[Federal Register Volume 81, Number 203 (Thursday, October 20, 2016)]
[Notices]
[Pages 72644-72651]
[FR Doc No: 2016-25379]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2016-0223]

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 46 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 November 21, 2016.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket No. FMCSA-2016-0223 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: Ms. 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 46 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

Colter E. Allen

    Mr. Allen, 32, has had ITDM since 2000. His endocrinologist
examined him in 2016 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. Allen understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Allen meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds an operator's license from Montana.

Bert F. Asa

    Mr. Asa, 52, has had ITDM since 2016. His endocrinologist examined
him in 2016 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. Asa understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. Asa meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His optometrist examined him
in 2016 and certified that he does not have diabetic retinopathy. He
holds a Class A CDL from Colorado.

Brandon D. Baird

    Mr. Baird, 36, has had ITDM since 1989. His endocrinologist
examined him in 2016 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. Baird understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Baird meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2016 and certified that he does not
have diabetic retinopathy. He holds an operator's license from
Tennessee.

Glenn C. Blank

    Mr. Blank, 74, has had ITDM since 2016. His endocrinologist
examined him in 2016 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. Blank understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Blank meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds a Class B CDL from Pennsylvania.

Michael H. Blosser

    Mr. Blosser, 61, has had ITDM since 2016. His endocrinologist
examined him in 2016 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. Blosser understands

diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Blosser meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Washington.

Francis A. Boadu

    Mr. Boadu, 60, has had ITDM since 2015. His endocrinologist
examined him in 2016 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. Boadu understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Boadu meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2016 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from Massachusetts.

John K. Brown

    Mr. Brown, 54, has had ITDM since 2016. His endocrinologist
examined him in 2016 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. Brown understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Brown meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds a Class D CDL from Kentucky.

Timothy L. Dahlberg

    Mr. Dahlberg, 65, has had ITDM since 2007. His endocrinologist
examined him in 2016 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. Dahlberg understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Dahlberg meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Wisconsin.

Randy S. Dorn

    Mr. Dorn, 54, has had ITDM since 1998. His endocrinologist examined
him in 2016 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. Dorn understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. Dorn meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His optometrist examined him
in 2016 and certified that he does not have diabetic retinopathy. He
holds an operator's license from Wisconsin.

Troy E. Dreisbach

    Mr. Dreisbach, 52, has had ITDM since 2015. His endocrinologist
examined him in 2016 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. Dreisbach understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Dreisbach meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds an operator's license from Pennsylvania.

Janice K. Epperson

    Ms. Epperson, 70, has had ITDM since 2016. Her endocrinologist
examined her in 2016 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. Epperson understands diabetes
management and monitoring, has stable control of her diabetes using
insulin, and is able to drive a CMV safely. Ms. Epperson meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). Her
optometrist examined her in 2016 and certified that she does not have
diabetic retinopathy. She holds a Class A CDL from Missouri.

Chase L. Fugere

    Mr. Fugere, 22, has had ITDM since 2006. His endocrinologist
examined him in 2016 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. Fugere understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Fugere meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds an operator's license from North Dakota.

Richard A. Geiger

    Mr. Geiger, 55, has had ITDM since 2000. His endocrinologist
examined him in 2016 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. Geiger understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Geiger meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2016 and certified that he has stable
nonproliferative diabetic retinopathy. He holds a Class B CDL from
Illinois.

Kenneth B. Golden, Jr.

    Mr. Golden, 73, has had ITDM since 2014. His endocrinologist
examined him in 2016 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. Golden understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Golden meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from New York.

Todd K. Grama

    Mr. Grama, 49, has had ITDM since 2015. His endocrinologist
examined him in 2016 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. Grama understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Grama meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from New York.

Rick L. Hendrickson

    Mr. Hendrickson, 54, has had ITDM since 2015. His endocrinologist
examined him in 2016 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. Hendrickson understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Hendrickson meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds an operator's license from North Dakota.

Glenn E. Hoffman

    Mr. Hoffman, 60, has had ITDM since 2015. His endocrinologist
examined him in 2016 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. Hoffman understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Hoffman meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Florida.

