[Federal Register Volume 86, Number 143 (Thursday, July 29, 2021)]
[Proposed Rules]
[Pages 40791-40793]
[FR Doc No: 2021-15923]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Parts 166 and 167

[Docket No. USCG-2021-0345]

Port Access Route Study: The Pacific Coast From Washington to
California

AGENCY: Coast Guard, DHS.

ACTION: Notification of study; request for comments.

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SUMMARY: The Coast Guard is conducting a Port Access Route Study (PARS)
to evaluate safe access routes for the movement of vessel traffic
proceeding to or from ports or places along the western seaboard of the
United States and to determine whether a Shipping Safety Fairway
(``Fairway'') and/or routing measures should be established, adjusted
or modified. The PARS will evaluate the continued applicability of, and
the need for modifications to, current vessel routing measures. The
data gathered during this Pacific Coast PARS (PACPARS) may result in
the establishment of one or more new vessel routing measures,
modification of existing routing measures, or disestablishment of
existing routing measures off the Pacific Coast between Washington and
California. To assist us in conducting the PACPARS, we invite your
responses to questions in the SUPPLEMENTARY INFORMATION section. The
recommendations of the study may consider future rulemaking action or
potential international agreements.

DATES: Comments and related material must be received on or before
January 25, 2022.

ADDRESSES: You may submit comments identified by docket number USCG-
2021-0345 using the Federal eRulemaking Portal https://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTAL INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notification of study, call or email LCDR Sara Conrad, Coast Guard
Pacific Area (PAC-54), U.S. Coast Guard; telephone<PHONE_NUMBER>,
email<EMAIL_ADDRESS>or Mr. Tyrone Conner, Eleventh Coast Guard
District (dpw), U.S. Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>or Mr. John Moriarty, Thirteenth Coast Guard
District (dpw), U.S. Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
U.S.C. United States Code
PAC Pacific Area Command
PARS Port Access Route Study
PACPARS Pacific Coast Port Access Route Study
EEZ Exclusive Economic Zone

RNA Regulated Navigation Areas
TSS Traffic Separation Scheme

II. Background, Purpose, and Legal Basis

    A. Requirement for PARS: Under the Ports and Waterways Safety Act,
(PWSA) (46 U.S.C. 70003(c)(1)), the Commandant of the Coast Guard shall
designate necessary fairways \1\ and traffic separations schemes (TSSs)
to provide safe access routes for vessels proceeding to and from United
States ports. The designation of fairways and TSSs recognizes the
paramount right of navigation over all other uses in the designated
areas.
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    \1\ Fairway or shipping safety fairway is a lane or corridor in
which no artificial island or fixed structure, whether temporary or
permanent, will be permitted. Temporary underwater obstacles may be
permitted under certain conditions described for specific areas.
Aids to navigation approved by the Coast Guard may be established in
a fairway. See 33 CFR 166.105(a).
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    The PWSA requires the Coast Guard to conduct a PARS, i.e. a study
of potential traffic density and the need for safe access routes for
vessels, before establishing or adjusting fairways or TSSs. Through the
study process, we must coordinate with Federal, State, and foreign
state agencies (as appropriate) and consider the views of maritime
community representatives, environmental groups, and other interested
stakeholders. A primary purpose of this coordination is, to the extent
practicable, to reconcile the need for safe access routes with other
reasonable waterway uses such as construction and operation of
renewable energy facilities and other uses of the Pacific Ocean in the
study area.
    B. Previous Port Access Route Studies: The approaches to San
Francisco, CA, were last studied in 2009, and the final results were
published in the Federal Register on June 20, 2011 (76 FR 35805). The
study was conducted to evaluate the continued applicability of and the
potential need for modifications to the vessel routing to help reduce
the risk of marine casualties and increase the efficiency of vessel
traffic in the study area. The PARS for the Strait of Juan de Fuca,
Haro Strait, Boundary Pass, Rosario Strait, the Strait of Georgia, and
adjacent waters was completed in November 2000, published in the
Federal Register on January 22, 2001 (66 FR 6514). The study was
conducted to evaluate the need for modifications to current vessel
routing and traffic management measures due to increase in maritime
activities. The PARS for the approaches to Los Angeles-Long Beach and
in the Santa Barbara Channel was last completed in June 2011, and the
final results were published in the Federal Register in November 2011
(76 FR 67395). The study was conducted to evaluate the continued
applicability of and the potential need for modifications to the
traffic separation schemes. However, there has never been a PARS
conducted for the entire pacific coast of the United States designed to
analyze all vessel traffic proceeding to and from all the ports and
transiting through the United States EEZ.
    C. Need for a New Port Access Route Study: Given the current
forecasted development of aquaculture farms, offshore renewable energy,
commercial space ports/re-entry sites, expansion of marine sanctuaries,
development of ports supporting Panamax vessels, potential LNG ports
and additional increasing commercial traffic, the Coast Guard has
determined that a PACPARS needs to be conducted. This PARS will focus
on the coastwise shipping routes and near coastal users of the Pacific
Ocean between the coastal ports, and the approaches to coastal ports
within the EEZ. This PACPARS will help the Coast Guard determine what
impact, if any, the siting, construction and operation of new
developments may have on existing near coastal users of the Pacific
Ocean, and the potential impact of shipping to other maritime users. To
ensure safety of navigation, the Coast Guard will determine the impacts
of rerouting traffic, funneling traffic, and placement of structures
that may obstruct navigation. Some of the impacts may include increased
vessel traffic density, more restricted offshore vessel routing, fixed
navigation obstructions, underwater cable hazards, and economic
impacts. Analyzing the various impacts will require a thorough
understanding of the interrelationships of shipping, other commercial
and recreational uses, and port operations.
    The goal of the PACPARS is to enhance navigational safety by
examining existing shipping routes and waterway uses, and, to the
extent practicable, reconciling the paramount right of navigation
within designated port access routes with other waterway uses such as
the development of aquaculture farms, offshore renewable energy,
commercial space ports/re-entry sites, marine sanctuaries, ports
supporting Panamax vessels, potential LNG ports and additional
commercial vessel traffic.

III. Information Requested

    Timelines, Study Area, Focus, and Process: Coast Guard Pacific Area
Command will conduct a PACPARS and should take several years to
complete. The study area will encompass all vessel traffic patterns
approaching and departing major ports along the west coast to include
all current Traffic Separation Schemes and vessel maneuvering along the
Pacific Coast from Washington to California and all federal navigable
waters out to the EEZ. The PACPARS will focus on vessel traffic and
navigation mitigation techniques to improve and support safe navigation
transits within the major Pacific Coast Ports and the United States
EEZ.
    As part of this study, we will analyze current and historical
vessel traffic, fishing vessel information, agency and stakeholder
experience in vessel traffic management, navigation, ship handling, and
effects of weather. We encourage you to participate in the study
process by submitting comments in response to this document.
    We will publish the results of the PARS in the Federal Register. It
is possible that the study may validate existing vessel routing
measures and conclude that no changes are necessary. It is also
possible that the study may recommend one or more changes to enhance
navigational safety and the efficiency of vessel traffic. The
recommendations may lead to future rulemakings or appropriate
international agreements.
    Possible Scope of the Recommendations: We are attempting to
determine the scope of any safety concerns associated with vessel
transits in the study area. The information gathered during the study
should help us identify concerns and mitigating solutions.
Considerations might include: (1) Maintain the current vessel routing
measures; (2) modify the existing traffic separation schemes; (3)
create one or more precautionary areas; (4) create one or more inshore
traffic zones; (5) establish area(s) to be avoided; (6) create deep-
draft routes; (7) establish Regulated Navigation Areas (RNA) with
specific vessel operating requirements to ensure safe navigation near
shallow water; (8) identify any other appropriate ships' routing
measures; (9) use this study for future decisions on routing measures
or other maritime traffic considerations and; (10) use this study to
inform other agencies concerning the impacts of their future endeavors.
    Questions: To help us conduct the PARS, we request information that
will help answer the following questions, although comments on other
issues addressed in this document are also welcome. In responding to a
question, please explain your reasons for each answer and follow the
instructions under ``Public Participation and Request for Comments''
above.

