Medical Review Board Task Report on Insulin Treated Diabetes Mellitus and Commercial Motor Vehicle Drivers, 62448-62450 [2016-21724]

Download as PDF ehiers on DSK5VPTVN1PROD with PROPOSALS 62448 Federal Register / Vol. 81, No. 175 / Friday, September 9, 2016 / Proposed Rules GSAR clause 552.212–4 Alternate I, and therefore all provisions of clause 552.212–4 Alternate I that apply to ‘‘materials’’ also apply to order-level materials. The ordering activity shall follow procedures under the Federal Travel Regulation and FAR Part 31 when order-level materials include travel. (3) Order-level materials shall only be acquired in direct support of an order and not as the primary basis. (4) The cumulative value of order-level materials awarded under an FSS order shall not exceed 33 percent of the total value of the order. (5) All order-level materials shall be placed under the Order-Level Materials SIN. (6) Prior to the placement of an order that includes order-level materials, the ordering activity shall follow procedures in FAR 8.404(h). (7) To support the price reasonableness of order-level materials, the contractor proposing order-level materials as part of a solution shall submit a minimum of three quotes obtained by the contractor for each order-level material above the micropurchase threshold. One of these three quotes may include materials furnished by the contractor under FAR 52.212–4 Alternate I (i)(1)(ii)(A) If the contractor cannot obtain three quotes, the contractor shall provide the rationale for why they cannot obtain three quotes to support the contracting officer’s determination in (d)(7) of this section. (8) The ordering activity contracting officer must make a determination that prices for all order-level materials are determined fair and reasonable. The ordering activity contracting officer may base their determination on a comparison of the quotes received in response to the task or delivery order solicitation or other relevant pricing information available. (9) Prior to an increase in the ceiling price of order-level materials above the micropurchase threshold, the ordering activity contracting officer shall— (i) Conduct an analysis of pricing and other relevant factors to determine if the action is in the best interest of the Government and obtain the approval at the levels described in FAR 8.405–6(d); or (ii) Follow the procedures at FAR 8.405– 6 for a change that modifies the general scope of the order. (10) In accordance with GSAR clause 552.215–71 Examination of Records by GSA, GSA has the authority to examine the contractor’s records for compliance with the pricing provisions in FAR clause 52.212–4 Alternate I, to include examination of any books, documents, papers, and records involving transactions related to the contract for overbillings, billing errors, and compliance with the IFF and the Sales Reporting clauses of the contract. (11) Order-level materials are exempt from the following clauses: (i) 552.216–70 Economic Price Adjustment—FSS Multiple Award Schedule Contracts. (ii) 552.238–71 Submission and Distribution of Authorized FSS Schedule Pricelists. (iii) 552.238–75 Price Reductions. VerDate Sep<11>2014 15:27 Sep 08, 2016 Jkt 238001 (End of Clause) [FR Doc. 2016–21610 Filed 9–8–16; 8:45 am] BILLING CODE 6820–61–P DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration 49 CFR Part 391 [Docket No. FMCSA–2005–23151] RIN 2126–AA95 Medical Review Board Task Report on Insulin Treated Diabetes Mellitus and Commercial Motor Vehicle Drivers Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of availability; request for comments. AGENCY: In May 2015, FMCSA published a notice of proposed rulemaking (NPRM) in the Federal Register to allow drivers with stable, well-controlled insulin-treated diabetes mellitus (ITDM) to be qualified to operate commercial motor vehicles (CMVs) in interstate commerce. The comment period closed on July 6, 2015 and the Agency received over 1,250 comments. In that same month, FMCSA requested the Medical Review Board (MRB) to provide the Agency with advice by reviewing and analyzing the comments and providing recommendations to FMCSA for its consideration. The Agency announces the availability of the MRB’s report and requests comments on the MRB recommendations. The Final MRB Task 15–01 Report is posted in the docket at FMCSA–2005–23151. DATES: Comments must be received on or before November 8, 2016. ADDRESSES: You may submit comments bearing the Federal Docket Management System (FDMS) Docket No. FMCSA– 2005–23151 using any of the following methods: • Federal eRulemaking Portal: Go to www.regulations.gov. Follow the on-line instructions for submitting comments. • Mail: Docket Management Facility; U.S. Department of Transportation, Room W12–140, 1200 New Jersey Avenue SE., Washington, DC 20590– 0001. • Hand Delivery or Courier: West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., ET, Monday through Friday, except Federal Holidays. • Fax: 1–202–493–2251. SUMMARY: PO 00000 Frm 00030 Fmt 4702 Sfmt 4702 Each submission must include FMCSA and docket number FMCSA– 2005–23151. Note that DOT posts all comments received without change to www.regulations.gov, including any personal information included in a comment. Please see the Privacy Act heading below. Docket: For access to the docket to read background documents or comments, go to www.regulations.gov at any time or visit Room W12–140 on the ground level of the West Building, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., ET, Monday through Friday, except Federal holidays. The on-line FDMS is available 24 hours each day, 365 days each year. If you want acknowledgment that we received your comments, please include a self-addressed, stamped envelope or postcard or print the acknowledgement page that appears after submitting comments on-line. Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, including any personal information the commenter provides, to www.regulations.gov, as described in the system of records notice (DOT/ALL–14 FDMS), which can be reviewed at www.dot.gov/privacy. FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, 1200 New Jersey Ave. SE., Washington, DC 20590, or by phone at (202) 366–4001 or by email at FMCSAMedical@dot.gov. If you have questions on viewing or submitting material to the docket, contact Docket Services, telephone (202) 366–9826. SUPPLEMENTARY INFORMATION: I. Public Participation and Request for Comments FMCSA encourages you to participate by submitting comments and related materials. Submitting Comments If you submit a comment, please include the docket number for this notice (FMCSA–2005–23151), indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so that FMCSA can contact you if there are questions regarding your submission. To submit your comment online, go to http://www.regulations.gov, put the E:\FR\FM\09SEP1.SGM 09SEP1 Federal Register / Vol. 81, No. 175 / Friday, September 9, 2016 / Proposed Rules docket number, FMCSA–2005–23151, in the keyword box, and click ‘‘Search.’’ When the new screen appears, click on the ‘‘Comment Now!’’ button and type your comment into the text box on the following screen. Choose whether you are submitting your comment as an individual or on behalf of a third party and then submit. If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 81⁄2 by 11 inches, suitable for copying and electronic filing. If you submit comments by mail and would like to know that they reached the facility, please enclose a stamped, selfaddressed postcard or envelope. FMCSA will consider these comments, in addition to the comments submitted in response to the NPRM, in determining how to proceed with this rulemaking. ehiers on DSK5VPTVN1PROD with PROPOSALS Viewing Comments and Documents To view comments, as well as any documents mentioned in this notice as being available in the docket, go to http://www.regulations.gov. Insert the docket number, FMCSA–2005–23151, in the keyword box, and click ‘‘Search.’’ Next, click the ‘‘Open Docket Folder’’ button and choose the document to review. If you do not have access to the Internet, you may view the docket online by visiting the Docket Management Facility in Room W12–140 on the ground floor of the DOT West Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., E.T., Monday through Friday, except Federal holidays. II. Background Diabetes mellitus is a disease manifested by the body’s inability to maintain normal function of insulin, a substance that controls glycemic levels in the blood. Diabetes presents a major health challenge, particularly those who drive CMVs in interstate commerce. Under 49 CFR 391.41(b)(3), 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. Since 2003, FMCSA has maintained an exemption program for individuals that use insulin to treat their diabetes mellitus, that allows them to drive in interstate commerce if their diabetes is stable and they meet criteria of the program. 68 FR 52441 (Sept. 3, 2003), as revised, 70 FR 67777 (Nov. 8, 2005). In May 2015, FMCSA issued an NPRM in the Federal Register to allow drivers with stable, well-controlled ITDM to be qualified to operate CMVs in interstate commerce. The NPRM VerDate Sep<11>2014 15:27 Sep 08, 2016 Jkt 238001 would enable individuals with ITDM to obtain a Medical Examiner’s Certificate (MEC) from a Certified Medical Examiner (CME) at least annually in order to operate in interstate commerce as long as evidence is presented by the treating clinician who prescribes insulin documenting that the driver’s condition is stable and well-controlled. The comment period on the NPRM closed on July 6, 2015, and the Agency received more than 1,250 comments. MRB Tasking The MRB was established to provide FMCSA with medical advice and recommendations on medical standards and guidelines for the physical qualifications of operators of CMVs, medical examiner education, and medical research. 49 U.S.C. 31149(a)(1). The MRB, in view of its statutory creation and advisory function, is chartered by the Department of Transportation as an advisory committee under the provisions of the Federal Advisory Committee Act. 5 U.S.C. App. See http:// www.facadatabase.gov/committee/ committee.aspx?cid=2084&aid=47. See also Announcement of Establishment of the Federal Motor Carrier Safety Administration Medical Review Board, 70 FR 57642 (Oct. 3, 2005). The members of the MRB are appointed by the Secretary to reflect expertise in a variety of medical specialties relevant to the driver fitness requirements of FMCSA. 