[Federal Register Volume 83, Number 10 (Tuesday, January 16, 2018)]
[Notices]
[Pages 2300-2306]
[FR Doc No: 2018-00562]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2017-0287]

Qualification of Drivers; Exemption Applications; Diabetes
Mellitus

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

ACTION: Notice of applications for exemption; request for comments.

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SUMMARY: FMCSA announces receipt of applications from 39 individuals
for an exemption from the prohibition in the Federal Motor Carrier
Safety Regulations (FMCSRs) against persons with insulin-treated
diabetes mellitus (ITDM) operating a commercial motor vehicle (CMV) in
interstate commerce. If granted, the exemptions would enable these
individuals with ITDM to operate CMVs in interstate commerce.

DATES: Comments must be received on or before February 15, 2018.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket No. FMCSA-2017-0287 using any of the
following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m.,
e.t., Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket number(s) for this notice. Note that all comments received will
be posted without change to http://www.regulations.gov, including any
personal information provided. Please see the Privacy Act heading below
for further information.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or 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., e.t., Monday through Friday,
except Federal holidays. The FDMS is available 24 hours each day e.t.,
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 online.
    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 http://www.regulations.gov, as described in
the system of records notice (DOT/ALL-14 FDMS), which can be reviewed
at http://www.dot.gov/privacy.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER>, [email protected], FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE, Room W64-224,
Washington, DC 20590-0001. Office hours are 8:30 a.m. to 5 p.m., e.t.,
Monday through Friday, except Federal holidays. If you have questions
regarding viewing or submitting material to the docket, contact Docket
Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the FMCSRs for a five-year period 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
statute also allows the Agency to renew exemptions at the end of the
five-year period. FMCSA grants exemptions from the FMCSRs for a two-
year period to align with the maximum duration of a driver's medical
certification.
    The 39 individuals listed in this notice have requested an
exemption from the diabetes prohibition in 49 CFR 391.41(b)(3).
Accordingly, the Agency will evaluate the qualifications of each
applicant to determine whether granting the exemption will achieve the
required level of safety mandated by statute.
    The physical qualification standard for drivers regarding diabetes
found in

49 CFR 391.41(b)(3) states that a person is physically qualified to
drive a CMV if that person has no established medical history or
clinical diagnosis of diabetes mellitus currently requiring insulin for
control. The Agency established the current requirement for diabetes in
1970 because several risk studies indicated that drivers with diabetes
had a higher rate of crash involvement than the general population.
    FMCSA established its diabetes exemption program, based on the
Agency's July 2000 study entitled ``A Report to Congress on the
Feasibility of a Program to Qualify Individuals with Insulin-Treated
Diabetes Mellitus to Operate in Interstate Commerce as Directed by the
Transportation Act for the 21st Century.'' The report concluded that a
safe and practicable protocol to allow some drivers with ITDM to
operate CMVs is feasible. The September 3, 2003 (68 FR 52441), Federal
Register notice in conjunction with the November 8, 2005 (70 FR 67777),
Federal Register notice provides the current protocol for allowing such
drivers to operate CMVs in interstate commerce.
    FMCSA notes that section 4129 of the Safe, Accountable, Flexible
and Efficient Transportation Equity Act: A Legacy for Users requires
the Secretary to revise its diabetes exemption program established on
September 3, 2003 (68 FR 52441). The revision must provide for
individual assessment of drivers with diabetes mellitus, and be
consistent with the criteria described in section 4018 of the
Transportation Equity Act for the 21st Century (49 U.S.C. 31305).
Section 4129 requires: (1) Elimination of the requirement for three
years of experience operating CMVs while being treated with insulin;
and (2) establishment of a specified minimum period of insulin use to
demonstrate stable control of diabetes before being allowed to operate
a CMV.
    In response to section 4129, FMCSA made immediate revisions to the
diabetes exemption program established by the September 3, 2003 notice.
FMCSA discontinued use of the three-year driving experience and
fulfilled the requirements of section 4129 while continuing to ensure
that operation of CMVs by drivers with ITDM will achieve the requisite
level of safety required of all exemptions granted under 49 U.S.C.
31136 (e). Section 4129(d) also directed FMCSA to ensure that drivers
of CMVs with ITDM are not held to a higher standard than other drivers,
with the exception of limited operating, monitoring and medical
requirements that are deemed medically necessary. The FMCSA concluded
that all of the operating, monitoring and medical requirements set out
in the September 3, 2003, notice, except as modified, were in
compliance with section 4129(d). Therefore, all of the requirements set
out in the September 3, 2003, notice, except as modified by the notice
in the Federal Register on November 8, 2005 (70 FR 67777), remain in
effect.

II. Qualifications of Applicants

Rodney C. Adams

    Mr. Adams, 55, has had ITDM since 2014. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Adams understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Adams meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2017 and certified that he does not have
diabetic retinopathy. He holds an operator's license from Connecticut.

Craig A. Ballard

    Mr. Ballard, 52, has had ITDM since 2017. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Ballard understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Ballard meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2017 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from Georgia.