    (1) What navigational hazards do vessels operating in the study
area face? Please describe.
    (2) Are there strains on the current vessel routing systems, such
as increasing traffic density associated with future growth? Please
describe.
    (3) Are modifications to existing vessel routing measures needed to
address hazards and improve traffic efficiency in the study area? If
so, please describe.
    (4) What costs and benefits are associated with the measures listed
as potential study considerations? What measures do you think are most
cost-effective?
    (5) What impacts, both positive and negative, would changes to
existing routing measures or new routing measures have on the study
area?
    (6) Where do you transit? Where are your transit routes? What
criteria are used in determining your transit routes?
    (7) Do you currently experience competing uses for the same
waterway areas or transit routes? If so, please describe.
    (8) Do you anticipate, or are you aware of, future competing uses
for the same waterway areas or transit routes? These could include
potential offshore energy projects, potential offshore aquaculture
projects, or otherwise.
    (9) Are there other environmental, cultural, tribal, marine mammal
or other impacts which should be considered during this Port Access
Route Study?

IV. Public Participation and Request for Comments

    We encourage you to submit comments through the Federal eRulemaking
Portal at https://www.regulations.gov. If your material cannot be
submitted using https://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions. If you submit comments, please include the docket number
for this notification of study and provide a reason for each suggestion
or recommendation.
    We accept anonymous comments. All comments received will be posted
without change to https://www.regulations.gov and will include any
personal information you have provided. For more about privacy and
submissions in response to this document, see DHS's eRulemaking System
of Records (85 FR 14226, March 11, 2020).
    Documents mentioned in this notification of study as being
available in the docket, and all public comments, will be in our online
docket at https://www.regulations.gov and can be viewed by following
that website's instructions.
    Additionally, if you go to the online docket and sign up for email
alerts, you will be notified when comments are posted.
    This document is published under the authority of 46 U.S.C.
70003(c)(1).

    Dated: July 21, 2021.
Michael F. McAllister,
Vice Admiral, U.S. Coast Guard, Commander, Pacific Area.
[FR Doc. 2021-15923 Filed 7-28-21; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 79, Number 99 (Thursday, May 22, 2014)]
[Notices]
[Pages 29433-29434]
[FR Doc No: 2014-11864]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

 [Project No. 7320-042]

Erie Boulevard Hydropower, L.P.; Notice of Application Ready for
Environmental Analysis, and Soliciting Comments, Recommendations, Terms
and Conditions, and Prescriptions

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: New Major License
    b. Project No.: 7320-042
    c. Date Filed: July 1, 2013
    d. Applicant: Erie Boulevard Hydropower, L.P.
    e. Name of Project: Chasm Hydroelectric Project
    f. Location: On the Salmon River in Franklin County, New York. The
project does not occupy any federal lands.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791 (a)-825(r)
    h. Applicant Contact: Steven Murphy, Licensing Manager, Erie
Boulevard Hydropower, L.P., 33 West 1st Street South, Fulton, New York,
13069,<PHONE_NUMBER> or email at<EMAIL_ADDRESS>    i. FERC Contact: John Mudre at<PHONE_NUMBER> or email at
<EMAIL_ADDRESS>    j. Deadline for filing comments, recommendations, terms and
conditions, and prescriptions: 60 days from the issuance date of this
notice; reply comments are due 105 days from the issuance date of this
notice.
    The Commission strongly encourages electronic filing. Please file
comments, recommendations, terms and conditions, and prescriptions
using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000
characters, without prior registration, using the eComment system at
http://www.ferc.gov/docs-filing/ecomment.asp. You must include your
name and contact information at the end of your comments. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, please send a paper copy to:
Secretary, Federal Energy Regulatory Commission, 888 First Street NE.,
Washington, DC 20426. The first page of any filing should include
docket number P-7320-042.
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of

that document on each person on the official service list for the
project. Further, if an intervenor files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency.
    k. This application has been accepted, and is ready for
environmental analysis at this time.
    l. Project Description: The existing Chasm Project consists of: (1)
a 201-foot-long, 32-foot-high maximum height concrete gravity-type dam
having a spillway section with crest elevation 1,283.8 feet mean sea
level (msl) about 100 feet long, surmounted by 2-foot-high flashboards
and having an intake section with steel trash racks and headgates; (2)
a reservoir having a surface area of about 22 acres and a gross storage
capacity of 74 acre-feet at normal pool elevation of 1,285.8 feet msl;
(3) a 7-foot-diameter welded steel pipeline approximately 3,355 feet in
length connecting to a 6-foot-diameter steel manifold pipeline just
upstream of the powerhouse; (4) a powerhouse containing three Francis-
type generating units having a total rated capacity of 3,350 kilowatts
operated under a 268-foot head and at a flow of 195 cubic feet per
second (cfs); (5) a 20-foot-wide, 850-foot-long tailrace; (6) three
2.2-kilovolt generator leads extending from the powerhouse about 74
feet to an adjacent swithchyard; (7) a 4.2-megavolt-ampere step-up
transformer located within the switchyard, connecting to a transmission
line owned and operated by the National Grid Corporation; and (8)
appurtenant facilities.
    Erie proposes a minimum flow of 15 cfs into the bypassed reach at
all times and would forego its existing ability to lower the minimum
bypass flow to 10 cfs when inflow is less than 85 cfs. In addition,
Erie proposes to maintain the impoundment elevation within 0.1 foot of
the spillway crest (or flashboards, when installed) when inflow is less
than 85 cfs and 0.25 foot when inflow is greater than 85 cfs.
    m. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC Online Support. A copy is also available for inspection and
reproduction at the address in item h above.
    All filings must (1) bear in all capital letters the title
``COMMENTS,'' ``REPLY COMMENTS,'' ``RECOMMENDATIONS,'' ``TERMS AND
CONDITIONS,'' or ``PRESCRIPTIONS;'' (2) set forth in the heading the
name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person protesting or intervening; and (4) otherwise
comply with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, recommendations, terms and conditions or prescriptions must
set forth their evidentiary basis and otherwise comply with the
requirements of 18 CFR 4.34(b). Agencies may obtain copies of the
application directly from the applicant. A copy of any protest or
motion to intervene must be served upon each representative of the
applicant specified in the particular application. A copy of all other
filings in reference to this application must be accompanied by proof
of service on all persons listed in the service list prepared by the
Commission in this proceeding, in accordance with 18 CFR 4.34(b) and
385.2010.
    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    n. A license applicant must file no later than 60 days following
the date of issuance of this notice: (1) A copy of the water quality
certification; (2) a copy of the request for certification, including
proof of the date on which the certifying agency received the request;
or (3) evidence of waiver of water quality certification.
    o. Procedural Schedule: The application will be processed according
to the following revised Hydro Licensing Schedule. Revisions to the
schedule may be made as appropriate.

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                 Milestone                           Target date
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Filing of comments, recommendations, terms  July 2014
 and conditions, and prescriptions.
Reply Comments Due........................  August 2014
Commission Issues Single EA...............  December 2014
Comments on Single EA due.................  January 2014
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    Dated: May 16, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-11864 Filed 5-21-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 88 (Tuesday, May 7, 2013)]
[Rules and Regulations]
[Page 26508]
[FR Doc No: 2013-10775]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[USCG-2013-0230]

Drawbridge Operation Regulations; Reynolds Channel, Nassau, NY

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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SUMMARY: The Commander, First Coast Guard District, has issued a
temporary deviation from the regulation governing the operation of the
Long Beach Bridge, mile 4.7, across Reynolds Channel at Nassau, New
York. Under this temporary deviation, the bridge may remain in the
closed position for an hour and a half to facilitate a public event,
the Town of Hempstead Annual Fireworks Display.

DATES: This deviation is effective between 9 p.m. and 10:30 p.m. on
July 12, 2013.

