[Federal Register Volume 76, Number 87 (Thursday, May 5, 2011)]
[Notices]
[Pages 25769-25773]
[FR Doc No: 2011-11012]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2011-0103]

Qualification of Drivers; Exemption Applications; Diabetes
Mellitus

AGENCY: Federal Motor Carrier Safety Administration (FMCSA).

ACTION: Notice of applications for exemption from the diabetes mellitus
standard; request for comments.

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SUMMARY: FMCSA announces receipt of applications from 24 individuals
for exemption from the prohibition against persons with insulin-treated
diabetes mellitus (ITDM) operating commercial motor vehicles (CMVs) in
interstate commerce. If granted, the exemptions would enable these
individuals with ITDM to operate CMVs in interstate commerce.

DATES: Comments must be received on or before June 6, 2011.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket No. FMCSA-2011-0103 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 FDMS published in
the Federal Register on January 17, 2008 (73 FR 3316), or you may visit
http://edocket.access.gpo.gov/2008/pdf/E8-785.pdf.

FOR FURTHER INFORMATION CONTACT: Dr. Mary D. Gunnels, Director, Medical
Programs,<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 24 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 the statutes.

Qualifications of Applicants

Alfonso L. Abeyta

    Mr. Abeyta, age 57, has had ITDM since 2006. His endocrinologist
examined him in 2010 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. Abeyta understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Abeyta meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2010 and certified that he does not have
diabetic retinopathy. He holds a Class A Commercial Driver's License
(CDL) from Texas.

Perfecto Aquino

    Mr. Aquino, 50, has had ITDM since 2008. His endocrinologist
examined him in 2010 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. Aquino understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Aquino meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2010 and certified that he has stable
nonproliferative diabetic retinopathy. He holds a Class A CDL from
Illinois.

James C. Ayotte

    Mr. Ayotte, 50, has had ITDM since 1977. His endocrinologist
examined him in 2010 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. Ayotte understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Ayotte meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2011 and certified that he does not have
diabetic retinopathy. He holds a Class D operator's license from South
Carolina.

John C. Beason

    Mr. Beason, 62, has had ITDM since 2010. His endocrinologist
examined him in 2010 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. Beason understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Beason meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2010 and certified that he has stable
nonproliferative diabetic retinopathy. He holds a Class A CDL from
Tennessee.

Charles A. Best

    Mr. Best, 27, has had ITDM since 2010. His endocrinologist examined
him in 2010 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. Best understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. Best meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His optometrist examined him
in 2010 and certified that he does not have diabetic retinopathy. He
holds a Class A CDL from Ohio.

Gregory E. Bichsel, II

    Mr. Bichsel, 42, has had ITDM since 2010. His endocrinologist
examined him in 2011 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. Bichsel understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Bichsel meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2011 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Montana.

Raymond D. Dubose

    Mr. Dubose, 53, has had ITDM since 2010. His endocrinologist
examined him in 2011 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. Dubose understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Dubose meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2011 and certified that he does not have
diabetic retinopathy. He holds a Class B CDL from Georgia.

Adam Errickson

    Mr. Errickson, 21, has had ITDM since 1998. His endocrinologist
examined him in 2011 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. Errickson understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Errickson meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2011 and certified that

he does not have diabetic retinopathy. He holds a Class D operator's
license from New Jersey.

Jon M. Greiner

    Mr. Greiner, 58, has had ITDM since 2003. His endocrinologist
examined him in 2011 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. Greiner understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Greiner meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2011 and certified that he does not
have diabetic retinopathy. He holds a Class D operator's license from
Minnesota.

Gregory M. Hoyt

    Mr. Hoyt, 38, has had ITDM since 2003. His endocrinologist examined
him in 2011 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. Hoyt understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. Hoyt meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined
him in 2010 and certified that he does not have diabetic retinopathy.
He holds a Class D operator's license from Vermont.

Robert E. Jackson

    Mr. Jackson, 44, has had ITDM since 2002. His endocrinologist
examined him in 2010 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. Jackson understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Jackson meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2010 and certified that he does not
have diabetic retinopathy. He holds a Class C operator's license from
North Carolina.

Kimm D. Jacobson

    Mr. Jacobson, 56, has had ITDM since 2006. His endocrinologist
examined him in 2010 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. Jacobson understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Jacobson meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2010 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Minnesota.

Daryl D. Jibben

    Mr. Jibben, 54, has had ITDM since 2000. His endocrinologist
examined him in 2011 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. Jibben understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Jibben meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2011 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Minnesota.

Jimmy G. Lee, Jr.

    Mr. Lee, 29, has had ITDM since 2009. His endocrinologist examined
him in 2010 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. Lee understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. Lee meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His optometrist examined him
in 2010 and certified that he does not have diabetic retinopathy. He
holds a Class A CDL from North Carolina.

Daniel S. May

    Mr. May, 22, has had ITDM since 2010. His endocrinologist examined
him in 2011 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. May understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. May meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His optometrist examined him
in 2011 and certified that he does not have diabetic retinopathy. He
holds a Class A CDL from Iowa.

Gerald D. McElya

    Mr. McElya, 51, has had ITDM since 2010. His endocrinologist
examined him in 2011 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. McElya understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. McElya meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2010 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from Texas.

Michael L. Moore

    Mr. Moore, 45, has had ITDM since 2010. His endocrinologist
examined him in 2011 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. Moore understands

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

Stacey W. Nelson

    Mr. Nelson, 34, has had ITDM since 2007. His endocrinologist
examined him in 2011 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. Nelson understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Nelson meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2011 and certified that he has stable
proliferative and nonproliferative diabetic retinopathy in both eyes.
He holds a Class A CDL from Nebraska.

Ervin W. Ponto

    Mr. Ponto, 61, has had ITDM since 2008. His endocrinologist
examined him in 2010 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. Ponto understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Ponto meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2010 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from Minnesota.

Donald B. Ramaley

    Mr. Ramaley, 69, has had ITDM since 2009. His endocrinologist
examined him in 2011 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. Ramaley understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Ramaley meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2011 and certified that he does not
have diabetic retinopathy. He holds a Class B CDL from Pennsylvania.

Bart H. Rideout

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

Floyd M. Tyler

    Mr. Tyler, 72, has had ITDM since 2010. His endocrinologist
examined him in 2011 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. Tyler understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Tyler meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2010 and certified that he has stable
nonproliferative diabetic retinopathy. He holds a Class A CDL from
Pennsylvania.

Richard G. Wunderlich

    Mr. Wunderlich, 61, has had ITDM since 2009. His endocrinologist
examined him in 2010 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. Wunderlich understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Wunderlich meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2011 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Minnesota.

Mathew E. Yeates

    Mr. Yeates, 32, has had ITDM since 2008. His endocrinologist
examined him in 2010 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. Yeates understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Yeates meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2010 and certified that he does not have
diabetic retinopathy. He holds a Class D operator's license from Utah.