David E. Bauman

    Mr. Bauman, 61, has had ITDM since 2016. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Bauman understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Bauman meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2017 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Nebraska.

Ryan C. Bayless

    Mr. Bayless, 22, has had ITDM since 2005. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Bayless understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Bayless meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2017 and certified that he has stable
nonproliferative diabetic retinopathy. He holds an operator's license
from Missouri.

Dennis E. Bellerive

    Mr. Bellerive, 68, has had ITDM since 2017. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Bellerive understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Bellerive meets
the requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2017 and certified that he does not have
diabetic retinopathy. He holds a Class B CDL from New Hampshire.

Billy G. Boren, Jr.

    Mr. Boren, 43, has had ITDM since 2017. His endocrinologist
examined him in 2017 and certified that he has had no

severe hypoglycemic reactions resulting in loss of consciousness,
requiring the assistance of another person, or resulting in impaired
cognitive function that occurred without warning in the past 12 months
and no recurrent (two or more) severe hypoglycemic episodes in the last
five years. His endocrinologist certifies that Mr. Boren understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Boren meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2017 and certified that he does not have
diabetic retinopathy. He holds a Class D CDL from Kentucky.

Joseph H. Bove

    Mr. Bove, 50, has had ITDM since 2015. His endocrinologist examined
him in 2017 and certified that he has had no severe hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 12 months and no recurrent (two or
more) severe hypoglycemic episodes in the last five years. His
endocrinologist certifies that Mr. Bove understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. Bove meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined
him in 2017 and certified that he does not have diabetic retinopathy.
He holds an operator's license from New York.

Gary W. Brooks

    Mr. Brooks, 61, has had ITDM since 2001. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Brooks understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Brooks meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2017 and certified that he has stable
nonproliferative diabetic retinopathy. He holds an operator's license
from California.

Carl E. Bryant

    Mr. Bryant, 72, has had ITDM since 2015. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Bryant understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Bryant meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2017 and certified that he does not have
diabetic retinopathy. He holds a Class B CDL from New York.

Vernon C. Buchanan

    Mr. Buchanan, 58, has had ITDM since 2016. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Buchanan understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Buchanan meets
the requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2017 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Pennsylvania.

Phillip L. Butler

    Mr. Butler, 36, has had ITDM since 2013. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Butler understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Butler meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2017 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Virginia.

Tyler H. Cardwell

    Mr. Cardwell, 34, has had ITDM since 2006. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Cardwell understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Cardwell meets
the requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2017 and certified that he does not have
diabetic retinopathy. He holds an operator's license from Mississippi.

Arleigh D. Chapman

    Mr. Chapman, 65, has had ITDM since 2013. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Chapman understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Chapman meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2017 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Pennsylvania.

Richard J. Dinzeo

    Mr. Dinzeo, 48, has had ITDM since 2010. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Dinzeo understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Dinzeo meets the
requirements of the vision standard at

49 CFR 391.41(b)(10). His ophthalmologist examined him in 2017 and
certified that he does not have diabetic retinopathy. He holds a Class
B CDL from Minnesota.

Mark A. Donahoo

    Mr. Donahoo, 52, has had ITDM since 2017. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Donahoo understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Donahoo meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2017 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Missouri.

James W. Felske

    Mr. Felske, 49, has had ITDM since 1989. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Felske understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Felske meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2017 and certified that he does not
have diabetic retinopathy. He holds an operator's license from
Illinois.

Christopher L. Fleming

    Mr. Fleming, 45, has had ITDM since 2016. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Fleming understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Fleming meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2017 and certified that he does not have
diabetic retinopathy. He holds an operator's license from Georgia.

Jason R. Gassaway

    Mr. Gassaway, 43, has had ITDM since 2017. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Gassaway understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Gassaway meets
the requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2017 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from New Mexico.

Owen D. Gibbons

    Mr. Gibbons, 41, has had ITDM since 2015. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Gibbons understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Gibbons meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2017 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Pennsylvania.

James L. Goodwin, 3rd

    Mr. Goodwin, 38, has had ITDM since 2009. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Goodwin understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Goodwin meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2017 and certified that he does not have
diabetic retinopathy. He holds an operator's license from Maryland.

Richard J. Grenvik

    Mr. Grenvik, 60, has had ITDM since 2017. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Grenvik understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Grenvik meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2017 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from Minnesota.

Michael K. Gunn

    Mr. Gunn, 64, has had ITDM since 2004. His endocrinologist examined
him in 2017 and certified that he has had no severe hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 12 months and no recurrent (two or
more) severe hypoglycemic episodes in the last five years. His
endocrinologist certifies that Mr. Gunn understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. Gunn meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined
him in 2017 and certified that he does not have diabetic retinopathy.
He holds a Class B CDL from Wisconsin.

Kermit F. Hicks, Jr.