ADDRESSES: The docket for this deviation, [USCG-2013-0230] is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH.'' Click on Open Docket Folder on the line
associated with this deviation. You may also visit the Docket
Management Facility in Room W12-140, on the ground floor of the
Department of Transportation West Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Ms. Judy Leung-Yee, Project Officer,
First Coast Guard District<EMAIL_ADDRESS>or (212) 668-
7165. If you have questions on viewing the docket, call Barbara
Hairston, Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:  The Long Beach Bridge has a vertical
clearance of 20 feet at mean high water, and 24 feet at mean low water
in the closed position. The existing drawbridge operating regulations
are found at 33 CFR 117.799(g).
    The bridge owner, the County of Nassau Department of Public Works,
requested a bridge closure to facilitate a public event, the Town of
Hempstead Annual Fireworks Display.
    Under this temporary deviation, the Long Beach Bridge may remain in
the closed position between 9 p.m. and 10:30 p.m. on July 12, 2013.
    Reynolds Creek has commercial and recreational vessel traffic. No
objections were received from the waterway users.
    In accordance with 33 CFR 117.35(e), the bridge must return to its
regular operating schedule immediately at the end of the designated
deviation period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: April 24, 2013.
Gary Kassof,
Bridge Program Manager, First Coast Guard District.
[FR Doc. 2013-10775 Filed 5-6-13; 8:45 am]
BILLING CODE 9110-04-P


EPA-HQ-OAR-2006-0173

EPA Memo to Docket:

On October 5, 2007 EPA Administrator Stephen Johnson conducted a phone
call from Fred Krupp, Environmental Defense.  Mr. Krupp urged the
Administrator to approve California's request for a waiver.  The
Administrator advised Mr. Krupp that he has made no decisions concerning
the waiver request.


[Federal Register: September 29, 2009 (Volume 74, Number 187)]
[Notices]
[Page 49871-49872]
[DOCID:fr29se09-46]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP09-465-000]

Northern Natural Gas Company; Notice of Application

September 22, 2009.
    Take notice that on September 14, 2009, Northern Natural Gas
Company (Northern), 1111 South 103rd Street, Omaha, Nebraska 68124,
filed with the Federal Energy Regulatory Commission an application
under Section 7 of the Natural Gas Act to expand the existing
certificated storage boundary of the Cunningham storage field located
in Pratt and Kingman counties, Kansas, to include the Viola and Simpson
formations in the Extension Area (including Northern's acquisition of
all property interests), all as more fully set forth in the request
which is on file with the Commission and open to public inspection.
    In its application, Northern asserts the need to acquire additional
storage acres to control and mitigate storage gas migration from the
Cunningham storage field that is occurring to the north of Northern's
existing certificated storage boundary.
    Any questions regarding this application should be directed to
Michael T. Loeffler, Senior Director of Certificates and External
Affairs for Northern, 1111 South 103rd Street, Omaha, Nebraska 68124,
(402) 398-7103; or Bret Fritch, Senior Regulatory Analyst, at (402)
398-7140.
    The filing is available for review at the Commission in the Public
Reference Room or may be viewed on the Commission's Web site Web at
http://www.ferc.gov using the eLibrary link. Enter the docket number
excluding the last three digits in the docket number field to access
the document. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below file with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 14 copies of filings made in the proceeding with the Commission
and must mail a copy to the applicant and to every other party. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commentors will not be required to serve copies of filed
documents on all other parties. However, the non-party commentors will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the eFiling link at
http://www.ferc.gov. Persons unable to file electronically should
submit an original and 14 copies of the protest or intervention to the
Federal Energy regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
eLibrary link and is available for review in the Commission's Public
Reference Room in Washington, DC. There is an eSubscription link on the
Web site that enables subscribers to receive e-mail

notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: October 13, 2009.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-23404 Filed 9-28-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 228 (Wednesday, November 26, 2014)]
[Proposed Rules]
[Pages 70478-70479]
[FR Doc No: 2014-27954]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

CFR Part 71

[Docket No. FAA-2014-0729; Airspace Docket No. 14-ASO-10]

Proposed Establishment of Class E Airspace; Key Largo, FL

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 Key
Largo, FL, to accommodate new Area Navigation (RNAV) Global Positioning
System (GPS) Standard Instrument Approach Procedures (SIAPs) serving
Ocean Reef Club Airport. Controlled airspace is necessary for the
safety and management of instrument flight rules (IFR) operations at
the airport.

DATES: 0901 UTC. Comments must be received on or before January 12,
2015. The Director of the Federal Register approves this incorporation
by reference action under title 1, Code of Federal Regulations, part
51, subject to the annual revision of FAA, Order 7400.9 and publication
of conforming amendments.

ADDRESSES: Send comments on this rule to: U.S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New Jersey SE., Washington, DC 20590-0001; Telephone: 1-
800-647-5527; Fax:<PHONE_NUMBER>. You must identify the Docket Number
FAA-2014-0729; Airspace Docket No. 14-ASO-10, at the beginning of your
comments. You may also submit and review received comments through the
Internet at http://www.regulations.gov.
    You may review the public docket containing the rule, any comments
received, and any final disposition in person in the Dockets Office
(see ADDRESSES section for 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 office of the Eastern Service Center, Federal Aviation
Administration, Room 350, 1701 Columbia Avenue, College Park, Georgia
30337.

FOR FURTHER INFORMATION CONTACT: John Fornito, Airspace Specialist,
Operations Support Group, Eastern Service Center, Air Traffic
Organization, Federal Aviation Administration, P.O. Box 20636, Atlanta,
Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested persons are invited to comment on this rule 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 number. FAA-2014-0729; Airspace Docket
No. 14-ASO-10) 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. Those wishing the FAA to acknowledge receipt of
their comments on this notice must submit with those comments a self-
addressed, stamped postcard on which the following statement is made:
``Comments to Docket No. The postcard will be date/time stamped and
returned to the commenter. All communications received before the
specified closing date for comments will be considered before taking
action on the proposed rule. The proposal contained in this notice may
be changed in light of the comments received. A report summarizing each
substantive public contact with FAA personnel concerned with this
rulemaking will be filed in the docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded from and
comments submitted through http://www.regulations.gov. Recently
published rulemaking documents can also be accessed through the FAA's
Web page at http://www.faa.gov/air_traffic/publications/airspace_amendments/ Additionally, any person may obtain a copy of this
notice by submitting a request to the Federal Aviation Administration
(FAA), Office of Air Traffic Airspace Management, ATA-400, 800
Independence Avenue SW., Washington, DC 20591, or by calling (202) 267-
8783. Communications must identify both docket numbers for this notice.
Persons interested in being placed on a mailing list for future NPRM's
should contact the FAA's Office of Rulemaking,<PHONE_NUMBER>, to
request a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.

The Proposal

    The FAA is considering an amendment to Title 14, Code of Federal
Regulations (14 CFR) part 71 to establish Class E airspace at Key
Largo, FL, providing the controlled airspace required to support the
new RNAV (GPS) standard instrument approach procedures for Ocean Reef
Club Airport. Controlled airspace extending upward from 700 feet above
the surface within a 7-mile radius of the airport would be established
for IFR operations.

    Class E airspace designations are published in Paragraph 6005, of
FAA Order 7400.9Y, dated August 6, 2014, and effective September 15,
2014, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designations listed in this document will be published
subsequently in the Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore, (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this proposed rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority.
    This proposed rulemaking is promulgated under the authority
described in Subtitle VII, Part, A, Subpart I, Section 40103. Under
that section, the FAA is charged with prescribing regulations to assign
the use of airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This proposed regulation is within the scope
of that authority as it would establish Class E airspace at Ocean Reef
Club Airport, Key Largo, FL.
    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.

Lists of Subjects in 14 CFR Part 71:

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, 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 part 71 will continue 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 Federal Aviation
Administration Order 7400.9Y, Airspace Designations and Reporting
Points, dated August 6, 2014, and effective September 15, 2014, is
amended as follows:

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

* * * * *

ASO AL E5 Key Largo, FL [NEW]

Ocean Reef Club Airport, FL
    (Lat. 25[deg]19'31'' N., long. 80[deg]16'29'' W.)

    That airspace extending upward from 700 feet above the surface
within a 7-mile radius of. Ocean Reef Club Airport.

    Issued in College Park, Georgia, on November 17, 2014
Myron A. Jenkins,
Manager, Operations Group, Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2014-27954 Filed 11-25-14; 8:45 am]
BILLING CODE 4910-13-P


                    UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                               WASHINGTON, D.C.  20460

					OFFICE OF
	CHEMICAL SAFETY AND
	POLLUTION PREVENTION

MEMORANDUM

Date:		05-JUN-2014

Subject:	Sulfentrazone.  Section 3 Registration Request to Add New Use on Apples.  Summary of Analytical Chemistry and Residue Data.

