[Federal Register Volume 80, Number 156 (Thursday, August 13, 2015)]
[Notices]
[Page 48517]
[FR Doc No: 2015-19895]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL15-88-000]

Indicated Market Participants v. PJM Interconnection, L.L.C.;
Notice of Complaint

    Take notice that on August 6, 2015, pursuant to sections 206 and
306 of the Federal Power Act, 16 U.S.C. 824(e) and 825(e) and section
206 of the Federal Energy Regulatory Commission's (Commission) Rules of
Practice and Procedure, 18 CFR 385.206, Indicated Market Participants
(Complainant), filed a formal complaint against PJM Interconnection,
L.L.C. (Respondent), alleging that the Respondent's Open Access
Transmission Tariff is unjust and unreasonable to the extent it does
not allow the Respondent to consider total system costs in clearing
sell offers in the Capacity Performance Resources Delivery Years 2016-
2018 and 2017/2018, as more fully explained in the complaint.
    The Complainant certifies that copies of the complaint were served
on the contacts for the Respondent as listed on the Commission's list
of Corporate Officials and Respondent's representatives of record in
Docket No. ER15-623.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). 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. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for electronic 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 email notification when a document is added to a subscribed
docket(s). For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on August 17, 2015.

    Dated: August 7, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-19895 Filed 8-12-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: January 28, 2010 (Volume 75, Number 18)]
[Notices]
[Page 4581]
[DOCID:fr28ja10-84]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1870-DR; Docket ID FEMA-2008-0018]

Alabama; Amendment No. 2 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Alabama (FEMA-1870-DR), dated December 31, 2009, and
related determinations.

DATES: Effective Date: January 14, 2010.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance
Directorate, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, W. Michael
Moore, of FEMA is appointed to act as the Federal Coordinating Officer
for this disaster.
    This action terminates the appointment of Michael Bolch as Federal
Coordinating Officer for this disaster.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2010-1703 Filed 1-27-10; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 84, Number 176 (Wednesday, September 11, 2019)]
[Rules and Regulations]
[Pages 47880-47882]
[FR Doc No: 2019-19647]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2019-0775]
RIN 1625-AA00

Safety Zone for Hurricane Dorian; Coast Guard Maryland-National
Capital Region Captain of the Port Zone

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary safety zone for
all navigable waters within the Coast Guard Maryland-National Capital
Region Captain of the Port Zone. The safety zone is needed to protect
personnel, vessels, and the marine environment from potential hazards
created by the possible landfall of Hurricane Dorian. Entry of vessels
or persons into this zone is prohibited unless specifically authorized
by the Captain of the Port Maryland-National Capital Region.

DATES: This rule is effective without actual notice from September 11,
2019 until 5 a.m. on September 12, 2019. For the purposes of
enforcement, actual notice will be used from 5 a.m. on September 6,
2019, until September 11, 2019.

ADDRESSES: To view documents mentioned in this preamble as being

available in the docket, go to https://www.regulations.gov, type USCG-
2019-0775 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Mr. Ron Houck, Sector Maryland-National Capital Region
Waterways Management Division, U.S. Coast Guard; telephone 410-576-
2674, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

COTP Captain of the Port
CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because it is impracticable and contrary to
the public interest. Immediate action is required by the Coast Guard
due to the potential safety hazards vessels in these waterways present
to life, property and the environment during a hurricane. We must
establish this safety zone by September 6, 2019, to ensure that the
rule is in place in advance of Hurricane Dorian.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be impracticable and contrary to the public interest
because immediate action is needed to restrict vessel traffic to
protect life, property and the environment and respond to the potential
safety hazards associated with the nature and path of Hurricane Dorian.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 (previously 33 U.S.C. 1231). Hurricane Dorian continues to track
toward the mid-Atlantic region, with a most probable path inclusive of
the Chesapeake Bay, Maryland. The COTP Maryland-National Capital Region
has determined that potential hazards associated with the destructive
force associated with a hurricane necessitates establishment of a
temporary safety zone to protect the safety of life and property on
navigable waters starting September 6, 2019, will be a safety concern
for anyone within the COTP Maryland-National Capital Region Zone. This
rule is needed to protect personnel, vessels, and the marine
environment in the navigable waters within the safety zone during the
weather event.

IV. Discussion of the Rule

    This rule establishes a safety zone from 5 a.m. on September 6,
2019, until 5 a.m. on September 12, 2019, unless sooner terminated by
the Captain of the Port Maryland-National Capital Region. The safety
zone will cover all navigable waters within the COTP Maryland-National
Capital Region Zone, as described in 33 CFR 3.25-15. The duration of
the zone is intended to protect personnel, vessels, and the marine
environment in these navigable waters due to the expected impact of
Hurricane Dorian. Except for vessels already at berth, mooring, or
anchor, all vessels underway within this safety zone at the time it is
implemented are to depart the zone. No vessel or person will be
permitted to enter the safety zone without obtaining permission from
the COTP or a designated representative. To seek permission to enter,
vessels and persons may contact the COTP or the COTP's representative
by telephone number<PHONE_NUMBER> or on Marine Band Radio VHF-FM channel
16 (156.8 MHz). Those in the safety zone must comply with all lawful
orders or directions given to them by the COTP or the COTP's designated
representative.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the duration of
the safety zone. The effect of this regulation will not be significant
due to the limited time that will be regulated (less than a week) and
that vessel traffic will be allowed to transit through the zone once
the hurricane has passed, when it has been determined safe to do so,
and with the permission of the COTP Maryland-National Capital Region.
Moreover, the Coast Guard will issue Broadcast Notice to Mariners via
VHF-FM marine channel 16 about the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Public Law 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The