    Mr. Hicks, 49, has had ITDM since 2006. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or

more) severe hypoglycemic episodes in the last five years. His
endocrinologist certifies that Mr. Hicks understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Hicks meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2017 and certified that he does not
have diabetic retinopathy. He holds an operator's license from Ohio.

Raymond D. Hill

    Mr. Hill, 67, has had ITDM since 2015. His endocrinologist examined
him in 2017 and certified that he has had no severe hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 12 months and no recurrent (two or
more) severe hypoglycemic episodes in the last five years. His
endocrinologist certifies that Mr. Hill understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. Hill meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His optometrist examined him
in 2017 and certified that he does not have diabetic retinopathy. He
holds a Class A CDL from Minnesota.

Rob D. Karaus

    Mr. Karaus, 41, has had ITDM since 1994. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Karaus understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Karaus meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2017 and certified that he has stable
nonproliferative diabetic retinopathy. He holds an operator's license
from Indiana.

Garnie T. Mauk, Jr.

    Mr. Mauk, 58, has had ITDM since 2017. His endocrinologist examined
him in 2017 and certified that he has had no severe hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 12 months and no recurrent (two or
more) severe hypoglycemic episodes in the last five years. His
endocrinologist certifies that Mr. Mauk understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. Mauk meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined
him in 2017 and certified that he has stable nonproliferative diabetic
retinopathy. He holds a Class A CDL from Tennessee.

Jose Medelez

    Mr. Medelez, 59, has had ITDM since 2017. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Medelez understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Medelez meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2017 and certified that he has stable
nonproliferative diabetic retinopathy. He holds a Class A CDL from
Oregon.

Alexander P. Paice

    Mr. Paice, 37, has had ITDM since 2013. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Paice understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Paice meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2017 and certified that he does not have
diabetic retinopathy. He holds an operator's license from Utah.

Charles Petit-Homme

    Mr. Petit-Homme, 59, has had ITDM since 2015. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Petit-Homme understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Petit-Homme meets
the requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2017 and certified that he does not
have diabetic retinopathy. He holds a Class B CDL from New York.

Phillip G. Putzke

    Mr. Putzke, 37, has had ITDM since 1988. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Putzke understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Putzke meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2017 and certified that he has stable
nonproliferative diabetic retinopathy. He holds an operator's license
from South Dakota.

James A. Smit

    Mr. Smit, 52, has had ITDM since 2015. His endocrinologist examined
him in 2017 and certified that he has had no severe hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 12 months and no recurrent (two or
more) severe hypoglycemic episodes in the last five years. His
endocrinologist certifies that Mr. Smit understands diabetes management
and monitoring and has stable control of his diabetes using insulin.
Mr. Smit meets the requirements of the vision standard at 49 CFR
391.41(b)(10). His optometrist examined him in 2017 and certified that
he does not have diabetic retinopathy. He holds a Class A CDL from
Minnesota.

Gregory E. Sorenson

    Mr. Sorenson, 54, has had ITDM since 2016. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Sorenson understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Sorenson meets
the requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2017 and certified that he does not have
diabetic retinopathy. He holds an operator's license from Indiana.

Sharon P. Soucy

    Ms. Soucy, 68, has had ITDM since 2017. Her endocrinologist
examined her in 2017 and certified that she has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. Her endocrinologist certifies that Ms. Soucy understands
diabetes management and monitoring has stable control of her diabetes
using insulin, and is able to drive a CMV safely. Ms. Soucy meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). Her
ophthalmologist examined her in 2017 and certified that she does not
have diabetic retinopathy. She holds a Class B CDL from Alaska.

Robin T. Spence

    Ms. Spence, 61, has had ITDM since 2015. Her endocrinologist
examined her in 2017 and certified that she has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. Her endocrinologist certifies that Ms. Spence understands
diabetes management and monitoring has stable control of her diabetes
using insulin, and is able to drive a CMV safely. Ms. Spence meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). Her
optometrist examined her in 2017 and certified that she does not have
diabetic retinopathy. She holds a Class A CDL from Oklahoma.

Anthony P. Sweeney

    Mr. Sweeney, 52, has had ITDM since 2015. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Sweeney understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Sweeney meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2017 and certified that he has stable
nonproliferative diabetic retinopathy. He holds a Class A CDL from
Maryland.

Richard A. Sweeting

    Mr. Sweeting, 50, has had ITDM since 2017. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Sweeting understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Sweeting meets
the requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2017 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Georgia.

Steven J. Voorhees

    Mr. Voorhees, 62, has had ITDM since 2012. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Voorhees understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Voorhees meets
the requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2017 and certified that he does not have
diabetic retinopathy. He holds an operator's license from Montana.

Jeffery E. Wall

    Mr. Wall, 46, has had ITDM since 2016. His endocrinologist examined
him in 2017 and certified that he has had no severe hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 12 months and no recurrent (two or
more) severe hypoglycemic episodes in the last five years. His
endocrinologist certifies that Mr. Wall understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. Wall meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined
him in 2017 and certified that he does not have diabetic retinopathy.
He holds an operator's license from North Carolina.

