[Federal Register Volume 81, Number 40 (Tuesday, March 1, 2016)]
[Notices]
[Pages 10632-10633]
[FR Doc No: 2016-04372]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0811]

Enforcement Policy Regarding Investigational New Drug
Requirements for Use of Fecal Microbiota for Transplantation To Treat
Clostridium difficile Infection Not Responsive to Standard Therapies;
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft document entitled ``Enforcement Policy
Regarding Investigational New Drug Requirements for Use of Fecal
Microbiota for Transplantation to Treat Clostridium difficile Infection
Not Responsive to Standard Therapies; Draft Guidance for Industry.''
The draft guidance document provides members of the medical and
scientific community and other interested persons with notice that,
when finalized, we intend to exercise enforcement discretion under
limited conditions, regarding the investigational new drug (IND)
requirements for the use of fecal microbiota for transplantation (FMT)
to treat C. difficile infection not responding to standard therapies.
The draft guidance replaces the draft guidance of the same title dated
March 2014 and, when finalized, is intended to supersede the document
of the same title, dated July 2013.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by May 31, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2013-D-0811 for ``Enforcement Policy Regarding Investigational New
Drug Requirements for Use of Fecal Microbiota for Transplantation to
Treat Clostridium difficile Infection Not Responsive to Standard
Therapies.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at http://www.regulations.gov or at the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies, total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments, and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments

received, go to http://www.regulations.gov and insert the docket
number, found in brackets in the heading of this document, into the
``Search'' box and follow the prompts, and/or go to the Division of
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to
the Office of Communication, Outreach and Development, Center for
Biologics Evaluation and Research (CBER), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist the office in
processing your requests. The draft guidance may also be obtained by
mail by calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.

FOR FURTHER INFORMATION CONTACT: Gretchen Opper, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft document entitled
``Enforcement Policy Regarding Investigational New Drug Requirements
for Use of Fecal Microbiota for Transplantation to Treat Clostridium
difficile Infection Not Responsive to Standard Therapies.'' The draft
guidance document provides members of the medical and scientific
community and other interested persons with notice that, when
finalized, we intend to exercise enforcement discretion under limited
conditions, regarding the IND requirements for the use of FMT to treat
C. difficile infection not responding to standard therapies. FDA
intends to exercise this discretion, provided that: (1) The licensed
health care provider treating the patient obtains adequate consent from
the patient or his or her legally authorized representative for the use
of FMT products. The consent should include, at a minimum, a statement
that the use of FMT products to treat C. difficile is investigational
and a discussion of its reasonably foreseeable risks; (2) the FMT
product is not obtained from a stool bank; and (3) the stool donor and
stool are qualified by screening and testing performed under the
direction of the licensed health care provider for the purpose of
providing the FMT product for treatment of the patient.
    FDA has developed this policy to assure that patients with C.
difficile infection not responding to standard therapies may have
access to this treatment, while addressing and controlling the risks
that centralized manufacturing in stool banks presents to subjects. FDA
intends for this to be an interim policy, while the Agency develops a
comprehensive approach for the study and use of FMT products under IND.
    A stool bank is defined, for the purpose of this guidance, as an
establishment that collects, prepares, and stores FMT product for
distribution to other establishments, health care providers, or other
entities for use in patient therapy or clinical research. An
establishment that collects or prepares FMT products solely under the
direction of licensed health care providers for the purpose of treating
their patients (e.g., a hospital laboratory) is not considered to be a
stool bank under this guidance.
    In the draft guidance, FDA provides that the stool bank sponsor may
request a waiver of certain IND regulations relating to the obligations
of investigators and subinvestigators (e.g., certain sections of the
Statement of Investigator Form FDA 1572 that may not be applicable to
FMT provided to the health care provider to treat their patients) (21
CFR 312.10). FDA is requesting comments on which IND regulations are
appropriate to waive. In particular, FDA is requesting comments on the
requirement for institutional review board review of the use of FMT to
treat patients with C. difficile infection not responding to standard
therapies when the FMT is provided by a stool bank (21 CFR
312.23(a)(1)(iv) and 21 CFR 312.66).
    In the draft guidance, FDA proposes a revised policy with regard to
patient access to FMT. The provision that the donor be known either to
the patient or to the treating licensed health care provider, a concept
that was used in the March 2014 draft guidance, was subject to
difficulties in interpretation, and the revised approach more
accurately reflects our intent to mitigate risk, based on the number of
patients exposed to a particular donor or manufacturing practice rather
than the risk inherent from any one donor. Although FDA acknowledges
that directed donations present different risks than stool bank
donations, the number of persons exposed through a directed donation
will be limited. FDA also requests comments on this revised policy. The
draft guidance replaces the draft guidance of the same title, dated
March 2014 and, when finalized, is intended to supersede the document
of the same title, dated July 2013.
    The draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Enforcement
Policy Regarding Investigational New Drug Requirements for Use of Fecal
Microbiota for Transplantation to Treat Clostridium difficile Infection
Not Responsive to Standard Therapies.'' 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

    The draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 312 have been approved under
OMB control number 0910-0014. The collections of information in 21 CFR
part 50 have been approved under OMB control number 0910-0755.

III. Electronic Access

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

    Dated: February 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04372 Filed 2-29-16; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 225 (Friday, November 24, 2023)]
[Rules and Regulations]
[Pages 82255-82257]
[FR Doc No: 2023-25849]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 73

[Docket No. FAA-2023-2041; Airspace Docket No. 23-ASO-30]
RIN 2120-AA66

Renaming of Restricted Areas R-3002A, R-3002B, R-3002C, R-3002D,
R-3002E, R-3002F, and R-3002G; Fort Benning, GA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action is an administrative change to rename restricted
areas R-3002A, R-3002B, R-3002C, R-3002D, R-3002E, R-3002F, and R-
3002G; Fort Benning, GA, and to update the using agency description to
reflect the change. This action partially implements recommendations of
the Commission on the Naming of Items (Naming Commission) of the
Department of Defense (DoD) as established by section 370 of the Fiscal
Year (FY) 2021 National Defense Authorization Act (NDAA).

DATES: Effective date 0901 UTC, January 25, 2024.

ADDRESSES: A copy of this final rule, and all background material may
be viewed online at www.regulations.gov using the FAA Docket number.
Electronic retrieval help and guidelines are available on the website.
It is available 24 hours each day, 365 days each year.

FOR FURTHER INFORMATION CONTACT: Brian Vidis, Rules and Regulations
Group, Office of Policy, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
the airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it updates the information in the airspace descriptions of
restricted areas R-3002A, R-3002B, R-3002C, R-3002D, R-3002E, R-3002F,
and R-3002G.

