3c: Hearing Exemptions

On February 1, 2013, FMCSA announced in a Notice of Final Disposition titled, Qualification of Drivers; Application for Exemptions; National Association of the Deaf, (78 FR 7479), its decision to grant requests from 40 individuals for exemptions from the Agency’s physical qualifications standard concerning hearing for interstate CMV drivers. The regulation and the associated advisory criteria published in the Code of Federal Regulations as the ‘‘Instructions for Performing and Recording Physical Examinations’’ have resulted in numerous drivers being prohibited from operating CMVs in interstate commerce based on the fact that they are unable to meet the hearing requirements. After notice and opportunity for public comment, the Agency concluded that granting exemptions for these CMV drivers will provide a level of safety that is equivalent to or greater than the level of safety maintained without the exemptions. FMCSA granted exemptions that allow these 40 individuals to operate CMVs in interstate commerce for a 2-year period. Since the February 1, 2013, notice, the Agency has published additional notices granting requests from 450 individuals for exemptions from the Agency’s physical qualifications standard concerning hearing for interstate CMV drivers. As requests for hearing exemptions are received, the Agency will continue to follow the same process in determining whether or not granting exemptions for these CMV drivers will provide a level of safety that is equivalent to or greater than the level of safety maintained without the exemptions. The exemptions preempt State laws and regulations and may be renewed.

IC-3d: Seizure Exemptions

On January 15, 2013, FMCSA announced in a Notice of Final Disposition titled, Qualification of Drivers; Exemption Applications; Epilepsy and Seizure Disorders, (78 FR 3069), its decision to grant requests from 22 individuals for exemptions from the regulatory requirement that interstate CMV drivers have ‘‘no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause loss of consciousness or any loss of ability to control a CMV.’’ The regulation and the associated advisory criteria published in the Code of Federal Regulations as the ‘‘Instructions for Performing and Recording Physical Examinations’’ have resulted in numerous drivers being prohibited from operating CMVs in interstate commerce based on the fact that they have had one or more seizures and are taking anti- seizure medication, rather than an individual analysis of their circumstances by a qualified ME. The Agency concluded that granting exemptions for these CMV drivers will provide a level of safety that is equivalent to or greater than the level of safety maintained without the exemptions. FMCSA granted exemptions that allow these 22 individuals to operate CMVs in interstate commerce for a 2-year period. Since the January 15, 2013, notice, the Agency has published additional notices granting requests from 324 individuals for exemptions from the regulatory requirement that interstate CMV drivers have ‘‘no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause loss of consciousness or any loss of ability to control a CMV.’’ As requests for seizure exemptions are received, the Agency will continue to follow the same process in determining whether or not granting exemptions for these CMV drivers will provide a level of safety that is equivalent to or greater than the level of safety maintained without the exemptions. The exemptions preempt State laws and regulations and may be renewed.

IC-4: Skill Performance Evaluation (SPE) Certificate Program (formerly the Limb Waiver Program)

Individuals who are not physically qualified to drive under 49 CFR § 391.41 due to a limb impairment must file an application for and be issued a SPE certificate (formerly a limb waiver) in order to be physically qualified. This is specified in 49 CFR § 391.49. The application must be submitted to the appropriate FMCSA Service Center in which the driver has legal residence. If the application is submitted jointly by the driver who seeks the SPE certificate and by the motor carrier who will employ the driver applicant, the application must be submitted to the FMCSA Service Center closest to where the motor carrier’s principal place of business is located. If the SPE certificate is granted by FMCSA, the motor carrier must retain a copy of it in the DQ file for 3 years after the driver’s employment is terminated. The SPE certificate is valid for 2 years (unless otherwise specified) and may be renewed.

IC-5: National Registry of Certified Medical Examiners Final Rule

On April 20, 2012, FMCSA revised this Information Collection Request (ICR) due to a final rule titled, National Registry of Certified Medical Examiners (77 FR 24104). The final rule requires MEs that conduct medical examinations for interstate CMV drivers to complete training concerning FMCSA physical qualification standards, pass a certification test and maintain competence through periodic retraining and retesting. ME candidates submit demographic and eligibility data in order to register on the National Registry website to begin the certification process. ME candidates must pass a certification test administered by a FMCSA-approved testing organization that verifies eligibility and forwards test results to the National Registry. The final rule also requires MEs to transmit, to the National Registry, the results of each completed CMV driver medical examination on a monthly basis and provide copies of MER Forms and MECs to authorized representatives or agents of FMCSA or authorized State or local enforcement agency representatives upon request. The final rule requires employers to verify the national registry number of the ME for each driver examined by a certified ME listed on the National Registry and place a note regarding verification in the DQ file.

IC-6: Medical Examiner's Certification Integration Final Rule

On April 23, 2015, FMCSA revised this ICR due to a final rule titled, Medical Examiner's Certification Integration, (80 FR 22790), a follow-on rule to the National Registry final rule and the Medical Certification Requirements as Part of the CDL final rule. The purpose of the principal requirements established in the Medical Examiner’s Certification Integration final rule is to modify the requirements adopted in the two previous rules. The Medical Examiner’s Certification Integration final rule requires:

1. Certified MEs performing medical examinations on CMV drivers to use a newly developed MER Form, MCSA-5875, in place of the current MER Form.

2. Certified MEs to use Form MCSA-5876 for the MEC.

3. Certified MEs to report results of all completed CMV drivers’ medical examinations (including the results of examinations where the driver was found not to be qualified) to FMCSA by midnight (local time) of the next calendar day following the examination. The reporting of results includes all CMV drivers (CDL/CLP and non-CDL/CLP) who are required to be medically certified to operate in interstate commerce and allows, but does not require, MEs to transmit any information about examinations performed in accordance with the FMCSRs with any applicable State variances, which will be valid for intrastate operations only.

4. For applicants/holders of CLPs/CDLs (interstate and intrastate), FMCSA to electronically transmit driver identification, examination results, and restriction information, from the National Registry system, to the State Driver’s Licensing Agencies (SDLAs) for examinations performed in accordance with the FMCSRs (49 CFR §§ 391.41 – 391.49), as well as information about any examinations reported by MEs that are performed in accordance with applicable State variances. This includes those that have been voided by FMCSA because it finds that an ME has certified a driver who does not meet the physical certification standards. This eliminates the requirement for motor carriers to verify that CDL/CLP drivers (only) were examined by a certified ME listed on the National Registry.

5. FMCSA to electronically transmit medical variance information (exemptions, skills performance evaluation certificates and grandfathered exemptions) for all CMV drivers to the SDLAs.

Electronic transmission of this information will allow authorized State and Federal enforcement officials to be able to view the most current and accurate information regarding the medical status of the driver.

IC-7: Qualifications of Drivers: Diabetes Standard

As described in the introduction, this revision to the information collection request is primarily due to the Agency’s development of a final rule titled Qualifications of Drivers; Diabetes Standard (83 FR 47486, September 19, 2018).

The purpose of the Qualifications of Drivers; Diabetes Standard final rule is to permit drivers with a stable insulin regimen and properly controlled ITDM to operate CMVs in interstate commerce. Currently, drivers with ITDM are prohibited from driving CMVs in interstate commerce unless they obtain an exemption from the Federal diabetes standard set forth in 49 CFR § 391.41(b)(3). The final rule enables an ITDM individual to obtain a MEC from a certified ME for up to a maximum of 12 months if the TC, the healthcare professional who manages, and prescribes insulin for, the treatment of the individual’s diabetes, certifies to the certified ME that the individual maintains a stable insulin regimen and proper control of his or her diabetes, and the certified ME determines that the individual meets FMCSA’s physical qualification standards. Certified MEs would be able to certify drivers with ITDM for up to 12 months provided:

1. The TC provides information to the certified ME via the Insulin-Treated Diabetes Mellitus Assessment Form, MCSA-5870, on which the TC certifies that the individual maintains a stable insulin regimen and proper control of his or her diabetes.

2. The certified ME receives the Insulin-Treated Diabetes Mellitus Assessment Form, MCSA-5870, no later than 45 days after it has been completed and signed by the individual’s TC for each physical qualification examination.

3. The certified ME performs a physical qualification examination, considers the information provided by the TC, and determines that the individual meets FMCSA’s physical qualification standards in 49 C.F.R. §§ 391.41(b) and 391.46 and can safely operate a CMV.

This ICR supports the U.S. Department of Transportation (DOT) Strategic Goal of Safety by ensuring that CMV drivers are medically qualified to operate trucks and buses on our nation’s highways.

2. HOW, BY WHOM, AND FOR WHAT PURPOSE IS THE INFORMATION USED

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.

CMV Driver Population

Third-party requirements of this ICR are being considered. This ICR reflects both interstate drivers subject to the FMCSRs and intrastate drivers subject to compatible State regulations² and has been updated based on current statistics. In addition, a small number of drivers transporting 8 or less migrant workers more than 75 miles in interstate commerce that are still subject to the medical certification requirements of 49 § CFR 398 are included in this population. The National Registry of Certified Medical Examiners final rule requires certified MEs to report the results of each CMV drivers’ medical examination completed to FMCSA. Although Federal regulations do not require States to comply with the medical requirements in the FMCSRs, most States do mirror the Federal requirements; therefore, we assume this burden is consistent with other FMCSA ICs. If intrastate CMV drivers are subject to compatible State regulations, the Agency anticipates that it is likely that these drivers will use certified MEs on the National Registry for their medical qualification examinations. FMCSA recognizes that using the entire intrastate CMV driver population may be a high estimation, but uses this conservatively high estimation because the Agency does not have an exact number and there is nothing to preclude intrastate CMV drivers from being examined by a certified ME listed on the National Registry.

IC-1: Physical Qualification Standards

Information used to determine and certify driver medical fitness must be collected 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. Therefore, MEs must provide specific driver medical examination information for every driver they examine on medical forms required by FMCSA and into the National Registry. Drivers must provide identification and healthy history information on medical forms required by FMCSA. The purpose for providing this information is to enable the ME to determine 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. If this information was not required, the threat to public safety would be immense and unacceptable.

IC-2: Resolution of Medical Conflict

The medical conflict application provision provides a mechanism for drivers and motor carriers to request FMCSA to make a final decision to resolve conflicting medical evaluations when either party does not accept the decision of a medical specialist. FMCSA uses the information collected from the applicant, including medical information, to determine if the driver should or should not be qualified. Without this provision and its incumbent driver medical information collection requirements, an unqualified person may be permitted to drive and qualified persons may be prevented from driving.

IC-3 and IC-4: Medical Exemptions and SPEs

FMCSA may, on a case by case basis, grant a medical exemption from a physical qualification standard set forth in 49 CFR § 391.41, if the Agency determines the exemption is in the interest of the public and would likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved by complying with the regulation. Information collected under 49 CFR § 381.310 is necessary for FMCSA to make this determination. Individuals with limb impairments are permitted to operate a CMV, but only when they are otherwise qualified and are granted a SPE certificate by FMCSA. FMCSA must collect medical information about the driver’s medical condition in order to determine eligibility to receive a SPE certificate.

IC-5: National Registry of Certified Medical Examiners

Motor carriers are permitted to employ only drivers who are medically certified to drive. Applicants with certain medical conditions are not qualified to drive. MEs who examine and certify interstate CMV drivers must effectively determine whether drivers are medically qualified to operate a CMV. The National Registry final rule requires MEs to provide contact and employment information when registering to become a certified ME. This data is used to provide the public with contact information for those medical professionals who are certified by FMCSA to conduct interstate CMV driver medical examinations.

MEs that conduct medical examinations for interstate CMV drivers are required to complete training concerning FMCSA physical qualification standards, pass a certification test and maintain competence through periodic retraining every 5 years and retesting every 10 years. FMCSA records the completion of refresher training in the ME’s National Registry account. The re-certification test is administered by an FMCSA-approved test center that transmits the test results to the National Registry. FMCSA uses test results information to determine that the ME has passed the test and to track participant test-taking trends as well as provide applicants for ME certification with test results and follow-up information.

In order to determine ME compliance with FMCSA medical standards and guidelines in performing CMV driver medical examinations, the National Registry requires MEs to electronically transmit the results of each CMV driver medical examination they complete on a monthly basis to the National Registry, to record their national registry number on each MEC they issue under 49 CFR § 391.43(g)(2), and to provide copies of MER Forms and MECs to authorized representatives or agents of FMCSA or authorized State or local enforcement agency representatives upon request. Motor carriers are required to verify that each non-CDL driver was examined by a certified ME listed on the National Registry and place a note relating to the verification in the DQ file as proof that the motor carrier has met its obligation to require drivers to comply with the regulations that apply to the driver (49 U.S.C. 31135(a) and
49 CFR § 390.11).

IC-6: Medical Examiner’s Certification Integration

As a follow-on rule to the National Registry, information collection requirements for the implementation of the Medical Examiner’s Certification Integration final rule affect medical examiners and their administrative assistants, drivers, and motor carriers.

The final rule requires:

1. Certified MEs performing medical examinations on CMV drivers to use a newly developed MER Form, MCSA-5875, in place of the current MER Form. The MER Form is used by the ME to record the details and results of a CMV driver’s medical examination and will be maintained by the ME. The Agency is required by SAFETEA-LU to conduct periodic reviews of a select number of MEs on the National Registry. The purpose of this review is to ensure driver examinations are being conducted properly and to periodically review a representative sample of the MER Forms associated with the name and numerical identifiers of applicants transmitted for errors, omissions, or other indications of improper certification. Therefore, the ME will be required to provide a copy of the MER Form to authorized representatives or agents of FMCSA or authorized State or local enforcement agency representatives upon request. If the Agency should find it appropriate in conducting any review of the performance of MEs on the National Registry, to obtain copies of the MER Form and supporting medical records for CMV drivers examined, submission to the Agency will be required via the certified ME’s individual password-protected National Registry web account.

2. Certified MEs to use Form MCSA-5876 for the MEC. The purpose of the MEC Form is to document that the driver has been medically examined and certified, in accordance with 49 CFR § 391.43, as physically qualified to operate a CMV in interstate commerce. FMCSA will provide MEC information via the CMV Driver Medical Examination Results Form, MCSA-5850, for CDL/CLP drivers to the SDLA electronically via CDLIS for entry into the appropriate CDL driver record. For physically qualified non-CDL drivers, the MEs will continue to issue a paper MEC, Form MCSA-5876 to the driver. A copy of this form will remain with the ME and will only be provided to authorized representatives or agents of FMCSA or authorized State or local enforcement agency representatives upon request.