Samuel E. Ward

    Mr. Ward, 67, has had ITDM since 2010. His endocrinologist examined
him in 2017 and certified that he has had no severe hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 12 months and no recurrent (two or
more) severe hypoglycemic episodes in the last five years. His
endocrinologist certifies that Mr. Ward understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. Ward meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His optometrist examined him
in 2017 and certified that he does not have diabetic retinopathy. He
holds a Class B CDL from Kansas.

III. Request for Comments

    In accordance with 49 U.S.C. 31136(e) and 31315, FMCSA requests
public comment from all interested persons on the exemption petitions
described in this notice. We will consider all comments received before
the close of business on the closing date indicated in the dates
section of the notice.

IV. Submitting Comments

    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 and
in the search box insert the docket number FMCSA-2017-0287 and click
the search button. When the new screen appears, click on the blue
``Comment Now!'' button on the right hand side of the page. On the new
page, enter information required including the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. 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.
    We will consider all comments and materials received during the
comment period. FMCSA may issue a final determination at any time after
the close of the comment period.

V. Viewing Comments and Documents

    To view comments, as well as any documents mentioned in this
preamble, go to http://www.regulations.gov and in the search box insert
the docket number FMCSA-2017-0287 and click ``Search.'' Next, click
``Open Docket Folder'' and you will find all documents and comments
related to this notice.

    Issued on: January 5, 2018.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2018-00562 Filed 1-12-18; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register: November 7, 2007 (Volume 72, Number 215)]
[Rules and Regulations]
[Page 62795-62797]
[DOCID:fr07no07-9]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

49 CFR Part 385

FMCSA Policy on Calculating Crash Rates and Driver, Vehicle, and
Hazardous Materials Out-of-Service Rates and the Top 30 Percent of the
National Average Under 49 CFR 385.407

AGENCY: Federal Motor Carrier Safety Administration (FMCSA).

ACTION: Notice of enforcement policy.

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

SUMMARY: FMCSA may not issue a hazardous materials safety permit to a
motor carrier that has a crash rate, driver, vehicle or hazardous
material out-of-service rate in the top 30 percent of the national
average pursuant to 49 CFR 385.407. This document states the FMCSA
policy on calculating motor carrier crash rates, and driver, vehicle,
and hazardous material out-of-service rates that represent the top 30
percent of the national average as indicated in the Motor Carrier
Management Information System (MCMIS). The document explains how FMCSA
calculates the top thirty percent of the national average and how it
calculates whether a single motor carrier falls within the top thirty
percent of the national average in each of these categories. The
document restates without change the FMCSA policy that has been
publicly available on its Web site since January 2005.

EFFECTIVE DATE: January 3, 2005.

FOR FURTHER INFORMATION CONTACT: James O. Simmons, Office of
Enforcement and Compliance, Hazardous Materials Division, 1200 New
Jersey Avenue, SE., Washington, DC 20590,<PHONE_NUMBER> (voice),
<EMAIL_ADDRESS>(e-mail), Debra S. Straus, Office of the Chief

Counsel,<PHONE_NUMBER> (voice), or<EMAIL_ADDRESS>(e-mail).

SUPPLEMENTARY INFORMATION:
    Background: Congress established the hazardous materials safety
permit (safety permit) requirement as part of the Hazardous Materials
Transportation Uniform Safety Act of 1990 (``HMTUSA'') Public Law 101-
615, 104 Stat. 3244 (Nov. 16, 1990). On January 1, 2000, the Federal
Motor Carrier Safety Administration (FMCSA) was established as a
separate administration within the U.S. Department of Transportation
pursuant to the Motor Carrier Safety Improvement Act of 1999. FMCSA
assumed responsibility for the enforcement of hazardous materials
transportation laws by motor vehicle transportation. On June 30, 2004,
FMCSA issued a Final Rule containing the regulations implementing the
safety permit program. 69 FR 39350.
    The Final Rule, codified at 49 CFR Part 385, identifies who must
hold a safety permit, establishes the application process for a safety
permit, and the conditions that must be satisfied before FMCSA will
issue a safety permit to a carrier. Those conditions are set out in 49
CFR 385.407.
    Section 385.407 requires that a carrier must have a
``Satisfactory'' safety rating, must certify that it has a satisfactory
security program, and must be properly registered with the Pipeline and
Hazardous Materials Safety Administration (PHMSA). 49 CFR
385.407(a)(1), 385.407(b) & (c). Section 385.407(a)(2) additionally
states that FMCSA will not issue a safety permit to a motor carrier
that * * *:

    (ii) Has a crash rate in the top 30 percent of the national
average as indicated in the FMCSA Motor Carrier Management
Information System (MCMIS); or
    (iii) Has a driver, vehicle, hazardous materials, or total out-
of-service rate in the top 30 percent of the national average as
indicated in the MCMIS.