49 U.S.C. 31149(a)(2). In an effort to assist in the development of the final rule, on July 15, 2015, FMCSA requested advice from the MRB for the Agency to consider. Specifically, FMCSA asked the members to review and analyze all comments from medical professionals and associations, and identify factors the Agency should consider when making a decision about the next steps in the diabetes rulemaking. A public meeting to discuss this matter was held by the MRB on July 21 and 22, 2015. The Agency received the MRB’s final report on September 1, 2015. Details of the meeting, including the original task, final report and supporting materials used by the MRB are posted on the Agency’s public Web site: https:// www.fmcsa.dot.gov/medical-reviewboard-mrb-meeting-topics. MRB Final Report The MRB’s final report is available in the docket for this rulemaking (in addition to being available on the Agency’s public Web site). The final report contains a number of detailed recommendations for FMCSA to consider as it develops a final rule. The PO 00000 Frm 00031 Fmt 4702 Sfmt 4702 62449 Agency believes that public comment on the recommendations will assist it in evaluating the advice it has received from the MRB. Comments must be limited to addressing the recommendations in the MRB final report. A summary of the report’s major recommendations is set out below: The MRB recommended that ITDM drivers be medically disqualified unless they meet the following requirements demonstrating their stable, wellcontrolled ITDM: 1. The driver must provide an FMCSA Drivers With Insulin Treated Diabetes Mellitus Assessment Form (set out in the recommendations) to a medical examiner that has been completed and signed by the treating clinician. The treating clinician must be a Doctor of Medicine, a Doctor of Osteopathy, a Nurse Practitioner or a Physician’s Assistant who prescribed insulin to the driver and is knowledgeable regarding the treatment of diabetes. 2. The driver must receive a complete ophthalmology or optometry exam, including dilated retinal exam, at least every 2 years documenting the presence or absence of retinopathy/macular edema and the degree of retinopathy and/or macular edema if present (using the International Classification of Diabetic Retinopathy and Diabetic Macular Edema). The MRB recommended that medical examiners be allowed to certify an ITDM driver as medically qualified for a time period of no longer than 1 year only if the driver has not experienced any of the 8 disqualifying factors below (which the MRB believes should be listed in 49 CFR 391.46): 1. Any episode of severe hypoglycemia within the previous 6 months. 2. Blood sugar less than 60 milligrams per deciliter (mg/dL) demonstrated in current glucose logs. 3. Hypoglycemia appearing in the absence of warning symptoms (i.e., hypoglycemic unawareness). 4. An episode of severe hypoglycemia, blood sugar less than 60 mg/dl, or hypoglycemic unawareness within the previous 6 months; the driver should be medically disqualified and must remain disqualified for at least 6 months. 5. Uncontrolled diabetes, as evidenced by Hemoglobin A1c (HbA1c) level greater than 10 percent. A driver could be reinstated when HbA1c level is less than or equal to 10 percent. 6. Stage 3 or 4 diabetic retinopathy; a driver should be permanently disqualified. 7. Signs of target organ damage; a driver should be disqualified until the E:\FR\FM\09SEP1.SGM 09SEP1 62450 Federal Register / Vol. 81, No. 175 / Friday, September 9, 2016 / Proposed Rules matter is resolved by treatment, if possible. 8. Inadequate record of selfmonitoring of blood glucose; a driver should be disqualified for inadequate records until the driver can demonstrate adequate evidence of glucose records (minimum 1 month). In addition, the MRB stated that, if a driver is medically disqualified due to not meeting the ITDM criteria listed above, the driver should remain disqualified for at least 6 months. Comments Requested Comments are requested on any and all of the recommendations provided in the advisory final report from the Medical Review Board but only on those recommendations. To the extent possible, comments should include supporting materials, such as, for example, data analyses, studies, reports, or journal articles. FMCSA will consider these comments, in addition to the comments submitted in response to the NPRM, in determining how to proceed with this rulemaking. Issued on: August 30, 2016. Larry W. Minor, Associate Administrator for Policy. [FR Doc. 2016–21724 Filed 9–8–16; 8:45 am] BILLING CODE 4910–EX–P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service 50 CFR Part 17 [Docket No. FWS–R2–ES–2016–0099; 4500030113] RIN 1018–BA74 Endangered and Threatened Wildlife and Plants; Endangered Species Status for Guadalupe Fescue AGENCY: Information Requested Fish and Wildlife Service, Interior. Proposed rule. ACTION: We, the U.S. Fish and Wildlife Service (Service), propose