PC Code:  129081
DP Barcode:  D415626
Decision No.:  483232
Registration Nos.:  279-3370, 279-3189, & 279-3220
Petition No.:  3E8202
Regulatory Action:  Amended Section 3
Risk Assessment Type:  NA
Case No.:  7231
TXR No.:  NA
CAS No.:  122836-35-5
MRID No.:  49124501
40 CFR:  §180.498

From:		George F. Kramer, Ph.D., Branch Senior Chemist
		Registration Action Branch 1 (RAB1)
		Health Effects Division (HED, 7509P)

Through:	Charles W. Smith III, Branch Chief
		RAB1/HED (7509P)

         To:		Laura Nollen/Barbara Madden, RM 05
	Registration Division (RD, 7505P)

Executive Summary

Sulfentrazone is an aryl triazolinone herbicide used to control a variety of broadleaf weeds.  The mode-of-action for controlling emerging weeds is by protoporphyrinogen oxidase (PPO) inhibition.  Sulfentrazone acts by the same mechanism as the diphenyl ether herbicides in which membrane disruption is initiated by the inhibition of PPO in the chlorophyll biosynthetic pathway and leads to the subsequent build-up of toxic intermediates.  Plants emerging from soils treated with sulfentrazone turn necrotic and die shortly after exposure to light.

The Interregional Research Project No. 4 (IR-4) has submitted a petition proposing the establishment of permanent tolerances for the combined residues of the free and conjugated forms of sulfentrazone, including its metabolites and degradates, in or on the commodities in the table below.  Compliance with the proposed tolerance levels specified below is to be determined by measuring only the sum of sulfentrazone (N-[2,4-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-yl]phenyl]methanesulfonamide) and its metabolites HMS (N-(2,4-dichloro-5-(4-(difluoromethyl)-4,5-dihydro-3-hydroxymethyl-5-oxo-1H-1,2,4-triazol-1-yl)phenyl)methanesulfonamide) and DMS (N-(2,4-dichloro-5-(4-(difluoromethyl)-4,5-dihydro-5-oxo-1H-1,2,4-triazol-1-yl)phenyl)methanesulfonamide, calculated as the stoichiometric equivalent of sulfentrazone in or on the following commodity:

Apple
0.15

A tolerance is currently established under 40 CFR §180.498(a)(1) for the combined residues of sulfentrazone and its major metabolite, HMS, in/on soybean seed at 0.05 ppm.  In addition, permanent tolerances are established under 40 CFR §180.498(a)(2) for the combined residues of sulfentrazone and its metabolites HMS and DMS in/on several food commodities; these established tolerances range from 0.15 ppm (various plant commodities) to 0.40 ppm (peanut meal and Brassica, leafy greens, subgroup 5B).  Tolerances for the combined residues of sulfentrazone and its metabolites HMS and DMS have been established under 40 CFR §180.498(c) in connection with regional registrations; these include tolerances for residues in/on succulent lima bean, succulent cowpea, and wheat grain at 0.15 ppm.  Finally, tolerances are established under 40 CFR §180.498(d) for inadvertent and indirect combined residues of sulfentrazone and its metabolites HMS and DMS in/on cereal grain (excluding sweet corn) bran, forage, grain, hay, hulls, stover, and straw at 0.1-0.6 ppm as a result of the application of sulfentrazone to growing crops.

The sulfentrazone end-use products (EPs) relevant for this registration request include Spartan[(R)] Herbicide (EPA Reg. No. 279-3189; 75% dry-flowable or DF formulation) and Spartan[(R)] 4F Herbicide (EPA Reg. No. 279-3220; 4 lb/gal flowable-concentrate (FlC) formulation).  The petitioner requests the amendment of these EP labels to incorporate a new use on apples.  These EPs are proposed for a maximum seasonal rate of 0.375 lb ai/A using ground equipment with a pre-harvest interval (PHI) of 14 days.

The nature of the residue in plants is adequately understood.  Data concerning the metabolism of sulfentrazone following preemergent applications in soybeans and confined rotational crops were submitted in conjunction with the soybean petition (PP#4F04407, D211168).  The HED Metabolism Committee determined that sulfentrazone and its metabolite HMS are the residues of concern in soybeans, and that sulfentrazone and its metabolites HMS and DMS (free and conjugated) are the residues of concern in rotational crops (D226434, 6/14/96, G. Kramer).  In addition, HED concluded that the results of the rotational crop metabolism studies may be translated to support preemergent uses on all crops (D220548, 3/13/96, G. Kramer).  Data concerning the metabolism of sulfentrazone following postemergent applications in corn, soybean, and radish were submitted in conjunction with recent petitions (D389972, 5/9/12, G. Kramer).  The metabolism of sulfentrazone was similar to that following preemergent application; no additional major metabolites were identified.  HED thus concludes metabolism data are now available to support postemergence applications and that sulfentrazone and its metabolites HMS and DMS (free and conjugated) are the residues of concern.

The nature of the residue in livestock is adequately understood based on acceptable ruminant and poultry metabolism studies.  Sulfentrazone per se and its metabolites HMS and DMS were identified as the residues of concern in meat, milk, poultry, and eggs.

There is an adequate residue analytical method for the purposes of tolerance enforcement.  A gas chromatography (GC) method for the determination of sulfentrazone and its metabolites DMS and HMS was submitted with a petition for a sulfentrazone tolerance on soybeans (PP#4F04407).  A petition method validation (PMV) was successfully completed by the Agency's Analytical Chemistry Laboratory (ACL).  The limit of quantitation (LOQ) and limit of detection (LOD) were determined to be 0.05 ppm and 0.005-0.025 ppm, respectively.  The method has been forwarded to the Food and Drug Administration (FDA) for inclusion in the Pesticide Analytical Methods Vol. II (PAM II).

The data requirements for multiresidue methods (MRMs) are fulfilled.  The FDA MRMs are not suitable as enforcement methods since sulfentrazone residues of concern were not successfully recovered by the FDA MRMs.

Samples of raw agricultural and processed commodities were analyzed for residues of sulfentrazone and its metabolites DMS and HMS using a liquid chromatograph equipped with tandem mass spectrometers (LC/MS/MS) method.  The validated LOQ was 0.025-0.05 ppm for each analyte.  These methods are adequate for data collection based on acceptable method validation and concurrent recovery data.

The submitted field trial residue data apple are adequate.  The field trial data reflect the proposed use patterns; an adequate number of trials were conducted in the appropriate geographic regions; and samples were analyzed for the residue of concern using validated data-collection methods.  The storage intervals were also validated.

No quantifiable residues were found in apples treated at an exaggerated rate (5X); therefore, separate tolerances are not required for apple processed commodities.

Analytical standards for sulfentrazone and its metabolites DMS and HMS are currently available at the EPA National Pesticide Standards.  However, as the existing stocks are depleted, the Repository has requested that the registrant provide additional amounts of sulfentrazone (5 g) and HMS (3 g).

No Codex, Canadian, or Mexican maximum residue limits (MRLs) have been established for sulfentrazone on apples.  Therefore, harmonization of MRLs and U.S. tolerances is not an issue at this time.

Regulatory Recommendations and Residue Chemistry Deficiencies

There are no residue chemistry issues that would preclude granting an unconditional registration for the requested use on apples.  The proposed uses and the submitted data support the establishment of the following tolerances for the combined residues of free and conjugated sulfentrazone and its metabolites HMS and DMS in/on:

Apple
0.15

A human-health risk assessment is forthcoming.

Background

The chemical structure and nomenclature of sulfentrazone are presented in Table 1, and the physicochemical properties of the technical grade of sulfentrazone are presented in Table 2.