    The safety permit requirement became effective for motor carriers
on the date after January 1, 2005, when the motor carrier was required
to file a Motor Carrier Identification Report Form (MCS-150) according
to a schedule set forth in 49 CFR 390.19(a). A motor carrier is
required to file its MCS-150 form every two years. Thus, the safety
permit requirement was implemented over the course of two years as
motor carriers subject to the permit requirement reached the date for
filing their MCS-150. The application for the safety permit was
incorporated into the MCS-150, as an expanded form entitled ``MCS-150B
or Combined Motor Carrier Identification Report and HM Permit
Application.''
    On or about January 3, 2005, the Office of Enforcement and
Compliance (OEC) published on its public Web site \1\ the formula for
determining the national average, the crash rates and driver, vehicle
and hazmat out-of-service (OOS) rates that established the threshold
for the ``top 30 percent of the national average,'' and other
information about calculating these rates. The website also explained
how a carrier can calculate its own crash and OOS rates. For OOS rates,
OEC explained that it determined the top 30 percent of the national
average as follows:
---------------------------------------------------------------------------

    \1\ http://www.safersys.org/HazMatRatesPost.aspx#OOSRates.

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

    To calculate this percentage for (OOS) Rate, FMCSA looked at the
driver, vehicle, or HM OOS percentage rates of all carriers (HM and
non-HM) for calendar years 2003 and 2004. FMCSA then determined what
the numerical value was that resulted in 70 percent of the carriers
having a driver, vehicle, or HM OOS percentage rate lower than that
figure, and 30 percent of the carriers having a driver, vehicle, or
HM OOS percentage rate higher than that figure.

    The published guidance also instructed carriers on how to calculate
their OOS percentage rates:

    Divide the total number of out-of-service inspections from the
previous twelve month time period for each category by the total
number of inspections for that category for the same twelve month
time period. For example, if for the previous twelve month time
period a motor carrier had twenty driver inspections and two of
these resulted in an out-of-service condition then the Driver out-
of-service rate would be 0.10. (2 / 20 x 100% = 10%)

    The OEC Web site provided notice to the regulated community on how
FMCSA would establish the national averages and cut-offs for the top,
or worst-performing, 30 percent of the motor carrier population. Using
these formulas, FMCSA established the thresholds for crash rates,
vehicle, driver, and hazardous materials OOS rates and published these
thresholds on its Web site in January 2005. The thresholds remained
effective for the first two years of the program. In January 2007,
using data for calendar years 2005 and 2006, FMCSA recalculated the top
thirty percent of the national average and published the threshold
crash rates, driver, vehicle, and hazardous materials OOS rates that
would be effective in 2007 and 2008. The threshold rates were as
follows:

----------------------------------------------------------------------------------------------------------------
                                                  Motor carrier     Driver OOS      Vehicle OOS     Hazmat  OOS
                                                   crash rate          rate            rate            rate
----------------------------------------------------------------------------------------------------------------
2005 & 2006...................................             0.125           8.92%           33.3%           5.88%

2007 & 2008...................................             0.125           9.52%          33.33%           6.06%
----------------------------------------------------------------------------------------------------------------

Challenges to the Rule

    Over the course of the two-year implementation period of the safety
permit requirement, two motor carriers that were denied safety permits
challenged the adequacy of the notice to the regulated community of
FMCSA's method for calculating the top thirty percent of the national
average and the crash and OOS rates for individual carriers. Despite
the clear and accessible notice on the agency's public Web site of the
threshold rates and the method by which these rates and those of
individual carriers are calculated, the challenging motor carriers
asserted that this notice was insufficient because it was not published
in the Federal Register. FMCSA maintains its position that adequate and
fair notice was provided to the regulated community of the method by
which it would apply the conditions for issuing a safety permit under
49 CFR 385.407. Nevertheless, to foreclose further challenges, FMCSA is
restating its methodology through this publication in the Federal
Register.

Subpart E--Hazardous Materials Safety Permits

Calculating Crash Rates

    Under 49 CFR 385.407(a)(2)(ii), FMCSA may not issue a safety permit
to a motor carrier that has a crash rate in the top 30 percent of the
national average as indicated in the MCMIS. To calculate the threshold
rate above which a motor carrier's crash rate will fall into the top,
or worst-performing, 30 percent of the national average, FMCSA looked
at all carriers in its census (HM and non-HM) that had more than one
crash during the previous two-years. To calculate the national average,
FMCSA:
    (1) Determined the number of crashes for each qualifying carrier
over a two-year period.
    (2) Determined the number of power units that the carrier operated
over the two year period.
    (3) For each carrier, divided the number of crashes by the number
of power units times 2 to determine each carrier's crash rate, i.e.,
[( of crashes) / ( of power units x 2) = crash rate].
    (4) Using these rates, determined the numerical value that resulted
in 70 percent of the carriers having a crash rate lower than that
figure, and 30 percent of the carriers having a crash rate higher than
that figure.
    The resulting numerical value represents the threshold for the
worst-performing 30 percent of the national average. The threshold
crash rate will be recalculated every two years using the crash data
from the previous two years. FMCSA examines two years of data in order
to evaluate crash rates that accurately represent occurrences in the
industry and that will remain consistent throughout the two-year period
during which carriers are required to apply for a safety permit. (The
calculations to determine crash rates have been performed in this
manner since the inception of the program in January 2005. Information
on the Web site erroneously indicated that only one year of data was
considered in setting the national averages when in fact two years of
data has consistently been used.)
    FMCSA examines one year of crash data to determine the crash rate
for an individual carrier that is applying for a safety permit. The
carrier will divide the number of crashes for the previous twelve-month
period by the total number of power units that it operated during that
twelve-month period. For example, if a motor carrier had 2 crashes and
10 power units, the crash rate would be 0.20 based upon a calculation
of (2 = 10 = 0.20). FMCSA examines one year of data to remain
consistent with FMCSA practice of reviewing one year of records during
a compliance review. FMCSA does not consider a single crash to be
statistically valid. Thus, crash rates will be calculated only for
carriers with more than one crash in the previous twelve-month period.