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).
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    \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.
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    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 USC. 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.

    Issued on: April 21, 2011.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2011-11012 Filed 5-4-11; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 76, Number 6 (Monday, January 10, 2011)]
[Notices]
[Page 1422]
[FR Doc No: 2011-199]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

January 03, 2011.
    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Numbers: RP11-1670-000.
    Applicants: Eastern Shore Natural Gas Company.
    Description: Eastern Shore Natural Gas Company submits tariff
filing per 154.312: General Section 4 Rate Case to be effective 2/1/
2011.
    Filed Date: 12/30/2010.
    Accession Number: 20101230-5089.
    Comment Date: 5 p.m. Eastern Time on Tuesday, January 11, 2011.

    Docket Numbers: RP11-1671-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Iroquois Gas Transmission System, L.P. submits tariff
filing per 154.204: 12/30/10 Negotiated Rates--JP Morgan Ventures
Energy Corporation to be effective 1/1/2011.
    Filed Date: 12/30/2010.
    Accession Number: 20101230-5108.
    Comment Date: 5 p.m. Eastern Time on Tuesday, January 11, 2011.

    Docket Numbers: RP11-1672-000.
    Applicants: CenterPoint Energy Gas Transmission Company.
    Description: CenterPoint Energy Gas Transmission Company submits
tariff filing per 154.204: By Displacement Language to be effective 2/
1/2011.
    Filed Date: 12/30/2010.
    Accession Number: 20101230-5109.
    Comment Date: 5 p.m. Eastern Time on Tuesday, January 11, 2011.

    Docket Numbers: RP11-1673-000.
    Applicants: Florida Gas Transmission Company, LLC.
    Description: Florida Gas Transmission Company, LLC submits tariff
filing per 154.204: Contract Provisions to be effective 1/30/2011.
    Filed Date: 12/30/2010.
    Accession Number: 20101230-5169.
    Comment Date: 5 p.m. Eastern Time on Tuesday, January 11, 2011.

    Docket Numbers: RP11-1674-000.
    Applicants: Florida Gas Transmission Company, LLC.
    Description: Florida Gas Transmission Company, LLC submits tariff
filing per 154.204: Service Agreements to be effective 2/28/2011.
    Filed Date: 12/30/2010.
    Accession Number: 20101230-5180.
    Comment Date: 5 p.m. Eastern Time on Tuesday, January 11, 2011.

    Docket Numbers: RP11-1675-000.
    Applicants: Arlington Storage Company, LLC.
    Description: Arlington Storage Company, LLC submits tariff filing
per 154.203: Arlington Storage Company, Seneca Lake Compliance Filing
to be effective 1/31/2011.
    Filed Date: 12/30/2010.
    Accession Number: 20101230-5214.
    Comment Date: 5 p.m. Eastern Time on Tuesday, January 11, 2011.

    Docket Numbers: RP11-1676-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Iroquois Gas Transmission System. L.P. Measurement
Variance/Fuel Use Factors utilized by Iroquois during the period July
1--Dec. 31, 2010.
    Filed Date: 12/30/2010.
    Accession Number: 20101230-5250.
    Comment Date: 5 p.m. Eastern Time on Tuesday, January 11, 2011.

    Docket Numbers: RP11-1677-000.
    Applicants: Gulf Crossing Pipeline Company LLC.
    Description: Gulf Crossing Pipeline Company LLC submits tariff
filing per 154.204: Devon Amendment to be effective 1/1/2011.
    Filed Date: 01/03/2011.
    Accession Number: 20110103-5113.
    Comment Date: 5 p.m. Eastern Time on Tuesday, January 18, 2011.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St. NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-199 Filed 1-7-11; 8:45 am]
BILLING CODE 6717-01-P


Taconite Risk and Technology Review (RTR) - Meeting Agenda
Date: Tuesday, 10/11/2016
Time: 10:00 AM EST
Call-in number:<PHONE_NUMBER>
--------------------------------------------------------------------------------
Participants:
 --------------------------------------------------------------------------------
EPA:	David Putney, OAQPS/SPPD/MICG
 --------------------------------------------------------------------------------
Contractor:	Mark Bahner, RTI
 --------------------------------------------------------------------------------
Industry:
--------------------------------------------------------------------------------
      Name	Company/Facility(ies)	Contact Info.
--------------------------------------------------------------------------------
      Kelsey Johnson	Iron Mining Association<EMAIL_ADDRESS>--------------------------------------------------------------------------------
      Candice Maxwell	Cliffs Natural Resources<EMAIL_ADDRESS>--------------------------------------------------------------------------------
      Tasha Niemi	Cliffs Natural Resources<EMAIL_ADDRESS>--------------------------------------------------------------------------------
      Michael Long	Cliffs Natural Resources<EMAIL_ADDRESS>--------------------------------------------------------------------------------
      Jennifer Ramsdell	Cliffs Natural Resources<EMAIL_ADDRESS>--------------------------------------------------------------------------------
      Brent Ketzenberger	Cliffs Natural Resources<EMAIL_ADDRESS>--------------------------------------------------------------------------------
      Julie Lucas	Cliffs Natural Resources<EMAIL_ADDRESS>--------------------------------------------------------------------------------
      Jason Aagenes	Cliffs Natural Resources<EMAIL_ADDRESS>--------------------------------------------------------------------------------
      Chrissy Bartovich	US Steel<EMAIL_ADDRESS>--------------------------------------------------------------------------------
      Julianne Kurdila	ArcelorMittal<EMAIL_ADDRESS>--------------------------------------------------------------------------------
      Jaime Johnson	ArcelorMittal<EMAIL_ADDRESS>--------------------------------------------------------------------------------
      Rich Zavoda	ArcelorMittal<EMAIL_ADDRESS>--------------------------------------------------------------------------------
      David Vidmar	Magnetation<EMAIL_ADDRESS>--------------------------------------------------------------------------------
      Kevin Petz	Steel Dynamics<EMAIL_ADDRESS>--------------------------------------------------------------------------------
General:
 Industry universe - Are there any taconite iron ore processing facilities that are not members of the MN Iron Mining Association (e.g., Michigan facilities or perhaps the facilities owned by Magnetation, Inc., since it is a newer company?)
 Contact info - Preferred contact information (names, phone numbers, email address, etc.) for the taconite iron ore processing facilities in general and Northshore, Minntac, and Magnetation Plant in particular.
 Site visits - EPA would like to visit some of the facilities as to familiarize itself with the operations of the taconite iron ore processing facilities. Specifically, EPA would like to visit the Northshore facility (this facility is of particular interest due to the presence of amphibole fibers), the Minntac facility (this facility is of particular interest as it is the largest operation and, presumably, would have more operations to view), and the Magnetation Plant 1 facility (this facility is of particular interest due to the use of a new technology to concentrate iron ore).
 Risk Review:
 General info  -  In order to better inform the residual risk modeling input file, we will be collecting general information regarding emissions of HAP, emission point locations, and stack parameters.
 Fuel types - According to the background information documents associated with the initial taconite iron ore processing NESHAP, the indurating furnaces at these facilities can burn natural gas, coal, oil, and a variety of other fuels. In order to develop the upcoming testing requirements (see "Testing" below) we will need to know what fuel(s) each facility's indurating furnace(s) burn(s). That is, which fuels is it capable of burning and which fuels does it typically (i.e., over the last couple of years of operation) burn?
 Temporal variations - EPA would like to discuss the temporal variation in emissions at these facilities. During the risk assessment for these facilities we will need to estimate how much higher peak emissions are than normal emissions. The default multiplier we use is 10  -  that is, we estimate that peak emissions are 10 times higher than normal emissions. However, for some industries (e.g., those with processes that do not vary much over time but rather operate at a much more steady state) that multiplier is a lower number. This may well be the case for taconite iron ore processing facilities.
 HAP concentrations - We would also like to discuss the variations (or relative lack thereof, as the case may be) in concentrations of metal hazardous air pollutants (e.g., arsenic, manganese, nickel, etc.) in the taconite iron processed by your member companies. That is, do they have reason to believe that concentrations of these impurities in the ore vary significantly over time, or that they vary very little? This is of particular interest in the case of mercury.
 Startup, Shutdown, and Malfunction (SSM) - In response to recent court decisions, we may be required to remove any exemptions to compliance with the emissions standards included in 40 CFR part 63, subpart RRRRR (subpart 5R) during periods of SSM. This is often an item of interest on the part of industry and we are soliciting any input the facilities might have on this issue. For example, do they have reason to believe (e.g., any parametric monitoring or emission data obtained during periods of SSM) that they could (or could not, as the case may be) comply with the emission standards already in subpart 5R during periods of SSM?

