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 August 31, 2018. This revision is due to the Agency’s anticipation of a final rule to revise its regulations to eliminate the blanket prohibition against insulin-dependent diabetic individuals’ operation of commercial motor vehicles (CMV) in interstate commerce. The final rule is based on the Agency’s 2015 Notice of Proposed Rulemaking (NPRM) and subsequent announcement of the availability of recommendations provided by FMCSA’s Medical Review Board (MRB) after an analysis of the comments received in response to the NPRM. The primary purpose of the Qualifications of Drivers: Diabetes Standard NPRM is to permit drivers with stable, well-controlled insulin-treated diabetes mellitus (ITDM) to operate commercial motor vehicles (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 NPRM proposes to allow drivers with ITDM to operate a CMV in interstate commerce if the treating clinician1 (TC) provides documentation to the certified Medical Examiner (ME) that the condition is stable and well-controlled. The NPRM proposes to remove the information collection requirement for the Diabetes Exemption Program and add a new information collection requirement for the TC to provide written notification to the ME following an examination of the driver. However, based on the MRB’s analysis of the comments received and their recommendations, FMCSA is considering replacing the TC statement with a form titled Insulin-Treated Diabetes Mellitus Assessment Form to be completed by the TC and provided to the ME. The addition of this requirement will add 33,616 annual burden hours and $2,823,744 annual salary costs. However, eliminating the Diabetes Exemption Program will result in 2,219 less annual burden hours and $68,645 less annual salary costs. Therefore, the final rule would provide a net increase of 31,397 in annual burden hours and $2,755,099 in salary costs from the proposed updated annual burden hours and costs.
Part A. Justification
CIRCUMSTANCES THAT MAKE THE COLLECTION OF INFORMATION NECESSARY
FMCSA’s current regulations require that CMV operators meet certain physical qualifications 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 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 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 that outline specific criteria to be approved for 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 hearing 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.’’ Title 49 CFR § 381.300 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 21st 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 two 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 developed an example or template that drivers could use to apply 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 30 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 53 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)
Persons 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. 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 MERs 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 Med-Cert 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:
Certified MEs performing medical examinations on CMV drivers to use a newly developed MER Form, MCSA-5875, in place of the current MER Form.
Certified MEs to use Form MCSA-5876 for the MEC.
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.
For applicants/holders of CLP/CDLs (interstate and intrastate), FMCSA to electronically transmit 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. 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.
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 due to the Agency’s development of a NPRM titled, Qualifications of Drivers: Diabetes Standard (80 FR 25260), and subsequent announcement of the availability of recommendations provided by FMCSA’s Medical Review Board (MRB) after an analysis of the comments received in response to the NPRM (81 FR 62448).
The purpose of the Qualifications of Drivers: Diabetes Standard NPRM is to permit drivers with stable, well-controlled ITDM to operate CMVs in interstate commerce. The NPRM proposed to allow drivers with ITDM to operate a CMV in interstate commerce if the TC provides written notification to the ME that the driver’s condition is stable and well-controlled. This proposal would enable drivers with ITDM to obtain a MEC for up to 1 year from a certified ME listed on the National Registry provided:
The driver monitors and maintains blood glucose records as determined by the TC and submits those records to the TC at the time of the TC evaluation.
The TC evaluates the driver and provides written notification to the ME that the driver has had no severe hypoglycemic reaction and has properly managed the diabetes during the last 12 months.
The ME examines the driver in accordance with 49 CFR 391.43 and determines that the driver has stable, well-controlled diabetes, is free of complications that might impair the ability to operate a CMV, and meets all the other qualifying standards in 49 CFR 391.41(b).
However, based on the MRB’s analysis of the comments received and their recommendations, FMCSA is considering replacing the TC statement with a form to be completed by the TC and provided to the ME. This information is necessary for the ME, with input from the TC, to make a qualification determination based on whether or not the driver meets all the other physical qualification requirements of 49 CFR 391.41(b) to operate a CMV and whether or not the driver is effectively managing his/her diabetes in a way that ensures he/she is able to 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. 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 Federal 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 used this conservatively high estimation since the Agency doesn’t 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 in order for our highways to be safe. FMCSA is the Federal government agency authorized to require the collection of this information, and the authorizing regulations are located at 49 CFR 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 MERs 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:
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 MERs 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 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 MERs 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.
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.
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.
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.
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 NPRM titled Qualifications of Drivers: Diabetes Standard, and subsequent announcement of the availability of recommendations provided by FMCSA’s Medical Review Board (MRB) after an analysis of the comments received in response to the NPRM (81 FR 62448). The purpose of the Qualifications of Drivers: Diabetes Standard NPRM is to permit drivers with stable, well-controlled ITDM to operate CMVs in interstate commerce. The NPRM proposed to allow drivers with ITDM to operate a CMV in interstate commerce if the TC provides written notification to the ME that the condition is stable and well-controlled. However, based on the MRB’s analysis of the comments received and their recommendations, FMCSA is considering replacing the TC statement with a form, the Insulin Treated Diabetes Mellitus Assessment Form, to be completed by the TC and provided to the ME. The information provided by the TC will enable the ME to make a qualification determination based on whether or not the driver meets all the other physical qualification requirements of 49 CFR 391.41(b) to operate a CMV and whether or not the driver is effectively managing his/her diabetes in a way that ensures he/she is able 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 MERs 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 NPRM is to permit drivers with stable, well-controlled ITDM to operate CMVs in interstate commerce. The NPRM proposed to allow drivers with ITDM to operate a CMV in interstate commerce if the TC provides written notification to the ME that the condition is stable and well-controlled. However, based on the MRB’s analysis of the comments received and their recommendations, FMCSA is considering replacing the TC statement with a form to be completed by the TC and provided to the ME.