3. Certified MEs to report results of each completed CMV drivers’ (interstate and intrastate) medical examination (including the results of examinations where the driver was found not to be qualified) to FMCSA by midnight (local time) of the next calendar day following the examination via the MCSA-5850. The reporting of results includes all CMV drivers (CDL/CLP and non-CDL/CLP) who are required to be medically certified to operate in interstate commerce and allows, but does not require, MEs to transmit any information about examinations performed in accordance with the FMCSRs with any applicable State variances, which will be valid for intrastate operations only.

4. For CLP/CDL applicants/holders, FMCSA to electronically transmit the data including driver identification, examination results, and restriction information, from the National Registry system, to the SDLAs for examinations performed in accordance with the FMCSRs (49 CFR §§ 391.41 – 391.49), as well as information about any examinations reported by MEs that are performed in accordance with applicable State variances for entry into the appropriate CDL driver record where it becomes an electronic version of the MEC. This eliminates the requirement for motor carriers to verify that CDL/CLP drivers (only) were examined by a certified ME listed on the National Registry. This information will be housed in the National Registry and will only be provided to authorized representatives or agents of FMCSA or authorized State or local enforcement agency representatives upon request.

5. FMCSA to electronically transmit medical variance (exemptions, skill performance evaluation certificates, and grandfathered exemptions) information for all CMV drivers to the SDLAs. A medical variance is issued by FMCSA to a driver who would otherwise not meet the physical qualification standards in 49 CFR § 391.41(b). Therefore, the medical variance information originates with FMCSA who electronically transmits the information for all CMV drivers from the National Registry to the appropriate SDLAs whenever FMCSA issues, renews, or rescinds a medical variance. The SDLAs are required to update CDLIS driver records each business day with medical variance information transmitted from FMCSA for CDL/CLP drivers. This allows the most current information about the medical status of CDL/CLP drivers to be made available promptly and accurately. Transmission of this information also allows authorized State and Federal enforcement officials to be able to view the most current and accurate information regarding the medical status of the CDL/CLP driver, all information on the MEC, and the medical variance information to include the issued and expiration dates.

IC-7: Qualifications of Drivers; Diabetes Standard

This is a new information collection based on the Agency’s development of a final rule titled Qualifications of Drivers; Diabetes Standard (83 FR 47486, September 19, 2018). The purpose of the Qualifications of Drivers; Diabetes Standard final rule is to permit drivers with a stable insulin regimen and properly controlled ITDM to operate CMVs in interstate commerce. The final rule enables an ITDM individual to obtain a MEC from a certified ME for up to a maximum of 12 months if the TC, the healthcare professional who manages, and prescribes insulin for, the treatment of the individual’s diabetes, certifies to the certified ME that the individual maintains a stable insulin regimen and proper control of his or her diabetes, and the certified ME determines that the individual meets FMCSA’s physical qualification standards. The information provided by the TC will enable the ME to make a qualification determination based on whether the driver meets all the physical qualification requirements of 49 CFR §§ 391.41(b) and 391.46 to safely operate a CMV.

3. EXTENT OF AUTOMATED INFORMATION COLLECTION

IC-1: Physical Qualification Standards

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. FMCSA does not require MEs to maintain these records electronically. However, there is nothing to preclude a ME from maintaining electronic records of the medical examinations he/she conducts. FMCSA is continuously evaluating new information technology in an attempt to decrease the burden on motor carriers and MEs.

IC-2: Resolution of Medical Conflict

If two MEs disagree about the medical certification of a driver, the requirements set forth in 49 CFR § 391.47 mandate that the applicant (driver or motor carrier) submit a copy of a report including results of all medical testing and the opinion of an impartial medical specialist in the field in which the medical conflict arose. The applicant may, if they choose to do so, submit the information above using fax and/or email.

IC-3: Medical Exemptions

The Agency currently has two established exemption programs that outline specific criteria to be approved for an exemption from the vision and diabetes standards set forth in 49 CFR § 391.41. The application for these programs can be downloaded from the FMCSA website. In addition, both the Diabetes and Vision Exemption Programs maintain a database of application information. Although not established programs, due to numerous requests, in 2013, the Agency began granting exemptions from the Agency’s physical qualifications standard concerning hearing for interstate CMV drivers and the regulatory requirement that interstate CMV drivers have ‘‘no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause loss of consciousness or any loss of ability to control a CMV.’’ The application process for all exemptions currently provides for electronic collection of the application information by FMCSA for those applicants that choose to do so. They are able to fax or scan and email documents to FMCSA.

IC-4: SPE Certificate Program

Individuals with limb impairments are permitted to operate a CMV, but only when they are otherwise qualified and are granted a SPE certificate by FMCSA. The application process currently provides for electronic collection of the application by FMCSA for those applicants that choose to do so. They are able to download the application from the FMCSA website and to fax or scan and email to the appropriate FMCSA Service Center in which the driver has legal residence for processing. If the application is submitted jointly by the driver who seeks the SPE certificate and by the motor carrier who will employ the driver applicant, the application must be submitted to the FMCSA Service Center closest to where the motor carrier’s principal place of business is located, for processing. In addition, each FMCSA Service Center maintains a database of SPE application information.

IC-5: National Registry of Certified Medical Examiners

The National Registry requires ME candidates to submit contact and employment data; test centers to submit test results data; certified MEs to submit CMV driver medical examination results, and when requested, copies of MER forms and MECs electronically via the National Registry website. Testing organizations apply online to become approved to administer the FMCSA ME certification test. They submit contact information and documentation explaining how they will meet FMCSA requirements. In addition, motor carriers are required to verify the national registry number on the MEC and place a note regarding verification in the DQ file. This verification is accomplished by the motor carrier going to the National Registry website and searching the National Registry by entering the national registry number listed on the document being verified.

IC-6: Medical Examiner’s Certification Integration

The purpose of the principal requirements established in the Medical Examiner’s Certification Integration final rule is to modify the requirements adopted in the two previous rules so that the driver identification, examination results, and restriction information for all CMV drivers is electronically transmitted to FMCSA by midnight (local time) of the next calendar day after the examination by a certified ME listed on the National Registry and then the information for CDL/CLP drivers is electronically transmitted to the SDLA for entry into the appropriate driver record within one business day of receipt from FMCSA, eliminating the need for the driver to provide the SDLA with a paper MEC. In addition, FMCSA is required to electronically transmit medical variance (exemptions, skill performance evaluation certificates, and grandfathered exemptions) information for all CMV drivers to the SDLAs, eliminating the requirement for drivers to provide variance information to the SDLA.

IC-7: Qualifications of Drivers; Diabetes Standard

The purpose of the Qualifications of Drivers; Diabetes Standard final rule is to permit drivers with a stable insulin regimen and properly controlled ITDM to operate CMVs in interstate commerce. The final rule enables an ITDM individual to obtain a MEC from a certified ME for up to a maximum of 12 months if the TC, the healthcare professional who manages, and prescribes insulin for, the treatment of the individual’s diabetes, certifies to the certified ME that the individual maintains a stable insulin regimen and proper control of his or her diabetes, and the certified ME determines that the individual meets FMCSA’s physical qualification standards.

FMCSA allows TCs to provide the Insulin-Treated Diabetes Mellitus Assessment Form, MCSA-5870, to the certified MEs, if the TCs choose to do so, using electronic communication such as fax or email. Consistent with 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 25 percent of the forms would be transmitted electronically. It is estimated that approximately 25 percent of exemption and SPE data is transmitted electronically, and 100 percent of the National Registry data is transmitted electronically. As indicated above, exemption and SPE applicants may submit application information electronically. ME candidates submit contact and employment data; test centers submit test results data; certified MEs submit CMV driver medical examination results, and, when requested, copies of MER forms via the National Registry website; and TC’s may submit forms electronically.

4. EFFORTS TO IDENTIFY DUPLICATION

FMCSA is the only Federal agency with the authority to regulate the qualifications of CMV drivers operating in interstate commerce. Therefore, there is no Federal agency duplication. The Administrative Procedure Act allows for public comment which would provide a means to identify any duplication that exists. Comments to the docket on FMCSA rulemaking notices have not revealed any duplication of the information collections discussed in this document.

5. EFFORTS TO MINIMIZE THE BURDEN ON SMALL BUSINESSES

IC-5: National Registry of Certified Medical Examiners

The National Registry does impact motor carriers, MEs, and the firms that employ them, many of them considered small entities. The main impact on the motor carriers is replacing drivers who cannot maintain medical certification with new drivers who are physically qualified. The Regulatory Flexibility Analysis conducted by the Agency revealed that even for sole proprietorships, the direct costs of hiring a new driver would amount to less than 2 percent of annual revenue, not a significant economic impact. The impact on MEs and firms that employ them comes from the initial costs imposed on MEs during the training phase. However, the Regulatory Flexibility Analysis conducted by the Agency revealed that even for firms that generate relatively modest revenue, this cost amounts to only 0.5 percent of revenue. Therefore, this final rule will not have a significant impact on a significant number of firms in either the healthcare or motor carrier industry.

IC-6: Medical Examiner’s Certification Integration

Increasing the frequency of collection of CMV driver medical examination results data through the Medical Examiner’s Certification Integration final rule does affect medical clinics and practices, so there will be some impact on small businesses. However, because this data has always been recorded on the MEC, and since May 21, 2014, has been electronically reported on a monthly basis as a requirement of the National Registry of Certified Medical Examiners final rule, it is anticipated that this final rule will not have a significant impact or require a significant time burden. Information collection from employers, some of whom are small businesses, will decrease, because the final rule eliminates the National Registry number verification requirement for CDL/CLP drivers.

IC-7: Qualifications of Drivers; Diabetes Standard

Requiring the TC of a driver with ITDM to provide the Insulin-Treated Diabetes Mellitus Assessment Form, MCSA-5870, to the certified ME does affect medical clinics and practices. As such, there will be some impact on small businesses. However, because this is the driver’s TC and the TC routinely collects this information, it is anticipated that this information collection will not have a significant impact on small businesses or require a significant time burden.

6. IMPACT OF LESS FREQUENT COLLECTION OF INFORMATION

CMV Driver Medical Examinations (IC-1, IC-2, IC-5, IC-6, and IC-7)

Due to the potential for onset of new conditions or changes in existing conditions that may adversely affect a driver’s ability to drive safely and/or cause incapacitation that could be a risk to public safety, periodic re-evaluation and recertification is required to assess driver physical qualification. MECs may be issued for up to 2 years after the date of examination. However, drivers with certain medical conditions must be certified more frequently than every 2 years. MEs have discretion to certify for shorter time periods on a case-by-case basis for medical conditions that require closer monitoring or that are more likely to change over time. In addition, SAFETEA-LU requires MEs to transmit to FMCSA’s Chief Medical Officer, electronically and on a monthly basis, driver information and results of any CMV driver medical examinations conducted during the previous month. Less frequent collection of driver data, MER forms, and MECs would compromise FMCSA’s ability to determine ME compliance with FMCSA medical standards and guidelines in performing CMV driver medical examinations, which could result in MEs listed on the National Registry who should be removed and possibly drivers that don’t meet the physical qualification standards possessing a MEC. Less frequent data collection would also result in decreased validity of the data (i.e., less frequent data submission may increase the error rate due to unintentional omission of examination information). Therefore, less frequent collection of driver examination results is not an option.

Reporting of CMV Driver Medical Examination Results (IC-6)

In order to automate the medical certification as part of the CDL process, the Medical Examiner’s Certification Integration final rule requires MEs to report results of all completed CMV drivers’ medical examinations (including the results of examinations where the driver was found not to be qualified) to FMCSA by midnight (local time) of the next calendar day following the examination. If this information was collected less frequently, the driver’s record would not always provide accurate information regarding the driver’s physical qualification status. Therefore, less frequent collection of driver examination results is not an option.

Medical Exemptions and SPEs (IC-3 and IC-4)

FMCSA may, on a case by case basis, grant a medical exemption from a physical qualification standard set forth in 49 CFR § 391.41, if the Agency determines the exemption is in the interest of the public and would likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved by complying with the regulation. Individuals with limb impairments are permitted to operate a CMV, but only when they are otherwise qualified and are granted a SPE certificate by FMCSA. Title 49 CFR § 381.300 establishes the procedures that persons must follow to request exemptions from FMCSA safety regulations. Without an exemption, individuals who do not meet the requirements in 49 CFR § 391.41 would not be qualified to operate a CMV in interstate commerce. The Agency requires all exemptions be renewed every 2 years to ensure that the granting of the exemption does not diminish safety under 49 CFR § 381.310. Exemption holders are required to submit annual medical information for review to ensure the driver continues to meet the physical qualification requirements. In the interest of highway safety, the medical examination, exemption, and SPE renewal should not be performed less frequently.

Certification of MEs (IC-5)

FMCSA needs to certify as many healthcare professionals as possible to meet the CMV driver demand. To certify these healthcare professionals, they must meet the requirements outlined in the National Registry final rule, which includes registering on the National Registry website, completing required training, and passing a certification test, all of which involve information collection. Less frequent collection of ME candidate test results and identity and eligibility information means that there are less healthcare professionals attempting to become certified which would result in fewer certified MEs being available to the CMV driver and motor carrier population. This could place a huge burden on drivers and motor carriers to find certified MEs to perform their medical examinations. Therefore, less frequent collection of ME candidate test results and identity and eligibility information is not an option.

Verification that ME is Certified by FMCSA (IC-5 and IC-6)

The National Registry requires motor carriers to verify the national registry number of the MEs who certify their drivers and place a note in the DQ file. Less frequent verification of the National Registry numbers by motor carriers would mean drivers may not have been examined by a certified ME listed on the National Registry and they may no longer meet the physical qualifications standards of the FMCSRs even though they were previously certified as physically qualified. However, as part of the Medical Examiner’s Certification Integration final rule, employers will no longer be required to verify that the ME is listed on the National Registry for CDL/CLP driver examinations because FMCSA will be electronically transmitting MEC information for these drivers only if they were examined by a certified MEs listed on the National Registry.