Ombudsman evaluates these actions annually and rates each agency's
responsiveness to small business. If you wish to comment on actions by
employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The
Coast Guard will not retaliate against small entities that question or
complain about this rule or any policy or action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01 and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have
determined that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves a safety zone that will prohibit entry
within the COTP Maryland-National Capital Region Zone for six days, as
described in 33 CFR 3.25-15, due to the expected impact of Hurricane
Dorian. It is categorically excluded from further review under
paragraph L60(c) in Table 3-1 of U.S. Coast Guard Environmental
Planning Implementing Procedures 5090.1.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

0
2. Add Sec.  165.T05-0775 to read as follows:

Sec.  165.T05-0775  Safety Zone for Hurricane DORIAN; Coast Guard
Maryland-National Capital Region Captain of the Port Zone.

    (a) Location. The following area is a safety zone: All navigable
waters of the Coast Guard Captain of the Port Maryland-National Capital
Region Zone, as described in 33 CFR 3.25-1.
    (b) Definitions. As used in this section--
    Captain of the Port Maryland-National Capital Region means the
Commander, U.S. Coast Guard Sector Maryland-National Capital Region.
    Designated representative means any Coast Guard commissioned,
warrant, or petty officer who has been authorized by the Captain of the
Port Maryland-National Capital Region (COTP) to assist in the
enforcement of the safety zone.
    (c) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, you may not enter the safety zone described in
paragraph (a) of this section unless authorized by the COTP or the
COTP's designated representative. All vessels entering the safety zone
may be boarded and examined by the Coast Guard under existing
regulations, prior to entry, to ensure compliance with the general
safety zone regulations.
    (2) Except for vessels already at berth, mooring, or anchor, all
vessels underway within this safety zone on September 6, 2019, are to
depart the zone.
    (3) To seek permission to enter, contact the COTP or the COTP's
representative by telephone number<PHONE_NUMBER> or on Marine Band Radio
VHF-FM channel 16 (156.8 MHz). Those in the safety zone must comply
with all lawful orders or directions given to them by the COTP or the
COTP's designated representative.
    (4) The Coast Guard vessels enforcing this section can be contacted
on Marine Band Radio VHF-FM channel 16 (156.8 MHz). Upon being hailed
by a U.S. Coast Guard vessel, or other Federal, State, or local agency
vessel, by siren, radio, flashing light, or other means, the operator
of a vessel shall proceed as directed.
    (5) The U.S. Coast Guard may be assisted in the patrol and
enforcement of the zone by Federal, State, and local agencies.

    Dated: September 5, 2019.
Joseph B. Loring,
Captain, U.S. Coast Guard, Captain of the Port Maryland-National
Capital Region.
[FR Doc. 2019-19647 Filed 9-10-19; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 85, Number 15 (Thursday, January 23, 2020)]
[Notices]
[Pages 3934-3935]
[FR Doc No: 2020-01084]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1393]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Patent Term
Restoration; Due Diligence Petitions; Filing, Format, and Content of
Petitions

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
February 24, 2020.

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 0910-0233.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, 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.

Patent Term Restoration; Due Diligence Petitions; Filing, Format, and
Content of Petitions 21 CFR Part 60

OMB Control Number 0910-0233--Extension

    This information collection supports Agency regulations. FDA's
patent extension activities are conducted under the authority of the
Drug Price Competition and Patent Term Restoration Act of 1984 (21
U.S.C. 355(j)) and the Generic Animal Drug and Patent Term Restoration
Act of 1988 (35 U.S.C. 156). New human drug, animal drug, human
biological, medical device, food additive, or color additive products
regulated by FDA must undergo FDA safety, or safety and effectiveness
review before marketing is permitted. If the product is covered by a
patent, part of the patent's term may be consumed during this review,
which diminishes the value of the patent.
    In enacting the Drug Price Competition and Patent Term Restoration
Act of 1984 and the Generic Animal Drug and Patent Term Restoration Act
of 1988, Congress sought to encourage development of new, safer, and
more effective medical and food additive products. It did so by
authorizing the U.S. Patent and Trademark Office (USPTO) to extend the
patent term by a portion of the time during which FDA's safety and
effectiveness review prevented marketing of the product. The length of
the patent term extension is generally limited to a maximum of 5 years
and is calculated by USPTO based on a statutory formula. When a patent
holder submits an application for patent term extension to USPTO, USPTO
requests information from FDA, including the length of the regulatory
review period for the patented product. If USPTO concludes that the
product is eligible for patent term extension, FDA publishes a notice
that describes the length of the regulatory review period and the dates
used to calculate that period. Interested parties may request, under
Sec.  60.24 (21 CFR 60.24), revision of the length of the regulatory
review period, or may petition under Sec.  60.30 (21 CFR 60.30) to
reduce the regulatory review period by any time where marketing
approval was not pursued with ``due diligence.''
    The statute (21 CFR 60.36) defines due diligence as ``that degree
of attention, continuous directed effort, and timeliness as may
reasonably be expected from, and are ordinarily exercised by, a person
during a regulatory review period.'' As provided in Sec.  60.30(c), a
due diligence petition ``shall set forth sufficient facts, including
dates if possible, to merit an investigation by FDA of whether the
applicant acted with due diligence.'' Upon receipt of a due diligence
petition, FDA reviews the petition and evaluates whether any change in
the regulatory review period is necessary. If so, the corrected
regulatory review period is published in the Federal Register. A due
diligence petition not satisfied with FDA's decision regarding the
petition may, under Sec.  60.40 (21 CFR 60.40), request an informal
hearing for reconsideration of the due diligence determination.
Petitioners are likely to include persons or organizations having
knowledge that FDA's marketing permission for that product was not
actively pursued throughout the regulatory review period. The
information collection for which an extension of approval is being
sought is the use of the statutorily created due diligence petition.
    During the calendar years 2016 through 2018, 16 requests for
revision of the regulatory review period were submitted under Sec.
60.24(a). In addition, a total of three due diligence petitions were
submitted under Sec.  60.30. There have been no requests for hearings
under Sec.  60.40; however, for purposes of this information collection
approval, we estimate that we may receive one submission annually.
    In the Federal Register of August 21, 2019 (84 FR 43606), we
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 Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Number of         Total          Average                         Average
         21 CFR part 60--Patent term restoration             Number of     responses per     responses      burden per      Total hours    annual burden
                                                            respondents     respondent      (2016-2018)      response       (2016-2018)        hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
60.24; revision of regulatory review period                           12           1.333              16             100           1,600          533.33
 determinations.........................................
60.30; due diligence petitions..........................               1               1               3              50             150              50
60.40; due diligence hearings...........................               1               1               1              10              10             3.3
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............  ..............          586.63
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    Our estimated burden for the information collection reflects a
small increase (+7 responses) associated with submissions received
under Sec.  60.24 in previous years.

