[Federal Register Volume 66, Number 147 (Tuesday, July 31, 2001)]
[Notices]
[Pages 39548-39553]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-19045]


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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2001-9800]


Qualification of Drivers; Exemption Applications; Diabetes

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of intent to issue exemptions and request for comments.

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SUMMARY: This notice announces the FMCSA's proposal to issue exemptions 
to certain insulin-using diabetic drivers of commercial motor vehicles 
(CMVs), from the diabetes mellitus prohibitions contained in the 
Federal Motor Carrier Safety Regulations (FMCSRs). The FMCSA requests 
comments on its proposed exemption program, but we are not accepting 
applications for exemptions at this time. If a decision to proceed with 
the exemption program is made, the exemptions would be granted only to 
those applicants who meet the specific conditions and comply with all 
the requirements of the exemption. Exemptions would be issued for a 
period of two years. After the two years, those holding exemptions 
would need to reapply for another two-year exemption.

DATES: Comments must be received on or before October 1, 2001.

ADDRESSES: You can mail, hand deliver, fax, or electronically submit 
written comments to the Docket Management Facility, U.S. Department of 
Transportation, Room PL-401, 400 Seventh Street, SW., Washington, DC 
20590; FAX (202) 493-2251, online at http://dmses.dot.gov/submit. 
Please include the docket number that appears in the heading of this 
document in your comment. You can examine and copy all comments from 9 
a.m. to 5 p.m., e.t., Monday through Friday, except Federal holidays at 
the docket facility. You can also examine the docket on the Internet at 
http://dms.dot.gov. If you want us to

[[Page 39549]]

notify you of receipt of your comments, please include a self-
addressed, stamped envelope or postcard, or after submitting comments 
electronically, print the acknowledgment page.

FOR FURTHER INFORMATION CONTACT: For further information about the 
proposed diabetes exemption program in this notice, Ms. Sandra 
Zywokarte, Office of Bus and Truck Standards and Operations, (202) 366-
2987; for information about legal issues related to this notice, Mr. 
Joseph Solomey, Office of the Chief Counsel, (202) 366-1374, FMCSA, 
Department of Transportation, 400 Seventh Street, SW., Washington, DC 
20590. Office hours are from 7:45 a.m. to 4:15 p.m., e.t., Monday 
through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Background

    The motor carrier regulatory functions of the Federal Highway 
Administration (FHWA) were transferred to the recently created Federal 
Motor Carrier Safety Administration (FMCSA). The history and delegation 
of authority to the FMCSA was published in the Federal Register on 
January 4, 2000 (65 FR 220). The agency established the current 
standard for diabetes in 1970 because several risk studies indicated 
that diabetic drivers had a higher rate of accident involvement than 
the general population. The diabetes requirement provides:
    A person is physically qualified to drive a commercial motor 
vehicle if that person has no established medical history or clinical 
diagnosis of diabetes mellitus currently requiring insulin for control. 
49 CFR 391.41(b)(3).
    Since 1970, the agency engaged in several activities to address the 
issue of diabetes and CMV operation. On March 28, 1977, the agency 
published an Advance Notice of Proposed Rulemaking (ANPRM) to solicit 
comments on the diabetes standard (42 FR 16452). The agency terminated 
this rulemaking in November 1977 without amending the standard, after 
determining that the more substantive comments and the literature cited 
in the ANPRM supported the prohibition against the operation of CMVs by 
insulin-using diabetics because of highway safety concerns. On November 
25, 1987, the agency published a new ANPRM (52 FR 45204) requesting 
comments on petitions from two individuals and the American Diabetes 
Association to eliminate the blanket prohibition against insulin-using 
diabetics and grant waivers on a case-by-case basis. In September 1987, 
a Conference on Diabetic Disorders and Commercial Drivers was held to 
review the diabetes standard in light of advances in the care of 
diabetics. Conference participants (physicians, scientists, federal 
officials and representatives from the motor carrier industry) 
recommended that some drivers with diabetes could be certified to drive 
depending upon insulin use and under certain conditions (absence of 
recurrent hypoglycemia, safe driving record, etc.) (Federal Highway 
Administration, Conference on Diabetic Disorders and Commercial 
Drivers; Final Report, 1988). Following this, the agency published a 
Notice of Proposed Rulemaking (55 FR 41208) requesting comments on a 
proposal to revise the diabetes standard to allow insulin-using 
diabetics to operate CMVs and sponsored a 1990 risk assessment that 
estimated various levels of accidents among diabetic drivers depending 
upon the severity of hypoglycemia (Federal Highway Administration, 
Insulin-using Commercial Motor Vehicle Drivers, 1992). The estimated 
level of accidents was deemed acceptable and a Notice of Intent to 
Issue Waivers was published in 1992. This led to a 1993 waiver program, 
based on a three-year safe driving record while using insulin and 
medical examinations by the required specialists.
    The diabetes waiver program, originally part of a research study, 
was terminated in 1996. The D.C. Circuit Court of Appeals had found 
that the initial determination that the agency's vision waiver program 
would not adversely affect the safe operation of CMVs was ``devoid of 
empirical support in the record'' and, therefore, contrary to law 
(Advocates for Highway and Auto Safety v. Federal Highway 
Administration, 28 F. 3d 1288 (D.C. Circuit 1994)). Although the 
decision initially affected only the vision waiver program, it had a 
direct effect on the diabetes program because of the similar approach 
used to prequalify drivers. Those drivers holding waivers at the 
program's termination were allowed to continue to operate CMVs in 
interstate commerce under grandfather provisions at 49 CFR 391.64.