 Technology Review:
 New developments and/or improvements  -  EPA will be soliciting information on any new developments and/or improvements in practices, processes and control technologies to reduce emissions of hazardous air pollutants (HAP) considering cost and feasibility that have been put into practice at the taconite iron ore processing facilities since promulgation of subpart 5R.
 Hg emissions reduction - Through discussions with staff in the Minnesota Pollution Control Agency EPA has learned that taconite iron ore processing facilities located in Minnesota are required to reduce their mercury (Hg) emissions by 75% by 2020. This could impact the technology review portion of the RTR project. EPA would like to get information from companies as to the methods they are proposing to use to achieve the required reductions in Hg emissions and any data (e.g., emissions testing) obtained to date that would suggest that the proposed methods will achieve those reductions.
 Testing:
 Operational status - Based on Internet information about the taconite iron ore processing source category we noticed that, as with many metals industries, some facilities may well be currently idled due to unfavorable economic conditions. Information on this (i.e., which facilities are currently operating and which ones are not) would be very helpful as we develop a testing plan for the industry. This testing plan will be sent out (probably later this year) in an information request under the authority of section 114 of the Clean Air Act (CAA) and is also often an item of intense interest on the part of industry. We will be soliciting input from companies during the development of this information request. Our current understanding about the operational status is as presented in the table below. Please inform us of any errors in the table and any expected near-term changes in the operational status of these facilities.
Parent Company
Facility
Subpart RRRRR?
Operating Status
US Steel  -  Minnesota Ore Operations
Keetac
1 Mine Road
Keewatin, MN 55753
Yes
Idle
US Steel
Minntac
8819 Old Hwy 169
Moutain Iron, MN 55768
Yes
Operational
Cliffs
United Taconite - Fairlane Plant
8479 Townline Road
Forbes, MN 55738
Yes
Idle
Cliffs
Northshore - Silver Bay Plant
10 Outer Drive
Silver Bay, MN 55614
Yes
Idle
Cliffs (USS 14%)
Hibbing Minnesota Taconite Plant
4950 County Hwy 5 North
Hibbing, MN 55746
Yes
Operational
Cliffs Erie/Steel Dynamics
Mesabi Nugget
Hoyt Lakes Mining Area
Hoyt Lakes, MN
Yes
Idle
ArcelorMittal
Minorca Mine
5950 Old Hwy 53 North
Virginia, MN 55792
Yes
Operational
Essar Steel
Essar Steel Minnesota
17113 County Road 58
Nashwauk, MN 55769
Yes
Construction not occurring
Cliffs (USS 15%)
Tilden Mining Company
1 Tilden Mine Road
Ishpeming, MI 49849
Yes
Operational
Cliffs
Empire Mine
101 Empire Mine Road
Palmer, MI 49871
Yes
Shut down August 2016
Magnetation
Magnetation - Plant 1
35001 County Road 571
Keewatin, MN 55753
No
Idle
Magnetation
Magnetation - Plant 2
27692 County Road 10
Bovey, MN 55709
No
Idle
Magnetation/Steel Dynamics/Mining Resources LLC
Magnetation - Plant 3
11050 US Hwy 169
Chisholm, MN 55719
No
Idle
Magnetation - Mag Mining
Magnetation - Plant 4
28754 County Road 61
Grand Rapids, MN 55744
No
Idle
Magnetation
Magnetation Pellet Plant
64 East 100 North
Reynolds, IN 47980Reynolds
No
Operational
 Emission sources - According to the preamble for the initial 40 CFR part 63, subpart RRRRR, most of the hazardous air pollutant emissions from these taconite iron ore processing facilities are emitted from the indurating furnaces. Therefore, any new testing required via the upcoming information request will likely focus on the indurating furnaces. To that end, it would be very helpful to collect information on the amount of organic material is included in the feed materials to those furnaces - or evidence to show that organic material is not included in the feed materials, as the case may be.
 Test submission years - Through the section 114 information request mentioned above, we will be requesting copies of recent tests conducted on subject emission sources from member companies. Typically, "recent" is defined as within the last 3 years. However, member companies may have strong compelling interest in increasing this window to 4 or 5 years. If this is the case, we would like to discuss that possibility.
 Test result units - The test results are all required to be reported in lb/ton of taconite pellets produced. That's different from the existing standard, which is concentration-based. This may cause problems if there are confidentiality claims regarding production rate. Therefore we wanted to discuss that with the industry before sending the section 114 testing plan to industry.
 New testing - In response to recent court decisions, we may be required to gather emissions data for HAP not currently regulated under subpart 5R (e.g., for dioxins/furans, mercury and asbestos) via the section 114 testing plan.
 Asbestos fibers - Also through the section 114 information request mentioned above, we will be seeking information on emissions data and/or fence line concentrations of amphibole fibers such as those emitted from the Northshore facility. Do any other member companies have reason to believe that the taconite ore they process (and therefore their emissions) include amphibole fibers? Or evidence to suggest that they do not?


