[Federal Register Volume 78, Number 58 (Tuesday, March 26, 2013)]
[Proposed Rules]
[Pages 18266-18267]
[FR Doc No: 2013-06944]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2013-0185; Airspace Docket No. 13-ANM-8]

Proposed Establishment of Class E Airspace; Gillette, WY

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to establish Class E airspace at the
Gillette VHF Omni-Directional Radio Range/Distance Measuring Equipment
(VOR/DME), Gillette, WY to facilitate vectoring of Instrument Flight
Rules (IFR) aircraft under control of Denver, Salt Lake City and
Minneapolis Air Route Traffic Control Centers (ARTCCs). The FAA is
proposing this action to enhance the safety and management of aircraft
operations within the National Airspace System.

DATES: Comments must be received on or before May 10, 2013.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590;
telephone<PHONE_NUMBER>. You must identify FAA Docket No. FAA-2013-
0185; Airspace Docket No. 13-ANM-8, at the beginning of your comments.
You may also submit comments through the Internet at http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Eldon Taylor, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue SW., Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

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 (FAA Docket No.
FAA 2013-0185 and Airspace Docket No. 13-ANM-8) and be submitted in
triplicate to the Docket Management System (see ADDRESSES section for
address and phone number). You may also submit comments through the
Internet at http://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed stamped
postcard on which the following statement is made: ``Comments to FAA
Docket No. FAA-2013-0185 and Airspace Docket No. 13-ANM-8''. The
postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified closing date
for comments will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the closing date
for comments. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRM's

    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/airports_airtraffic/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 Northwest Mountain Regional Office of the Federal
Aviation Administration, Air Traffic Organization, Western Service
Center, Operations Support Group, 1601 Lind Avenue SW., Renton, WA
98057.
    Persons interested in being placed on a mailing list for future
NPRM's should contact the FAA's Office of Rulemaking,<PHONE_NUMBER>,
for a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) Part 71 by establishing Class E en route domestic
airspace extending upward from 1,200 feet above the surface at the
Gillette VOR/DME, Gillette, WY. This action would contain aircraft
while in IFR conditions under control of Denver, Salt Lake City and
Minneapolis ARTCCs by vectoring aircraft from en route airspace to
terminal areas.
    Class E airspace designations are published in paragraph 6006, of
FAA Order 7400.9W, dated August 8, 2012, and effective September 15,
2012, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation listed in this document will be published
subsequently in this Order.
    The FAA has determined this proposed regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this proposed regulation; (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 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.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes
the authority for 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 would establish controlled airspace at Gillette VOR/DME,
Gillette, WY.
    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1E, ``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(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 the Federal
Aviation Administration Order 7400.9W, Airspace Designations and
Reporting Points, dated August 8, 2012, and effective September 15,
2012 is amended as follows:

Paragraph 6006 En Route Domestic Airspace Areas.

* * * * *

ANM WY E6 Gillette, WY [New]

Gillette VOR/DME, WY
    (Lat. 44[deg]20'52'' N., long. 105[deg]32'37'' W.)

    That airspace extending upward from 1,200 feet above the surface
within an area bounded by lat. 43[deg]01'57'' N., long.
107[deg]06'08'' W.; to lat. 42[deg]52'37'' N., long. 107[deg]47'58''
W.; to lat. 44[deg]09'12'' N., long. 108[deg]02'32'' W.; to lat.
44[deg]38'58'' N., long. 106[deg]53'16'' W.; to lat. 45[deg]48'16''
N., long. 106[deg]34'25'' W.; to lat. 45[deg]36'35'' N., long.
104[deg]05'26'' W.; to lat. 45[deg]06'45'' N., long. 100[deg]48'20''
W.; to lat. 44[deg]02'34'' N., long. 100[deg]44'12'' W.; to lat.
43[deg]40'10'' N., long. 99[deg]37'18'' W.; to lat. 43[deg]14'52''
N., long. 100[deg]08'15'' W.; to lat. 43[deg]41'03'' N., long.
101[deg]28'52'' W.; to lat. 44[deg]40'23'' N., long. 101[deg]32'34''
W.; to lat. 44[deg]44'40'' N., long. 104[deg]52'04'' W.; to lat.
43[deg]29'00'' N., long. 104[deg]14'29'' W.; to lat. 43[deg]22'06''
N., long. 104[deg]46'22'' W.; to lat. 44[deg]35'02'' N., long.
105[deg]59'24'' W.; thence to the point of beginning.

    Issued in Seattle, Washington, on March 18, 2013.
Clark Desing,
Manager, Operations Support Group, Western Service Center.
[FR Doc. 2013-06944 Filed 3-25-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 165 (Thursday, August 25, 2011)]
[Notices]
[Pages 53141-53142]
[FR Doc No: 2011-21747]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4009-DR; Docket ID FEMA-2011-0001]

Minnesota; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Minnesota (FEMA-4009-DR), dated July 28,
2011, and related determinations.

DATES: Effective Date: July 28, 2011.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated July 28, 2011, the President issued a major disaster declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''), as follows:

    I have determined that the damage in certain areas of the State
of Minnesota resulting from severe storms, flooding, and tornadoes
during the period of July 1-11, 2011, is of sufficient severity and
magnitude to warrant a major disaster declaration under the Robert
T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C.
5121 et seq. (the ``Stafford Act''). Therefore, I declare that such
a major disaster exists in the State of Minnesota.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Public Assistance in the
designated areas and Hazard Mitigation throughout the State.
Consistent with the requirement that Federal assistance is
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance and Hazard Mitigation will be limited to 75
percent of the total eligible costs.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order

12148, as amended, Lawrence Sommers, of FEMA is appointed to act as the
Federal Coordinating Officer for this major disaster.
    The following areas of the State of Minnesota have been designated
as adversely affected by this major disaster:

    Chisago, Isanti, Kandiyohi, Lincoln, Lyon, McLeod, Meeker, Mille
Lacs, Pine, Pipestone, Redwood, Renville, Stearns, and Yellow
Medicine Counties and the Mille Lacs Band of Ojibwe for Public
Assistance.
    All counties and Indian Tribes within the State of Minnesota are
eligible to apply for assistance under the Hazard Mitigation Grant
Program.