Background

    The FY 2021 NDAA directed the DoD to establish a commission
relating to assigning, modifying, or removing of names, symbols,
displays, monuments, and paraphernalia to assets of the DoD that
commemorate the Confederate States of America or any person who served
voluntarily with the Confederate States of America.\1\ In January 2023,
the Secretary of Defense directed all DoD organizations to begin full
implementation of the Naming Commission's recommendations. As approved
by the Secretary of Defense, the name ``Fort Benning, GA'' is changed
to ``Fort Moore, GA.'' Consequently, this rulemaking action implements
the requisite changes to part 73 by updating the airspace descriptions
of restricted areas R-3002A, R-3002B, R-3002C, R-3002D, R-3002E, R-
3002F, and R-3002G to reflect the new name.
---------------------------------------------------------------------------

    \1\ Public Law 116-283, 134 Stat. 3388, Jan. 1, 2021.
---------------------------------------------------------------------------

The Rule

    This action amends 14 CFR part 73 by updating the airspace titles
and using agency descriptions for restricted areas R-3002A, R-3002B, R-
3002C, R-3002D, R-3002E, R-3002F, and R-3002G by removing the name
``Fort Benning, GA'' and replacing it with ``Fort Moore, GA.'' This
action consists of administrative name changes only and does not affect
the boundaries, altitudes, time of designation, or activities conducted
in the airspace. Therefore, notice and public procedure under 5 U.S.C.
553(b) is unnecessary.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under
Department of Transportation (DOT) Regulatory Policies and Procedures
(44 FR 11034; February 26, 1979); and (3) does not warrant preparation
of a regulatory evaluation as the anticipated impact is so minimal.
Since this is a routine matter that only affects air traffic procedures
and air navigation, it is certified that this rule, when promulgated,
does not have a significant economic impact on a substantial number of
small entities under the criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action of making administrative
name changes to restricted areas R-3002A, R-3002B, R-3002C, R-3002D, R-
3002E, R-3002F, and R-3002G, which do not alter the boundaries,
altitudes, or time of designation, qualifies for categorical exclusion
under the National Environmental Policy Act (42 U.S.C. 4321 et seq.)
and its implementing regulations at 40 CFR part 1500, and in accordance
with FAA Order 1050.1F, Environmental Impacts: Policies and Procedures,
paragraph 5-6.5a, which categorically excludes from further
environmental impact review rulemaking actions that designate or modify
classes of airspace areas, airways, routes, and reporting points (see
14 CFR part 71, Designation of Class A, B, C, D, and E Airspace Areas;
Air Traffic Service Routes; and Reporting Points); and paragraph 5-
6.5d--Modification of the technical description of special use airspace
(SUA) that does not alter the dimensions, altitudes, or times of
designation of the airspace (such as changes in designation of the
controlling or using agency, or correction of typographical errors). In
accordance with FAA Order 1050.1F, paragraph 5-2 regarding
Extraordinary Circumstances, the FAA has reviewed this action for
factors and circumstances in which a normally categorically excluded
action may have a significant environmental impact requiring further
analysis. The FAA has determined that no extraordinary circumstances
exist that warrant preparation of an environmental assessment or
environmental impact study.

List of Subjects in 14 CFR Part 73

    Airspace, Prohibited areas, Restricted areas.

The Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 73 as follows:

PART 73--SPECIAL USE AIRSPACE

0
1. The authority citation for 14 CFR part 73 continues to read as
follows:

    Authority: 49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p.389.

Sec.  73.30  Georgia [Amended]

0
2. Section 73.30 is amended as follows:
* * * * *

R-3002A, Fort Benning, GA [Removed]

R-3002B, Fort Benning, GA [Removed]

R-3002C, Fort Benning, GA [Removed]

R-3002D, Fort Benning, GA [Removed]

R-3002E, Fort Benning, GA [Removed]

R-3002F, Fort Benning, GA [Removed]

R-3002G, Fort Benning, GA [Removed]

R-3002A Fort Moore, GA [New]

    Boundaries. Beginning at lat. 32[deg]31'12'' N, long.
84[deg]50'11'' W; to lat. 32[deg]19'03'' N, long. 84[deg]41'42'' W;
thence along the Central of Georgia Railroad; to lat. 32[deg]19'09'' N,
long. 84[deg]42'27'' W; to lat. 32[deg]19'14'' N, long. 84[deg]42'52''
W; to lat. 32[deg]19'23'' N, long. 84[deg]43'18'' W; to lat.
32[deg]19'35'' N, long. 84[deg]43'49'' W; to lat. 32[deg]19'43'' N,
long. 84[deg]44'29'' W; to lat. 32[deg]19'55'' N, long. 84[deg]45'06''
W; to lat. 32[deg]20'13'' N, long. 84[deg]45'54'' W; to lat.
32[deg]20'30'' N, long. 84[deg]46'32'' W; to lat. 32[deg]20'53'' N,
long. 84[deg]46'55'' W; to lat. 32[deg]20'55'' N, long. 84[deg]47'38''
W; to lat. 32[deg]15'25'' N, long. 84[deg]47'32'' W; to lat.
32[deg]15'26'' N, long. 84[deg]48'37'' W; to lat. 32[deg]15'17'' N,
long. 84[deg]48'37'' W; thence along River Bend Road; to lat.
32[deg]15'17'' N, long. 84[deg]48'48'' W; to lat. 32[deg]15'06'' N,
long. 84[deg]49'08'' W; to lat. 32[deg]14'48'' N, long. 84[deg]49'26''
W; to lat. 32[deg]14'38'' N, long. 84[deg]49'53'' W; to lat.
32[deg]14'32'' N, long. 84[deg]50'15'' W; to lat. 32[deg]14'22'' N,
long. 84[deg]50'30'' W; to lat. 32[deg]14'12'' N, long. 84[deg]50'36''
W; to lat. 32[deg]14'22'' N, long. 84[deg]52'22'' W; to lat.
32[deg]15'07'' N, long. 84[deg]52'21'' W; to lat. 32[deg]15'06'' N,
long. 84[deg]52'38'' W; to lat. 32[deg]15'33'' N, long. 84[deg]52'37''
W; to lat. 32[deg]15'34'' N, long. 84[deg]53'11'' W; to lat.
32[deg]20'15'' N, long. 84[deg]58'36'' W; thence along Dixie Rd./First
Division Rd; to lat. 32[deg]20'36'' N, long. 84[deg]58'15'' W; to lat.
32[deg]20'53'' N, long. 84[deg]57'55'' W; to lat. 32[deg]21'03'' N,
long. 84[deg]57'40'' W; to lat. 32[deg]21'11'' N, long. 84[deg]57'24''
W; to lat. 32[deg]21'08'' N, long. 84[deg]56'55'' W; to lat.
32[deg]21'13'' N, long. 84[deg]56'04'' W; to lat. 32[deg]21'33'' N,
long. 84[deg]55'35'' W; to lat. 32[deg]21'50'' N, long. 84[deg]55'16''
W; to lat. 32[deg]21'53'' N, long. 84[deg]55'00'' W; to lat.
32[deg]22'06'' N, long. 84[deg]54'41'' W; to lat. 32[deg]23'01'' N,
long. 84[deg]55'44'' W; to lat. 32[deg]24'48'' N, long. 84[deg]52'52''
W; to lat. 32[deg]25'36'' N, long. 84[deg]52'52'' W; to lat.
32[deg]25'44'' N, long. 84[deg]53'30'' W; to lat. 32[deg]26'19'' N,
long. 84[deg]53'31'' W; to lat. 32[deg]26'20'' N, long. 84[deg]53'54''
W; to lat. 32[deg]27'19'' N, long. 84[deg]53'53'' W; to lat.
32[deg]27'17'' N, long. 84[deg]52'10'' W; to lat. 32[deg]28'46'' N,
long. 84[deg]52'08'' W; to lat. 32[deg]28'44'' N, long. 84[deg]50'47''
W; to lat. 32[deg]29'43'' N, long. 84[deg]50'59'' W; to lat.
32[deg]30'35'' N, long. 84[deg]50'50'' W; to lat. 32[deg]30'39'' N,
long. 84[deg]50'23'' W; thence to the point of beginning.
    Designated altitudes. Surface to 4,000 feet MSL.
    Time of designation. Intermittent, 0600-0200 local time, daily;
other times by NOTAM 6 hours in advance.
    Controlling agency. FAA, Atlanta TRACON.
    Using agency. U.S. Army, Commanding General, Infantry Center and
Fort Moore, GA.