FMCSA proposes to allow the statement from the TC to be provided to the ME, if they choose to do so, using electronic communication such as fax and/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 MERs 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 Procedures Act allows for public comment which would provide a means of 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 a 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 form to the ME certifying that the driver’s condition is stable and well-controlled 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 he or she already 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, MERs, 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 MERs 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.
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 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.
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
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 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 Federal 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 used this conservatively high estimation since the Agency doesn’t 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 5.6M 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 31 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 3,668,000 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 |
5,600,000 |
2,800,000 |
31% |
3,668,000 |
IC-1: FMCSA Physical Qualification Standards
Information Collection Tasks of the Medical Examination, MER, 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 |
20 minutes |
Complete and furnish one copy of the MEC to the driver |
1 minutes |
Driver Task
Task |
Time to Complete Task |
Complete driver health history portion of the MER |
5 minutes |
Motor Carrier Tasks
Task |
Time to Complete Task |
File MEC in DQ record |
1 minutes |
It takes a ME approximately 20 minutes to complete, document, and file the MER. It takes the driver 5 minutes to complete the health history section of the MER. 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, and MEC are detailed in the tables below.
ME Annual Burden Hours and Salary Costs to Complete, Document, and File MER
Hourly wage of ME |
Number of drivers examined |
Time to complete, document, and file MER |
Annual hours to complete, document, and file MER |
Annual salary cost for ME to complete, document, and file MER |
$89.00 |
3,668,000 |
20 minutes |
1,223,000 |
$108,847,000 |
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 |
$89.00 |
3,668,000 |
1 minute |
61,000 |
$5,429,000 |
CMV Driver Annual Burden Hours and Salary Costs to Complete the Health History Section of the MER
Hourly wage of CMV driver |
Number of drivers examined |
Time to complete health history section of MER |
Annual hours for drivers to complete health history section of MER |
Annual salary costs for drivers to complete health history section of MER |
$31.00 |
3,668,000 |
5 minutes |
305,700 |
$9,476,700 |
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 |
$19.00 |
3,668,000 |
1 minute |
61,000 |
$1,159,000 |
Total Annual Burden Hours for MER/MEC
Annual hours to complete, document, and file MER |
Annual hours to complete and furnish copy of MEC to driver |
Annual hours for drivers to complete health history section of MER |
Annual hours for motor carrier administrative personnel to file MEC in DQ record |
Total annual burden hours |
1,223,000 |
61,000 |
305,700 |
61,000 |
1,650,700 |
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 |
$114,276,000 |
$9,476,700 |
$1,159,000 |
$124,911,700 |
IC-1 Annual Burden Hours: 1,650,700[(3,668,000 drivers x 20 minutes/60 minutes) + (3,668,000 MECs x 1 minute/60 minutes) + (3,668,000 drivers x 5 minutes/60 minutes) + 3,668,000 MECs x 1 minute/60 minutes)]
IC-1 Annual Number of Respondents: 4,248,000(3,668,000 drivers + 40,000 MEs4 + 540,000 motor carrier administrative personnel5)
IC-1 Annual Number of Responses: 14,672,000(3,668,000 health history + 3,668,000 MERs + 3,668,000 MECs issued + 3,668,000 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 is 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 |
$22 |
3 |
1 hour |
3 |
$66 |
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 |
$22 |
1 |
8 hours |
8 |
$176 |
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 |
$66 |
$176 |
$242 |
IC-2 Annual Burden Hours: 11 hours [(3 applications x 1 hour) + (1 application x 8 hours)]
IC-2 Annual Number of Respondents: 540,000 (540,000 motor carriers)
IC-2 Annual Number of Responses: 3
IC-3 Exemptions
IC-3a: Diabetes Exemption Program
The Diabetes Exemption 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 |
Tine to Complete Task |
Complete new diabetes exemption application |
1 hour |
Complete renewal diabetes exemption application |
1 hour |
Provide copy of MER to FMCSA |
2 minutes |
Motor Carrier Task
Task |
Time to Complete Task |
Copy and file exemption in DQ record |
1 minute |
