[Federal Register Volume 80, Number 218 (Thursday, November 12, 2015)]
[Notices]
[Pages 70067-70074]
[FR Doc No: 2015-28740]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2015-0336]

Qualification of Drivers; Exemption Applications; Diabetes
Mellitus

AGENCY: Federal Motor Carrier Safety Administration (FMCSA).

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

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SUMMARY: FMCSA announces receipt of applications from 54 individuals
for exemption from the prohibition against persons with insulin-treated
diabetes mellitus (ITDM) operating commercial motor vehicles (CMVs) 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 December 14, 2015.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket No. FMCSA-2015-0336 using any of the
following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the on-line 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.,
Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket numbers 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., Monday through Friday,
except Federal holidays. The Federal Docket Management System (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: Christine A. Hydock, Chief, Medical
Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE., Room W64-113,
Washington, DC 20590-0001. Office hours are 8:30 a.m. to 5 p.m., e.t.,
Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

I. Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the Federal Motor Carrier Safety Regulations for a 2-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 2-year period. The 54 individuals listed
in this

notice have recently requested such an exemption from the diabetes
prohibition in 49 CFR 391.41(b)(3), which applies to drivers of CMVs in
interstate commerce. 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.

II. Qualifications of Applicants

Ramon Becerra

    Mr. Becerra, 44, has had ITDM since 2015. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Becerra understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Becerra meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2015 and certified that he does not have
diabetic retinopathy. He holds an operator's license from Indiana.

Harry L. Blakely

    Mr. Blakely, 52, has had ITDM since 2015. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Blakely understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Blakely meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2015 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Minnesota.

Steven J. Bloemker

    Mr. Bloemker, 55, has had ITDM since 2012. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Bloemker understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Bloemker meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2015 and certified that he does not
have diabetic retinopathy. He holds an operator's license from Ohio.

Billy J. Bookout

    Mr. Bookout, 23, has had ITDM since 1995. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Bookout understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Bookout meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2015 and certified that he does not
have diabetic retinopathy. He holds an operator's license from
Oklahoma.

David M. Brady

    Mr. Brady, 46, has had ITDM since 2013. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Brady understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Brady meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2015 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Nebraska.

William G. Bush

    Mr. Bush, 62, has had ITDM since 2015. His endocrinologist examined
him in 2015 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 (2 or
more) severe hypoglycemic episodes in the last 5 years. His
endocrinologist certifies that Mr. Bush understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. Bush meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His optometrist examined him
in 2015 and certified that he does not have diabetic retinopathy. He
holds a Class A CDL from Illinois.

Gene D. Carey, Jr.

    Mr. Carey, 44, has had ITDM since 2014. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Carey understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Carey meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2015 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Pennsylvania.

James C. Decker

    Mr. Decker, 66, has had ITDM since 2014. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Decker understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Decker meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2015 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from California.

Richard D. Doherty

    Mr. Doherty, 54, has had ITDM since 1974. His endocrinologist
examined him in 2015 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 (2 or more) severe
hypoglycemic episodes in the last 5 years. His endocrinologist
certifies that Mr. Doherty understands diabetes management and
monitoring, has stable control of his diabetes using insulin, and is
able to drive a CMV safely. Mr. Doherty meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined
him in 2015 and certified that he has stable nonproliferative diabetic
retinopathy. He holds a Class B CDL from Massachusetts.

Richard N. Dunn

    Mr. Dunn, 57, has had ITDM since 2014. His endocrinologist examined
him in 2015 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 (2 or
more) severe hypoglycemic episodes in the last 5 years. His
endocrinologist certifies that Mr. Dunn understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. Dunn meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined
him in 2015 and certified that he does not have diabetic retinopathy.
He holds a Class B CDL from Kansas.

Thomas C. Eklund

    Mr. Eklund, 65, has had ITDM since 2015. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Eklund understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Eklund meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2015 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Oregon.

Rodney L. Forrister, Jr.

    Mr. Forrister, 30, has had ITDM since 1995. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Forrister understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Forrister meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2015 and certified that he does not have
diabetic retinopathy. He holds a chauffeur's license from Michigan.

Ronald J. Gasper

    Mr. Gasper, 55, has had ITDM since 2012. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Gasper understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Gasper meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2015 and certified that he has stable
nonproliferative diabetic retinopathy. He holds a Class A CDL from
South Dakota.