Jeffrey S. Horvath

    Mr. Horvath, 37, has had ITDM since 2011. His endocrinologist
examined him in 2016 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. Horvath understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Horvath meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Ohio.

Herbert S. Johnson, II

    Mr. Johnson, 58, has had ITDM since 2015. His endocrinologist
examined him in 2016 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. Johnson understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Johnson meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Iowa.

Randall L. Johnson

    Mr. Johnson, 52, has had ITDM since 2016. His endocrinologist
examined him in 2016 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. Johnson understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Johnson meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds a Class B CDL from Georgia.

Gary D. Jones

    Mr. Jones, 55, has had ITDM since 2015. His endocrinologist
examined him in 2016 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. Jones understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Jones meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2016 and certified that he has stable
proliferative diabetic retinopathy. He holds a Class A CDL from Iowa.

Charles C. Kennedy

    Mr. Kennedy, 23, has had ITDM since 2013. His endocrinologist
examined him in 2016 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. Kennedy understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Kennedy meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds an operator's license from Utah.

John A. Larson

    Mr. Larson, 66, has had ITDM since 2012. His endocrinologist
examined him

in 2016 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. Larson understands diabetes management and
monitoring, has stable control of his diabetes using insulin, and is
able to drive a CMV safely. Mr. Larson meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His optometrist examined him
in 2016 and certified that he does not have diabetic retinopathy. He
holds a Class A CDL from Minnesota.

Jose A. Lucero

    Mr. Lucero, 59, has had ITDM since 2014. His endocrinologist
examined him in 2016 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. Lucero understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Lucero meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2016 and certified that he has stable
nonproliferative diabetic retinopathy. He holds a Class A CDL from
Arizona.

Gerry A. Lutz

    Mr. Lutz, 56, has had ITDM since 2015. His endocrinologist examined
him in 2016 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. Lutz understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. Lutz meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His optometrist examined him
in 2016 and certified that he does not have diabetic retinopathy. He
holds a Class A CDL from Iowa.

Gary P. Marquez

    Mr. Marquez, 54, has had ITDM since 2015. His endocrinologist
examined him in 2016 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. Marquez understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Marquez meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from California.

George F. McCrory

    Mr. McCrory, 46, has had ITDM since 2016. His endocrinologist
examined him in 2016 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. McCrory understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. McCrory meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Missouri.

Richard R. McDonald

    Mr. McDonald, 57, has had ITDM since 2016. His endocrinologist
examined him in 2016 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. McDonald understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. McDonald meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from New York.

William P. McLemore, Jr.

    Mr. McLemore, 62, has had ITDM since 2002. His endocrinologist
examined him in 2016 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. McLemore understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. McLemore meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2016 and certified that he does not
have diabetic retinopathy. He holds a Class B CDL from Illinois.

Jason M. Moch

    Mr. Moch, 26, has had ITDM since 2014. His endocrinologist examined
him in 2016 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. Moch understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. Moch meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His optometrist examined him
in 2016 and certified that he does not have diabetic retinopathy. He
holds an operator's license from North Dakota.

George K. Namauu, Jr.

    Mr. Namauu, 49, has had ITDM since 2016. His endocrinologist
examined him in 2016 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. Namauu understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Namauu meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His

ophthalmologist examined him in 2016 and certified that he has stable
proliferative diabetic retinopathy. He holds an operator's license from
Hawaii.

Ashby J. Nuckols

    Mr. Nuckols, 55, has had ITDM since 2015. His endocrinologist
examined him in 2016 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. Nuckols understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Nuckols meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2016 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from Virginia.

Encarnacion Oranday, Jr.

    Mr. Oranday, 60, has had ITDM since 2011. His endocrinologist
examined him in 2016 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. Oranday understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Oranday meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds an operator's license from Texas.

Jonathan P. Preissler

    Mr. Preissler, 23, has had ITDM since 2005. His endocrinologist
examined him in 2016 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. Preissler understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Preissler meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds an operator's license from
Massachusetts.