There are approximately 1,297 new applications for diabetes exemptions submitted annually, and it takes an average of 1 hour to complete an application6. There are approximately 874 renewals submitted annually, and it takes an average of 1 hour to complete a renewal application. There are currently 2,088 active diabetes exemptions and an average of 728 exemptions are issued per year. FMCSA estimates that it takes the driver 2 minutes to provide a copy of the MER 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 |
$31.00 |
1,297 |
1 hour |
1,297 |
$40,207 |
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 |
$31.00 |
874 |
1 hour |
874 |
$27,094 |
CMV Driver Annual Burden Hours and Salary Costs to Provide MER with Diabetes Exemption Application
Hourly wage of CMV Driver |
Number of diabetes exemption applications per year |
Time to provide MER to FMCSA |
Annual hours to provide MER to FMCSA |
Annual salary costs for CMV Driver to provide MER to FMCSA |
$31.00 |
2,171 |
1 minute |
36 |
$1,116 |
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 |
$19.00 |
728 |
1 minute |
12 |
$228 |
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 to FMCSA
|
Annual hours for motor carrier administrative personnel to copy and file diabetes exemption |
Total annual burden hours |
1,297 |
874 |
36 |
12 |
2,219 |
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 to FMCSA |
Annual salary costs for motor carrier administrative personnel to copy and file diabetes exemption |
Total annual salary costs |
$40,207 |
$27,094 |
$1,116 |
$228 |
$68,645 |
IC-3a Annual Burden Hours: 2,219 hours [(1,297 new applications x 1 hour) + (874 renewal applications x 1 hour) + (2,171 exemptions x 1 minute/60 minutes) + (728 exemptions x 1 minute/60 minutes)]
IC-3a Annual Number of Respondents: 542,171 (2,171 drivers + 540,000 motor carrier administrative personnel)
IC-3a Annual Number of Responses: 2,899 (2,171 applications + 728 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 |
3 minutes |
There are approximately 1,316 new applications for vision exemptions submitted annually, and it takes approximately 1 hour for a driver to complete the application7. There are approximately 890 renewal applications for vision exemptions submitted annually, and it takes approximately 1 hour for a driver to complete the application. Currently, there are 2,355 active vision exemptions and an average of 612 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 |
$31.00 |
1,316 |
1 hour |
1,316 |
$40,796 |
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 |
$31.00 |
890 |
1 hour |
890 |
$27,590 |
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 |
$19.00 |
612 |
1 minute |
10 |
$190 |
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 |
1,316 |
890 |
10 |
2,216 |
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 |
$40,796 |
$27,590 |
$190 |
$68,576 |
IC-3b Annual Burden Hours: 2,216 hours [(1,316 new applications x 1 hour) + (890 renewal applications x 1 hour) + (612 exemptions x 1 minute/60 minutes)]
IC-3b Annual Number of Respondents: 542,206 (2,206 drivers + 540,000 motor carrier administrative personnel)
IC-3b Annual Number of Responses: 2,818 (2,206 applications + 612 exemptions)
IC-3c: Hearing Exemptions
To apply for a hearing exemption, it requires drivers and motor carriers to complete the following 2 tasks. Time burdens for each task are provided in the tables below.
Driver Task
Task |
Time to Complete Task |
Complete application for new hearing exemption |
15 minutes |
Motor Carrier Task
Task |
Time to Complete Task |
Copy and file exemption in DQ file |
1 minute |
There are approximately 190 new applications for hearing exemptions filed annually8. An exemption is valid for 2 years, but may be renewed. Because the Agency just began granting hearing exemptions in 2013, there have not been any renewals to report. Currently, there are 70 active drivers with hearing exemptions. It takes an estimated 15 minutes for a driver to complete an application for a hearing exemption. 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 |
$31.00 |
190 |
15 minutes |
48 |
$1,488 |
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 |
$19.00 |
70 |
1 minute |
1 |
$19.00 |
Total Annual Burden Hours for Hearing Exemptions
Annual hours for drivers to complete new hearing exemption application |
Annual hours for motor carrier administrative personnel to copy and file hearing exemptions |
Total annual burden hours for hearing exemptions |
48 |
1 |
49 |
Total Annual Salary costs for Hearing Exemptions
Annual Salary costs for drivers to complete new hearing exemption application |
Annual salary costs for motor carrier administrative personnel to copy and file hearing exemptions |
Total annual salary costs |
$1,488 |
$19.00 |
$1,507.00 |
IC-3c Annual Burden Hours: 49 hours [(190 new applications x 15 minutes/60 minutes) + (70 exemptions x 1 minute/60 minutes)]
IC-3c Annual Number of Respondents: 540,190 (190 drivers + 540,000 motor carrier administrative personnel)
IC-3c Annual Number of Responses: 260 (190 applications + 70 exemptions)
IC-3d: Seizure Exemptions
To apply for a seizure exemption, it requires drivers and motor carriers to complete the following 2 tasks. Time burdens for each task are provided in the tables below.