Calculating Out-of-Service (OOS) Rates

    Under 49 CFR 385.407(a)(2)(iii), FMCSA may not issue a safety
permit to a motor carrier that has a driver, vehicle, hazardous
material or total out-of-service (OOS) rate in the top 30 percent of
the national average as indicated in the MCMIS. To calculate the
threshold rates above which a motor carrier's rate will fall into the
top, or worst-performing, 30 percent of the national average for each
of the listed categories, FMCSA separately examined the driver,
vehicle, or hazmat OOS rate of all the carriers in its census. OEC did
not include carriers that only had one inspection and only considered
hazmat carriers in the calculation for the hazmat OOS rate. OEC
examined two years of data, initially for calendar years 2003 and 2004,
and subsequently, for calendar years 2005 and 2006.
    In each category, OEC determined the OOS rate for each qualifying
carrier in the census by dividing the total number of OOS violations by
the total number of inspections over the two-year period. For the
hazmat OOS rate, the total number of hazmat OOS violations was divided
by the total number of hazmat inspections over the two-year period. OEC
then determined the numerical value that resulted in 70 percent of the
carriers having a driver, vehicle, or hazmat OOS rate lower than that
figure, and 30 percent of the carriers having a driver, vehicle, or
hazmat OOS percentage rate higher than that figure. These numbers
established the threshold above which a carrier falls into the top, or
worst-performing, 30 percent of the national average in each category.
OEC determined that looking at a total OOS rate was redundant and that
total OOS rates were adequately considered by the examination of OOS
rates in each of the three categories. The threshold rates representing
the cut-off for the top thirty percent of the national average will be
recalculated every two years on the first workday of the year. The
first calculations for the national average were made on January 3,
2005 using the available MCMIS data for calendar years 2003 and 2004,
the second calculations for the national average were made on January
3, 2007, using the available MCMIS data for calendar years 2005 and
2006.
    A motor carrier calculates its OOS rate in each of the three
categories by examining the number of inspections and OOS violations
during the preceding twelve-month period. The carrier must then divide
the number of OOS violations for the category by the total number of
inspections for that category. The resulting figure is the motor
carrier's OOS rate for the particular category. For example, if during
the previous twelve-month period, a motor carrier had twenty driver
inspections and two of these resulted in an OOS condition, the driver
OOS rate would be 0.10 (2 / 20 = 0.10 or 10%). Each of the OOS
categories, Driver, Vehicle, and Hazardous Materials, shall be
calculated separately. FMCSA does not consider a single OOS inspection
in any category to be statistically valid and thus will not deny a
permit to a carrier based upon an OOS

rate that results from a single OOS inspection.

    Issued on: October 31, 2007.
John H. Hill,
Administrator.
 [FR Doc. E7-21833 Filed 11-6-07; 8:45 am]

BILLING CODE 4910-EX-P


[Federal Register Volume 83, Number 60 (Wednesday, March 28, 2018)]
[Notices]
[Pages 13288-13290]
[FR Doc No: 2018-06154]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6397]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Food Labeling;
Calorie Labeling of Articles of Food in Vending Machines and Nutrition
Labeling of Standard Menu Items in Restaurants and Similar Retail Food
Establishments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing that a proposed collection of information has been submitted
to the Office of Management and Budget

(OMB) for review and clearance under the Paperwork Reduction Act of
1995.