Jeremy J. Giesbrecht

    Mr. Giesbrecht, 40, has had ITDM since 2014. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Giesbrecht understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Giesbrecht meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2015 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Indiana.

David F. Goehring

    Mr. Goehring, 57, has had ITDM since 2015. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Goehring understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Goehring meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2015 and certified that he has stable
proliferative diabetic retinopathy. He holds a Class A CDL from
Wisconsin.

Robert J. Golding

    Mr. Golding, 47, has had ITDM since 2015. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Golding understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Golding meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2015 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from Maine.

Ethan T. Heideman

    Mr. Heideman, 23, has had ITDM since 2006. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Heideman understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Heideman meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2015

and certified that he does not have diabetic retinopathy. He holds a
Class A CDL from Minnesota.

Benjamin R. Hickerson

    Mr. Hickerson, 33, has had ITDM since 2014. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Hickerson understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Hickerson meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2015 and certified that he does not have
diabetic retinopathy. He holds an operator's license from California.

Timothy J. Hrinak

    Mr. Hrinak, 31, has had ITDM since 1994. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Hrinak understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Hrinak meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2015 and certified that he does not have
diabetic retinopathy. He holds an operator's license from Pennsylvania.

Kevin M. Hunt

    Mr. Hunt, 31, has had ITDM since 2015. His endocrinologist examined
him in 2015 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 (2 or
more) severe hypoglycemic episodes in the last 5 years. His
endocrinologist certifies that Mr. Hunt understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. Hunt meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His optometrist examined him
in 2015 and certified that he does not have diabetic retinopathy. He
holds a chauffeur's license from Michigan.

David T. Issler

    Mr. Issler, 50, has had ITDM since 1996. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Issler understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Issler meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2015 and certified that he does not have
diabetic retinopathy. He holds an operator's license from New York.

Todd D. Jacquin

    Mr. Jacquin, 54, has had ITDM since 2000. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Jacquin understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Jacquin meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2015 and certified that he does not
have diabetic retinopathy. He holds an operator's license from North
Carolina.

Bruce E. Kerr

    Mr. Kerr, 59, has had ITDM since 2013. His endocrinologist examined
him in 2015 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 (2 or
more) severe hypoglycemic episodes in the last 5 years. His
endocrinologist certifies that Mr. Kerr understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. Kerr meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His optometrist examined him
in 2015 and certified that he does not have diabetic retinopathy. He
holds an operator's license from Kentucky.

Mark C. Kucharski

    Mr. Kucharski, 38, has had ITDM since 1989. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Kucharski understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Kucharski meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2015 and certified that he has stable
nonproliferative diabetic retinopathy. He holds an operator's license
from Colorado.

Philip M. LaPierre

    Mr. LaPierre, 49, has had ITDM since 1977. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. LaPierre understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. LaPierre meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2015 and certified that he does not have
diabetic retinopathy. He holds a Class B CDL from Maine.

Mary J. Martin

    Ms. Martin, 48, has had ITDM since 2014. Her endocrinologist
examined her in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
Her endocrinologist certifies that Ms. Martin understands diabetes

management and monitoring has stable control of her diabetes using
insulin, and is able to drive a CMV safely. Ms. Martin meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). Her
ophthalmologist examined her in 2015 and certified that she has stable
nonproliferative diabetic retinopathy. She holds a Class B CDL from
Pennsylvania.

Peter J. Meier

    Mr. Meier, 43, has had ITDM since 2012. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Meier understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Meier meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2015 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Washington.

Terry J. Miller

    Mr. Miller, 59, has had ITDM since 2015. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Miller understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Miller meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2015 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Wisconsin.

Michael E. Morel

    Mr. Morel, 59, has had ITDM since 2014. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Morel understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Morel meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2015 and certified that he does not have
diabetic retinopathy. He holds a Class B CDL from New Hampshire.

Marvin K. Mosley

    Mr. Mosley, 49, has had ITDM since 2011. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Mosley understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Mosley meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2015 and certified that he does not have
diabetic retinopathy. He holds an operator's license from South
Carolina.

Eric Nieves, Jr.