    Dated: January 16, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-01084 Filed 1-22-20; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 214 (Thursday, November 5, 2015)]
[Notices]
[Pages 68525-68526]
[FR Doc No: 2015-28202]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Revised Restricted Service List for a Programmatic
Agreement for Managing Properties Included in or Eligible for Inclusion
in the National Register of Historic Places

Beverly Lock and Dam Water Power.  Project No. 13404-002
Devola Lock and Dam Water Power    Project No. 13405-002
 Project.
Malta/McConnelsville Lock and Dam  Project No. 13406-002
 Water Power Project.
Lowell Lock and Dam Water Power    Project No. 13407-002
 Project.
Philo Lock and Dam Water Power     Project No. 13408-002
 Project.
Rokeby Lock and Dam Water Power    Project No. 13411-002
 Project.

    On September 10, 2015, the Federal Energy Regulatory Commission
(Commission) issued notice of a proposed restricted service list for
the preparation of a programmatic agreement for managing properties
included in, or eligible for inclusion in, the National Register of
Historic Places at each of the following proposed projects: (1) Beverly
Lock & Dam Water Power Project No. 13404; (2) Devola Lock & Dam Water
Power Project No. 13405; (3) Malta Lock & Dam Water Power Project No.
13406; (4) Lowell Lock & Dam Water Power Project No. 13407; (5) Philo
Lock & Dam Water Power Project No. 13408; (6) and Rokeby Lock & Dam
Water Power Project No. 13411. Rule 2010(d)(1) of the Commission's
Rules of Practice and Procedure, 18 CFR 385.2010(d)(1) (2014), provides
for the establishment of such a list for a particular phase or issue in
a proceeding to eliminate unnecessary expense or improve administrative
efficiency. Under Rule 385.2010(d)(4), persons on the official service
list are to be given notice of any proposal to establish a restricted
service list and an opportunity to show why they should also be
included on the restricted service list or why a restricted service
list should not be established.
    On October 29, 2015, Valincia Darby, Regional Environmental
Protection Assistant for the Department of the Interior, requested to
be added to the restricted service list and be included as a consulting
party in the section 106 of

the National Historic Preservation Act consultation process so that she
may stay apprised and provide project input.
    Under Rule 385.2010(d)(2), any restricted service list will contain
the names of each person on the official service list, or the person's
representative, who, in the judgment of the decisional authority
establishing the list, is an active participant with respect to the
phase or issue in the proceeding for which the list is established.
Valincia Darby has identified an interest in issues relating to the
management of historic properties at the Beverly Lock and Dam Water
Power Project, Devola Lock and Dam Water Power Project, Malta/
McConnelsville Lock and Dam Water Power Project, Lowell Lock and Dam
Water Power Project, Philo Lock and Dam Water Power Project, and Rokeby
Lock and Dam Water Power Project. Therefore, she and her
representatives will be added to the restrictive service list.
    Accordingly, the restricted service list issued on September 10,
2015, for Projects Nos. 13404, 13405, 12406, 13407, 13408, and 13411 is
revised to add the following person: Valincia Darby or representative,
Regional Environmental Protection Assistant, Department of the
Interior, OEPC, 200 Chestnut Street, Rm 244, Philadelphia, PA 19106.

    Dated: October 30, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-28202 Filed 11-4-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 57 (Friday, March 23, 2018)]
[Notices]
[Page 12753]
[FR Doc No: 2018-05970]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[FRL-9975-26--Region 6]

Clean Air Act Operating Permit Program; Petitions for Objection
to State Operating Permit for ExxonMobil Corporation, ExxonMobil
Baytown Olefins Plant, Harris County, Texas

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of final Order on Petition for objection to Clean Air
Act title V operating permit.