[Federal Register Volume 76, Number 219 (Monday, November 14, 2011)]
[Notices]
[Pages 70434-70435]
[FR Doc No: 2011-29246]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13011-003]

Shelbyville Hydro LLC; Notice of Application Tendered for Filing
With the Commission and Soliciting Additional Study Requests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Major License.
    b. Project No.: 13011-003.
    c. Date filed: October 28, 2011.
    d. Applicant: Shelbyville Hydro LLC (Shelbyville Hydro), a wholly-
owned subsidiary of Symbiotics LLC.
    e. Name of Project: Lake Shelbyville Dam Hydroelectric Project.
    f. Location: On the Kaskaskia River, in Shelby County, Illinois at
an existing dam owned and operated by the U.S. Corps of Engineers
(Corps). The project would occupy 3.24 acres of federal lands managed
by the Corps.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Mr. Brent L. Smith, Chief Operating Officer,
Symbiotics LLC 371 Upper Terrace, Suite 2, Bend, OR 97702; Telephone
(541) 330-8779.
    i. FERC Contact: Lesley Kordella,<PHONE_NUMBER> or
<EMAIL_ADDRESS>    j. Cooperating agencies: Federal, state, local, and tribal agencies
with jurisdiction and/or special expertise with respect to
environmental issues that wish to cooperate in the preparation of the
environmental document should follow the instructions for filing such
requests described in item l below. Cooperating agencies should note
the Commission's policy that agencies that cooperate in the preparation
of the environmental document cannot also intervene. See, 94 FERC ]
61,076 (2001).
    k. Pursuant to Section 4.32(b)(7) of 18 CFR of the Commission's
regulations, if any resource agency, Indian Tribe, or person believes
that an additional scientific study should be conducted in order to
form an adequate factual basis for a complete analysis of the
application on its merit, the resource agency, Indian Tribe, or person
must file a request for a study with the Commission not later than 60
days from the date of filing of the application, and serve a copy of
the request on the applicant.
    l. Deadline for filing additional study requests and requests for
cooperating agency status: December 27, 2011.
    All documents may be filed electronically via the Internet. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit
brief comments up to 6,000 characters, without prior registration,
using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the
end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>or toll free at 1-(866) 208-3676,
or for TTY,<PHONE_NUMBER>. Although the Commission strongly encourages
electronic filing, documents may also be paper-filed. To paper-file,
mail an original and seven copies to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426.
    m. The application is not ready for environmental analysis at this
time.
    n. The project would be located at an existing dam owned and
operated by the Corps-St. Louis District. The existing Lake Shelbyville
Dam was constructed in 1963 for the purposes of flood control,
recreation development, water supply, navigation release, and fish and
wildlife conservation. In August of 1970, the USACE closed the gates to
start the initial filling of the lake. The West Okaw and Kaskaskia
rivers were inundated 17 miles upstream of the dam.
    The Lake Shelbyville Dam is an earthen embankment with an elevation
of 643 feet above mean sea level (MSL). The dam is 3,025 feet long and
rises 108 feet above the river bed. The concrete spillway is located at
593 feet MSL and is topped by three Tainter gates that are
approximately 45 feet wide by 37 feet high. The two regulating outlet
structures release water through the face of the spillway. The
impoundment above the Lake Shelbyville Dam, referred to as Lake
Shelbyville, varies according to flood control operations controlled by
the Corps. Lake Shelbyville has a maximum storage capacity of 684,000
acre-feet. Of the 684,000 acre-feet of storage, 474,000 acre-feet have
been designated for flood control.
    The average depth of the reservoir is 16 feet and the maximum is 67
feet.

    The proposed Lake Shelbyville Project would consist of: (1) A
powerhouse located downstream on the western embankment of the
spillway; (2) a penstock, which would be connected to the west outlet
structure, and extend along the western bank to the powerhouse; (3) a
trash rack with 4-inch spacing that would be integrated into the
existing intake structure; (4) a new transformer pad located adjacent
to the powerhouse; (5) a modified access road that would pass to the
west of the powerhouse; (6) a parking lot on the west side of the
powerhouse; (7) a 49-foot-long by 105-foot-wide tailrace; (8) 407 feet
of 12.47-kilovolt (kV) buried transmission line to connect the project
to the existing Shelby Electric Cooperative substation located 900 feet
downstream of the dam; (9) three turbine-generator units for a combined
installed capacity of 6.8 megawatts; and (10) appurtenant facilities.
The projected annual energy generation would be 20.3 gigawatt hours.
    The project would operate in a run-of-release mode utilizing
releases from Lake Shelbyville as they are dictated by the Corps, with
no proposed change to the Corps' facility operation. Power generation
would be seasonally variable as flow regimens and pool levels are set
forth by the Corps. The project would generate power using flows
between 130 cfs (cubic feet per second) to 1,500 cfs. When flows are
below 130 cfs, all flows would be passed through the existing outlet
structure and the project would then be offline. When flows are greater
than 1,500 cfs, excess flow would be passed through the existing outlet
structure.
    o. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC Online Support. A copy is also available for inspection and
reproduction at the address in item h above.
    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    p. With this notice, we are initiating consultation with the
Illinois State Historic Preservation Officer (SHPO), as required by
Sec.  106, National Historic Preservation Act, and the regulations of
the Advisory Council on Historic Preservation, 36, CFR, at 800.4.
    q. Procedural schedule: The application will be processed according
to the following preliminary Hydro Licensing Schedule. Revisions to the
schedule will be made as appropriate.

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

------------------------------------------------------------------------
Issue Notice of Acceptance or            December 2011.
 Deficiency Letter.
Request Additional Information.........  January 2012.
Issue Acceptance Letter................  March 2012.
Issue Scoping Document 1 for Comments..  April 2012.
Comments on Scoping Document 1.........  May 2012.
Issue Scoping Document 2 (if necessary)  June 2012.
Issue notice of ready for environmental  July 2012.
 analysis.
Commission issues a single EA..........  February 2013.
------------------------------------------------------------------------

    Final amendments to the application must be filed with the
Commission no later than 30 days from the issuance date of the notice
of ready for environmental analysis.

    Dated: November 3, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-29246 Filed 11-10-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 183 (Friday, September 22, 2017)]
[Notices]
[Pages 44422-44424]
[FR Doc No: 2017-20283]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0501]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Third Party
Disclosure and Recordkeeping Requirements for Reportable Food

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by October
23, 2017.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0643.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Third Party Disclosure and Recordkeeping Requirements for Reportable
Food--21 U.S.C. 350f