    Mr. Nieves, 44, has had ITDM since 2015. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Nieves understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Nieves meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2015 and certified that he has stable
nonproliferative diabetic retinopathy. He holds an operator's license
from New York.

Jerry D. Pearce

    Mr. Pearce, 37, has had ITDM since 2012. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Pearce understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Pearce meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2015 and certified that he does not have
diabetic retinopathy. He holds an operator's license from New Mexico.

George W. Pottle, IV

    Mr. Pottle, 55, has had ITDM since 2013. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Pottle understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Pottle meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2015 and certified that he does not
have diabetic retinopathy. He holds an operator's license from Maine.

Kenneth A. Prine

    Mr. Prine, 57, has had ITDM since 2002. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Prine understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Prine meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2015 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Washington.

Charles R. Ratcliff, Jr.

    Mr. Ratcliff, 59, has had ITDM since 2012. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5
years. His endocrinologist certifies that Mr. Ratcliff understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Ratcliff meets
the requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2015 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Virginia.

Joseph B. Ribitzki

    Mr. Ribitzki, 38, has had ITDM since 2015. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Ribitzki understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Ribitzki meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2015 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from Arkansas.

Roger D. Richey

    Mr. Richey, 57, has had ITDM since 2015. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Richey understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Richey meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2015 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Indiana.

Michael G. Sanchez

    Mr. Sanchez, 42, has had ITDM since 2014. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Sanchez understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Sanchez meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2015 and certified that he does not have
diabetic retinopathy. He holds a Class B CDL from California.

Guido J. Scarafoni

    Mr. Scarafoni, 67, has had ITDM since 2009. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Scarafoni understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Scarafoni meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2015 and certified that he does not
have diabetic retinopathy. He holds a Class B CDL from Massachusetts.

Jeffrey M. Schleisman

    Mr. Schleisman, 29, has had ITDM since 1992. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Schleisman understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Schleisman meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2015 and certified that he has stable
proliferative diabetic retinopathy. He holds a Class A CDL from Iowa.

Scott J. Schmidt

    Mr. Schmidt, 49, has had ITDM since 2015. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Schmidt understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Schmidt meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2015 and certified that he does not have
diabetic retinopathy. He holds a Class B CDL from Nebraska.

Lori A. Shaffnit

    Ms. Shaffnit, 55, has had ITDM since 2014. Her endocrinologist
examined her in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
Her endocrinologist certifies that Ms. Shaffnit understands diabetes
management and monitoring has stable control of her diabetes using
insulin, and is able to drive a CMV safely. Ms. Shaffnit meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). Her
ophthalmologist examined her in 2015 and certified that she does not
have diabetic retinopathy. She holds a Class B CDL from Iowa.

Sanampreet Singh

    Mr. Singh, 22, has had ITDM since 2008. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Singh understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Singh meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2015 and certified that he does not have
diabetic retinopathy.

He holds an operator's license from California.

Joshua A. Snyder

    Mr. Snyder, 31, has had ITDM since 2013. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Snyder understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Snyder meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2015 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from West Virginia.

Christophe M. Stephens

    Mr. Stephens, 43, has had ITDM since 2014. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Stephens understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Stephens meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2015 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Tennessee.

Michael A. Stille

    Mr. Stille, 52, has had ITDM since 1991. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Stille understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Stille meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2015 and certified that he has stable
nonproliferative diabetic retinopathy. He holds an operator's license
from Georgia.

Leonard Tawahongva

    Mr. Tawahongva, 56, has had ITDM since 2015. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Tawahongva understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Tawahongva meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2015 and certified that he does not have
diabetic retinopathy. He holds an operator's license from Arizona.

Edward M. Taylor

    Mr. Taylor, 65, has had ITDM since 2014. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Taylor understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Taylor meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2015 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Nebraska.

Donald L. Trogdon

    Mr. Trogdon, 54, has had ITDM since 2012. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Trogdon understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Trogdon meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2015 and certified that he does not have
diabetic retinopathy. He holds an operator's license from Idaho.

Gregory S. Van Hal

    Mr. Van Hal, 56, has had ITDM since 1977. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Van Hal understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Van Hal meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2015 and certified that he has stable
proliferative diabetic retinopathy. He holds an operator's license from
Minnesota.