to list Festuca ligulata (Guadalupe fescue), a plant species from the Chihuahuan Desert of west Texas and Mexico, as an endangered species under the Endangered Species Act of 1973, as amended (Act). If we finalize this rule as proposed, it would extend the Act’s protections to this species. DATES: We will accept comments received or postmarked on or before November 8, 2016. Comments submitted electronically using the Federal eRulemaking Portal (see ADDRESSES, ehiers on DSK5VPTVN1PROD with PROPOSALS SUMMARY: VerDate Sep<11>2014 15:27 Sep 08, 2016 Jkt 238001 below) must be received by 11:59 p.m. Eastern time on the closing date. We must receive requests for public hearings, in writing, at the address shown in FOR FURTHER INFORMATION CONTACT by October 24, 2016 ADDRESSES: You may submit comments by one of the following methods: (1) Electronically: Go to the Federal eRulemaking Portal: http:// www.regulations.gov. In the Search box, enter FWS–R2–ES–2016–0099, which is the docket number for this rulemaking. Then click on the Search button. On the resulting page, in the Search panel on the left side of the screen, under the Document Type heading, click on the Proposed Rules link to locate this document. You may submit a comment by clicking on ‘‘Comment Now!’’ (2) By hard copy: Submit by U.S. mail or hand-delivery to: Public Comments Processing, Attn: FWS–R2–ES–2016– 0099, U.S. Fish and Wildlife Service, MS: BPHC, 5275 Leesburg Pike, Falls Church, VA 22041–3803. We request that you send comments only by the methods described above. We will post all comments on http:// www.regulations.gov. This generally means that we will post any personal information you provide us (see Public Comments, below, for more information). FOR FURTHER INFORMATION CONTACT: Adam Zerrenner, Field Supervisor, U.S. Fish and Wildlife Service, Austin Ecological Services Field Office, 10711 Burnet Rd., Suite 200, Austin, TX 78758; telephone 512–490–0057; or facsimile 512–490–0974. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 800–877–8339. SUPPLEMENTARY INFORMATION: Public Comments We intend that any final action resulting from this proposed rule will be based on the best available scientific and commercial data and will be as accurate and as effective as possible. Therefore, we request comments or information from other concerned governmental agencies, Native American tribes, the scientific community, industry, or any other interested parties concerning this proposed rule. We particularly seek comments concerning: (1) Guadalupe fescue’s biology, range, and population trends, including: (a) Biological or ecological requirements of the species, including habitat requirements for soils, reproduction, and associated species; PO 00000 Frm 00032 Fmt 4702 Sfmt 4702 (b) Genetics and taxonomy; (c) Historical and current range, including distribution patterns; (d) Historical and current population levels, and current and projected trends; and (e) Past and ongoing conservation measures for the species, its habitat, or both. (2) Factors that may affect the continued existence of the species, which may include habitat modification or destruction, overutilization, disease, predation, the inadequacy of existing regulatory mechanisms, or other natural or manmade factors. (3) Biological, commercial trade, or other relevant data concerning any threats (or lack thereof) to this species and existing regulations that may be addressing those threats. Please include sufficient information with your submission (such as scientific journal articles or other publications) to allow us to verify any scientific or commercial information you include. Please note that submissions merely stating support for or opposition to the action under consideration without providing supporting information, although noted, will not be considered in making a determination, as section 4(b)(1)(A) of the Act (16 U.S.C. 1531 et seq.) directs that determinations as to whether any species is an endangered or threatened species must be made ‘‘solely on the basis of the best scientific and commercial data available.’’ You may submit your comments and materials concerning this proposed rule by one of the methods listed above in ADDRESSES. We request that you send comments only by the methods described in ADDRESSES. If you submit information via http:// www.regulations.gov, your entire submission—including any personal identifying information—will be posted on the Web site. If your submission is made via a hardcopy that includes personal identifying information, you may request at the top of your document that we withhold this information from public review. However, we cannot guarantee that we will be able to do so. We will post all hardcopy submissions on http://www.regulations.gov. Comments and materials we receive, as well as supporting documentation we used in preparing this proposed rule, will be available for public inspection on http://www.regulations.gov, or by appointment, during normal business hours, at the U.S. Fish and Wildlife Service, Austin Ecological Services Field Office (see FOR FURTHER INFORMATION CONTACT). E:\FR\FM\09SEP1.SGM 09SEP1