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

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-21747 Filed 8-24-11; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 77, Number 27 (Thursday, February 9, 2012)]
[Notices]
[Page 6814]
[FR Doc No: 2012-3056]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4042-DR; Docket ID FEMA-2012-0002]

Virginia; Amendment No. 5 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the Commonwealth of Virginia (FEMA-4042-DR), dated November 4,
2011, and related determinations.

DATES: Effective Date: February 1, 2012.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the Commonwealth of Virginia is hereby amended to include the
following areas among those areas determined to have been adversely
affected by the event declared a major disaster by the President in his
declaration of November 4, 2011.

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

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2012-3056 Filed 2-8-12; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register: August 17, 2007 (Volume 72, Number 159)]
[Notices]
[Page 46257-46258]
[DOCID:fr17au07-95]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56239; File No. SR-CBOE-2007-84]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing of a Proposed Rule Change To Amend
CBOE's Rule Pertaining to Verification Requests for Trade Reporting
Minor Rule Violations

August 10, 2007.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on July 18, 2007, the Chicago Board Options Exchange, Incorporated
(``CBOE'' or ``Exchange'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I, II, and III below, which Items have been substantially
prepared by the Exchange. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend CBOE Rule 17.50 (Imposition of Fines
for Minor Rule Violations) Interpretation and Policy .02(b) regarding
verification requests for fines imposed pursuant to the provisions of
CBOE Rule 17.50(g)(4) (Failure to Submit Trade Information on Time and
Failure to Submit Trade Information to the Price Reporter).
    The text of the proposed rule change is available on the Exchange's
Web site (http://www.cboe.com), at the Exchange's principal office, and

at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of, and basis for, the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of this proposal is to increase the ``look-back''
period in connection with determining the maximum number of
transactions during a given month for which a member fined under CBOE
Rule 17.50(g)(4) can request verification. The Exchange proposes to
increase this ``look-back'' period from a rolling 18-month period to a
rolling 24-month period. CBOE Rule 6.51 provides, in part, that a
participant in each transaction to be designated by the Exchange must
report or ensure the transaction is reported to the Exchange within 90
seconds of the execution, in a form and manner prescribed by the
Exchange, so that the trade information may be reported to time and
sales reports. Transactions not reported within 90 seconds after
execution, in accordance with CBOE Rule 6.51(a)(i), shall be designated
as late. The Exchange recently amended CBOE Rule 17.50(g)(4) and
lengthened its ``look-back'' period for assessing fine amounts to a
rolling 24-month period for violations of CBOE Rule 6.51 in connection
with trade reporting.\3\ The Exchange believes that lengthening the
rolling period for determining the maximum number of transactions
during a given month for which a member can submit verification
requests to a 24-month period will serve as an effective deterrent to
such violative conduct.
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    \3\ See Securities Exchange Act Release No. 54827 (November 29,
2006), 71 FR 70810 (December 6, 2006) (approving SR-CBOE-2006-81).
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2. Statutory Basis
    The Exchange believes that the proposed rule changes will
strengthen its ability to carry out its oversight responsibilities as a
self-regulatory organization and reinforce its surveillance and
enforcement functions. The Exchange believes that the proposed rule
change is consistent with section 6(b) of the Act,\4\ in general, and
furthers the objectives of section 6(b)(5) of the Act,\5\ in
particular, in that it would promote just and equitable principles of
trade, facilitate transactions in securities, remove impediments to and
perfect the mechanisms of a free and open market and a national market
system, and protect investors and the public interest.
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    \4\ 15 U.S.C. 78f(b).
    \5\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    This proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve such proposed rule change, or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File No. SR-CBOE-2007-84 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, Station Place, 100 F
Street, NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-CBOE-2007-84. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of CBOE. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-CBOE-2007-84 and should be
submitted on or before September 7, 2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\6\
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    \6\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-16210 Filed 8-16-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 77, Number 119 (Wednesday, June 20, 2012)]
[Notices]
[Page 37035]
[FR Doc No: 2012-14982]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER12-1987-000]

O.L.S. Energy-Agnews, Inc.; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
O.L.S. Energy-Agnews, Inc.'s application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is July 2, 2012.
    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 Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding 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 email notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please email<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: June 11, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-14982 Filed 6-19-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 169 (Thursday, September 1, 2022)]
[Rules and Regulations]
[Pages 53668-53670]
[FR Doc No: 2022-18913]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2022-0687]
RIN 1625-AA00

Safety Zone; Ohio River Mile Marker 317.5 to Mile Marker 318.5,
Catlettsburg, KY

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a safety zone for all
navigable waters of the Ohio River between mile markers 317.5 and
318.5. The safety zone is needed to protect personnel, vessels, and the
marine environment from the potential hazards created by a fireworks
display. Entry of vessels or persons into this zone is prohibited
unless specifically authorized by Captain of the Port Sector Ohio
Valley or a designated representative.

DATES: This rule is effective from 8:15 p.m. through 9:15 p.m. on
September 2, 2022.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2022-0687 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 MST2 Justin Selan, Marine Safety Unit Huntington, U.S.
Coast Guard;<PHONE_NUMBER>, [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 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 we must establish the safety zone by
September 2, 2022 and lack sufficient time to request public comments
and respond to these comments before the safety zone must be
established.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be contrary to the public interest because immediate
action is needed to respond to the potential safety hazards associated
with the Catlettsburg Labor Day Fireworks Display taking place on the
Ohio River between mile marker 317.5 and mile marker 318.5.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034. The Captain of the Port Ohio Valley (COTP) has determined that
potential hazards associated with Catlettsburg Labor Day Fireworks
Display starting September 2, 2022, will be a safety concern for anyone
on the Ohio River from mile marker 317.5 to mile marker 318.5. This
rule is needed to protect personnel, vessels, and the marine
environment from potential hazards associated with a fireworks display.