Driver Task
Task |
Time to Complete Task |
Complete application for new seizure exemption |
30 minutes |
Motor Carrier Task
Task |
Tine to Complete Task |
Copy and file exemption in DQ file |
1 minute |
There are approximately 120 new applications for seizure exemptions filed annually9. An exemption is valid for two years, but may be renewed. Because the Agency just began granting seizure exemptions in 2013, there have not been any renewals to report. Currently, there are 80 active drivers with seizure exemptions. It takes an estimated 30 minutes for a driver to complete an application for a seizure exemption. 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 |
$31.00 |
120 |
30 minutes |
60 |
$1,860 |
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 |
$19.00 |
80 |
1 minute |
1 |
$19.00 |
Total Annual Burden Hours for Seizure Exemptions
Annual hours for drivers to complete new seizure exemption application |
Annual hours for motor carrier administrative personnel to copy and file seizure exemptions |
Total annual burden hours for seizure exemptions |
60 |
1 |
61 |
Total Annual Salary Costs for Seizure Exemptions
Annual Salary costs for drivers to complete new seizure exemption application |
Annual salary costs for motor carrier administrative personnel to copy and file seizure exemptions |
Total annual salary costs for seizure exemptions |
$1,860 |
$19.00 |
$1,879 |
IC-3d Annual Burden Hours: 61 hours [(120 new applications x 30 minutes/60 minutes) + (80 exemptions x 1 minute/60 minutes)]
IC-3d Annual Number of Respondents: 540,120 (120 drivers + 540,000 motor carrier administrative personnel)
IC-3d Annual Number of Responses: 200 (120 applications + 80 exemptions)
IC-3 Total Annual Burden Hours: 4,545 hours [(1,297 new applications x 1 hour) + (874 renewal applications x 1 hour) + (2,171 exemptions x 1 minute/60 minutes) + (728 exemptions x 1 minute/60 minutes) + (1,316 new applications x 1 hour) + (890 renewal applications x 1 hour) + (612 exemptions x 1 minute/60 minutes) + (190 new applications x 15 minutes/60 minutes) + (70 exemptions x 1 minute/60 minutes) + (120 new applications x 30 minutes/60 minutes) + (80 exemptions x 1 minute/60 minutes)]
IC-3 Total Annual Number of Respondents: 2,164,687 (542,171 + 542,206 + 540,190 + 540,120)
IC-3 Total Annual Number of Responses: 6,177 (2,899 + 2,818 + 260 + 200)
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 |
Tine to Complete Task |
Complete application for new SPE |
2 hours |
Complete application for SPE renewal |
2 hours |
Provide copy of MER 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 3,295 active SPE certificates10. An SPE certificate is valid for 2 years. There are approximately 700 new SPE applications each year. It takes a driver approximately 2 hours to complete the application for a new SPE certificate. There are approximately 900 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 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 |
$31.00 |
700 |
2 hours |
1,400 |
$43,400 |
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 |
$31.00 |
900 |
2 hours |
1,800 |
$55,800 |
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 |
$31.00 |
1,600 |
2 minutes |
53 |
$1,643 |
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 |
$19.00 |
1,100 |
1 minute |
18 |
$342 |
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 |
3,200 |
53 |
18 |
3,271 |
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 |
$99,200 |
$1,643 |
$342 |
$101,185 |
IC-4 Annual Burden Hours: 3,271 hours [(700 new applications x 2 hours) + (900 renewal applications x 2 hours) + (1,600 applications x 2 minutes/60 minutes) + (1,100 SPE certificates x 1 minute/60 minutes)]
IC-4 Annual Number of Respondents: 541,600 (1,600 drivers + 540,000 motor carrier administrative personnel)
IC-4 Annual Number of Responses: 2,700 (1,600 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 Task
Task |
Minutes to Complete Task |
Provide registration information |
15 |
Testing Organization Task
Task |
Minutes to Complete Task |
Upload ME test results to FMCSA |
5 |
It is estimated that at least 40,000 ME candidates will have registered and applied to take the certification test annually for the first 2 years of National Registry implementation, or an average of 20,000 applicants per year for the first 2 years. However, FMCSA anticipates the number of MEs registering will decrease noticeably after the first 2 years of implementation. 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 20,000 ME candidates annually. It takes private-sector testing organization personnel approximately 5 minutes to collect and upload to FMCSA data and test results. However, FMCSA anticipates the number of MEs taking the certification test will decrease noticeably after the first 2 years of implementation. 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
Annual salary 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 |
20,000 |
15 minutes |
5,000 |
$445,000 |
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 |
20,000 |
5 minutes |
1,667 |
$31,673 |
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 |
5,000 |
1,667 |
6,667 |
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 |
$445,000 |
$31,673 |
$476,673 |
IC-5a Annual Burden Hours: 6,667 hours [(20,000 MEs x 15 minutes/60 minutes) + (20,000 MEs x 5 minutes/60 minutes)]
IC-5a Annual Number of Respondents: 21,000 (20,000 MEs + 1,000 test centers11)
IC-5a Annual Number of Responses: 40,000 (20,000 registrations + 20,000 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 estimates12 that respondents will provide CMV driver examination data a maximum of 12 times per year for 3,668,000 examinations conducted and will file 3,668,000 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 |
$18 |
3,668,000 |
2 minutes |
122,267 |
$2,200,806 |
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 |
$18 |
3,668,000 |
30 seconds |
30,567 |
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 |
$18 |
1,834,000 |
1 minute |
30,567 |
$550,206 |
Total Annual Burden Hours for Reporting CMV Driver Medical Examination Results
Annul 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 |
122,267 |
30,567 |
30,567 |
183,401 |
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 |
$2,200,806 |
$550,206 |
$550,206 |
$3,301,218 |
IC-5b Annual Burden Hours: 183,401[(3,668,000 MCSA-5850s x 2 minutes/60 minutes) + (3,668,000 MECs x 30 seconds/3600 seconds) + (1,834,000 MECs x 1 minute/60 minutes)]
IC-5b Annual Number of Respondents: 40,000 (40,000 ME administrative personnel)13
IC-5b Annual Number of Responses: 9,170,000(3,668,000 MCSA-5850s + 3,668,000 MECs + 1,834,000 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 MERs 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 1,000 times a year. The specifics of the National Registry monitoring and auditing plan are still in the planning stages; therefore, this is being provided as 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 to FMCSA upon request. The total annual time and cost burdens to respondents for reporting providing MERs to FMCSA upon request are detailed in the table below.