Agencies

[Federal Register Volume 81, Number 175 (Friday, September 9, 2016)]
[Proposed Rules]
[Pages 62448-62450]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21724]


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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

49 CFR Part 391

[Docket No. FMCSA-2005-23151]
RIN 2126-AA95


Medical Review Board Task Report on Insulin Treated Diabetes 
Mellitus and Commercial Motor Vehicle Drivers

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

ACTION: Notice of availability; request for comments.

-----------------------------------------------------------------------

SUMMARY: In May 2015, FMCSA published a notice of proposed rulemaking 
(NPRM) in the Federal Register to allow drivers with stable, well-
controlled insulin-treated diabetes mellitus (ITDM) to be qualified to 
operate commercial motor vehicles (CMVs) in interstate commerce. The 
comment period closed on July 6, 2015 and the Agency received over 
1,250 comments. In that same month, FMCSA requested the Medical Review 
Board (MRB) to provide the Agency with advice by reviewing and 
analyzing the comments and providing recommendations to FMCSA for its 
consideration. The Agency announces the availability of the MRB's 
report and requests comments on the MRB recommendations. The Final MRB 
Task 15-01 Report is posted in the docket at FMCSA-2005-23151.

DATES: Comments must be received on or before November 8, 2016.

ADDRESSES: You may submit comments bearing the Federal Docket 
Management System (FDMS) Docket No. FMCSA-2005-23151 using any of the 
following methods:
     Federal eRulemaking Portal: Go to www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Docket Management Facility; U.S. Department of 
Transportation, Room W12-140, 1200 New Jersey Avenue SE., Washington, 
DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room 
W12-140, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 
5 p.m., ET, Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Each submission must include FMCSA and docket number FMCSA-2005-
23151. Note that DOT posts all comments received without change to 
www.regulations.gov, including any personal information included in a 
comment. Please see the Privacy Act heading below.
    Docket: For access to the docket to read background documents or 
comments, go to www.regulations.gov at any time or visit Room W12-140 
on the ground level of the West Building, 1200 New Jersey Avenue SE., 
Washington, DC, between 9 a.m. and 5 p.m., ET, Monday through Friday, 
except Federal holidays. The on-line FDMS is available 24 hours each 
day, 365 days each year. If you want acknowledgment that we received 
your comments, please include a self-addressed, stamped envelope or 
postcard or print the acknowledgement page that appears after 
submitting comments on-line.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits 
comments from the public to better inform its rulemaking process. DOT 
posts these comments, without edit, including any personal information 
the commenter provides, to www.regulations.gov, as described in the 
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at 
www.dot.gov/privacy.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, 1200 New 
Jersey Ave. SE., Washington, DC 20590, or by phone at (202) 366-4001 or 
by email at FMCSAMedical@dot.gov. If you have questions on viewing or 
submitting material to the docket, contact Docket Services, telephone 
(202) 366-9826.