Feasibility Study To Qualify Insulin-Treated Diabetics To Operate CMVs

    On June 9, 1998, the President signed the Transportation Equity Act 
for the 21st Century (TEA-21) (Pub. L. 105-178, 112 Stat. 107). Section 
4018 of the TEA-21 directed the Secretary of Transportation (the 
Secretary) to determine if it is feasible to develop a safe and 
practicable program for allowing individuals with insulin-treated 
diabetes mellitus (ITDM) to operate CMVs in interstate commerce. In 
making the determination, the Secretary was directed to evaluate 
research and other relevant information on the effects of ITDM on 
driving performance. TEA-21 stated that, to accomplish this, the 
Secretary shall consult the states with regard to their programs for 
CMV operation by ITDM drivers, evaluate the Department of 
Transportation's (DOT) policies in other modes of transportation, 
analyze pertinent risk data, consult with interested groups 
knowledgeable about diabetes and related issues, and assess the 
possible legal consequences of permitting ITDM individuals to operate 
CMVs in interstate commerce. TEA-21 also directed the Secretary to 
report the findings to Congress and, if a program is feasible, describe 
the elements of a protocol to permit individuals with ITDM to operate 
CMVs. The report was submitted to Congress on August 23, 2000, and 
concludes that a safe and practicable protocol to allow some ITDM 
individuals to operate CMVs is feasible. A copy of the report is 
included in the docket. The FMCSA's feasibility assessment included a 
review of background research on the risk of driving with diabetes. 
Although the relationship between diabetes and automobile crashes had 
been assessed since 1965, the epidemiological evidence from 1965 to 
1991 produced conflicting results. The lack of consistent results was 
in many cases caused by flawed methodology. Further, none of the 
studies addressed the operation of CMVs. With the termination of the 
waiver program and its research component, the agency lacked clear risk 
assessment information.
    A literature review was conducted on the treatment and management 
of ITDM. The research results showed positive findings. Six studies 
have been reported in the literature. The two largest and most reported 
studies (The Diabetes Control and Complications Trial and the United 
Kingdom Prospective Diabetes Study Group) represented the most 
extensive investigations of insulin therapy and had similar findings. 
Both showed that patients experienced reductions in blood glucose 
levels and significantly fewer microvascular complications with 
intensive treatment. However, the studies also showed significant 
adverse effects from insulin use, notably, a significantly higher rate 
of hypoglycemia.
    Investigation of the policies of other DOT modal administrations 
regarding ITDM showed that only the Federal Aviation Administration 
(FAA) has a well-developed program. In 1994, the

[[Page 39550]]