R-3002B Fort Moore, GA [New]

    Boundaries. Beginning at lat. 32[deg]31'12'' N, long.
84[deg]50'11'' W; to lat. 32[deg]19'03'' N, long. 84[deg]41'42'' W;
thence along the Central of Georgia Railroad; to lat. 32[deg]19'09'' N,
long. 84[deg]42'27'' W; to lat. 32[deg]19'14'' N, long. 84[deg]42'52''
W; to lat. 32[deg]19'23'' N, long. 84[deg]43'18'' W; to lat.
32[deg]19'35'' N, long. 84[deg]43'49'' W; to lat. 32[deg]19'43'' N,
long. 84[deg]44'29'' W; to lat. 32[deg]19'55'' N, long. 84[deg]45'06''
W; to lat. 32[deg]20'13'' N, long. 84[deg]45'54'' W; to lat.
32[deg]20'30'' N, long. 84[deg]46'32'' W; to lat. 32[deg]20'53'' N,
long. 84[deg]46'55'' W; to lat. 32[deg]20'55'' N, long. 84[deg]47'38''
W; to lat. 32[deg]15'25'' N, long. 84[deg]47'32'' W; to lat.
32[deg]15'26'' N, long. 84[deg]48'37'' W; to lat. 32[deg]15'17'' N,
long. 84[deg]48'37'' W; thence along River Bend Road; to lat.
32[deg]15'17'' N, long. 84[deg]48'48'' W; to lat. 32[deg]15'06'' N,
long. 84[deg]49'08'' W; to lat. 32[deg]14'48'' N, long. 84[deg]49'26''
W; to lat. 32[deg]14'38'' N, long. 84[deg]49'53'' W; to lat.
32[deg]14'32'' N, long. 84[deg]50'15'' W; to lat. 32[deg]14'22'' N,
long. 84[deg]50'30'' W; to lat. 32[deg]14'12'' N, long. 84[deg]50'36''
W; to lat. 32[deg]14'22'' N, long. 84[deg]52'22'' W; to lat.
32[deg]15'07'' N, long. 84[deg]52'21'' W; to lat. 32[deg]15'06'' N,
long. 84[deg]52'38'' W; to lat. 32[deg]15'33'' N, long. 84[deg]52'37''
W; to lat. 32[deg]15'34'' N, long. 84[deg]53'11'' W; to lat.
32[deg]20'15'' N, long. 84[deg]58'36'' W; thence along Dixie Rd/First
Division Rd; to lat. 32[deg]20'36'' N, long. 84[deg]58'15'' W; to lat.
32[deg]20'53'' N, long. 84[deg]57'55'' W; to lat. 32[deg]21'03'' N,
long. 84[deg]57'40'' W; to lat. 32[deg]21'11'' N, long. 84[deg]57'24''
W; to lat. 32[deg]21'08'' N, long. 84[deg]56'55'' W; to lat.
32[deg]21'13'' N, long. 84[deg]56'04'' W; to lat. 32[deg]21'33'' N,
long. 84[deg]55'35'' W; to lat. 32[deg]21'50'' N, long. 84[deg]55'16''
W; to lat. 32[deg]21'53'' N, long. 84[deg]55'00'' W; to lat.
32[deg]22'06'' N, long. 84[deg]54'41'' W; to lat. 32[deg]23'01'' N,
long. 84[deg]55'44'' W; to lat. 32[deg]24'48'' N, long. 84[deg]52'52''
W; to lat. 32[deg]25'36'' N, long. 84[deg]52'52'' W; to lat.
32[deg]25'44'' N, long. 84[deg]53'30'' W; to lat. 32[deg]26'19'' N,
long. 84[deg]53'31'' W; to lat. 32[deg]26'20'' N, long. 84[deg]53'54''
W; to lat. 32[deg]27'19'' N, long. 84[deg]53'53'' W; to lat.
32[deg]27'17'' N, long. 84[deg]52'10'' W; to lat. 32[deg]28'46'' N,
long. 84[deg]52'08'' W; to lat. 32[deg]28'44'' N, long. 84[deg]50'47''
W; to lat. 32[deg]29'43'' N, long. 84[deg]50'59'' W; to lat.
32[deg]30'35'' N, long. 84[deg]50'50'' W; to lat. 32[deg]30'39'' N,
long. 84[deg]50'23'' W; thence to the point of beginning.
    Designated altitudes. 4,000 feet MSL to 8,000 feet MSL.
    Time of designation. Intermittent, 0600-0200 local time, daily;
other times by NOTAM 6 hours in advance.
    Controlling agency. FAA, Atlanta TRACON.
    Using agency. U.S. Army, Commanding General, Infantry Center and
Fort Moore, GA.