IV. Discussion of the Rule

    This rule establishes a safety zone from 8:15 p.m. through 9:15
p.m. on September 2, 2022. The safety zone will cover all navigable
waters between mile markers 317.5 and 318.5 on the Ohio River. The
duration of the safety zone is intended to protect personnel, vessels,
and the marine environment from potential hazards created by a
fireworks display.
    No vessel or person will be permitted to enter the safety zone
without obtaining permission from the COTP or a designated
representative. A designated representative is a commissioned, warrant,
or petty officer of the U.S. Coast Guard (USCG) assigned to units under
the operational control of the COTP. To seek permission to enter,
contact the COTP or a designated representative via VHF-FM channel 16,
or through Marine Safety Unit Huntington at<PHONE_NUMBER>. Persons and
vessels permitted to enter the safety zone must comply with all lawful
orders or directions issued by the COTP or designated representative.
The COTP or a designated representative will inform the public of the
effective period for the safety zone as well as any changes in the
dates and times of enforcement through Local Notice to Mariners (LNMs),
Broadcast Notices to Mariners (BNMs), and/or Marine Safety Information
Bulletins (MSIBs), as appropriate.

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 Executive Order 12866. 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 duration of the safety zone. This safety zone impacts a
1-mile stretch of the Ohio River for a limited duration of less than 2
hours. Vessel traffic will be informed about the safety zone through
local notices to mariners. Moreover, the Coast Guard will issue
Broadcast Notices to Mariners via VHF-FM marine channel 16 about the
zone and the rule allows vessels to seek permission to transit the
zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000.

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not
have a significant economic impact on a substantial number of small
entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (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
safety zone lasting from 8:15 p.m. through 9:15 p.m. on September 2,
2022, that will limit access of the Ohio River from mile marker 317.5
to mile marker 318.5. 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; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No.
00170.1, Revision No. 01.2.

0
2. Add Sec.  165.T08-0687 to read as follows:

Sec.  165.T08-0687  Safety Zone; Ohio River, Catlettsburg, KY.

    (a) Regulated area. The regulations in this section apply to the
following area: all navigable waters of the Ohio River from mile marker
317.5 to mile marker 318.5 near 26th Street Catlettsburg, KY.
    (b) Definitions. Designated representative means a Coast Guard
Patrol Commander (PATCOM), 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 Ohio Valley (COTP) in the enforcement of the regulations in this
section.
    Participant means all persons and vessels registered with the event
sponsor as a participants in the race.
    (c) Regulations. (1) The Coast Guard may patrol the event area
under the direction of a designated Coast Guard Patrol Commander. The
Patrol Commander may be contacted on Channel 16 VHF-FM (156.8 MHz) by
the call sign ``PATCOM.''
    (2) All persons and vessels not registered with the sponsor as
participants or official patrol vessels are considered spectators. The
``official patrol vessels'' consist of any Coast Guard, state or local
law enforcement and sponsor provided vessels assigned or approved by
the Commander, Eighth Coast Guard District, to patrol the event.
    (3) Spectator vessels desiring to transit the regulated area may do
so only with prior approval of the Patrol Commander and when so
directed by that officer and will be operated at a no wake speed in a
manner which will not endanger participants in the event or any other
craft.
    (4) No spectator shall anchor, block, loiter, or impede the through
transit of participants or official patrol vessels in the regulated
area during the effective dates and times, unless cleared for entry by
or through an official patrol vessel.
    (5) The Patrol Commander may forbid and control the movement of all
vessels in the regulated area. When hailed or signaled by an official
patrol vessel, a vessel shall come to an immediate stop and comply with
the directions given. Failure to do so may result in expulsion

from the area, citation for failure to comply, or both
    (6) Any spectator vessel may anchor outside the regulated area
specified above, but may not anchor in, block, or loiter in a navigable
channel.
    (7) The Patrol Commander may terminate the event or the operation
of any vessel at any time it is deemed necessary for the protection of
life or property.
    (8) To seek permission to enter, contact the COTP or the COTP's
representative by VHF-FM marine radio channel 16 or phone at 1-800-253-
7465. Those in the regulated area must comply with all lawful orders or
directions given to them by the COTP or the designated representative.
    (9) The COTP will provide notice of the regulated area through
advanced notice via local notice to mariners and broadcast notice to
mariners and by on-scene designated representatives.
    (d) Enforcement periods. This safety zone will be enforced from
8:15 p.m. to 9:15 p.m. on September 2, 2022.

    Dated: August 25, 2022.
H.R. Mattern,
Captain, U.S. Coast Guard, Captain of the Port Ohio Valley.
[FR Doc. 2022-18913 Filed 8-31-22; 8:45 am]
BILLING CODE 9110-04-P


This document represents the best judgment of the EPA staff conducting analyses to support the Phase II Section 316( b) rule at this time. It does not represent the final position of the Administrator or EPA on this rulemaking. EPA reserves the right to change or amend any of the statements within this document up until the time that the EPA Administrator takes final action on this rule.

Page 1 of 5 Response to Greg Seegert, EA Questions Regarding Derivation of Study Costs Presented in the Information Collection Request ( ICR) for the Proposed Phase II Rule.

On June 20, 2001, EPA staff and their consultants participated in a conference call with Greg Seegert from EA Engineering, Science, and Technology, Inc. He has been retained by the Utility Water Act Group ( UWAG) to review the rulemaking record associated with the proposed section 316( b) Phase II rule for cooling water intake structures at large existing utility and nonutility power producers. His questions concerned the derivation of study costs presented in the Information Collection Request ( ICR) for the Proposed Phase II Rule. To respond to his questions and to provide additional clarification, the following was developed.

General Derivation of Study Activities and Costs Burden estimates developed for the Source Water Biological Characterization Study ( SWBC) for the Phase I final rule were used as the basis for the burden estimates for the Impingement Mortality and Entrainment Characterization ( IMEC) study for the Phase II proposed rule. The IMEC study for the Phase II proposed rule covers the same types of activities as the SWBC study for the Phase I final rule. Labor rates were based on the BLS Occupational Outlook Handbook 2002 2003. Based on the experience of scientists who have performed similar studies in the past it was estimated that most facilities will not have the appropriate expertise in house and will contract the study to consultants. Therefore, the burden estimates, operation and maintenance costs, and labor rate loading factors for the anticipated activities reflect that the work was performed by both in house staff and contract biologists.

