[Federal Register Volume 85, Number 180 (Wednesday, September 16, 2020)]
[Rules and Regulations]
[Pages 57712-57714]
[FR Doc No: 2020-18407]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2020-0180; FRL-10012-89-Region 9]

Air Plan Approval; California; Feather River Air Quality
Management District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to approve a revision to the Feather River Air Quality
Management District (FRAQMD) portion of the California State
Implementation Plan (SIP). This revision concerns emissions of volatile
organic compounds (VOCs) from vehicle and mobile equipment coating
operations. We are approving a local rule that regulates these emission
sources under the Clean Air Act (CAA or the Act).

DATES: This rule will be effective on October 16, 2020.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R09-OAR-2020-0180. All documents in the docket are
listed on the https://www.regulations.gov website. Although listed in
the index, some information is not publicly available, e.g.,
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, is not placed on the internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available through https://www.regulations.gov, or please
contact

the person identified in the FOR FURTHER INFORMATION CONTACT section
for additional availability information.

FOR FURTHER INFORMATION CONTACT: Christine Vineyard, EPA Region IX, 75
Hawthorne St., San Francisco, CA 94105. By phone:<PHONE_NUMBER> or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to the EPA.

Table of Contents

I. Proposed Action
II. Public Comments and EPA Responses
III. EPA Action
IV. Incorporation by Reference
V. Statutory and Executive Order Reviews

I. Proposed Action

    On May 8, 2020 (85 FR 27344), the EPA proposed to approve the
following rule into the California SIP.

----------------------------------------------------------------------------------------------------------------
           Local agency                  Rule No.              Rule Title             Amended        Submitted
----------------------------------------------------------------------------------------------------------------
FRAQMD...........................  3.19...............  Vehicle and Mobile            08/01/2016      01/24/2017
                                                         Equipment Coating
                                                         Operations.
----------------------------------------------------------------------------------------------------------------

    We proposed to approve this rule because we determined that it
complies with the relevant CAA requirements. Our proposed action
contains more information on the rule and our evaluation.

II. Public Comments and EPA Responses

    The EPA's proposed action provided a 30-day public comment period.
During this period, we received one comment from Mr. Evan Stull, New
Jersey:
    Comment: Mr. Stull believes VOC levels in paint can be forcibly cut
down under the EPA's authority. Further, he believes that the
contamination of the air under the Clean Air Act is grounds to expand
the EPA's role in the spread of VOCs and their toxic fumes.
    Response: EPA appreciates the comment, but believes it is not
germane to our action.

III. EPA Action

    No comments were submitted that change our assessment of the rule
as described in our proposed action. Therefore, as authorized in
section 110(k)(3) of the Act, the EPA is fully approving this rule into
the California SIP.

IV. Incorporation by Reference

    In this rule, the EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, the EPA is finalizing the incorporation by reference of the
FRAQMD rules described in the amendments to 40 CFR part 52 set forth
below. The EPA has made, and will continue to make, these documents
available through www.regulations.gov and at the EPA Region IX Office
(please contact the person identified in the FOR FURTHER INFORMATION
CONTACT section of this preamble for more information).

V. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, the EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 3,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide the EPA with the discretionary authority
to address, as appropriate, disproportionate human health or
environmental effects, using practicable and legally permissible
methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where the EPA or an Indian tribe
has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the rule does not have tribal implications and will not
impose substantial direct costs on tribal governments or preempt tribal
law as specified by Executive Order 13175 (65 FR 67249, November 9,
2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. The EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Ozone, Particulate matter,
Reporting and recordkeeping requirements, Volatile organic compounds.

    Dated: August 17, 2020.
John Busterud,
Regional Administrator, Region IX.

    For the reasons stated in the preamble, the EPA amends 40 CFR part
52 as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart F--California

0
2. Section 52.220 is amended by adding paragraphs (c)(442)(i)(E)(5) and
(c)(497)(i)(E) to read as follows:

Sec.  52.220  Identification of plan-in part.