R-3002C Fort Moore, GA [New]

    Boundaries. Beginning at lat. 32[deg]31'12'' N, long.
84[deg]50'11'' W; to lat. 32[deg]19'03'' N, long. 84[deg]41'42'' W;
thence along the Central of Georgia Railroad; to lat. 32[deg]19'09'' N,
long. 84[deg]42'27'' W; to lat. 32[deg]19'14'' N, long. 84[deg]42'52''
W; to lat. 32[deg]19'23'' N, long. 84[deg]43'18'' W; to lat.
32[deg]19'35'' N, long. 84[deg]43'49'' W; to lat. 32[deg]19'43'' N,
long. 84[deg]44'29'' W; to lat. 32[deg]19'55'' N, long. 84[deg]45'06''
W; to lat. 32[deg]20'13'' N, long. 84[deg]45'54'' W; to lat.
32[deg]20'30'' N, long. 84[deg]46'32'' W; to lat. 32[deg]20'53'' N,
long. 84[deg]46'55'' W; to lat. 32[deg]20'55'' N, long. 84[deg]47'38''
W; to lat. 32[deg]15'25'' N, long. 84[deg]47'32'' W; to lat.
32[deg]15'26'' N, long. 84[deg]48'37'' W; to lat. 32[deg]15'17'' N,
long. 84[deg]48'37'' W; thence along River Bend Road; to lat.
32[deg]15'17'' N, long. 84[deg]48'48'' W; to lat. 32[deg]15'06'' N,
long. 84[deg]49'08'' W; to lat. 32[deg]14'48'' N, long. 84[deg]49'26''
W; to lat. 32[deg]14'38'' N, long. 84[deg]49'53'' W; to lat.
32[deg]14'32'' N, long. 84[deg]50'15'' W; to lat. 32[deg]14'22'' N,
long. 84[deg]50'30'' W; to lat. 32[deg]14'12'' N, long. 84[deg]50'36''
W; to lat. 32[deg]14'22'' N, long. 84[deg]52'22'' W; to lat.
32[deg]15'07'' N, long. 84[deg]52'21'' W; to lat. 32[deg]15'06'' N,
long. 84[deg]52'38'' W; to lat. 32[deg]15'33'' N, long. 84[deg]52'37''
W; to lat. 32[deg]15'34'' N, long. 84[deg]53'11'' W; to lat.
32[deg]20'15'' N, long. 84[deg]58'36'' W; thence along Dixie Rd/First
Division Rd; to lat. 32[deg]20'36'' N, long. 84[deg]58'15'' W; to lat.
32[deg]20'53'' N, long. 84[deg]57'55'' W; to lat. 32[deg]21'03'' N,
long. 84[deg]57'40'' W; to lat. 32[deg]21'11'' N, long. 84[deg]57'24''
W; to lat. 32[deg]21'08'' N, long. 84[deg]56'55'' W; to lat.
32[deg]21'13'' N, long. 84[deg]56'04'' W; to lat. 32[deg]21'33'' N,
long. 84[deg]55'35'' W; to lat. 32[deg]21'50'' N, long. 84[deg]55'16''
W; to lat. 32[deg]21'53'' N, long. 84[deg]55'00'' W; to lat.
32[deg]22'06'' N, long. 84[deg]54'41'' W; to lat. 32[deg]23'01'' N,
long. 84[deg]55'44'' W; to lat. 32[deg]24'48'' N, long. 84[deg]52'52''
W; to lat. 32[deg]25'36'' N, long. 84[deg]52'52'' W; to lat.
32[deg]25'44'' N, long. 84[deg]53'30'' W; to lat. 32[deg]26'19'' N,
long. 84[deg]53'31'' W; to lat.

32[deg]26'20'' N, long. 84[deg]53'54'' W; to lat. 32[deg]27'19'' N,
long. 84[deg]53'53'' W; to lat. 32[deg]27'17'' N, long. 84[deg]52'10''
W; to lat. 32[deg]28'46'' N, long. 84[deg]52'08'' W; to lat.
32[deg]28'44'' N, long. 84[deg]50'47'' W; to lat. 32[deg]29'43'' N,
long. 84[deg]50'59'' W; to lat. 32[deg]30'35'' N, long. 84[deg]50'50''
W; to lat. 32[deg]30'39'' N, long. 84[deg]50'23'' W; thence to the
point of beginning.
    Designated altitudes. 8,000 feet MSL to 14,000 feet MSL.
    Time of designation. Intermittent by NOTAM 6 hours in advance.
    Controlling agency. FAA, Atlanta TRACON.
    Using agency. U.S. Army, Commanding General, Infantry Center and
Fort Moore, GA.

R-3002D Fort Moore, GA [New]

    Boundaries. Beginning at lat. 32[deg]31'12'' N, long.
84[deg]50'11'' W; to lat. 32[deg]31'52'' N, long. 84[deg]50'25'' W; to
lat. 32[deg]33'05'' N, long. 84[deg]45'27'' W; thence along the Central
of Georgia Railroad; to lat. 32[deg]32'52'' N, long. 84[deg]45'00'' W;
to lat. 32[deg]32'43'' N, long. 84[deg]44'08'' W; to lat.
32[deg]32'34'' N, long. 84[deg]43'40'' W; to lat. 32[deg]32'22'' N,
long. 84[deg]43'13'' W; to lat. 32[deg]32'18'' N, long. 84[deg]42'53''
W; to lat. 32[deg]32'08'' N, long. 84[deg]42'38'' W; to lat.
32[deg]32'05'' N, long. 84[deg]42'26'' W; to lat. 32[deg]32'11'' N,
long. 84[deg]42'12'' W; to lat. 32[deg]32'13'' N, long. 84[deg]41'54''
W; to lat. 32[deg]32'10'' N, long. 84[deg]41'38'' W; to lat.
32[deg]32'06'' N, long. 84[deg]41'25'' W; to lat. 32[deg]32'08'' N,
long. 84[deg]41'17'' W; to lat. 32[deg]32'15'' N, long. 84[deg]41'01''
W; to lat. 32[deg]32'20'' N, long. 84[deg]40'56'' W; to lat.
32[deg]32'07'' N, long. 84[deg]40'44'' W; to lat. 32[deg]31'06'' N,
long. 84[deg]41'43'' W; to lat. 32[deg]31'04'' N, long. 84[deg]40'54''
W; to lat. 32[deg]32'04'' N, long. 84[deg]38'16'' W; to lat.
32[deg]29'16'' N, long. 84[deg]38'17'' W; to lat. 32[deg]29'10'' N,
long. 84[deg]39'25'' W; to lat. 32[deg]18'35'' N, long. 84[deg]39'30''
W; to lat. 32[deg]18'23'' N, long. 84[deg]41'09'' W; to lat.
32[deg]19'03'' N, long. 84[deg]41'42'' W; thence to the point of
beginning.
    Designated altitudes. Surface to 8,000 feet MSL.
    Time of designation. Intermittent, 0600-0200 local time, daily;
other times by NOTAM 6 hours in advance.
    Controlling agency. FAA, Atlanta TRACON.
    Using agency. U.S. Army, Commanding General, Infantry Center and
Fort Moore, GA.