Lazario R. Watkins

    Mr. Watkins, 25, has had ITDM since 2011. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Watkins understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Watkins meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2015 and certified that he does not have
diabetic retinopathy. He holds an operator's license from North
Carolina.

Eric J. Watson

    Mr. Watson, 27, has had ITDM since 2014. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist

certifies that Mr. Watson understands diabetes management and
monitoring, has stable control of his diabetes using insulin, and is
able to drive a CMV safely. Mr. Watson meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His optometrist examined him
in 2015 and certified that he does not have diabetic retinopathy. He
holds an operator's license from New York.

William T. White

    Mr. White, 47, has had ITDM since 2012. His endocrinologist
examined him in 2015 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 (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. White understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. White meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2015 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Washington.

J. Ryan Wolf

    Mr. Wolf, 39, has had ITDM since 2015. His endocrinologist examined
him in 2015 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 (2 or
more) severe hypoglycemic episodes in the last 5 years. His
endocrinologist certifies that Mr. Wolf understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. Wolf meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined
him in 2015 and certified that he does not have diabetic retinopathy.
He holds an operator's license from Indiana.

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 date section
of the notice.
    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).\1\ 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).
---------------------------------------------------------------------------

    \1\ Section 4129(a) refers to the 2003 notice as a ``final
rule.'' However, the 2003 notice did not issue a ``final rule'' but
did establish the procedures and standards for issuing exemptions
for drivers with ITDM.
---------------------------------------------------------------------------

    Section 4129 requires: (1) Elimination of the requirement for 3
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 3-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.

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-2015-0336 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 material received during the
comment period and may change this proposed rule based on your
comments. FMCSA may issue a final rule 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, To submit your comment online, go to http://www.regulations.gov and in the search box insert the docket number
FMCSA-2015-0336 and click ``Search.'' Next, click ``Open Docket
Folder'' and you will find all documents and comments related to the
proposed rulemaking.

    Dated: November 5, 2015.
 Larry W. Minor,
 Associate Administrator for Policy.
[FR Doc. 2015-28740 Filed 11-10-15; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 85, Number 128 (Thursday, July 2, 2020)]
[Notices]
[Pages 39917-39918]
[FR Doc No: 2020-14263]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0145]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Reporting Associated
With Animal Drug and Animal Generic Drug User Fees

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) 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: Submit written comments (including recommendations) on the
collection of information by August 3, 2020.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0540. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
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.

Reporting Associated With Animal Drug and Animal Generic Drug User
Fees--21 U.S.C. 379j-12 and 379j-21