DATES: Fax written comments on the collection of information by April
27, 2018.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0782.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Calorie Labeling of Articles of Food in Vending Machines and Nutrition
Labeling of Standard Menu Items in Restaurants and Similar Retail Food
Establishments--21 CFR Part 101

OMB Control Numbers 0910-0782 and 0910-0783--Consolidation

    This information collection supports FDA regulations under 21 CFR
101. As published in the Federal Register of December 1, 2014 (79 FR
71156 and 71259), regulations at 21 CFR 101.8 and 101.11 were revised
to provide for the nutritional analysis of certain foods and for the
disclosure of that information on applicable products purchased by
consumers. The regulations also provide for the registration of certain
individuals who become subject to the requirements, for which we
developed Form FDA 3757 entitled, ``DHHS/FDA Menu and Vending Machine
Labeling Voluntary Registration,'' to assist respondents in this
regard. To keep the registration active, respondents must renew the
registration every other year within 60 days prior to the expiration of
the establishment's current registration with FDA, or it will
automatically expire.
    In the Federal Register of December 12, 2017 (82 FR 58425), we
published a 60-day notice requesting public comment on the proposed
information collection. A number of comments were received in response
to the notice. The comments were generally supportive of the
information collection, but included concerns about the potential
effect the ongoing or delayed rulemaking to establish specific
packaging requirements (e.g., font-size of labeling, compliance dates)
might have on the associated third-party disclosure burden. Other
comments questioned whether FDA needed all data currently being sought
by the applicable regulations and suggested the registration schedule
be relaxed, especially given the small number of respondents.
    We are very appreciative of these comments. At the same time, upon
our own review of the information collection, we are seeking to
consolidate the burden currently approved under OMB control number
0910-0783 with 0910-0782 because it is intended to account for similar
collection activities and is supported by the same collection
instrument (Form FDA 3757) identified above. Also, as neither the
public comments we received nor our own evaluation suggested we revise
our original figures, we are retaining the currently approved estimated
burden for the information collection, which is as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
    21 CFR 101.8 and 101.11                        Number of                     Average burden
  registration using form FDA      Number of     responses per   Total annual   per response (in    Total hours
             3757                 respondents     respondent       responses         hours)
----------------------------------------------------------------------------------------------------------------
Sec.   101.8(d); initial                    13               1              13  2...............              26
 registration.
Sec.   101.8(d); registration               19               1              19  .5 (30 minutes).             9.5
 renewal.
Sec.   101.11(d) initial                 3,559               1           3,559  2...............           7,118
 registration.
Sec.   101.11(d) registration            5,340               1           5,340  .5 (30 minutes).           2,670
 reviewal.
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................         9,823.5
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                                   Table 2--Estimated Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    Annual
        21 CFR part 101            Number of     frequency per   Total annual   Hours per record    Total hours
                                 recordkeepers   recordkeeper       records
----------------------------------------------------------------------------------------------------------------
                                    Initial Burden (Annualized over 3 years)
----------------------------------------------------------------------------------------------------------------
Sec.   101.8(c)(2)(i)(A);               69,017               1          69,017  .25 (15 minutes)          17,254
 Initial nutrition analysis.
----------------------------------------------------------------------------------------------------------------
                                                  Annual Burden
----------------------------------------------------------------------------------------------------------------
Sec.   101.8(c)(2)(i)(A);               30,059               1          30,059  .25 (15 minutes)           7,515
 Recurring nutrition analysis.
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................          24,769
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                           Table 3--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of                     Average burden
        21 CFR part 101            Number of      disclosures    Total annual    per disclosure     Total hours
                                  respondents   per respondent    disclosures      (in hours)
----------------------------------------------------------------------------------------------------------------
Sec.   101.8(c)(2)(i); calorie             282              11           3,102  1...............           3,102
 analysis.
Sec.   101.8(c)(2)(ii);                  3,279           2,122       6,958,038  .21 (12.5              1,461,188
 calorie declaration signage.                                                    minutes).
Sec.   101.8(e)(1); vending              3,279             125         409,875  .025 (1.5                 10,247
 operator contact information.                                                   minutes).
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................       1,474,537
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with the information collection.

    These figures are based on our analyses in support of the
underlying rulemaking cited above and there is no burden increase since
the previous OMB approvals. Because these are newly established
information collection provisions, we continue to evaluate the
collection burden and solicit public comment, noting that the effective
dates and/or compliance dates for certain provisions have not yet been
realized.

    Dated: March 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06154 Filed 3-27-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: September 9, 2010 (Volume 75, Number 174)]
[Rules and Regulations]
[Page 54771-54773]
[DOCID:fr09se10-6]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2010-0755]
RIN 1625-AA00

Safety Zone; Thunder on the Bay, Chesapeake Bay, Buckroe Beach
Park, Hampton, VA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a 210-foot radius safety zone
on the navigable waters of Chesapeake Bay in Hampton, VA in support of
the Thunder on the Bay fireworks event. This action is intended to
restrict vessel traffic movement to protect mariners and spectators
from the hazards associated with aerial fireworks displays.

