[Federal Register Volume 78, Number 248 (Thursday, December 26, 2013)]
[Notices]
[Pages 78479-78486]
[FR Doc No: 2013-30711]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2013-0192]

Qualification of Drivers; Exemption Applications; Diabetes
Mellitus

AGENCY: Federal Motor Carrier Safety Administration (FMCSA).

ACTION: Notice of applications for exemptions.

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SUMMARY: FMCSA announces receipt of applications from 46 individuals
for exemptions 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 January 27, 2014.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket No. FMCSA-2013-0192 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: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review DOT's Privacy Act Statement for the Federal Docket
Management System (FDMS) published in the Federal Register on January
17, 2008 (73 FR 3316).

FOR FURTHER INFORMATION CONTACT: Elaine M. Papp, Chief, Medical
Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE., Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5

p.m., Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

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.

Qualifications of Applicants

William B. Andrus

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

Chad E. Anger

    Mr. Anger, 38, has had ITDM since 1998. His endocrinologist
examined him in 2013 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. Anger understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Anger meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2013 and certified that he does not have
diabetic retinopathy. He holds a Class D operator's license from
Wisconsin.

Thomas C. Aston

    Mr. Aston, 78, has had ITDM since 2005. His endocrinologist
examined him in 2013 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. Aston understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Aston meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2013 and certified that he does not
have diabetic retinopathy. He holds an operator's license from
Maryland.

Jared F. Beard

    Mr. Beard, 24, has had ITDM since 2000. His endocrinologist
examined him in 2013 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. Beard understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Beard meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2013 and certified that he does not have
diabetic retinopathy. He holds a Class D operator's license from North
Dakota.

Edward Blake

    Mr. Blake, 67, has had ITDM since 2012. His endocrinologist
examined him in 2013 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. Blake understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Blake meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2013 and certified that he has stable
nonproliferative diabetic retinopathy. He holds a Class A CDL from
Georgia.

Jerrel F. Bower

    Mr. Bower, 59, has had ITDM since 2009. His endocrinologist
examined him in 2013 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. Bower understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Bower meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2013 and certified that he has stable
nonproliferative diabetic retinopathy. He holds a Class A CDL from
Missouri.

Jerry A. Campbell

    Mr. Campbell, 51, has had ITDM since 2010. His endocrinologist
examined him in 2013 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. Campbell understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Campbell meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2013 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Ohio.

Brian M. Chase

    Mr. Chase, 22, has had ITDM since 2013. His endocrinologist
examined him in 2013 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. Chase understands

diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Chase meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2013 and certified that he diabetic
retinopathy. He holds a Class A CDL from Virginia.

Charles R. Clayton

    Mr. Clayton, 53, has had ITDM since 2013. His endocrinologist
examined him in 2013 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. Clayton understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Clayton meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2013 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from New Jersey.

Phillip Covel

    Mr. Covel, 46, has had ITDM since 2012. His endocrinologist
examined him in 2013 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. Covel understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Covel meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2013 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Nebraska.

Ariel Cuevas

    Mr. Cuevas, 43, has had ITDM since 2011. His endocrinologist
examined him in 2013 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. Cuevas understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Cuevas meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2013 and certified that he does not have
diabetic retinopathy. He holds a Class B CDL from New Jersey.

Glen C. Davis

    Mr. Davis, 42, has had ITDM since 1995. His endocrinologist
examined him in 2013 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. Davis understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Davis meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2013 and certified that he does not
have diabetic retinopathy. He holds a Class D operator's license from
Tennessee.

Nicholas P. Dube

    Mr. Dube, 25, has had ITDM since 1997. His endocrinologist examined
him in 2013 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. Dube understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. Dube meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined
him in 2013 and certified that he has stable nonproliferative diabetic
retinopathy. He holds an operator's license from Rhode Island.

Arthur W. Ehrenzeller

    Mr. Ehrenzeller, 73, has had ITDM since 2005. His endocrinologist
examined him in 2013 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. Ehrenzeller understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Ehrenzeller meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2013 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from Pennsylvania.

Manuel Elizondo

    Mr. Elizondo, 43, has had ITDM since 2012. His endocrinologist
examined him in 2013 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. Elizondo understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Elizondo meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2013 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Texas.

Michael K. Farris

    Mr. Farris, 45, has had ITDM since 2012. His endocrinologist
examined him in 2013 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. Farris understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Farris meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2013 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Indiana.

Merino Fernandes

    Mr. Fernandes, 57, has had ITDM since 2008. His endocrinologist
examined him in 2013 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. Fernandes understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Fernandes meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2013 and certified that he does not
have diabetic retinopathy. He holds an operator's license from
Illinois.

Craig J. Gadley, Sr.

    Mr. Gadley, 54, has had ITDM since 2009. His endocrinologist
examined him in 2013 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. Gadley understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Gadley meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2013 and certified that he does not have
diabetic retinopathy. He holds a Class B CDL from New York.

Daniel Grove, Jr.

    Mr. Grove, 38, has had ITDM since 2006. His endocrinologist
examined him in 2013 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. Grove understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Grove meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2013 and certified that he does not have
diabetic retinopathy. He holds a Class C operator's license from
Pennsylvania.

Mary F. Guilfoy

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

James M. Hatcher

    Mr. Hatcher, 60, has had ITDM since 2013. His endocrinologist
examined him in 2013 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. Hatcher understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Hatcher meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2013 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Mississippi.