* * * * *
    (c) * * *
    (442) * * *
    (i) * * *
    (E) * * *
    (5) Previously approved on June 11, 2015 in paragraph
(c)(442)(i)(E)(4) of this section and now deleted with replacement in
(c)(497)(i)(E)(1), Rule 3.19, ``Vehicle and Mobile Equipment Coating
Operations,'' amended on August 1, 2016.
* * * * *
    (497) * * *
    (i) * * *
    (E) Feather River Air Quality Management District
    (1) Rule 3.19, ``Vehicle and Mobile Equipment Coating Operations,''
amended on August 1, 2016.
    (2) [Reserved]
* * * * *
[FR Doc. 2020-18407 Filed 9-15-20; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 69 (Wednesday, April 12, 2017)]
[Notices]
[Page 17714]
[FR Doc No: 2017-07301]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE., Washington, DC
20549-2736

Extension:
    Rule 425, [OMB Control No. 3235-0521, SEC File No. 270-462]

    Notice is hereby given, that pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.
    Rule 425 (17 CFR 230.425) under the Securities Act of 1933 (15
U.S.C. 77a et seq.) requires the filing of certain prospectuses and
communications under Rule 135 (17 CFR 230.135) and Rule 165 (17 CFR
230.165) in connection with business combination transactions. The
purpose of the rule is to permit more oral and written communications
with shareholders about tender offers, mergers and other business
combination transactions on a more timely basis, so long as the written
communications are filed on the date of first use. Approximately 7,160
issuers file communications under Rule 425 at an estimated 0.25 hours
per response for a total of 1,790 annual burden hours (0.25 hours per
response x 7,160 responses).
    Written comments are invited on: (a) Whether the collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information will have practical
utility; (b) the accuracy of the agency's estimate of the burden
imposed by the collection of information; (c) ways to enhance the
quality, utility, and clarity of the information collected; and (d)
ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    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 control number.
    Please direct your written comment to Pamela Dyson, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 100 F Street NE., Washington, DC 20549 or send an email
to<EMAIL_ADDRESS>
    Dated: April 6, 2017.
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-07301 Filed 4-11-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 122 (Friday, June 24, 2011)]
[Notices]
[Pages 37169-37171]
[FR Doc No: 2011-15928]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2011-0140]

Qualification of Drivers; Exemption Applications; Vision

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

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

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SUMMARY: FMCSA announces receipt of applications from 17 individuals
for exemption from the vision requirement in the Federal Motor Carrier
Safety Regulations. If granted, the exemptions would enable these
individuals to qualify as drivers of commercial motor vehicles (CMVs)
in interstate commerce without meeting the Federal vision standard.

DATES: Comments must be received on or before July 25, 2011.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket No. FMCSA-2011-0140 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 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: Elaine M. Papp, Chief, 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.''

FMCSA can renew exemptions at the end of each 2-year period. The 17
individuals listed in this notice have each requested such an exemption
from the vision requirement in 49 CFR 391.41(b)(10), which applies to
drivers of CMVs in interstate commerce. Accordingly, the Agency will
evaluate the qualifications of each applicant to determine whether
granting an exemption will achieve the required level of safety
mandated by statute.

Qualifications of Applicants

Danny F. Burnley

    Mr. Burnley, age 49, has loss of vision in his right eye due to a
traumatic injury that occurred during his late teens or early twenties.
The best corrected visual acuity in his right eye is 20/400 and in his
left eye, 20/20. Following an examination in 2011, his optometrist
noted, ``Based upon my findings and medical expertise, I Jamison J.
Heffron, O.D. hereby certify Danny Burnley to be visually able to
safely operate a commercial motor vehicle.'' Mr. Burnley reported that
he has driven straight trucks for 3 years, accumulating 6,000 miles and
tractor-trailer combinations for 3 years, accumulating 6,000 miles. He
holds a Class A Commercial Driver's License (CDL) from Kentucky. His
driving record for the last 3 years shows no crashes and no convictions
for moving violations in a CMV.

Bruce A. Cameron

    Mr. Cameron, 58, has had a branch retinal vein occlusion in his
left eye since 2005. The best corrected visual acuity in his right eye
is 20/20 and in his left eye, count-finger vision. Following an
examination in 2011, his optometrist noted, ``In my opinion, Mr.
Cameron has sufficient vision to perform the driving tasks required to
operate a commercial vehicle.'' Mr. Cameron reported that he has driven
straight trucks for 45 years, accumulating 225,000 miles and tractor-
trailer combinations for 30 years, accumulating 150,000 miles. He holds
a Class A CDL from North Dakota. His driving record for the last 3
years shows no crashes and no convictions for moving violations in a
CMV.