FAA determined that selected ITDM individuals can be considered for 
special issuance of a third-class Airman Medical Certificate under a 
screening, glucose management, and monitoring protocol. The program 
evolved through a series of steps in which the agency capitalized on 
its experience, reviewed relevant research, consulted medical experts, 
and considered comments from the public and interested organizations.
    As a part of its feasibility determination, the FMCSA examined how 
the states treated drivers with ITDM. Although the states have the 
option to apply the FMCSRs to the medical qualifications for intrastate 
CMV operators, they also have the flexibility to deviate from the 
FMCSRs. A few states have chosen to adopt the federal standards and not 
allow ITDM individuals to operate CMVs. Some states have granted 
grandfather rights to drivers who were already driving intrastate, 
while allowing no new drivers after a specific date. Other states have 
programs whereby drivers can apply for the opportunity to operate in 
intrastate commerce. Based on several surveys of the states and contact 
with individual states, the programs of four states (Utah, Michigan, 
Kentucky and Delaware) are presented in the report as examples of more 
extensive approaches. These states have screening, operating and 
monitoring protocols of varying degrees of intensity and coverage, but 
do not monitor results.
    The report presents four recent risk assessment studies (1995 to 
1997) that specifically address diabetes and the operation of CMVs. Two 
of the studies were performed in Canada, while the other two were 
conducted by the Office of Motor Carrier Safety (now the FMCSA). The 
first study analyzed insurance data for 1,307 truck drivers and found 
that diabetics operating smaller trucks had significantly higher 
accident rates (diabetics operating large combination trucks did not 
have higher rates) (Dionne, G., Desjardin, D., LaBerge-Nadeau, C. and 
Moag, U., ``Medical Conditions, Risk Exposure, and Truck Driver's 
Accidents: An Analysis with Count Data Regression Models,'' Accident 
Analysis and Prevention, 27(3), p. 295-305; 1995). Insulin use was not 
considered. The second Canadian study used the same database and 
concluded that diabetic drivers did not have accidents that were 
significantly more severe than those without the condition (severity 
was defined by injuries and fatalities). The third study used data from 
the FHWA waiver program (Federal Highway Administration, Final 
Descriptive Report: ``Qualifications of Drivers-Vision, Diabetes, 
Hearing and Epilepsy,'' 1997). The analysis of these data showed that 
the accident rate of the diabetes waiver program drivers was lower than 
the national rate. The last study looked at 723 ITDM drivers of large 
trucks and a comparison group of 1,297 drivers with commercial driver's 
licenses (Federal Highway Administration, ``A Preliminary Study of the 
Risk Associated with the Operation of Commercial Motor Vehicles by 
Drivers with Insulin-Treated Diabetes Mellitus,'' 1999). After 
adjustment for confounding, the results showed no significant 
differences between the two groups in accident rate or severity. The 
ITDM drivers in this study had at least 3 years experience operating a 
commercial vehicle with the condition. All of the recent studies 
specifically concerned with diabetes and CMV operation show that 
drivers with that condition have a level of safety that is the same or 
better than a comparison group or the national accident rate.
    The FMCSA also assembled a panel of physicians expert in the 
treatment of diabetes. The panel was asked to address the screening and 
monitoring issues that would be associated with a process to allow ITDM 
individuals to operate CMVs. Responding with written reports and 
through discussion at a meeting in Washington, DC, the panel expressed 
the opinion that advances in the treatment of diabetes make it possible 
both to control the disease and to permit the identification of those 
individuals capable of doing so. The panel identified methods to avoid 
acute complications, including hypoglycemia, and endorsed a protocol 
for monitoring glucose before and during the operation of a CMV. The 
panel concluded that from a medical standpoint a process was feasible 
for permitting some individuals with ITDM to operate CMVs.
    The report concludes that a safe and practicable protocol to allow 
some ITDM individuals to operate CMVs is feasible. The research on the 
treatment and management of ITDM, combined with the determinations of 
the medical panel, indicate that the disease and its adverse effects 
can be successfully controlled and monitored. Moreover, recent risk 
assessments provide evidence that diabetic CMV operators can perform in 
an acceptably safe manner. Finally, the program operated by the FAA and 
the analysis of the agency's diabetes waiver study program demonstrate 
that it is possible to screen and monitor ITDM individuals so that safe 
performance is feasible.
    The report further concludes that a viable program protocol for 
allowing individuals with ITDM to operate CMVs would require three 
components. The first is a screening component to identify qualified 
applicants. This process would examine the applicant's experience and 
safety in operating CMVs, the applicant's history of hypoglycemia, and 
the results of examinations by the required medical specialists 
(endocrinologists and ophthalmologists). The second component would 
provide guidelines for managing ITDM, including supplies to be used and 
the protocol for monitoring and maintaining appropriate blood glucose 
levels. The last component would specify the process to be used for 
monitoring ITDM commercial drivers. It would address the required 
medical examinations and the schedule for their submission. It also 
would indicate how glucose measures should be taken and reviewed, and 
specify how episodes of severe hypoglycemia and accidents should be 
reported. These components are based largely on the structure of the 
FAA and FHWA/FMCSA waiver programs. They are presented in detail in the 
report.
    Finally, the report addresses the legal consequences of permitting 
ITDM individuals to drive CMVs in interstate commerce. It was 
determined that the legal consequences of a rule (including a 
regulation, policy or standard adopted pursuant to the Administrative 
Procedure Act (APA)) fall into two categories: (1) An APA challenge to 
the validity of the rule and (2) tort liability for damages sustained 
in an accident involving an ITDM driver. The assessment concluded that 
these consequences are no different from those associated with any 
other rule involving driver standards and qualifications. For employers 
that hire ITDM drivers, the rule might expose them to new standards of 
responsibility for monitoring the health of drivers who meet federal 
guidelines.
    Based on the research presented in the Report to Congress, the 
FMCSA has decided that evidence and precedence indicate the appropriate 
form for implementing a process would be an exemption program. Evidence 
indicates that diabetes is a chronic disease which requires constant 
control, especially ITDM, and needs, therefore, ongoing monitoring to 
ensure that the disease is under control. The evidence also strongly 
suggests that the process which guarantees an acceptable level of 
safety is one that thoroughly screens ITDM drivers who wish to operate 
CMVs and periodically monitors the disease-controlling behavior of 
those successfully screened. Experience indicates, through the FAA and 
FHWA/