7. SPECIAL CIRCUMSTANCES

IC-5: National Registry of Certified Medical Examiners

SAFETEA-LU requires certified MEs listed on the National Registry to electronically transmit to FMCSA on at least a monthly basis, driver information and results of any CMV driver medical examinations conducted during the previous month. Less frequent collection of driver examination results data would compromise FMCSA’s ability to determine ME compliance with FMCSA medical standards and guidelines in performing CMV driver medical examinations and would decrease the validity of the data.

IC-6: Medical Examiner’s Certification Integration

The Medical Examiner’s Certification Integration final rule requires certified MEs listed on the National Registry to report results of each completed CMV drivers’ medical examination (including the results of examinations where the driver was found not to be qualified) to FMCSA by midnight (local time) of the next calendar day following the examination. For CDL/CLP holders, FMCSA will electronically transmit driver identification, examination results, and restriction information from the National Registry system to the SDLAs. The reporting requirements were changed from monthly to daily to allow authorized State and Federal enforcement officials to be able to view the most current and accurate information regarding the medical status of the CMV driver, all information on the MEC, and the medical variance information to include the issued and expiration dates.

8. COMPLIANCE WITH 5 CFR § 1320.8

IC-5: National Registry of Certified Medical Examiners

On December 1, 2008, FMCSA published an NPRM titled, National Registry of Certified Medical Examiners (73 FR 73129). The NPRM contained information about the ME training and certification testing process including the information collection requirements. The NPRM also defined the requirements for reporting CMV driver examination results data and submitting MER forms and MECs. In response to the NPRM, FMCSA received numerous comments. Several commenters provided recommendations or voiced concern about various parts of the proposed requirements, including increased costs and training requirements for MEs, the implementation period, and the lack of a developed training curriculum. All comments submitted to the Agency in response to the NRPM, were addressed in the National Registry of Certified Medical Examiners final rule published on April 20, 2012 (77 FR 24104).

On March 16, 2011, FMCSA published an additional notice (76 FR 14366) requesting comment on a modification of the information collection requirements under consideration by the Agency. As explained above, FMCSA responded to the comments on the modification of the information collection in the National Registry of Certified Medical Examiners final rule published on April 20, 2012 (77 FR 24014).

IC-6: Medical Examiner’s Certification Integration

On May 10, 2013, FMCSA published an NPRM titled, Medical Examiner’s Certification Integration (78 FR 27343) and requested comments from the public. The NPRM defined the requirements for increased reporting of CMV driver examination results data and the use of MER Form, MCSA-5875 and MEC, Form MCSA-5876. The NPRM also described the process for electronic transmission of medical certification information from the National Registry to the SDLAs. In response to the NPRM, FMCSA received numerous comments. Several commenters provided recommendations or voiced concern about various parts of the proposed requirements, such as identification of the system that will be used for the electronic transmission of MEC data to the SDLAs, transmission of data for all CMV drivers not just CDL and CLP holders, transmission of data for those drivers operating in intrastate service, daily reporting requirements for MEs, and new form requirements. All comments submitted to the Agency in response to the NRPM, were addressed in the Medical Examiner’s Certification Integration final rule published on April 23, 2015.

IC-7: Qualifications of Drivers; Diabetes Standard

On May 4, 2015, FMCSA published an NPRM titled Qualifications of Drivers; Diabetes Standard (80 FR 25260) and requested comments from the public. The NPRM proposed to allow drivers with ITDM to operate CMVs in interstate commerce if the TC provided written notification to the certified ME that the driver’s condition was stable and well-controlled. However, based on an analysis of the comments received, FMCSA considered replacing the TC statement with a form to be completed by the TC and provided to the certified ME.

On July 27, 2017, FMCSA published a 60-day notice and requested comments from the public about replacing the previously proposed written notification from the TC with a form titled, Insulin-Treated Diabetes Mellitus Assessment Form (82 FR 35041). In response to the notice, FMCSA only received five substantive comments regarding the form, which were addressed in the Qualifications of Drivers; Diabetes Standard final rule and acted as the 30-day notice for the proposed information collection (83 FR 47486, September 19, 2018). FMCSA did not receive any comments in response to the burden of the IC.

9. PAYMENTS OR GIFTS TO RESPONDENTS

Respondents to this ICR do not receive any payments or gifts.

10. ASSURANCE OF CONFIDENTIALITY

All ICs

All information collected is protected by reasonable security safeguards against loss or unauthorized access, destruction, usage, modification, or disclosure. These safeguards incorporate standards and practices required for Federal information systems under the Federal Information System Management Act and are detailed in Federal Information Processing Standards Publication 200, Minimum Security Requirements for Federal Information and Information Systems, NIST Special Publication 800-53, Rev. 4, Security and Privacy Controls for Federal Information Systems and Organizations, dated April 30, 2013. FMCSA has a comprehensive information security and privacy program that contains management, operational, and technical safeguards that are appropriate for the protection of the information collected.

All medical records are kept confidential. The information is retained by FMCSA in accordance with the requirements of the Privacy Act of 1974. FMCSA, in accordance with 49 CFR §§ 391.51 and 398.3, requires the MEC that contains limited information (i.e. driver identification, whether or not medically qualified, and variance information) or a copy of the MVR obtained from the SDLA and a note regarding verification of the national registry number on the MEC to be kept in the DQ file maintained by the motor carrier.

IC-3 and IC-4: Exemptions and SPE

The exemption and SPE programs require the collection and submission of detailed medical information that FMCSA would not otherwise collect. Therefore, all exemption and SPE records are safeguarded in accordance with applicable rules and policies, including all applicable DOT automated systems security and access policies. Strict controls have been imposed to minimize the risk of compromising the information that is being stored. Access to the computer system containing these records is limited to those individuals who have a need to know the information for the performance of their official duties and who have appropriate clearances and permissions. All records are protected from unauthorized access through appropriate administrative, physical, and technical safeguards against loss or unauthorized access, destruction, usage, modification, or disclosure

IC-5: National Registry of Certified Medical Examiners

Records in the National Registry system are safeguarded in accordance with applicable rules and policies, including all applicable DOT automated systems security and access policies. Strict controls have been imposed to minimize the risk of compromising the information that is being stored. Access to the computer system containing the records in the registry is limited to those individuals who have a need to know the information for the performance of their official duties and who have appropriate clearances and permissions. All records in the National Registry system are protected from unauthorized access through appropriate administrative, physical, and technical safeguards. All access to the National Registry system is logged and monitored.

FMCSA has developed secure processes for the transmission of information, records control and repository, and the ability to retrieve and search records. A secure information system and web interface is being used, by which each ME registered in the National Registry receives a unique login ID and password upon his or her acceptance into the National Registry. MEs and designated ME Administrative Assistants (MEAAs) are able to access this information system but limited to only view, edit, and change the ME’s own identification, contact, medical credential, employer contact, and training information; request voluntary removal from the National Registry; and to securely submit the required CMV driver medical examination results data.

Testing organizations also have password-protected access to the National Registry system, limited to view and verify the ME’s eligibility to take the certification test. Testing organizations that offer online testing provide a means to authenticate the identity of the person taking the test, to monitor the activity of the person taking the test, and to prevent the person taking the test from reproducing the contents of the test, as required by 49 CFR § 390.107(b). Testing organizations must develop policies and procedures when using automated monitoring online systems. These policies and procedures must be presented to each candidate taking the test. Testing organizations are required to submit their procedures to FMCSA as part of their application to become an approved testing organization. FMCSA conducts security assessments of testing organizations’ data systems, including site visits, to ensure protection of information collected before approving them to administer the certification test.

Logical access controls restrict users of the National Registry. These controls are guided by the principles of least privilege and need to know. Role-based user accounts are created with specific job functions allowing only authorized accesses, which are necessary to accomplish assigned tasks in accordance with compelling operational needs and business functions of the National Registry. Any changes to user roles require approval of the System Manager.

The National Registry maintains an auditing function that tracks all user activities in relation to data, including access and modification. Through technical controls including firewalls, intrusion detection, encryption, access control lists, and other security methods, FMCSA prevents unauthorized access to data stored in the National Registry. These controls meet federally mandated information assurance and privacy requirements. The National Registry system is approved through the Security Authorization Process under the National Institute of Standards and Technology.

The secure system encrypts all documents. The redress process described in the Individual Participation and Redress section of the Privacy Impact Assessment for the National Registry is a mechanism to maintain and improve accuracy of information.

IC-6: Medical Examiner’s Certification Integration

As a follow-on rule to the National Registry, all safeguards described above also apply to the Medical Examiner’s Certification Integration final rule. In addition, the Medical Examiner’s Certification Integration final rule includes the use of CDLIS as the system to be used to transfer MEC and medical variance (exemptions, skill performance evaluation certificates, and grandfathered exemptions) information from the National Registry to the SDLAs. DOT has determined that CDLIS is not a Federal “system of records,” as defined by the Privacy Act of 1974 (5U.S.C. $552a), because the records in CDLIS are not controlled by DOT. CDLIS is operated by the American Association of Motor Vehicle Administrators (AAMVA).

11. JUSTIFICATION FOR COLLECTION OF SENSITIVE INFORMATION

IC-1: Physical Qualification Standards

The medical examination process requires the ME to inquire about aspects of driver physical and mental health, including history of frequent alcohol use, illicit drug use or habit-forming medication use. CMV drivers give consent to the collection of this information by signing the MER Form, MCSA-5875 prior to the examination.

IC-3 and IC-4: Exemptions and SPE

The exemption and SPE programs require the collection and submission of detailed medical information that FMCSA would not otherwise collect as part of the exemption and SPE processes in order to confirm the driver is otherwise physically qualified.

IC-5: National Registry of Certified Medical Examiners and IC-6: Medical Examiner’s Certification Integration

FMCSA collects ME registration data in order to match on-site documentation with verification of identity and testing eligibility (e.g., proof of State licensure that allows performance of physical examinations and proof of completion of training that conforms to the FMCSA core curriculum specifications). FMCSA collects test results data to track participant test-taking trends as well as provide respondents with test results and follow-up information. MEs provide their consent during the registration process to becoming a certified ME.

MEs are required to submit CMV driver medical examination results (e.g., medically qualified, medically unqualified, pending determination) in conjunction with driver identification information. This information becomes the electronic version of the MEC. Submission of this medical certification information is necessary to tie a specific ME to a specific driver examination in order to monitor the performance of certified MEs, as required by SAFETEA-LU.

IC-7: Qualifications of Drivers; Diabetes Standard

The Insulin-Treated Diabetes Mellitus Assessment Form, MCSA-5870, requires the collection and submission of detailed medical information related to drivers with ITDM that FMCSA would not otherwise collect as part of the physical qualification processes. Such information is necessary for the certified ME, with input from the TC, to make a qualification determination regarding whether the driver meets all the physical qualification requirements of 49 CFR §§ 391.41(b) and 391.46 to safely operate a CMV.

12. ESTIMATE OF BURDEN HOURS FOR INFORMATION REQUESTED

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 drivers of 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, resulting in a required collection of information about the physical qualification of CMV drivers. The information is collected through the medical examination of the CMV driver and supporting physical qualification records.

Population of CMV Drivers

The population of CMV drivers has been updated throughout this document based on current statistics. This number reflects both interstate drivers subject to the FMCSRs and intrastate drivers subject to compatible State regulations. In addition, a small number of drivers transporting 8 or less migrant workers more than 75 miles in interstate commerce that are still subject to the medical certification requirements of 49 CFR § 398 are included in this population. The National Registry of Certified Medical Examiners final rule requires certified MEs to report the results of each CMV driver’s medical examination completed to FMCSA. Although Federal regulations do not require States to comply with the medical requirements in the FMCSRs, most States do mirror the Federal requirements; therefore, we assume this burden is consistent with other FMCSA ICs. If intrastate CMV drivers are subject to compatible State regulations, the Agency anticipates that it is likely that these drivers will use certified MEs on the National Registry for their medical qualification examinations. FMCSA recognizes that using the entire intrastate CMV driver population may be a high estimation, but uses this conservatively high estimation because the Agency does not have an exact number and there is nothing to preclude intrastate CMV drivers from being examined by a certified ME listed on the National Registry.

There are approximately 6 million drivers³ subject to the FMCSA medical standards. Periodic re-evaluation and recertification is required to assess driver physical qualification, due to the potential for onset of new conditions or changes in existing conditions that may adversely affect a driver’s ability to drive safely and/or cause incapacitation that could be a risk to public safety. A MEC can be issued for up to 2 years after the date of examination. However, drivers with certain medical conditions must be certified more frequently than every 2 years. MEs have discretion to certify for shorter time periods, on a case-by-case basis, for medical conditions that require closer monitoring or are more likely to change over time. Halving the number of drivers underestimates the total number of examinations that are conducted annually. In addition, for various other reasons, drivers may find that they need to be examined more frequently. As a result of these exceptions to the biennial medical certification schedule, the Agency estimates that the actual number of medical examinations conducted annually is 40.20 percent greater than would be the case if all drivers were only examined biennially. As detailed in the table below, the Agency estimates that approximately 4,206,000 examinations are conducted annually.

Population of CMV Drivers Subject to FMCSA Medical Standards and Examined Annually

Baseline	Exams every 2 years – ½ of that population	Adjustment for out-of-cycle exams	Drivers examined annually
6,000,000	3,000,000	40.20%	4,206,000

IC-1: FMCSA Physical Qualification Standards

Information Collection Tasks of the Medical Examination, MER Form, and MEC

The FMCSRs require MEs, drivers, and motor carriers to complete the following 4 tasks. Time burdens for each task are provided in the tables below.

ME Tasks

Task	Time to Complete Task
Complete, Document, and File MER Form	20 minutes
Complete and furnish the original paper MEC to the driver	1 minute

Driver Task

Task	Time to Complete Task
Complete driver health history portion of the MER Form	5 minutes

Motor Carrier Task

Task	Time to Complete Task
File MEC in DQ record	1 minute

It takes a ME approximately 20 minutes to complete, document, and file the MER Form. It takes the driver 5 minutes to complete the health history section of the MER Form. It takes a ME approximately 1 minute to complete the MEC and furnish one copy to the driver examined. It takes a motor carrier approximately 1 minute to file the MEC. The total annual time and cost burdens to respondents for the medical examination, MER Form, and MEC are detailed in the tables below.