Charles E. Carter

    Mr. Carter, 54, has complete loss of vision in his left eye due to
a traumatic injury sustained in 1992. The best corrected visual acuity
in his right eye is 20/20. Following an examination in 2011, his
optometrist noted, ``In my own opinion, Charles has sufficient vision
to perform driving tasks required to operate a commercial vehicle.''
Mr. Carter reported that he has driven tractor-trailer combinations for
5 years, accumulating 360,000 miles. He holds a Class A CDL from
Michigan. His driving record for the last 3 years shows no crashes and
no convictions for moving violations in a CMV.

Ronald J. Claud

    Mr. Claud, 65, has had retinal scarring in his left eye due to a
traumatic injury since 1962. The best corrected visual acuity in his
right eye is 20/20 and in his left eye, 3/180. Following an examination
in 2011, his optometrist noted, ``I do not see any reason why he cannot
obtain a commercial vehicle drivers license.'' Mr. Claud reported that
he has driven straight trucks for 40 years, accumulating 200,000 miles
and tractor-trailer combinations for 28 years, accumulating 168,000
miles. He holds a Class C operator's license from New York. His driving
record for the last 3 years shows no crashes and no convictions for
moving violations in a CMV.

Stewart K. Clayton

    Mr. Clayton, 50, has had inferior retinal coloboma in his right eye
since birth. The best corrected visual acuity in his right eye is 20/
100 and in his left eye, 20/20. Following an examination in 2010, his
optometrist noted, ``Mr. Clayton has sufficient vision to perform
driving tasks required to operate a commercial vehicle.'' Mr. Clayton
reported that he has driven straight trucks for 31 years, accumulating
744,000 miles and tractor-trailer combinations for 31 years,
accumulating 744,000 miles. He holds a Class A CDL from Texas. His
driving record for the last 3 years shows no crashes and no convictions
for moving violations in a CMV.

Sean R. Conorman

    Mr. Conorman, 40, has had amblyopia in his left eye since
childhood. The best corrected visual acuity in his right eye is 20/20
and in his left eye, 20/200. Following an examination in 2011, his
ophthalmologist noted, ``In my opinion, patient has sufficient vision
to perform the driving tasks required to operate a commercial
vehicle.'' Mr. Conorman reported that he has driven straight trucks for
5.9 years, accumulating 236,000 miles and tractor-trailer combinations
for 5.6 years, accumulating 280,000 miles. He holds a Class A CDL from
Michigan. His driving record for the last 3 years shows no crashes and
no convictions for moving violations in a CMV.

Jackie R. Frederick

    Mr. Frederick, 61, has had amblyopia in his right eye since
childhood. The best corrected visual acuity in his right eye is 20/70
and in his left eye, 20/20. Following an examination in 2011, his
optometrist noted, ``In my opinion, his vision is sufficient to perform
the driving tasks required for operating a commercial vehicle.'' Mr.
Frederick reported that he has driven straight trucks for 15 years,
accumulating 240,000 miles. He holds a Class A CDL from Alabama. His
driving record for the last 3 years shows no crashes and no convictions
for moving violations in a CMV.

Robert E. Graves

    Mr. Graves, 42, has a prosthetic right eye due to a traumatic
injury since age 3. The best corrected visual acuity in his left eye is
20/15. Following an examination in 2011, his optometrist noted, ``He
has sufficient vision to perform the driving tasks required to operate
a commercial vehicle.'' Mr. Graves reported that he has driven straight
trucks for 24 years, accumulating 48,000 miles and driven tractor-
trailer combinations for 22 years, accumulating 440,000 miles. He holds
a Class A CDL from Nebraska. His driving record for the last 3 years
shows no crashes but one conviction for speeding in a CMV. He exceeded
the speed limit by 10 miles per hour

Brian P. Millard

    Mr. Millard, 38, has had amblyopia in his left eye since childhood.
The best corrected visual acuity in his right eye is 20/20 and in his
left eye, 20/100. Following an examination in 2011, his ophthalmologist
noted, ``Based on recent examinations, patient has sufficient vision to
operate a commercial vehicle.'' Mr. Millard reported that he has driven
straight trucks for 17 years, accumulating 1.3 million miles. He holds
a Class B CDL from North Carolina. His driving record for the last 3
years shows no crashes and no convictions for moving violations in a
CMV.