[[Page 39551]]

FMCSA programs, such a process is best implemented as an exemption 
program, and that type of program is currently defined and authorized 
in Section 4007 of TEA-21.

Authority--Waivers and Exemptions

    On June 9, 1998, the agency's waiver authority changed with 
enactment of the Transportation Equity Act for the 21st Century (TEA-
21), Public Law No. 105-178, 112 Stat. 107. Section 4007 of TEA-21 
amended the waiver provisions of 49 U.S.C. 31315 and 31136(e) to change 
the standard for evaluating waiver requests, to distinguish between a 
waiver and an exemption, and to establish term limits for both. Under 
revised sections 31315 and 31136(e), the FMCSA may grant a waiver for a 
period of up to 3 months or an exemption for a renewable 2-year period.
    The amendments to 49 U.S.C. 31315 and 31136(e) also changed the 
criteria for exempting a person from application of a regulation. 
Previously an exemption was appropriate if it was consistent with the 
public interest and the safe operation of CMVs. Now the FMCSA may grant 
an exemption 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.'' The new standard provides the 
FMCSA greater flexibility and discretion to deal with exemptions than 
the previous standard. (See H.R. Conf. Rep. No. 105-550, at 489 
(1998).)
    The TEA-21 requires the FMCSA to publish a notice in the Federal 
Register for each exemption requested, explaining that the request has 
been filed, and providing the public an opportunity to inspect the 
safety analysis and any other relevant information known to the agency, 
and comment on the request. Prior to granting a request for an 
exemption, the agency must publish a notice in the Federal Register 
identifying the person or class of persons who will receive the 
exemption, the provisions from which the person will be exempt, the 
effective period, and all terms and conditions of the exemption. The 
terms and conditions established by the FMCSA must ensure that 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 
regulation.
    In addition, the agency is required to monitor the implementation 
of each exemption to ensure compliance with its terms and conditions. 
If the FMCSA denies a request for an exemption, the agency must publish 
a notice in the Federal Register identifying the person who was denied 
the exemption and the reasons for the denial.
    Generally, the duration of exemptions issued under the authority of 
section 4007 is limited to two years from the date of approval, but may 
be renewed. The FMCSA is required to immediately revoke an exemption 
if: (1) The person fails to comply with the terms and conditions of the 
exemption; (2) the exemption has resulted in a lower level of safety 
that was maintained before the exemption was granted; or (3) 
continuation of the exemption would not be consistent with the goals 
and objectives of the regulations issued under the authority of 49 
U.S.C. 31315 and 31136(e).

