[Federal Register Volume 87, Number 246 (Friday, December 23, 2022)]
[Notices]
[Pages 79027-79028]
[FR Doc No: 2022-27907]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-473, OMB Control No. 3235-0530]

Proposed Collection; Comment Request; Extension: Rule 32a-4

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. 350l et seq.), the Securities and Exchange
Commission (``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.
    Section 32(a)(2) of the Investment Company Act of 1940 (15 U.S.C.
80a 31(a)(2)) (``Act'') requires that the selection of a registered
management investment company's or registered face-amount certificate
company's (collectively, ``funds'') independent public accountant be
submitted to shareholders for ratification or rejection. Rule 32a-4
under the Investment Company Act (17 CFR 270.32a-4) exempts a fund from
this requirement if, among other things, the fund has an audit
committee consisting entirely of independent directors. The rule
permits continuing oversight of a fund's accounting and auditing
processes by an independent audit committee in place of a shareholder
vote.
    Among other things, in order to rely on rule 32a-4, a fund's board
of directors must adopt an audit committee charter and must preserve
that charter, and any modifications to the charter, permanently in an
easily accessible place. The purpose of these conditions is to ensure
that Commission staff will be able to monitor the duties and
responsibilities of an audit committee of a fund relying on the rule.
    Commission staff estimates that on average the board of directors
takes 15 minutes to adopt the audit committee charter. Commission staff
has estimated that with an average of 9 directors on the board,\1\
total director time to adopt the charter is 2.25 hours. Combined with
an estimated \1/2\ hour of paralegal time to prepare the charter for
board review, the staff estimates a total one-time collection of
information burden of 2.75 hours for each fund. Once a board adopts an
audit committee charter, the charter is preserved as part of the fund's
records. Commission staff estimates that there is no annual hourly
burden associated with preserving the charter in accordance with this
rule.\2\
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    \1\ This estimate is based on staff experience and on
discussions with a representative of an entity that surveys funds
and calculates fund board statistics based on responses to its
surveys.
    \2\ This estimate is based on staff experience and discussions
with funds regarding the hour burden related to maintenance of the
charter.
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    Because virtually all existing funds have now adopted audit
committee charters, the annual one-time collection of information
burden associated with adopting audit committee charters is limited to
the burden incurred by newly established funds. Commission staff
estimates that fund sponsors establish approximately 120 new funds each

year,\3\ and that all of these funds will adopt an audit committee
charter in order to rely on rule 32a-4. Thus, Commission staff
estimates that the annual one-time hour burden associated with adopting
an audit committee charter under rule 32a-4 is approximately 330
hours.\4\
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    \3\ This estimate is based on the average annual number of
notifications of registration on Form N-8A filed from 2019 to 2021.
    \4\ This estimate is based on the following calculation: (2.75
burden hours for establishing charter x 120 new funds = 330 burden
hours).
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    When funds adopt an audit committee charter in order to rely on
rule 32a-4, they also may incur one-time costs related to hiring
outside counsel to prepare the charter. Commission staff estimates that
those costs average approximately $1500 per fund.\5\ As noted above,
Commission staff estimates that approximately 120 new funds each year
will adopt an audit committee charter in order to rely on rule 32a-4.
Thus, Commission staff estimates that the ongoing annual cost burden
associated with rule 32a-4 in the future will be approximately
$180,000.\6\
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    \5\ Costs may vary based on the individual needs of each fund.
However, based on the staff's experience and conversations with
outside counsel that prepare these charters, legal fees related to
the preparation and adoption of an audit committee charter usually
average $1,500 or less. The Commission also understands that model
audit committee charters are available, which reduces the costs
associated with drafting a charter.
    \6\ This estimate is based on the following calculations: ($1500
cost of adopting charter x 120 newly established funds = $180,000).
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    These estimates of average costs are made solely for the purposes
of the Paperwork Reduction Act. The estimates are not derived from a
comprehensive or even a representative survey or study of the costs of
Commission rules. The collections of information required by rule 32a-4
are necessary to obtain the benefits of the rule. The Commission is
seeking OMB approval, because an agency may not conduct or sponsor, and
a person is not required to respond to, a collection of information
unless it displays a currently valid control number.
    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 21, 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 19, 2022.
Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2022-27907 Filed 12-22-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 88 (Thursday, May 7, 2015)]
[Notices]
[Page 26242]
[FR Doc No: 2015-10575]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM98-1-000]

Records Governing Off-the-Record Communications; Public Notice

    This constitutes notice, in accordance with 18 CFR 385.2201(b), of
the receipt of prohibited and exempt off-the-record communications.
    Order No. 607 (64 FR 51222, September 22, 1999) requires Commission
decisional employees, who make or receive a prohibited or exempt off-
the-record communication relevant to the merits of a contested
proceeding, to deliver to the Secretary of the Commission, a copy of
the communication, if written, or a summary of the substance of any
oral communication.
    Prohibited communications are included in a public, non-decisional
file associated with, but not a part of, the decisional record of the
proceeding. Unless the Commission determines that the prohibited
communication and any responses thereto should become a part of the
decisional record, the prohibited off-the-record communication will not
be considered by the Commission in reaching its decision. Parties to a
proceeding may seek the opportunity to respond to any facts or
contentions made in a prohibited off-the-record communication, and may
request that the Commission place the prohibited communication and
responses thereto in the decisional record. The Commission will grant
such a request only when it determines that fairness so requires. Any
person identified below as having made a prohibited off-the-record
communication shall serve the document on all parties listed on the
official service list for the applicable proceeding in accordance with
Rule 2010, 18 CFR 385.2010.
    Exempt off-the-record communications are included in the decisional
record of the proceeding, unless the communication was with a
cooperating agency as described by 40 CFR 1501.6, made under 18 CFR
385.2201(e)(1)(v).
    The following is a list of off-the-record communications recently
received by the Secretary of the Commission. The communications listed
are grouped by docket numbers in ascending order. These filings are
available for electronic review at the Commission in the Public
Reference Room or may be viewed on the Commission's Web site at http://www.ferc.gov using the eLibrary link. Enter the docket number,
excluding the last three digits, in the docket number field to access
the document. For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>.

----------------------------------------------------------------------------------------------------------------
             Docket No.                 File date                       Presenter or requester
----------------------------------------------------------------------------------------------------------------
Prohibited:........................
    1. CP13-193-000................          3-9-15  Elizabeth Morra.\1\
    2. CP15-26-000.................         4-27-15  Mildred H. Danch.
Exempt:............................
    1. CP15-93-000.................          4-8-15  FERC Staff.\2\
    2. CP13-483-000, CP13-492-000..         4-14-15  U.S. Department of the Interior.
    3. CP13-483-000, CP13-492-000..         4-15-15  FERC Staff.\3\
    4. CP13-483-000, CP13-492-000..         4-17-15  Hon. Peter A. DeFazio.
    5. CP14-347-000................         4-17-15  Ambassador Kim Beazley, Australia.
    6. CP14-96-000.................         4-20-15  Linda D. Puglisi, Town Supervisor.
----------------------------------------------------------------------------------------------------------------
\1\ Phone record.
\2\ Email record.
\3\ Phone record.