Edward S. Ionescu

    Mr. Ionescu, 43, has had ITDM since 2012. His endocrinologist
examined him in 2013 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. Ionescu understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Ionescu meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2013 and certified that he does not
have diabetic retinopathy. He holds a Class B CDL from Illinois.

Jeffrey James

    Mr. James, 51, has had ITDM since 2013. His endocrinologist
examined him in 2013 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. James understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. James meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2013 and certified that he does not have
diabetic retinopathy. He holds an operator's license from Alaska.

Hayward S. Mason

    Mr. Mason, 59, has had ITDM since 2008. His endocrinologist
examined him in 2013 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. Mason understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Mason meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2013 and certified that he does not
have diabetic retinopathy. He holds a Class B CDL from New York.

Guy B. Mayes

    Mr. Mayes, 62, has had ITDM since 2009. His endocrinologist
examined him in 2013 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. Mayes understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Mayes meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2013 and certified that

he does not have diabetic retinopathy. He holds a Class A CDL from
Washington.

Ashun R. Merritt

    Mr. Merritt, 25, has had ITDM since 1997. His endocrinologist
examined him in 2013 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. Merritt understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Merritt meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2013 and certified that he does not have
diabetic retinopathy. He holds a Class C operator's license from
Georgia.

Herbert A. Morton

    Mr. Morton, 38, has had ITDM since 2013. His endocrinologist
examined him in 2013 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. Morton understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Morton meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2013 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from California.

Colby A. Nutter

    Mr. Nutter, 21, has had ITDM since 1992. His endocrinologist
examined him in 2013 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. Nutter understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Nutter meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2013 and certified that he does not
have diabetic retinopathy. He holds an operator's license from
Virginia.

Jayrome D. Rimolde

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

Gale Roland

    Mr. Roland, 59, has had ITDM since 2011. His endocrinologist
examined him in 2013 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. Roland understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Roland meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2013 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Pennsylvania.

Larry J. Sanders

    Mr. Sanders, 59, has had ITDM since 2011. His endocrinologist
examined him in 2013 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. Sanders understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Sanders meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2013 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Maryland.

Kelly T. Scholl

    Mr. Scholl, 45, has had ITDM since 2011. His endocrinologist
examined him in 2013 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. Scholl understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Scholl meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2013 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Minnesota.

Antonio A. Sena

    Mr. Sena, 64, has had ITDM since 1991. His endocrinologist examined
him in 2013 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. Sena understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. Sena meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined
him in 2013 and certified that he does not have diabetic retinopathy.
He holds a Class B CDL from California.

Gregory G. Sisco

    Mr. Sisco, 44, has had ITDM since 2013. His endocrinologist
examined him in 2013 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. Sisco understands diabetes
management and monitoring,

has stable control of his diabetes using insulin, and is able to drive
a CMV safely. Mr. Sisco meets the requirements of the vision standard
at 49 CFR 391.41(b)(10). His optometrist examined him in 2013 and
certified that he does not have diabetic retinopathy. He holds a Class
A CDL from Iowa.

Travers L. Stephens

    Mr. Stephens, 49, has had ITDM since 2012. His endocrinologist
examined him in 2013 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 2013 and certified that he does not have
diabetic retinopathy. He holds an operator's license from Georgia.

Brittany K. Tomasko

    Ms. Tomasko, 28, has had ITDM since 1993. Her endocrinologist
examined her in 2013 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. Tomasko understands diabetes
management and monitoring has stable control of her diabetes using
insulin, and is able to drive a CMV safely. Ms. Tomasko meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). Her
optometrist examined her in 2013 and certified that she does not have
diabetic retinopathy. She holds an operator's license from California.

Johnny G. Wallace

    Mr. Wallace, 58, has had ITDM since 2012. His endocrinologist
examined him in 2013 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. Wallace understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Wallace meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2013 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Arkansas.

Daren Warren

    Mr. Warren, 41, has had ITDM since 2011. His endocrinologist
examined him in 2013 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. Warren understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Warren meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2013 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from New York.

Aaron E. Webb

    Mr. Webb, 40, has had ITDM since 2012. His endocrinologist examined
him in 2013 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. Webb understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. Webb meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined
him in 2013 and certified that he does not have diabetic retinopathy.
He holds a Class A CDL from Washington.

Billy J. Webb, Jr.

    Mr. Webb, 59, has had ITDM since 2005. His endocrinologist examined
him in 2013 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. Webb understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. Webb meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His optometrist examined him
in 2013 and certified that he does not have diabetic retinopathy. He
holds an operator's license from Mississippi.

Alan T. Whalen

    Mr. Whalen, 51, has had ITDM since 2009. His endocrinologist
examined him in 2013 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. Whalen understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Whalen meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2013 and certified that he does not have
diabetic retinopathy. He holds a Class D operator's license from New
York.

Thomas L. Whitley

    Mr. Whitley, 59, has had ITDM since 2013. His endocrinologist
examined him in 2013 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. Whitley understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Whitley meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2013 and certified that he does not
have diabetic retinopathy. He holds an operator's license from Indiana.