ME Annual Burden Hours and Salary Costs to Complete, Document, and File MER Form

Hourly wage of ME	Number of drivers examined	Time to complete, document, and file MER Form	Annual hours to complete, document, and file MER Form	Annual salary cost for ME to complete, document, and file MER Form
$89.67	4,206,000	20 minutes	1,402,000	$125,717,340

ME Annual Burden Hours and Salary Costs to Complete and Furnish a copy of MEC to the Driver Examined

Hourly wage of ME	Number of MECs issued	Time to complete and furnish a copy of MEC to the driver	Annual hours to complete and furnish a copy of MEC to the driver	Annual salary cost for ME to complete and furnish a copy of MEC to the driver
$89.67	4,206,000	1 minute	70,100	$6,285,867

CMV Driver Annual Burden Hours and Salary Costs to Complete the Health History Section of the MER Form

Hourly wage of CMV driver	Number of drivers examined	Time to complete health history section of MER Form	Annual hours for drivers to complete health history section of MER Form	Annual salary costs for drivers to complete health history section of MER Form
$30.00	4,206,000	5 minutes	350,500	$10,515,000

Motor Carrier Administrative Personnel Annual Burden Hours and Salary Costs to File the MEC in the DQ record

Hourly wage of administrative personnel	Number of MECs issued	Time to file MEC in DQ record	Annual hours for motor carrier administrative personnel to file MEC in DQ record	Annual salary costs for motor carrier administrative personnel to file MEC in DQ record
$21.17	4,206,000	1 minute	70,100	$1,484,017

Total Annual Burden Hours for MER Form/MEC

Annual hours to complete, document, and file MER Form	Annual hours to complete and furnish copy of MEC to driver	Annual hours for drivers to complete health history section of MER Form	Annual hours for motor carrier administrative personnel to file MEC in DQ record	Total annual burden hours
1,402,000	70,100	350,500	70,100	1,892,700

Total Annual Salary Costs for MER Form/MEC

Annual salary costs for MEs	Annual salary costs for CMV drivers	Annual salary costs for motor carrier administrative personnel	Total annual salary costs
$132,003,207	$10,515,000	$1,484,017	$144,002,224

IC-1 Annual Burden Hours: 1,892,700 [(4,206,000 drivers x 20 minutes/60 minutes) + (4,206,000 MECs x 1 minute/60 minutes) + (4,206,000 drivers x 5 minutes/60 minutes) + 4,206,000 MECs x 1 minute/60 minutes)]

IC-1 Annual Number of Respondents: 4,813,510 (4,206,000 drivers + 56,360 MEs⁴ + 551,150 motor carrier administrative personnel⁵)

IC-1 Annual Number of Responses: 16,824,000 (4,206,000 health history + 4,206,000 MER Forms + 4,206,000 MECs issued + 4,206,000 MECs filed)

IC-2: Resolution of Medical Conflict

The FMCSRs require motor carriers to complete the following 2 tasks. Time burdens for each task are provided in the tables below.

Motor Carrier Tasks

Task		Time to Complete Task
Submit application to FMCSA for resolution (3 cases per year)	1 hour
Attend a hearing if FMCSA deems necessary (1 hearing per year)	8 hours

The motor carrier would generally submit the application to FMCSA for a resolution of medical conflict, and would attend a hearing if FMCSA deems it necessary to hold a hearing. The motor carrier would need approximately 1 hour to prepare paperwork for each case and an additional 8 hours to attend any hearing. There are about 3 cases per year submitted to FMCSA for resolution of conflicting medical opinions. One of every three cases are sent to a hearing before an Administrative Law Judge. The total annual time and cost burdens to respondents for the resolution of medical conflicts are detailed in the tables below.

Motor Carrier Annual Burden Hours and Salary Costs to Submit Application to FMCSA for Resolution of Medical Conflict

Average hourly wage of motor carrier staff	Number of applications per year	Time to submit application	Annual hours for application submission	Annual salary cost for application submission
$24.69	3	1 hour	3	$74

Motor Carrier Annual Burden Hours and Salary Costs to Attend Hearing if FMCSA Deems Necessary

Average hourly wage of motor carrier staff	Number of hearings per year	Time to attend hearing	Annual hours for attending hearings	Annual salary cost for attending hearings
$24.69	1	8 hours	8	$198

Total Annual Burden Hours for Resolution of Medical Conflict

Annual hours for application submission	Annual hours for attending hearings	Total annual burden hours
3	8	11

Total Annual Salary Costs for Resolution of Medical Conflict

Annual salary costs for application	Annual salary costs for attending hearings	Total annual salary costs
$74	$198	$272

IC-2 Annual Burden Hours: 11 hours [(3 applications x 1 hour) + (1 application x 8 hours)]

IC-2 Annual Number of Respondents: 3 (3 applications)

IC-2 Annual Number of Responses: 3

IC-3 Exemptions

IC-3a: Diabetes Exemption Program

The Diabetes Exemption Program currently requires drivers and motor carriers to complete the following 4 tasks. Time burdens for each task are provided in the tables below.

Driver Tasks

Task	Time to Complete Task
Complete new diabetes exemption application	1 hour
Complete renewal diabetes exemption application	1 hour
Provide copy of MER Form to FMCSA	1 minute

Motor Carrier Task

Task	Time to Complete Task
Copy and file exemption in DQ record	1 minute

There are approximately 1,422 new applications for diabetes exemptions submitted annually, and it takes an average of 1 hour to complete an application⁶. There are approximately 1,110 renewals submitted annually, and it takes an average of 1 hour to complete a renewal application. There are currently 4,256 active diabetes exemptions and an average of 1,470 exemptions are issued per year. FMCSA estimates that it takes the driver 1 minute to provide a copy of the MER Form to FMCSA for submission with the diabetes exemption application. It takes an estimated 1 minute for motor carrier administrative personnel to make a copy of the exemption certificate and file it in the DQ record. The total annual time and cost burdens to respondents for the Diabetes Exemption Program are detailed in the tables below.

CMV Driver Annual Burden Hours and Salary Costs to Complete Application for New Diabetes Exemption

Average hourly wage of CMV Driver	Number of new diabetes exemption applications per year	Time to complete new diabetes exemption application	Annual hours to complete new diabetes exemption application	Annual salary costs to complete new diabetes exemption application
$30.00	1,422	1 hour	1,422	$42,660

CMV Driver Annual Burden Hours and Salary Costs to Complete Application for a Renewal Diabetes Exemption

Average hourly wage of CMV Driver	Number of renewal diabetes exemption applications per year	Time to complete renewal diabetes exemption application	Annual hours to complete renewal diabetes exemption application	Annual salary costs to complete renewal diabetes exemption application
$30.00	1,110	1 hour	1,110	$33,300

CMV Driver Annual Burden Hours and Salary Costs to Provide MER Form with Diabetes Exemption Application

Hourly wage of CMV Driver	Number of diabetes exemption applications per year	Time to provide MER Form to FMCSA	Annual hours to provide MER Form to FMCSA	Annual salary costs for CMV Driver to provide MER Form to FMCSA
$30.00	2,532	1 minute	42	$1,260

Motor Carrier Annual Burden Hours and Salary Costs to Copy and File Diabetes Exemption in DQ Record

Average hourly wage for motor carrier administrative personnel	Total number of diabetes exemptions to file per year	Time to copy and file diabetes exemption in DQ record	Annual hours for copying and filing diabetes exemption in DQ record	Annual salary costs for copying and filing diabetes exemption in DQ record
$21.17	1,470	1 minute	25	$529

Total Annual Burden Hours for Diabetes Exemption Program

Annual hours for drivers to complete new diabetes exemption application	Annual hours for drivers to complete renewal diabetes exemption application	Annual hours for drivers to provide MER Form to FMCSA	Annual hours for motor carrier administrative personnel to copy and file diabetes exemption	Total annual burden hours
1,422	1,110	42	25	2,599

Total Annual Salary Costs for Diabetes Exemption Program

Annual salary costs for drivers to complete new diabetes exemption application	Annual salary costs for drivers to complete renewal diabetes exemption application	Annual salary cost for driver to provide MER Form to FMCSA	Annual salary costs for motor carrier administrative personnel to copy and file diabetes exemption	Total annual salary costs
$42,660	$33,300	$1,260	$529	$77,749

IC-3a Annual Burden Hours: 2,599 hours [(1,422 new applications x 1 hour) + (1,110 renewal applications x 1 hour) + (2,532 exemptions x 1 minute/60 minutes) + (1,470 exemptions x 1 minute/60 minutes)]

IC-3a Annual Number of Respondents: 4,002 (2,532 drivers + 1,470 motor carriers)

IC-3a Annual Number of Responses: 4,002 (2,532 applications + 1,470 exemptions)

IC-3b: Vision Exemption Program

The vision exemption program requires drivers and motor carriers to complete the following 3 tasks. Time burdens for each task are provided in the tables below.

Driver Tasks

Task	Time to Complete Task
Complete application for new vision exemption	1 hour
Complete application for vision exemption renewal	1 hour

Motor Carrier Task

Task	Time to Complete Task
Copy and file exemption in DQ file	1 minute

There are approximately 858 new applications for vision exemptions submitted annually, and it takes approximately 1 hour for a driver to complete the application⁷. There are approximately 847 renewal applications for vision exemptions submitted annually, and it takes approximately 1 hour for a driver to complete the application. Currently, there are 3,164 active vision exemptions and an average of 1,199 exemptions are issued per year. It takes an estimated 1 minute for motor carrier administrative personnel to make a copy of the exemption certificate and file it in the DQ record. The total annual time and cost burdens to respondents for the Vision Exemption Program are detailed in the tables below.

CMV Driver Annual Burden Hours and Salary Costs to Complete Application for New Vision Exemption

Average hourly wage of CMV Driver	Number of new vision exemption applications per year	Time to complete new vision exemption application	Annual hours to complete new vision exemption application	Annual salary costs to complete new vision exemption application
$30.00	858	1 hour	858	$25,740

CMV Driver Annual Burden Hours and Salary Costs to Complete Application for Renewal Vision Exemption

Average hourly wage of CMV Driver	Number of renewal vision exemption applications per year	Time to complete renewal vision exemption application	Annual hours to complete renewal vision exemption application	Annual salary costs to complete renewal vision exemption application
$30.00	847	1 hour	847	$25,410

Motor Carrier Annual Burden Hours and Salary Costs to Copy and File Vision Exemption in DQ Record

Average hourly wage for Motor Carrier Administrative Personnel	Total number of exemptions to file per year	Time to complete copy and file vision exemption	Annual hours for filing a copy of vision exemption in DQ record	Annual salary costs for filing a copy of vision exemption in DQ record
$21.17	1,199	1 minute	20	$423

Total Annual Burden Hours for Vision Exemptions

Annual hours for drivers to complete new vision exemption application	Annual hours for drivers to complete renewal vision exemption application	Annual hours for motor carrier administrative personnel to copy and file exemption	Total annual burden hours for vision exemption
858	847	20	1,725

Total Annual Salary costs for Vision Exemptions

Annual salary costs for drivers to complete new vision exemption application	Annual salary costs for drivers to complete renewal vision exemption application	Annual salary costs for motor carrier administrative personnel to copy and file exemption	Total annual salary costs
$25,740	$25,410	$423	$51,573

IC-3b Annual Burden Hours: 1,725 hours [(858 new applications x 1 hour) + (847 renewal applications x 1 hour) + (1,199 exemptions x 1 minute/60 minutes)]

IC-3b Annual Number of Respondents: 2,904 (1,705 drivers + 1,199 motor carriers)

IC-3b Annual Number of Responses: 2,904 (1,705 applications + 1,199 exemptions)

IC-3c: Hearing Exemptions

To apply for a hearing exemption, it requires drivers and motor carriers to complete the following 3 tasks. Time burdens for each task are provided in the tables below.

Driver Tasks

Task	Time to Complete Task
Complete application for new hearing exemption	15 minutes
Complete application for renewal hearing exemption	15 minutes

Motor Carrier Task

Task	Time to Complete Task
Copy and file exemption in DQ file	1 minute

There are approximately 106 new applications for hearing exemptions filed annually⁸, and it takes approximately 15 minutes for a driver to complete the application. An exemption is valid for 2 years, but may be renewed. There are approximately 20 renewal applications filed annually⁹, and it takes approximately 15 minutes for a driver to complete the application. Currently, there are 450 active drivers with hearing exemptions and an average of 70 exemptions are issued per year. It takes an estimated 1 minute for the motor carrier administrative personnel to make a copy of the exemption certificate and file it in the DQ record. The total annual time and cost burdens to respondents for hearing exemptions are detailed in the tables below.

CMV Driver Annual Burden Hours and Salary Costs to Complete Application for New Hearing Exemption

Average hourly wage of CMV driver	Number of new hearing exemption applications per year	Time to complete hearing exemption application	Annual hours to complete new hearing exemption application	Annual salary costs to complete new hearing exemption application
$30.00	106	15 minutes	27	$810

CMV Driver Annual Burden Hours and Salary Costs to Complete Application for Renewal Hearing Exemption

Average hourly wage of CMV driver	Number of renewal hearing exemption applications per year	Time to complete hearing exemption application	Annual hours to complete new hearing exemption application	Annual salary costs to complete new hearing exemption application
$30.00	20	15 minutes	5	$150

Motor Carrier Annual Burden Hours and Salary Costs to Copy and File Hearing Exemption in DQ Record

Average hourly wage for motor carrier administrative personnel	Total number of hearing exemptions to file per year	Time to copy and file hearing exemption	Annual hours for filing copy of hearing exemption in the DQ record	Annual salary costs for filing copy of hearing exemption in the DQ record
$21.17	70	1 minute	1	21

Total Annual Burden Hours for Hearing Exemptions

Annual hours for drivers to complete new hearing exemption application	Annual hours for drivers to complete renewal hearing exemption application	Annual hours for motor carrier administrative personnel to copy and file hearing exemptions	Total annual burden hours for hearing exemptions
27	5	1	33

Total Annual Salary costs for Hearing Exemptions

Annual Salary costs for drivers to complete new hearing exemption application	Annual Salary costs for drivers to complete renewal hearing exemption application	Annual salary costs for motor carrier administrative personnel to copy and file hearing exemptions	Total annual salary costs
$810	$150	$21	$981

IC-3c Annual Burden Hours: 33 hours [(106 new applications x 15 minutes/60 minutes) + (20 renewal applications x 15 minutes/60 minutes) + (70 exemptions x 1 minute/60 minutes)]

IC-3c Annual Number of Respondents: 196 (126 drivers + 70 motor carriers)

IC-3c Annual Number of Responses: 196 (126 applications + 70 exemptions)

IC-3d: Seizure Exemptions

To apply for a seizure exemption, it requires drivers and motor carriers to complete the following 3 tasks. Time burdens for each task are provided in the tables below.