    Dated: April 30, 2015.
Kimberly D. Bose,
Secretary.
[FR Doc. 2015-10575 Filed 5-6-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 80 (Tuesday, April 26, 2022)]
[Notices]
[Pages 24550-24551]
[FR Doc No: 2022-08838]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 516-512]

Dominion Energy South Carolina, Inc.; Notice of Application
Accepted for Filing and Soliciting Comments, Motions To Intervene, and
Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Application Type: Non-Project Use of Project Lands and Waters.
    b. Project No: 516-512.
    c. Date Filed: March 23, 2022.
    d. Applicant: Dominion Energy South Carolina, Inc.

    e. Name of Project: Saluda Hydroelectric Project.
    f. Location: The project is located on the Saluda River in
Richland, Lexington, Saluda, and Newberry counties, near Columbia,
South Carolina.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: Dan Adams, Senior Lake Management
Representative, Dominion Energy South Carolina, Inc.,<PHONE_NUMBER>,
[email protected].
    i. FERC Contact: Mary Karwoski,<PHONE_NUMBER>,
[email protected].
    j. Deadline for filing comments, motions to intervene, and
protests: May 19, 2022.
    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 protected],<PHONE_NUMBER> (toll
free), or<PHONE_NUMBER> (TTY). In lieu of electronic filing, you may
submit a paper copy. Submissions sent via the U.S. Postal Service must
be addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street NE, Room 1A, Washington, DC 20426.
Submissions sent via any other carrier must be addressed to: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, Maryland 20852. The first page of any filing should
include the docket number P-516-512. Comments emailed to Commission
staff are not considered part of the Commission record.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person whose name appears on the official service
list for the project. Further, if an intervenor files comments or
documents with the Commission relating to the merits of an issue that
may affect the responsibilities of a particular resource agency, they
must also serve a copy of the document on that resource agency.
    k. Description of Request: Dominion Energy South Carolina, Inc.
requests Commission authorization to modify the existing Putnam's
Landing marina to add 77 additional boat slips to accommodate a total
of 120 watercraft. The proposed modifications include removal of
existing dilapidated docks and installation of a new fixed wooden pier
walkway with metal gangway leading to a new 120-slip dock tree; a new
fueling/pump-out/handicap dock; dredging of approximately 450 cubic
yards (cy) in a 0.3-acre area of Lake Murry; placement of approximately
890 cy of clean fill material for shoreline stabilization; construction
of dry dock launch, abutments, and removal and replacement of
approximately 1340 linear feet of bulkhead; and construction of a
temporary sheet pile dam to dewater 0.05 acres of Lake Murry to
facilitate construction of the new dry dock launch. The proposed dock
tree would extend approximately 202 feet from the 360-foot full pool
elevation of Lake Murray and run parallel to the shoreline, spanning
approximately 638 feet of shoreline. Ancillary structures, such as dry
dock storage, office buildings, roads, parking lots, and water quality
ponds would be constructed in the uplands above the 360-foot full pool
elevation.
    l. Locations of the Application: This filing may be viewed on the
Commission's website at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. You may also register
online at http://www.ferc.gov/docs-filing/esubscription.asp to be
notified via email of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or email
[email protected], for TTY, call<PHONE_NUMBER>. Agencies may
obtain copies of the application directly from the applicant.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214, respectively. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    o. Filing and Service of Documents: Any filing must (1) bear in all
capital letters the title ``COMMENTS'', ``PROTEST'', or ``MOTION TO
INTERVENE'' as applicable; (2) set forth in the heading the name of the
applicant and the project number of the application to which the filing
responds; (3) furnish the name, address, and telephone number of the
person commenting, protesting or intervening; and (4) otherwise comply
with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis. Any filing made by an intervenor must be accompanied
by proof of service on all persons listed in the service list prepared
by the Commission in this proceeding, in accordance with 18 CFR
385.2010.

    Dated: April 19, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-08838 Filed 4-25-22; 8:45 am]
BILLING CODE 6717-01-P


April 25, 2007

Minutes of the

United States Environmental Protection Agency (EPA)

Human Studies Review Board (HSRB)

April 10, 2007 Public Teleconference

Docket Number: EPA-HQ-ORD-2006-0998

Committee Members:	(See EPA HSRB Members list – Attachment A)

Dates and Times:  	Tuesday, April 10, 2007, 1:00 PM – 3:00 PM

(See Federal Register Notice – Attachment B)

Location: 		via teleconference

Purpose: 	The EPA Human Studies Review Board (HSRB) provides advice,
information, and recommendations on issues related to the scientific and
ethical aspects of human subjects research.

Attendees: 	Chair: 			Celia B. Fisher, Ph.D.

Board Members:

David C. Bellinger, Ph.D.

William S. Brimijoin, Ph.D.

Gary L. Chadwick, PharmD, MPH, CIP

Janice Chambers, Ph.D., D.A.B.T.

Richard Fenske, Ph.D., MPH

Susan S. Fish, PharmD, MPH

Suzanne C. Fitzpatrick, Ph.D., D.A.B.T.

Kannan Krishnan, Ph.D.

KyungMann Kim, Ph.D., CCRP

Michael D. Lebowitz, Ph.D., FCCP

Sean M. Philpott, Ph.D.

Richard Sharp, Ph.D.

Meeting Summary:	Meeting discussions generally followed the issues and
general timing as presented in the meeting Agenda (Attachment C), unless
noted otherwise in these minutes.

Introductory Remarks, Meeting Administrative Procedures, and Meeting
Process

Dr. Celia Fisher (HSRB Chair) opened the teleconference meeting with an
introduction and identification of the HSRB, or Board, members
participating in the call.  Dr. Fisher explained that the purpose of the
meeting was to review and approve the January 24, 2007 draft HSRB
meeting report (Attachment D) and respond to questions raised by EPA’s
Office of Pesticide Programs (OPP).

Dr. Paul Lewis (Designated Federal Officer [DFO], HSRB, Office of the
Science Advisor [OSA], EPA) thanked Dr. Fisher and the Board for their
participation in the teleconference and the efforts they put into their
review of the report from the January 24, 2007 meeting.  Dr. Lewis
explained that the HSRB is subject to Federal Advisory Committee Act
(FACA) requirements.  As the DFO, Dr. Lewis serves as liaison between
the HSRB and EPA.  He works with the appropriate officials to ensure
compliance with all appropriate ethics regulations.  Each member of the
Board has filed a standard government financial disclosure form that has
been reviewed by EPA to ensure that all ethics disclosures have been
met.

Dr. Lewis asked Board members and public commenters to identify
themselves each time they speak for the purposes of the audio recording
and meeting minutes.  He requested that members of the public hold their
remarks until the designated public comment period and limit their
remarks to 5 minutes.

Dr. Lewis stated that the documents discussed by the HSRB, including the
draft January 24, 2007 HSRB meeting report, are available at the
public docket; the address for the docket was included in the Federal
Register notice announcing this teleconference meeting.  As per FACA
requirements, the meeting minutes will include descriptions of matters
discussed and the conclusions reached by the Board.  As the DFO,
Dr. Lewis will prepare the minutes and have them certified by the HSRB
Chair within 90 calendar days of the meeting.  In addition, the minutes
will be available at the public docket and posted on the HSRB Web site.

Public Comments

Dr. Fisher invited oral public comment on the January 2007 HSRB meeting
report.  No oral public comments were presented.

Board Discussion and Decision on Report

Dr. Fisher introduced the written comments submitted by EPA’s Office
of Pesticide Programs (OPP) and stated that these comments would be
discussed during the teleconference.  Dr. Alicia Carriquiry was unable
to attend the teleconference, but sent Dr. Fisher her response to
OPP’s comments.

For the tick repellency study, EMD-003, OPP suggested that the Complete
Protection Time (CPT) range of 6.5 to 12 hours be changed to 6.5 to 15
hours for the pump spray (p. 11, line 28).  This revision was accepted
by the Board.

OPP questioned the Board’s recommendation regarding use of different
statistical analysis procedures across studies EMD-003 and EMD-004, and
protocol SCI-001.  At the January 24, 2007 HSRB meeting, the Board
suggested transitioning to more accurate methods of calculating
efficacy, but recognized that a change in analytical techniques might
limit the ability to compare new studies to older studies and create
confusion for consumers (p. 13, lines 15-20 and p. 19, lines 6-12).  Dr.
Michael Lebowitz questioned how EPA, manufacturers, or investigators can
compare results of new studies to those of older studies and whether
there are clear, easily referenced EPA guidelines regarding appropriate
statistical analysis of efficacy studies.  The HSRB should review any
current EPA guidelines before suggesting changes to the current analysis
processes.  Mr. William Jordan (OPP, EPA) responded that OPP has
internal procedures for conducting efficacy studies that describe how to
conduct statistical analysis.  Given the comments at the January 24,
2007 HSRB meeting and in the Board’s draft meeting report, OPP is
reevaluating this issue.  There are consistency issues regarding
statistical analysis procedures used by different EPA offices.  EPA
intends to address this situation with input from the Board at a future
HSRB meeting.  Questions also have arisen concerning how to reconcile
protection times calculated using previous or current methods with those
determined using new methods.  Mr. Jordan expects that once a plan is
established for the conduct of new studies and analysis of results, EPA
will discuss with the Board this new process.