Charles R. Quilty

    Mr. Quilty, 55, has had ITDM since 2016. His endocrinologist
examined him in 2016 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. Quilty understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Quilty meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2016 and certified that he does not
have diabetic retinopathy. He holds an operator's license from
Illinois.

Joseph M. Rowe

    Mr. Rowe, 60, has had ITDM since 2015. His endocrinologist examined
him in 2016 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. Rowe understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. Rowe meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His optometrist examined him
in 2016 and certified that he does not have diabetic retinopathy. He
holds a Class A CDL from Missouri.

Donald G. Runyon

    Mr. Runyon, 58, has had ITDM since 2016. His endocrinologist
examined him in 2016 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. Runyon understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Runyon meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds a Class B CDL from Indiana.

John B. Simpson

    Mr. Simpson, 72, has had ITDM since 1976. His endocrinologist
examined him in 2016 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. Simpson understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Simpson meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2016 and certified that he has stable
nonproliferative diabetic retinopathy. He holds an operator's license
from New Hampshire.

Ronnie J. Smith

    Mr. Smith, 24, has had ITDM since 2006. His endocrinologist
examined him in 2016 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. Smith understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Smith meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2016 and certified that he has stable
nonprofliferative diabetic retinopathy. He holds an operator's license
from North Carolina.

Troy Smith

    Mr. Smith, 46, has had ITDM since 2016. His endocrinologist
examined him in 2016 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. Smith understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Smith meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2016 and certified that he does not
have diabetic retinopathy. He holds an operator's license from Ohio.

Mitchell A. Thomas

    Mr. Thomas, 31, has had ITDM since 2015. His endocrinologist
examined him in 2016 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. Thomas understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Thomas meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Minnesota.

James M. Vavao

    Mr. Vavao, 47, has had ITDM since 2005. His endocrinologist
examined him in 2016 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. Vavao understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Vavao meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds a Class B CDL from California.

Steven A. Vilardo

    Mr. Vilardo, 48, has had ITDM since 2016. His endocrinologist
examined him in 2016 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. Vilardo understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Vilardo meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Kentucky.

Joseph H. Wamsley

    Mr. Wamsley, 42, has had ITDM since 2013. His endocrinologist
examined him in 2016 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. Wamsley understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Wamsley meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds an operator's license from West
Virginia.

Richelle Y. Wyatt

    Ms. Wyatt, 58, has had ITDM since 2013. Her endocrinologist
examined her in 2016 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. Wyatt understands diabetes
management and monitoring, has stable control of her diabetes using
insulin, and is able to drive a CMV safely. Ms. Wyatt meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). Her
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. She holds a Class B CDL from Pennsylvania.

Roy O. Young

    Mr. Young, 60, has had ITDM since 2016. His endocrinologist
examined him in 2016 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. Young understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Young meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Pennsylvania.

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-2016-0223 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. 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-2016-0223 and click ``Search.'' Next, click
``Open Docket Folder'' and you will find all documents and comments
related to this notice.

    Issued on: October 14, 2016.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2016-25379 Filed 10-19-16; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 82, Number 210 (Wednesday, November 1, 2017)]
[Notices]
[Pages 50705-50707]
[FR Doc No: 2017-23732]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-81950; File No. SR-BatsBZX-2017-71]

Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Update
Rule 21.1 To Adopt a New Time in Force Applicable to the Exchange's
Equity Options Platform

October 26, 2017.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on October 20, 2017, Cboe BZX Exchange, Inc. (the ``Exchange'')
(formerly known as Bats BZX Exchange, Inc.) filed with the Securities
and Exchange Commission