OMB Control Number 0910-0643--Extension

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended
by the Food and Drug Administration Amendments Act of 2007 (FDAAA)
(Pub. L. 110-85), requires the establishment of a Reportable Food
Registry (the Registry) by which instances of reportable food must be
submitted to FDA by responsible parties and may be submitted by public
health officials. Section 417 of the FD&C Act (21 U.S.C. 350f) defines
``reportable food'' as an ``article of food (other than infant formula)
for which there is a reasonable probability that the use of, or
exposure to, such article of food will cause serious adverse health
consequences or death to humans or animals.'' (Section 417(a)(2) of the
FD&C Act.) We believe that the most efficient and cost effective means
to implement the Registry is by utilizing our electronic Safety
Reporting Portal. The information collection provisions associated with
the submission of reportable food reports has been approved under OMB
control number 0910-0643.
    In conjunction with the reportable foods requirements, section 417
of the FD&C Act also establishes third party disclosure and
recordkeeping burdens. Specifically, we may require the responsible
party to notify the immediate previous source(s) and/or immediate
subsequent recipient(s) of a reportable food (section 417(d)(6)(B)(i)
to (ii) of the FD&C Act). Similarly, we may also require the
responsible party that is notified (i.e., the immediate previous source
and/or immediate subsequent recipient) to notify their own immediate
previous source(s) and/or immediate subsequent recipient(s) of a
reportable food (section 417(d)(7)(C)(i) to (ii) of the FD&C Act).
    Notification to the immediate previous source(s) and immediate
subsequent recipient(s) of the article of food may be accomplished by
electronic communication methods such as email, fax, or text messaging
or by telegrams, mailgrams, or first-class letters. Notification may
also be accomplished by telephone call or other personal contacts but
we recommend that such notifications also be confirmed by one of the
previous methods and/or documented in an appropriate manner. We may
require that the notification include any or all of the following data
elements: (1) The date on which the article of food was determined to
be a reportable food; (2) a description of the article of food
including the quantity or amount; (3) the extent and nature of the
adulteration; (4) the results of any investigation of the cause of the
adulteration if it may have originated with the responsible party, if
known; (5) the disposition of the article of food, when known; (6)
product information typically found on packaging including product
codes, use-by dates, and the names of manufacturers, packers, or
distributors sufficient to identify the article of food; (7) contact
information for the responsible party; (8) contact information for
parties directly linked in the supply chain and notified under section
417(d)(6)(B) or 417(d)(7)(C) of the FD&C Act, as applicable; (9) the
information required by FDA to be included in the notification provided
by the responsible party involved under section 417(d)(6)(B) or
417(d)(7)(C) of the FD&C Act or required to report under section
417(d)(7)(A) of the FD&C Act; and (10) the unique number described in
section 417(d)(4) of the FD&C Act (section 417(d)(6)(B)(iii)(I),
(d)(7)(C)(iii)(I), and (e) of the FD&C Act). We may also require that
the notification provides information about the actions that the
recipient of the notification will perform and/or any other information
we may require (section 417(d)(6)(B)(iii)(II) and (III),
(d)(7)(C)(iii)(II) and (III) of the FD&C Act).
    Section 417(g) of the FD&C Act requires that responsible persons

maintain records related to reportable foods for a period of 2 years.
    The congressionally identified purpose of the Registry is to
provide ``a reliable mechanism to track patterns of adulteration in
food [which] would support efforts by the Food and Drug Administration
to target limited inspection resources to protect the public health''
(FDAAA, section 1005(a)(4)). The reporting and recordkeeping
requirements described previously are designed to enable FDA to quickly
identify and track an article of food (other than infant formula) for
which there is a reasonable probability that the use of or exposure to
such article of food will cause serious adverse health consequences or
death to humans or animals. We use the information collected under
these provisions to help ensure that such products are quickly and
efficiently removed from the market.
    As required under section 1005(f) of FDAAA and to assist industry,
we have issued the guidance document entitled, ``Questions and Answers
Regarding the Reportable Food Registry as Established by the Food and
Drug Administration Amendments Act of 2007,'' which is available at
https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm180761.htm. The guidance
contains questions and answers relating to the requirements under
section 417 of the FD&C Act, including: (1) How, when, and where to
submit reports to FDA; (2) who is required to submit reports to FDA;
(3) what is required to be submitted to FDA; and (4) what may be
required when providing notifications to other persons in the supply
chain of an article of food. The guidance also refers to previously
approved collections of information found in FDA regulations. The
collections of information in questions 20 and 21 of the guidance have
been approved under OMB control number 0910-0249.
    Description of Respondents: Mandatory respondents to this
collection of information are the owners, operators, or agents in
charge of a domestic or foreign facility engaged in manufacturing,
processing, packing, or holding food for consumption in the United
States (``responsible parties'') who have information on a reportable
food. Voluntary respondents to this collection of information are
Federal, State, and local public health officials who have information
on a reportable food.
    In the Federal Register of June 7, 2017 (82 FR 26489), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    We estimate the burden of this collection of information as
follows:

                                               Table 1--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                Number of
              Activity/section                  Number of      disclosures    Total annual          Average burden per disclosure           Total hours
                                               respondents   per respondent    disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notifying immediate previous source of the            1,200               1           1,200  0.6 (36 minutes)...........................             720
 article of food under section
 417(d)(6)(B)(i) of the FD&C Act (mandatory
 reporters only).
Notifying immediate subsequent recipient of           1,200               1           1,200  0.6 (36 minutes)...........................             720
 the article of food under section
 417(d)(6)(B)(ii) of the FD&C Act
 (mandatory reporters only).
Notifying immediate previous source of the                1           1,200         0.6 (36  720........................................
 article of food under section                                                     minutes)
 417(d)(7)(C)(i) of the FD&C Act (mandatory
 reporters only).
Notifying immediate subsequent recipient of           1,200               1           1,200  0.6 (36 minutes)...........................             720
 the article of food under section
 417(d)(7)(C)(ii) of the FD&C Act
 (mandatory reporters only).
                                            ------------------------------------------------                                             ---------------
    Total..................................  ..............  ..............  ..............  ...........................................           2,880
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Third Party Disclosure: We estimate that approximately 1,200
reportable food events with mandatory reporters will occur annually.
Based on past FDA experiences, we estimate that we could receive 200 to
1,200 ``reportable'' food reports annually from 200 to 1,200 mandatory
and voluntary users of the electronic reporting system. We utilized the
upper-bound estimate of 1,200 for these calculations.
    We estimate that notifying the immediate previous source(s) will
take 0.6 hours per reportable food and notifying the immediate
subsequent recipient(s) will take 0.6 hours per reportable food. We
also estimate that it will take 0.6 hours for the immediate previous
source and/or the immediate subsequent recipient to also notify their
immediate previous source(s) and/or immediate subsequent recipient(s).
The Agency bases its estimate on its experience with mandatory and
voluntary reports submitted to FDA.
    Although it is not mandatory under FDAAA, section 1005, that
responsible persons notify the sources and recipients of instances of
reportable food, for purposes of the burden estimate we are assuming
FDA would exercise its authority and require such notifications in all
such instances for mandatory reporters. This notification burden will
not affect voluntary reporters of reportable food events. Therefore, we
estimate that the total burden of notifying the immediate previous
source(s) and immediate subsequent recipient(s) under section
417(d)(6)(B)(i) and (ii), (d)(7)(C)(i) and (ii) of the FD&C Act for
1,200 reportable foods will be 2,880 hours annually (1,200 x 0.6 hours)
+ (1,200 x 0.6 hours) + (1,200 x 0.6 hours) + (1,200 x 0.6 hours). This
annual burden is shown in table 1.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                Number of
              Activity/section                  Number of      records per    Total annual         Average burden per recordkeeping         Total hours
                                              recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Maintenance of reportable food records                1,200               1           1,200  0.25 (15 minutes)..........................             300
 under section 417(g) of the FD&C Act--
 mandatory reports.
Maintenance of reportable food records                    4               1               4  0.25 (15 minutes)..........................               1
 under section 417(g) of the FD&C Act--
 voluntary reports.
                                            ------------------------------------------------                                             ---------------
    Total..................................  ..............  ..............  ..............  ...........................................             301
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Recordkeeping: As noted previously, section 417(g) of the FD&C Act
requires that responsible persons maintain records related to
reportable foods reports and notifications under section 417 of the
FD&C Act for a period of 2 years. Based on past FDA experiences, we
estimate that each mandatory report and its associated notifications
will require 30 minutes of recordkeeping for the 2-year period, or 15
minutes per record per year. The annual recordkeeping burden for
mandatory reportable food reports and their associated notifications is
thus estimated to be 300 hours (1,200 x 0.25 hours).
    We do not expect that records will always be kept in relation to
voluntary reportable food reports. Therefore, we estimate that records
will be kept for four voluntary reports we expect to receive annually.
The recordkeeping burden associated with voluntary reports is thus
estimated to be 1 hour annually (4 x 0.25 hours). The estimated total
annual recordkeeping burden will be 301 hours annually (1,200 x 0.25
hours) + (4 x 0.25 hours). This annual burden is shown in table 2.