Certified ME Administrative Personnel Annual Burden Hours and Salary Costs to Provide MERs to FMCSA upon Request
Hourly wage of ME administrative personnel |
Number of MERs requested per year |
Time to provide MER to FMCSA |
Annual hours to provide MERs to FMCSA |
Annual salary costs for ME administrative personnel to provide MERs to FMCSA |
$18.00 |
1,000 |
5 minutes |
83 |
$1,494 |
IC-5c Annual Burden Hours: 83 hours (1,000 MERs x 5 minutes/60 minutes)
IC-5c Annual Number of Respondents: 40,000 (40,000 ME administrative personnel)
IC-5c Annual Number of Responses: 1,000 (1,000 MERs)
IC-5d: National Registry of Certified Medical Examiners - Verification of National Registry Number
The National Registry requires administrative personnel of motor carrier 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 3,668,000 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 |
$19.00 |
3,668,000 |
4 minutes |
244,533 |
$4,646,127 |
IC-5d Annual Burden Hours: 244,533 hours (3,668,000 verifications x 4 minutes/60 minutes)
IC-5d Annual Number of Respondents: 540,000 (540,000 motor carrier administrative personnel)
IC-5d Annual Number of Responses: 3,668,000 (3,668,000 verifications)
IC-5 Total Annual Burden Hours: 434,684hours [(20,000 MEs x 15 minutes/60 minutes) + (20,000 MEs x 5 minutes/60 minutes) + (3,668,000 MCSA-5850s x 2 minutes/60 minutes) + (3,668,000 MECs x 30 seconds/3600 seconds) + (1,834,000 MECs x 1 minute/60 minutes) + (1,000 MERs x 5 minutes/60 minutes) + (3,668,000 verifications x 4 minutes/60 minutes)]
IC-5 Total Annual Number of Respondents: 641,000 (21,000 + 40,000 + 40,000 + 540,000)
IC-5 Total Annual Number of Responses: 12,879,000(40,000 + 9,170,000 + 1,000 + 3,668,000)
IC-6: Medical Examiner’s Certification Integration Final Rule
Annual Burden Hours for First 3 Years
There are no additional annual burden hours or costs to respondents imposed by the Medical Examiner’s Certification Integration final rule during the first 3 years of implementation of the final rule. Therefore, all the IC activities imposed on the MEs, drivers, and motor carriers over the first 3 years of implementing the Medical Examiner’s Certification Integration final rule will remain unchanged.
4th and Subsequent Years
Annual Burden Hours for 4th 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 4th and subsequent years of implementation. However, MEs will no longer be required to complete and furnish a written copy of the 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 is a net reduction in the information collection requirements defined in the Medical Examiner’s Certification Integration final rule during the 4th 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 |
2,600,00014 |
1,300,000 |
31% |
1,703,000 |
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 3,668,000 times. FMCSA estimates that MEs will handwrite 1,703,000 MECs per year for inter- and intrastate 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 |
$89.00 |
1,703,000 |
1 minute |
28,383 |
$2,526,087* |
* This provides a time savings of 32,617 hours and a cost savings of $2,902,913/year to IC-1
Changes to IC-1
Total Annual Burden Hours for MER/MEC
Annual hours to complete, document, and file MER |
Annual hours to complete and furnish copy of MEC to driver |
Annual hours for drivers to complete health history section of MER |
Annual hours for motor carrier administrative personnel to file MEC in DQ record |
Total annual burden hours |
1,223,000 |
28,383 |
305,700 |
61,000 |
1,618,083 |
IC-1 Annual Burden Hours: 1,618,083 [(3,668,000 drivers x 20 minutes/60 minutes) + (1,703,000 MECs x 1 minute/60 minutes) + (3,668,000 drivers x 5 minutes/60 minutes) + 3,668,000 MECs x 1 minute/60 minutes)]
IC-1 Annual Number of Respondents: 4,248,000 (3,668,000 drivers + 40,000 MEs15 + 540,000 motor carrier administrative personnel16)
IC-1 Annual Number of Responses: 12,707,000 (3,668,000 health history + 3,668,000 MERs + 1,703,000 MECs issued + 3,668,000 MECs filed)
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 |
$111,373,087 |
$9,476,700 |
$1,159,000 |
$122,008,787 |
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 |
500,00017 |
250,000 |
31% |
327,500 |
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 327,500 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 |
$19.00 |
327,500 |
4 minutes |
21,833 |
$414,827 * |
*This provides a time savings of 222,700 hours and a cost savings of $4,231,300 to IC-5d.