The following steps were followed in deriving the study burden and cost estimates.

  Step 1: Develop list and description of each study activity.   Step 2: Develop initial hourly burden estimates for each of the activities.   Step 3: Develop estimates for the labor categories and experience level of the people performing the tasks. These estimates were derived using best professional judgment ( BPJ) of consultants who have many years experience doing similar studies. The Bureau of Labor Statistic's ( BLS) Occupational Outlook Handbook 2000 2001 was used to derive hourly wages for each labor category. Then the BLS's Employment Cost Trends for March 2001 were used to develop a fully loaded labor rate.   Step 4: Develop estimates of the likely capital, operation & maintenance, and other direct costs. This document represents the best judgment of the EPA staff conducting analyses to support the Phase II Section 316( b) rule at this time. It does not represent the final position of the Administrator or EPA on this rulemaking. EPA reserves the right to change or amend any of the statements within this document up until the time that the EPA Administrator takes final action on this rule.

Page 2 of 5 Below is a description of each study activity and the assumed burden by labor category, followed by the anticipated number of total hours for the study in parenthesis.

Implement Sampling Samples will be taken at each facility on a biweekly basis over three years ( i. e., 26 sampling events), assuming 3 sites and 5 samples at each site, for a total of 1,170 samples. It was estimated ( based on experience performing similar studies) that sampling will require 30% more effort at estuary sites than at freshwater sites, due to increased logistical complexities and the higher density of organisms typically present.

  The facility manager will make occasional seasonal visits to supervise the sampling ( 8 hrs freshwater / 10 hrs estuary).   Facility junior technical staff spend approximately one hour every two weeks to review the monitoring results from the sampling events ( 78 hrs freshwater / 101 hrs estuary).   The manager of the contracted firm spends two hours supervising the sampling every two weeks ( 160 hrs).   A biologist and a biological technician each spend 20 hrs every two weeks ( approximately 1 hr 20 minutes each per freshwater sample and 1 hr 45 min each per estuary sample) conducting sampling ( 1,560 hrs freshwater / 2,028 hrs estuary).   A statistician spends a week each year analyzing the sampling results ( 120 hrs).   Clerical staff spend 20 hours a year handling and delivering sampling results to the facility and contracted employees ( 60 hrs).

Profile of Source Water Biota Based on the past experience of consultants who have performed similar studies, it was assumed that much of the work of profiling the source water biota will be carried out by contracted employees. However, the facility manager will take a more active role in reviewing this work as this information will form the basis of the study results that he submits to the Director   The facility manager spends 1 day per year reviewing lab results and documentation ( 32 hrs).   Facility junior technical staff spend approximately 6 to 7 hours a year assisting the facility manager with the review of lab results and documentation ( 20 hrs).   The manager of the contracted firm spends 1 day per year reviewing lab results and documentation ( 32 hrs). This document represents the best judgment of the EPA staff conducting analyses to support the Phase II Section 316( b) rule at this time. It does not represent the final position of the Administrator or EPA on this rulemaking. EPA reserves the right to change or amend any of the statements within this document up until the time that the EPA Administrator takes final action on this rule.

Page 3 of 5   A biologist spends 20 hrs per year reviewing and characterizing the data based on lab results and statistical analysis ( 60 hrs).   A biological technician spends approximately 6 to 7 hours a year assisting the biologist with the review of lab results ( 20 hrs).   Clerical staff spend approximately 2 to 3 hours a year handling the lab results and documentation ( 8 hrs).

Identification of Critical Species The identification of critical species will be based on the profiles of source water biota, the results of the statistical analysis, and a review of current information. Identification of critical species will be carried out by the contracted employees. However, the facility manager will take a more active role in reviewing this work as this information will form the basis of the study results that he submits to the State.

  The facility manager spends 3 days reviewing biota profiles and current information ( 32 hrs).   Facility junior technical staff spend approximately 20 hours assisting the facility manager with reviewing biota profiles and current information ( 20 hrs).   The manager of the contracted firm spends approximately 20 hours assisting the facility manager with reviewing biota profiles and current information ( 20 hrs).   A biologist spends one week assisting the facility manager with reviewing biota profiles and current information ( 40 hrs).   Clerical staff spend 3 hours gathering materials and documents ( 3 hrs).

Write Study and Submit for Review by Director The study will be written towards the end of the third year, primarily by the facility manager and junior staff.

  The facility manager spends 2 weeks outlining the report, writing critical sections, and reviewing the work done by the junior staff ( 80 hrs).   Facility junior technical staff spend approximately 4 weeks drafting the bulk of the report and supporting materials ( 160 hrs).   The manager of the contracted firm spends approximately one day assisting the facility manager by providing expert opinion when needed and one day reviewing a draft of the study ( 16 hrs).   A biologist spends one day assisting with providing expert opinion and reviewing study ( 8 hrs). This document represents the best judgment of the EPA staff conducting analyses to support the Phase II Section 316( b) rule at this time. It does not represent the final position of the Administrator or EPA on this rulemaking. EPA reserves the right to change or amend any of the statements within this document up until the time that the EPA Administrator takes final action on this rule.

Page 4 of 5   A statistician also spends one day assisting with providing expert opinion and reviewing study ( 8 hrs).   Clerical staff spends 8 hours assisting with preparing the report for submission ( 8 hrs).

Recordkeeping Due to the necessity of the study for obtaining a permit, the facility staff and the contracted employees will spend time to ensure that both paper and electronic copies of all results, analyses, studies, and reviews are maintained.

  The facility manager spends 6 hours maintaining records ( 6 hrs).   Facility junior technical staff spend 12 hours maintaining records ( 12 hrs).   The manager of the contracted firm spends 6 hours maintaining records ( 6 hrs).   Clerical staff spends 3 days maintaining records ( 24 hrs).