Steven D. Nash

    Mr. Nash, 56, has had histoplasmosis in his left eye since birth.
The visual acuity in his right eye is 20/20 and in his left eye, 20/
450. Following an examination in 2011, his optometrist noted, ``I feel
that Mr. Nash has sufficient vision to perform the driving tasks
required to operate a commercial vehicle.'' Mr. Nash reported that he
has driven straight trucks for 20 years, accumulating 900,000 miles. He
holds a Class A CDL from Iowa. His driving

record for the last 3 years shows no crashes and no convictions for
moving violations in a CMV.

Merle M. Price

    Mr. Price, 56, has a prosthetic right eye due to a traumatic injury
that occurred 36 years ago. The visual acuity in his left eye is 20/20.
Following an examination in 2011, his optometrist noted, ``I certify
that Mr. Price demonstrates that he has sufficient vision to perform
the driving tasks required to operate a commercial vehicle.'' Mr. Price
reported that he has driven straight trucks for 5 years, accumulating
25,000 miles and tractor-trailer combinations for 20 years,
accumulating 500,000 miles. He holds a Class A CDL from Iowa. His
driving record for the last 3 years shows no crashes and no convictions
for moving violations in a CMV.

Terrence F. Ryan

    Mr. Ryan, 49, has had refractive amblyopia in his left eye since
childhood. The best corrected visual acuity in his right eye is 20/20
and in his left eye, 20/50. Following an examination in 2011, his
optometrist noted, ``I certify in my medical opinion that Terrence Ryan
has sufficient vision to operate a commercial vehicle.'' Mr. Ryan
reported that he has driven straight trucks for 12 years, accumulating
600,000 miles and tractor-trailer combinations for 14 years,
accumulating 1.1 million miles. He holds a Class A CDL from Florida.
His driving record for the last 3 years shows one crash for which he
was not cited, and no convictions for moving violations in a CMV.

Kirby R. Sands

    Mr. Sands, 49, has had a cornea scar in his right eye, due to a
traumatic injury sustained at age 9. The best corrected visual acuity
in his right eye is hand motion vision and in his left eye, 20/15.
Following an examination in 2011, his optometrist noted, ``My
conclusion is that Kirby Sands is qualified to perform the driving
tasks required to operate a commercial vehicle.'' Mr. Sands reported
that he has driven straight trucks for 5 years, accumulating 128,000
miles and tractor-trailer combinations for 15 years, accumulating 1.8
million miles. He holds a Class A CDL from Iowa. His driving record for
the last 3 years shows no crashes and not convictions for moving
violations in a CMV.

Dennis W. Stubrich

    Mr. Stubrich, 57, has had Eales' disease in his right eye since
1984. The best corrected visual acuity in his right eye is 20/60 and in
his left eye, 20/20. Following an examination in 2010, his
ophthalmologist noted, ``In my opinion, Mr. Stubrich's vision is
sufficient to perform driving tasks required to operate commercial
vehicles.'' Mr. Stubrich reported that he has driven straight trucks
for 26 years, accumulating 1.7 million miles and tractor-trailer
combinations for 5 years, accumulating 72,000 miles. He holds a Class A
CDL from Pennsylvania. His driving record for the last 3 years shows no
crashes and no convictions for moving violations in a CMV.

Stephen W. Verrette

    Mr. Verrette, 44, has had cataract in his right eye due to a
traumatic injury sustained at age 10. The best corrected visual acuity
in his right eye is 20/150 and in his left eye, 20/20. Following an
examination in 2011, his optometrist noted, ``In light of this, I feel
Steve can safely perform driving tasks necessary to operate a
commercial motor vehicle.'' Mr. Verrette reported that he has driven
straight trucks for 25 years, accumulating 75,000 miles. He holds a
Class A CDL from Michigan. His driving record for the last 3 years
shows no crashes and no convictions for moving violations in a CMV.