DATES: This rule is effective from 9:15 p.m. to 10 p.m. on September
17, 2010.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2010-0755 and are available online
by going to http://www.regulations.gov, inserting USCG-2010-0755 in the
``Keyword'' box, and then clicking ``Search.'' They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or e-mail LT Michael DiPace, Sector Hampton Roads
Waterways Management Division, Coast Guard; telephone<PHONE_NUMBER>, e-
mail<EMAIL_ADDRESS>If you have questions on viewing the
docket, call Renee V. Wright, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because any delay encountered in this
regulation's effective date by publishing a NPRM would be contrary to
public interest since immediate action is needed to provide for the
safety of life and property on navigable waters. Additionally, this
temporary safety zone will be enforced for approximately forty-five
minutes on Friday, September 17, 2010 while the fireworks display is in
progress.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Due to the need for immediate
action, the restriction of vessel traffic is necessary to protect life,
property and the environment during the fireworks

event. Therefore, a 30-day notice is impracticable. Delaying the
effective date would be contrary to the safety zone's intended
objectives: Protecting persons and vessels involved in the event and
enhancing public and maritime safety.

Basis and Purpose

    On September 17, 2010, the City of Hampton, VA will sponsor a
fireworks display on the Buckroe Beach Park Fishing Pier over the
navigable waters of the Chesapeake Bay in approximate position
37[deg]02'23'' N/076[deg]17'22'' W (NAD 1983). Due to the need to
protect mariners and spectators from the hazards associated with the
fireworks display, such as the accidental discharge of fireworks,
dangerous projectiles, and falling hot embers or other debris, vessel
traffic will be temporarily restricted within 210 feet of the fireworks
launch site.

Discussion of Rule

    The Coast Guard is establishing a temporary safety zone on the
navigable waters of the Chesapeake Bay within the area bounded by a
210-foot radius circle centered on position 37[deg]02'23'' N,
076[deg]17'22'' W (NAD 1983). This safety zone will be established in
the vicinity of Buckroe Beach Park in Hampton, VA from 9:15 p.m. to 10
p.m. on September 17, 2010. In the interest of public safety, general
navigation within the safety zone will be restricted during the
specified date and times. Except for participants and vessels
authorized by the Coast Guard Captain of the Port, or his
representative, no person or vessel may enter or remain in the
regulated area.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order. Although this regulation restricts access
to the safety zone, the effect of this rule will not be significant
because: (i) The safety zone will be in effect for a limited duration;
(ii) the zone is of limited size; and (iii) the Coast Guard will make
notifications via maritime advisories so mariners can adjust their
plans accordingly.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities.
    This rule will affect the following entities, some of which may be
small entities: The owners or operators of vessels intending to transit
the specified portion of The Chesapeake Bay from 9:15 p.m. to 10 p.m.
on September 17, 2010.
    This safety zone will not have a significant economic impact on a
substantial number of small entities for the following reasons: (1)
This rule will be enforced for only forty-five minutes on September 17,
2010; (2) Vessel traffic will be able to navigate safely around the
zone without significant impact to their transit plans; and (3) Before
the effective period begins, we will issue maritime advisories.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that Order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
rule is categorically excluded, under figure 2-1, paragraph (34)(g), of
the Instruction. This rule involves establishing a safety zone around a
fireworks display and is expected to have no impact on the water or
environment. This zone is designed to protect mariners and spectators
from the hazards associated with aerial fireworks displays. An
environmental analysis checklist and a categorical exclusion
determination are available in the docket where indicated under
ADDRESSES.

List of Subject 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub.
L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add Sec.  165.T05-0755 to read as follows:

Sec.  165.T05-0755  Safety Zone; Thunder on the Bay, Chesapeake Bay,
Buckroe Beach Park, Hampton, VA.

    (a) Location. The following area is a safety zone: All navigable
waters of the Chesapeake Bay within the area bounded by a 210-foot
radius circle centered on position 37[deg]02'23'' N/076[deg]17'22'' W
(NAD 1983).
    (b) Definition. Captain of the Port Representative means any U.S.
Coast Guard commissioned, warrant or petty officer who has been
authorized by the Captain of the Port, Hampton Roads, Virginia to act
on his or her behalf.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.23 of this part, entry into this zone is prohibited unless
authorized by the Captain of the Port, Hampton Roads or designated
representative.
    (2) The operator of any vessel in the immediate vicinity of this
safety zone shall:
    (i) Stop the vessel immediately upon being directed to do so by any
commissioned, warrant or petty officer on shore or on board a vessel
that is displaying a U.S. Coast Guard Ensign.
    (ii) Proceed as directed by any commissioned, warrant or petty
officer on shore or on board a vessel that is displaying a U.S. Coast
Guard Ensign.
    (3) The Captain of the Port, Hampton Roads can be reached through
the Command Duty Officer at Sector Hampton Roads in Portsmouth,
Virginia at telephone number<PHONE_NUMBER>.
    (4) The Coast Guard Representatives enforcing the safety zone can
be contacted on VHF-FM marine band radio channel 13 (165.65 Mhz) and
channel 16 (156.8 Mhz).
    (d) Enforcement Period. This regulation will be enforced from 9:15
p.m. to 10 p.m. on September 17, 2010.

    Dated: August 10, 2010.
M.S. Ogle,
Captain, U.S. Coast Guard, Captain of the Port Hampton Roads.
[FR Doc. 2010-22418 Filed 9-8-10; 8:45 am]
BILLING CODE 9110-04-P