OMB Control Numbers 0910-0540--Extension

    This information collection supports FDA's animal drug and animal
generic drug user fee programs. The Animal Drug User Fee Act of 2003
(ADUFA) (Pub. L. 108-130) amended the Federal Food, Drug, and Cosmetic
Act (FD&C Act) by adding section 740 of the FD&C Act (21 U.S.C 379j-
12), which requires that FDA assess and collect user fees with respect
to new animal drug applications for certain applications, products,
establishments, and sponsors. It also requires the Agency to grant a
waiver from, or a reduction of, those fees in certain circumstances.
The Animal Generic Drug User Fee Act of 2008 (AGDUFA) (Pub. L. 110-316)
added section 741 of the FD&C Act (21 U.S.C. 379j-21), which
establishes three different kinds of user fees: (1) Fees for certain
types of abbreviated applications for generic new animal drugs; (2)
annual fees for certain generic new animal drug products; and (3)
annual fees for certain sponsors of abbreviated applications for
generic new animal drugs and/or investigational submissions for generic
new animal drugs (21 U.S.C. 379j-21(a)). On August 14, 2018, H.R. 5554,
the Animal Drug and Animal Generic Drug User Fee Amendments of 2018,
was signed into law to reauthorize the ADUFA and AGDUFA programs
administered by FDA.
    Sponsors of new animal drug applications prepare and submit user
fee cover sheets. The Animal Drug User Fee cover sheet (Form FDA 3546)
is designed to collect the minimum necessary information to determine
whether a fee is required for the review of an application or
supplement or whether an application fee waiver was granted, to
determine the amount of the fee required, and to ensure that each
animal drug user fee payment is appropriately linked to the animal drug
application for which payment is made. The form, when completed
electronically, results in the generation of a unique payment
identification number used by FDA to track the payment. The information
collected is used by FDA's Center for Veterinary Medicine (CVM) to
initiate the administrative screening of new animal drug applications
and supplements. The information collection associated with the Animal
Drug User Fee cover sheet currently is approved under OMB control
number 0910-0539.
    Sponsors of abbreviated new animal drug applications also prepare
and submit user fee cover sheets. The Animal Generic Drug User Fee
cover sheet (Form FDA 3728) similarly is designed to collect the
minimum necessary information to determine whether a fee is required
for review of an application, to determine the amount of the fee
required, and to ensure that each animal generic drug user fee payment
is appropriately linked to the abbreviated new animal drug application
for which payment is made. The form, when completed electronically,
results in the generation of a unique payment identification number
used by FDA to track the payment. The information collected is used by
CVM to initiate the administrative screening of abbreviated new animal
drug applications. The information collection associated with the
Animal Generic Drug User Fee cover sheet currently is approved under
OMB control number 0910-0632.
    FDA has also developed a guidance for industry (GFI) #170 entitled
``Animal Drug User Fees and Fee Waivers and Reductions.'' This guidance
provides guidance on the types of fees FDA is authorized to collect
under section 740 of the FD&C Act, and how to request waivers and
reductions from these fees. Further, this guidance also describes what
information FDA recommends be submitted in support of a request for a
fee waiver or reduction; how to submit such a request; and FDA's
process for reviewing requests. FDA uses the information submitted by
respondents to determine whether to grant the requested fee waiver or
reduction. The information collection associated with GFI #170
currently is approved under OMB control number 0910-0540.
    The information collection provisions approved under OMB control
numbers 0910-0539, 0910-0540, and 0910-0632 are similar in that they
support FDA's animal drug and animal generic drug user fee programs.
Thus, with this notice, FDA proposes to consolidate these collections
of information into one OMB control number for government efficiency
and to allow the public to look to one OMB control number for all
reporting associated with FDA's animal drug and animal generic drug
user fee programs. Because we are proposing to combine all reporting
associated with FDA's animal drug user fees into one collection, we are
consolidating the burden under OMB control number 0910-0540 and
discontinuing OMB control numbers 0910-0539 and 0910-0632.

    Description of Respondents: Respondents to this collection of
information are new animal drug applicants and abbreviated new animal
drug applicants. In addition, requests for waivers or reductions of
user fees may be submitted by a person responsible for paying or
potentially responsible for paying any of the animal drug user fees
assessed, including application fees, product fees, establishment fees,
or sponsor fees.
    In the Federal Register of January 23, 2020 (85 FR 3929), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
    FD&C act section; activity            FDA form No.           Number of     responses per   Total  annual      Average burden  per       Total hours
                                                                respondents     respondent       responses             response
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             User Fee Cover Sheets, by Type
--------------------------------------------------------------------------------------------------------------------------------------------------------
740(a)(1); Animal Drug User Fee    FDA 3546.................              21               1              21  1.........................              21
 Cover Sheet.
741; Animal Generic Drug User Fee  FDA 3728.................              20               2              40  0.08 (5 minutes)..........               3
 Cover Sheet.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                           Waivers and Other Requests, by Type
--------------------------------------------------------------------------------------------------------------------------------------------------------
740(d)(1)(A); significant barrier  N/A......................              55               1              55  2.........................             110
 to innovation.
740(d)(1)(B); fees exceed cost...  N/A......................               8            3.75              30  0.5 (30 minutes)..........              15
740(d)(1)(C); free-choice feeds..  N/A......................               5               1               5  2.........................              10
740(d)(1)(D); minor use or minor   N/A......................              69               1              69  2.........................             138
 species.
740(d)(1)(E); small business.....  N/A......................               1               1               1  2.........................               2
Request for reconsideration of a   N/A......................               1               1               1  2.........................               2
 decision.
Request for review (user fee       N/A......................               1               1               1  2.........................               2
 appeal officer).
                                                             -------------------------------------------------------------------------------------------
    Total........................  .........................  ..............  ..............  ..............  ..........................             303
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    For the purpose of this consolidation, we rely on our previous
estimates of the number of user fee cover sheet and waiver and other
request submissions. We estimate 21 respondents will each submit 1
Animal Drug User Fee cover sheet (Form FDA 3546) for a total of 21
responses. We estimate 20 respondents will each submit 2 Animal Generic
Drug User Fee cover sheets (Form FDA 3728) for a total of 40 responses.
Our estimate of the number of waiver and other request submissions is
detailed in table 1. These estimates are consistent with our previous
estimates except for the row labeled, Request for review (user fee
appeal officer), for which we have increased the estimated number of
respondents from zero to one and the average burden per response from 0
to 2 hours to correct the error in our previous submission. We base our
estimates of the average burden per response on our experience with the
submission of similar cover sheets and waiver and other requests.
    The information collection reflects an increase in burden by an
additional 26 hours and 62 responses due to the consolidation of the
information collections covered by OMB control numbers 0910-0539,
``Animal Drug User Fee Cover Sheet,'' and 0910-0632, ``Animal Generic
Drug User Fee Cover Sheet'' and the correction of the error in our
previous submission.