(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Exchange. The Exchange
has designated this proposal as a ``non-controversial'' proposed rule
change pursuant to Section 19(b)(3)(A) of the Act \3\ and Rule 19b-
4(f)(6)(iii) thereunder,\4\ which renders it effective upon filing with
the Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange filed a proposal to update Rule 21.1 to adopt a new
Time in Force applicable to the Exchange's equity options platform
(``BZX Options'').
    The text of the proposed rule change is available at the Exchange's
Web site at www.markets.cboe.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
Sections A, B, and C below, of the most significant parts of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    In 2016, the Exchange and its affiliates Bats BYX Exchange, Inc.
(now known as Cboe BYX Exchange, Inc.) (``BYX''), Bats EDGA Exchange,
Inc. (now known as Cboe EDGA Exchange, Inc.) (``EDGA''), and Bats EDGX
Exchange, Inc. (now known as Cboe EDGX Exchange, Inc.) (``EDGX'')
received approval to affect a merger (the ``Merger'') of the Exchange's
indirect parent company, Bats Global Markets, Inc. (``BGM''), with CBOE
Holdings, Inc. (now known as Cboe Global Markets, Inc.) (``CBOE
Holdings''), the direct parent of Chicago Board Options Exchange,
Incorporated (now known as Cboe Exchange, Inc.) (``Cboe Options'') and
C2 Options Exchange, Incorporated (now known as Cboe C2 Exchange, Inc.)
(``C2 Options'', and together with the Exchange, BYX, EDGA, EDGX, and
Cboe Options the ``Cboe Affiliated Exchanges'').\5\ The Cboe Affiliated
Exchanges are working to align certain system functionality, retaining
only intended differences between the Cboe Affiliated Exchanges, in the
context of a technology migration. In the context of such migration,
the Exchange is working to align its systems to offer certain features
currently offered by Cboe Options and C2 Options as well as striving to
maintain consistent technology with the options platform operated by
EDGX (``EDGX Options''). Although the Exchange intentionally offers
certain features that differ from those offered by its affiliates and
will continue to do so, the Exchange believes that offering similar
functionality to the extent practicable will reduce potential confusion
for Users.
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 79585 (December 16,
2016), 81 FR 93988 (December 22, 2016) (SR-BatsBZX-2016-68; SR-
BatsBYX-2016-29; SR-BatsEDGA-2016-24; SR-BatsEDGX-2016-60).
---------------------------------------------------------------------------

    The Exchange proposes to amend Exchange Rule 21.1, Definitions, to
add a new Time in Force, namely the time in force of ``At the Open'' or
``OPG''.
    As proposed, ``At the Open'' or ``OPG'' shall mean, for an order so
designated, an order that shall only participate in the opening process
on the Exchange. An OPG order not executed in the opening process will
be cancelled. The Exchange's affiliate, EDGX Options, recently received
approval of various rule changes, including the adoption of a Time in
Force of OPG that is identical to the Exchange's proposed rule.\6\ The
Exchange notes that other options exchanges also offer Times in Force
that, similar to OPG, limit an order to participating in an exchange's
opening process.\7\
---------------------------------------------------------------------------

    \6\ See Securities Exchange Act Release No. 81891 (October 17,
2017) (SR-Bats-EDGX-2017-29).
    \7\ See, e.g., C2 Rule 6.10(c)(7); ISE Rule 715(o).
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \8\ in general, and furthers the objectives of Section
6(b)(5) of the Act \9\ in particular, in that it is designed to promote
just and equitable principles of trade, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general to protect investors and the public interest.
In particular, consistent rules and functionality between the Exchange
and its affiliated exchanges will reduce complexity and help avoid
potential confusion by the Users of the Exchange that are also
participants on other Cboe Affiliated Exchanges.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes the proposed amendment will reduce complexity
and increase the understanding of the Exchange's operations for all
Users of the Exchange. In particular, by offering the same Times in
Force as EDGX Options, the Exchange will avoid confusion from market
participants that participate on both the Exchange and EDGX Options. In
turn, when Cboe Options and C2 Options are migrated to the same
technology as that of the Exchange, Users of the Exchange and other
Cboe Affiliated Exchanges will have access to similar functionality on
all Cboe Affiliated Exchanges. As such, the proposed rule change would
foster cooperation and coordination with persons engaged in
facilitating transactions in securities and would remove impediments to
and perfect the mechanism of a free and open market and a national
market system.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The Exchange notes that the
proposal will promote consistency between the Exchange and its
affiliated exchanges, and is part of a larger technology integration
that will ultimately reduce complexity for Users of the Exchange that
are also participants on other Cboe Affiliated Exchanges. The Exchange
does not believe that the proposed changes will have any direct impact
on competition. Thus, the Exchange does not believe that the proposal
creates any significant impact on competition.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any written comments from members or other interested parties.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-
4(f)(6) thereunder.\10\
---------------------------------------------------------------------------