Driver Tasks

Task	Time to Complete Task
Complete application for new seizure exemption	30 minutes
Complete application for renewal seizure exemption	30 minutes

Motor Carrier Task

Task	Time to Complete Task
Copy and file exemption in DQ file	1 minute

There are approximately 117 new applications for seizure exemptions filed annually¹⁰, and it takes approximately 30 minutes for a driver to complete the application. An exemption is valid for two years, but may be renewed. There are approximately 23 renewal applications filed annually¹¹, and it takes approximately 30 minutes for the driver to complete the application. Currently, there are 324 active drivers with seizure exemptions and an average of 90 exemptions are issued per year. It takes an estimated 1 minute for the motor carrier administrative personnel to make a copy of the exemption certificate and file it in the DQ record. The total annual time and cost burdens to respondents for seizure exemptions are detailed in the tables below.

CMV Driver Annual Burden Hours and Salary Costs to Complete Application for New Seizure Exemption

Average hourly wage of CMV driver	Number of new seizure exemption applications per year	Time to complete seizure exemption application	Annual hours to complete new seizure exemption application	Annual salary costs to complete new seizure exemption application
$30.00	117	30 minutes	59	$1,770

CMV Driver Annual Burden Hours and Salary Costs to Complete Application for Renewal Seizure Exemption

Average hourly wage of CMV driver	Number of renewal seizure exemption applications per year	Time to complete seizure exemption application	Annual hours to complete new seizure exemption application	Annual salary costs to complete new seizure exemption application
$30.00	23	30 minutes	12	$360

Motor Carrier Annual Burden Hours and Salary Costs to Copy and File Seizure Exemption in DQ Record

Average hourly wage for motor carrier administrative personnel	Total number of seizure exemptions to file per year	Time to copy and file seizure exemption	Annual hours for filing copy of seizure exemption in the DQ record	Annual salary costs for filing copy of seizure exemption in the DQ record
$21.17	90	1 minute	2	$42

Total Annual Burden Hours for Seizure Exemptions

Annual hours for drivers to complete new seizure exemption application	Annual hours for drivers to complete renewal seizure exemption application	Annual hours for motor carrier administrative personnel to copy and file seizure exemptions	Total annual burden hours for seizure exemptions
59	12	2	73

Total Annual Salary Costs for Seizure Exemptions

Annual Salary costs for drivers to complete new seizure exemption application	Annual Salary costs for drivers to complete renewal seizure exemption application	Annual salary costs for motor carrier administrative personnel to copy and file seizure exemptions	Total annual salary costs for seizure exemptions
$1,770	$360	$42	$2,172

IC-3d Annual Burden Hours: 73 hours [(117 new applications x 30 minutes/60 minutes) + (23 applications x 30 minutes/60 minutes) + (90 exemptions x 1 minute/60 minutes)]

IC-3d Annual Number of Respondents: 230 (140 drivers + 90 motor carriers)

IC-3d Annual Number of Responses: 230 (140 applications + 90 exemptions)

IC-3 Total Annual Burden Hours: 4,430 hours [(1,422 new applications x 1 hour) + (1,110 renewal applications x 1 hour) + (2,532 exemptions x 1 minute/60 minutes) + (1,470 exemptions x 1 minute/60 minutes) + (858 new applications x 1 hour) + (847 renewal applications x 1 hour) + (1,199 exemptions x 1 minute/60 minutes) + (106 new applications x 15 minutes/60 minutes) + (20 renewal applications x 15 minutes/60 minutes) + (70 exemptions x 1 minute/60 minutes) + (117 new applications x 30 minutes/60 minutes) + (23 renewal applications x 30 minutes/60 minutes) + (90 exemptions x 1 minute/60 minutes)]

IC-3 Total Annual Number of Respondents 7,332 (4,002+ 2,904 + 196 + 2300)

IC-3 Total Annual Number of Responses: 7,332 (4,002 + 2,904 + 196 + 230)

IC-4: Skill Performance Evaluation (SPE) Certificate Program (formerly the Limb Waiver Program)

The SPE program requires drivers and motor carriers to complete the following 4 tasks. Time burdens for each task are provided in the tables below.

Driver Tasks

Task	Time to Complete Task
Complete application for new SPE	2 hours
Complete application for SPE renewal	2 hours
Provide copy of MER Form to FMCSA	2 minutes

Motor Carrier Task

Task	Time to Complete Task
Copy and file exemption in DQ record	1 minute

There are currently an estimated 3,974 active SPE certificates¹². An SPE certificate is valid for 2 years. There are approximately 359 new SPE applications each year. It takes a driver approximately 2 hours to complete the application for a new SPE certificate. There are approximately 967 SPE renewal applications each year. It takes a driver approximately 2 hours to complete the application for a renewal SPE certificate. In addition, it takes the driver approximately an additional 2 minutes to provide FMCSA with a copy of the MER Form and MEC. There are approximately 1,100 SPE certificates issued each year. It takes approximately 1 minute for the motor carrier to make a copy of the SPE certificate and file it in the DQ record. The total annual time and cost burdens to respondents for the SPE certificate program are detailed in the tables below.

CMV Driver Annual Burden Hours and Salary Costs to Complete Application for New SPE

Average hourly wage of CMV driver	Number of new SPE applications per year	Time to complete new SPE application	Annual hours to complete new SPE application	Annual salary costs to complete new SPE application
$30.00	359	2 hours	718	$21,540

CMV Driver Annual Burden Hours and Salary Costs Complete Application for Renewal SPE

Average hourly wage of CMV driver	Number of renewal applications per year	Time to complete SPE renewal application	Annual hours to complete SPE renewal application	Annual salary costs to complete SPE renewal application
$30.00	967	2 hours	1,934	$58,020

CMV Driver Annual Burden Hours and Salary Costs to Provide MER/MEC with SPE Application

Hourly wage of CMV driver	Number of SPE applications per year	Time to provide MER/MEC to FMCSA	Annual hours to provide MER/MEC to FMCSA	Annual salary costs for CMV Driver to provide MER/MEC to FMCSA
$30.00	1,326	2 minutes	44.2	$1,326

Motor Carrier Annual Burden Hours and Salary Costs to Copy and file SPE Certificate in DQ Record

Average hourly wage for motor carrier administrative personnel	Total number of SPE certificates	Tine to copy and file SPE certificate	Annual hours for copying and filing SPE certificate in the DQ record	Annual salary costs for copying and filing SPE certificate in the DQ record
$21.17	1,100	1 minute	18	$381

Total Annual Burden Hours for SPE

Annual hours for driver to complete new and renewal SPE applications	Annual hours to provide MER/MEC to FMCSA	Annual hours for motor carrier administrative personnel to copy and file SPE certificate	Total annual burden hours
2,652	44	18	2,714

Total Annual Salary costs for SPE

Annual salary costs for driver to apply for new or renewal SPE	Annual salary costs for driver to provide MER/MEC to FMCSA	Annual salary costs for motor carrier to copy and file the SPE certificate in the DQ record	Total annual salary costs
$79,560	$1,326	$381	$81,267

IC-4 Annual Burden Hours: 2,714 hours [(359 new applications x 2 hours) + (967 renewal applications x 2 hours) + (1,326 applications x 2 minutes/60 minutes) + (1,100 SPE certificates x 1 minute/60 minutes)]

IC-4 Annual Number of Respondents: 2,426 (1,326 drivers + 1,100 motor carriers)

IC-4 Annual Number of Responses: 2,426 (1,326 applications + 1,100 SPE certificates)

IC-5: National Registry of Certified Medical Examiners

IC-5a: National Registry of Certified Medical Examiners – Registering and Testing

The registration and testing process of the National Registry requires MEs and testing organizations to complete the following 2 tasks. Time burdens for each task are provided in the tables below.

ME Tasks

Task	Minutes to Complete Task
Read the prerequisite requirements and provide medical license issue state and medical profession	2
Provide employer and primary practice address and contact information	3
Provide medical license, certificate, or registration number and expiration date	1
Read the IT Rules of Behavior and check accept	2
Read the National Registry Terms of Use and check accept	2
Provide pre medical examiner certification test training provider and accreditation details	3
Review all submitted information and select submit	2
National Registry submission confirmation, no action	0
Total time to provide registration information	15

Testing Organization Task

Task	Minutes to Complete Task
Upload ME test results to FMCSA	5

Currently there are 56,360 certified MEs listed on the National Registry. On average, 15,139 healthcare professionals register each year to become certified MEs. It takes approximately 15 minutes for a ME candidate to register on the National Registry website. Currently, 3 national private-sector testing organizations deliver the FMCSA ME certification test to an average 10,708 ME candidates annually. The testing organizations have reported that there are 1,000 testing centers. It takes private-sector testing organization personnel approximately 5 minutes to collect and upload to FMCSA data and test results. The total annual time and cost burdens to respondents for the registration and testing to become a certified ME are detailed in the tables below.

ME Annual Burden Hours and Salary Costs to Provide Registration Information

Hourly wage of ME	Average number of MEs registering per year	Time to complete registration	Annual hours for MEs to provide registration information to NR	Annual salary costs for MEs to provide registration information to NR
$89.67	15,139	15 minutes	3,785	$339,401

Testing Organization Annual Burden Hours and Salary Costs to Upload ME Test Results to FMCSA

Hourly wage of data entry personnel	Average number of tests uploaded per year	Time to upload test results	Annual hours to upload test results	Annual salary for data entry personnel to upload test results
$19	10,708	5 minutes	892	$16,948

Total Annual Burden Hours for Registration and Uploading Test Results

Annual hours for MEs to provide registration information to NR	Annual hours to upload test results	Total annual burden hours
3,785	892	4,677

Total Annual Salary costs for Registration and Uploading Test Results

Annual salary costs for MEs to provide registration information to NR	Annual salary costs for data entry personnel to upload test results	Total annual salary costs
$339,401	$16,948	$356,349

IC-5a Annual Burden Hours: 4,677 hours [(15,139 MEs x 15 minutes/60 minutes) + (10,708 MEs x 5 minutes/60 minutes)]

IC-5a Annual Number of Respondents: 16,139 (15,139 MEs + 1,000 test centers)

IC-5a Annual Number of Responses: 25,847 (15,139 registrations + 10,708 tests uploaded)

IC-5b: National Registry of Certified Medical Examiners - CMV Driver Medical Examination Results

The National Registry requires administrative personnel of certified MEs to complete the following 3 tasks. Time burdens for each task are provided in the tables below.

Certified ME Administrative Personnel Tasks

Task	Time to Complete Task
Enter results of driver examinations on MCSA-5850 and transmit MCSA-5850 (MEC information) to FMCSA	2 minutes
File MEC	30 seconds
Provide copy of MEC to motor carrier	1 minute

FMCSA estimates¹³ that respondents will provide CMV driver examination data a maximum of 12 times per year for 4,206,000 examinations conducted and will file 4,206,000 MECs per year. It is estimated that it will take ME administrative personnel 2 minutes to enter and transmit the driver’s examination results to FMCSA, through the National Registry, via the MCSA-5850. It is estimated that it will take ME administrative personnel 30 seconds to file the MEC. In addition, FMCSA estimates that half of the motor carriers request a copy of the MEC and it takes administrative personnel 1 minute to provide a copy of the MEC to a motor carrier. The total annual time and cost burdens to respondents for reporting CMV driver medical examination results are detailed in the tables below.

Certified ME Administrative Personnel Annual Burden Hours and Salary Costs to Enter and Transmit Results via the MCSA-5850

Hourly wage of administrative personnel	Number of 5850s to enter and transmit per year	Time to enter and transmit results via MCSA-5850	Annul hours to enter and transmit results via MCSA-5850	Annual costs to enter and transmit results via MCSA-5850
$22.87	4,206,000	2 minutes	140,200	$3,206,374

Certified ME Administrative Personnel Annual Burden Hours and Salary Costs to File MEC

Hourly wage of administrative personnel	Number of MECs filed	Time to file MEC	Annual hours to file MECs	Annual costs to file MECs
$22.87	4,206,000	30 seconds	35,050	$801,594

Certified ME Administrative Personnel Annual Burden Hours and Salary Costs to Provide Copy of MEC to Motor Carrier

Hourly wage of administrative personnel	Number of times per year MEC is provided to motor carrier	Time to provide MEC to motor carrier	Annual hours to provide MEC to motor carrier	Annual costs to provide MEC to motor carrier
$22.87	2,103,000	1 minute	35,050	$801,594

Total Annual Burden Hours for Reporting CMV Driver Medical Examination Results

Annual hours to enter and transmit results via MCSA-5850	Annual hours to file MECs	Annual hours to provide MECs to motor carrier	Total annual burden hours
140,200	35,050	35,050	210,300

Total Annual Salary costs for Reporting CMV Driver Medical Examination Results

Annual costs to enter and transmit results via MCSA-5850	Annual costs to file MECs	Annual costs to provide MECs to motor carrier	Total annual salary costs
$3,206,374	$801,594	$801,594	$4,809,562

IC-5b Annual Burden Hours: 210,300 [(4,206,000 MCSA-5850s x 2 minutes/60 minutes) + (4,206,000 MECs x 30 seconds/3600 seconds) + (2,103,000 MECs x 1 minute/60 minutes)]

IC-5b Annual Number of Respondents: 56,360 (56,360 ME administrative personnel)¹⁴

IC-5b Annual Number of Responses: 10,515,000 (4,206,000 MCSA-5850s + 4,206,000 MECs + 2,103,000 MECs to motor carrier)

IC-5c: National Registry of Certified Medical Examiners - Providing Medical Examination Reports to FMCSA Upon Request

The National Registry requires administrative personnel of certified MEs to complete the following task. Time burden for the task is provided in the table below.