Finalize Study based on Director Review EPA anticipates that the Director will have questions and comments on the study that will require the facility staff to revise the study further.

  The facility manager spends 2 days reviewing the Director's comments and questions and then crafting appropriate responses ( 16 hrs).   Facility junior technical staff spend 4 days revising the study ( 32 hrs).   Clerical staff spend one day resubmitting the study and maintaining records ( 8 hrs).

Other Direct Costs Other direct costs ( ODCs) were also expected to vary for facilities depending on whether they were located adjacent to freshwater waterbody or an estuary. It was estimated based on the past experience of consultants who have performed similar studies that estuary facilities will incur 30% more ODC costs than those located on freshwater rivers or streams. The three year totals are as follows.

  Study ODCs for freshwater facilities is $ 7,800.   Study ODCs for estuary facilities is $ 13,000. This document represents the best judgment of the EPA staff conducting analyses to support the Phase II Section 316( b) rule at this time. It does not represent the final position of the Administrator or EPA on this rulemaking. EPA reserves the right to change or amend any of the statements within this document up until the time that the EPA Administrator takes final action on this rule.

Page 5 of 5 Capital and Operation & Maintenance Costs Based on the experience of consultants who have performed similar studies in the past, it was assumed that the actual laboratory analysis of samples will be performed by an outside laboratory. Therefore these costs were considered O & M costs.

  The laboratory analysis cost per sampling event was estimated at $ 100 per freshwater sample ($ 117,000 total lab cost), and $ 130 per estuary sample plus 30% effort increase ($ 197,730 in lab costs).   Additionally, it was anticipated that the facility will be charged approximately $ 500 annually in additional fees for materials and other incidental costs incurred by the laboratory ($ 1,500 total).


[Federal Register Volume 80, Number 86 (Tuesday, May 5, 2015)]
[Notices]
[Pages 25768-25769]
[FR Doc No: 2015-10445]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2008-0106; FMCSA-2009-0086]

Qualification of Drivers; Exemption Applications; Vision

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

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

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

DATES: This decision is effective June 12, 2015. Comments must be
received on or before June 4, 2015.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) numbers: Docket No. [Docket No. FMCSA-2008-
0106; FMCSA-2009-0086], using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the on-line instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and
5 p.m., Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket number for this notice. Note that DOT posts all comments
received without change to http://www.regulations.gov, including any
personal information included in a comment. Please see the Privacy Act
heading below.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The Federal Docket Management System (FDMS) is
available 24 hours each day, 365 days each year. If you want
acknowledgment that we received your comments, please include a self-
addressed, stamped envelope or postcard or print the acknowledgement
page that appears after submitting comments on-line.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

FOR FURTHER INFORMATION CONTACT: Charles A. Horan, III, Director,
Carrier, Driver and Vehicle Safety Standards,<PHONE_NUMBER>,
<EMAIL_ADDRESS>FMCSA, Department of Transportation, 1200 New
Jersey Avenue SE., Room W64-224, Washington, DC 20590-0001. Office
hours are from 8:30 a.m. to 5 p.m. Monday through Friday, except
Federal holidays.

SUPPLEMENTARY INFORMATION:

I. Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may renew an exemption
from the vision requirements in 49 CFR 391.41(b)(10), which applies to
drivers of CMVs in interstate commerce, for a two-year period if it
finds ``such exemption would likely achieve a level of safety that is
equivalent to or greater than the level that would be achieved absent
such exemption.'' The procedures for requesting an exemption (including
renewals) are set out in 49 CFR part 381.

II. Exemption Decision

    This notice addresses 10 individuals who have requested renewal of
their exemptions in accordance with FMCSA procedures. FMCSA has
evaluated these 10applications for renewal on their merits and decided
to extend each exemption for a renewable two-year period. They are:
Michael D. Abel (NE), Paul M. Christina (PA), Kenneth W. Dunn (TN),
Edward J. Grant (IL), Johnny K. Hiatt (NC), Richard S. Hoffman (ID),
Jeffrey M. Mueller (MO), George M. Nelson (OH), Christopher A. Weidner
(CT), Paul A. Wolfe (OH).

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

III. Basis for Renewing Exemptions

    Under 49 U.S.C. 31315(b)(1), an exemption may be granted for no
longer than two years from its approval date and may be renewed upon
application for additional two year periods. In accordance with 49
U.S.C. 31136(e) and 31315, each of the 10 applicants has satisfied the
entry conditions for obtaining an exemption from the vision
requirements (74 FR 19267; 74 FR 28094; 76 FR 32016; 78 FR 32703). Each
of these 10 applicants has requested renewal of the exemption and has
submitted evidence showing that the vision in the better eye continues
to meet the requirement specified at 49 CFR 391.41(b)(10) and that the
vision impairment is stable. In addition, a review of each record of
safety while driving with the respective vision deficiencies over the
past two years indicates each applicant continues to meet the vision
exemption requirements. These factors provide an adequate basis for
predicting each driver's ability to continue to drive safely in
interstate commerce. Therefore, FMCSA concludes that extending the
exemption for each renewal applicant for a period of two years is
likely to achieve a level of safety equal to that existing without the
exemption.

IV. Public Participation and Request for Comments

    FMCSA encourages you to participate by submitting comments and
related materials.

Submitting Comments

    If you submit a comment, please include the docket number for this
notice (FMCSA-2008-0106; FMCSA-2009-0086), indicate the specific
section of this document to which each comment applies, and provide a
reason for each suggestion or recommendation. You may submit your
comments and material online or by fax, mail, or hand delivery, but
please use only one of these means. FMCSA recommends that you include
your name and a mailing address, an email address, or a phone number in
the body of your document so the Agency can contact you if it has
questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov and
put the docket number, ``FMCSA-2008-0106; FMCSA-2009-0086'' in the
``Keyword'' box, and click ``Search.'' When the new screen appears,
click on ``Comment Now!'' button and type your comment into the text
box in the following screen. Choose whether you are submitting your
comment as an individual or on behalf of a third party and then submit.
If you submit your comments by mail or hand delivery, submit them in an
unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the facility, please enclose a stamped,
self-addressed postcard or envelope. FMCSA will consider all comments
and material received during the comment period and may change this
notice based on your comments.