Joseph A. Wells

    Mr. Wells, 46, had a corneal transplantation in the 1990s and
retinal detachment repair in 2009 due to a prior history of trauma in
his right eye. The best corrected visual acuity in his right eye is 20/
70 and in his left eye, 20/20. Following an examination in 2011, his
ophthalmologist noted, ``I believe based on the clinical examination,
he is capable of operating commercial motor vehicles without
difficulty.'' Mr. Wells reported that he has driven straight trucks for
25 years, accumulating 1.2 million miles. He holds a Class A CDL from
Illinois. His driving record for the last 3 years shows no crashes and
no convictions for moving violations in a CMV.

Leslie H. Wylie

    Mr. Wylie, 55, has loss of vision in his right eye due to a
traumatic injury sustained in 1985. The best corrected visual acuity in
his right eye is 20/400 and in his left eye, 20/20. Following an
examination in 2010, his ophthalmologist noted, as long as he meets the
criteria in regard to his visual field for operation of a commercial
vehicle, I see no problems with his operation of a commercial
vehicle.'' Mr. Wylie reported that he has driven straight trucks for 17
years, accumulating 3,400 miles and tractor-trailer combinations for 17
years, accumulating 3,400 miles. He holds a Class D operator's license
from Idaho. His driving record for the last 3 years shows no crashes
and no convictions for moving violations in a CMV.

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. The Agency will consider all comments
received before the close of business July 25, 2011. Comments will be
available for examination in the docket at the location listed under
the ADDRESSES section of this notice. The Agency will file comments
received after the comment closing date in the public docket, and will
consider them to the extent practicable.
    In addition to late comments, FMCSA will also continue to file, in
the public docket, relevant information that becomes available after
the comment closing date. Interested persons should monitor the public
docket for new material.

    Issued on: June 17, 2011.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2011-15928 Filed 6-23-11; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 76, Number 46 (Wednesday, March 9, 2011)]
[Notices]
[Pages 12950-12951]
[FR Doc No: 2011-5248]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Numbers: RP11-1845-000.
    Applicants: ANR Pipeline Company.
    Description: ANR Pipeline Company submits tariff filing per
154.403(d)(2): Fuel Filing 2011 to be effective 4/1/2011.
    Filed Date: 03/01/2011.
    Accession Number: 20110301-5102.
    Comment Date: 5 p.m. Eastern Time on Monday, March 14, 2011.

    Docket Numbers: RP11-1846-000.
    Applicants: Cimarron River Pipeline, LLC.
    Description: Cimarron River Pipeline, LLC submits tariff filing per
154.403(d)(2): Fuel Tracker 2011 to be effective 4/1/2011.
    Filed Date: 03/01/2011.
    Accession Number: 20110301-5129.
    Comment Date: 5 p.m. Eastern Time on Monday, March 14, 2011.

    Docket Numbers: RP11-1847-000.
    Applicants: Florida Gas Transmission Company, LLC.
    Description: Florida Gas Transmission Company, LLC submits tariff
filing per 154.203: Compliance with CP09-17-000 to be effective 4/1/
2011.
    Filed Date: 03/01/2011.
    Accession Number: 20110301-5135.
    Comment Date: 5 p.m. Eastern Time on Monday, March 14, 2011.

    Docket Numbers: RP11-1848-000.
    Applicants: Equitrans, L.P.
    Description: Equitrans, L.P. submits tariff filing per 154.204:
Non-Conforming Agreement Filing--Stand Energy Corporation to be
effective 4/1/2011.
    Filed Date: 03/01/2011.
    Accession Number: 20110301-5138.
    Comment Date: 5 p.m. Eastern Time on Monday, March 14, 2011.

    Docket Numbers: RP11-1849-000.
    Applicants: Empire Pipeline, Inc.
    Description: Empire Pipeline, Inc. submits tariff filing per
154.203: Annual Report of Compressor Fuel Factor (GT&C 23.5) to be
effective N/A.
    Filed Date: 03/01/2011.
    Accession Number: 20110301-5142.
    Comment Date: 5 p.m. Eastern Time on Monday, March 14, 2011.