ME Administrative Personnel Task

Task	Minutes to Complete Task
Provide copies of MER forms to FMCSA upon request	5

As part of the National Registry of Certified Medical Examiners monitoring and auditing required by SAFETEA-LU, FMCSA estimates that authorized representatives of FMCSA will request MEs to provide copies of the MER Form 1,000 times a year. FMCSA has developed a plan to monitor and audit ME performance as required by SAFETEA-LU. The numbers being provided are an estimate and will be updated once accurate numbers become available. It is estimated that it will take ME administrative personnel 5 minutes to provide the MER Form to FMCSA upon request. The total annual time and cost burdens to respondents for reporting providing MER forms to FMCSA upon request are detailed in the table below.

Certified ME Administrative Personnel Annual Burden Hours and Salary Costs to Provide MER forms to FMCSA upon Request

Hourly wage of ME administrative personnel	Number of MER Forms requested per year	Time to provide MER Form to FMCSA	Annual hours to provide MER Forms to FMCSA	Annual salary costs for ME administrative personnel to provide MER forms to FMCSA
$22.87	1,000	5 minutes	83	$1,898

IC-5c Annual Burden Hours: 83 hours (1,000 MER forms x 5 minutes/60 minutes)

IC-5c Annual Number of Respondents: 56,360 (56,360 ME administrative personnel)

IC-5c Annual Number of Responses: 1,000 (1,000 MER forms)

IC-5d: National Registry of Certified Medical Examiners - Verification of National Registry Number

The National Registry requires administrative personnel of motor carriers to complete the following task. Time burden for the task is provided in the table below.

Motor Carrier Task

Task	Time to Complete Task
Verify national registry number, write a note regarding the verification, file note in DQ record	4 minutes

FMCSA estimates motor carriers will verify the national registry number for 4,206,000 drivers per year who are medically certified. It is estimated it will take motor carrier administrative personnel 4 minutes to verify the national registry number, write a note regarding the verification, and file the note in the DQ record. The total annual time and cost burdens to respondents for verification of the national registry number are detailed in the table below.

Motor Carrier Administrative Personnel Annual Burden Hours and Salary Costs to Verify National Registry Number, write a Note Regarding Verification, and File Note in DQ Record

Hourly wage of motor carrier administrative personnel	Number of times national registry number will be verified	Time to verify national registry number, write a note regarding the verification, file note in DQ record	Annual hours to verify national registry number, write a note regarding the verification, file note in DQ record	Annual salary costs for administrative personnel to verify national registry number, write a note regarding the verification, file note in DQ record
$21.17	4,206,000	4 minutes	280,400	$5,936,068

IC-5d Annual Burden Hours: 280,400 hours (4,206,000 verifications x 4 minutes/60 minutes)

IC-5d Annual Number of Respondents: 551,150 (551,150 motor carrier administrative personnel)

IC-5d Annual Number of Responses: 4,206,000 (4,206,000 verifications)

IC-5 Total Annual Burden Hours: 495,460 hours [(15,139 MEs x 15 minutes/60 minutes) + (10,708 MEs x 5 minutes/60 minutes) + (4,206,000 MCSA-5850s x 2 minutes/60 minutes) + (4,206,000 MECs x 30 seconds/3600 seconds) + (2,103,000 MECs x 1 minute/60 minutes) + (1,000 MER forms x 5 minutes/60 minutes) + (4,206,000 verifications x 4 minutes/60 minutes)]

IC-5 Total Annual Number of Respondents: 680,009 (15,139 + 56,360 + 56,360 + 551,150)

IC-5 Total Annual Number of Responses: 14,747,847 (25,847 + 10,515,000 + 1,000 + 4,206,000)

IC-6: Medical Examiner’s Certification Integration Final Rule

Annual Burden Hours for First 6 Years (6/22/15 – 6/22/21)

This section has been updated to maintain the annual burden hours and costs for the first 6 years instead of for the first 3 years. As the Medical Examiner’s Certification Integration final rule compliance date of June 22, 2018, approached, FMCSA reluctantly concluded that it would not be able to electronically transmit MEC information from the National Registry to the SDLAs nor would the SDLAs be able to electronically receive the MEC information from the National Registry for posting to the CDLIS driver record as intended by the Medical Examiner’s Certification Integration final rule. Due to a number of delays including an incident that occurred in early December 2017 causing the Agency to take the National Registry offline leading to interruptions in the development of the process for the electronic transmission of MEC information and medical variances, the final specifications for the electronic transmission of MEC information have not been completed. Under these circumstances, neither the Agency nor the stakeholders would be able to rely on the CDLIS driver record as official proof of medical certification unless drivers continue to provide the original paper MEC to the SDLAs, as is being done presently. All of the functions regarding electronic transmission of data that were to be implemented on June 22, 2018, are dependent upon the implementation of information technology infrastructure that was not be available on June 22, 2018. For this reason, on June 21, 2018, FMCSA published a notice (83 FR 28774) extending the compliance date for several of the provisions in the Medical Examiner’s Certification Integration final rule (80 FR 22790) extending the compliance date for several of the provisions in the Medical Examiner’s Certification Integration final rule (80 FR 22790) to June 22, 2021, to ensure that the SDLAs have sufficient time once the final specifications are released to make the necessary information technology programming changes. However, beginning on June 22, 2018, certified MEs are still required to report results of all completed CMV drivers’ medical examinations (including the results of examinations where the driver was found not to be qualified) to FMCSA by midnight (local time) of the next calendar day following the examination and must continue issuing the original paper MEC to qualified drivers. As a result of this extension, there are no additional annual burden hours or costs to respondents imposed by the Medical Examiner’s Certification Integration final rule during the first 6 years of implementation of the final rule. Therefore, all the IC activities imposed on the MEs, drivers, and motor carriers over the first 6 years of implementing the Medical Examiner’s Certification Integration final rule will remain unchanged.

Totals for IC-1, IC-2, IC-3, IC-4, IC-5, and IC-6 (first 6 years)

	Annual Burden Hours	Annual Respondents	Annual Responses
IC-1	1,892,700	4,813,510	16,824,000
IC-2	11	3	3
IC-3	4,430	7,332	7,332
IC-4	2,714	2,426	2,426
IC-5	495,460	680,009	14,747,847
IC-6*	0	0	0
Total	2,395,315	65,503,280	31,581,608

*IC-6 does not have any annual burden hours, respondents, or responses.

7^th and Subsequent Years

Annual Burden Hours for 7^th and Subsequent Years

There are no additional annual burden hours or costs to respondents imposed by the Medical Examiner’s Certification Integration final rule during the 7^th and subsequent years of implementation. However, MEs will no longer be required to complete and furnish the original written MEC (IC-1) to the driver examined when the driver is a CDL/CLP holder. This information will be electronically transmitted to the SDLA. In addition, employers will no longer be required to verify the ME’s National Registry (IC-5d) number for CDL/CLP driver examinations because only certified MEs listed on the National Registry will be able to forward MEC information to the National Registry. Therefore, there will be a net reduction in the information collection requirements defined in the Medical Examiner’s Certification Integration final rule during the 7^th and subsequent years. IC-6a and IC-6b below provide details of the reduction in annual burden hours and costs.

IC-6a: Medical Examiner’s Certification Integration Final Rule – National Registry Reporting CMV Driver Medical Examination Results

Population of CMV Drivers for Written MEC (Completing and Providing a Copy to Driver)

Baseline	Exams every 2 years – ½ of that population	Adjustment for out-of-cycle exams	Drivers receiving MECs annually
2,000,00015	1,000,000	40.20%	1,402,000

The Medical Examiner’s Certification Integration final rule requires the ME to complete the following task. The time burden for this task is provided in the table below.

ME Task to Complete and Furnish Copy of MEC to Driver Examined

Task	Time to Complete Task
Complete and furnish one copy of MEC to driver	1 minute

FMCSA estimates that the number of times per year that administrative personnel of certified MEs will enter and transmit CMV driver medical examination results to the National Registry via the MCSA-5850 is 4,206,000 times. FMCSA estimates that MEs will handwrite 2,032,900 MECs per year for intrastate and interstate non-CDL/CLP holders. The total annual time and cost burdens to respondents for this task are detailed in the table below.

ME Annual Burden Hours and Salary Costs to Complete and Furnish Copy of MEC to Driver Examined

Hourly wage of ME	Number of written MECs issued	Time to complete and furnish copy of MEC to driver	Annual hours to complete and furnish copy of MEC to driver	Annual salary costs for ME to complete and furnish copy of MEC to driver
$89.67	1,402,000	1 minute	23,367	$2,095,319

Changes to IC-1 (beginning 6/22/21)

Total Annual Burden Hours for MER/MEC

Annual hours to complete, document, and file MER Form	Annual hours to complete and furnish copy of MEC to driver	Annual hours for drivers to complete health history section of MER Form	Annual hours for motor carrier administrative personnel to file MEC in DQ record	Total annual burden hours
1,402,000	23,367	350,500	70,100	1,845,967

Total Annual Salary Costs for MER/MEC

Annual salary costs for MEs	Annual salary costs for CMV drivers	Annual salary costs for motor carrier administrative personnel	Total annual salary costs
$127,563,307	$10,515,000	$1,484,017	$139,562,324

IC-1 Annual Burden Hours: 1,845,967 [(4,206,000 drivers x 20 minutes/60 minutes) + (4,206,000 MECs x 1 minute/60 minutes) + (4,206,000 drivers x 5 minutes/60 minutes) + 1,402,000 MECs x 1 minute/60 minutes)]

IC-1 Annual Number of Respondents: 4,813,510 (4,206,000 drivers + 56,360 MEs¹⁶ + 551,150 motor carrier administrative personnel¹⁷)

IC-1 Annual Number of Responses: 14,020,000 (4,206,000 health history + 4,206,000 MER Forms + 1,402,000 MECs issued + 4,206,000 MECs filed)

IC-6b: Medical Examiner’s Certification Integration Final Rule – National Registry Verification of National Registry Number

Population for Verification of National Registry Number

Baseline	Exams every 2 years – ½ of that population	Adjustment for out-of-cycle exams	Drivers receiving MECs annually
700,00018	350,000	40.20%	490,700

Changes to IC-5d (beginning 6/22/21)

The Medical Examiner’s Certification Integration final rule requires administrative personnel of motor carriers to complete 1 task. The time burden for the task is provided in the table below.

Motor Carrier Administrative Personnel Task

Task	Time to Complete Task
Verify national registry number, write a note regarding verification, file note in DQ record	4 minutes

FMCSA will be providing medical certification information to the SDLAs from only those MEs who are certified and listed on the National Registry. Therefore, verification of the ME’s national registry number will not be required for CDL/CLP drivers. FMCSA estimates that motor carriers will need to verify the National Registry number for 490,700 interstate non-CDL drivers who are medically certified per year. It is estimated that it will take the motor carrier administrative personnel 4 minutes to verify the national registry number, write a note regarding the verification, and file the note in the DQ record. The total annual time and cost burdens to respondents for verifying the national registry number are detailed in the table below.

Motor Carrier Administrative Personnel Annual Burden Hours and Salary Costs to Verify National Registry Number, Write Note Regarding Verification, and File Note in DQ Record

Hourly wage of motor carrier administrative personnel	Number of times the national registry number will need to be verified	Time to verify national registry number, write note regarding verification, file note in DQ record	Annual hours to verify national registry number, write note regarding verification, file note in DQ record	Annual salary costs for motor carrier administrative personnel to verify national registry number, write note regarding verification, file note in DQ record
$21.17	490,700	4 minutes	32,713	$692,534

Changes to IC-5d

IC-5d Annual Burden Hours: 32,713 hours (490,700 verifications x 4 minutes/60 minutes)

IC-5d Annual Number of Respondents: 551,150 (551,150 motor carrier administrative personnel)

IC-5d Annual Number of Responses: 490,700 (490,700 verifications)

Changes to IC-5

IC-5 Total Annual Burden Hours: 247,473 hours [(15,139 MEs x 15 minutes/60 minutes) + (10,708 MEs x 5 minutes/60 minutes) + (4,206,000 MCSA-5850s x 2 minutes/60 minutes) + (4,206,000 MECs x 30 seconds/3600 seconds) + (2,103,000 MECs x 1 minute/60 minutes) + (1,000 MER forms x 5 minutes/60 minutes) + (490,700 verifications x 4 minutes/60 minutes)]

IC-5 Total Annual Number of Respondents: 680,009 (15,139 + 56,360 + 56,360 + 551,150)

IC-5 Total Annual Number of Responses: 11,032,547 (25,847 + 10,515,000 + 1,000 + 490,700)

Totals for IC-1, IC-2, IC-3, IC-4, IC-5, and IC-6 (7^th and subsequent years)

	Annual Burden Hours	Annual Respondents	Annual Responses
IC-1	1,845,967	4,813,510	14,020,000
IC-2	11	3	3
IC-3	4,430	4,503	7,559
IC-4	2,714	1,326	2,426
IC-5	247,773	680,009	11,032,547
IC-6*	0	0	0
Total	2,100,895	5,499,351	25,062,535

*IC-6 does not have any annual burden hours, respondents, or responses but resulted in decreases to IC-1 and IC-5.

Total Annual Burden Hours for ICR: 2,100,895 hours (1,845,967 hours for IC-1 + 11 hours for IC-2 + 4,430 hours for IC-3 + 2,714 hours for IC-4 + 247,773 hours for IC-5 + 0 hours for IC-6)

Total Annual Number of Respondents for ICR: 5,499,351 (4,813,510 + 3 + 4,503 + 1,326 + 680,009 + 0)

Total Annual Number of Responses for ICR: 25,062,535 (14,020,00 + 3 + 7,559 + 2,426 + 11,032,547 + 0)

current approved IC Annual Burden Hours and Costs

The table below represents the current approved annual burden hours and salary and wage costs for all approved IC activities.