Table 1.  Sulfentrazone Nomenclature.
Chemical structure

Common name
Sulfentrazone
Company experimental name
F6285; FMC 97285
IUPAC name
2',4'-dichloro-5'-(4-difluoromethyl-4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-yl)methanesulfonanilide
CAS name
N-(2,4-dichloro-5-(4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-yl)phenyl)methanesulfonamide
CAS registry number
122836-35-5
End-use product (EP)
4 lb/gal FlC formulation (Spartan[(R)] 4F Herbicide; EPA Reg. No. 279-3220) and 75% DF formulation (Spartan[(R)] Herbicide; EPA Reg. No. 279-3189)
Chemical structure of DMS metabolite

Common name
3-desmethyl sulfentrazone; DMS
Chemical name
N-(2,4-dichloro-5-(4-(difluoromethyl)-4,5-dihydro-5-oxo-1H-1,2,4-triazol-1-yl)phenyl)methanesulfonamide
Chemical structure of HMS metabolite

Common name
3-hydroxymethyl sulfentrazone; HMS
Chemical name
N-(2,4-dichloro-5-(4-(difluoromethyl)-4,5-dihydro-3-hydroxymethyl-5-oxo-1H-1,2,4-triazol-1-yl)phenyl)methanesulfonamide

Table 2.  Physicochemical Properties of Technical Grade Sulfentrazone.
Parameter
Value
Reference
Melting range
120-122 ºC
DP# 288712, 3/6/03, G. Kramer, G. Reddy, and L. Liu
pH
4.78 at 23 ºC

Density
0.53 g/cm[3]

Water solubility
4.0 x 10[2] ug/g

Solvent solubility
18.6% w/w in acetonitrile

Vapor pressure
8 x 10[-10] mm Hg

Dissociation constant, pKa
6.56

Octanol/water partition coefficient, Log(KOW)
1.49 at pH 5

UV/visible absorption spectrum
Not available

860.1200 Directions for Use

A list of the sulfentrazone end-use products relevant to this registration request is presented in Table 3.  The proposed crop use directions are summarized in Table 4A.  Information regarding rotational crop restrictions is listed in Table 4B.

Table 3.  Summary of Proposed End-Use Products.
Trade Name
                                   Reg. No.
                             ai (% of formulation)
                               Formulation Type
Target Crops
Target Pests
Spartan[(R)] 4F Herbicide
                                   279-3220
                                     39.6
                                 (4 lb ai/gal)
                                      FlC
Rhubarb, Turnips, Sunflower Subgroup 20B, Cowpeas, Wheat (Spring), Tree Nut Crop Group 14, Pistachio, Low-Growing Berry Crop Group 13-07, Citrus Fruit Crop Group 10-10, Nongrass Animal Feeds Crop Group 18
Broadleaf, grass, and sedge weeds.
Spartan[(R)] Herbicide
                                   279-3189
                                      75
                                      DF

                            F6285 4F CAL Herbicide
                                   279-3370
                              39.6 (4 lb ai/gal)
                                      FlC
Rhubarb, Turnips, Sunflower Subgroup 20B, Wheat (Spring), Tree Nut Crop Group 14, Pistachio, Low-Growing Berry Crop Group 13-07, Citrus Fruit Crop Group 10-10, Nongrass Animal Feeds Crop Group 18

Table 4.  Summary of Proposed Directions for Use of Sulfentrazone.
                         App. Timing; Type; and Equip.
                          Formulation (EPA Reg. No.)
                               Application Rates
                             Max. # App. per Year
                            Max. Yearly App. Rate
                        Use Directions and Limitations
                       Citrus Fruit Crop Group 10-10[c]
Apply as soil application to orchard floors or as uniform band application directed towards base of the trunk of trees.

Ground, impregnated onto dry bulk fertilizer.
                             Spartan 4F Herbicide
                                  (279-3320)
                             0.125 - 0.375 lb ai/A

                                   Up to 3
                                 0.375 lb ai/A
*General use directions:  min of 10 GPA.
PHI = 14 days.
RTI = 60 days.
Apply using ground equipment only; do not use airblast sprayer or apply by air.
Avoid direct or indirect spray contact with foliage and fruit.

                            F6285 4F CAL Herbicide
                                  (279-3370)

                               Spartan Herbicide
                                  (279-3189)

Conclusions:  The use directions are adequate to allow HED an assessment of whether the submitted residue data reflect the maximum residues likely to occur.

860.1300 Nature of the Residue  -  Plants

The nature of the residue in plants is adequately understood.  Data concerning the metabolism of sulfentrazone following preemergent applications in soybeans and confined rotational crops were submitted in conjunction with the soybean petition (PP#4F04407, D211168).  The HED Metabolism Committee determined that sulfentrazone and its metabolite HMS are the residues of concern in soybeans, and that sulfentrazone and its metabolites HMS and DMS (free and conjugated) are the residues of concern in rotational crops (D226434, 6/14/96, G. Kramer).  In addition, HED concluded that the results of the rotational crop metabolism studies may be translated to support preemergent uses on all crops (D220548, 3/13/96, G. Kramer).  Data concerning the metabolism of sulfentrazone following postemergent applications in corn, soybean, and radish were submitted in conjunction with recent petitions (D389972, 5/9/12, G. Kramer).  The metabolism of sulfentrazone was similar to that following preemergent application; no additional major metabolites were identified.  HED thus concludes metabolism data are now available to support postemergence applications and that sulfentrazone and its metabolites HMS and DMS (free and conjugated) are the residues of concern.

860.1300 Nature of the Residue  - Livestock

Adequate ruminant and poultry metabolism studies were submitted in conjunction with the soybean petition (PP#4F04407).  The metabolism of sulfentrazone in livestock differs from that in plants as metabolism proceeds only by oxidation of the 3-methyl group to form HMS, followed by further oxidation to form sulfentrazone carboxylic acid which is decarboxylated to DMS.  Sulfentrazone per se and its metabolites HMS and DMS were identified as the residues of concern in meat, milk, poultry, and eggs.

860.1340 Residue Analytical Methods

Enforcement Method

A GC analytical method for the determination of sulfentrazone, DMS, and HMS residues (free and conjugated) in/on various matrices was submitted with a petition for a sulfentrazone tolerance on soybeans (PP#4F04407).  A PMV was successfully completed by the Agency's ACL.  The LOQ and LOD were determined to be 0.05 ppm and 0.005-0.025 ppm, respectively.  HED concluded that the method is suitable for enforcement purposes (D233520, G. Kramer, 3/25/97).  The method was forwarded to FDA for inclusion in PAM II (Letter, G. Kramer, 9/18/98).  This method is suitable for enforcement of the tolerances associated with this petition.

Data-Collection Methods

Samples of raw agricultural commodities (RACS) and processed commodities were analyzed for residues of sulfentrazone and its metabolites DMS and HMS using a modified LC/MS/MS analytical method from study number P-3171 titled "Magnitude of the Residue of Sulfentrazone in/on Field Corn as a Rotated Crop Following Soybeans Treated with Authority Herbicide: Re-Analysis of Selected Trials using Revised Methodology."

Briefly, homogenized samples were refluxed with acetone:0.25N HCl (3:1, v:v) for 1 hour followed by filtration and concentration, then refluxed a second time with 1N HCI for 2 hours to free all conjugated analytes of concern and to completely convert sulfentrazone-3-carboxlic acid (SCA) to DMS.  The method quantifies residues of SCA as DMS and calculates SCA residues by a molecular weight-conversion factor (1.118).  SCA is a metabolism intermediate in formation of DMS.  After filtration, the aqueous solution was brought to volume with water and analyzed by LC/MS/MS.  Residues of the metabolites were not determined in parent equivalents.  The LOQ, determined as the lowest level of method validation (LLMV), was 0.025-0.05 ppm for all analytes in all matrices; the experimental LOD was 0.005-0.02 ppm.

The data-collection methods described above are adequate based on acceptable method validation and concurrent recovery data.

860.1360 Multiresidue Methods

MRM data for sulfentrazone and HMS were previously submitted and forwarded to FDA (Memo, 2/7/95, G. Kramer).  Neither compound was recovered by any of the protocols.  The FDA PESTDATA database dated 10/99 (PAM Vol. I, Appendix II) indicates that DMS is not recovered using MRM Sections 303 (Mills, Onley, and Gaither; Protocol E, nonfatty) and 304 (Mills, fatty food).  No information for recovery of DMS using Section 302 (Luke Method; Protocol D) is available.

860.1380 Storage Stability

IR-4 conducted concurrent storage stability studies with the apple field trials.  The results indicate that residues of sulfentrazone, DMS, and HMS are stable under frozen storage conditions in/on apple for up to 743 days (24.4 months).  Samples were stored frozen (<0 °C at the processing facility and analytical laboratory) from harvest/processing to analysis for 761 days (25 months) for apple (RAC), 783 days (25.8 months) for juice, and 748 days (24.6 months) for wet pomace.