    \10\ 17 CFR 240.19b-4(f)(6). As required under Rule 19b-
4(f)(6)(iii), the Exchange provided the Commission with written
notice of its intent to file the proposed rule change, along with a
brief description and the text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission.
---------------------------------------------------------------------------

    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \11\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6)(iii) \12\ permits the
Commission to designate a shorter time if such action is consistent
with the protection of investors and the public interest. The Exchange
has asked the Commission to waive the 30-day operative delay so that
the proposal may become operative immediately upon filing. The
Commission notes that the proposed rule change is based on EDGX Rule
21.1(f)(6) and is identical to such rule. Thus, the Commission believes
that waiver of the operative delay is consistent with the protection of
investors and the public because the proposal does not present any new
or novel issues that have not been previously considered by the
Commission. Therefore, the Commission hereby waives the 30-day
operative delay and designates the proposal operative upon filing.\13\
---------------------------------------------------------------------------

    \11\ 17 CFR 240.19b-4(f)(6).
    \12\ 17 CFR 240.19b-4(f)(6)(iii).
    \13\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-BatsBZX-2017-71 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-BatsBZX-2017-71. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change. Persons submitting
comments are cautioned that we do not redact or edit personal
identifying information from comment submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-BatsBZX-2017-71 and should
be submitted on or before November 22, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-23732 Filed 10-31-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: September 18, 2006 (Volume 71, Number 180)]
[Notices]
[Page 54640-54641]
[DOCID:fr18se06-55]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP06-447-000]

Williston Basin Interstate Pipeline Company; Notice of
Application

September 8, 2006.
    On September 6, 2006, Williston Basin Interstate Pipeline Company,
(Williston Basin) 1250 West Century Avenue, Bismarck, ND 58503,
pursuant to section 7(c) of the Natural Gas Act (NGA) and part 157 of
the Commission's regulations, filed an abbreviated application for a
certificate of public convenience and necessity seeking authority to
install and operate, on a temporary basis, two leased natural gas
compressor units in its existing Elk Basin Compressor Station, along
with all auxiliary and appurtenant facilities associated with the
installation of the temporary compression facilities. This filing is
available for review at the Commission in the Public Reference Room or
may be viewed on the Commission's Web site at http://www.ferc.gov using

the ``e-Library'' link. Enter the docket number excluding the last
three digits in the docket number field to access the document. For
assistance, contact FERC at<EMAIL_ADDRESS>or call toll-
free,<PHONE_NUMBER>, or for TTY,<PHONE_NUMBER>.
    Any questions regarding this application should be directed to
Keith A. Tiggelaar, Director of Regulatory Affairs, Williston Basin
Interstate Pipeline Company, P.O. Box 5601, Bismarck, North Dakota
58506-5601, phone<PHONE_NUMBER><EMAIL_ADDRESS>    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below file with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 14 copies of filings made in the proceeding with the Commission
and must mail a copy to the applicant and to every other party. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project

provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commenters will not be required to serve copies of filed
documents on all other parties. However, the non-party commenters will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    Protests and interventions may be filed electronically via the
Internet in lieu of paper; see, 18 CFR 385.2001(a)(1)(iii) and the
instructions on the Commission's Web site under the ``e-Filing'' link.
The Commission strongly encourages electronic filings.
    Comment Date: September 18, 2006.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-15381 Filed 9-15-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 121 (Wednesday, June 24, 2015)]
[Notices]
[Pages 36336-36338]
[FR Doc No: 2015-15526]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2015-0385; FRL-9929-21]