    Dated: September 19, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-20283 Filed 9-21-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 102 (Wednesday, May 27, 2020)]
[Notices]
[Pages 31849-31850]
[FR Doc No: 2020-11323]

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

Federal Aviation Administration

Commercial Space Transportation Advisory Committee: Notice of
Public Meeting

AGENCY: Federal Aviation Administration, Department of Transportation.

ACTION: Notice of Public Meeting.

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SUMMARY: This notice announces a meeting of the Commercial Space
Transportation Advisory Committee for June 22, 2020.

DATES: The June 22, 2020 meeting will be held from 8:45 a.m. to 12:00
p.m. Eastern Time. Requests for accommodations to a disability must be
received by June 15, 2020.
    Requests to speak during the meeting must be submitted by June 15,
2020, to DOT and include a written copy of their remarks. Requests to
submit written materials to be reviewed during the meeting must be
received by DOT no later than June 15, 2020.
    Notices for the September 2020 and March 2021 meetings will be
published in the Federal Register at least 15 calendar days before the
day of the meeting.

ADDRESSES: The June 15, 2020 meeting will be an internet-only meeting.
No physical meeting is planned. Instructions on how to attend the
meeting, copies of meeting minutes, and a detailed agenda will be
posted on the COMSTAC internet website at: https://www.faa.gov/space/additional_information/comstac/.

FOR FURTHER INFORMATION CONTACT: James Hatt, Designated Federal
Officer, U.S. Department of Transportation, at<EMAIL_ADDRESS>
Any committee related request should be sent to the person listed in
this section.

SUPPLEMENTAL INFORMATION:

I. Background

    The Commercial Space Transportation Advisory Committee was created
under the Federal Advisory Committee Act (FACA), in accordance with
Public Law 92-463. Since its inception, COMSTAC has provided
information, advice, and recommendations to the U.S. Department of
Transportation through FAA regarding technology, business, and policy
issues relevant to oversight of the U.S. commercial space
transportation sector.

II. Agenda

    At the June 22, 2020 meeting, the agenda will cover the following
topics:
Secretary of Transportation Elaine Chao Welcome Remarks
FAA Administrator Steve Dickson Welcome Remarks
FAA Associate Administrator for Commercial Space Transportation, Gen.
Wayne Monteith Welcome Remarks
Committee Member Introductions
FAA/AST Updates
AST's Priorities for 2020-2021
Public Comments/Other Business

III. Public Participation

    The June 22, 2020 meeting is open to the public. The meeting can be
viewed by the public using the internet website link posted above. The
U.S. Department of Transportation is committed to providing equal
access to this meeting for all participants. If you need alternative
formats or services because of a disability, such as sign language,
interpretation, or other ancillary aids, please contact the person
listed in the FOR FURTHER INFORMATION CONTACT section by June 15, 2020.
    There will be approximately thirty minutes allotted for oral
comments from members of the public joining a COMSTAC meeting. To
accommodate as many speakers as possible, the time for each commenter
may be limited. Individuals wishing to reserve speaking time during the
meeting must submit a request at the time of registration, as well as
the name, address, and organizational affiliation of the proposed
speaker. If the number of registrants requesting to make statements is
greater than can be reasonably accommodated during the meeting, the FAA
Office of Commercial Space Transportation may conduct a lottery to
determine the speakers. Speakers are requested to submit a written copy
of their prepared remarks for inclusion in the meeting records and for
circulation to COMSTAC members. All prepared remarks submitted on time
will be accepted and considered as part of the record. Any member of
the public may present a written statement to the committee at any
time.

    Issued in Washington, DC, this 21 day of May 2020.
James A. Hatt,
Designated Federal Officer, Commercial Space Transportation Advisory
Committee, Federal Aviation Administration, Department of
Transportation.
[FR Doc. 2020-11323 Filed 5-26-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 247 (Friday, December 23, 2011)]
[Notices]
[Pages 80362-80363]
[FR Doc No: 2011-32960]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2007-1121; FRL-9509-4]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Fuel Quality Regulations for Diesel Fuel Sold in
2001 & Later Years; for Tax-Exempt (Dyed) Highway Diesel Fuel; & Non-
Road Locomotive & Marine Diesel Fuel (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this notice announces that an Information
Collection Request (ICR) has been forwarded to the Office of Management
and Budget (OMB) for review and approval. This is a request to renew an
existing approved collection. The ICR, which is abstracted below,
describes the nature of the information collection and its estimated
burden and cost.

DATES: Additional comments may be submitted on or before January 23,
2012.