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

SUMMARY: The Environmental Protection Agency (EPA) Administrator signed
an Order dated March 1, 2018, denying a Petition dated August 8, 2016
from the Environmental Integrity Project, Sierra Club, and Air Alliance
Houston. The Petition requested that the EPA object to a Clean Air Act
(CAA) title V operating permit issued by the Texas Commission on
Environmental Quality (TCEQ) to ExxonMobil Corporation (ExxonMobil) for
its Baytown Olefins Plant located in Harris County, Texas.

ADDRESSES: The EPA requests that you contact the individual listed in
the FOR FURTHER INFORMATION CONTACT section to view copies of the final
Order, the Petition, and other supporting information. You may review
copies of the final Order, the Petition, and other supporting
information at the EPA Region 6 Office, 1445 Ross Avenue, Dallas, Texas
75202-2733. You may view the hard copies Monday through Friday, from 9
a.m. to 3 p.m., excluding federal holidays. If you wish to examine
these documents, you should make an appointment at least 24 hours
before the visiting day. Additionally, the final Order and Petition are
available electronically at: https://www.epa.gov/title-v-operating-permits/title-v-petition-database.

FOR FURTHER INFORMATION CONTACT: Aimee Wilson, EPA Region 6, (214) 665-
7596, [email protected].

SUPPLEMENTARY INFORMATION: The CAA affords EPA a 45-day period to
review and object to, as appropriate, operating permits proposed by
state permitting authorities under title V of the CAA. Section
505(b)(2) of the CAA authorizes any person to petition the EPA
Administrator to object to a title V operating permit within 60 days
after the expiration of the EPA's 45-day review period if the EPA has
not objected on its own initiative. Petitions must be based only on
objections to the permit that were raised with reasonable specificity
during the public comment period provided by the state, unless the
petitioner demonstrates that it was impracticable to raise these issues
during the comment period or unless the grounds for the issue arose
after this period.
    The EPA received the Petition from the Environmental Integrity
Project, Sierra Club, and Air Alliance Houston dated August 8, 2016,
requesting that the EPA object to the issuance of operating permit no.
O1553, issued by TCEQ to ExxonMobil Baytown Olefins Plant in Harris
County, Texas. The Petition claims that: (1) TCEQ did not have the
authority to create a federally-enforceable PAL permit at the time PAL6
was issued, (2) the PAL6 permit is not federally enforceable because of
alleged defects with how TCEQ calculated the facility's baseline
emissions, and (3) PAL6 does not establish a PAL for PM2.5.
    On March 1, 2018, the EPA Administrator issued an Order denying the
Petition. The Order explains the basis for EPA's decision.
    Sections 307(b) and 505(b)(2) of the CAA provide that a petitioner
may request judicial review of those portions of an order that deny
issues in a petition. Any petition for review shall be filed in the
United States Court of Appeals for the appropriate circuit no later
than May 22, 2018.

    Dated: March 16, 2018.
Anne Idsal,
Regional Administrator, Region 6.
[FR Doc. 2018-05970 Filed 3-22-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 243 (Wednesday, December 18, 2013)]
[Notices]
[Pages 76704-76705]
[FR Doc No: 2013-29946]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2005-22194; FMCSA-2007-0017]

Qualification of Drivers; Exemption Applications; Vision

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

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

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

SUMMARY: FMCSA announces its decision to renew the exemptions from the
vision requirement in the Federal Motor Carrier Safety Regulations for
16 individuals. FMCSA has statutory authority to exempt individuals
from the vision requirement if the exemptions granted will not
compromise safety. The Agency has concluded that granting these
exemption renewals will provide a level of safety that is equivalent to
or greater than the level of safety maintained without the exemptions
for these commercial motor vehicle (CMV) drivers.

DATES: This decision is effective January 8, 2014. Comments must be
received on or before January 17, 2014.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) numbers: Docket No. [Docket No. FMCSA-2005-
22194; FMCSA-2007-0017], 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 or Courier: 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 number for this notice. Note that DOT posts all comments
received without change to http://www.regulations.gov, including any
personal information included in a comment. Please see the Privacy Act
heading below.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The Federal Docket Management System (FDMS) is
available 24 hours each day, 365 days each year. If you want
acknowledgment that we received your comments, please include a self-
addressed, stamped envelope or postcard or print the acknowledgement
page that appears after submitting comments on-line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review DOT's Privacy Act Statement for the Federal Docket
Management System (FDMS) published in the Federal Register on January
17, 2008 (73 FR 3316).

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

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may renew an exemption
from the vision requirements in 49 CFR 391.41(b)(10), which applies to
drivers of CMVs in interstate commerce, for a two-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 procedures for requesting an exemption (including
renewals) are set out in 49 CFR part 381.