Randall S. Williams

    Mr. Williams, 58, has had ITDM since 2011. His endocrinologist
examined him in 2013 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.
Williams understands diabetes management and monitoring, has stable
control of his diabetes using insulin, and is able to drive a CMV
safely. Mr. Williams meets the requirements of the vision standard at
49 CFR 391.41(b)(10). His optometrist examined him in 2013 and
certified that he does not have diabetic retinopathy. He holds a Class
A CDL from Pennsylvania.

Tomme J. Wirth

    Mr. Wirth, 75, has had ITDM since 2008. His endocrinologist
examined him in 2013 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. Wirth understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Wirth meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2013 and certified that he does not have
diabetic retinopathy. He holds a Class B CDL from Iowa.

Charles J. Wirth

    Mr. Wirth, 54, has had ITDM since 2012. His endocrinologist
examined him in 2013 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. Wirth understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Wirth meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2013 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Wisconsin.

Thomas A. Wysocki

    Mr. Wysocki, 51, has had ITDM since 1998. His endocrinologist
examined him in 2013 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. Wysocki understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Wysocki meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2013 and certified that he does not
have diabetic retinopathy. He holds a Class B CDL from New Jersey.

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.

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-2013-0192 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.

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-2013-0192 and click ``Search.'' Next, click ``Open Docket
Folder'' and you will find all documents and comments related to the
proposed rulemaking.

    Issued on: December 16th, 2013.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2013-30711 Filed 12-24-13; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register: July 22, 2008 (Volume 73, Number 141)]
[Notices]
[Page 42641-42645]
[DOCID:fr22jy08-97]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-58168; File No. SR-Phlx-2008-53]

Self-Regulatory Organizations; Philadelphia Stock Exchange, Inc.;
Notice of Filing of a Proposed Rule Change Relating to an Exchange
Member's Conduct of Doing Business With the Public

July 16, 2008.
    Pursuant to Section 19(b)(1) of the Securities and Exchange Act of
1934 (``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on July 11, 2008, the Philadelphia Stock Exchange, Inc. (``Phlx''
or ``Exchange'') filed with the Securities and Exchange Commission
(``Commission'' or ``SEC'') the proposed rule change as described in
Items I, II, and III below, which items have been substantially
prepared by the Exchange. 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.
---------------------------------------------------------------------------

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

    The Exchange proposes to amend Phlx Rules 1024 (Conduct of Accounts
for Options Trading), 1025 (Supervision of Accounts), 1027
(Discretionary Accounts), and 1049 (Communications to Customers) that
govern an Exchange member's conduct of doing business with the public.
Specifically, the proposed rule change would require that member
organizations integrate the responsibility for supervision of a member
organizations' public customer options business into their overall
supervisory and compliance programs. In addition, the proposed rule
change would strengthen member organizations' supervisory procedures
and internal controls as they relate to a members' public customer
options business.
    The text of the proposed rule change is available at the Phlx, the
Commission's Public Reference Room and http://www.phlx.com/regulatory/
reg_rulefilings.aspx.

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 aspects of such
statements.

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

1. Purpose
    a. Integration of Options Supervision
    The purpose of the proposed rule change is to create a supervisory
structure for options that is similar to that required by New York
Stock Exchange (``NYSE'') Rule 342 and National Association of
Securities Dealers (``NASD'') Rule 3010.\3\ The proposed rule change
would eliminate the requirement that member organizations qualified to
do a public customer business in options must designate a single person
to act as Senior Registered Options Principal (``SROP'') for the member
organization and that each such member organization designate a
specific individual as a Compliance Registered Options Principal
(``CROP''). Instead member organizations would be required to integrate
the SROP and CROP functions into their overall supervisory and
compliance programs. The proposed rule change is substantively similar
to recent amendments to the rules of the Chicago Board Options
Exchange, Inc. (``CBOE'') which were approved by the Commission.\4\
---------------------------------------------------------------------------

    \3\ On July 26, 2007, the Commission approved a proposed rule
change filed by NASD to amend NASD's Certificate of Incorporation to
reflect its name change to Financial Industry Regulatory Authority,
Inc., or FINRA, in connection with the consolidation of the member
firm regulatory functions of NASD and NYSE Regulation, Inc. See
Securities Exchange Act Release No. 56146 (July 26, 2007), 72 FR
42190 (August 1, 2007). The FINRA rule book currently consists of
both NASD rules and certain NYSE Rules that FINRA has incorporated.
    \4\ See Securities Exchange Act Release No. 56971 (December 14,
2007), 72 FR 72804 (December 21, 2007) (SR-CBOE-2007-106).
---------------------------------------------------------------------------

    The SROP concept was first introduced by Phlx and other options
exchanges during the early years of the development of the listed
options market. Initially, member organizations were required to
designate one or more persons qualified as Registered Options
Principals (``ROPs'') having supervisory responsibilities in respect of
the member organization's options business. As the number of ROPs at
larger member organizations began to increase, Phlx imposed an
additional requirement that member organizations designate one of their
ROPs as the SROP. This was intended to eliminate confusion as to where
the compliance and supervisory responsibilities lay by centralizing in
a single supervisory officer overall responsibility for the supervision
of a member organization's options activities.\5\ Subsequently,
following the recommendation of the Commission's Options Study, Phlx
and other options exchanges required member organizations to designate
a CROP to be responsible for the member organization's overall
compliance program in respect of its options activities.\6\ The CROP
may be the same person who is designated as SROP.
---------------------------------------------------------------------------