R-3002E Fort Moore, GA [New]

    Boundaries. Beginning at lat. 32[deg]31'12'' N, long.
84[deg]50'11'' W; to lat. 32[deg]31'52'' N, long. 84[deg]50'25'' W; to
lat. 32[deg]33'05'' N, long. 84[deg]45'27'' W; thence along the Central
of Georgia Railroad; to lat. 32[deg]32'52'' N, long. 84[deg]45'00'' W;
to lat. 32[deg]32'43'' N, long. 84[deg]44'08'' W; to lat.
32[deg]32'34'' N, long. 84[deg]43'40'' W; to lat. 32[deg]32'22'' N,
long. 84[deg]43'13'' W; to lat. 32[deg]32'18'' N, long. 84[deg]42'53''
W; to lat. 32[deg]32'08'' N, long. 84[deg]42'38'' W; to lat.
32[deg]32'05'' N, long. 84[deg]42'26'' W; to lat. 32[deg]32'11'' N,
long. 84[deg]42'12'' W; to lat. 32[deg]32'13'' N, long. 84[deg]41'54''
W; to lat. 32[deg]32'10'' N, long. 84[deg]41'38'' W; to lat.
32[deg]32'06'' N, long. 84[deg]41'25'' W; to lat. 32[deg]32'08'' N,
long. 84[deg]41'17'' W; to lat. 32[deg]32'15'' N, long. 84[deg]41'01''
W; to lat. 32[deg]32'20'' N, long. 84[deg]40'56'' W; to lat.
32[deg]32'07'' N, long. 84[deg]40'44'' W; to lat. 32[deg]31'06'' N,
long. 84[deg]41'43'' W; to lat. 32[deg]31'04'' N, long. 84[deg]40'54''
W; to lat. 32[deg]32'04'' N, long. 84[deg]38'16'' W; to lat.
32[deg]29'16'' N, long. 84[deg]38'17'' W; to lat. 32[deg]29'10'' N,
long. 84[deg]39'25'' W; to lat. 32[deg]18'35'' N, long. 84[deg]39'30''
W; to lat. 32[deg]18'23'' N, long. 84[deg]41'09'' W; to lat.
32[deg]19'03'' N, long. 84[deg]41'42'' W; thence to the point of
beginning.
    Designated altitudes. 8,000 feet MSL to 14,000 feet MSL.
    Time of designation. Intermittent by NOTAM 6 hours in advance.
    Controlling agency. FAA, Atlanta TRACON.
    Using agency. U.S. Army, Commanding General, Infantry Center and
Fort Moore, GA.

R-3002F Fort Moore, GA [New]

    Boundaries. Beginning at lat. 32[deg]27'17'' N, long.
84[deg]52'10'' W; to lat. 32[deg]28'46'' N, long. 84[deg]52'08'' W; to
lat. 32[deg]28'44'' N, long. 84[deg]50'47'' W; to lat. 32[deg]29'43''
N, long. 84[deg]50'59'' W; to lat. 32[deg]30'35'' N, long.
84[deg]50'50'' W; to lat. 32[deg]30'39'' N, long. 84[deg]50'23'' W; to
lat. 32[deg]31'12'' N, long. 84[deg]50'11'' W; to lat. 32[deg]31'52''
N, long. 84[deg]50'25'' W; to lat. 32[deg]33'05'' N, long.
84[deg]45'27'' W; thence along the Central of Georgia Railroad; to lat.
32[deg]32'52'' N, long. 84[deg]45'00'' W; to lat. 32[deg]32'43'' N,
long. 84[deg]44'08'' W; to lat. 32[deg]32'34'' N, long. 84[deg]43'40''
W; to lat. 32[deg]32'22'' N, long. 84[deg]43'13'' W; to lat.
32[deg]32'18'' N, long. 84[deg]42'53'' W; to lat. 32[deg]32'08'' N,
long. 84[deg]42'38'' W; to lat. 32[deg]32'05'' N, long. 84[deg]42'26''
W; to lat. 32[deg]32'11'' N, long. 84[deg]42'12'' W; to lat.
32[deg]32'13'' N, long. 84[deg]41'54'' W; to lat. 32[deg]32'10'' N,
long. 84[deg]41'38'' W; to lat. 32[deg]32'06'' N, long. 84[deg]41'25''
W; to lat. 32[deg]32'08'' N, long. 84[deg]41'17'' W; to lat.
32[deg]32'15'' N, long. 84[deg]41'01'' W; to lat. 32[deg]32'20'' N,
long. 84[deg]40'56'' W; to lat. 32[deg]32'07'' N, long. 84[deg]40'44''
W; to lat. 32[deg]31'06'' N, long. 84[deg]41'43'' W; to lat.
32[deg]31'04'' N, long. 84[deg]40'54'' W; to lat. 32[deg]32'04'' N,
long. 84[deg]38'16'' W; to lat. 32[deg]29'16'' N, long. 84[deg]38'17''
W; to lat. 32[deg]29'10'' N, long. 84[deg]39'25'' W; to lat.
32[deg]18'35'' N, long. 84[deg]39'30'' W; to lat. 32[deg]18'23'' N,
long. 84[deg]41'09'' W; to lat. 32[deg]19'03'' N, long. 84[deg]41'42''
W; thence along the Central of Georgia Railroad; to lat. 32[deg]19'09''
N, long. 84[deg]42'27'' W; to lat. 32[deg]19'14'' N, long.
84[deg]42'52'' W; to lat. 32[deg]19'23'' N, long. 84[deg]43'18'' W; to
lat. 32[deg]19'35'' N, long. 84[deg]43'49'' W; to lat. 32[deg]19'43''
N, long. 84[deg]44'29'' W; to lat. 32[deg]19'55'' N, long.
84[deg]45'06'' W; to lat. 32[deg]20'13'' N, long. 84[deg]45'54'' W; to
lat. 32[deg]20'30'' N, long. 84[deg]46'32'' W; to lat. 32[deg]20'53''
N, long. 84[deg]46'55'' W; to lat. 32[deg]20'55'' N, long.
84[deg]47'38'' W; thence to the point of beginning.
    Designated altitudes. 14,000 feet MSL to FL 250.
    Time of designation. Intermittent by NOTAM 6 hours in advance.
    Controlling agency. FAA, Atlanta TRACON.
    Using agency. U.S. Army, Commanding General, Infantry Center and
Fort Moore, GA.