Process for Applying for an Exemption

    The procedures for applying for an exemption are at 49 CFR 381.300. 
The person applying for an exemption is required to send a written 
request (which could be a typed or handwritten letter (printed)) to the 
Federal Motor Carrier Safety Administrator. The written request must 
include basic information such as the identity of the person who would 
be covered by the exemption, the name of the motor carrier or other 
entity that would be responsible for the use or operation of CMVs 
during the exemption period, and the principal place of business of the 
motor carrier or other entity. Under section 381.310, the application 
must include a written statement that: (1) Describes the event or CMV 
operation for which the exemption would be used; (2) identifies the 
regulation from which the applicant is requesting relief; (3) estimates 
the total number of drivers and CMVs that would be operating under the 
terms and conditions of the exemption; and (4) explains how the 
recipient of the exemption would ensure that they achieve a level of 
safety that is equivalent to, or greater than, the level of safety that 
would be obtained by complying with the regulation.

FMCSA Procedures for the Review of Exemption Applications

    Section 381.315 requires the FMCSA to review an application for an 
exemption and prepare, for the Administrator's signature, a Federal 
Register notice requesting public comment. After a review of the 
comments received, a recommendation will be made to the Administrator. 
Notice of the Administrator's final decision will be published in the 
Federal Register. The FMCSA would attempt to issue a final decision 
within 180 days of the date it receives an individual's completed 
application. However, if the applicant should omit important details or 
other information necessary for the agency to conduct a comprehensive 
evaluation, the FMCSA would attempt to issue a final decision within 
180 days of the date the additional information is received (49 CFR 
381.315 and 381.320). The FMCSA recognizes that this potential six-
month waiting period may seem burdensome. However, the agency must 
carefully evaluate each and every application for regulatory relief 
from the diabetes standard, to assess the potential safety performance 
of each applicant. In addition, the agency must prepare and submit the 
candidate's application for public notice and comment in the Federal 
Register and then evaluate comments received before making a final 
decision. The FMCSA's overriding concern is to ensure the safety of 
interstate commercial operations. The agency would notify all 
applicants in writing once a final decision is made.

Application Information

    In considering exemptions, the FMCSA must ensure that the issuance 
of diabetes exemptions would not be contrary to the public interest and 
that the exemption achieves an acceptable level of safety. Exemptions, 
therefore, would only be granted to ITDM individuals who meet certain 
conditions. These conditions, which are based on the research 
literature, relevant DOT and State exemption programs and with 
substantial input from a panel of endocrinologists, are set forth 
below. Applicants for an exemption from the ITDM prohibition would be 
required to submit their applications in a letter (there would be no 
application form), include all supporting documentation, and use the 
following format:

Vital Statistics
Name (First Name, Middle Initial, Last Name):
Address (House Number and Street Name, City, State, and Zip Code):
Telephone Number (Area Code and Number):
Sex (Male or Female):
Date of Birth (Month, Day, Year):
Age:
Social Security Number:
State Driver's License Number (List all licenses held to operate a 
commercial motor vehicle (CMV) during the 3-year period immediately 
preceding the date of application.):
Driver's License Expiration Date:
Driver's License Classification Code (If not a commercial driver's 
license (CDL) classification code, specify what vehicles may be 
operated under such code):
Driver's License Date of Issuance (Month, Day, Year):

[[Page 39552]]

Experience
Number of years driving straight trucks:
Approximate number of miles per year driving straight trucks:
Number of years driving tractor-trailer combinations:
Approximate number of miles per year driving tractor-trailer 
combinations:
Number of years driving buses:
Approximate number of miles per year driving buses:
Present Employment
Employer's Name (If Applicable):
Employer's Address:
Employer's Telephone Number:
Type of Vehicle Operated and GVWR (Straight Truck, Tractor-Trailer 
Combination, Bus):
Commodities Transported (e.g., General Freight, Liquids in Bulk (in 
cargo tanks), Steel, Dry-Bulk, Large Heavy Machinery, Refrigerated 
Products):
Estimated number of miles driven per week:
Estimated number of daylight driving hours per week:
Estimated number of nighttime driving hours per week:
States in which you will drive if issued an exemption:

    In addition, the applications must include supporting documentation 
showing that the applicant:
    (1) Possesses a valid intrastate CDL or a license (non-CDL) to 
operate a CMV,
    (2) Has operated a CMV, with a diabetic condition controlled by the 
use of insulin, for the three-year period immediately preceding 
application,
    (3) Has a driving record for that three-year period that:
    Contains no suspensions or revocations of the applicant's driver's 
license for the operation of any motor vehicle (including their 
personal vehicle);
    Contains no involvement in an accident for which the applicant 
received a citation for a moving traffic violation while operating a 
CMV;
    Contains no involvement in an accident for which the applicant 
contributed to the cause of the accident; and
    Contains no convictions for a disqualifying offense or more than 
one serious traffic violation, as defined in 49 CFR 383.5, while 
operating a CMV,
    (4) Has no other disqualifying conditions including diabetes-
related complications,
    (5) Has had no recurrent (two or more) hypoglycemic reactions 
resulting in a loss of consciousness or seizure within the past five 
years. A period of one year of demonstrated stability is required 
following the first episode of hypoglycemia,
    (6) Has had no recurrent hypoglycemic reactions requiring the 
assistance of another person within the past five years. A period of 
one year of demonstrated stability is required following the first 
episode of hypoglycemia,
    (7) Has had no recurrent hypoglycemic reactions resulting in 
impaired cognitive function which occurred without warning symptoms 
within the past five years. A period of one year of demonstrated 
stability is required following the first episode of hypoglycemia,
    (8) Has provided a board-certified or board-eligible 
endocrinologist, who is knowledgeable about diabetes, with a complete 
medical history including:

The date insulin use began;
Diabetes diagnosis and disease history;
All hospitalization records; Consultation notes for diagnostic 
examinations;
Special studies pertaining to the diabetes;
Follow-up reports; and
    Reports of any hypoglycemic insulin reactions within the last five 
years,

    (9) Has been examined by a board-certified or board-eligible 
endocrinologist who has conducted a complete medical examination. The 
complete medical examination must consist of a comprehensive evaluation 
of the applicant's medical history and current status with a report 
including the following information:

    Two measures of glycosylated hemoglobin, the first 90 days prior 
to the last and current measure;
    Insulin dosages and types, diet utilized for control and any 
significant factors such as smoking, alcohol use, and other 
medications or drugs taken; and
    Examinations to detect any peripheral neuropathy or circulatory 
insufficiency of the extremities,

    (10) Submits a signed statement prepared by the examining 
endocrinologist indicating the following medical determinations:

    The endocrinologist is familiar with the applicant's medical 
history for the past five years either through actual treatment over 
that time or through consultation with a physician who has treated 
the applicant during that time;
    The applicant has been using insulin to control his/her diabetes 
from the date of the application back to the date the three years of 
driving experience began;
    The applicant has been educated in diabetes and its management, 
thoroughly informed of and understands the procedures which must be 
followed to monitor and manage his/her diabetes and what procedures 
should be followed if complications arise; and
    The applicant has the ability and has demonstrated willingness 
to properly monitor and manage his/her diabetes,

    (11) Submits a separate signed statement from an examining 
ophthalmologist that the applicant has been examined and that the 
applicant does not have clinically significant disease including 
unstable proliferative diabetic retinopathy (i.e., unstable advancing 
disease of blood vessels in the retina) and meets the vision standard 
at 49 CFR 391.41(b)(10).