Current Approved IC Annual Burden Hours and Salary Costs (First 6 years of IC-6)

IC Activities for MEs, Drivers, and Motor Carriers	Current Annual Burden Hours for the IC Activities	Current Annual Salary and Wage Costs for the IC Activities
FMCSA Physical Qualification Standards: Medical Examination Report Form and Medical Examiner’s Certificate	1,892,700	$144,002,224
Resolution of Medical Conflict	11	$272
Diabetes Exemption Program	2,599	$77,749
Vision Exemption Program	1,725	$51,573
Hearing Exemptions	33	$981
Seizure Exemptions	73	$2,172
SPE	2,714	$81,267
Medical Examiner Registration and Medical Examiner Test Results (upload)	4,677	$356,349
Reporting CMV Driver Medical Examination Results and filing and providing MEC	210,300	$4,809,562
Providing Medical Examination Report Copies to FMCSA	83	$1,898
Verification of National Registry Number	280,400	5,936,068
Total	2,395,315	$155,320,115

Current Approved IC Annual Burden Hours and Salary Costs (7^th and subsequent years of IC-6)

IC Activities for MEs, Drivers, and Motor Carriers	Current Annual Burden Hours for the IC Activities	Current Annual Salary and Wage Costs for the IC Activities
FMCSA Physical Qualification Standards: Medical Examination Report Form and Medical Examiner’s Certificate	1,845,967	$139,562,324
Resolution of Medical Conflict	11	$272
Diabetes Exemption Program	2,599	$77,749
Vision Exemption Program	1,725	$51,573
Hearing Exemptions	33	$981
Seizure Exemptions	73	$2,172
SPE	2,714	$81,267
Medical Examiner Registration and Medical Examiner Test Results (upload)	4,677	$356,349
Reporting CMV Driver Medical Examination Results and filing and providing MEC	210,300	$4,809,562
Providing Medical Examination Report Copies to FMCSA	83	$1,898
Verification of National Registry Number	32,713	692,534
Total	2,100,895	$145,636,681

IC-7: Qualifications of Drivers; Diabetes Standard

The purpose of the Qualifications of Drivers; Diabetes Standard final rule is to permit drivers with a stable insulin regimen and properly controlled ITDM to operate CMVs in interstate commerce. Currently, drivers with ITDM are prohibited from driving CMVs in interstate commerce unless they obtain an exemption from the Federal diabetes standard set forth in 49 CFR § 391.41(b)(3). The final rule enables an ITDM individual to obtain a MEC from a certified ME for up to a maximum of 12 months if the TC, the healthcare professional who manages, and prescribes insulin for, the treatment of the individual’s diabetes, certifies to the certified ME that the individual maintains a stable insulin regimen and proper control of his or her diabetes, and the certified ME determines that the individual meets FMCSA’s physical qualification standards. Certified MEs would be able to certify drivers with ITDM for up to 12 months provided:

1. The TC provides information to the certified ME via the Insulin-Treated Diabetes Mellitus Assessment Form, MCSA-5870, on which the TC certifies that the individual maintains a stable insulin regimen and proper control of his or her diabetes.

2. The certified ME receives the Insulin-Treated Diabetes Mellitus Assessment Form, MCSA-5870, no later than 45 days after it has been completed and signed by the individual’s TC for each physical qualification examination.

3. The certified ME performs a physical qualification examination, considers the information provided by the TC, and determines that the individual meets FMCSA’s physical qualification standards in 49 C.F.R. §§ 391.41(b) and 391.46 and can safely operate a CMV.

In effect, the final rule removes the information collection requirement for the Diabetes Exemption Program (IC-3a) and adds a new information collection (IC-7) for the TC to provide the Insulin-Treated Diabetes Mellitus Assessment Form, MCSA-5870, to the ME following an examination of the driver.

Population of CMV Drivers with ITDM

Drivers Receiving Completed Form from TC Annually

4,906¹⁹

The Qualifications of Drivers; Diabetes Standard final rule requires the TC to complete the following task. The time burden for this task is provided in the table below.

TC Task

Task	Time to Complete Task
Complete the Insulin-Treated Diabetes Mellitus Assessment Form, MCSA-5870	8 minutes

FMCSA estimates that the number of times per year that TCs will complete the Insulin-Treated Diabetes Mellitus Assessment Form, MCSA-5870, evaluating the health of the driver being treated for diabetes, is4,906. The total annual time and cost burdens to respondents for this task are detailed in the table below.

TC Annual Burden Hours and Salary Costs to Complete a Form Evaluating the Health of a CMV Driver with ITDM

Hourly wage of TC	Number of forms completed	Time to complete form	Annual hours to complete forms	Annual salary costs for TC to complete forms
$92.38	4,906	8 minutes	654	$60,416

As described in the table above, the Qualifications of Drivers; Diabetes Standard as provided in the final rule will add 6654 annual burden hours and $$60,417 annual salary costs. However, eliminating the Diabetes Exemption Program results in 2,599 less annual burden hours and $77,749 less annual salary costs. Therefore, the Qualifications of Drivers; Diabetes Standard as provided in the final rule will provide a total decrease of 1,945 in annual burden hours and $16,162 in salary costs.

TOTALS – INFORMATION COLLECTION TASKS FOR ALL MEDICAL QUALIFICATION REQUIREMENTS

The table below represents the proposed annual burden hours and salary and wage costs for all approved IC activities with the addition of a proposed IC-7 and elimination of the Diabetes Exemption Program.

Proposed Total Annual Burden Hours and Salary Costs (First 6 years IC-6)

IC Activities for MEs, Drivers, and Motor Carriers	Proposed Annual Burden Hours for the IC Activities	Proposed Annual Salary and Wage Costs for the IC Activities
FMCSA Physical Qualification Standards: Medical Examination Report Form and Medical Examiner’s Certificate	1,892,700	$144,002,224
Resolution of Medical Conflict	11	$272
Vision Exemption Program	1,725	$51,573
Hearing Exemptions	33	$981
Seizure Exemptions	73	$2,172
SPE	2,714	$81,267
Medical Examiner Registration	3,785	$339,401
Medical Examiner Test Results (upload)	892	$16,948
Reporting CMV Driver Medical Examination Results and filing and providing MEC	210,300	$4,809,562
Providing Medical Examination Report Copies to FMCSA	83	$1,898
Verification of National Registry Number	280,400	$5,936,068
Completing form for ITDM Drivers	654	$60,417
Total	$2,393,370	$155,302,783

Proposed Total Annual Burden Hours and Salary Costs (7^th and subsequent years IC-6)

IC Activities for MEs, Drivers, and Motor Carriers	Proposed Annual Burden Hours for the IC Activities	Proposed Annual Salary and Wage Costs for the IC Activities
FMCSA Physical Qualification Standards: Medical Examination Report Form and Medical Examiner’s Certificate	1,845,967	$139,562,324
Resolution of Medical Conflict	11	$272
Vision Exemption Program	1,725	$51,573
Hearing Exemptions	33	$981
Seizure Exemptions	73	$2,172
SPE	2,714	$81,267
Medical Examiner Registration	3,785	$339,401
Medical Examiner Test Results (upload)	892	$16,948
Reporting CMV Driver Medical Examination Results and filing and providing MEC	210,300	$4,809,562
Providing Medical Examination Report Copies to FMCSA	83	$1,898
Verification of National Registry Number	32,713	$692,534
Completing form for ITDM Drivers	654	$60,417
Total	2,098,963	$145,619,349

Hourly Wage Data

Driver hourly wage data used in the analysis are obtained from the Bureau of Labor Statistics (BLS) Occupational Employment Statistics 2016 Occupational Profiles²⁰ and 2016 BLS Quarterly Releases of Employer Costs of Employee Compensation.²¹ The average wage for heavy truck drivers and intercity bus drivers is $20.53 per hour, to which is added $9.54 for hourly benefits ($9.54 = ($9.62 + $9.50 + $9.47 + $9.57)/4). This results in a total hourly labor cost of $30.07, rounded to $30 hereinafter ($30.07 = $20.53 + $9.54).

ME average hourly wage is a weighted average of hourly wages for healthcare professionals in practice areas that are eligible to apply for certification on the National Registry. Medical Doctor (MD) is a one of the practice areas included in the list of MEs listed on the National Registry. This analysis assumes that this practice area includes internists and family and general practice physicians. The weighted average hourly wage for these physicians is then included in the derivation of the average hourly wage for all practice areas that encompass the National Registry. The table below shows the BLS Occupational Codes for the practice areas included in the weighted average hourly wages for MDs.

Derivation of Medical Doctor Average Wage
Practice Area and BLS Occupational Code	Number of Providers (BLS Data)	% of Total MEs	Hourly Wage	Weighted Average Wage
Internist (29-1063)	122,970	73.1%	$96.54	$70.55
Family, General Practice (29-1062)	45,290	26.9%	$97.04	$26.12
Average Hourly Wage	168,260	100.0%		$96.67

The $96.67 average hourly wage and population for MDs is included in the calculation of the weighted average hourly wage for all practice areas that are eligible to apply for certification and listing on the National Registry. The weighted average is based on the distribution of MEs listed on the National Registry on May 12, 2017. The table below summarizes the calculation of the $68.95 weighted average hourly to which is added $21.09 per hour for benefits, the sum of which is $96.67.²²

Practice Area (BLS Occupational Code)	Number of Medical Examiners (National Registry Data)	% of Total MEs	Hourly Wage	Weighted Average Hourly Wage
Chiropractor (29-1011)	3,586	6.5%	$39.04	$2.55
MD (29-1062 and 29-1063)	18,462	33.6%	$96.67	$32.46
Nurse Practitioner (29-1171)	18,038	32.8%	$50.30	$16.50
Occupational Therapist (29-1121)	5	0.0%	$40.25	$0.00
Osteopath (29-1069)	4,182	7.6%	$98.83	$7.52
Physician's Assistant (29-1071)	10,709	19.5%	$49.08	$9.56
Physical Therapist (29-1123)	8	0.0%	$41.93	$0.01
Average Wage	54,990	100%		$68.59
Benefits				$21.09
Average Wage with Benefits				$89.68

Employees of MEs, motor carriers, and testing organizations that perform administrative tasks related to recording, dissemination, and recordkeeping of medical data and MECs are included in the estimate of the overall reporting burden. Motor carriers also have administrative tasks associated with preparation and submission of applications for medical conflict resolution. The average hourly wages for these are those for occupations defined by BLS that are consistent with the nature of the tasks and whether the employer is a motor carrier, ME, or testing organization. The average hourly wages with benefits for these individuals are obtained from the same BLS sources described above. The average hourly wages with benefits are summarized in the table below. Benefits account for approximately 28% of the hourly wage.²³

Employer/BLS Occupation (Occupational Code)	Hourly Wage with Benefits
Motor Carrier: Information and File Clerk (43-4000)	$21.17
Motor Carrier: Human Resources-Non-Payroll Staff (43-4071)	$24.69
Medical Examiner: Medical Transcriptionist (43-1461)	$22.87
Testing Organization: File Clerk (43-4071)	$19.00

13. ESTIMATE OF TOTAL ANNUAL COSTS TO RESPONDENTS

There are no other estimated annual costs to respondents.

14. ESTIMATE OF COST TO THE FEDERAL GOVERNMENT

IC-1: Physical Qualification Standards

The cost to the Federal government due to the medical examination process requirements is minimal because FMCSA does not receive or process the documents.

IC-2: Resolution of Medical Conflict

The cost to the Federal government for the resolution of medical conflict is minimal; there are only about three cases per year submitted to FMCSA for resolution of conflicting medical opinions.

IC-3a: Diabetes Exemption Program

Contractors supporting the Diabetes Exemption Program currently cost the Federal Government $1.025M. There is no specific cost to the government for government personnel incurred by this IC, as all government personnel are working within their normal position duties. It is estimated that the contracting officer’s representative (COR) spends an average of 10% of his or her time on this IC²⁴, which is 208 hours²⁵. Hourly employee compensation for the COR is shown in the table below.

Estimate of COR hourly employee compensation (Federal Government)²⁶

Federal Wage Series	Occupation	General Schedule Designation	Hourly Wage	Locality Pay Adjustment	Fringe Benefit Rate	Hourly Cost
610	Nurse Consultant	14 Step 5	$48.69	28.22%	28.00%	$79.79

The COR will spend approximately 208 hours annually working on this contract. This leads to an estimated annual cost of $16,621.45 (208 annual hours x $79.91 = $16,621.45).

Estimated total annual cost of COR Federal Labor

Federal Wage Series	Occupation	General Schedule Designation	Yearly Hours Worked	Total Annual Cost to Government
610	Nurse Consultant	14 Step 5	208	$16,621.45

Therefore, the total annual cost to the Federal government is $1.042M. However, as part of the Qualifications of Drivers; Diabetes Standard final rule, this program will be eliminated.

IC-3b: Vision Exemption Program

Contractors supporting the Vision Exemption Program currently cost the Federal Government $727,385. There is no specific cost to the government for government personnel incurred by this IC, as all government personnel are working within their normal position duties. It is estimated that the COR spends an average of 10% of his or her time on this IC²⁷, which is 208 hours. Hourly employee compensation for the COR is shown in the table below.

Estimate of COR hourly employee compensation (Federal Government)²⁸

Federal Wage Series	Occupation	General Schedule Designation	Hourly Wage	Locality Pay Adjustment	Fringe Benefit Rate	Hourly Cost
610	Nurse Consultant	14 Step 5	$48.69	28.22%	28.00%	$79.91

The COR will spend approximately 208 hours annually working on this contract. This leads to an estimated annual cost of $16,621.45 (208 annual hours x $79.71 = $16,621,45).

Estimated total annual cost of COR Federal Labor

Federal Wage Series	Occupation	General Schedule Designation	Yearly Hours Worked	Total Annual Cost to Government
610	Nurse Consultant	14 Step 5	208	$16,621.45

Therefore, the total annual cost to the Federal government is $744,006.

IC-3c: Hearing Exemptions

Hearing exemptions are processed by a Nurse Consultant. It is estimated that the employee spends an average of 40% of their time on this IC²⁹, which is 832 hours. Hourly employee compensation is shown in the table below.