Dr. Fisher asked for a description of EPA’s current guidelines and
whether the Board could have access to them.  Mr. Jordan explained that
when EPA receives results from companies, the company has typically
performed a statistical analysis and presents the analysis to EPA.  EPA
evaluates the results, but performs its own analysis if it believes the
approach used by the company is not appropriate.  Mr. Jordan added that
he did not know if there were formal documents describing EPA guidelines
and offered to obtain the information and present it to the HSRB at a
future meeting.

Dr. KyungMann Kim commented that his impression from the January 24,
2007 HSRB meeting was that the analyses were not checked by an EPA staff
member who is trained in statistics.  He explained that the Kaplan Meier
estimate he described at the January 2007 meeting is not a new
technique, but rather has been widely used for more than 50 years in
human clinical studies.  Mr. Jordan agreed that EPA needs to revisit its
approach to the statistical analysis of these studies.  Work is underway
to address this issue, but no conclusions regarding the use of new
approaches or transitioning to these approaches have been reached.  Dr.
Fisher stated that the HSRB will have difficulty making recommendations
on this matter if specific guidelines for analytical techniques are not
available.

Mr. Jordan commented that he did not have a full understanding of the
extent to which EPA has consistently used the same approach for
statistical analysis in past years.  In recent years, analyses have been
relatively consistent.  However, in some of the older repellant efficacy
studies evaluated by EPA, the approaches used for statistical analyses
are unknown.  Dr. Lebowitz suggested that the Board should discuss with
members of OPP and any other relevant EPA offices recommended
statistical approaches for efficacy studies at a future meeting.  Dr.
Kannan Krishnan supported this suggestion.  He added that to be fair to
the proponents and OPP, comments related to analyses should be captured
as a separate category in the report rather than being attached to a
particular protocol.  Dr. Fisher stated that she will discuss with
Dr. Lewis and members of OPP how to proceed on this issue during the
next administrative planning teleconference.

The Board discussed limiting comments pertaining to encouraging EPA to
consider different analytical techniques to the HSRB Consensus and
Rationale section of the report.  Redundant verbiage (i.e., p. 12, line
36-45) would be eliminated.  Upon review of the statement in the HSRB
Consensus and Rationale for EMD-003 (p. 13, lines 15-20), the Board
decided to remove the word “recent” and the second sentence was
changed to read, “…how a transition to more appropriate methods of
calculating efficacy for the specific data set can be introduced…”
Because the issue of encouraging EPA to consider different analytical
techniques pertains to EMD-003, EMD-004, and SCI-001, this change would
be made in all three sections of the report.

OPP raised questions concerning the HSRB’s comments on the
desirability of serologic or molecular testing to ensure that field
studies were conducted in areas known to be free of vector-borne
diseases.  The Board commented that such studies would have been
desirable for EMD-003 and EMD-004, but lack of such studies did not
appear to compromise the safety of the subjects (p. 21, lines 14-20).
However, for SCI-001, the Board recommended that mosquitoes be collected
so that serologic or molecular testing could be performed (p. 25, lines
40-42).  OPP believes that these comments are inconsistent.  Three
conditions for testing were discussed, including the following:

Is it sufficient protection if field tests are conducted only in areas
where known vector-borne diseases have not been detected by county and
state health or vector/mosquito control agencies for at least one month?

If #1 is satisfied, are serologic or molecular analyses needed to
confirm the zone is free of known pathogens?

Do serologic or molecular analyses need to always be conducted
post-study to confirm the absence of pathogens for specific mosquitoes
that landed on participants?

Dr. Lebowitz commented that public health agencies usually trap and test
mosquitoes using serologic techniques in addition to monitoring a
sentinel flock and testing them serologically as well.  For the
protection of the subjects, trapping landing mosquitoes for serologic
testing is desirable because it would allow subjects to be warned of the
potential presence of vector-borne pathogens and treated if necessary.
Option #2 would not be necessary if option #3 was performed.

Dr. Sean Philpott noted that for molecular or serologic testing,
mosquitoes are pooled.  This would provide an alert to the group as a
whole, not to individuals.  He agreed with Dr. Lebowitz that there
should be no requirement to conduct post-study testing if an independent
control agency has confirmed that the test area is pathogen-free in the
previous month.  Dr. Fisher asked Board members to consider whether a
lack of post-study testing would place subjects at unacceptable risk of
harm or if post-study testing would be ideal if possible.  The Board
agreed to change references to “recommended” post-study testing for
SCI-001 (p. 25, line 40) to “suggested” post-study testing.

Dr. Fisher related a series of questions and requests for clarification
from OPP regarding research design comments for SCI-001.  OPP asked
whether the comments made for Experimental design and Statistical
analysis (p. 23, lines 31-39) were consensus recommendations.  Drs.
Fisher and Janice Chambers said that although there is no reason to
believe the products will be more or less effective on a given limb, the
conservative approach would be to randomize the limb used in the testing
protocol.  Dr. Krishnan noted that while randomization is used in the
protocol, it is ignored in the data analysis.  The Board agreed that the
comments under Experimental design should be considered by OPP to be
suggestions, not recommendations.

Concerning the comments under Statistical analysis (p. 23, lines 36-43
and p. 24, lines 1-8), OPP explained that the goal of this research is
to establish CPT and not necessarily to compare CPTs across products.
Dr. Kim remarked that Board comments should be taken as a suggested
approach to develop more sensitive or appropriate comparisons.  Dr.
Krishnan agreed that the primary objective of the study was to test
efficacy; comparison of products was a secondary goal.  Dr. Fisher
stated that the Board’s recommendation is that if comparisons are
made, use of the analytical approach suggested by the Board should be
considered.

Dr. Fisher introduced discussion on Interpretation of results (p. 24,
lines 9-14).  OPP questioned the Board’s comments concerning whether
the sample used in SCI-001 was a representative sample, considering the
Board had accepted use of a similar sample for EMD-003 and EMD-004.  Dr.
Kim stated that the sample sizes used in EMD-003 and EMD-004 are not
properly justified for statistical analysis.  Measures of variability
and between-treatment effect size are needed to appropriately determine
sample size.  Statements made in the analyses concerning p values and
adequate power are baseless.  Dr. Kim clarified that sample sizes will
be inconsistent across different studies because of differences in
variability and effect size.  The use of the same sample size in all of
these studies indicates that the investigators did not have adequate
justification for sample size.  Submissions of protocols to EPA should
ensure that there is appropriate justification for use of a given sample
size.  Dr. Fisher explained that the Board suggests that EPA consider
these recommendations and asks investigators to provide justification
for their analyses.  The Board will then evaluate whether the data
generated will be useful to EPA.  Board members decided that the report
should include a statement indicating that justification of sample size
and other analytical techniques is essential.

Also under Interpretation of results, the Board considered the
composition of the sample and whether it was representative.  Dr.
Chambers noted that because the sample did not include the elderly,
people sensitive to mosquitoes, children, or pregnant or nursing women,
the sample is not truly representative.  Dr. Fisher remarked that under
the ethics rules applied to these studies, these individuals cannot be
included.  Drs. Susan Fish and Chambers expressed concern about the
small sample size.  In the population, people can vary in their
“attractiveness” to mosquitoes by as much as 100-fold; additionally,
people who are sensitive to mosquito bites probably would not agree to
participate in these studies.  Differences in attractiveness could
impact efficacy of the repellants.  Given this degree of variability in
sensitivity and attractiveness to mosquitoes, it is unlikely that the 10
subjects included in the sample span this range of variability.  Dr.
Fisher agreed that because the sample is unlikely to include individuals
with a wide range of sensitivity, the data must be interpreted
judiciously.  The Board members agreed that the use of “friends,
neighbors, and academic associates” of Dr. Carroll was less of a
concern than that the sample is not a true random sample.  Drs. Chambers
and Kim noted that rarely are truly representative samples used in
intervention studies; they agreed that a statement should be made
concerning interpretation of results, given that the sample is not
random.  The Board agreed to delete the statement concerning the
inclusion of “friends, neighbors, and academic associates” of Dr.
Carroll in the study (p. 24, line 13).