    \5\ See Securities and Exchange Commission, 96th Cong., 1st
Sess., Report of the Special Study of the Options Markets (Comm.
Print 1978) 316 fn. 11.
    \6\ Id. at P. 335
---------------------------------------------------------------------------

    Since the SROP and CROP requirements were first imposed, the
supervisory function in respect of the options activities of most
securities firms has been integrated into the matrix of supervisory and
compliance functions in respect of the firms' other securities
activities. This not only reflects the maturity of the options market,
but also recognizes the ways in which the uses of options themselves
have become more integrated with other securities in the implementation
of particular strategies. Thus, the current requirement for a
separately designated senior supervisor in respect of all aspects of a
member organization's options activities, rather than clarifying the
allocation of supervisory

responsibilities within the member organization, may have just the
opposite effect by failing to take into account the way in which these
responsibilities are actually assigned. By permitting supervision of a
member organization's options activities to be handled in the same
manner as the supervision of its other securities and futures
activities, the proposed rule change will ensure that supervisory
responsibility over each segment of the member organization's business
is assigned to the best qualified person in the member organization,
thereby enhancing the overall quality of supervision. The same holds
true for the compliance function.
    For example, member organizations generally designate one person to
have supervisory responsibility over the application of margin
requirements and other matters pertaining to the extension of credit.
The proposed rule change would enable a member organization to include
within the scope of such a person's duties the supervision over the
proper margining of options accounts, thereby assuring that the most
qualified person is charged with this responsibility and at the same
time eliminating any uncertainty that might now exist as to whether
this responsibility lies with the senior credit supervisor or with the
SROP.
    Similarly, the proposed rule change would allow a member
organization to specifically designate one or more individuals as being
responsible for approving a ROP's acceptance of discretionary accounts
\7\ and exceptions to a member organization's suitability standards for
trading uncovered short options.\8\ The proposed rule changes would
allow member organizations the flexibility to assign such
responsibilities, which formerly rested with the SROP and/or CROP, to
more than one ROP qualified individual where the member organization
believes it advantageous to do so to enhance its supervisory or
compliance structure. Typically, a member organization may wish to
divide these functions on the basis of geographic region or functional
considerations. Phlx Rule 1024 would be amended to clarify the
qualification requirements of individuals designated as ROPs.\9\ Rule
1024 would also be amended to specify the registration requirements of
individuals who accept orders from non-broker-dealer customers.\10\
---------------------------------------------------------------------------

    \7\ See proposed Phlx Rule 1027(a)(i).
    \8\ See proposed Phlx Rule 1024(c).
    \9\ See proposed Commentaries .06 and .07 to Phlx Rule 1024.
    \10\ See proposed Commentary .08 to Phlx Rule 1024.
---------------------------------------------------------------------------

    The proposed rule change would call for options discretionary
accounts, the acceptance of which must be approved by a ROP qualified
individual (other than the ROP who accepted the account), to be
supervised in the same manner as the supervision of other securities
accounts that are handled on a discretionary basis.\11\ The proposed
rule change would eliminate the requirement that discretionary options
orders be approved on the day of entry by a ROP (with one exception as
described below).\12\ This requirement predates the Options Study and
is not consistent with the use of supervisory tools in computerized
format or exception reports generated after the close of a trading day.
No similar requirement exists for supervision of other securities
accounts that are handled on a discretionary basis.\13\ Discretionary
orders must be reviewed in accordance with a member organization's
written supervisory procedures. The proposed rule change would ensure
that supervisory responsibilities are assigned to specific ROP
qualified individuals, thereby enhancing the quality of supervision.
---------------------------------------------------------------------------

    \11\ See proposed Phlx Rule 1025.
    \12\ See proposed Phlx Rule 1027(a).
    \13\ See e.g., NYSE Rule 408.
---------------------------------------------------------------------------

    Phlx Rule 1027 would be revised by adding, as Commentary .01, a
requirement that any member organization that does not utilize
computerized surveillance tools for the frequent and appropriate review
of discretionary account activity must establish and implement
procedures to require ROP qualified individuals who have been
designated to review discretionary accounts to approve and initial each
discretionary order on the day entered. The Exchange believes that any
member organization that does not utilize computerized surveillance
tools to monitor discretionary account activity should continue to be
required to perform the daily manual review of discretionary orders.
    Under the proposed rule change, options discretionary accounts will
continue to receive frequent appropriate supervisory review by
designated ROP qualified individuals. Additionally, member
organizations will continue to be required to designate ROP qualified
individuals to review and approve the acceptance of options
discretionary accounts in order to determine whether the ROP accepting
the account had a reasonable basis for believing that the customer was
able to understand and bear the risks of the proposed strategies or
transactions.\14\ This requirement provides an additional level of
supervisory audit over options discretionary accounts that does not
exist for other securities discretionary accounts.
---------------------------------------------------------------------------

    \14\ See proposed Phlx Rule 1027(a).
---------------------------------------------------------------------------

    In addition, the proposed rule change would require that each
member organization submit to the Exchange a written report by April 1
of each year, that details the member organization's supervision and
compliance effort, including its options compliance program, during the
preceding year and reports on the adequacy of the member organization's
ongoing compliance processes and procedures.\15\
---------------------------------------------------------------------------

    \15\ See proposed Phlx Rule 1025(g), which is modeled after NYSE
Rule 342.30.
---------------------------------------------------------------------------