SUPPLEMENTARY INFORMATION:

I. Public Participation and Request for Comments

    FMCSA encourages you to participate by submitting comments and 
related materials.

Submitting Comments

    If you submit a comment, please include the docket number for this 
notice (FMCSA-2005-23151), indicate the specific section of this 
document to which each comment applies, and provide a reason for each 
suggestion or recommendation. You may submit your comments and material 
online or by fax, mail, or hand delivery, but please use only one of 
these means. FMCSA recommends that you include your name and a mailing 
address, an email address, or a phone number in the body of your 
document so that FMCSA can contact you if there are questions regarding 
your submission.
    To submit your comment online, go to http://www.regulations.gov, 
put the

[[Page 62449]]

docket number, FMCSA-2005-23151, in the keyword box, and click 
``Search.'' When the new screen appears, click on the ``Comment Now!'' 
button and type your comment into the text box on the following screen. 
Choose whether you are submitting your comment as an individual or on 
behalf of a third party and then submit. If you submit your comments by 
mail or hand delivery, submit them in an unbound format, no larger than 
8\1/2\ by 11 inches, suitable for copying and electronic filing. If you 
submit comments by mail and would like to know that they reached the 
facility, please enclose a stamped, self-addressed postcard or 
envelope.
    FMCSA will consider these comments, in addition to the comments 
submitted in response to the NPRM, in determining how to proceed with 
this rulemaking.

Viewing Comments and Documents

    To view comments, as well as any documents mentioned in this notice 
as being available in the docket, go to http://www.regulations.gov. 
Insert the docket number, FMCSA-2005-23151, in the keyword box, and 
click ``Search.'' Next, click the ``Open Docket Folder'' button and 
choose the document to review. If you do not have access to the 
Internet, you may view the docket online by visiting the Docket 
Management Facility in Room W12-140 on the ground floor of the DOT West 
Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 
a.m. and 5 p.m., E.T., Monday through Friday, except Federal holidays.

II. Background

    Diabetes mellitus is a disease manifested by the body's inability 
to maintain normal function of insulin, a substance that controls 
glycemic levels in the blood. Diabetes presents a major health 
challenge, particularly those who drive CMVs in interstate commerce. 
Under 49 CFR 391.41(b)(3), 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. Since 2003, FMCSA has maintained an exemption 
program for individuals that use insulin to treat their diabetes 
mellitus, that allows them to drive in interstate commerce if their 
diabetes is stable and they meet criteria of the program. 68 FR 52441 
(Sept. 3, 2003), as revised, 70 FR 67777 (Nov. 8, 2005).
    In May 2015, FMCSA issued an NPRM in the Federal Register to allow 
drivers with stable, well-controlled ITDM to be qualified to operate 
CMVs in interstate commerce. The NPRM would enable individuals with 
ITDM to obtain a Medical Examiner's Certificate (MEC) from a Certified 
Medical Examiner (CME) at least annually in order to operate in 
interstate commerce as long as evidence is presented by the treating 
clinician who prescribes insulin documenting that the driver's 
condition is stable and well-controlled. The comment period on the NPRM 
closed on July 6, 2015, and the Agency received more than 1,250 
comments.

MRB Tasking

    The MRB was established to provide FMCSA with medical advice and 
recommendations on medical standards and guidelines for the physical 
qualifications of operators of CMVs, medical examiner education, and 
medical research. 49 U.S.C. 31149(a)(1). The MRB, in view of its 
statutory creation and advisory function, is chartered by the 
Department of Transportation as an advisory committee under the 
provisions of the Federal Advisory Committee Act. 5 U.S.C. App. See 
http://www.facadatabase.gov/committee/committee.aspx?cid=2084&aid=47. 
See also Announcement of Establishment of the Federal Motor Carrier 
Safety Administration Medical Review Board, 70 FR 57642 (Oct. 3, 2005). 
The members of the MRB are appointed by the Secretary to reflect 
expertise in a variety of medical specialties relevant to the driver 
fitness requirements of FMCSA. 49 U.S.C. 31149(a)(2).
    In an effort to assist in the development of the final rule, on 
July 15, 2015, FMCSA requested advice from the MRB for the Agency to 
consider. Specifically, FMCSA asked the members to review and analyze 
all comments from medical professionals and associations, and identify 
factors the Agency should consider when making a decision about the 
next steps in the diabetes rulemaking. A public meeting to discuss this 
matter was held by the MRB on July 21 and 22, 2015. The Agency received 
the MRB's final report on September 1, 2015. Details of the meeting, 
including the original task, final report and supporting materials used 
by the MRB are posted on the Agency's public Web site: https://www.fmcsa.dot.gov/medical-review-board-mrb-meeting-topics.