Conclusions:  The available storage stability data for sulfentrazone are adequate to support the storage conditions and durations of samples from the submitted crop field trials and processing studies.  There are no storage stability issues and no corrections for storage stability need be applied to the field trial and processing studies.

860.1480 Meat, Milk, Poultry, and Eggs

HED previously determined that, based on the established sulfentrazone tolerances for soybean and cereal grain commodities and the results of the livestock metabolism studies, conventional feeding studies are not required.

Wet apple pomace is the only significant new feedstuff for livestock (ruminants only).  As no quantifiable residues were found in apples treated at an exaggerated rate (5X) and tolerances are established for feed items at higher levels than the recommended tolerance for the combined residues of sulfentrazone, DMS, and HMS of 0.15 ppm for apple (e.g., 0.50 ppm for wheat forage), the proposed new use on apples is not expected to increase the livestock dietary burdens.

860.1500 Crop Field Trials

DER Reference List	49124501.der1.docx

IR-4 has submitted field trial data for sulfentrazone on apple.  Twelve field trials were conducted in the United States during the 2009 growing season in the North American Free Trade Agreement (NAFTA) Growing Zones 1 (NY; 2 trials), 2 (NJ and NC; 2 trials), 5 (MI; 2 trials), 9 (CO; 1 trial), 10 (CA; 1 trial), and 11 (ID and WA; 4 trials).

Each trial consisted of one untreated plot and one treated plot.  At each trial location, the treated plot received a single soil broadcast or banded application of Spartan[(R)] 4F Herbicide made to each side of the orchard row at 0.360-0.393 lb ai/A (1X).  Applications were made using ground equipment in spray volumes of 11-40 gal/A without an adjuvant.  Samples of mature apples were harvested at a PHI of 13-15 days.

In samples harvested at a 13- to 15-day PHI following a single soil broadcast or banded application of the 4 lb ai/gal SC formulation at a total seasonal rate of 0.360-0.393 lb ai/A, residues of sulfentrazone and metabolites DMS and HMS were each below the LOQ (<0.05 ppm) in/on all samples of apples.  Combined residues of sulfentrazone, DMS, and HMS (and per-trial averages) were <0.15 (<0.15) ppm.

No residue-decline data were submitted; however, these data are not required because residues were non-quantifiable in/on all samples at the earliest harvest time.

Conclusions:  The submitted residue data are adequate to fulfill data requirements apples.  The number and locations of the crop field trials are in accordance with OPPTS Guideline 860.1500 (Table 5).  The available data will support the proposed use pattern.

TABLE 5.  Trial Numbers and Geographical Locations.
NAFTA Growing Zones
                                     Apple

                                   Submitted
                                 Requested[1]

                                    Canada
                                     U.S.
1
                                       2
                                      --
                                      4/3
2
                                     2[2]
                                      --
                                      2/1
5
                                       2
                                      --
                                      3/2
9
                                       1
                                      --
                                      1/1
10
                                       1
                                      --
                                      1/1
11
                                       4
                                      --
                                      5/4
Total
                                      12

                                     16/12
[1]  As per OCSPP 860.1500, Tables 1 and 5 for apple.  The second number reflects a 25% reduction in the number of field trials allowed for the crop as a representative commodity in support of a crop group/subgroup tolerance or when application results in no quantifiable residues.
[2]  The Zone 2 trial conducted in NJ was located near the border of Zone 1.

As all residues were <LOQ, the recommended tolerance for the combined residues of sulfentrazone, DMS, and HMS is 0.15 ppm for apple.

860.1520 Processed Food and Feed

DER Reference List	49124501.der2.docx

IR-4 has submitted a processing study with sulfentrazone on apple.  In one apple trial conducted in NY during the 2009 growing season, a treated plot received a single soil-banded application of Spartan[(R)] 4F Herbicide made to each side of the orchard row at a rate of 1.919 lb ai/A (~5X).  Applications were made using ground equipment in spray volumes of 25.6 gal/A without an adjuvant.  Samples of mature apples were harvested at a PHI of 15 days and processed into pasteurized juice and wet pomace using simulated commercial procedures.  Processing was conducted by A.C.D.S. Research, Inc. (North Rose, NY).  Adequate descriptions were provided of the processing procedures, including material balance summaries.

In samples harvested at a 15-day PHI following a single soil-banded application of the 4 lb ai/gal SC formulation at a total seasonal rates of 1.919 lb ai/A, residues of sulfentrazone and metabolites DMS and HMS were each below the LOQ (<0.05 ppm) in/on all samples of apples (RAC), juice, and wet pomace.  Processing factors could not be calculated because residues were below the LOQ in both the RAC and processed commodities.

Conclusions:  These data indicate that significant concentration of sulfentrazone residues are unlikely to occur in the processed fractions of apples; therefore, separate tolerances are not required for apple processed commodities.

860.1650 Submittal of Analytical Reference Standards

Analytical standards for sulfentrazone (expiration date 7/1/15) and its metabolites DMS (expiration date 8/1/17) and HMS (expiration date 8/31/18) are currently available at the EPA National Pesticide Standards Repository (personal communication with Theresa Cole, 4/21/14).  However, as the existing stocks are depleted, the Repository has requested that the registrant provide additional amounts of sulfentrazone (5 g) and HMS (3 g).  They should be sent to the Analytical Chemistry Lab, which is located at Fort Meade, to the attention of either Theresa Cole or Thuy Nygen at the following address:

	USEPA
	National Pesticide Standards Repository/Analytical Chemistry Branch/OPP
	701 Mapes Road
	Fort George G. Meade, MD  20755-5350

(Note that the mail will be returned if the extended zip code is not used.)

860.1850/1900 Confined/Field Accumulation in Rotational Crops

As apple trees are not rotated, rotational crop issues are not relevant to the current petition.

860.1550 Proposed Tolerances

The HED Metabolism Committee has determined that the parent compound, sulfentrazone, and the metabolite HMS are the residues of concern in soybeans, and that sulfentrazone and the metabolites HMS and DMS are the residues of concern in rotational crops (D226434, 6/14/96, G. Kramer).

Sulfentrazone tolerances are currently established under 40 CFR §180.498.  A tolerance is established under 40 CFR §180.498(a)(1) for the combined residues of sulfentrazone and its major metabolite, HMS, in/on soybean seed at 0.05 ppm.  Permanent tolerances are established under 40 CFR §180.498(a)(2) for "combined residues of the free and conjugated forms of sulfentrazone, including its metabolites and degradates, in or on the commodities in the table below.  Compliance with the tolerance levels specified below is to be determined by measuring only the sum of sulfentrazone (N-[2,4-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-yl]phenyl]methanesulfonamide) and its metabolites HMS (N-(2,4-dichloro-5-(4-(difluoromethyl)-4,5-dihydro-3-hydroxymethyl-5-oxo-1H-1,2,4-triazol-1-yl)phenyl)methanesulfonamide) and DMS (N-(2,4-dichloro-5-(4-(difluoromethyl)-4,5-dihydro-5-oxo-1H-1,2,4-triazol-1-yl)phenyl)methanesulfonamide, calculated as the stoichiometric equivalent of sulfentrazone in or on the following commodities."

No Codex, Canadian, or Mexican MRLs have been established for sulfentrazone on the subject crop.  Therefore, harmonization of MRLs and U.S. tolerances is not an issue at this time.  An International Residue Limits form is appended to this Summary Document.

A tolerance summary for sulfentrazone is presented in Table 6.