    Dated: June 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-14263 Filed 7-1-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 53 (Thursday, March 19, 2015)]
[Rules and Regulations]
[Pages 14314-14318]
[FR Doc No: 2015-06373]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0326; FRL-9924-24]

Sodium L-Lactate and Sodium DL-Lactate; Exemption From the
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of sodium L-

lactate and sodium DL-lactate when used as inert ingredients
(surfactants) in pesticide formulations applied to growing crops or to
raw agricultural commodities after harvest. Exponent, on behalf of
Archer Daniels Midland Company, submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment
of an exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of sodium L-lactate and sodium DL-lactate.

DATES: This regulation is effective March 19, 2015. Objections and
requests for hearings must be received on or before May 18, 2015, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2014-0326, is available at
http:[sol][sol]www.regulations.gov or at the Office of Pesticide
Programs Regulatory Public Docket (OPP Docket) in the Environmental
Protection Agency Docket Center (EPA/DC), West William Jefferson
Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC
20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Public Reading Room is<PHONE_NUMBER>, and the telephone
number for the OPP Docket is<PHONE_NUMBER>. Please review the visitor
instructions and additional information about the docket available at
http:[sol][sol]www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW. Washington, DC 20460-0001; main telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Publishing Office's e-CFR site at
http:[sol][sol]www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/
Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2014-0326 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
May 18, 2015. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2014-0326, by one of
the following methods:
     Federal eRulemaking Portal:
http:[sol][sol]www.regulations.gov. Follow the online instructions for
submitting comments. Do not submit electronically any information you
consider to be CBI or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http:[sol][sol]www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at
http:[sol][sol]www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of August 1, 2014 (79 FR 44729) (FRL-9911-
67), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP IN-10693) by
Exponent, 1150 Connecticut Ave. NW., Washington, DC 20036, on behalf of
Archer Daniels Midland Company, 4666 E. Faries Parkway, Decatur, IL
62526. The petition requested that 40 CFR 180.910 be amended by
establishing an exemption from the requirement of a tolerance for
residues of sodium L-lactate (CAS Reg. No. 867-56-1) and sodium DL-
lactate (CAS Reg. No. 72-17-3) when used as an inert ingredients
(surfactants) in pesticide formulations applied to growing crops or to
raw agricultural commodities after harvest. That document referenced a
summary of the petition prepared by Exponent, the petitioner, which is
available in the docket, http://www.regulations.gov. There were no
comments received in response to the notice of filing.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a

reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
. ''
    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert in conjunction with possible exposure to residues of the inert
ingredient through food, drinking water, and through other exposures
that occur as a result of pesticide use in residential settings. If EPA
is able to determine that a finite tolerance is not necessary to ensure
that there is a reasonable certainty that no harm will result from
aggregate exposure to the inert ingredient, an exemption from the
requirement of a tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for sodium L-lactate and sodium DL-
lactate including exposure resulting from the exemption established by
this action. EPA's assessment of exposures and risks associated with
sodium L-lactate and sodium DL-lactate follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by sodium L-lactate and sodium DL-lactate
as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-
observed-adverse-effect-level (LOAEL) from the toxicity studies are
discussed in this unit.
    The Agency has reviewed the data submitted by the petitioner. The
data submitted includes data on lactic acid. Sodium lactate, the sodium
salt of lactic acid, is expected to readily disassociate into the
lactate and sodium ions in the body upon ingestion. Lactic acid also
typically converts to lactate in the body. Because sodium L-lactate and
sodium DL-lactate readily disassociate into the lactate and sodium ions
in the body, the Agency has concluded that the data on L-lactic acid
(often referred to as lactic acid) can be used in conjunction with the
data on another lactate salt, calcium lactate, and that these data are
adequate to characterize the toxicity of sodium L-lactate and sodium
DL-lactate.
    Acute oral and inhalation toxicity of lactic acid to rats and acute
dermal toxicity of lactic acid to rabbits are low (oral LD50
>3,500 milligrams/kilogram (mg/kg); inhalation LC50 >5
milligrams/Liter (mg/l); dermal LD50 >2,000 mg/kg). L-lactic
acid is severely irritating and corrosive to rabbit skin. Dilute
solutions of lactic acid are irritating to the eyes of rabbits. L-
Lactic acid is not a dermal sensitizer in guinea pigs. In an oral
feeding study, two groups of (strain not-specified) received daily
doses of 1,000 and 2,000 mg/kg/day of sodium lactate (as lactic acid)
over 14 to 16 days. Body analyses of the animals showed no accumulation
of lactate. No developmental or reproductive toxicity studies are
available for sodium L-lactate or sodium DL-lactate; however, a
developmental toxicity study for lactic acid resulted in no maternal or
developmental effects and none of the reproductive parameters were
affected in mice at 570 mg/kg/day. Additionally, sodium L-lactate and
DL-lactate are not expected to be mutagenic or carcinogenic based on
the presence of the lactic acid metabolite in the human body. Lactic
acid is transported to the liver and converted by lactic acid
dehydrogenase to pyruvate. Pyruvate, in turn can be converted into free
glucose, stored as glycogen, and utilized in other metabolic
transformations (Krebs cycle). In addition, in a 2-year combined
chronic toxicity/carcinogenicity study in rats with calcium lactate,
there was no evidence of carcinogenicity or systemic toxicity at doses
up to 5,000 mg/kg/day.

B. Toxicological Points of Departure/Levels of Concern

    Sodium L-lactate and sodium DL-lactate are naturally occurring
compounds and when disassociated, are normal constituents of the human
body. No toxicological endpoint of concern has been identified.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to sodium L-lactate and sodium DL-lactate, EPA considered
likely exposure from the use of sodium L-lactate and sodium DL-lactate
as an inert ingredient in pesticides applied to growing crops or to raw
agricultural commodities after harvest. Since no toxicological endpoint
of concern has been identified and since the metabolic processes
involving sodium L-lactate and sodium DL-lactate are well understood,
the Agency has determined that a quantitative dietary exposure
assessment is not necessary. While dietary exposure may result from the
use of sodium L-lactate and sodium DL-lactate as an inert ingredient in
pesticide formulations applied to growing crops or to raw agricultural
commodities after harvest, the amount of sodium L-lactate and sodium
DL-lactate contained in pesticide formulations and applied to growing
crops or to raw agricultural commodities after harvest would be at
levels far below its natural occurrence in foods and endogenous
production in the human body.
    By comparison, L-lactic acid (CAS Reg. No. 79-33-4) is a naturally
occurring compound found in many foods and is also a human metabolite
that results from various biochemical pathways. Humans are generally
exposed to lactic acid on a daily basis in significant quantities
because it is naturally present in many food products that are derived
through natural fermentation, such as cheese, yogurt, soy sauce,
sourdough, meat products, and pickled vegetables.
    2. Dietary exposure from drinking water. Dietary exposure from
drinking water to sodium L-lactate and sodium DL-lactate can occur by
drinking water that has been contaminated by run-off from a pesticide
treated area. Since an endpoint for risk assessment was not identified,
a quantitative dietary exposure assessment from drinking water for
sodium L-lactate and sodium DL-lactate was not conducted.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure

(e.g., textiles (clothing and diapers), carpets, swimming pools, and
hard surface disinfection on walls, floors, tables).
    There is a potential for residential exposure to pesticide products
containing sodium L-lactate and sodium DL-lactate, however,
quantitative residential exposure assessment was not conducted since no
endpoint of concern was identified.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found sodium L-lactate and sodium DL-lactate to share a
common mechanism of toxicity with any other substances, and sodium L-
lactate and sodium DL-lactate does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that sodium L-lactate and
sodium DL-lactate does not have a common mechanism of toxicity with
other substances. For information regarding EPA's efforts to determine
which chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at
http:[sol][sol]www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an
additional tenfold (10X) margin of safety for infants and children in
the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children.
    Because of the non-toxic nature of sodium L-Lactate and sodium DL-
lactate, there are no threshold effects that would trigger the
application of section 408(b)(2)(C).