R-3002G Fort Moore, GA [New]

    Boundaries. Beginning at lat. 32[deg]20'15'' N, long.
84[deg]58'36'' W; to lat. 32[deg]15'34'' N, long. 84[deg]53'11'' W; to
lat. 32[deg]15'32'' N, long. 84[deg]54'02'' W; to lat. 32[deg]15'04''
N, long. 84[deg]55'24'' W; to lat. 32[deg]14'27'' N, long.
84[deg]54'50'' W; to lat. 32[deg]14'25'' N, long. 84[deg]56'53'' W; to
lat. 32[deg]14'36'' N, long. 84[deg]56'53'' W; to lat. 32[deg]14'38''
N, long. 84[deg]57'56'' W; to lat. 32[deg]16'36'' N, long.
84[deg]57'58'' W; to lat. 32[deg]16'36'' N, long. 84[deg]58'35'' W; to
lat. 32[deg]17'39'' N, long. 84[deg]58'35'' W; to lat. 32[deg]17'40''
N, long. 84[deg]58'54'' W; thence to the point of beginning.
    Designated altitudes. Surface to 14,000 feet MSL.
    Time of designation. Intermittent, 0600-0200 Eastern time daily;
other times by NOTAM 6 hours in advance.
    Controlling agency. FAA, Atlanta TRACON.
    Using agency. U.S. Army, Commanding General, Infantry Center and
Fort Moore, GA.
* * * * *

    Issued in Washington, DC, on November 16, 2023.
Karen L. Chiodini,
Acting Manager, Rules and Regulations Group.
[FR Doc. 2023-25849 Filed 11-22-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 230 (Monday, December 1, 2014)]
[Notices]
[Pages 71111-71112]
[FR Doc No: 2014-28196]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1952]

Seventh Annual Sentinel Initiative; Public Workshop; Amendment of
Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; amendment of notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
amendment to the notice of a public workshop entitled ``Seventh Annual
Sentinel Initiative'' to be held on February 5, 2015. The workshop was
announced in the Federal Register of October 22, 2014. This amendment
reflects the addition of a Comments section and updates an incorrect
Web site in the Meeting Materials section.

FOR FURTHER INFORMATION CONTACT: Carlos Bell, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6358, Silver Spring, MD 20993, 301-796-
3714, FAX:<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    In the Federal Register of October 22, 2014 (79 FR 63130), FDA
announced that a public workshop entitled ``Seventh Annual Sentinel
Initiative'' will be held on February 5, 2015.
    1. On page 63131, in the second column, in the sixth line of the
Meeting Materials section, the Web site ``http://www.brookings.edu//health/events'' is changed to read ``http://www.brookings.edu/events''.
    2. On page 63131, in the second column, a Comments section is added
between the Meeting Materials section and the Transcripts section to
read:
    ``Comments: FDA is holding this public workshop to obtain
information about a variety of topics on active medical product
surveillance. The deadline for submitting comments regarding this
public workshop is March 10, 2015.
    Regardless of attendance in person or through the Web cast,
interested persons may submit either electronic comments to http://www.regulations.gov or written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. 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.''

    Dated: November 20, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-28196 Filed 11-28-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 71 (Thursday, April 13, 2023)]
[Rules and Regulations]
[Page 22380]
[FR Doc No: 2023-07749]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2023-0180]

Safety Zone; Fireworks Display; Chesapeake Bay, Norfolk, VA

AGENCY: Coast Guard, Department of Homeland Security (DHS).

ACTION: Notification of enforcement of regulation.

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

SUMMARY: The Coast Guard will enforce a safety zone for the Shore Thing
Independence Day Celebration on June 30, 2023, in Virginia Beach, VA,
to protect against hazards associated with a fireworks display and
provide for the safety of life on navigable waterways during this
event. Our regulation for marine events within the Fifth Coast Guard
District identifies the regulated area for this event in Norfolk, VA.
During the enforcement period, entry of vessels or persons into this
zone is prohibited unless specifically authorized by the Captain of the
Port Virginia.

DATES: The regulations in 33 CFR 165.506 will be enforced for the
location identified as Item 3 in table 3 to paragraph (h)(3) from 9:30
p.m. until 9:45 p.m. on June 30, 2023.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notification of enforcement, call or email LCDR Ashley Holm, Chief,
Waterways Management Division, Sector Virginia, U.S. Coast Guard;
telephone<PHONE_NUMBER> email [email protected].

SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the safety zone
in 33 CFR 165.506 for Shore Thing Independence Day Celebration
regulated area from 9:30 p.m. to 9:45 p.m. on June 30, 2023. This
action is being taken to provide for the safety of life on navigable
waterways during this event, which will feature live fireworks. Our
regulation for marine events within the Fifth Coast Guard District,
Sec.  165.506, specifies the location of the regulated area for the
Shore Thing Independence Day Celebration, which encompasses portions of
the Chesapeake Bay located near Ocean View Fishing Pier. During the
enforcement period, neither persons nor vessels may enter, remain in,
or transit through the safety zone unless specifically authorized by
the Captain of the Port Virginia.
    In addition to this notification of enforcement in the Federal
Register, the Coast Guard plans to provide notification of this
enforcement period via the Local Notice to Mariners and marine
information broadcasts.

    Dated: March 16, 2023.
Jennifer A. Stockwell,
Captain, U.S. Coast Guard, Captain of the Port Virginia.
[FR Doc. 2023-07749 Filed 4-12-23; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: June 29, 2009 (Volume 74, Number 123)]
[Notices]
[Page 31025-31027]
[DOCID:fr29jn09-50]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice Of Filings 1

June 18, 2009.
    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG09-52-000.
    Applicants: Escondido Energy Center, LLC.
    Description: Notice of Self-Certification of EWG Status of
Escondido Energy Center, LLC.
    Filed Date: 06/15/2009.
    Accession Number: 20090615-5111.
    Comment Date: 5 p.m. Eastern Time on Monday, July 6, 2009.

    Docket Numbers: EG09-53-000.
    Applicants: Chula Vista Energy Center, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Chula Vista Energy Center, LLC.
    Filed Date: 06/15/2009.
    Accession Number: 20090615-5117.
    Comment Date: 5 p.m. Eastern Time on Monday, July 6, 2009.

    Docket Numbers: EG09-54-000.
    Applicants: Northwest Wind Partners, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Northwest Wind Partners, LLC.
    Filed Date: 06/15/2009.
    Accession Number: 20090615-5138.
    Comment Date: 5 p.m. Eastern Time on Monday, July 6, 2009.

    Docket Numbers: EG09-55-000.
    Applicants: GenConn Middletown LLC.
    Description: GenConn Middletown LLC's Notice of Self Certification
of Exempt Wholesale Generator Status.
    Filed Date: 06/15/2009.
    Accession Number: 20090615-5145.
    Comment Date: 5 p.m. Eastern Time on Monday, July 6, 2009.

    Docket Numbers: EG09-56-000.
    Applicants: GenConn Devon LLC.
    Description: GenConn Devon LLC's Notice of Self Certification of
Exempt Wholesale Generator Status.
    Filed Date: 06/15/2009.
    Accession Number: 20090615-5146.
    Comment Date: 5 p.m. Eastern Time on Monday, July 6, 2009.

    Docket Numbers: EG09-57-000.
    Applicants: NaturEner Glacier Wind Energy 2, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of NaturEner Glacier Wind Energy 2, LLC.
    Filed Date: 06/17/2009.
    Accession Number: 20090617-5124.
    Comment Date: 5 p.m. Eastern Time on Wednesday, July 8, 2009.