    Proposed Phlx Rule 1025(h) would require that each member
organization submit, by April 1st of each year, a copy of the Phlx Rule
1025(g) annual report to one or more of its control persons or, if the
member organization has no control person, to the audit committee of
its board of directors or its equivalent committee or group.\16\
---------------------------------------------------------------------------

    \16\ See proposed Phlx Rule 1025(h) which is modeled after NYSE
Rule 354.
---------------------------------------------------------------------------

    Proposed Phlx Rule 1025(g) would provide that a member organization
that specifically includes its options compliance program in a report
that complies with substantially similar NYSE and NASD rule
requirements will be deemed to have satisfied the requirements of Phlx
Rules 1025(g) and 1025(h).
    Although the proposed rule change would eliminate entirely the
positions and titles of the SROP and CROP, member organizations would
still be required to designate a single general partner or executive
officer to assume overall authority and responsibility for internal
supervision, control of the member organization and compliance with
securities laws and regulations.\17\ Member organizations would also be
required to designate specific qualified individuals as having
supervisory or compliance responsibilities over each aspect of the
member organization's options activities and to set forth the names and
titles of these individuals in their written supervisory
procedures.\18\ This is consistent with the integration of options
supervision into the overall supervisory and compliance structure of a
member organization. In connection with the approval of these proposed
rule changes, the Exchange intends to review member organizations'
written supervisory and compliance procedures in the course of the
Exchange's routine examination of member organizations to

ensure that supervisory and compliance responsibilities are adequately
defined.
---------------------------------------------------------------------------

    \17\ See proposed Phlx Rule 1025(a).
    \18\ See proposed Commentary .02 to Phlx Rule 1025.
---------------------------------------------------------------------------

    The Exchange believes that the proposed rule changes recognize that
options are no longer in their infancy, have become more integrated
with other securities in the implementation of particular strategies,
and thus should not continue to be regulated as though they are new and
experimental products. The Exchange believes that the proposed rule
change is appropriate and would not materially alter the supervisory
operations of member organizations. The Exchange believes the
supervisory and compliance structure in place for non-options products
at most member organizations is not materially different from the
structure in place for options.
b. Supervisory Procedures and Internal Controls
    The Exchange also proposes to amend certain rules to strengthen
member and member organizations' supervisory procedures and internal
controls as they relate to the members' public customer options
business. The proposed rule changes described below are modeled after
NYSE and NASD rules approved by the Commission in 2004.\19\ The
Exchange believes the following proposal to strengthen member
supervisory procedures and internal controls is appropriate and
consistent with the preceding proposal to integrate options and non-
options sales practice supervision and compliance functions.
---------------------------------------------------------------------------

    \19\ See Securities Exchange Act Release Nos. 49882 (June 17,
2004), 69 FR 35108 (June 23, 2004) (SR-NYSE-2002-36) and 49883 (June
17, 2004), 69 FR 35092 (June 23, 2004) (SR-NASD-2002-162).
---------------------------------------------------------------------------

    Phlx Rule 1025(a)(iii) would be revised to require the development
and implementation of written policies and procedures reasonably
designed to supervise sales managers and other supervisory personnel
who service customer options accounts (i.e., who act in the capacity of
a registered representative).\20\ This requirement would apply to
branch office managers, sales managers, regional/district sales
managers, or any person performing a similar supervisory function. Such
policies and procedures are expected to encompass all options sales-
related activities. Proposed Phlx Rule 1025(a)(iii)(A) would require
that supervisory reviews of producing sales managers be conducted by a
qualified ROP who is either senior to, or otherwise ``independent of'',
the producing manager under review.\21\ This provision is intended to
ensure that all options sales activity of a producing manager is
monitored for compliance with applicable regulatory requirements by
persons who do not have a personal interest in such activity.
---------------------------------------------------------------------------

    \20\ See proposed Phlx Rule 1025(a)(iii) which is modeled after
NYSE Rule 342.19.
    \21\ An ``otherwise independent'' person is defined in proposed
Phlx Rule 1025(a)(iii)(A) as one who: may not report either directly
or indirectly to the producing manager under review; must be
situated in an office other than the office of the producing
manager; must not otherwise have supervisory responsibility over the
activity being reviewed; and must alternate such review
responsibility with another qualified person every two years or
less. Further, if a person designated to review a producing manager
receives an override or other income derived from that producing
manager's customer activity that represents more than 10% of the
designated person's gross income derived from the member
organization over the course of a rolling twelve-month period, the
member organization must establish alternative senior or otherwise
independent supervision of that producing manager to be conducted by
a qualified Registered Options Principal other than the designated
person receiving the income.
---------------------------------------------------------------------------

    Proposed Phlx Rule 1025(a)(iii)(B) would provide a limited
exception for members so limited in size and resources that there is no
qualified person senior to, or otherwise independent of, the producing
manager to conduct the review. In this case, the reviews may be
conducted by a qualified ROP to the extent practicable. Under proposed
Phlx Rule 1025(a)(iii)(C), a member relying on the limited size and
resources exception must document the factors used to determine that
compliance with each of the ``senior'' or ``otherwise independent''
standards of Phlx Rule 1025(a)(iii)(A) is not possible, and that the
required supervisory systems and procedures in place with respect to
any producing manager comply with the provisions of Phlx Rule
1025(a)(iii)(A) to the extent practicable.\22\
---------------------------------------------------------------------------