Requirements for ITDM Individuals Who Have Been Issued an Exemption 
To Operate CMV'S

    There are special conditions attached to the issuance of any 
exemption for ITDM. The following requirements would be imposed:
    (1) Individuals with ITDM shall maintain appropriate medical 
supplies for glucose management while preparing for the operation of a 
CMV and during its operation. The supplies should include the 
following:
    An acceptable glucose monitor with memory;
    Supplies needed to obtain adequate blood samples and to measure 
blood glucose;
    Insulin to be used as necessary; and
    An amount of rapidly absorbable glucose to be used as necessary,
    (2) Prior to and while driving, the individual with ITDM shall 
adhere to the following protocol for monitoring and maintaining 
appropriate blood glucose levels:
    Check glucose before starting to drive and take corrective action 
if necessary. If glucose is 100 mg/dl, take glucose or food and recheck 
in 30 minutes. Do not drive if glucose is 100 mg/dl. Repeat the process 
until glucose is >100 mg/dl;
    While driving check glucose every two to four hours and take 
appropriate action to maintain it in the range of 100 to 400 mg/dl;
    Have food available at all times when driving. If glucose is 100 
mg/dl, stop driving and eat. Recheck in 30 minutes and repeat procedure 
until glucose is >100 mg/dl; and
    If glucose is >400 mg/dl, stop driving until glucose returns to the 
100-400 mg/dl range. If more than two hours after last insulin 
injection and eating, take additional insulin. Recheck blood glucose in 
30 minutes. Don't resume driving until glucose is 400 mg/dl.

Monitoring for ITDM Individuals Who Have Been Issued an Exemption 
to Operate CMV'S

    In addition to the requirements for controlling ITDM, exemption 
recipients will be monitored during the period that

[[Page 39553]]

the exemption is valid. Monitoring will be conducted by requiring the 
exemption recipients to submit the following information to the FMCSA:
    (1) Submit to a comprehensive medical evaluation by an 
endocrinologist on an annual basis. The evaluation will include a 
general physical examination and a report of glycosylated hemoglobin 
concentration. The evaluation will also involve an assessment of the 
individual's willingness and ability to monitor and manage the diabetic 
condition;
    (2) Provide records of all daily glucose measurements taken with an 
acceptable device (with memory). These measurements will be reviewed by 
a specialist on a quarterly basis;
    (3) Provide on an annual basis confirmation by an ophthalmologist 
that there is no proliferative diabetic retinopathy and no clinically 
significant disease that prevents the individual from meeting the 
current vision standards at 49 CFR 391.41(b)(10);
    (4) Annual documentation by an endocrinologist of ongoing education 
in management of diabetes and hypoglycemia awareness;
    (5) Report, upon determination of an endocrinologist or other 
physician, any episode of severe hypoglycemia, significant 
complications or inability to manage diabetes; and
    (6) Report any involvement in an accident or any other adverse 
event and whether or not they are related to an episode of 
hypoglycemia.

Request for Comments

    The FMCSA is requesting public comment from all interested persons 
on its intent to issue exemptions to certain insulin-using diabetic 
drivers of CMVs, from the diabetes requirement in 49 CFR 391.41(b)(3), 
and relevant issues discussed in this notice. All comments received 
before the close of business on the closing date indicated above will 
be considered and will be available for examination in the docket room 
at the above address. Comments received after the closing date will be 
filed in the docket and will be considered to the extent practicable. 
However, the FMCSA may issue a final notice of intent to establish a 
process for considering exemptions from the diabetes requirement in 
accordance with 49 U.S.C. 311315 and 31136(e), and publish in the 
Federal Register that decision at any time after the close of the 
comment period. The FMCSA will also continue to file in the docket 
relevant information which becomes available. Interested persons should 
continue to examine the docket for new material.

Paper Reduction Act

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501, et 
seq.), Federal agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information they 
conduct, sponsor, or require through regulations. The FMCSA has 
determined that this notice of intent contains collection of 
information requirements for the purposes of the PRA. The proposed 
exemption program, when made final, will impact the currently-approved 
information collection, ``Medical Qualification Requirements.'' This 
approval is covered by OMB Approval No. 2126-0006 and is due to expire 
on October 31, 2003. The FMCSA estimates that approximately 200 
applications for exemption could be filed annually and that it would 
take an average of 90 minutes to complete an application.

    Authority: 49 U.S.C. 322, 31136 and 31315; and 49 CFR 1.73.

    Issued on: July 25, 2001.
Brian M. McLaughlin,
Acting Deputy Administrator.
[FR Doc. 01-19045 Filed 7-30-01; 8:45 am]
BILLING CODE 4910-EX-P