    Docket Numbers: EG09-58-000.
    Applicants: NaturEner Montana Wind Energy 2, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of NaturEner Montana Wind Energy 2, LLC.
    Filed Date: 06/17/2009.
    Accession Number: 20090617-5125.
    Comment Date: 5 p.m. Eastern Time on Wednesday, July 8, 2009.

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

    Docket Numbers: ER06-1355-003.
    Applicants: Evergreen Wind Power, LLC.
    Description: Evergreen Wind Power, LLC submits a revised market-
based tariff that reflects the correct tariff sheet designations.
    Filed Date: 06/11/2009.
    Accession Number: 20090616-0135.
    Comment Date: 5 p.m. Eastern Time on Thursday, July 2, 2009.

    Docket Numbers: ER07-53-001.
    Applicants: American Transmission Company, LLC.
    Description: American Transmission Co, LLC submits an executed
Large Generator Interconnection Agreement.
    Filed Date: 06/15/2009.
    Accession Number: 20090617-0051.
    Comment Date: 5 p.m. Eastern Time on Monday, July 6, 2009.

    Docket Numbers: ER08-1574-006.
    Applicants: ORNI 18, LLC.
    Description: Notice of Non-Material Change in Status of ORNI 18,
LLC.
    Filed Date: 06/17/2009.
    Accession Number: 20090617-5155.
    Comment Date: 5 p.m. Eastern Time on Wednesday, July 8, 2009.

    Docket Numbers: ER09-759-002.
    Applicants: E. ON U.S. LLC.
    Description: EON US LLC submits Network Integration Transmission
Service Agreement and Network Operating Agreement for service to the
Kentucky Municipal Power Agency.
    Filed Date: 06/15/2009.
    Accession Number: 20090617-0002.
    Comment Date: 5 p.m. Eastern Time on Monday, July 6, 2009.

    Docket Numbers: ER09-949-001.
    Applicants: Central Illinois Light Company, Central Illinois Public
Service Company, Illinois Power Company.
    Description: Central Illinois Light Company et al. submit Original
Sheet 1 et al. First Revised Rate Schedule FERC No 43.
    Filed Date: 06/15/2009.
    Accession Number: 20090615-0046.
    Comment Date: 5 p.m. Eastern Time on Monday, July 6, 2009.

    Docket Numbers: ER09-1142-001.
    Applicants: New York Independent System Operator, Inc.
    Description: New York Independent System Operator, Inc submits
Second Revised Sheet No 467.00A et al. to FERC Electric Tariff,
Original Volume 2.
    Filed Date: 06/17/2009.
    Accession Number: 20090618-0089.
    Comment Date: 5 p.m. Eastern Time on Wednesday, June 24, 2009.

    Docket Numbers: ER09-1210-001.
    Applicants: Wells Fargo Commodities, LLC.
    Description: Wells Fargo Commodities, LLC submits Original Sheets
No 2 and No 4 to FERC Electric Tariff, Original Volume 1.
    Filed Date: 06/17/2009.
    Accession Number: 20090618-0088.
    Comment Date: 5 p.m. Eastern Time on Wednesday, July 8, 2009.

    Docket Numbers: ER09-1295-000.
    Applicants: El Paso Electric Company.
    Description: El Paso Electric Company Request for Waiver
Authorization Pursuant to Section 205.
    Filed Date: 06/12/2009.
    Accession Number: 20090612-5047.
    Comment Date: 5 p.m. Eastern Time on Monday, July 6, 2009.

    Docket Numbers: ER09-1297-000.
    Applicants: Northern Colorado Wind Energy, LLC.
    Description: Northern Colorado Wind Energy, LLC's request for
authorization to sell energy and capacity at market-based rates, and
waiver of the 60-day notice requirements.
    Filed Date: 06/12/2009.
    Accession Number: 20090616-0054.
    Comment Date: 5 p.m. Eastern Time on Monday, July 6, 2009.

    Docket Numbers: ER09-1300-000.
    Applicants: GenConn Devon, LLC.
    Description: GenConn Devon, LLC submits for acceptance Original
Sheet 1 to FERC Electric Tariff, Original Volume 1 to be effective 7/
30/09.
    Filed Date: 06/15/2009.
    Accession Number: 20090616-0052.
    Comment Date: 5 p.m. Eastern Time on Monday, July 6, 2009.

    Docket Numbers: ER09-1301-000.
    Applicants: GenConn Middletown, LLC.
    Description: GenConn Middletown, LLC submits Original Sheet 1 et
al. to FERC Electric Tariff, Original Volume 1 to be effective 7/30/09.
    Filed Date: 06/15/2009.
    Accession Number: 20090616-0053.
    Comment Date: 5 p.m. Eastern Time on Monday, July 6, 2009.

    Docket Numbers: ER09-1302-000.
    Applicants: Northwest Wind Partners, LLC.
    Description: Northwest Wind Partners, LLC submits Petition
requesting acceptance of FERC Electric Tariff, Original Volume 1.
    Filed Date: 06/16/2009.
    Accession Number: 20090617-0053.
    Comment Date: 5 p.m. Eastern Time on Tuesday, July 7, 2009.

    Docket Numbers: ER09-1305-000.
    Applicants: Maine Public Service Company.
    Description: Maine Public Service Company submits informational
filing setting forth the changes in open access transmission tariff
charges effective 6/1/09 together with back-up material.
    Filed Date: 06/15/2009.
    Accession Number: 20090616-0146.
    Comment Date: 5 p.m. Eastern Time on Monday, July 6, 2009.

    Docket Numbers: ER09-1306-000.
    Applicants: Kansas City Power & Light Company.
    Description: Kansas City Power & Light Company submits Original
Sheet 1, Rate Schedule FERC 132 to be effective 8/14/09.

    Filed Date: 06/15/2009.
    Accession Number: 20090616-0147.
    Comment Date: 5 p.m. Eastern Time on Monday, July 6, 2009.

    Docket Numbers: ER09-1307-000.
    Applicants: EnergyConnect, Inc.
    Description: EnergyConnect, Inc submits an application for
authorization to sell energy, capacity and/or ancillary services
through the provisions of demand response services in wholesale
transactions etc.
    Filed Date: 06/16/2009.
    Accession Number: 20090618-0113.
    Comment Date: 5 p.m. Eastern Time on Tuesday, July 7, 2009.

    Docket Numbers: ER09-1308-000.
    Applicants: Westar Energy, Inc.
    Description: Westar Energy, Inc submits FERC Electric Rate Schedule
323, a Supplemental Generation Agreement with the City of Osage City,
Kansas dated as of 6/15/09.
    Filed Date: 06/16/2009.
    Accession Number: 20090617-0026.
    Comment Date: 5 p.m. Eastern Time on Tuesday, July 7, 2009.