    Docket Numbers: RP11-1850-000.
    Applicants: Sea Robin Pipeline Company, LLC.
    Description: Sea Robin Pipeline Company, LLC submits tariff filing
per 154.204: Hurricane Surcharge Filing 3-1-11 to be effective 4/1/
2011.
    Filed Date: 03/01/2011.
    Accession Number: 20110301-5157.
    Comment Date: 5 p.m. Eastern Time on Monday, March 14, 2011.

    Docket Numbers: RP11-1851-000.
    Applicants: Millennium Pipeline Company, LLC.
    Description: Millennium Pipeline Company's Annual Report of
Operational Transactions for Calendar Year 2010.
    Filed Date: 03/01/2011.
    Accession Number: 20110301-5173.
    Comment Date: 5 p.m. Eastern Time on Monday, March 14, 2011.

    Docket Numbers: RP11-1852-000.
    Applicants: TransColorado Gas Transmission Company LLC.
    Description: Annual Fuel Gas Reimbursement Percentage Report of
TransColorado Gas Transmission Company LLC.
    Filed Date: 03/01/2011.
    Accession Number: 20110301-5199.
    Comment Date: 5 p.m. Eastern Time on Monday, March 14, 2011.

    Docket Numbers: RP11-1853-000.
    Applicants: Columbia Gas Transmission, LLC.
    Description: Columbia Gas Transmission, LLC submits tariff filing
per 154.204: Negotiated Rate Service Agreement--Kinzer to be effective
4/1/2011.
    Filed Date: 03/01/2011.
    Accession Number: 20110301-5208.

    Comment Date: 5 p.m. Eastern Time on Monday, March 14, 2011.

    Docket Numbers: RP11-1854-000.
    Applicants: Colorado Interstate Gas Company.
    Description: Quarterly Lost Unaccounted for and Other Fuel--FL&U of
Colorado Interstate Gas Company.
    Filed Date: 03/01/2011.
    Accession Number: 20110301-5210.
    Comment Date: 5 p.m. Eastern Time on Monday, March 14, 2011.

    Docket Numbers: RP11-1855-000.
    Applicants: Florida Gas Transmission Company, LLC.
    Description: Florida Gas Transmission Company, LLC submits tariff
filing per 154.203: Baseline Filing Volume No. 1-A to be effective 4/1/
2011.
    Filed Date: 03/01/2011.
    Accession Number: 20110301-5212.
    Comment Date: 5 p.m. Eastern Time on Monday, March 14, 2011.

    Docket Numbers: RP11-1856-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Gulf South Pipeline Company, LP submits tariff filing
per 154.204: EnCana Marketing Negotiated Rate Agreement Amendment to be
effective 2/24/2011.
    Filed Date: 03/01/2011.
    Accession Number: 20110301-5231.
    Comment Date: 5 p.m. Eastern Time on Monday, March 14, 2011.

    Docket Numbers: RP11-1857-000.
    Applicants: Florida Gas Transmission Company, LLC.
    Description: Florida Gas Transmission Company, LLC submits tariff
filing per 154.204: Housekeeping Filing 3-1-11 to be effective 4/1/
2011.
    Filed Date: 03/01/2011
    Accession Number: 20110301-5236.
    Comment Date: 5 p.m. Eastern Time on Monday, March 14, 2011.

    Docket Numbers: RP11-1858-000.
    Applicants: Florida Gas Transmission Company, LLC.
    Description: Florida Gas Transmission Company, LLC submits tariff
filing per 154.204: Fuel Filing 3-1-11 to be effective 4/1/2011.
    Filed Date: 03/01/2011.
    Accession Number: 20110301-5274.
    Comment Date: 5 p.m. Eastern Time on Monday, March 14, 2011.

    Docket Numbers: RP11-1859-000.
    Applicants: Equitrans, L.P.
    Description: Equitrans, L.P. submits tariff filing per 154.204:
Pipeline Safety Cost Tracker Annual Filing to be effective 4/1/2011.
    Filed Date: 03/01/2011.
    Accession Number: 20110301-5280.
    Comment Date: 5 p.m. Eastern Time on Monday, March 14, 2011.