Exemption Decision

    This notice addresses 16 individuals who have requested renewal of
their exemptions in accordance with FMCSA procedures. FMCSA has
evaluated these 16 applications for renewal on their merits and decided
to extend each exemption for a renewable two-year period. They are:

Garry A. Baker (OH)
Richard D. Becotte (NH)
Wayne A. Burnett (NC)
Alex G. Dlugolenski (CT)
Clinton D. Edwards (NE)
Jimmy D. Gregory (AR)
Boleslaw Makowsi (WI)
Joseph W. Meacham (LA)
Charles M. Moore (TX)
Gary T. Murray (GA)
Anthony D. Ovitt (VT)
John R. Parsons, III (VA)
Martin Postma (IL)
Steven S. Reinsvold (WI)
George E. Todd (WV)
Bradley A. Weiser (OH)

    The exemptions are extended subject to the following conditions:
(1) That each individual has a physical examination every year (a) by
an ophthalmologist or optometrist who attests that the vision in the
better eye continues to meet the requirements in 49 CFR 391.41(b)(10),
and (b) by a medical examiner who attests that the individual is
otherwise physically qualified under 49 CFR 391.41; (2) that each
individual provides a copy of the ophthalmologist's or optometrist's
report to the medical examiner at the time of the annual medical
examination; and (3) that each individual provide a copy of the annual
medical certification to the employer for retention in the driver's
qualification file and retains a copy of the certification on his/her
person while driving for presentation to a duly authorized Federal,
State, or local enforcement official. Each exemption will be valid for
two years unless rescinded earlier by FMCSA. The exemption will be
rescinded if: (1) the person fails to comply with the terms and
conditions of the exemption; (2) the exemption has resulted in a lower
level of safety than was maintained before it was granted; or (3)
continuation of the exemption would not be consistent with the goals
and objectives of 49 U.S.C. 31136(e) and 31315.

Basis for Renewing Exemptions

    Under 49 U.S.C. 31315(b)(1), an exemption may be granted for no
longer than two years from its approval date and may be renewed upon
application for additional two year periods. In accordance with 49
U.S.C. 31136(e) and 31315, each of the 16 applicants has satisfied the
entry conditions for obtaining an exemption from the vision
requirements (70 FR 57353; 70 FR 72689; 72 FR 62897; 72 FR 67340; 73 FR
1395; 74 FR 60021; 74 FR 65845; 76 FR 70210; 76 FR 78728). Each of
these 16 applicants has requested renewal of the

exemption and has submitted evidence showing that the vision in the
better eye continues to meet the requirement specified at 49 CFR
391.41(b)(10) and that the vision impairment is stable. In addition, a
review of each record of safety while driving with the respective
vision deficiencies over the past two years indicates each applicant
continues to meet the vision exemption requirements.
    These factors provide an adequate basis for predicting each
driver's ability to continue to drive safely in interstate commerce.
Therefore, FMCSA concludes that extending the exemption for each
renewal applicant for a period of two years is likely to achieve a
level of safety equal to that existing without the exemption.

Request for Comments

    FMCSA will review comments received at any time concerning a
particular driver's safety record and determine if the continuation of
the exemption is consistent with the requirements at 49 U.S.C. 31136(e)
and 31315. However, FMCSA requests that interested parties with
specific data concerning the safety records of these drivers submit
comments by January 17, 2014.
    FMCSA believes that the requirements for a renewal of an exemption
under 49 U.S.C. 31136(e) and 31315 can be satisfied by initially
granting the renewal and then requesting and evaluating, if needed,
subsequent comments submitted by interested parties. As indicated
above, the Agency previously published notices of final disposition
announcing its decision to exempt these 16 individuals from the vision
requirement in 49 CFR 391.41(b)(10). The final decision to grant an
exemption to each of these individuals was made on the merits of each
case and made only after careful consideration of the comments received
to its notices of applications. The notices of applications stated in
detail the qualifications, experience, and medical condition of each
applicant for an exemption from the vision requirements. That
information is available by consulting the above cited Federal Register
publications.
    Interested parties or organizations possessing information that
would otherwise show that any, or all, of these drivers are not
currently achieving the statutory level of safety should immediately
notify FMCSA. The Agency will evaluate any adverse evidence submitted
and, if safety is being compromised or if continuation of the exemption
would not be consistent with the goals and objectives of 49 U.S.C.
31136(e) and 31315, FMCSA will take immediate steps to revoke the
exemption of a driver.

Submitting Comments

    You may submit your comments and material online or by fax, mail,
or hand delivery, but please use only one of these means. FMCSA
recommends that you include your name and a mailing address, an email
address, or a phone number in the body of your document so that FMCSA
can contact you if there are questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov and
in the search box insert the docket numbers FMCSA-2005-22194; FMCSA-
2007-0017 and click the search button. When the new screen appears,
click on the blue ``Comment Now!'' button on the right hand side of the
page. On the new page, enter information required including the
specific section of this document to which each comment applies, and
provide a reason for each suggestion or recommendation. If you submit
your comments by mail or hand delivery, submit them in an unbound
format, no larger than 8[frac12] by 11 inches, suitable for copying and
electronic filing. If you submit comments by mail and would like to
know that they reached the facility, please enclose a stamped, self-
addressed postcard or envelope.
    We will consider all comments and material received during the
comment period and may change this proposed exemption based on your
comments. FMCSA may issue a final rule at any time after the close of
the comment period.

Viewing Comments and Documents

    To view comments, as well as any documents mentioned in this
preamble, To submit your comment online, go to http://www.regulations.gov and in the search box insert the docket number
FMCSA-2005-22194; FMCSA-2007-0017 and click ``Search.'' Next, click
``Open Docket Folder'' and you will find all documents and comments
related to the proposed exemption.

    Issued on: December 3, 2013.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2013-29946 Filed 12-17-13; 8:45 a.m.]
BILLING CODE 4910-EX-P


[Federal Register Volume 87, Number 156 (Monday, August 15, 2022)]
[Notices]
[Pages 50077-50078]
[FR Doc No: 2022-17488]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC22-99-000.
    Applicants: Energywell Think Holdings, LLC, ENGIE Retail, LLC.
    Description: Joint Application for Authorization Under Section 203
of the Federal Power Act of ENGIE Retail, LLC, et al.
    Filed Date: 8/8/22.
    Accession Number: 20220808-5191.
    Comment Date: 5 p.m. ET 8/29/22.