    \22\ Paragraph 1025(a)(iii)(D) of Phlx Rule 1025 would provide
that a member organization that complies with requirements of the
NYSE or the NASD that are substantially similar to the requirements
in Phlx Rules 1025(a)(iii)(A), (a)(iii)(B) and (a)(iii)(C) will be
deemed to have met such requirements.
---------------------------------------------------------------------------

    Proposed Phlx Rule 1025(c)(i) would require member organizations to
develop and maintain adequate controls over each of their business
activities.\23\ The proposed rule would further require that such
controls include the establishment of procedures to independently
verify and test the supervisory systems and procedures for those
business activities. Member organizations would be required to include
in the annual report prepared pursuant to Phlx Rule 1025(g) a review of
their efforts in this regard, including a summary of the tests
conducted and significant exceptions identified. The Exchange believes
proposed Phlx Rule 1025(c)(i) would enhance the quality of member
organizations' supervision.\24\
---------------------------------------------------------------------------

    \23\ Current Phlx Rule 1025(c) regarding designation of foreign
currency options principals was renumbered as 1025(i).
    \24\ See proposed Phlx Rule 1025(c)(i) which is modeled after
NYSE Rule 342.23. Paragraph (c)(ii) of Phlx Rule 1025 would provide
that a member organization that complies with requirements of the
NYSE or the NASD that are substantially similar to the requirements
in Phlx Rule 1025(c)(i) will be deemed to have met such
requirements.
---------------------------------------------------------------------------

    Proposed Phlx Rule 1025(d) would establish requirements for branch
office inspections similar to the requirements of NYSE Rule 342.24.
Specifically, Phlx Rule 1025(d) would require a member organization to
inspect, at least annually, each supervisory branch office and inspect
each non-supervisory branch office at least once every three years.\25\
The proposed rule would further require that persons who conduct a
member organization's annual branch office inspection must be
independent of the direct supervision or control of the branch office
(i.e., not the branch office manager, or any person who directly or
indirectly reports to such manager, or any person to whom such manager
directly reports). The Exchange believes that requiring branch office
inspections to be conducted by someone who has no significant financial
interest in the success of a branch office should lead to more
objective and vigorous inspections.
---------------------------------------------------------------------------

    \25\ Proposed Phlx Rules 1025(d)(i)(A) and (B) would provide
members with two exceptions from the annual branch office inspection
requirement: a member may demonstrate to the satisfaction of the
Exchange that other arrangements may satisfy the Rule's requirements
for a particular branch office, or based upon a member
organization's written policies and procedures providing for a
systematic risk-based surveillance system, the member organization
submits a proposal to the Exchange and receives, in writing, an
exemption from this requirement pursuant to Phlx Rule 1025(e).
---------------------------------------------------------------------------

    Under proposed Phlx Rule 1025(e), any member organization seeking
an exemption, pursuant to Phlx Rule 1025(d)(ii), from the annual branch
office inspection requirement would be required to submit to the
Exchange written policies and procedures for systematic risk-based
surveillance of its branch offices, as defined in Phlx Rule 1025(e).
Proposed Phlx Rule 1025(f) would require that annual branch office
inspection programs include, at a minimum, testing and verification of
specified internal controls.\26\ Paragraph (d)(3) of Phlx Rule 1025
would provide that a member organization that complies with
requirements of the NYSE or the NASD that are substantially similar to
the requirements in Phlx Rules 1025(d), (e) and (f) will be deemed to
have met such requirements.
---------------------------------------------------------------------------

    \26\ See proposed Phlx Rules 1025(e) and (f) which are modeled
after NYSE Rules 342.25 and 342.26.
---------------------------------------------------------------------------

    In conjunction with the proposed changes to Phlx Rules 1025(d), (e)
and

(f), the Exchange proposes to add new Commentary .09 to Phlx Rule 1024
to define ``branch office'' in a way that is substantially similar to
the definition of branch office in NYSE Rule 342.10.
    Proposed Phlx Rule 1024(g)(iv) would require a member organization
to designate a Chief Compliance Officer (CCO). Proposed Phlx Rule
1025(g)(v) would require each member organization's Chief Executive
Officer (CEO), or equivalent, to certify annually per subsection (A)
that the member organization has in place processes to: (1) Establish
and maintain policies and procedures reasonably designed to achieve
compliance with applicable Exchange rules and federal securities laws
and regulations; (2) modify such policies and procedures as business,
regulatory, and legislative changes and events dictate; and (3) test
the effectiveness of such policies and procedures on a periodic basis,
the timing of which is reasonably designed to ensure continuing
compliance with Exchange rules and federal securities laws and
regulations.
    Proposed Phlx Rule 1025(g)(v) would further require that the CEO
attest the CEO has conducted one or more meetings with the CCO in the
preceding 12 months to discuss the compliance processes in proposed
Phlx Rule 1025(g)(v), that the CEO has consulted with the CCO and other
officers to the extent necessary to attest to the statements in the
certification, and the compliance processes are evidenced in a report,
reviewed by the CEO, CCO, and such other officers as the member
organization deems necessary to make the certification, that is
provided to the member organization's board of directors and audit
committee (if such committee exists).\27\
---------------------------------------------------------------------------