    Docket Numbers: ER09-1315-000.
    Applicants: Southern California Edison Company.
    Description: Southern California Edison Company submits First
Revised Sheet 30A to an Agreement for Interconnection Service Agreement
2 with California Independent System Operator Corp et al.
    Filed Date: 06/17/2009.
    Accession Number: 20090618-0091.
    Comment Date: 5 p.m. Eastern Time on Wednesday, July 8, 2009.

    Docket Numbers: ER09-1316-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc
submits a Facilities Construction Agreement with Heartland Wind LLC
etc.
    Filed Date: 06/17/2009.
    Accession Number: 20090618-0090.
    Comment Date: 5 p.m. Eastern Time on Wednesday, July 8, 2009.

    Take notice that the Commission received the following open access
transmission tariff filings:

    Docket Numbers: OA08-18-002.
    Applicants: Black Hills Colorado Electric Utility Company, LP
    Description: Black Hills Colorado Electric Utility Co, LP submits a
revised version of Attachment K to its open access transmission tariff.
    Filed Date: 06/15/2009.
    Accession Number: 20090617-0004.
    Comment Date: 5 p.m. Eastern Time on Monday, July 6, 2009.

    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 any subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. E9-15262 Filed 6-26-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 238 (Tuesday, December 13, 2022)]
[Notices]
[Pages 76221-76222]
[FR Doc No: 2022-26961]

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

SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-470, OMB Control No. 3235-0529]

Proposed Collection; Comment Request; Extension: Rule 17f-7

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

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3521) (``Paperwork Reduction Act''), the
Securities and Exchange Commission (the ``Commission'') is soliciting
comments on the collections of information summarized below. The
Commission plans to submit these existing collections of information to
the Office of Management and Budget (``OMB'') for extension and
approval.
    Rule 17f-7 (17 CFR 270.17f-7) permits a fund under certain
conditions to maintain its foreign assets with an eligible securities
depository, which has to meet minimum standards for a depository. The
fund or its investment adviser generally determines whether the
depository complies with those requirements based on information
provided by the fund's primary custodian (a bank that acts as global
custodian). The depository custody arrangement also must meet certain
conditions. The fund or its adviser must receive from the primary
custodian (or its agent) an initial risk analysis of the depository
arrangements, and the fund's contract with its primary custodian must
state that the custodian will

monitor risks and promptly notify the fund or its adviser of material
changes in risks. The primary custodian and other custodians also are
required to agree to exercise at least reasonable care, prudence, and
diligence.
    The collection of information requirements in rule 17f-7 are
intended to provide workable standards that protect funds from the
risks of using foreign securities depositories while assigning
appropriate responsibilities to the fund's primary custodian and
investment adviser based on their capabilities. The requirement that
the foreign securities depository meet specified minimum standards is
intended to ensure that the depository is subject to basic safeguards
deemed appropriate for all depositories. The requirement that the fund
or its adviser must receive from the primary custodian (or its agent)
an initial risk analysis of the depository arrangements, and that the
fund's contract with its primary custodian must state that the
custodian will monitor risks and promptly notify the fund or its
adviser of material changes in risks, is intended to provide essential
information about custody risks to the fund's investment adviser as
necessary for it to approve the continued use of the depository. The
requirement that the primary custodian agree to exercise reasonable
care is intended to provide assurances that its services and the
information it provides will meet an appropriate standard of care.
    The staff estimates that each of approximately 1,445 investment
advisers \1\ will make an average of 8 responses annually under the
rule to address depository compliance with minimum requirements, any
indemnification or insurance arrangements, and reviews of risk analyses
or notifications.\2\ The staff estimates each response will take 6
hours, requiring a total of approximately 48 hours for each adviser.\3\
Thus the total annual burden associated with these requirements of the
rule is approximately 69,360.\4\
---------------------------------------------------------------------------

    \1\ From a review of the Form ADV filings and Form N-CEN
filings, respectively, as of December 31, 2021 and for filings
received through August 31, 2022, Commission staff estimated that
1,445 registered investment advisers managed or sponsored open-end
registered funds (including exchange-traded funds) and closed-end
registered funds.
    \2\ 1,445 advisers x 8 responses = 11,560 responses.
    \3\ 8 responses per adviser x 6 hours per response = 48 hours
per adviser.
    \4\ 1,445 advisers x 48 hours per adviser = 69,360 hours.
---------------------------------------------------------------------------

    In addition, based on public filings made with the Commission, we
estimate that there are approximately 38 global custodians that are
engaged to perform global custodial services to funds and thus subject
to the provisions of rule 17f-7.\5\ This estimate is based on
information that is publicly available on Form N-CEN filings.\6\ The
staff further estimates that during each year, each of approximately 38
global custodians will make an average of 4 responses to analyze
custody risks and provide notice of any material changes to custody
risk under the rule.\7\ The staff estimates that each response will
take 260 hours, requiring approximately 1,040 hours annually per global
custodian.\8\ Thus the total annual burden associated with this
specific aspect of the rule is approximately 39,520 hours.\9\ The staff
estimates that the total annual hour burden associated with all
collection of information requirements of the rule is therefore 108,880
hours.\10\
---------------------------------------------------------------------------

    \5\ We analyzed Form N-CEN filings for registrants as of
December 31, 2021 and based on these filings, we estimated the
number of global custodians that have been retained by funds and are
subject to the provisions of rule 17f-7 to be 38.
    \6\ See Item C.12.a.vii.7 of Form N-CEN.
    \7\ 38 custodians x 4 responses = 152 responses.
    \8\ 260 hours per response x 4 responses per global custodian =
1,040 hours per global custodian.
    \9\ 38 global custodians x 1,040 hours per global custodian =
39,520 hours.
    \10\ 69,360 hours + 39,520 hours = 108,880 hours.
---------------------------------------------------------------------------

    The estimate of average burden hours is made solely for the
purposes of the Paperwork Reduction Act and is not derived from a
comprehensive or even a representative survey or study of the costs of
Commission rules and forms. Compliance with the collection of
information requirements of the rule is necessary to obtain the benefit
of relying on the rule's permission for funds to maintain their assets
in foreign custodians. The information provided under rule 17f-7 will
not be kept confidential. An agency may not conduct or sponsor, and a
person is not required to respond to, a collection of information
unless it displays a currently valid OMB control number.
    Written comments are invited on: (a) whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information
shall have practical utility; (b) the accuracy of the Commission's
estimate of the burden of 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 by February 13, 2023.
    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 currently valid OMB control number.
    Please direct your written comments to: David Bottom, Acting
Director/Chief Information Officer, Securities and Exchange Commission,
c/o John Pezzullo, 100 F Street NE, Washington, DC 20549 or send an
email to: [email protected].

    Dated: December 7, 2022.
Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2022-26961 Filed 12-12-22; 8:45 am]
BILLING CODE 8011-01-P