Changes to IC-5d
IC-5d Annual Burden Hours: 21,833 hours (327,500 verifications x 4 minutes/60 minutes)
IC-5d Annual Number of Respondents: 540,000 (540,000 motor carrier administrative personnel)
IC-5d Annual Number of Responses: 327,500 (327,500 verifications)
Changes to IC-5
IC-5 Total Annual Burden Hours: 211,984 hours [(20,000 MEs x 15 minutes/60 minutes) + (20,000 MEs x 5 minutes/60 minutes) + (3,668,000 MCSA-5850s x 2 minutes/60 minutes) + (3,668,000 MECs x 30 seconds/3600 seconds) + (1,834,000 MECs x 1 minute/60 minutes) + (1,000 MERs x 5 minutes/60 minutes) + (327,500 verifications x 4 minutes/60 minutes)]
IC-5 Total Annual Number of Respondents: 641,000 (21,000 + 40,000 + 40,000 + 540,000)
IC-5 Total Annual Number of Responses: 9,538,500 (40,000 + 9,170,000 + 1,000 + 327,500)
Therefore, as a result of the Medical Examiner’s Certification Integration final rule, the annual burden hours for IC-1 have decreased by 462,267 hours and the annual burden hours for IC-5 have decreased by 334,116 hours for a total of 796,383 less annual burden hours. The annual costs for IC-1 have decreased by $2,902,913 and the annual costs of IC-5 have decreased by $4,231,300 for a total cost savings of $7,134,213.
Totals for IC-1, IC-2, IC-3, IC-4, IC-5, and IC-6
|
Annual Burden Hours |
Annual Respondents |
Annual Responses |
IC-1 |
1,618,083 |
4,248,000 |
12,707,000 |
IC-2 |
11 |
540,000 |
3 |
IC-3 |
4,545 |
2,164,687 |
6,177 |
IC-4 |
3,271 |
541,600 |
2,700 |
IC-5 |
211,984 |
641,000 |
9,538,500 |
IC-6* |
0 |
0 |
0 |
Total |
1,837,894 |
8,135,287 |
22,254,380 |
*IC-6 does not have any annual burden hours, respondents, or responses. Its implementation reduced the annual burden hours and responses for IC-1 and IC-5.
Total Annual Burden Hours for ICR: 1,837,894 hours (1,618,083 hours for IC-1 + 11 hours for IC-2 + 4,545 hours for IC-3 + 3,271 hours for IC-4 + 211,984 hours for IC-5 + 0 hours for IC-6)
Total Annual Number of Respondents for ICR: 8,135,287 (4,248,000 + 540,000 + 2,164,687 + 541,600 + 641,000 + 0)
Total Annual Number of Responses for ICR: 22,254,380 (12,707,000+ 3 + 6,177 + 27400 + 9,538,500 + 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
IC Activities for MEs, Drivers, and Motor Carriers |
Annual Burden Hours for the IC Activities |
Annual Salary and Wage Costs for the IC Activities |
FMCSA Physical Qualification Standards: Medical Examination Report Form and Medical Examiner’s Certificate |
1,618,083 |
$122,008,787 |
Resolution of Medical Conflict |
11 |
$242 |
Diabetes Exemption Program |
2,219 |
$68,645 |
Vision Exemption Program |
2,216 |
$68,576 |
Hearing Exemptions |
49 |
$1,507 |
Seizure Exemptions |
61 |
$1,879 |
SPE |
3,271 |
$101,185 |
Medical Examiner Registration |
5,000 |
$445,000 |
Medical Examiner Test Results (upload) |
1,667 |
$31,673 |
Reporting CMV Driver Medical Examination Results and filing and providing MEC |
183,401 |
$3,301,218 |
Providing Medical Examination Report Copies to FMCSA |
83 |
$1,494 |
Verification of National Registry Number |
21,833 |
$414,827 |
Total |
1,837,894 |
$126,445,033 |
IC-7: Qualifications of Drivers: Diabetes Standard
The primary purpose of the Qualifications of Drivers: Diabetes Standard NPRM is to permit drivers with stable, well-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 NPRM proposed to allow drivers with ITDM to operate a CMV in interstate commerce if the TC provides written notification to the ME that the condition is stable and well-controlled. This would enable drivers with ITDM to obtain a MEC for up to 1 year from a certified ME listed on the National Registry provided:
The driver monitors and maintains blood glucose records as determined by the TC and submits those records to the TC at the time of the TC evaluation.
The TC evaluates the person and provides documentation to the ME that the driver has had no severe hypoglycemic reaction and has properly managed the diabetes during the last 12 months.
The ME examines the driver in accordance with 49 CFR 391.43 and determines that the driver has stable, well-controlled diabetes, is free of complications that might impair the ability to operate a CMV, and meets all the other qualifying standards in 49 CFR 391.41(b).
The NPRM proposed to remove the information collection requirement for the Diabetes Exemption Program (IC-3a) and add a new information collection (IC-7) for the TC to provide written notification to the ME following an examination of the driver.
Population of CMV Drivers with ITDM
Drivers Receiving Statement from TC Annually |
209,66418 |
The Qualifications of Drivers: Diabetes Standard NPRM requires the TC to complete the following task. The time burden for this task is provided in the table below.