The Board discussed Inclusion/Exclusion criteria (p. 24, lines 26-30).
Dr. Fisher proposed that the bullet title be changed to “Sample Size
Considerations for Subject Drop-Outs.”  This change was accepted by
the Board.  The Board agreed that better development or explanation of
inclusion/exclusion criteria was needed, along with an explanation of
how data from these individuals would be used in the analysis.

OPP requested clarification of the Board’s comments concerning the
Assumption of normality of CPT measurements (p. 24, lines 31-37).  Dr.
Kim explained that if CPT is determined for SCI-001 the same way as for
EMD-003, the normality assumption is inappropriate.  If the sample size
is only 10 per group, the data will not be normally distributed.  Dr.
Carriquiry’s comments noted that the statistical analysis methods used
in this protocol rely on the assumption that the measurements are
normal.  Because of the small sample size, departures from normality can
have significant consequences on the validity of the proposed
methodology.  The Board agreed to recommend that the appropriate
analyses and models, given the true distribution of the data, should be
used by the investigator.  Dr. Fish proposed the text be changed to,
“In choosing the appropriate statistical analysis methods, one should
consider the distribution of the data.”  The Board agreed to this
change and determined that mention of specific models would be deleted.

The Board agreed to delete the bullets titled Comparison to Ultrathon
(p. 24, lines 44-45) and Typo (p. 24, line 46).  The Board agreed to
accept the typographical changes suggested by OPP.

The Board agreed that the HSRB Consensus and Rationale for Scientific
Considerations (p. 25, lines 2-12) should be modified to indicate that
the Board raised concerns about sample size and statistical design and
analyses that should be addressed; the statement concerning comparison
of the recommendations to Agency guideline requirements should be
deleted.  Dr. Kim questioned the wording of the first bullet under
Scientific Considerations for SCI-001 (p. 3, lines 13-15).  The Board
agreed to delete this bullet.

Dr. Fisher opened discussion on Ethical Considerations for SCI-001.  In
the report, the Board stated that the protocol does not describe how
untreated controls would be recruited (p. 26, lines 11-12).  OPP
requested clarification of the Board’s comments concerning the
qualification of the Independent Investigational Review Board (IIRB) (p.
26, lines 36-40).  OPP asked if the Board was requiring EPA to assess
IIRB qualifications for this protocol.  Dr. Fisher and the Board agreed
that although information on IIRB qualifications would be reassuring, at
this point the statement is a comment, not a recommendation.

Dr. Krishnan asked the Board to discuss the summary comments on page 3
concerning the statistical design of protocol SCI-001 (bullet 1, lines
13-15).  The Board agreed to delete this comment because they currently
do not have information on EPA guidelines concerning statistical design
of efficacy protocols.  They agreed that this issue should be discussed
at a future HSRB meeting.

Dr. Philpott asked for clarification of OPP’s suggested deletion of
Subpart L from the ethical requirements for EMD-003 (p. 16, line 11).
Subpart L specifically excludes children and nursing or pregnant women
from studies, such as EMD-003.  Dr. Fisher agreed that Subpart L would
not be deleted and that she and Dr. Lewis would discuss with Mr. John
Carley (OPP, EPA) why OPP had indicated in its comments that only
Subpart K applied to the protocol.

Regarding the HSRB Consensus and Rationale for Scientific Considerations
for EMD-004 (p. 19, lines 1-13), no changes were made aside from the
deletion of the comments about use of different statistical analysis
techniques.  No changes were made to the HSRB Consensus and Rationale
for Ethical Considerations for EMD-004 (p. 22, lines 14-26).

Dr. Fisher asked each Board member for their approval of the revised
January 24, 2007 draft meeting report.  All Board members in attendance
at the teleconference meeting approved the report.  Dr. Fisher thanked
Board members for their participation.

Dr. Lewis reminded HSRB members that the next face-to-face meeting would
be held April 18-20, 2007 in Arlington, Virginia.  The June 2007 HSRB
meeting will cover agenda topics and also will provide time for the HSRB
to review and approve the report from the April 2007 meeting.

The meeting was adjourned by the Chair.

Respectfully submitted:

Paul I. Lewis, Ph.D.

Designated Federal Officer

Human Studies Review Board

United States Environmental Protection Agency

Certified to be true by:

Celia B. Fisher, Ph.D.

Chair

Human Studies Review Board

United States Environmental Protection Agency

NOTE AND DISCLAIMER:  The minutes of this public meeting reflect diverse
ideas and suggestions offered by Board members during the course of
deliberations within the meeting.  Such ideas, suggestions, and
deliberations do not necessarily reflect definitive consensus advice for
the Board members.  The reader is cautioned to not rely on the minutes
to represent final, approved, consensus advice and recommendations
offered to the Agency.  Such advice and recommendations may be found in
the final report prepared and transmitted to the EPA Science Advisor
following the public meeting.

Attachments

Attachment A 		HSRB Members

Attachment B 		Federal Register Notice Announcing Meeting

Attachment C 		Meeting Agenda

Attachment D 		January 24, 2007 EPA Human Studies Review Board Meeting

Proposed Final Draft Report

Attachment A

EPA HSRB Members

Chair

Celia B. Fisher, Ph.D.

Marie Ward Doty Professor of Psychology

Director, Center for Ethics Education

Fordham University

Bronx, NY

Vice Chair

William S. Brimijoin, Ph.D.

Chair and Professor

Molecular Pharmacology and Experimental Therapeutics

Mayo Foundation

Rochester, MN

Members

David C. Bellinger, Ph.D.

Professor of Neurology

Harvard Medical School

Professor in the Department of Environmental Health

Harvard School of Public Health Children's Hospital

Boston, MA

Alicia Carriquiry, Ph.D. *

Professor

Department of Statistics

Iowa State University

Ames, IA

Gary L. Chadwick, PharmD, MPH, CIP

Associate Provost

Director, Office for Human Subjects Protection

University of Rochester

Rochester, NY

Janice Chambers, Ph.D., D.A.B.T.

William L. Giles Distinguished Professor

Director, Center for Environmental Health Sciences

College of Veterinary Medicine

Mississippi State University

Mississippi State, MS

Richard Fenske, Ph.D., MPH

Professor

University of Washington

Department of Environmental and Occupational Health Sciences

Seattle, WA

Susan S. Fish, PharmD, MPH

Associate Professor, Biostatistics & Epidemiology

Boston University School of Public Health

Co-Director, MA in Clinical Investigation

Boston University School of Medicine

Boston, MA

Suzanne C. Fitzpatrick, Ph.D., D.A.B.T.

Senior Science Policy Analyst

Office of the Commissioner

Office of Science and Health Coordination

U.S. Food and Drug Administration

Rockville, MD

KyungMann Kim, Ph.D., CCRP

Professor and Associate Chair

Department of Biostatistics & Medical Informatics

School of Medicine and Public Health

University of Wisconsin-Madison

Madison, WI

Kannan Krishnan, Ph.D.

Professor

Département de santé environnementale et santé au travail

Faculté de médicine

Université de Montréal

Montréal, QC

Michael D. Lebowitz, Ph.D., FCCP

Professor of Public Health & Medicine

University of Arizona

Tucson, AZ

Lois D. Lehman-Mckeeman, Ph.D. *

Distinguished Research Fellow, Discovery Toxicology

Bristol-Myers Squibb Company

Princeton, NJ

Jerry A. Menikoff, M.D. *

Associate Professor of Law, Ethics & Medicine

Director of the Institute for Bioethics, Law and Public Policy

University of Kansas Medical Center

Kansas City, KS

Sean M. Philpott, Ph.D.

Policy and Ethics Director

Global Campaign for Microbicides

Program for Appropriate Technology in Health

Washington, DC

Richard Sharp, Ph.D.