Viewing Comments and Documents

    To view comments, as well as any documents mentioned in this
preamble as being available in the docket, go to http://www.regulations.gov and in the search box insert the docket number,
``FMCSA-2008-0106; FMCSA-2009-0086'' in the ``Keyword'' box and click
``Search.'' Next, click ``Open Docket Folder'' button choose the
document listed to review. If you do not have access to the Internet,
you may view the docket online by visiting the Docket Management
Facility in Room W12-140 on the ground floor of the DOT West Building,
1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5
p.m., e.t., Monday through Friday, except Federal holidays.

    Issued on: April 29, 2015.
 Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2015-10445 Filed 5-4-15; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 86, Number 183 (Friday, September 24, 2021)]
[Notices]
[Page 53129]
[FR Doc No: 2021-20657]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-93066; File No. SR-NYSEArca-2021-52]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of
Withdrawal of a Proposed Rule Change To Amend the NYSE Arca Equities
Fees and Charges

September 20, 2021.

I. Introduction

    On June 14, 2021, NYSE Arca, Inc. (``NYSE Arca'' or the
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change (File No. SR-NYSEArca-2021-52) to amend the NYSE
Arca Equities Fees and Charges (``Fee Schedule'').\3\ The proposed rule
change was immediately effective upon filing with the Commission
pursuant to Section 19(b)(3)(A) of the Act.\4\ The proposed rule change
was published for comment in the Federal Register on July 6, 2021.\5\
The Commission received no comment letters regarding the proposed rule
change. On August 5, 2021, the Commission, pursuant to Section
19(b)(3)(C) of the Act,\6\ temporarily suspended and instituted
proceedings to determine whether to approve or disapprove the
proposal.\7\ On September 14, 2021, the Exchange withdrew the proposed
rule change (SR-NYSEArca-2021-52).
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 92291 (June 29,
2021), 86 FR 35551 (July 6, 2021) (``Notice'').
    \4\ 15 U.S.C. 78s(b)(3)(A). A proposed rule change may take
effect upon filing with the Commission if it is designated by the
exchange as ``establishing or changing a due, fee, or other charge
imposed by the self-regulatory organization on any person, whether
or not the person is a member of the self-regulatory organization.''
15 U.S.C. 78s(b)(3)(A)(ii).
    \5\ See Notice, supra note 3.
    \6\ 15 U.S.C. 78s(b)(3)(C).
    \7\ See Securities Exchange Act Release No. 92583 (August 5,
2021), 86 FR 44116 (August 11, 2021).
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    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-20657 Filed 9-23-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 171 (Wednesday, September 4, 2019)]
[Notices]
[Page 46522]
[FR Doc No: 2019-19093]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL 9999-10-OW]

Open Meeting of the Environmental Financial Advisory Board

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of open meeting.

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

SUMMARY: The Environmental Protection Agency's (EPA) Environmental
Financial Advisory Board (EFAB) will hold a public meeting on October
16-18, 2019 in the Kansas City, Missouri metropolitan area. The EFAB is
an EPA advisory committee chartered under the Federal Advisory
Committee Act to provide advice and recommendations to EPA on creative
approaches to funding environmental programs, projects, and activities.
    The purpose of this meeting is to discuss recommendations from EFAB
work products; to discuss changes to the EFAB's process of selecting
new topics and developing recommendations; and to discuss stormwater
funding and financing. The meeting is open to the public; however,
seating is limited. All members of the public who wish to attend the
meeting must register in advance, no later than Monday, September 30,
2019 at https://epaefaboctober2019.eventbrite.com.

DATES: A workgroup of the board, the Stormwater Infrastructure
Taskforce/Workgroup will meet on Wednesday, October 16, 2019 from 9
a.m.-5 p.m. The full board meeting will be held Thursday, October 17,
2019 from 9 a.m.-5 p.m. and Friday, October 18, 2019 from 9 a.m.-12
p.m.

ADDRESSES: The Fontaine--A Kansas City Hotel, 901 W. 48th Place, Kansas
City, MO 64112.

FOR FURTHER INFORMATION CONTACT: For information on access or services
for individuals with disabilities, or to request accommodations for a
disability, please contact Tara Johnson at<PHONE_NUMBER> or
<EMAIL_ADDRESS>at least 10 business days prior to the meeting to
allow as much time as possible to process your request.

    Dated: August 21, 2019.
Andrew Sawyers,
Director, Office of Wastewater Management, Office of Water.
[FR Doc. 2019-19093 Filed 9-3-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 73 (Tuesday, April 18, 2017)]
[Notices]
[Pages 18293-18294]
[FR Doc No: 2017-07769]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0736]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Tracking Network for
PETNet, LivestockNet, and SampleNet

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Fax written comments on the collection of information by May 18,
2017.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0680.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Cappezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North,
10A63, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Tracking Network for PETNet, LivestockNet, and SampleNet OMB Control
Number 0910-0680--Revision

    The Center for Veterinary Medicine and the Partnership for Food
Protection developed a Web-based tracking network (the tracking
network) to allow Federal, State, and Territorial regulatory and public
health Agencies to share safety information about animal food.
Information is submitted to the tracking network by regulatory and
public health Agency employees with membership rights. The efficient
exchange of safety information is necessary because it improves early
identification and evaluation of a risk associated with an animal food
product. We use the information to assist regulatory Agencies to
quickly identify and evaluate a risk and take whatever action is
necessary to mitigate or eliminate exposure to the risk. Earlier
identification and communication with respect to emerging safety
information may also mitigate the potential adverse economic impact for
the impacted parties associated with such safety issues. The tracking
network was developed under the requirements set forth under section
1002(b) of the Food and Drug Administration Amendments Act of 2007
(FDAAA) (Pub. L. 110-085). Section 1002(b) of FDAAA required FDA, in
relevant part, to establish a pet food early warning alert system.
    Currently we receive two types of reports via the tracking network:
(1) Reports of pet food-related illness and product defects associated
with dog food, cat food, and food for other pets, which are submitted
via the Pet Event Tracking Network (PETNet); and (2) reports of animal
food-related illness and product defects associated with animal food
for livestock animals, aquaculture species, and horses, which are
submitted via LivestockNet. We are revising the collection to include a
third type of report that would be submitted via ``SampleNet.''
SampleNet will collect reports about animal food laboratory samples
considered adulterated by State or FDA regulators. SampleNet will allow
Federal, State, and Territorial regulatory and public health Agencies
to share laboratory data related to adulterated samples for