Estimate of hourly employee compensation (Federal Government)³⁰

Federal Wage Series	Occupation	General Schedule Designation	Hourly Wage	Locality Pay Adjustment	Fringe Benefits Rate	Hourly Cost
343	Program and Management Analyst	12 Step 5	$34.65	28.22%	28.00%	$56.87

The employee will spend approximately 832 hours annually processing hearing exemptions. This leads to an estimated annual cost of $47,314.29 (832 annual hours x $56.87 = $47,314.29).

Estimated total annual cost of Federal Labor

Federal Wage Series	Occupation	General Schedule Designation	Yearly Hours Worked	Total Annual Cost to Government
343	Program and Management Analyst	12 Step 5	832	$47,319.29

Therefore, the total annual cost to the Federal government for hearing exemptions is $47,319.29.

IC-3d: Seizure Exemptions

Seizure exemptions are processed by a Nurse Consultant. It is estimated that the employee spends an average of 40% of their time on this IC³¹, which is 832 hours. Hourly employee compensation is shown in the table below.

Estimate of hourly employee compensation (Federal Government)³²

Federal Wage Series	Occupation	General Schedule Designation	Hourly Wage	Locality Pay Adjustment	Fringe Benefit Rate	Hourly Cost
343	Program and Management Analyst	12 Step 5	$34.65	28.22%	28.00%	$56.87

The employee will spend approximately 832 hours annually processing seizure exemptions. This leads to an estimated annual cost of $47,314.29 (832 annual hours x $56.87 = $47,314.29).

Estimated total annual cost of Federal Labor

Federal Wage Series	Occupation	General Schedule Designation	Yearly Hours Worked	Total Annual Cost to Government
343	Program and Management Analyst	12 Step 5	832	$47,314.29

Therefore, the total annual cost to the Federal government for seizure exemptions is $47,314.29.

IC-4: SPE Certificate Program

The SPE program is implemented at each of the four FMCSA Service Centers. Currently, there are two full-time Medical Program Specialists (GS-12 and GS-13) that are responsible for two Service Centers each. These personnel spend 100% of their time on the SPE program, processing new and renewal SPE applications. This includes analyzing the SPE applications and supporting documentation including factorial analysis and processing of SPE certificate forms; analyzing paperwork provided by the certified evaluator; consulting with the Division Administrator and issuing the SPE certificate; program reporting and data management; and recordkeeping. Hourly employee compensation is shown in the table below.

Estimate of hourly employee compensation (Federal Government)³³

Federal Wage Series	Occupation	General Schedule Designation	Hourly Wage	Locality Pay Adjustment	Fringe Benefit Rate	Hourly Cost
301	Medical Program Specialist	12 Step 5	$34.65	27.47%	28.00%	$56.54
301	Medical Program Specialist	13 Step 5	$41.07	21.16%	28.00%	$63.69

These are full time employees whose job as Medical Program Specialists is to process SPE applications. This leads to an estimated annual cost of $250,076 (2,080 annual hours x $56.64 + 2,080 annual hours x $63.69 = $250,076).

Estimated total annual cost of Federal Labor

Federal Wage Series	Occupation	General Schedule Designation	Yearly Hours Worked	Total Annual Cost to Government
301	Medical Program Specialist	12 Step 5	2080	$117,593.83
301	Medical Program Specialist	13 Step 5	2080	$132,482.12

Therefore, the annual cost to the Federal government for the SPE certificate program is approximately $250,076.

IC-5: National Registry of Certified Medical Examiners

The Agency is currently in the 7^th year of the National Registry system implementation. Therefore, the cost to the Federal government for the Interagency Agreement that supports the National Registry has decreased to include only annual operations and maintenance costs, infrastructure support, system security, help desk, communications, and analysis of $577,824. The operations and maintenance costs include hosting of the database, data input, database security, ME account access, customer support for users, and continuity of operations. In addition, FMCSA has developed a plan to monitor and audit ME performance as required by SAFETEA-LU. This plan will be implemented by one FMCSA staff person at a GS-09 grade level. This person will spend approximately 90% of their time, 1,872 hours annually, monitoring and auditing ME performance³⁴. It is estimated that the COR spends an average of 10% of his or her time on this IC³⁵, which is 208 hours. Hourly employee compensation is shown in the tables below.

Estimate of hourly employee compensation (Federal Government)³⁶

Federal Wage Series	Occupation	General Schedule Designation	Hourly Wage	Locality Pay Adjustment	Fringe Benefit Rate	Hourly Cost
343	Program and Management Analyst	9 Step 5	$23.89	28.22%	28.00%	$39.21

The employee will spend approximately 1,872 hours annually monitoring and auditing ME performance. This leads to an estimated annual cost of $57,358 (1,872 annual hours x $30.64 = $57,358).

Estimated total annual cost of Federal Labor

Federal Wage Series	Occupation	General Schedule Designation	Yearly Hours Worked	Total Annual Cost to Government
343	Program and Management Analyst	9 Step 5	1872	$73,398.59

Estimate of COR hourly employee compensation (Federal Government)³⁷

Federal Wage Series	Occupation	General Schedule Designation	Hourly Wage	Locality Pay Adjustment	Fringe Benefit Rate	Hourly Cost
343	Program and Management Analyst	12 Step 5	$34.65	28.22%	28.00%	$56.87

The COR will spend approximately 208 hours annually working on this contract. This leads to an estimated annual cost of $11,828.57 (208 annual hours x $56.87 = $11,828.57).

Estimated total annual cost of COR Federal Labor

Federal Wage Series	Occupation	General Schedule Designation	Yearly Hours Worked	Total Annual Cost to Government
343	Program and Management Analyst	12 Step 5	208	$11,828.57

Therefore, the total annual cost to the Federal government for the National Registry is $663,051

IC-6: Medical Examiner's Certification Integration Final Rule

The total annual cost for the Medical Examiner’s Certification Integration final rule is approximately $894,724.

FMCSA estimated the cost of modifying the National Registry system to provide medical certification and variance information to the States electronically including analysis/requirements development, application development, infrastructure support, security, help desk, communications, and analysis provided through an interagency agreement, will cost the following:

Year 1 - $268,200

Year 2 - $472,500

Year 3 - $210,000

In addition, there will be annual operations and maintenance costs of $577,824.

For purposes of this Supporting Statement, averaging the development costs over the first 3 years of implementation and adding annual operations and maintenance costs for the first 3 years yields an annual cost of

$894,724 [$950,700/3 years = $316,900 + $577,824 for a total of $894,724].

There is no specific cost to the government for government personnel incurred by this IC, as all government personnel are working within their normal position duties. It is estimated that the COR spends an average of 10% of his or her time on this IC³⁸, which is 208 hours. Hourly employee compensation for the COR is shown in the table below.

Estimate of COR hourly employee compensation (Federal Government)³⁹

Federal Wage Series	Occupation	General Schedule Designation	Hourly Wage	Locality Pay Adjustment	Fringe Benefit Rate	Hourly Cost
343	Program and Management Analyst	12 Step 5	$56.87	28.22%	28.00%	$56.87

The COR will spend approximately 208 hours annually working on this contract. This leads to an estimated annual cost of $11,828.57 (208 annual hours x $56.87 = $11,828.57).

Estimated total annual cost of COR Federal Labor

Federal Wage Series	Occupation	General Schedule Designation	Yearly Hours Worked	Total Annual Cost to Government
343	Program and Management Analyst	12 Step 5	208	$11,828.57

Therefore, the total annual cost to the Federal government for this IC is $906,553.

IC-7: Qualifications of Drivers: Diabetes Standard Final Rule

There is no cost to the Federal Government for the Qualifications of Drivers; Diabetes Standard final rule. However, there is a cost savings of approximately $1.042 M annually because the Federal Government would no longer conduct the Diabetes Exemption Program.

TOTAL - ALL MEDICAL QUALIFICATION REQUIREMENTS

The total annual cost to the Federal government for all medical certification requirements is as follows:

IC	Annual Cost to the Federal Government
IC-3 Exemption Programs	$838,635
IC-4 SPE Certificate Program	$250,076
IC-5 National Registry	$663,051
IC-6 Medical Examiner’s Certification Integration Final Rule	$906,553
IC-7 Qualifications of Drivers; Diabetes Standard NPRM	$0
Total	$2,658,315

Annual Cost to Federal Government: $2,658,315 ($744,006 for the Vision Exemption Program + $47,314 for Hearing Exemptions + $47,314 for Seizure Exemptions + $250,076 for the SPE Certificate Program + $663,051 for National Registry + $906,553 for Medical Examiner’s Certification Integration Final Rule)

15. EXPLANATION OF PROGRAM CHANGES OR ADJUSTMENTS

Program change – due to a net increase in information collection requirements defined in the Qualification of Drivers; Diabetes Standard final rule. The Qualifications of Drivers; Diabetes Standard proposes to add 654 annual burden hours and $60,417 annual salary costs. However, eliminating the Diabetes Exemption Program results in 2,599 less annual burden hours and $77,749 less annual salary costs. Therefore, the final rule would provide a net decrease of1,945 in annual burden hours and $17,332 in salary costs from the proposed updated annual burden hours and costs.

Current Approved Annual Burden Hours for all ICs for the next 3 years	2,395,315
Proposed Annual Burden Hours for all ICs for the next 3 years	2,393,370
Total Decrease in Annual Burden Hours for all ICs for the next 3 years	1,945
Current Approved Annual Burden Hours for all ICs for 7th and subsequent years	2,100,895
Proposed Annual Burden hours for all ICs for 7th and subsequent years	2,098,950
Total Decrease in Annual Burden Hours for all ICs for 7th and subsequent years	1,945

16. PUBLICATION OF RESULTS OF DATA COLLECTION

This information would not be published with the following exception.

National Registry Medical Examiner Registration Data: As indicated, this data is used to provide the public with contact information for those medical professionals who have satisfactorily completed the certification test and are listed on the National Registry. MEs listed on the National Registry elect to have their contact and professional information listed in a public, online database.

17. APPROVAL FOR NOT DISPLAYING THE EXPIRATION DATE OF OMB APPROVAL

FMCSA is not seeking an exemption for displaying the expiration date of the OMB approval.

18. EXCEPTIONS TO CERTIFICATION STATEMENT

There are no exceptions to the certification statement.

Part B. Collections of Information Employing Statistical Methods

This IC does not employ statistical methodologies.

1Treating clinician means a healthcare professional who manages, and prescribes insulin for, the treatment of the driver’s diabetes mellitus as authorized by the healthcare professional’s applicable State licensing authority.

2 FMCSA 2016 Pocket Guide to Large Truck and Bus Statistics – 6 M CMV Drivers

3FMCSA 2016 Pocket Guide to Large Truck and Bus Statistics.

4Number of certified MEs listed on the National Registry as of October 11, 2017.

5Estimated number of motor carriers based on FMCSA 2016 Pocket Guide to Large Truck and Bus Statistics.

6 Data reported by FMCSA contractor for the Diabetes Exemption Program.

7Data reported by FMCSA contractor for Vision Exemption Program.

8Data reported by the Medical Programs Division.

9Previously, renewal numbers were not available.

10Data reported by Medical Programs Division.

11Previously, renewal numbers were not available.

12Data reported by FMCSA Service Centers for FY17.

13Data reported by Medical Programs Division.

14Number of certified MEs listed on the National Registry as of October 11, 2017.

156,000,000 CMV drivers less the sum of 3.1M interstate CDL drivers 900,000 intrastate CDL drivers = 2,000,000.

16Number of certified MEs listed on the National Registry as of October 11, 2017.

17Estimated number of motor carriers based on FMCSA 2016 Pocket Guide to Large Truck and Bus Statistics.

18700,000 interstate non-CDL drivers in FMCSA 2016 Pocket Guide to Large Truck and Bus Statistics.

19Calculation based on the number of ITDM individuals that would comply with the exemption program in the absence of the final rule. This value equals the three-year average of the sum of (1) 3,945 FMCSA active exemptions as of December 31, 2016, (2) the Agency’s estimate of 934 ITDM individuals holding intrastate CDLs and exemptions issued under a State exemption program, and (3) annual growth of 27 ITDM individuals who would comply with the rule, or an exemption program, in the absence of the final rule..

20 The BLS data is available at https://www.bls.gov/oes/current/oes_stru.htm (Accessed April 25,2017). The occupational codes for truck drivers and transit/intercity bus drivers are 53-3032 and 53-3021, respectively. s

21 The Employer Costs of Employee Compensation Quarterly News Releases are available at: https://www.bls.gov/ect/ (Accessed April 17, 2017). The hourly benefits are reported in Table 9 of the Quarterly News Releases.

22Quarterly News Releases, Table 9, Management and Professionals, All Service Industries.

23 BLS 2016 Quarterly News Releases, Table 9, Sales and Office, All Service Industries.

24Information obtained from current contract COR.

25Based on a 2,080-hour work year.

26Office of Personnel Management, “2018 General Schedule (GS) Locality Pay Tables,” January 2018. https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/2018/general-schedule (accessed July 17, 2018).

27Information obtained from current contract COR.

28Office of Personnel Management, “2018 General Schedule (GS) Locality Pay Tables,” January 2018. https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/2018/general-schedule (accessed July 17, 2018).

29Information obtained from current employee.

30Office of Personnel Management, “2018 General Schedule (GS) Locality Pay Tables,” January 2018. https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/2018/general-schedule (accessed July 17, 2018).

31Information obtained from current employee.

32Office of Personnel Management, “2018 General Schedule (GS) Locality Pay Tables,” January 2018. https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/2018/general-schedule (accessed July 17, 2018).

33Office of Personnel Management, “2018 General Schedule (GS) Locality Pay Tables,” January 2018. https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/2018/general-schedule (accessed July 17, 2018).

34Information obtained from Medical Programs Division Chief.

35Information obtained from current contract COR.

36Office of Personnel Management, “2018 General Schedule (GS) Locality Pay Tables,” January 2018. https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/2018/general-schedule (accessed July 17, 2018).

37Office of Personnel Management, “2018 General Schedule (GS) Locality Pay Tables,” January 2018. https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/2018/general-schedule (accessed July 17, 2018).

38Information obtained from current contract COR.

39Office of Personnel Management, “2018 General Schedule (GS) Locality Pay Tables,” January 2018. https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/2018/general-schedule (accessed July 17, 2018).

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