Assistant Professor of Medicine with the Center for Medical Ethics and
Health Policy

Baylor College of Medicine

Houston, TX

* Not in attendance at teleconference

Attachment B

Federal Register Notice Announcing Meeting

Human Studies Review Board (HSRB); Notification of a Public
Teleconference To Review Its Draft Report From the January 24, 2007 HSRB
Meeting

[Federal Register: March 13, 2007 (Volume 72, Number 48)]

[Notices]

[Page 11358-11359]

[DOCID:fr13mr07-51]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2006-0998; FRL-8287-2]

Human Studies Review Board (HSRB); Notification of a Public
Teleconference To Review Its Draft Report From the January 24, 2007 HSRB
Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The EPA Human Studies Review Board (HSRB) announces a public
teleconference meeting to discuss its draft HSRB report from the January
24, 2007 HSRB meeting.

DATES: The teleconference will be held on April 10, 2007, from 1 to
approximately 3 p.m. (Eastern Time).

Location: The meeting will take place via telephone only.

Meeting Access: For information on access or services for individuals
with disabilities, please contact the DFO at least 10 business days
prior to the meeting using the information under FOR

FURTHER INFORMATION CONTACT, so that appropriate arrangements can be
made.

Procedures for Providing Public Input: Interested members of the public
may submit relevant written or oral comments for the HSRB to consider
during the advisory process. Additional information concerning
submission of relevant written or oral comments is provided in Unit I.D.
of this notice.

FOR FURTHER INFORMATION CONTACT: Members of the public who wish to
obtain the call-in number and access code to participate in the
telephone conference, request a current draft copy of the Board's report
or who wish further information may contact Lu-Ann Kleibacker, EPA,
Office of the Science Advisor, (8105R), Environmental Protection Agency,
1200 Pennsylvania Avenue, NW, Washington, DC 20460; or via
telephone/voice mail at<PHONE_NUMBER>. General information concerning
the EPA HSRB can be found on the EPA Web site at   HYPERLINK
"http://www.epa.gov/osa/hsrb/"

http://www.epa.gov/osa/hsrb/ .

ADDRESSES: Submit your written comments, identified by Docket ID No.
EPA-HQ-ORD-2006-0998, by one of the following methods:   HYPERLINK "

http://www.regulations.gov"

http://www.regulations.gov  Follow the on-line instructions for
submitting comments.

E-mail:   HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>.

Mail: ORD Docket, Environmental Protection Agency, Mailcode: 28221T,
1200 Pennsylvania Ave., NW, Washington, DC 20460.

Hand Delivery: EPA Docket Center (EPA/DC), Public Reading Room,
Infoterra Room

(Room Number 3334), EPA West Building, 1301 Constitution Avenue, NW,
Washington, DC 20460, Attention Docket ID No. EPA-ORD-2006-0998.
Deliveries are only accepted from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. Special arrangements should be made
for deliveries of boxed information.

Instructions: Direct your comments to Docket ID No.
EPA-HQ-ORD-2006-0998. EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at   HYPERLINK "http://www.regulations.gov"
http://www.regulations.gov , including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through   HYPERLINK
"http://www.regulations.gov"  http://www.regulations.gov   or e-mail.
The   HYPERLINK "http://www.regulations.gov"  http://www.regulations.gov
 Web site is an ``anonymous access'' system, which means EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send an e-mail comment directly to EPA,
without going through   HYPERLINK "http://www.regulations.gov"
http://www.regulations.gov , your e-mail address will be automatically
captured and included as part of the comment that is placed in the
public docket and made available on the Internet. If you submit an
electronic comment, EPA recommends that you include your name and other
contact information in the body of your comment and with any disk or
CD-ROM you submit. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment. Electronic files should avoid the use of
special characters, any form of encryption, and be free of any defects
or viruses.

I. Public Meeting

A. Does This Action Apply to Me?

This action is directed to the public in general. This action may,
however, be of interest to persons who conduct or assess human studies,
especially studies on substances regulated by EPA, or to persons who are
or may be required to conduct testing of chemical substances under the
Federal Food, Drug, and Cosmetic Act (FFDCA) or the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA). Since other entities may also be
interested, the Agency has not attempted to describe all the specific
entities that may be affected by this action.

If you have any questions regarding the applicability of this action to
a particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

B. How Can I Access Electronic Copies of This Document and Other

Related Information?

In addition to using regulations.gov, you may access this Federal
Register document electronically through the EPA Internet under the
``Federal Register'' listings at   HYPERLINK
"http://www.epa.gov/fedrgstr/"  http://www.epa.gov/fedrgstr/

Docket: All documents in the docket are listed in the   HYPERLINK
"http://www.regulations.gov"  http://www.regulations.gov  index.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is

restricted by statute. Certain other material, such as copyrighted
material, will be publicly available only in hard copy. Publicly
available docket materials are available either electronically in
HYPERLINK "http://www.regulations.gov"  http://www.regulations.gov  or
in hard copy at the ORD Docket, EPA/DC, Public Reading Room, Infoterra
Room (Room Number 3334), EPA West Building, 1301 Constitution Ave., NW.,
Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Public Reading Room is<PHONE_NUMBER>, and the telephone
number for the ORD Docket is<PHONE_NUMBER>.

The January 24, 2007 HSRB meeting draft report is now available. You may
obtain electronic copies of this document, and certain other related
documents that might be available electronically, from the
regulations.gov Web site and the HSRB Internet Home Page at   HYPERLINK
"http://www.epa.gov/osa/hsrb/"  http://

www.epa.gov/osa/hsrb/ . For questions on document availability or if you
do not have access to the Internet, consult the person listed under FOR
FURTHER INFORMATION CONTACT.

C. What Should I Consider as I Prepare My Comments for EPA?

You may find the following suggestions helpful for preparing your
comments:

    1. Explain your views as clearly as possible.

    2. Describe any assumptions that you used.

    3. Provide copies of any technical information and/or data you used
that support your views.

    4. Provide specific examples to illustrate your concerns.

    5. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.

D. How May I Participate in This Meeting?

You may participate in this meeting by following the instructions in
this section. To ensure proper receipt by EPA, it is imperative that you
identify docket ID number EPA-HQ-ORD-2006-0998 in the subject line on
the first page of your request.

1. Oral comments. Requests to present oral comments will be accepted up
to April 3, 2007. To the extent that time permits, interested persons
who have not pre-registered may be permitted by the Chair of the HSRB to
present oral comments at the meeting. Each individual or group wishing
to make brief oral comments to the HSRB is strongly advised to submit
their request (preferably via e-mail) to the person listed under FOR
FURTHER INFORMATION CONTACT no later than noon, eastern time, April 3
2007, in order to be included on the meeting agenda and to provide
sufficient time for the HSRB Chair and HSRB DFO to review the meeting
agenda to provide an appropriate public comment period. The request
should identify the name of the individual making the presentation and
the organization (if any) the individual will represent. Oral comments
before the HSRB are limited to 5 minutes per individual or organization.
Please note that this includes all individuals appearing either as part
of, or on behalf of an organization. While it is our intent to hear a
full range of oral comments on the science and ethics issues under
discussion, it is not our intent to permit organizations to expand these
time limitations by having numerous individuals sign up separately to
speak on their behalf. If additional time is available, there may be
flexibility in time for public comments.

2. Written comments. Although you may submit written comments at any
time, for the HSRB to have the best opportunity to review and consider
your comments as it deliberates on its report, you should submit your
comments at least 5 business days prior to the beginning of this
teleconference. If you submit comments after this date, those comments
will be provided to the Board members, but you should recognize that the
Board members may not have adequate time to consider those comments
prior to making a decision. Thus, if you plan to submit written
comments, the Agency strongly encourages you to submit such comments no
later than noon, Eastern Time, April 3, 2007. You should submit your
comments using the instructions in Unit 1.C. of this notice. In
addition, the Agency also requests that person(s) submitting comments
directly to the docket also provide a copy of their comments to the
person listed under FOR FURTHER INFORMATION CONTACT. There is no limit
on the length of written comments for consideration by the HSRB.

E. Background

The EPA Human Studies Review Board will be reviewing its draft report
from the January 24, 2007 HSRB meeting. Background on the January 24,
2007 HSRB meeting can be found at Federal Register 71 249, 78200
(December 28, 2006) and at the HSRB Web site   HYPERLINK "

http://www.epa.gov/osa/hsrb/"

http://www.epa.gov/osa/hsrb/ . The Board may also discuss planning for
future HSRB meetings.