    \27\ See proposed Phlx Rule 1025(g)(v) which is modeled after
NASD Rule 3013 and NYSE Rule 342.30(e).
---------------------------------------------------------------------------

    Under proposed Phlx Rule 1025(b)(ii), a member, upon a customer's
written instructions, may hold mail for a customer who will not be at
his or her usual address for no longer than two months if the customer
is on vacation or traveling, or three months if the customer is going
abroad. This provision would help ensure that members that hold mail
for customers who are away from their usual addresses, do so only
pursuant to the customer's written instructions and for a specified,
relatively short period of time.\28\
---------------------------------------------------------------------------

    \28\ See proposed Phlx Rule 1025(b)(ii) which is modeled after
NASD Rule 3110(i).
---------------------------------------------------------------------------

    Proposed Phlx Rule 1025(b)(iii) would require that, before a
customers options order is executed, the account name or designation
must be placed upon the memorandum for each transaction. In addition,
only a qualified ROP may approve any changes in account names or
designations. The ROP also must document the essential facts relied
upon in approving the changes and maintain the record in a central
location. A member would be required to preserve any account
designation change documentation for a period of not less than three
years, with the documentation preserved for the first two years in an
easily accessible place, as the term ``easily accessible place'' is
used in Exchange Act Rule 17a-4.\29\ The Exchange believes the proposed
rule would help to protect account name and designation information
from possible fraudulent activity.\30\
---------------------------------------------------------------------------

    \29\ See 17 CFR 240.17a-4.
    \30\ See proposed Phlx Rule 1025(b)(iii) which is modeled after
NASD Rule 3110(j).
---------------------------------------------------------------------------

    Phlx Rule 1027(e) allows member organizations to exercise time and
price discretion on orders for the purchase or sale of a definite
number of options contracts in a specified security. The Exchange
proposes to amend its Rule 1027(e) to limit the duration of this
discretionary authority to the day it is granted, absent written
authorization to the contrary. In addition, the proposed rule would
require any exercise of time and price discretion to be reflected on
the customer order ticket. The proposed one-day limitation would not
apply to time and price discretion exercised for orders effected with
or for an institutional account (as defined in the rule) pursuant to
valid Good-Till-Cancelled instructions issued on a ``not held'' basis.
The Exchange believes that investors will receive greater protection by
clarifying the time such discretionary orders remain pending.\31\
---------------------------------------------------------------------------

    \31\ See proposed Phlx Rule 1027(e) which is modeled after NASD
Rule 2510(d)(1).
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\32\ in general, and furthers the objectives of Section
6(b)(5), specifically,\33\ in that it is designed to perfect the
mechanism of a free and open market and the national market system,
protect investors and the public interest and promotes just and
equitable principles of trade. The proposal would achieve this by
enabling the Exchange to amend its rules to require member
organizations to integrate the responsibility for supervision of a
member organization's public customer options business into their
overall supervisory and compliance programs, and to strengthen member
organizations' supervisory procedures and internal controls as they
relate to a member's public customer options business.
---------------------------------------------------------------------------

    \32\ 15 U.S.C. 78f(b).
    \33\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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 not necessary or appropriate in
furtherance of the purposes of the Act.

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

    The Exchange did not solicit comments or receive any written
comments on the proposed rule change.

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

    Within 35 days of the date of publication on this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the Exchange consents, the Commission will:
    (A) By order approve such proposed rule change, or
    (B) Institute proceedings to determine whether the proposed rule
change should be 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 e-mail to<EMAIL_ADDRESS>Please include
File No. SR-Phlx-2008-53 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-Phlx-2008-53. This
file number should be included on the subject line if e-mail 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 inspection and copying in the Commission's Public
Reference Room, 100 F Street, NE., Washington, DC 20549, on official
business days between the hours of 10 a.m. and 3 p.m. Copies of such
filing also will be available for inspection and copying at the
principal office of the Phlx. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-Phlx-2008-53 and should be submitted on or before August
12, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\34\
---------------------------------------------------------------------------

    \34\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Acting Secretary.
 [FR Doc. E8-16685 Filed 7-21-08; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 78, Number 79 (Wednesday, April 24, 2013)]
[Notices]
[Pages 24290-24291]
[FR Doc No: 2013-09663]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2013-17]

Petition for Exemption; Summary of Petition Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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

SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of 14 CFR. The purpose of this notice is to
improve the public's awareness of, and participation in, this aspect of
FAA's regulatory activities. Neither publication of this notice nor the
inclusion or omission of information in the summary is intended to
affect the legal status of the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before May 14, 2013.

ADDRESSES: You may send comments identified by Docket Number FAA-2013-
0156 using any of the following methods:
     Government-wide rulemaking Web site: Go to http://www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Send comments to the Docket Management Facility;
U.S. Department of Transportation, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590.
     Fax: Fax comments to the Docket Management Facility at
202-493-2251.
     Hand Delivery: Bring comments to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket Web site, anyone can
find and read the comments received into any of our dockets, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time or to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Mr. Mark B. James, Aerospace Engineer,
Standards Office (ACE-111), Small Airplane Directorate, Aircraft
Certification Service, FAA; telephone number<PHONE_NUMBER>, fax number
(816) 329-4090, email at<EMAIL_ADDRESS>Andrea Copeland, ARM-208,
Office of Rulemaking, FAA,

800 Independence Avenue SW; Washington, DC 20591; email
<EMAIL_ADDRESS>(202) 267-8081.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on April 18, 2013.
Brenda D. Courtney,
Acting Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2013-0156
    Petitioner: Wipaire, Inc
    Section of 14 CFR Affected: Sec. Sec.  23.3(a) and 135.113
    Description of Relief Sought: Wipaire is petitioning to increase
the maximum number of passenger seats to ten, less pilot seats, on the
Wipaire modified Cessna Caravan, Model C-208, and Cessna Grand Caravan,
Model C-208B. Increasing the number of passenger seats to ten would
still be within the Type Certification maximum seat number of eleven,
including crew.