Registration Review; Dockets Opened for Review and Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: With this document, EPA is opening the public comment period
for several registration reviews. Registration review is EPA's periodic
review of pesticide registrations to ensure that each pesticide
continues to satisfy the statutory standard for registration, that is,
the pesticide can perform its intended function without unreasonable
adverse effects on human health or the environment. Registration review
dockets contain information that will assist the public in
understanding the types of information and issues that the Agency may
consider during the course of registration reviews. Through this
program, EPA is ensuring that each pesticide's registration is based on
current scientific and other knowledge, including its effects on human
health and the environment. This document also announces the Agency's
intent not to open registration review dockets for pyrazon, trypsin
modulating oostatic factor, and xanthine and oxypurinol. These
pesticides do not currently have any actively registered pesticide
products and are not, therefore, scheduled for review under the
registration review program.

DATES: Comments must be received on or before August 24, 2015.

ADDRESSES: Submit your comments identified by the docket identification
(ID) number for the specific pesticide of interest provided in the
table in Unit III.A., by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (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://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://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For pesticide specific information
contact: The person identified as a contact in the table in Unit III.A.
Also include the docket ID number listed in the table in Unit III.A.
for the pesticide of interest.
    For general information contact: Richard Dumas, Pesticide Re-
Evaluation Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, farmworker, and agricultural advocates; the chemical industry;
pesticide users; and members of the public interested in the sale,
distribution, or use of pesticides. Since others also may be
interested, the Agency has not attempted to describe all the specific
entities that may be affected by this action.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the pesticides
discussed in this document, compared to the general population.

II. Authority

    EPA is initiating its reviews of the pesticides identified in this
document pursuant to section 3(g) of the Federal Insecticide,
Fungicide, and Rodenticide

Act (FIFRA) (7 U.S.C. 136a(g)) and the Procedural Regulations for
Registration Review at 40 CFR part 155, subpart C. Section 3(g) of
FIFRA provides, among other things, that the registrations of
pesticides are to be reviewed every 15 years. Under FIFRA, a pesticide
product may be registered or remain registered only if it meets the
statutory standard for registration given in FIFRA section 3(c)(5) (7
U.S.C. 136a(c)(5)). When used in accordance with widespread and
commonly recognized practice, the pesticide product must perform its
intended function without unreasonable adverse effects on the
environment; that is, without any unreasonable risk to man or the
environment, or a human dietary risk from residues that result from the
use of a pesticide in or on food.

III. Registration Reviews

 A. What action is the agency taking?

    As directed by FIFRA section 3(g), EPA is reviewing the pesticide
registrations identified in the table in this unit to assure that they
continue to satisfy the FIFRA standard for registration-that is, they
can still be used without unreasonable adverse effects on human health
or the environment. A pesticide's registration review begins when the
Agency establishes a docket for the pesticide's registration review
case and opens the docket for public review and comment. At present,
EPA is opening registration review dockets for the cases identified in
the following table.

              Table 1--Registration Review Dockets Opening
------------------------------------------------------------------------
  Registration review case                           Contact and contact
        name and No.              Docket ID No.          information
------------------------------------------------------------------------
Acequinocyl, 7621...........  EPA-HQ-OPP-2015-0203  Margaret Hathaway,
<EMAIL_ADDRESS>(703) 305-
                                                     5076.
Aspergillus flavus, 6008....  EPA-HQ-OPP-2015-0281  Michael Glikes,
<EMAIL_ADDRESS>(703) 305-
                                                     6231.
n-Butyl Mercaptan, 6055.....  EPA-HQ-OPP-2015-0262  Menyon Adams,
<EMAIL_ADDRESS>(703) 347-8496.
Chlorine Dioxide (includes    EPA-HQ-OPP-2015-0267  Stephen Savage,
 Sodium Chlorite), 4023<EMAIL_ADDRESS>(703) 347-
                                                     0345.
Cycloate, 2125..............  EPA-HQ-OPP-2015-0288  Matthew Manupella,
<EMAIL_ADDRESS>(703) 347-
                                                     0411.
Diclosulam, 7249............  EPA-HQ-OPP-2015-0285  Matthew Manupella,
<EMAIL_ADDRESS>(703) 347-
                                                     0411.
Furfural, 2305..............  EPA-HQ-OPP-2014-0764  Jolene Trujillo
<EMAIL_ADDRESS>(303) 312-
                                                     6579.
Mancozeb, 0643..............  EPA-HQ-OPP-2015-0291  Steve Snyderman,
<EMAIL_ADDRESS>(703) 347-
                                                     0249.
Metiram, 0644...............  EPA-HQ-OPP-2015-0290  Brittany Pruitt,
<EMAIL_ADDRESS>(703) 347-
                                                     0289.
Propanil, 0226..............  EPA-HQ-OPP-2015-0052  Joel Wolf,
<EMAIL_ADDRESS><PHONE_NUMBER>.
------------------------------------------------------------------------