Dated: March 7, 2007.

George Gray,

EPA Science Advisor.

[FR Doc. E7-4565 Filed 3-12-07; 8:45 am]

BILLING CODE 6560-50-P

Attachment C

3/16/07

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

HUMAN STUDIES REVIEW BOARD (HSRB)

PUBLIC TELECONFERENCE MEETING

APRIL 10, 2007

1:00 pm -3:00 pm (Eastern Time)

HSRB MEETING FOR REVIEW AND APPROVAL OF

DRAFT JANUARY 24, 2007 HSRB MEETING REPORT *

HSRB WEB SITE http://www.epa.gov/osa/hsrb/

Docket Telephone:<PHONE_NUMBER>

Docket Number: EPA-HQ-ORD-2006-0998

Meeting location via telephone only

Members of the public may obtain the call in number at<PHONE_NUMBER>

1:00 PM	Introduction and Identification of Board Members – Celia
Fisher,

Ph.D. (HSRB Chair)

1:15 PM	Welcome – Warren Lux, MD (Human Studies Research Review
Official, Office of the Science Advisor, [OSA])

1:20 PM	Meeting Administrative Procedures - Paul Lewis, Ph.D.
(Designated Federal Officer, HSRB, OSA, EPA)

1:25 PM	Meeting Process – Celia Fisher, Ph.D. (HSRB Chair)

1:30 PM	Public Comments

1:45 PM 	Board Discussion and Decision on Report - Celia Fisher, Ph.D.
(HSRB Chair)

Completed Insect Repellent Completed Efficacy Studies

EMD-003

EMD-004

Insect Repellent Efficacy Protocol SCI-001

2:45 PM 	Summary and Next Steps - Celia Fisher, Ph.D. (HSRB Chair) and
Paul Lewis, Ph.D. (Designated Federal Officer, HSRB, EPA)

3:00 PM 	Adjournment

* Please be advised that agenda times are approximate. For further
information, please contact the Designated Federal Officer for this
meeting, Paul Lewis via telephone:<PHONE_NUMBER> or email:
<EMAIL_ADDRESS>

 PAGE

  PAGE  1


[Federal Register Volume 83, Number 22 (Thursday, February 1, 2018)]
[Proposed Rules]
[Pages 4611-4612]
[FR Doc No: 2018-01795]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2017-1083; Airspace Docket No. 17-ACE-13]

Proposed Amendment of Class D and E Airspace; Kansas City, MO;
and Revocation of Class E Airspace; Kansas City, MO

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to amend Class D airspace at Charles B.
Wheeler Downtown Airport, Kansas City, MO; remove Class E airspace
designated as an extension to Class D airspace at Charles B. Wheeler
Downtown Airport; and amend Class E airspace extending upward from 700
feet above the surface at Kansas City International Airport, Kansas
City, MO, and Charles B. Wheeler Downtown Airport. The FAA is proposing
this action due to the decommissioning of the Riverside VHF
omnidirectional range (VOR) facility, which provided navigation
guidance for the instrument procedures to Charles B. Wheeler Downtown
Airport. The VOR has been decommissioned as part of the VOR Minimum
Operational Network (MON) Program. This action also would amend the
airspace designations of Class D airspace and Class E airspace
extending upward from 700 feet above the surface for these airports.
Additionally, the geographic coordinates and airport name are being
updated to coincide with the FAA's aeronautical database. This action
is necessary for the safety and management of instrument flight rules
(IFR) operations at these airports.

DATES: Comments must be received on or before March 19, 2018.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE, West
Building Ground Floor, Room W12-140, Washington, DC 20590; telephone
(202) 366-9826, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2017-1083; Airspace Docket No. 17-ACE-13 at the beginning of your
comments. You may also submit comments through the internet at http://www.regulations.gov. You may review the public docket containing the
proposal, any comments received, and any final disposition in person in
the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through
Friday, except federal holidays.
    FAA Order 7400.11B, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11B at NARA, call<PHONE_NUMBER>, or go
to https://www.archives.gov/federal-register/cfr/ibr-locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Jeffrey Claypool, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone<PHONE_NUMBER>.

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
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 would support IFR operations at Charles B. Wheeler Downtown
Airport, and Kansas City International Airport, Kansas City, MO.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2017-1083;
Airspace Docket No. 17-ACE-13.'' The postcard will be date/time stamped
and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at http://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address and phone number)
between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the Federal Aviation Administration, Air Traffic
Organization, Central Service Center, Operations Support Group, 10101
Hillwood Parkway, Fort Worth, TX 76177.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11B, Airspace
Designations and Reporting Points, dated August 3, 2017, and effective
September 15, 2017. FAA Order 7400.11B is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11B lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 that would:
    Amend the Class D airspace at Charles B. Wheeler Downtown Airport
by

updating the header of the airspace designation to Kansas City, MO,
(from Kansas City Charles B. Wheeler Downtown Airport, MO) to comply
with FAA Order 7400.2L, Procedures for Handling Airspace Matters;
adding an extension 1 mile each side of the 012[deg] bearing from the
Charles B. Wheeler Downtown RWY 19 LOC from the 4.2-mile radius to 4.4
miles from the airport; adding an extension 1 mile each side of the
013[deg] bearing from the airport from the 4.2-mile radius to 4.3 miles
north of the airport; adding an extension 1 mile each side of the
215[deg] bearing from the Charles B. Wheeler Downtown RWY 03 LOC from
the 4.2-mile radius to 4.5 miles northeast of the airport; adding an
extension 1 mile each side of the 218[deg] bearing from the airport
from the 4.2-mile radius to 5 miles south of the airport; and updating
the geographic coordinates of the airport to coincide with the FAA's
aeronautical database;
    Remove the Class E airspace designated as an extension to Class D
airspace at Charles B. Wheeler Downtown Airport as the airspace is no
longer required; and
    Amend Class E airspace extending upward from 700 feet above the
surface at Kansas City, MO, by updating the header of the airspace
designation to Kansas City, MO, (from Kansas City International
Airport, MO) to comply with FAA Order 7400.2L; updating the name and
geographic coordinates of Charles B. Wheeler Downtown Airport
(previously Kansas City Downtown Airport) and the geographic
coordinates of Sherman Army Airfield (AAF), KS, to coincide with the
FAA's aeronautical database; removing the Kansas City VORTAC, DOTTE
LOM, Riverside VOR/DME, ILS RWY 19R localizer, ILS RWY 19 localizer,
ILS RWY 1L localizer, and ILS RWY 1R localizer from the airspace
description; removing all current extensions at Kansas City
International Airport and Charles B. Wheeler Downtown Airport; and
adding an extension 2 miles each side of the 215[deg] bearing from the
Charles B. Wheeler Downtown RWY 03 LOC from the 6.7-mile radius to 8.7
miles south of the Charles B. Wheeler Downtown Airport.
    Airspace reconfiguration is necessary due to the decommissioning of
the Riverside VOR as part of the VOR MON Program and for the safety and
management of IFR operations at these airports.
    Class D and E airspace designations are published in paragraphs
5000, 6004, and 6005, respectively, of FAA Order 7400.11B, dated August
3, 2017, and effective September 15, 2017, which is incorporated by
reference in 14 CFR 71.1. The Class D and E airspace designations
listed in this document will be published subsequently in the Order.

Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore: (1) Is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
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 will only affect air traffic procedures and air navigation, it is
certified that this proposed rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
 1. The authority citation for 14 CFR part 71 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.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11B,
Airspace Designations and Reporting Points, dated August 3, 2017, and
effective September 15, 2017, is amended as follows:

Paragraph 5000 Class D Airspace.