purposes of surveillance, mitigation, work planning, and supporting the
animal food standard requirements.
    PETNet and LivestockNet reports share the following common data
elements, the majority of which are drop down menu choices: Product
details (product name, lot code, product form, and the manufacturer or
distributor/packer (if known)), the species affected, number of animals
exposed to the product, number of animals affected, body systems
affected, product problem/defect, date of onset or the date product
problem was detected, the State where the incident occurred, the origin
of the information, whether there are supporting laboratory results,
and contact information for the reporting member (i.e., name, telephone
number will be captured automatically when member logs in to the
system). For the LivestockNet report, additional data elements specific
to livestock animals will be captured: Product details (indication of
whether the product is a medicated feed under 21 CFR 558.3(b)(8),
product packaging, and intended purpose of the product), class of the
animal species affected, and production loss. For PETNet reports, the
only additional data field is the animal life stage. The proposed
SampleNet reports will have the following data elements, many of which
are drop down menu choices: Product information (product name, lot
code, guarantor information, date and location of sample collection,
and product description); laboratory information (sample identification
number, the reason for testing, whether the food was reported to the
Reportable Food Registry, who performed the analysis); and results
information (analyte, test method, analytical results, whether the
results contradict a label claim or guarantee, and whether action was
taken as a result of the sample analysis).
    Description of Respondents: Respondents to the collection of
information are Federal, State, and Territorial regulatory and public
health Agency employees with membership access to the Animal Feed
Network.
    In the Federal Register of March 15, 2016 (81 FR 13794), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
            Activity                 Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
PETNet..........................              20               5             100          * 0.25              25
LivestockNet....................              20               5             100          * 0.25              25
SampleNet.......................              20               5             100          * 0.25              25
                                 -------------------------------------------------------------------------------
    Total.......................              75  ..............  ..............  ..............  ..............
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
* 15 minutes.

    Our estimate is based on our experience with the tracking network
over the past 3 years. We estimate that we will receive an average of 5
submissions from 20 respondents for each type of report, and that it
will take 15 minutes (0.25 hour) per response.

    Dated: April 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-07769 Filed 4-17-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 184 (Thursday, September 22, 2011)]
[Notices]
[Page 58820]
[FR Doc No: 2011-24321]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4028-DR; Docket ID FEMA-2011-0001]

Massachusetts; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the Commonwealth of Massachusetts (FEMA-4028-DR), dated September
3, 2011, and related determinations.

DATES: Effective Date: September 10, 2011.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the Commonwealth of Massachusetts is hereby amended to include the
following areas among those areas determined to have been adversely
affected by the event declared a major disaster by the President in his
declaration of September 3, 2011.

    Hampden and Hampshire Counties for Public Assistance, including
direct Federal assistance.

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

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-24321 Filed 9-21-11; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 85, Number 51 (Monday, March 16, 2020)]
[Notices]
[Pages 14949-14951]
[FR Doc No: 2020-05335]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-2456]

Slowly Progressive, Low-Prevalence Rare Diseases With Substrate
Deposition That Results From Single Enzyme Defects: Providing Evidence
of Effectiveness for Replacement or Corrective Therapies; 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 final guidance for industry entitled ``Slowly
Progressive, Low-Prevalence Rare Diseases With Substrate Deposition
That Results From Single Enzyme Defects: Providing Evidence of
Effectiveness for Replacement or Corrective Therapies.'' This document
provides guidance to sponsors on the evidence necessary to demonstrate
the effectiveness of investigational new drugs or new drug uses
intended for slowly progressive, low-prevalence rare diseases that are
associated with substrate deposition and are caused by single enzyme
defects.
    This guidance applies only to those low-prevalence rare diseases
with a well-characterized pathophysiology and in which changes in
substrate deposition can be readily measured in relevant tissue or
tissues. This guidance incorporates the comments received for and
finalizes the draft guidance of the same name issued on July 27, 2018.

DATES: The announcement of the guidance is published in the Federal
Register on March 16, 2020.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or

confidential business information, such as a manufacturing process.
Please note that if you include your name, contact information, or
other information that identifies you in the body of your comments,
that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-D-2456 for ``Slowly Progressive, Low-Prevalence Rare Diseases
With Substrate Deposition That Results From Single Enzyme Defects:
Providing Evidence of Effectiveness for Replacement or Corrective
Therapies.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002; or the Office of
Communication, Outreach, and Development, Center for Biologics
Evaluation and Research, 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 that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Hylton Joffe, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6300, Silver Spring, MD 20993-0002, 301-
796-1954; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for industry
entitled ``Slowly Progressive, Low-Prevalence Rare Diseases With
Substrate Deposition That Results From Single Enzyme Defects: Providing
Evidence of Effectiveness for Replacement or Corrective Therapies.''
This document provides guidance to sponsors on the evidence necessary
to demonstrate the effectiveness of investigational new drugs or new
drug uses intended for slowly progressive, low-prevalence rare diseases
that are associated with substrate deposition and are caused by single
enzyme defects. This guidance applies only to those low-prevalence rare
diseases with a well-characterized pathophysiology and in which changes
in substrate deposition can be readily measured in relevant tissue or
tissues.
    This guidance finalizes the draft guidance of the same name issued
on July 27, 2018 (83 FR 35653). FDA considered comments received on the
draft guidance in devising this final guidance. Changes from the draft
to the final guidance include the following: clarification that a ``low
prevalence'' condition may be defined as one affecting a very small
population (e.g., approximately a few thousand persons or fewer in the
United States); clarification that, in the absence of nonhuman data to
guide a potentially efficacious dose, animal toxicology data can inform
a safe starting human dose; and removal of language regarding assay
versus intrasubject variability--approaches to manage intrasubject
variability within specific drug development programs can be addressed
via formal sponsor meetings with the relevant division at FDA.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Slowly Progressive, Low-Prevalence Rare
Diseases With Substrate Deposition That Results From Single Enzyme
Defects: Providing Evidence of Effectiveness for Replacement or
Corrective 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

    This guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3521). 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. The collections of information for expedited programs
in the guidance for industry entitled ``Expedited Programs for Serious

Conditions--Drugs and Biologics'' (available at https://www.fda.gov/media/86377/download) have been approved under OMB control number 0910-
0765.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics, or https://www.regulations.gov.