Table 6.  Tolerance Summary for Sulfentrazone.
Commodity
                           Proposed Tolerance (ppm)
                        HED-Recommended Tolerance (ppm)
Correct Commodity Definition/Comments
Establish under 40 CFR §180.498(a)(2):
Apple
                                     0.15
                                     0.15

References

DP#:		389972
Subject:	Sulfentrazone.  Section 3 Registration Request to Add New Uses on Rhubarb, Turnips, Sunflower Subgroup 20B, Succulent Cowpea, Lima Bean, Vegetable Soybean, Wheat, Citrus Fruit Crop Group 10-10, Low-Growing Berry Crop Group 13-07, Tree Nut Crop Group 14, Clover, Alfalfa, and Pistachios.  Summary of Analytical Chemistry and Residue Data.
From:		G. Kramer
To:		K. Montague/B. Madden
Dated:		5/9/12
MRID(s):	483973-02 thru -09, 485148-01 thru -03

DP#:		288712
Subject:	Sulfentrazone  -  Briefing Memorandum for Meeting of Metabolism Assessment Review Committee
From:		G. Kramer
To:		Y. Donovan
Dated:		3/6/03
MRID(s):	None

DP#s:		287102, 286879, 287256, 287257
Subject:	PP#s 2F6391, 2E6498, 2E6405 & 2E6500.  Sulfentrazone in/on Dried Shelled Pea and Bean, Field Corn, Succulent Lima Bean, Potatoes and Asparagus.  Summary of Analytical Chemistry and Residue Data.
From:		G. Kramer
To:		D. Morgan/J. Miller
Dated:		1/10/03
MRID(s):	45537402, 45567404, 45739201, 45582201, 45752601, 45567403, 45582201

DP#:		276111
Subject:	PP#1E6311.  Sulfentrazone on Cabbage, Horseradish, and Mint.  Evaluation of Residue Data and Analytical Methods.
From:		G. Kramer
To:		S. Brothers/R. Forrest
Dated:		12/9/02
MRID(s):	45393501 and 45393502

DP#:		233520
Subject:	PP#4F04407.  Sulfentrazone (Authority Herbicide) for Use on Soybeans.  Results of Petition Method Validation (PMV).
From:		G. Kramer
To:		S. Robbins/K. Boyle
Dated:		3/25/97
MRID(s):	44118801 and 44118802

DP#:		226434
Subject:	HED Metabolism Committee of 5/20/96.  Sulfentrazone.  PP#4F04407.
From:		G. Kramer
To:		HED Metabolism Committee Members
Dated:		6/14/96
MRID(s):	None

DP#:		220548
Subject:	PP#4F04407.  Sulfentrazone for Use on Soybeans.  Data Waiver Request.
From:		G. Kramer
To:		J. Miller
Dated:		3/13/96
MRID(s):	None

DP#:		None
Subject:	Multiresidue Method Testing of sulfentrazone and 3-hydroxy methyl sulfentrazone.
From:		G. Kramer
To:		H. Hundley
Dated:		2/7/95
MRID(s):	43345416

Attachments:
Appendix I - International Residue Limit Sheet.

DOCUMENT TRACKING

RDI:  RAB1 Chemistry Team:  04/23/2014
Petition #:  3E8202
DP#s:  415626
PC Code:  129081

Template Version September 2005
Appendix I.  International Tolerances

International Residue Limits

                       Sulfentrazone (129081; 4/15/2014)
Summary of US and International Tolerances and Maximum Residue Limits
Residue Definition:
U.S.
Canada
Mexico[2]
Codex
40 CFR 180.498:
(2) sum of sulfentrazone (N-[2,4-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-yl]phenyl]methanesulfonamide) and its metabolites HMS (N-(2,4-dichloro-5-(4-(difluoromethyl)-4,5-dihydro-3-hydroxymethyl-5-oxo-1H-1,2,4-triazol-1-yl)phenyl)methanesulfonamide) and DMS (N-(2,4-dichloro-5-(4-(difluoromethyl)-4,5-dihydro-5-oxo-1H-1,2,4-triazol-1-yl)phenyl)methanesulfonamide, calculated as the stoichiometric equivalent of sulfentrazone
Plants (except dry soybeans):  N-[2,4-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-yl]-phenyl]methanesulfonamide, including the metabolites N-[2,4-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-hydroxymethyl-5-oxo-1H-1,2,4-triazol-1-yl]phenyl]methanesulfonamide and N-[2,4-dichloro-5-4-(difluoromethyl)-4,5-dihydro-5-oxo-1H-1,2,4-triazol-1-yl]phenyl]methanesulfonamide

None
Commodity[1]
Tolerance (ppm) /Maximum Residue Limit (mg/kg)

U.S.
Canada
Mexico[2]
Codex
Apple
0.15

Completed: M. Negussie; 04/16/2014
[1] Includes only commodities of interest for this action.  Tolerance values should be the HED recommendations and not those proposed by the applicant.
2 Mexico adopts U.S. tolerances and/or Codex MRLs for its export purposes.


[Federal Register Volume 76, Number 205 (Monday, October 24, 2011)]
[Notices]
[Pages 65716-65717]
[FR Doc No: 2011-27318]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

 Notice of Effectiveness of Exempt Wholesale Generator Status

------------------------------------------------------------------------
                                                           Docket No.
------------------------------------------------------------------------
Michigan Wind 2, LLC.................................       EG11-100-000
Bishop Hill Energy LLC...............................       EG11-101-000
Bishop Hill Energy III LLC...........................       EG11-102-000

Bishop Hill Energy II LLC............................       EG11-103-000
CSOLAR IV South, LLC.................................       EG11-104-000
Gratiot County Wind LLC..............................       EG11-105-000
Invenergy Wind Development Michigan LLC..............       EG11-106-000
Trinity Hills Wind Farm LLC..........................       EG11-107-000
High Plains Ranch II, LLC............................       EG11-108-000
Double ``C'' Limited.................................       EG11-109-000
High Sierra Limited..................................       EG11-110-000
Kern Front Limited...................................       EG11-111-000
Cogentrix of Alamosa, LLC............................       EG11-112-000
Hudson Ranch Power I LLC.............................       EG11-113-000
TPW Petersburg, LLC..................................       EG11-114-000
------------------------------------------------------------------------

    Take notice that during the month of September 2011, the status of
the above-captioned entities as Exempt Wholesale Generators became
effective by operation of the Commission's regulations. 18 CFR
366.7(a).

    Dated: October 17, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-27318 Filed 10-21-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 202 (Friday, October 20, 2023)]
[Notices]
[Page 72503]
[FR Doc No: 2023-23227]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4611-DR; Docket ID FEMA-2023-0001]

Louisiana; Amendment No. 9 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Louisiana (FEMA-4611-DR), dated August 29, 2021, and
related determinations.

DATES: This change occurred on August 19, 2023.

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

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

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

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2023-23227 Filed 10-19-23; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 88, Number 73 (Monday, April 17, 2023)]
[Notices]
[Pages 23433-23444]
[FR Doc No: 2023-08023]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-0249]

Authorization of Emergency Use of an In Vitro Diagnostic Device
in Response to an Outbreak of Mpox; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of an Emergency Use Authorization (EUA) (the Authorization)
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) in response
to an outbreak of mpox. FDA has issued an Authorization for an in vitro
diagnostic device as requested by Cue Health, Inc. The Authorization
contains, among other things, conditions on the emergency use of the
authorized product. The Authorization follows the August 9, 2022,
determination by the Secretary of Health and Human Services (HHS) that
there is a public health emergency, or a significant potential for a
public health emergency, that affects, or has a significant potential
to affect, national security or the health and security of U.S.
citizens living abroad, and that involves monkeypox virus. On the basis
of such determination, the Secretary of HHS declared, on September 7,
2022, that circumstances exist justifying the authorization of
emergency use of in vitro diagnostics for detection and/or diagnosis of
infection with the monkeypox virus, including in vitro diagnostics that
detect and/or diagnose infection with non-variola Orthopoxvirus,
pursuant to the FD&C Act, subject to terms of any authorization issued
under that section. The Authorization, which includes an explanation of
the reasons for issuance, is reprinted in this document.

DATES: The Authorization is effective as of March 17, 2023.

ADDRESSES: Submit written requests for single copies of an EUA to the
Office of Policy, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your request or include a Fax number
to which the Authorization may be sent. See the SUPPLEMENTARY
INFORMATION section for electronic access to the Authorization.

FOR FURTHER INFORMATION CONTACT: Kim Sapsford-Medintz, Office of
Product Evaluation and Quality, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 3216, Silver Spring, MD 20993-0002,<PHONE_NUMBER> (this is not a
toll-free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) allows FDA to
strengthen public health protections against biological, chemical,
radiological, or nuclear agent or agents. Among other things, section
564 of the FD&C Act allows FDA to authorize the use of an unapproved
medical product or an unapproved use of an approved medical product in
certain situations. With this EUA authority, FDA can help ensure that
medical countermeasures may be used in emergencies to diagnose, treat,
or prevent serious or life-threatening diseases or conditions caused by
biological, chemical, radiological, or nuclear agent or agents when
there are no adequate, approved, and available alternatives (among
other criteria).