* * * * *

ACE MO D Kansas City, MO [Amended]

Charles B. Wheeler Downtown Airport, MO
    (Lat. 39[deg]07'23'' N, long. 94[deg]35'34'' W)
Charles B. Wheeler Downtown RWY 19 LOC
    (Lat. 39[deg]06'50'' N, long. 94[deg]35'44'' W)
Charles B. Wheeler Downtown RWY 03 LOC
    (Lat. 39[deg]07'40'' N, long. 94[deg]35'17'' W)

    That airspace extending upward from the surface to and including
3,300 feet MSL within a 4.2-mile radius of Charles B. Wheeler
Downtown Airport, excluding that airspace within the Kansas City, MO
Class B airspace area; and within 1 mile each side of the 012[deg]
bearing from the Charles B. Wheeler Downtown RWY 19 LOC, extending
from the 4.2-mile radius to 4.4 miles north of the airport; and
within 1 mile each side of the 013[deg] bearing from the airport,
extending from the 4.2-mile radius to 4.3 miles north of the
airport; and within 1 mile each side of the 215[deg] bearing from
the Charles B. Wheeler Downtown RWY 03 LOC, extending from the 4.2-
mile radius to 4.5 miles south of the airport; and within 1 mile
each side of the 218[deg] bearing from the airport, extending from
the 4.2-mile radius to 5 miles south of the airport.

Paragraph 6004 Class E Airspace Areas Designated as an Extension to
a Class D or Class E Surface Area.

* * * * *

ACE MO E4 Kansas City Charles B. Wheeler Downtown Airport, MO [Removed]

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ACE MO E5 Kansas City, MO [Amended]

Kansas City International Airport, MO
    (Lat. 39[deg]17'51'' N, long. 94[deg]42'50'' W)
Charles B. Wheeler Downtown Airport, MO
    (Lat. 39[deg]07'23'' N, long. 94[deg]35'34'' W)
Charles B. Wheeler Downtown RWY 03 LOC
    (Lat. 39[deg]07'40'' N, long. 94[deg]35'17'' W)
Sherman Army Airfield (AAF), KS
    (Lat. 39[deg]22'03'' N, long. 94[deg]54'52'' W.)

    That airspace extending upward from 700 feet above the surface
within a 7.6-mile radius of Kansas City International Airport; and
within a 6.7-mile radius of Charles B. Wheeler Downtown Airport; and
within 2 miles each side of the 215[deg] bearing from the Charles B.
Wheeler Downtown RWY 03 LOC, extending from the 6.7-mile radius to
8.7 miles south of the Charles B. Wheeler Downtown Airport; and
within a 6.5-mile radius of the Sherman AAF.

    Issued in Fort Worth, Texas, on January 24, 2018.
Christopher L. Southerland,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2018-01795 Filed 1-31-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: December 12, 2005 (Volume 70, Number 237)]
[Proposed Rules]
[Page 73414-73415]
[DOCID:fr12de05-22]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R06-OAR-2004-TX-0001; FRL-8007-4]

Approval and Promulgation of Implementation Plans; Texas;
Memoranda of Understanding Between Texas Department of Transportation
and the Texas Commission on Environmental Quality

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA is proposing to approve a State Implementation Plan (SIP)
revision submitted by the Texas Commission on Environmental Quality
(TCEQ) on August 15, 2002. This SIP revision approves the adoption by
reference of a Memorandum of Understanding (MOU) between the TCEQ and
the Texas Department of Transportation (TxDOT). The MOU is adopted into
the Texas rule at 30 TAC, Chapter 7, Section 119. This MOU concerns the
coordination of environmental reviews associated with transportation
projects. The adoption by reference of this MOU, will streamline
coordination between the TCEQ and TxDOT by consolidating separate MOUs
currently in the air and water regulations. This action is important to
satisfy the need of the Commission and TxDOT to coordinate regulatory
programs and to ensure that overlapping areas of responsibility are
clarified. This approval will make the MOU revised regulations
Federally enforceable.

DATES: Comments must be received by January 11, 2006.

ADDRESSES: Comments may be mailed to Mr. Thomas Diggs, Chief, Air
Planning Section (6PD-L), Environmental Protection Agency, 1445 Ross
Avenue, Suite 1200, Dallas, Texas 75202-2733. Comments may also be
submitted electronically or through hand delivery/courier by following
the detailed instructions in the ADDRESSES section of the direct final
rule located in the rules section of this Federal Register.

FOR FURTHER INFORMATION CONTACT: Alima Patterson, State/Oversight
Section (6PD-O), Environmental Protection Agency, Region 6, 1445 Ross
Avenue, Suite 700, Dallas, Texas 75202-

2733, telephone<PHONE_NUMBER>; fax number<PHONE_NUMBER>; e-mail address
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION: In the final section of this Federal
Register, EPA is approving the State's SIP submittal as a direct rule
without prior proposal because the Agency views this as a
noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If no adverse comments are received in response to this action no
further activity is contemplated. If EPA receives adverse comments, the
direct final rule will be withdrawn and all public comments received
will be addressed in a subsequent final rule based on this proposed
rule. EPA will not institute a second comment period. Any parties
interested in commenting on this action should do so at this time.
    For additional information, see the direct final rule which is
located in the rules section of this Federal Register.

    Dated: November 18, 2005.
Richard E. Greene,
Regional Administrator, Region 6.
[FR Doc. 05-23914 Filed 12-9-05; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 114 (Wednesday, June 14, 2023)]
[Rules and Regulations]
[Pages 38749-38751]
[FR Doc No: 2023-12707]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2023-0467]
RIN 1625-AA87

Security Zone, Baltimore Harbor, MD.

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary security zone for
navigable waters within Baltimore Northwest Harbor, across the West
channel, in the vicinity of North Locust Point Marine Terminal. The
security zone is needed to protect distinguished guests and attendees
during the commission of the USS CARL M. LEVIN (DDG 120). Entry of
vessels or persons into this zone is prohibited unless specifically
authorized by the Captain of the Port, Sector Maryland-National Capital
Region.

DATES: This rule is effective from 8 a.m. until 1 p.m. on June 24,
2023.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2023-0467 in the search box and click ``Search.'' Next, in the Document
Type column, select ``Supporting & Related Material.''

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email BM1 Michael Klopp, Sector Maryland-NCR, Waterways
Management Division, U.S. Coast Guard: telephone<PHONE_NUMBER>, email
[email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

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 U.S. Navy informed the Coast Guard that the Commissioning of
the USS CARL M. LEVIN (DDG 120) will be held on June 24, 2023, in
Baltimore Harbor, MD. The commissioning will be in close proximity to
navigable waterways within the Captain of the Port, Maryland-National
Capital Region's Area of Responsibility, as set forth in 33 CFR 3.25-
15. On May 30, 2023, the U. S. Navy requested that a security zone be
established to be in effect before, during and after the commissioning
ceremony.
    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
public interest to delay the effective date of this rule. Immediate
action is needed to mitigate potential terrorist acts and to enhance
public and maritime safety and security. The Coast Guard is unable to
publish an NPRM in time to publish a final rule due to the short time
period between May 30, 2023, when the event planners notified the Coast
Guard of the security posture for the event, and June 24, 2023, when
the security zone must be in effect Delaying the effective date to
publish an NPRM would be contrary to the security zone's intended
objectives of mitigating potential terrorist acts and enhancing public
and maritime safety and security. It is therefore impracticable to
publish an NPRM.
    Under 5 U.S.C. 553(d)(3), the Coast Guard also 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 because immediate action to restrict
vessel traffic is needed to protect life, property and the environment,
and delaying the effective date would frustrate the security zone's
intended objectives of mitigating potential terrorist acts and
enhancing public and maritime safety and security when the event takes
place.

III. Legal Authority and Need for Rule

    The Coast Guard may issue security zone regulations under authority
in 46 U.S.C. 70051 and 70124. The Captain of the Port, Maryland-
National Capital Region (COTP) has determined that the commissioning of
a U.S. Naval Warship presents a potential target for terrorist attack,
sabotage, or other subversive acts, accidents, or other causes of
similar nature. This rule is needed to protect distinguished guests and
attendants of the commissioning ceremony of the USS CARL M. LEVIN (DDG
120) as well as personnel in and around the commissioning site,
navigable waterways, and waterfront facilities.