E. Aggregate Risks and Determination of Safety

    Taking into consideration all available information on sodium L-
lactate and sodium DL-lactate, EPA has determined that there is a
reasonable certainty that no harm to any population subgroup will
result from aggregate exposure to sodium L-lactate and sodium DL-
lactate under reasonable foreseeable circumstances. Therefore, the
establishment of an exemption from tolerance under 40 CFR 180.910 for
residues of sodium L-lactate and sodium DL-lactate when used as an
inert ingredient (surfactant) in pesticide formulations applied to
growing crops or to raw agricultural commodities after harvest, is safe
under FFDCA section 408.

V. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.

VI. Conclusion

    Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.910 for sodium L-lactate (CAS Reg. No.
867-56-1) and sodium DL-lactate (CAS Reg. No. 72-17-3) when used as an
inert ingredient (surfactant) in pesticide formulations applied to
growing crops or to raw agricultural commodities after harvest.

VII. Statutory and Executive Order Reviews

    This action establishes an exemption from the requirement of a
tolerance under FFDCA section 408(d) in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735,
October 4, 1993). Because this action has been exempted from review
under Executive Order 12866, this action is not subject to Executive
Order 13211, entitled ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of
Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997). This action does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA) (44 U.S.C. 3501 et seq.), nor does it require any special
considerations under Executive Order 12898, entitled ``Federal Actions
to Address Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the exemption in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: March 12, 2015.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. Amend Sec.  180.910, by adding alphabetically the following inert
ingredients to the table to read as follows:

Sec.  180.910  Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.

* * * * *

----------------------------------------------------------------------------------------------------------------
              Inert ingredients                        Limits                             Uses
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Sodium DL-lactate (CAS Reg. No. 72-17-3)....  .......................  Surfactant.

                                                  * * * * * * *
Sodium L-lactate (CAS Reg. No. 867-56-1)....  .......................  Surfactant.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2015-06373 Filed 3-18-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 234 (Wednesday, December 5, 2012)]
[Notices]
[Page 72429]
[FR Doc No: 2012-29314]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68319; File No. SR-NYSEArca-2012-109]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of
Designation of Longer Period for Commission Action on Proposed Rule
Change Relating to the Listing and Trading of Shares of the U.S. Equity
High Volatility Put Write Index Fund Under NYSE Arca Equities Rule
5.2(j)(3)

November 29, 2012.
    On September 27, 2012, NYSE Arca, Inc. (``Exchange'' or ``NYSE
Arca'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to list and trade shares (``Shares'') of the U.S.
Equity High Volatility Put Write Index Fund (``Fund'') under NYSE Arca
Equities Rule 5.2(j)(3). The proposed rule change was published in the
Federal Register on October 18, 2012.\3\ The Commission received no
comment letters on the proposal.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 68044 (October 12,
2012), 77 FR 64160 (``Notice'').
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \4\ provides that, within 45 days of
the publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day for this filing is December 2, 2012. The Commission is
extending this 45-day time period.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission finds that it is appropriate to designate a longer
period within which to take action on the proposed rule change so that
it has sufficient time to consider the proposed rule change. The
proposed rule change would allow the Exchange to list and trade Shares
of the Fund under NYSE Arca Equities Rule 5.2(j)(3), which governs the
listing and trading of Investment Company Units.
    Accordingly, the Commission, pursuant to Section 19(b)(2) of the
Act,\5\ designates January 16, 2013, as the date by which the
Commission should either approve or disapprove or institute proceedings
to determine whether to disapprove the proposed rule change (File
Number SR-NYSEArca-2012-109).
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(2).
    \6\ 17 CFR 200.30-3(a)(31).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-29314 Filed 12-4-12; 8:45 am]
BILLING CODE 8011-01-P