    EPA is also announcing that it will not be opening dockets for
pyrazon, trypsin modulating oostatic factor, and xanthine and
oxypurinol because these pesticides are not included in any products
currently registered under FIFRA section 3.
    The Agency will take separate actions to cancel any remaining FIFRA
section 24(c) Special Local Needs registrations (7 U.S.C. 136v) with
this active ingredient and to propose revocation of any affected
tolerances that are not supported for import purposes only.

B. Docket Content

    1. Review dockets. The registration review dockets contain
information that the Agency may consider in the course of the
registration review. The Agency may include information from its files
including, but not limited to, the following information:

 An overview of the registration review case status
 A list of current product registrations and registrants
 Federal Register notices regarding any pending registration
actions
 Federal Register notices regarding current or pending
tolerances
 Risk assessments
 Bibliographies concerning current registrations
 Summaries of incident data
 Any other pertinent data or information

    Each docket contains a document summarizing what the Agency
currently knows about the pesticide case and a preliminary work plan
for anticipated data and assessment needs. Additional documents provide
more detailed information. During this public comment period, the
Agency is asking that interested persons identify any additional
information they believe the Agency should consider during the
registration reviews of these pesticides. The Agency identifies in each
docket the areas where public comment is specifically requested, though
comment in any area is welcome.
    2. Other related information. More information on these cases,
including the active ingredients for each case, may be located in the
registration review schedule on the Agency's Web site at http://www.epa.gov/oppsrrd1/registration_review/schedule.htm. Information on
the Agency's registration review program and its implementing
regulation may be seen at http://www.epa.gov/oppsrrd1/registration_review.
    3. Information submission requirements. Anyone may submit data or
information in response to this document. To be considered during a
pesticide's registration review, the submitted data or information must
meet the following requirements:
     To ensure that EPA will consider data or information
submitted, interested persons must submit the data or information
during the comment period. The Agency may, at its discretion, consider
data or information submitted at a later date.
     The data or information submitted must be presented in a
legible and useable form. For example, an English translation must
accompany any material that is not in English and a written transcript
must accompany any information submitted as a diographic or
videographic record. Written material may be submitted in paper or
electronic form.
     Submitters must clearly identify the source of any
submitted data or information.
     Submitters may request the Agency to reconsider data or
information that the Agency rejected in a previous

review. However, submitters must explain why they believe the Agency
should reconsider the data or information in the pesticide's
registration review.
    As provided in 40 CFR 155.58, the registration review docket for
each pesticide case will remain publicly accessible through the
duration of the registration review process; that is, until all actions
required in the final decision on the registration review case have
been completed.

    Authority: 7 U.S.C. 136 et seq.

    Dated: June 17, 2015.
Neil G. Anderson,
Acting Director, Pesticide Re-Evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2015-15526 Filed 6-23-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 53 (Friday, March 18, 2016)]
[Notices]
[Pages 14860-14862]
[FR Doc No: 2016-06128]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0663]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Investigational New Drug Safety Reporting Requirements
for Human Drug and Biological Products and Safety Reporting
Requirements for Bioavailability and Bioequivalence Studies in Humans

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on Investigational New Drug
Safety Reporting Requirements for Human Drug and Biological Products
and Safety Reporting Requirements for Bioavailability and
Bioequivalence Studies in Humans.