[FR Doc. 2013-09663 Filed 4-23-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 197 (Friday, October 13, 2023)]
[Proposed Rules]
[Page 70919]
[FR Doc No: 2023-22637]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. FDA-2003-F-0321]

Kerry Inc.; Filing of Food Additive Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of petition.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that we have filed a petition, submitted by Kerry, Inc., proposing that
the food additive regulations be amended to provide for the safe use of
sodium alginate as a stabilizer and thickener in plant protein products
at a level not to exceed 3 percent.

DATES: The food additive petition was filed on August 9, 2023.

ADDRESSES: For access to the docket to read background documents or
comments received, go to https://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 Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Christopher Kampmeyer, Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under section 409(b)(5) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 348(b)(5)), we are giving notice that
we have filed a food additive petition (FAP 3A4836), submitted on
behalf of Kerry Inc., by ToxStrategies, LLC, 739 Thornapple Dr.,
Naperville, IL 60540. The petition proposes to amend the food additive
regulations in part 172 (21 CFR part 172) ``Food Additives Permitted
for Direct Addition to Food for Human Consumption'' to provide for the
safe use of sodium alginate as a stabilizer and thickener in plant
protein products (as defined in 21 CFR 170.3(n)(33)) at a level not to
exceed 3 percent.
    The petitioner has claimed that this action is categorically
excluded under 21 CFR 25.32(k) because the substance is intended to
remain in food through ingestion by consumers and that is not intended
to replace macronutrients in food. In addition, the petitioner has
stated that, to their knowledge, no extraordinary circumstances exist.
If FDA determines a categorical exclusion applies, neither an
environmental assessment nor an environmental impact statement is
required. If FDA determines a categorical exclusion does not apply, we
will request an environmental assessment and make it available for
public inspection.

    Dated: October 6, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22637 Filed 10-12-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 212 (Friday, November 1, 2019)]
[Notices]
[Pages 58724-58726]
[FR Doc No: 2019-23926]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-4042]

Chronic Hepatitis D Virus Infection: Developing Drugs for
Treatment; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Chronic
Hepatitis D Virus Infection: Developing Drugs for Treatment.'' The
purpose of this draft guidance is to assist sponsors in all phases of
development of antiviral drugs for the treatment of chronic hepatitis D
virus (HDV) infection. This guidance is intended to provide consistent
FDA advice to stakeholders regarding HDV drug development strategies.

DATES: Submit either electronic or written comments on the draft
guidance by December 31, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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-2019-D-4042 for ``Chronic Hepatitis D Virus Infection: Developing
Drugs for Treatment.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff 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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Aimee Hodowanec, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6341, Silver Spring, MD 20993-0002, 240-
402-5752.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Chronic Hepatitis D Virus Infection: Developing Drugs for
Treatment.'' The purpose of this draft guidance for industry is to
provide consistent recommendations for the development of antiviral
drugs for the treatment of chronic HDV infection. The guidance
addresses all phases of drug development, from nonclinical
considerations to phase 3 trial design recommendations.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Chronic
Hepatitis D Virus Infection: Developing Drugs for Treatment.'' It does
not establish any rights for any person and is not binding on FDA or
the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520).
The collection of information in 21 CFR part 314 for the submission of
new drug applications (NDAs) has been approved under OMB control number
0910-0001. The submission of biologics license applications (BLAs) has
been approved under OMB control number 0910-0338. The collection of
information in 21 CFR part 312, including submissions under subpart E,
has been approved under OMB control number 0910-0014. The submission of
prescription drug labeling under 21 CFR 201.56 and 201.57 has been
approved under OMB control number 0910-0572. The submission of
medication guides under 21 CFR part 208 has been approved under OMB
control number 0910-0393. The submission of prescription drug
advertisements under 21 CFR 202.1 has been approved under OMB control
number 0910-0686.
    The collection of information in the guidance for industry entitled
``Formal Meetings between the FDA and Sponsors or Applicants of PDUFA
(Prescription Drug User Fee Act) Products'' (available at https://www.fda.gov/media/109951/download), including requests for pre-NDA and
pre-BLA meetings and other meetings, has been approved under OMB
control number 0910-0429. The collection of information in the guidance
for industry entitled ``Expedited Programs for Serious Conditions--
Drugs and Biologics'' (available at https://www.fda.gov/media/86377/download),

including fast track designation, breakthrough therapy designation,
accelerated approval, and priority review designation, has been
approved under OMB control number 0910-0765.
    In accordance with the PRA, prior to publication of any final
guidance document, FDA intends to solicit public comment and obtain OMB
approval for any information collections recommended in this guidance
that are new or that would represent material modifications to those
previously approved collections of information found in FDA regulations
or guidances.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: October 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23926 Filed 10-31-19; 8:45 am]
 BILLING CODE 4164-01-P