MRB Final Report

    The MRB's final report is available in the docket for this 
rulemaking (in addition to being available on the Agency's public Web 
site). The final report contains a number of detailed recommendations 
for FMCSA to consider as it develops a final rule. The Agency believes 
that public comment on the recommendations will assist it in evaluating 
the advice it has received from the MRB. Comments must be limited to 
addressing the recommendations in the MRB final report. A summary of 
the report's major recommendations is set out below:
    The MRB recommended that ITDM drivers be medically disqualified 
unless they meet the following requirements demonstrating their stable, 
well-controlled ITDM:
    1. The driver must provide an FMCSA Drivers With Insulin Treated 
Diabetes Mellitus Assessment Form (set out in the recommendations) to a 
medical examiner that has been completed and signed by the treating 
clinician. The treating clinician must be a Doctor of Medicine, a 
Doctor of Osteopathy, a Nurse Practitioner or a Physician's Assistant 
who prescribed insulin to the driver and is knowledgeable regarding the 
treatment of diabetes.
    2. The driver must receive a complete ophthalmology or optometry 
exam, including dilated retinal exam, at least every 2 years 
documenting the presence or absence of retinopathy/macular edema and 
the degree of retinopathy and/or macular edema if present (using the 
International Classification of Diabetic Retinopathy and Diabetic 
Macular Edema).
    The MRB recommended that medical examiners be allowed to certify an 
ITDM driver as medically qualified for a time period of no longer than 
1 year only if the driver has not experienced any of the 8 
disqualifying factors below (which the MRB believes should be listed in 
49 CFR 391.46):
    1. Any episode of severe hypoglycemia within the previous 6 months.
    2. Blood sugar less than 60 milligrams per deciliter (mg/dL) 
demonstrated in current glucose logs.
    3. Hypoglycemia appearing in the absence of warning symptoms (i.e., 
hypoglycemic unawareness).
    4. An episode of severe hypoglycemia, blood sugar less than 60 mg/
dl, or hypoglycemic unawareness within the previous 6 months; the 
driver should be medically disqualified and must remain disqualified 
for at least 6 months.
    5. Uncontrolled diabetes, as evidenced by Hemoglobin A1c (HbA1c) 
level greater than 10 percent. A driver could be reinstated when HbA1c 
level is less than or equal to 10 percent.
    6. Stage 3 or 4 diabetic retinopathy; a driver should be 
permanently disqualified.
    7. Signs of target organ damage; a driver should be disqualified 
until the

[[Page 62450]]

matter is resolved by treatment, if possible.
    8. Inadequate record of self-monitoring of blood glucose; a driver 
should be disqualified for inadequate records until the driver can 
demonstrate adequate evidence of glucose records (minimum 1 month).
    In addition, the MRB stated that, if a driver is medically 
disqualified due to not meeting the ITDM criteria listed above, the 
driver should remain disqualified for at least 6 months.

Comments Requested

    Comments are requested on any and all of the recommendations 
provided in the advisory final report from the Medical Review Board but 
only on those recommendations. To the extent possible, comments should 
include supporting materials, such as, for example, data analyses, 
studies, reports, or journal articles. FMCSA will consider these 
comments, in addition to the comments submitted in response to the 
NPRM, in determining how to proceed with this rulemaking.

    Issued on: August 30, 2016.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2016-21724 Filed 9-8-16; 8:45 am]
BILLING CODE 4910-EX-P