ADDRESSES: Submit comments referencing Docket ID No. EPA-HQ-OAR-2007-
1121, to (1) EPA online using http://www.regulations.gov (our preferred
method), by email to<EMAIL_ADDRESS>or by mail to: EPA Docket
Center, Environmental Protection Agency, Air Docket, Mail Code 6102T,
1200 Pennsylvania Ave. NW., Washington, DC 20460, and (2) OMB by mail
to: Office of Information and Regulatory Affairs, Office of Management
and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street NW.,
Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Geanetta Heard, Environmental
Protection Specialist, Mail Code: 6406J, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone
number:<PHONE_NUMBER> fax number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On August 18, 2011 (76 FR 51362), EPA sought comments on this
ICR pursuant to 5 CFR 1320.8(d). EPA received no comments. Any
additional comments on this ICR should be submitted to EPA and OMB
within 30 days of this notice.
    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-OAR-2007-1121, which is available for online viewing at
www.regulations.gov, or in person viewing at the Air and Radiation
Docket in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301
Constitution Ave. NW., Washington, DC. The EPA/DC Public Reading Room
is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number for the Reading Room is (202) 566-
1744, and the telephone number for the Air Docket is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at http://www.regulations.gov, to submit or view public comments, access the
index listing of the contents of the docket, and

to access those documents in the docket that are available
electronically. Once in the system, select ``docket search,'' then key
in the docket ID number identified above. Please note that EPA's policy
is that public comments, whether submitted electronically or in paper,
will be made available for public viewing at www.regulations.gov as EPA
receives them and without change, unless the comment contains
copyrighted material, confidential business information (CBI), or other
information for which public disclosure is restricted by statute. For
further information about the electronic docket, go to
www.regulations.gov.
    Title: Fuel Quality Regulations for Diesel Fuel Sold in 2001 &
Later Years; for Tax-Exempt (Dyed) Highway Diesel Fuel; & Non-Road
Locomotive & Marine Diesel Fuel (Renewal).
    ICR numbers: EPA ICR No. 1718.09, OMB Control No. 2060-0308.
    ICR Status: This ICR is currently scheduled to expire on December
31, 2011. Under OMB regulations, the Agency may continue to conduct or
sponsor the collection of information while this submission is pending
at OMB. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information, unless it displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations in title 40 of the CFR, after appearing in the Federal
Register when approved, are listed in 40 CFR part 9, are displayed
either by publication in the Federal Register or by other appropriate
means, such as on the related collection instrument or form, if
applicable. The display of OMB control numbers in certain EPA
regulations is consolidated in 40 CFR part 9.
    Abstract: This ICR covers recordkeeping and reporting requirements
for motor vehicle diesel fuel and non-road, locomotive and marine
diesel fuel. It also includes recordkeeping and reporting associated
with the placement of codes on dyed diesel fuel (the dye is required
under IRS regulations). The main purpose for recordkeeping and
reporting is to ensure compliance with the regulations at 40 CFR Part
80, Subpart I--``Motor Vehicle, Non-Road, Locomotive, and Marine Diesel
Fuel.'' Most reporting is mandatory. Parties may assert a claim of
business confidentiality and submissions covered by such a claim will
be treated in accordance with procedures at 40 CFR part 2 and
established Agency procedures.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average .07
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    Respondents/Affected Entities: Private businesses selling diesel
fuel.
    Estimated Number of Respondents: 6,806.
    Frequency of Response: Annual, quarterly and/or on occasion..
    Estimated Total Annual Hour Burden: 18,950.
    Estimated Total Annual Cost: $2,084,500.
    Changes in the Estimates: There is a decrease of hours in the total
estimated burden currently identified in the OMB Inventory of Approved
ICR Burdens. For this renewal, we estimate a total annual burden of
18,950 hours. This represents a decrease of 266,311 hours. For the
expiring approval, we had estimated 285,261 hours. Most motor vehicle
diesel reporting has now ended, which was expected to reduce the
responses, hours, and costs. Likewise, laboratory qualifications have
virtually all been submitted already. However, please note that we have
changed how we accounted for the burden for this renewal. We have
modeled our estimates to match the in-use forms in order to assist
interested parties in providing comments. Therefore, some of the change
is associated with how we did the estimates in 2008 (expiring approval)
and now.

    Dated: December 16, 2011.
John Moses,
Director, Collection Strategies Division.
[FR Doc. 2011-32960 Filed 12-22-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 105 (Friday, May 31, 2019)]
[Rules and Regulations]
[Pages 25177-25178]
[FR Doc No: 2019-11374]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2019-0408]

Safety Zones; Annual Events in the Captain of the Port Buffalo
Zone

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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

SUMMARY: The Coast Guard will enforce certain safety zones located in
federal regulations for Annual Events in the Captain of the Port
Buffalo. This action is necessary and intended to protect the safety of
life and property on navigable waters prior to, during, and immediately
after these events. During each enforcement period, no person or vessel
may enter the respective safety zone without the permission of the
Captain of the Port Buffalo.

DATES: The regulations in 33 CFR 165.939(a)(4) as listed in Table
165.939 will be enforced from 9:30 p.m. through 10:15 p.m. on June 14,
2019. The regulations in 33 CFR 165.939(a)(5) as listed in Table
165.939 will be enforced from 9 p.m. through 10 p.m. on June 1, 2019.
The regulations in 33 CFR 165.939(a)(6) as listed in Table 165.939 will
be enforced from 8 a.m. through 5:30 p.m. on June 15, 2019.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice of enforcement, call or email LT Sean Dolan, Chief of Waterways
Management, U.S. Coast Guard Sector Buffalo telephone<PHONE_NUMBER>,
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the Safety
Zones; Annual Events in the Captain of the Port Buffalo Zone listed in
33 CFR 165.939 for the following events:
    (1) Seneca River Days, Baldwinsville, NY; The safety zone listed in
Table 165.939 as (a)(4) will be enforced from 9:30 p.m. through 10:15
p.m. on June 14, 2019 with a rain date of June 15, 2019.
    (2) Flagship Niagara Mariner's Ball Fireworks, Erie, PA; The safety
zone listed in Table 165.939 as (a)(5) will be enforced from 9 p.m.
through 10 p.m. on June 01, 2019.
    (3) Hope Chest Buffalo Niagara Dragon Boat Festival, Buffalo, NY;
The safety zone listed in Table 165.939 as (a)(6) will be enforced from
8:00 a.m. through 5:30 p.m. on June 15, 2019.
    Pursuant to 33 CFR 165.23, entry into, transiting, or anchoring
within the safety zones during an enforcement period is prohibited
unless authorized by the Captain of the Port Buffalo or a designated
representative. Those seeking permission to enter the safety zones may
request permission from the Captain of Port Buffalo via channel 16,
VHF-FM. Vessels and persons granted permission to enter the safety
zones shall obey the directions of the Captain of the Port Buffalo or a
designated representative. While within a safety

zone, all vessels shall operate at the minimum speed necessary to
maintain a safe course.
    This notice of enforcement is issued under authority of 33 CFR
165.939 and 5 U.S.C. 552 (a). In addition to this notice of enforcement
in the Federal Register, the Coast Guard will provide the maritime
community with advance notification of this enforcement period via
Broadcast Notice to Mariners or Local Notice to Mariners. If the
Captain of the Port Buffalo determines that the safety zone need not be
enforced for the full duration stated in this notification he or she
may use a Broadcast Notice to Mariners to grant general permission to
enter the respective safety zone.