IV. Discussion of the Rule

    This rule establishes a security zone from 8 a.m. until 1 p.m. on
June 24, 2023. The security zone will cover all navigable waters from
North Locust Point Marine Terminal across West Channel Harbor to the
yacht basin Oasis Marina in Northwest Harbor, MD. The duration of the
zone is intended to protect personnel in and around the commissioning
site, navigable waterways, and waterfront facilities. No vessel or
person will be permitted to enter the security zone without obtaining
permission from the COTP or a 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. This rule has not been designated a ``significant
regulatory action,'' under section 3(f) of Executive Order 12866, as
amended by Executive Order 14094 (Modernizing Regulatory Review).
Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB).
    This regulatory action determination is based on the size,
location, and limited duration of the security zone. This zone impacts
a small, designated area of the Northwest Harbor for 5 hours.

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
security 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 (Pub. L. 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
call or email 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.

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, Rev. 1, associated implementing instructions, 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
security zone lasting only 5 hours that will prohibit entry within
certain navigable waters of the Patapsco River. It is categorically
excluded from further review under paragraph L60(a) of Appendix A,
Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of
Environmental Consideration supporting this determination is available
in the docket. For instructions on locating the docket, see the
ADDRESSES section of this preamble.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email 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, 70124; 33 CFR 1.05-1, 6.04-1,
6.04-6, and 160.5; Department of Homeland Security Delegation No.
00170.1, Revision No. 01.3.

0
2. Add Sec.  165.T05-0467 to read as follows:

Sec.  165.T05-0467  Security Zone; Northwest Harbor, Baltimore, MD.

    (a) Location. The following area is a security zone: All navigable
waters of Northwest Harbor, encompassed by a line connecting the
following points beginning at 39[deg]16'21.32'' N, 076[deg]35'4.81'' W,
thence to 39[deg]16'33.74'' N, 076[deg]34'54.59'' W, thence to
39[deg]16'26.98'' N, 076[deg]34'43.79'' W, thence to 39[deg]16'26.18''
N, 076[deg]34'40.62'' W, thence to 39[deg]16'11.42'' N,
076[deg]34'46.56'' W, thence to 39[deg]16'10.56'' N, 076[deg]34'50.20''
W, and thence along the shore line back to the beginning point, located
at Baltimore, MD. These coordinates are based on WGS 84.
    (b) Definitions. As used in this section--
    Captain of the Port (COTP) means the Commander, U.S. Coast Guard
Sector Maryland-National Capital Region.
    Designated representative means any Coast Guard commissioned,
warrant, or petty officer, including a Coast Guard coxswain, petty
officer, or other officer operating a Coast Guard vessel and a Federal,
State, and local officer designated by or assisting the Captain of the
Port Maryland-National Capital Region (COTP) in the enforcement of the
security zone.
    (c) Regulations. (1) Under the general security zone regulations in
subpart D of this part, you may not enter the security zone described
in paragraph (a) of this section unless authorized by the COTP or the
COTP's designated representative.
    (2) 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 security zone must comply

with all lawful orders or directions given to them by the COTP or the
COTP's designated representative.
    (d) Enforcement. The U.S. Coast Guard may be assisted in the patrol
and enforcement of the zone by Federal, State, local agencies.
    (e) Enforcement period. This section will be enforced from 8 a.m.
until 1 p.m. on June 24, 2023.

    Dated: June 8, 2023.
David E. O'Connell,
Captain, U.S. Coast Guard, Captain of the Port Sector Maryland-National
Capital Region.
[FR Doc. 2023-12707 Filed 6-13-23; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 78, Number 7 (Thursday, January 10, 2013)]
[Rules and Regulations]
[Pages 2210-2211]
[FR Doc No: 2012-31742]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 49 and 51

[EPA-HQ-OAR-2003-0076; FRL-9767-8]
RIN 2060-AH37

Review of New Sources and Modifications in Indian Country: Notice
of Action Partially Granting Petition for Reconsideration and Denying
Request for Administrative Stay

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of action partially granting petition for
reconsideration and denying request for administrative stay.

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

SUMMARY: The EPA is providing notice that it has responded to a
petition for reconsideration and a request for an administrative stay
of certain provisions of the rule titled, ``Review of New Sources and
Modifications in Indian Country'' published on July 1, 2011. The EPA
received letters dated August 30, 2011, and November 4, 2011,
petitioning for reconsideration of various aspects of the minor new
source review (NSR) rule (the Petitions) and one provision of the
nonattainment major NSR rule pursuant to the Clean Air Act (CAA) from
the American Petroleum Institute (API), the Independent Petroleum
Association of America (IPAA) and America's Natural Gas Alliance (ANGA)
(collectively, the Petitioners). In the letter dated August 30, 2011,
the Petitioners asked, among other things, that the EPA reconsider the
synthetic minor source provisions of the minor NSR rule and requested
that the EPA stay the effective date of the minor NSR rule as it
relates to synthetic minor sources pending its reconsideration. In

the letter dated November 4, 2011, the Petitioners asked for
reconsideration of several aspects of the minor NSR rule and one aspect
of the nonattainment major NSR rule. The EPA considered the Petitions,
including the request for an administrative stay, along with
information contained in the rulemaking docket, in reaching a decision
on the Petitions generally and the request for an administrative stay
specifically. In letters to the Petitioners dated December 19, 2012,
the EPA Administrator, Lisa P. Jackson, expressed her intent to grant
reconsideration of several aspects of the Petitions and denied
reconsideration of several other aspects raised in the Petitions,
including the request for administrative stay. She took no action at
this time with respect to several other issues raised in the Petitions.
The denials of reconsideration and of the request for an administrative
stay constitute final agency action.

DATES: January 10, 2013.

FOR FURTHER INFORMATION CONTACT: Ms. Jessica Monta[ntilde]ez, Air
Quality Policy Division, Office of Air Quality Planning and Standards
(C504-03), U.S. Environmental Protection Agency, Research Triangle
Park, NC 27711, telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Where can I get copies of this document and other related
information?

    This Federal Register notice, the petitions for reconsideration and
the letter granting certain aspects of the petitions for
reconsideration and denying the request for an administrative stay are
available in the docket that the EPA established for the final rule
titled, ``Review of New Sources and Modifications in Indian Country,''
published on July 1, 2011, 76 FR 38748, under Docket ID No. EPA-HQ-OAR-
2003-0076. The table below identifies the Petitioners, the dates the
EPA received the Petitions, the document identification number of the
Petitions, the date of the EPA's response, and the document
identification number for the EPA's response.

----------------------------------------------------------------------------------------------------------------
                                                                                The EPA
                                    Dates of petitions to     Petition:       Date of the EPA        response:
            Petitioners                    the EPA          document No.          response         document  No.
                                                              in docket                              in docket
----------------------------------------------------------------------------------------------------------------
American Petroleum Institute (API)/ 08/30/2011 and 11/04/            0172  December 19, 2012....            0173
 Independent Petroleum Association   2011.
 of America (IPAA)/America's
 Natural Gas Alliance (ANGA).
----------------------------------------------------------------------------------------------------------------
Note: All document numbers listed in the table are in the form of ``EPA-HQ-OAR-2003-0076-xxxx.''

    All documents in the docket are listed on the http://www.regulations.gov Web site. Although listed in the index, some
information may not be publicly available, i.e., confidential business
information or other information whose disclosure is restricted by
statute. Certain other material, such as copyrighted material, is not
placed on the Internet and will be publicly available only in hard copy
form. Publicly available docket materials are available electronically
through http://www.regulations.gov or in hard copy at the EPA Docket
Center, Docket ID. No. EPA-HQ-OAR-2003-0076, EPA West, Room 3334, 1301
Constitution Avenue, North West, Washington, DC. The Public Reading
Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone number for the Public Reading
Room is<PHONE_NUMBER>, and the telephone number for the EPA Docket
Center is<PHONE_NUMBER>.
    In addition to being available in the docket, an electronic copy of
this Federal Register notice and the EPA's response letter to the
petitioners are also available on the World Wide Web at http://www.epa.gov/nsr and on the Tribal Air home page at http://www.epa.gov/oar/tribal.

II. Judicial Review

    Under CAA section 307(b), judicial review of this final action is
available only by filing a petition for review in the U.S. Court of
Appeals for the District of Columbia Circuit on or before March 11,
2013.

    Dated: December 27, 2012.
Gina McCarthy,
Assistant Administrator, Office of Air and Radiation.
[FR Doc. 2012-31742 Filed 1-9-13; 8:45 am]
BILLING CODE 6560-50-P