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG22-201-000.
    Applicants: Chaparral Springs, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Chaparral Springs, LLC.
    Filed Date: 8/8/22.
    Accession Number: 20220808-5149.
    Comment Date: 5 p.m. ET 8/29/22.

    Take notice that the Commission received the following Complaints
and Compliance filings in EL Dockets:

    Docket Numbers: EL22-83-000.
    Applicants: Invenergy Transmission LLC v. Midcontinent Independent
System Operator, Inc.
    Description: Complaint of Invenergy Transmission LLC vs.
Midcontinent Independent System Operator, Inc.
    Filed Date: 8/8/22.
    Accession Number: 20220808-5195.
    Comment Date: 5 p.m. ET 9/7/22.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER22-1679-000.
    Applicants: Google Energy LLC.
    Description: Second Supplement to April 22, 2022 Google Energy LLC
tariff filing.
    Filed Date: 8/8/22.
    Accession Number: 20220808-5187.
    Comment Date: 5 p.m. ET 8/29/22.

    Docket Numbers: ER22-2085-000.
    Applicants: Bear Ridge Solar LLC.
    Description: Bear Ridge Solar LLC Submits Supplemental Information
to its June 8, 2022 Request for Limited Relief from the Regulatory
Milestone Requirement of the NYISO's OATT.
    Filed Date: 8/3/22.
    Accession Number: 20220803-5156.
    Comment Date: 5 p.m. ET 8/24/22.

    Docket Numbers: ER22-2247-001.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Tariff Amendment: 2022-08-09_SA 3332 SIGE-Grandview
Solar Sub 1st Rev GIA (J783) to be effective 6/16/2022.
    Filed Date: 8/9/22.
    Accession Number: 20220809-5083.
    Comment Date: 5 p.m. ET 8/30/22.

    Docket Numbers: ER22-2623-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Tariff Amendment: Notice of Cancellation of ISA, SA
No. 5461 and ICSA SA No. 5462 to be effective 8/6/2022.
    Filed Date: 8/9/22.
    Accession Number: 20220809-5031.
    Comment Date: 5 p.m. ET 8/30/22.

    Docket Numbers: ER22-2624-000.
    Applicants: Middletown Coke Company, LLC.
    Description: Sec.  205(d) Rate Filing: Norma filing 2022 to be
effective 10/1/2022.
    Filed Date: 8/9/22.
    Accession Number: 20220809-5037.
    Comment Date: 5 p.m. ET 8/30/22.

    Docket Numbers: ER22-2625-000.
    Applicants: Basin Electric Power Cooperative.
    Description: Tariff Amendment: Basin Electric Notice of
Cancellation of

Service Agreement Nos. 48 & 49 to be effective 8/5/2022.
    Filed Date: 8/9/22.
    Accession Number: 20220809-5054.
    Comment Date: 5 p.m. ET 8/30/22.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: August 9, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-17488 Filed 8-12-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 143 (Thursday, July 27, 2017)]
[Notices]
[Pages 35001-35002]
[FR Doc No: 2017-15779]

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

SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-094; OMB Control No. 3235-0085]

Submission for OMB Review; 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 17a-11

    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'') has submitted to the Office of Management and Budget a
request for approval of extension of the previously approved collection
of information provided for in Rule 17a-11 (17 CFR 240.17a-11) under
the Securities Exchange Act of 1934 (15 U.S.C. 78a et seq.) (``Exchange
Act'').
    In response to an operational crisis in the securities industry
between 1967 and 1970, the Commission adopted Rule 17a-11 under the
Exchange Act on July 11, 1971. Rule 17a-11 requires broker-dealers that
are experiencing financial or operational difficulties to provide
notice to the Commission, the broker-dealer's designated examining
authority (``DEA''), and the Commodity Futures Trading Commission
(``CFTC'') if the broker-dealer is registered with the CFTC as a
futures commission merchant. Rule 17a-11 is an integral part of the
Commission's financial responsibility program which enables the
Commission, a broker-dealer's DEA, and the CFTC to increase
surveillance of a broker-dealer experiencing difficulties and to obtain
any additional information necessary to gauge the broker-dealer's
financial or operational condition.
    Rule 17a-11 also requires over-the-counter (``OTC'') derivatives
dealers and broker-dealers that are permitted to compute net capital
pursuant to Appendix E to Exchange Act Rule 15c3-1 to notify the
Commission when their tentative net capital drops below certain levels.