Treating Clinician Task
Task |
Time to Complete Task |
Write a statement evaluating the driver’s management of diabetes. |
3 minutes |
FMCSA estimates that the number of times per year that TCs will write statements evaluating the health of the driver being treated for diabetes is 209,664. 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 Write a Statement Evaluating the Health of a CMV Driver with ITDM
Hourly wage of TC |
Number of statements written |
Time to complete statement |
Annual hours to complete statements |
Annual salary costs for TC to complete statements |
$89.00 |
209,664 |
3 minutes |
10,483 |
$932,987 |
As described in the table above, the Qualifications of Drivers: Diabetes Standard as proposed in the NPRM will add 10,483 annual burden hours and $932,987 annual salary costs. However, eliminating the Diabetes Exemption Program results in 2,219 less annual burden hours and $68,645 less annual salary costs. Therefore, the Qualifications of Drivers: Diabetes Standard as proposed in the NPRM will provide a total increase of 8,264 in annual burden hours and $864,342 in salary costs.
However, based on the recommendations provided by FMCSA’s MRB after an analysis of the comments received in response to the NPRM, FMCSA is considering replacing the written notification from the TC with a form to be completed by the TC and provided to the certified ME. The information collected on the form could assist the ME in determining if the driver being examined has stable, well-controlled diabetes, is free of complications that might impair the ability to safely operate a CMV, and meets all the other qualifying standards in 49 CFR 391.41(b).
The information collection requirement for the Diabetes Exemption Program (IC-3a) will still be removed. The new information collection for the TC to provide the required form to the ME following an examination of the driver will become IC-7.
Population of CMV Drivers with ITDM
Drivers Receiving Completed form from TC Annually |
252,11719 |
The final rule would require the TC to complete the following task. The time burden for this task is provided in the table below.
Treating Clinician Task
Task |
Time to Complete Task |
Complete a required form evaluating the driver’s management of diabetes. |
8 minutes |
FMCSA estimates that the number of times per year that TCs would complete the required form evaluating the health of the driver being treated for diabetes is 252,117. 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 Write a Statement 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 |
$84.00 |
252,117 |
8 minutes |
33,616 |
$2,823,744 |
As described in the table above and based on the change to using a required form, the final rule would propose to add 33,616 annual burden hours and $2,823,744 annual salary costs. However, eliminating the Diabetes Exemption Program would result in 2,219 less annual burden hours and $68,645 less annual salary costs. Therefore, the final rule would propose a total increase of 31,397 in annual burden hours and $2,755,099 in salary costs.
TOTALS – INFORMATION COLLECTION TASKS FOR ALL MEDICAL QUALIFICATION REQUIREMENTS
Proposed Annual Burden Hours and Salary Costs
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 |
1,618,083 |
$122,008,787 |
Resolution of Medical Conflict |
11 |
$242 |
Vision Exemption Program |
2,216 |
$68,576 |
Hearing Exemptions |
49 |
$1,507 |
Seizure Exemptions |
61 |
$1,879 |
SPE |
3,271 |
$101,185 |
Medical Examiner Registration |
5,000 |
$445,000 |
Medical Examiner Test Results (upload) |
1,667 |
$31,673 |
Reporting CMV Driver Medical Examination Results and filing and providing MEC |
183,401 |
$3,301,218 |
Providing Medical Examination Report Copies to FMCSA |
83 |
$1,494 |
Verification of National Registry Number |
21,833 |
$414,827 |
Completed form for ITDM Drivers |
33,616 |
$2,823,744 |
Total |
1,869,291 |
$129,200,132 |
13. ESTIMATE OF TOTAL ANNUAL COSTS TO RESPONDENTS
Respondents’ salary costs associated with the burden hours are discussed above.
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 $910,000. However, as part of the Qualifications of Drivers: Diabetes Standard NPRM, this program will be eliminated.
IC-3b: Vision Exemption Program
Contractors supporting the Vision Exemption Program currently cost the Federal Government $727,385.
IC-3c: Hearing Exemptions
Hearing exemptions are processed by a Nurse Consultant that is a GS-12 with an average annual salary of $75,621. This person spends approximately 40% of their time processing hearing exemptions. Therefore, hearing exemptions approximate annual cost to the Federal Government is $30,248.
IC-3d:
Seizure Exemptions
Seizure exemptions are processed by a Nurse Consultant that is a GS-12 with an average annual salary of $75,621. This person spends approximately 40% of their time processing seizure exemptions. Therefore, seizure exemptions approximate annual cost to the Federal Government is $30,248.
IC-4: SPE Certificate Program
The SPE program is implemented at each of the four FMCSA Service Centers. Currently, there are two Medical Program Specialists (GS-12 with an average annual salary of $75,621) 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. The annual cost to the Federal government for the SPE certificate program is approximately $151,242.
IC-5: National Registry of Certified Medical Examiners
The Agency is currently in the 4th year of the National Registry system implementation. Therefore, the cost to the Federal government 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 that is a GS-09 with an approximate annual salary of $52,146. This person will spend approximately 90% of their time monitoring and auditing ME performance for an approximate annual cost of $46,931. Therefore, the total annual cost to the Federal government for the National Registry is $624,755.