DATES: Submit either electronic or written comments on the collection
of information by May 17, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2013-N-0663 for ``Investigational New Drug Safety Reporting
Requirements for Human Drug and Biological Products and Safety
Reporting Requirements for Bioavailability and Bioequivalence Studies
in Humans.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at http://www.regulations.gov or at the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be

made publicly available, you can provide this information on the cover
sheet and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Investigational New Drug Safety Reporting Requirements for Human Drug
and Biological Products and Safety Reporting Requirements for
Bioavailability and Bioequivalence Studies in Humans, OMB Control
Number 0910-0672--Extension

    In the Federal Register of October 31, 2013 (78 FR 65338), FDA
published a document entitled ``Investigational New Drug Safety
Reporting Requirements for Human Drug and Biological Products and
Safety Reporting Requirements for Bioavailability and Bioequivalence
Studies in Humans.'' The document clarified the Agency's expectations
for timely review, evaluation, and submission of relevant and useful
safety information and implemented internationally harmonized
definitions and reporting standards for IND safety reports. The
document also required safety reporting for bioavailability and
bioequivalence studies. The document was intended to improve the
utility of Investigational New Drug (IND) safety reports, expedite
FDA's review of critical safety information, better protect human
subjects enrolled in clinical trials, and harmonize safety reporting
requirements internationally.
    The rulemaking included the following information collection under
the PRA that was not already included in 21 CFR 312.32 and approved
under OMB control number 0910-0014.
    Section 312.32(c)(1)(ii) and (c)(1)(iii) requires reporting to FDA,
in an IND safety report, of potential serious risks from clinical
trials within 15 calendar days for findings from epidemiological
studies, pooled analyses of multiple studies, or other clinical studies
that suggest a significant risk in humans exposed to the drug.
    Section 312.32(c)(1)(iii) specifies the requirements for reporting
to FDA in an IND safety report potential serious risks from clinical
trials within 15 calendar days for findings from in vitro testing that
suggest a significant risk to humans.
    Section 312.32(c)(1)(iv) requires reporting to FDA in an IND safety
report within 15 calendar days of any clinically important increase in
the rate of occurrence of serious suspected adverse reactions over that
listed in the protocol or investigator brochure.
    The rulemaking also included new information collection under the
PRA by requiring safety reporting for bioavailability and
bioequivalence studies (21 CFR 320.31(d)).
    In tables 1 and 2 of this document, the estimates for ``No. of
Respondents,'' ``No. of Responses per Respondent,'' and ``Total Annual
Responses'' were obtained from the Center for Drug Evaluation and
Research (CDER) and the Center for Biologics Evaluation and Research
(CBER) reports and data management systems for submissions received in
2013, 2014, and 2015, and from other sources familiar with the number
of submissions received under the noted 21 CFR section. The estimates
for ``Hours per Response'' are unchanged based on information from CDER
and CBER individuals familiar with the burden associated with these
reports and from prior estimates received from the pharmaceutical
industry. FDA estimates the burden of this collection of information as
follows:

                             Table 1--Estimated Annual Reporting Burden--(CDER) \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
         21 CFR section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
320.31(d) Bioavailability and                 13              15             195              14           2,730
 Bioequivalence Safety Reports..
312.32(c)(1)(ii) and (c)(1)(iii)             100               6             600              12           7,200
 IND Safety Reports.............
312.32(c)(1)(iv) IND Safety                   10               1              10              12             120
 Reports........................
                                                                                ---------------
    Total (CDER)................  ..............  ..............  ..............  ..............          10,050
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                             Table 2--Estimated Annual Reporting Burden--(CBER) \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
         21 CFR section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
320.31(d) Bioavailability and                  1               1               1              14              14
 Bioequivalence Safety Reports..
312.32(c)(1)(ii) and (c)(1)(iii)             137               4             548              12           6,576
 IND Safety Reports.............
312.32(c)(1)(iv) IND Safety                    5             1.4               7              12              84
 Reports........................
                                                                                ---------------
    Total (CBER)................  ..............  ..............  ..............  ..............           6,674
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: March 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-06128 Filed 3-17-16; 8:45 am]
BILLING CODE 4164-01-P