    Docket Numbers: RP11-1860-000.
    Applicants: Dauphin Island Gathering Partners.
    Description: Dauphin Island Gathering Partners submits tariff
filing per 154.403: Storm Surcharge 2011 to be effective 4/1/2011.
    Filed Date: 03/02/2011.
    Accession Number: 20110302-5000.
    Comment Date: 5 p.m. Eastern Time on Monday, March 14, 2011.

    Docket Numbers: RP11-1861-000.
    Applicants: Energy West Development, Inc.
    Description: Energy West Development, Inc., Docket No. L&U Rate
Filing.
    Filed Date: 03/01/2011.
    Accession Number: 20110301-5290.
    Comment Date: 5 p.m. Eastern Time on Monday, March 14, 2011.

    Docket Numbers: RP11-1862-000.
    Applicants: Hardy Storage Company LLC.
    Description: Hardy Storage Company, LLC submits for filing its
annual report of its operational transactions (purchases, sales,
borrows or tenders of natural gas) for the twelve months ended December
31, 2010.
    Filed Date: 03/01/2011.
    Accession Number: 20110301-5292.
    Comment Date: 5 p.m. Eastern Time on Monday, March 14, 2011.

    Docket Numbers: RP11-1863-000.
    Applicants: Stingray Pipeline Company, L.L.C.
    Description: Report of Stingray Pipeline Company, L.L.C.
    Filed Date: 03/01/2011.
    Accession Number: 20110301-5293.
    Comment Date: 5 p.m. Eastern Time on Monday, March 14, 2011.

    Docket Numbers: RP11-1864-000.
    Applicants: Columbia Gulf Transmission Company.
    Description: Columbia Gulf Transmission Company submits its annual
report of its operational purchases and sales of natural gas for the
twelve months ended December 31, 2010.
    Filed Date: 03/01/2011.
    Accession Number: 20110301-5295.
    Comment Date: 5 p.m. Eastern Time on Monday, March 14, 2011.

    Docket Numbers: RP11-1865-000.
    Applicants: Columbia Gas Transmission, LLC.
    Description: Columbia Gas Transmission, LLC submits its annual
report of its operational transactions (purchases, sales, borrows or
tenders of natural gas) for the twelve months ended December 31, 2010.
    Filed Date: 03/01/2011.
    Accession Number: 20110301-5296.
    Comment Date: 5 p.m. Eastern Time on Monday, March 14, 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 docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: March 2, 2011.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-5248 Filed 3-8-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 28 (Friday, February 9, 2018)]
[Notices]
[Pages 5788-5790]
[FR Doc No: 2018-02591]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-E-0632]

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

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 LYNPARZA and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application 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 (in 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 No.
FDA-2016-E-0632 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; LYNPARZA.'' Received comments, those
filed in a timely manner (see ADDRESSES), will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 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,<PHONE_NUMBER>.

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 LYNPARZA
(olaparib). LYNPARZA is indicated as monotherapy in patients with
deleterious or suspected deleterious germline BRCA mutated (as detected
by an FDA-approved test) advanced ovarian cancer whom have been treated
with three or more prior lines of chemotherapy. Subsequent to this
approval, the USPTO received a patent term restoration application for
LYNPARZA (U.S. Patent No. 7,449,464) from Kudos Pharmaceuticals
Limited, and the USPTO requested FDA's assistance in determining this
patent's eligibility for patent term restoration. In a letter dated May
2, 2016, FDA advised the USPTO that this human drug product had
undergone a regulatory review period and that the approval of LYNPARZA
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
LYNPARZA is 3,012 days. Of this time, 2,692 days occurred during the
testing phase of the regulatory review period, while 320 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 (the FD&C Act) (21 U.S.C. 355(i)) became
effective: September 22, 2006. FDA has verified the applicant's claim
that September 22, 2006, is the date the investigational new drug
application (IND) 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: February
3, 2014. FDA has verified the applicant's claim that the new drug
application (NDA) for LYNPARZA (NDA 206162) was initially submitted on
February 3, 2014.
    3. The date the application was approved: December 19, 2014. FDA
has verified the applicant's claim that NDA 206162 was approved on
December 19, 2014.
    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 application for patent extension,
this applicant seeks 1,275 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. 2018-02591 Filed 2-8-18; 8:45 am]
 BILLING CODE 4164-01-P