    To ensure the provision of these types of notices to the
Commission, Rule 17a-11 requires every national securities exchange or
national securities association to notify the Commission when it learns
that a member broker-dealer has failed to send a notice or transmit a
report required under the Rule.
    Compliance with the Rule is mandatory. The Commission will
generally not publish or make available to any person notices or
reports received pursuant to Rule 17a-11. The Commission believes that
information obtained under Rule 17a-11 relates to a condition report
prepared for the use of the Commission, other federal governmental
authorities, and securities industry self-regulatory organizations
responsible for the regulation or supervision of financial
institutions.
    The Commission expects to receive 253 notices from broker-dealers
whose capital declines below certain specified levels or who are
otherwise experiencing financial or operational problems and ten
notices each year from national securities exchange or national
securities association notifying it that a member broker-dealer has
failed to send the Commission a notice or transmit a report required
under the Rule. The Commission expects that it will take approximately
one hour to prepare and transmit each notice.
    Rule 17a-11 also requires broker-dealers engaged in securities
lending or repurchase activities to either: (1) File a notice with the
Commission and their DEA whenever the total money payable against all
securities loaned, subject to a reverse repurchase agreement or the
contract value of all securities borrowed or subject to a repurchase
agreement, exceeds 2,500% of tentative net capital; or, alternatively,
(2) report monthly their securities lending and repurchase activities
to their DEA in a form acceptable to their DEA.
    The Commission estimates that, annually, six broker-dealers will
submit the monthly stock loan/borrow report. The Commission estimates
each firm will spend, on average, approximately one hour per month (or
twelve hours per year) of employee resources to prepare and send the
report or to prepare the information for the FOCUS report (as required
by the firm's DEA, if applicable). Therefore, the Commission estimates
the total annual reporting burden arising from this section of the
amendment will be approximately 72 hours.\1\
---------------------------------------------------------------------------

    \1\ 6 broker-dealers x 12 hours per year = 72 hours.
---------------------------------------------------------------------------

    Therefore, the total annual reporting burden associated with Rule
17a-11 is approximately 335 hours.\2\
---------------------------------------------------------------------------

    \2\ 253 + 10 + 72.
---------------------------------------------------------------------------

    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a current valid OMB control number.
    The public may view background documentation for this information
collection at the following Web site, www.reginfo.gov. Comments should
be directed to: (i) Desk Officer for the Securities and Exchange
Commission, Office of Information and Regulatory Affairs, Office of
Management and Budget, Room 10102, New Executive Office Building,
Washington, DC 20503 or by sending an email to:
<EMAIL_ADDRESS>and (ii) Pamela Dyson, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 100 F Street NE., Washington, DC 20549, or by sending an
email to<EMAIL_ADDRESS>Comments must be submitted to OMB within
30 days of this notice.

    Dated: July 21, 2017.
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-15779 Filed 7-26-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 44 (Monday, March 7, 2016)]
[Notices]
[Page 11788]
[FR Doc No: 2016-04958]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 3820-010]

General Electric Company, Aclara Meters LLC; Notice of
Application for Transfer of License and Soliciting Comments, Motions To
Intervene, and Protests

    On February 9, 2016, General Electric Company (transferor) and
Aclara Meters LLC (transferee) filed an application for transfer of
license of the Somersworth Project No. 3820. The project is located on
the Salmon Falls River in Stafford County, New Hampshire and York
County, Maine. The project does not occupy federal lands.
    The applicants seek Commission approval to transfer the license for
the Somersworth Project from the transferor to the transferee.
    Applicant Contact: For transferor: Ms. Lisa Price, General Manager,
Business Development, GE Energy Management, 401 Merritt 7--PH, Norwalk,
CT 06851-1000, Phone:<PHONE_NUMBER>, Email<EMAIL_ADDRESS>and John
H. Grady, Jones Day, 1420 Peachtree Street NE., Suite 800, Atlanta, GA
30309, Phone:<PHONE_NUMBER>, Email<EMAIL_ADDRESS>For
transferee: Mr. William ``Keith'' Beyea, Facilities Manager, Aclara
Meters LLC, 130 Main Street, Somersworth, NH 03878, Phone: 603-749-
8545, Email<EMAIL_ADDRESS>and Mr. M. Curtis Whittaker, Rath,
Young and Pignatelli, P.C., One Capital Plaza, Concord, NH 03301,
Phone:<PHONE_NUMBER>, Email<EMAIL_ADDRESS>    FERC Contact: Patricia W. Gillis,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    Deadline for filing comments, motions to intervene, and protests:
30 days from the date that the Commission issues this notice. The
Commission strongly encourages electronic filing. Please file comments,
motions to intervene, and protests using the Commission's eFiling
system at 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>(866) 208-3676 (toll free), or
(202) 502-8659 (TTY). In lieu of electronic filing, please send a paper
copy to: Secretary, Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426. The first page of any filing should
include docket number P-3820-010.

    Dated: February 24, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-04958 Filed 3-4-16; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 236 (Monday, December 13, 2021)]
[Notices]
[Pages 70846-70847]
[FR Doc No: 2021-26891]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-1285]

Oncologic Drugs Advisory Committee; Notice of Meeting;
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Oncologic Drugs Advisory
Committee. The general function of the committee is to provide advice
and recommendations to FDA on regulatory issues. The meeting will be
open to the public. FDA is establishing a docket for public comment on
this document.

DATES: The meeting will be held virtually on February 10, 2022, from 10
a.m. to 3 p.m. Eastern Time.