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 and 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].
IC-7: Qualifications of Drivers: Diabetes Standard NPRM
There is no cost to the Federal Government for the Qualifications of Drivers: Diabetes Standard NPRM. However, there is a cost savings of approximately $966,000 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 |
$848,377 |
IC-4 SPE Certificate Program |
$151,242 |
IC-5 National Registry |
$624,755 |
IC-6 Medical Examiner’s Certification Integration Final Rule |
$894,724 |
IC-7 Qualifications of Drivers: Diabetes Standard NPRM |
$0 |
Total |
$2,519,098 |
Annual Cost to Federal Government: $2,519,098 ($787,881 for the Vision Exemption Program + $30,248 for Hearing Exemptions + $30,248 for Seizure Exemptions + $151,242 for the SPE Certificate Program + $624,755 for National Registry + $894,724 for Medical Examiner’s Certification Integration Final Rule + $0 for the Qualifications of Drivers: Diabetes Standard NPRM)
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 NPRM. The Qualifications of Drivers: Diabetes Standard proposes to add 33,616 annual burden hours and $2,823,744 annual salary costs, by adding IC7, the Insulin Treated Diabetes Mellitus Assessment Form. However, eliminating the Diabetes Exemption Program, IC3a, where each applicant is required to provide evaluations, a medical report, from a ME, driver record, etc., results in 2,219 less annual burden hours and $68,645 less annual salary costs. Therefore, adding one information collection, IC7, and eliminating the other, IC3a, would provide a total increase of 31,397 in annual burden hours and $2,755,099 in salary costs.
Currently Approved Annual Burden Hours |
2,633,702 |
Proposed Annual Burden Hours for the Qualifications of Drivers: Diabetes Standard NPRM |
1,869,291 |
TOTAL Change in Burden Hours |
2,633,702 – 1,869,291 = 764,411 |
Details of Burden Hour Changes: |
|
Change in Annual Burden Hours to IC7 (+33,616 hrs.) and IC3a (-2,219hrs.) due to the Qualifications of Drivers: Diabetes Standard |
31,397 (33,616 – 2,219) |
Change in Annual Burden Hours to IC1 (-462,267 hrs.) and IC5 (-334,116 hrs.) due the Medical Examiner’s Certification Integration Final rule |
-796,383 |
Change to IC3 (-35 hrs.) and IC4 (+610 hrs.) due to Adjustment in Agency Estimates |
575 (-35+610) |
Change in Approved and Proposed Burden Hours |
31, 397-796,383+575 = -764,411 |
Additionally, as a result of the Medical Examiner’s Certification Integration final rule, the annual burden hours for IC-1, have decreased by 462,267 hours and the annual burden hours for IC-5 have decreased by 334,116 hours resulting in a total of 796,383 less annual burden hours. Therefore, the total change in burden hours due to both the Medical Examiner’s Certification Integration Final rule, and the Qualifications of Drivers: Diabetes Standard, is an increase of 31,397 hours and a decrease of 796,383 hours, resulting in a decrease of 764,411 burden hours. The estimated number of respondents decreased by 12,218,782. There was an increase of 575 burden hours due to an adjustment in Agency estimates for IC3 and IC4. Therefore, the total difference in burden hours is a decrease in 764,411 burden hours, as shown in the table above.
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 not 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.
1 Treating clinician means a healthcare professional who manages and prescribes insulin for treatment of the driver’s diabetes mellitus as authorized by the healthcare professional’s applicable State licensing authority.
2 FMCSA 2014 Pocket Guide to Large Truck and Bus Statistics – 5.6M CMV Drivers
3 FMCSA 2014 Pocket Guide to Large Truck and Bus Statistics
4 Estimated number of MEs necessary to meet the CMV driver population demand for medical examinations, used in the National Registry of Certified Medical Examiners Final Rule.
5 Estimated number of motor carriers based on FMCSA 2014 Pocket Guide to Large Truck and Bus Statistics.
6 Data reported by FMCSA contractor for the Diabetes Exemption Program.
7 Data reported by FMCSA contractor for Vision Exemption Program.
8 Data reported by the Medical Programs Division.
9 Data reported by Medical Programs Division.
10 Data reported by FMCSA Service Centers for FY14
11 Number of test centers reported by PSI, Comira, and Prometric.
12 Data reported by Medical Programs Division
13 Estimated 40,000 MEs to meet demand so 40,000 administrative personnel to report driver medical examination results.
14 5,6000,000 CMV drivers minus 3M interstate CDL drivers = 2,600,000
15 Estimated number of MEs necessary to meet the CMV driver population demand for medical examinations, used in the National Registry of Certified Medical Examiners Final Rule.
16 Estimated number of motor carriers based on 2010 FMCSA fact sheet.
17 500,000 interstate non-CDL drivers in FMCSA 2014 Pocket Guide to Large Truck and Bus Statistics
18 Calculation based on 5,6000,000 CMV drivers x .144 CMV drivers diagnosed with diabetes x .26 CMV drivers use insulin treatment,
19 Number provided by MC-PRE
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| File Modified | 0000-00-00 |
| File Created | 2021-01-21 |