    Dated: May 23, 2019.
Joseph S. Dufresne,
Captain, U.S. Coast Guard, Captain of the Port Buffalo.
[FR Doc. 2019-11374 Filed 5-30-19; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: June 25, 2007 (Volume 72, Number 121)]
[Notices]
[Page 34678]
[DOCID:fr25jn07-58]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-310-000]

Mojave Pipeline Company; Notice of Informal Settlement Conference

June 18, 2007.
    Take notice that an informal settlement conference will be convened
in this proceeding commencing at 10 a.m. on June 27, 2007, at the
offices of the Federal Energy Regulatory Commission, 888 First Street,
NE., Washington, DC 20426, for the purpose of exploring the possible
settlement of the above-referenced dockets.
    Any party, as defined by 18 CFR 385.102(c), or any participant as
defined by 18 CFR 385.102(b), is invited to attend. Persons wishing to
become a party must move to intervene and receive intervenor status
pursuant to the Commission's regulations (18 CFR 385.214).
    FERC conferences are accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations please
send an e-mail to<EMAIL_ADDRESS>or call toll free 1-866-208-
3372 (voice) or<PHONE_NUMBER> (TTY), or send a FAX to<PHONE_NUMBER> with
the required accommodations.
    For additional information, please contact Hollis Alpert at
<EMAIL_ADDRESS>(202) 502-8783.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-12179 Filed 6-22-07; 8:45 am]

BILLING CODE 6717-01-P


BEFORE THE

DEPARTMENT OF TRANSPORTATION

OFFICE OF THE SECRETARY

WASHINGTON, D.C.

____________________________________

90-Day Notice of 				)

						)

	Warbelow's Air Ventures, Inc.	)

						)		Docket OST-2004-17563

Of intent to terminate unsubsidized service	)

At Minto and Manley, Alaska			)

___________________________________	)

90-ESSENTIAL AIR SERVICE NOTICE OF

WARBELOW’S AIR VENTURES, INC.

OF INTENT TO TERMINATE UNSUBSIDIZED SERVICE

AT MINTO AND MANLEY, ALASKA

Communications with respect to this document should be addressed to:

Art Warbelow, President

Warbelow's Air Ventures, Inc.

3758 University Avenue South

Fairbanks, Alaska   99709

(907) 374-6202

May 12, 2004

NOTICE: Objections to this Notice are due on or before June 2, 2004

BEFORE THE

DEPARTMENT OF TRANSPORTATION

OFFICE OF THE SECRETARY

WASHINGTON, D.C.

____________________________________

90-Day Notice of 				)

	Warbelow's Air Ventures, Inc.	)

						)		Docket OST-2004-17563

Of intent to terminate unsubsidized service	)

At Minto and Manley, Alaska			)

___________________________________	)

90-ESSENTIAL AIR SERVICE NOTICE OF

WARBELOW’S AIR VENTURES, INC.

OF INTENT TO TERMINATE UNSUBSIDIZED SERVCIE

AT MINTO AND MANLEY, ALASKA

Warbelow's Air Ventures, Inc.(Warbelow’s) under 49 USC 41734 and 14
CFR 323.3(a)(5) hereby gives notice of its intent to terminate all
services at Minto, Alaska and Manley, Alaska effective on or before
August 12, 2004.

1.  Warbelow’s has its principal place of business at 3758 University
Avenue South, Fairbanks, Alaska   99709 and its telephone number is
(907) 474-0518,

2.  Warbelow’s holds a certificate of public convenience and necessity
under 49 USC to engage in scheduled air transportation of person,
property and ail between points in the United States.

3.  Warbelow’s currently provides three flights a week with small
aircraft between the points of Minto and Manley on one hand and the hub
point of Fairbanks, Alaska on the other.  The service is operated on
Monday, Wednesday and Friday on the following schedule:

	Depart FAI	1000		Arrive MLY	1040

	Depart MLY	1045		Arrive MNT	1110

	Depart MNT	1115		Arrive FAI	1145

4.  No other scheduled air service is provided at Minto and Manley.

5.  The Department of Transportation has determined the level of
Essential Air Service at Minto and Manley at two roundtrips per week
year around with small aircraft.

6.  There are no alternative services available at either of these
points.

7.  Warbelow’s has recently started service to these points after
Tanana Air Service withdrew, but based on Tanana’s historical revenue
in these markets, and Warbelow’s early experience, the route is not
viable without subsidy.

8.  Under 14 CFR 323.10(a)(3), objections to this notice are due in 20
days, or on June 2, 2004.

9.  Proof of Service on all persons specified in 14 CFR 323.7(a) is
attached.

Respectfully submitted,

Warbelow's Air Ventures, Inc.

____________________________

Art Warbelow, President

May 12, 2004

Service List

Andy Jimmie

Village Council Chief

P.O. Box 58026

Minto, AK   99758

Frank Gurtler

Village Council Chief

Manley Hot Springs, AK   99756-0000

Kip Knudson

Deputy Commissioner for Aviation

Alaska Department of Transportation and Public Facilities

P.O. Box 196900

Postmaster General

Assistant General Counsel, Transportation

475 L’Enfant Plaza West, SW

Washington, D.C.   20260

Karan K. Bhatia

Assistant Secretary for Aviation and International Affairs

Department of Transportation

400 Seventh Street, SW

Washington, D.C. 20590-0001


[Federal Register Volume 83, Number 28 (Friday, February 9, 2018)]
[Notices]
[Pages 5790-5791]
[FR Doc No: 2018-02590]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2016-E-2267 and FDA-2016-E-2269]

Determination of Regulatory Review Period for Purposes of Patent
Extension; ONIVYDE

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for ONIVYDE and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of applications to the Director
of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by April
10, 2018. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by August 8, 2018.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 10, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 10, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

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 Nos.
FDA-2016-E-2267 and FDA-2016-E-2269 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; ONIVYDE.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the dockets 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 Sec.  10.20 (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.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,

10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993,
301-796-3600.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product ONIVYDE
(irinotecan sucrose octasulfate). ONIVYDE in combination with
fluorouracil and leucovorin, is indicated for the treatment of patients
with metastatic adenocarcinoma of the pancreas after disease
progression following gemcitabine-based therapy. Subsequent to this
approval, the USPTO received patent term restoration applications for
ONIVYDE (U.S. Patent Nos. 8,147,867 and 8,329,213) from Merrimack
Pharmaceuticals, Inc., and the USPTO requested FDA's assistance in
determining the patents' eligibility for patent term restoration. In a
letter dated August 12, 2016, FDA advised the USPTO that this human
drug product had undergone a regulatory review period and that the
approval of ONIVYDE represented the first permitted commercial
marketing or use of the product. Thereafter, the USPTO requested that
FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
ONIVYDE is 2,536 days. Of this time, 2,354 days occurred during the
testing phase of the regulatory review period, while 182 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
November 13, 2008. FDA has verified the applicant's claim that November
13, 2008, is the date the investigational new drug application became
effective.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: April 24,
2015. FDA has verified the applicant's claim that the new drug
application (NDA) for ONIVYDE (NDA 207793) was initially submitted on
April 24, 2015.
    3. The date the application was approved: October 22, 2015. FDA has
verified the applicant's claim that NDA 207793 was approved on October
22, 2015.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 613 days or 1,215 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: February 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02590 Filed 2-8-18; 8:45 am]
 BILLING CODE 4164-01-P