II. Criteria for EUA Authorization

    Section 564(b)(1) of the FD&C Act provides that, before an EUA may
be issued, the Secretary of HHS must declare that circumstances exist
justifying the authorization based on one of the following grounds: (1)
a determination by the Secretary of Homeland Security that there is a
domestic emergency, or a significant potential for a domestic
emergency, involving a heightened risk of attack with a biological,
chemical, radiological, or nuclear agent or agents; (2) a determination
by the Secretary of Defense that there is a military emergency, or a
significant potential for a military emergency, involving a heightened
risk to U.S. military forces, including personnel operating under the
authority of title 10 or title 50, U.S. Code, of attack with (A) a
biological, chemical, radiological, or nuclear agent or agents or (B)
an agent or agents that may cause, or are otherwise associated with, an
imminently life-threatening and specific risk to U.S. military forces;
\1\ (3) a determination by the Secretary of HHS that there is a public
health emergency, or a significant potential for a public health
emergency, that affects, or has a significant potential to affect,
national security or the health and security of U.S. citizens living
abroad, and that involves a biological, chemical, radiological, or
nuclear agent or agents, or a disease or condition that may be
attributable to such agent or agents; or (4) the identification of a
material threat by the Secretary of Homeland Security pursuant to
section 319F-2 of the Public Health Service (PHS) Act (42 U.S.C. 247d-
6b) sufficient to affect national security or the health and security
of U.S. citizens living abroad.
---------------------------------------------------------------------------

    \1\ In the case of a determination by the Secretary of Defense,
the Secretary of HHS shall determine within 45 calendar days of such
determination, whether to make a declaration under section 564(b)(1)
of the FD&C Act, and, if appropriate, shall promptly make such a
declaration.
---------------------------------------------------------------------------

    Once the Secretary of HHS has declared that circumstances exist
justifying an authorization under section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug, device, or biological product if
the Agency concludes that the statutory criteria are satisfied. Under
section 564(h)(1) of the FD&C Act, FDA is required to publish in the
Federal Register a notice of each authorization, and each termination
or revocation of an authorization, and an explanation of the reasons
for the action. Under section 564(h)(1) of the FD&C Act, revisions to
an authorization shall be made available on the internet website of
FDA. Section 564 of the FD&C Act permits FDA to authorize the
introduction into interstate commerce of a drug, device, or biological
product intended for use in an actual or potential emergency when the
Secretary of HHS has declared that circumstances exist justifying the
authorization of emergency use. Products appropriate for emergency use
may include products and uses that are not approved, cleared, or
licensed under sections 505, 510(k), 512, or 515 of the FD&C Act (21
U.S.C. 355, 360(k), 360b, or 360e) or section 351 of the PHS Act (42
U.S.C. 262), or conditionally approved under section 571 of the FD&C
Act (21 U.S.C. 360ccc).

    FDA may issue an EUA only if, after consultation with the HHS
Assistant Secretary for Preparedness and Response, the Director of the
National Institutes of Health, and the Director of the Centers for
Disease Control and Prevention (to the extent feasible and appropriate
given the applicable circumstances), FDA \2\ concludes: (1) that an
agent referred to in a declaration of emergency or threat can cause a
serious or life-threatening disease or condition; (2) that, based on
the totality of scientific evidence available to FDA, including data
from adequate and well-controlled clinical trials, if available, it is
reasonable to believe that (A) the product may be effective in
diagnosing, treating, or preventing (i) such disease or condition or
(ii) a serious or life- threatening disease or condition caused by a
product authorized under section 564, approved or cleared under the
FD&C Act, or licensed under section 351 of the PHS Act, for diagnosing,
treating, or preventing such a disease or condition caused by such an
agent and (B) the known and potential benefits of the product, when
used to diagnose, prevent, or treat such disease or condition, outweigh
the known and potential risks of the product, taking into consideration
the material threat posed by the agent or agents identified in a
declaration under section 564(b)(1)(D) of the FD&C Act, if applicable;
(3) that there is no adequate, approved, and available alternative to
the product for diagnosing, preventing, or treating such disease or
condition; (4) in the case of a determination described in section
564(b)(1)(B)(ii) of the FD&C Act, that the request for emergency use is
made by the Secretary of Defense; and (5) that such other criteria as
may be prescribed by regulation are satisfied.
---------------------------------------------------------------------------

    \2\ The Secretary of HHS has delegated the authority to issue an
EUA under section 564 of the FD&C Act to the Commissioner of Food
and Drugs.
---------------------------------------------------------------------------

    No other criteria for issuance have been prescribed by regulation
under section 564(c)(4) of the FD&C Act.

III. The Authorization

    The Authorization follows the August 9, 2022, determination by the
Secretary of HHS that there is a public health emergency, or a
significant potential for a public health emergency, that affects, or
has a significant potential to affect, national security or the health
and security of U.S. citizens living abroad, and that involves
monkeypox virus. Notice of the Secretary's determination was provided
in the Federal Register on August 15, 2022 (87 FR 50090). On the basis
of such determination, the Secretary of HHS declared, on September 7,
2022, that circumstances exist justifying the authorization of
emergency use of in vitro diagnostics for detection and/or diagnosis of
infection with the monkeypox virus, including in vitro diagnostics that
detect and/or diagnose infection with non-variola Orthopoxvirus,
pursuant to section 564 of the FD&C Act, subject to the terms of any
authorization issued under that section. Notice of the Secretary's
declaration was provided in the Federal Register on September 13, 2022
(87 FR 56074). On March 17, 2023, having concluded that the criteria
for issuance of the Authorization under section 564(c) of the FD&C Act
are met, FDA issued an EUA to Cue Health, Inc., for the Cue Mpox
(Monkeypox) Molecular Test, subject to the terms of the Authorization.
The Authorization, which is included below in its entirety after
section IV of this document (not including the authorized versions of
the fact sheets and other written materials), provides an explanation
of the reasons for issuance, as required by section 564(h)(1) of the
FD&C Act. Any subsequent revision to the Authorization can be found
from FDA's web page at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.

IV. Electronic Access

    An electronic version of this document and the full text of the
Authorization is available on the internet at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
BILLING CODE 4164-01-P

[GRAPHIC] [TIFF OMITTED] TN17AP23.000

[GRAPHIC] [TIFF OMITTED] TN17AP23.001

[GRAPHIC] [TIFF OMITTED] TN17AP23.002

[GRAPHIC] [TIFF OMITTED] TN17AP23.003

[GRAPHIC] [TIFF OMITTED] TN17AP23.004

[GRAPHIC] [TIFF OMITTED] TN17AP23.005

[GRAPHIC] [TIFF OMITTED] TN17AP23.006

[GRAPHIC] [TIFF OMITTED] TN17AP23.007

[GRAPHIC] [TIFF OMITTED] TN17AP23.008

[GRAPHIC] [TIFF OMITTED] TN17AP23.009

    Dated: April 12, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-08023 Filed 4-14-23; 8:45 am]
BILLING CODE 4164-01-C


[Federal Register Volume 83, Number 201 (Wednesday, October 17, 2018)]
[Notices]
[Page 52498]
[FR Doc No: 2018-22553]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2018-0789]

Information Collection Request to Office of Management and
Budget; OMB Control Number: 1625-0069

AGENCY: Coast Guard, DHS.

ACTION: Notice; correction.

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

SUMMARY: The Coast Guard published a document in the Federal Register
on September 6, 2018, concerning a sixty-day notice requesting comments
on an Information Collection Request to the Office of Management and
Budget, Office of Information and Regulatory Affairs, requesting an
extension of its approval for the following collection of information:
1625-0069, Ballast Water Management Reporting and Recordkeeping;
without change. The document contained an error in the document title
in the header.

FOR FURTHER INFORMATION CONTACT: Mr. Anthony Smith, Office of
Information Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Correction

    In the Federal Register of September 6, 2018, in FR Doc. 2018-
19327, on page 45266, in the second column, in the header, correct the
title of the document to read:
    Information Collection Request to Office of Management and Budget;
OMB Control Number: 1625-0069

    Dated: October 11, 2018.
James D. Roppel,
 Acting Chief, U.S. Coast Guard, Office of Information Management.
[FR Doc. 2018-22553 Filed 10-16-18; 8:45 am]
 BILLING CODE 9110-04-P