    Dated: March 10, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-05335 Filed 3-13-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: July 18, 2006 (Volume 71, Number 137)]
[Notices]
[Page 40714-40715]
[DOCID:fr18jy06-53]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. ER06-987-000; ER06-987-001]

HLM Energy LLC; Notice of Issuance of Order

July 12, 2006.
    HLM Energy LLC (HLM Energy) filed an application for market-based
rate authority, with an accompanying tariff. The proposed market-based
rate tariff provides for the sale of energy and capacity at market-
based rates. HLM Energy also requested waivers of various Commission
regulations. In particular, HLM Energy requested that the Commission
grant blanket approval under 18 CFR part 34 of all future issuances of
securities and assumptions of liability by HLM Energy.
    On July 11, 2006, pursuant to delegated authority, the Director,
Division of Tariffs and Market Development--West, granted the requests
for blanket approval under part 34. The Director's order also stated
that the Commission would publish a separate notice in the Federal
Register establishing a period of time for the filing of protests.
Accordingly, any person desiring to be heard or to protest the blanket
approvals of issuances of securities or assumptions of liability by HLM
Energy should file a motion to intervene or protest with the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426, in accordance with Rules 211 and 214 of the Commission's Rules
of Practice and Procedure. 18 CFR 385.211, 385.214 (2004).
    Notice is hereby given that the deadline for filing motions to
intervene or protest is August 10, 2006.
    Absent a request to be heard in opposition by the deadline above,
HLM Energy is authorized to issue securities and assume obligations or
liabilities as a guarantor, indorser, surety, or otherwise in respect
of any security of another person; provided that such issuance or
assumption is for some lawful object within the corporate purposes of
HLM Energy, compatible with the public interest, and is reasonably
necessary or appropriate for such purposes.
    The Commission reserves the right to require a further showing that
neither public nor private interests will be adversely affected by
continued approvals of HLM Energy's issuances of securities or
assumptions of liability.
    Copies of the full text of the Director's Order are available from
the

Commission's Public Reference Room, 888 First Street, NE., Washington,
DC 20426. The Order may also 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 filed to access
the document. Comments, protests, and interventions may be filed
electronically via the Internet in lieu of paper. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings.

Magalie R. Salas,
Secretary.
[FR Doc. E6-11353 Filed 7-17-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 220 (Friday, November 14, 2014)]
[Proposed Rules]
[Page 68152]
[FR Doc No: 2014-27009]

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

40 CFR Part 63

[EPA-HQ-OAR-2010-0895; FRL-9919-15-OAR]
RIN 2060-AQ11

National Emission Standards for Hazardous Air Pollutants:
Ferroalloys Production; Extension of Comment Period

AGENCY: Environmental Protection Agency.

ACTION: Supplemental notice of proposed rulemaking; extension of public
comment period.

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

SUMMARY: The Environmental Protection Agency (EPA) is announcing that
the period for providing public comments on the October 6, 2014,
supplemental proposed rule titled ``National Emission Standards for
Hazardous Air Pollutants: Ferroalloys Production'' is being extended
for 18 days.

DATES: Comments. The public comment period for the supplemental
proposed rule published in the Federal Register on October 6, 2014, (79
FR 60238) is being extended for 18 days to December 8, 2014, in order
to provide the public additional time to submit comments and supporting
information. The EPA received a request for an extension from Eramet
Marietta, Incorporated and Felman Production, LLC in order to gather
and analyze data and formulate their comments on the supplemental
proposed amendments.

ADDRESSES: Comments. Written comments on the supplemental proposed rule
may be submitted to EPA electronically, by mail, by facsimile or
through hand delivery/courier. Please refer to the supplemental
proposal (79 FR 60238) for the addresses and detailed instructions.
    Docket. Publicly available documents relevant to this action are
available for public inspection either electronically at: http://www.regulations.gov or in hard copy at the EPA Docket Center, Room
3334, 1301 Constitution Avenue 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. A reasonable fee may be charged for copying.
The official public docket for this rulemaking is Docket No. EPA-HQ-
OAR-2010-0895.
    World Wide Web. The EPA Web site for this rulemaking is at: http://www.epa.gov/ttn/atw/ferroa/ferropg.html.

FOR FURTHER INFORMATION CONTACT: Mr. Phil Mulrine, Metals and Inorganic
Chemicals Group (D243-02), Sector Policies and Programs Division,
Office of Air Quality Planning and Standards, U.S. Environmental
Protection Agency, Research Triangle Park, North Carolina 27711;
Telephone number:<PHONE_NUMBER>; Fax number<PHONE_NUMBER>; Email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comment Period

    After considering the requests received from Eramet Marietta,
Incorporated and Felman Production, LLC to extend the public comment
period, the EPA has decided to extend the public comment period for an
additional 18 days. Therefore, the public comment period will end on
December 8, 2014, rather than November 20, 2014. This extension will
help ensure that the public has sufficient time to review the proposed
rule and the supporting technical documents and data available in the
docket.

List of Subjects in 40 CFR Part 63

    Air pollution control, Environmental protection, Hazardous
substances, Incorporation by reference, Reporting and recordkeeping
requirements.

    Dated: November 5, 2014.
Mary E. Henigin,
Acting Director, Office of Air Quality Planning and Standards.
[FR Doc. 2014-27009 Filed 11-13-14; 8:45 am]
BILLING CODE 6560-50-P