ADDRESSES: Please note that due to the impact of this COVID-19
pandemic, all meeting participants will be joining this advisory
committee meeting via an online teleconferencing platform. Answers to
commonly asked questions about FDA advisory committee meetings may be
accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2021-N-1285. The docket will close on February
9, 2022. Submit either electronic or written comments on this public
meeting by February 9, 2022. Please note that late, untimely filed
comments will not be considered. Electronic comments must be submitted
on or before February 9, 2022. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of February 9, 2022. 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.
    Comments received on or before January 27, 2022, will be provided
to the committee. Comments received after that date will be taken into
consideration by FDA. In the event that the meeting is cancelled, FDA
will continue to evaluate any relevant applications or information, and
consider any comments submitted to the docket, as appropriate.
    You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2021-N-1285 for ``Oncologic Drugs Advisory Committee; Notice of
Meeting; Establishment of a Public Docket; Request for Comments.''
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,<PHONE_NUMBER>.
     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.'' FDA 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 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 the information as ``confidential.'' Any information
marked as ``confidential'' will not be disclosed except in accordance
with 21 CFR 10.20 and other applicable disclosure law. For more
information about FDA's posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/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,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: LaToya Bonner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-2855, Fax:<PHONE_NUMBER>, [email protected], or FDA Advisory
Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in the
Washington, DC area). A notice in the Federal Register about last
minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the FDA's website at
https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to
the appropriate advisory committee meeting link, or call the advisory
committee information line to learn about possible modifications before
coming to the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: The meeting presentations will be heard, viewed, captioned,
and recorded through an online teleconferencing platform. The committee
will discuss biologics license application 761222, for sintilimab
injection, submitted by Innovent Biologics (Suzhou) Co., Ltd. The
proposed indication (use) for this product is in combination with
pemetrexed and platinum-based chemotherapy for the first-line treatment
of patients with Stage IIIB, IIIC, or Stage IV non-squamous non-small
cell lung cancer with no epidermal growth factor receptor or anaplastic
lymphoma kinase genomic tumor aberrations.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available on FDA's website at
the time of the advisory committee meeting. Background material and the
link to the online teleconference meeting room will be available at
https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll
down to the appropriate advisory committee meeting link. The meeting
will include slide presentations with audio components to allow the
presentation of materials in a manner that most closely resembles an
in-person advisory committee meeting.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
All electronic and written submissions submitted to the Docket (see
ADDRESSES) on or before January 27, 2022, will be provided to the
committee. Oral presentations from the public will be scheduled between
approximately 1 p.m. to 2 p.m. Eastern Time. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time
requested to make their presentation on or before January 19, 2022.
Time allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by January 20, 2022.
    For press inquiries, please contact the Office of Media Affairs at
[email protected] or<PHONE_NUMBER>.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact LaToya Bonner (see FOR FURTHER INFORMATION CONTACT) at least 7
days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: December 7, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26891 Filed 12-10-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 12 (Thursday, January 21, 2021)]
[Notices]
[Pages 6343-6344]
[FR Doc No: 2021-01125]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Requests for Proposals for Insulin Reimportation and Personal
Prescription Drug Importation

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

ACTION: Notice; requests for proposals.

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

SUMMARY: On September 24, 2020, the Department issued two requests for
proposals for the reimportation of insulin and the personal importation
of prescription drugs on its website. The Department is issuing this
Notice to include a revised version of the September 24, 2020 proposals
in the Federal Register.

DATES: Proposals submitted in response to the requests for proposals
shall be accepted and reviewed on a rolling basis, and until further
notice.

ADDRESSES: Responses to the requests for proposals should be submitted
to<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Nick Uehlecke, 200 Independence Ave
SW, Washington, DC 20201; or by email at<EMAIL_ADDRESS>or by
telephone at 1-877-696-6775.

SUPPLEMENTARY INFORMATION: On September 24, 2020, the Department issued
two requests for proposals for the reimportation of insulin and the
personal importation of prescription drugs on its website. The
proposals were issued consistent with FDA's authorities under sections
801 and 804 of the Food, Drug, and Cosmetic Act, 21 U.S.C. 381, 384.
The Department is issuing this Notice to include revised versions of
these proposals in the Federal Register.

    Dated: January 13, 2021.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-01125 Filed 1-19-21; 8:45 am]
BILLING CODE 4150-26-P


[Federal Register Volume 80, Number 118 (Friday, June 19, 2015)]
[Notices]
[Pages 35366-35367]
[FR Doc No: 2015-15076]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1434]

Size, Shape, and Other Physical Attributes of Generic Tablets and
Capsules; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Size, Shape, and
Other Physical Attributes of Generic Tablets and Capsules.'' This
guidance discusses FDA recommendations for the size, shape, and other
physical attributes of generic tablets and capsules intended to be
swallowed intact. FDA is concerned that differences in these physical
characteristics between generic drugs and the originator drug could
affect patient outcomes.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Debra Catterson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or Vilayat
Sayeed, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
240-402-9077.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Size, Shape, and Other Physical Attributes of Generic
Tablets and Capsules.'' FDA is concerned that the differences in size,
shape, and other physical characteristics between a generic drug and
the originator drug may affect patient compliance and acceptability of
medication regimens or could lead to medication errors. For example,
studies show that tablet size and shape can affect ease of swallowing;
generic tablets that are significantly larger than their corresponding
reference drug product may be more difficult to swallow, leading to
potential adverse events as well as noncompliance with treatment
regimens. FDA is recommending that generic manufacturers consider the
size, shape, and other physical characteristics of the originator drug
when developing a generic version.
    In the Federal Register of December 10, 2013 (78 FR 74154), this
guidance was published as a draft guidance. We have carefully reviewed
and considered the comments that were received on the draft guidance
and have made editorial changes primarily for clarification.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on the size, shape, and other physical
attributes of generic tablets and capsules. It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collection of information requested in the guidance is covered under
FDA regulations at 21 CFR part 314 and approved under OMB control
number 0910-0001.

III. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: June 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-15076 Filed 6-18-15; 8:45 am]
BILLING CODE 4164-01-P