[Federal Register Volume 86, Number 124 (Thursday, July 1, 2021)]
[Notices]
[Pages 35110-35112]
[FR Doc No: 2021-14116]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2021-0002; Internal Agency Docket No. FEMA-B-2148]

Changes in Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, Department of Homeland
Security.

ACTION: Notice.

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SUMMARY: This notice lists communities where the addition or
modification of Base Flood Elevations (BFEs), base flood depths,
Special Flood Hazard Area (SFHA) boundaries or zone designations, or
the regulatory floodway (hereinafter referred to as flood hazard
determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and
where applicable, in the supporting Flood Insurance Study (FIS)
reports, prepared by the Federal Emergency Management Agency (FEMA) for
each community, is appropriate because of new scientific or technical
data. The FIRM, and where applicable, portions of the FIS report, have
been revised to reflect these flood hazard determinations through
issuance of a Letter of Map Revision (LOMR), in accordance with Federal
Regulations. The LOMR will be used by insurance agents and others to
calculate appropriate flood insurance premium rates for new buildings
and the contents of those buildings. For rating purposes, the currently
effective community number is shown in the table below and must be used
for all new policies and renewals.

DATES: These flood hazard determinations will be finalized on the dates
listed in the table below and revise the FIRM panels and FIS report in
effect prior to this determination for the listed communities.
    From the date of the second publication of notification of these
changes in a newspaper of local circulation, any person has 90 days in
which to request through the community that the Deputy Associate
Administrator for Insurance and Mitigation reconsider the changes. The
flood hazard determination information may be changed during the 90-day
period.

ADDRESSES: The affected communities are listed in the table below.
Revised flood hazard information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table below. Additionally, the current
effective FIRM and FIS report for each community are accessible online
through the FEMA Map Service Center at https://msc.fema.gov for
comparison.
    Submit comments and/or appeals to the Chief Executive Officer of
the community as listed in the table below.

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
<EMAIL_ADDRESS>or visit the FEMA Mapping and Insurance
eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The specific flood hazard determinations are
not described for each community in this notice. However, the online
location and local community map repository address where the flood
hazard determination information is available for inspection is
provided.
    Any request for reconsideration of flood hazard determinations must
be submitted to the Chief Executive Officer of the community as listed
in the table below.
    The modifications are made pursuant to section 201 of the Flood
Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance
with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq.,
and with 44 CFR part 65.
    The FIRM and FIS report are the basis of the floodplain management
measures that the community is required either to adopt or to show
evidence of having in effect in order to qualify or remain qualified
for participation in the National Flood Insurance Program (NFIP).
    These flood hazard determinations, together with the floodplain
management criteria required by 44 CFR 60.3, are the minimum that are
required. They should not be construed to mean that the community must
change any existing ordinances that are more stringent in their
floodplain management requirements. The community may at any time enact
stricter requirements of its own or

pursuant to policies established by other Federal, State, or regional
entities. The flood hazard determinations are in accordance with 44 CFR
65.4.
    The affected communities are listed in the following table. Flood
hazard determination information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table below. Additionally, the current
effective FIRM and FIS report for each community are accessible online
through the FEMA Map Service Center at https://msc.fema.gov for
comparison.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

Michael M. Grimm,
Assistant Administrator for Risk Management, Department of Homeland
Security, Federal Emergency Management Agency.

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                                     Location and  case     Chief executive officer  of                                   Online location of letter  of map                           Community
         State and county                   No.                      community              Community map  repository                 revision                Date of  modification      No.
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Alabama:
    Hale.........................  Town of Moundville     The Honorable Tony Lester,      Maps and Zoning Department,    https://msc.fema.gov/portal/        Jul. 8, 2021..........       100096
                                   (20-04-3557P).          Mayor, Town of Moundville,      410 Market Street,             advanceSearch.
                                                           P.O. Box 98, Moundville, AL     Moundville, AL 35474.
                                                           35474.
    Hale.........................  Unincorporated areas   The Honorable Arthur Crawford,  Hale County Engineering and    https://msc.fema.gov/portal/        Jul. 8, 2021..........       100094
                                    of Hale County         Chairman, Hale County Board     Road Department, 703 Cork      advanceSearch.
                                   (20-04-3557P).          of Commissioners, P.O. Box      Street, Greensboro, AL
                                                           396, Greensboro, AL 36744.      36744.
    Lee..........................  Unincorporated areas   The Honorable Bill English,     Lee County Building            https://msc.fema.gov/portal/        Sep. 30, 2021.........       010250
                                    of Lee County          Chairman, Lee County            Inspections Department, 100    advanceSearch.
                                   (21-04-2326P).          Commission, P.O. Box 666,       Orr Avenue, Opelika,
                                                           Opelika, AL 36803.              AL36804.
    St. Clair....................  Unincorporated areas   The Honorable Paul Manning,     St. Clair County Flood         https://msc.fema.gov/portal/        Oct. 1, 2021..........       010290
                                    of St. Clair County    Chairman, St. Clair County      Management Department, 165     advanceSearch.
                                   (21-04-2404P).          Commission, 165 5th Avenue,     5th Avenue, Suite 100,
                                                           Suite 100, Ashville, AL         Ashville, AL 35953.
                                                           35953.
Arkansas: Benton.................  City of Rogers         The Honorable Greg Hines,       Community Development          https://msc.fema.gov/portal/        Oct. 4, 2021..........       050013
                                   (21-06-0048P).          Mayor, City of Rogers, 301      Department, 301 West           advanceSearch.
                                                           West Chestnut Street, Rogers,   Chestnut Street, Rogers, AR
                                                           AR 72756.                       72756.
Colorado:
    Arapahoe.....................  City of Centennial     The Honorable Stephanie Piko,   Southeast Metro Stormwater     https://msc.fema.gov/portal/        Oct. 8, 2021..........       080315
                                   (20-08-0871P).          Mayor, City of Centennial,      Authority, 7437 South          advanceSearch.
                                                           13133 East Arapahoe Road,       Fairplay Street, Centennial,
                                                           Centennial, CO 80112.           CO 80112.
    Broomfield...................  City and County of     The Honorable Patrick Quinn,    Engineering Department, 1      https://msc.fema.gov/portal/        Oct. 1, 2021..........       085073
                                    Broomfield             Mayor, City and County of       DesCombes Drive, Broomfield,   advanceSearch.
                                   (21-08-0022P).          Broomfield, 1 DesCombes         CO 80020.
                                                           Drive, Broomfield, CO 80020.
    Denver.......................  City and County of     The Honorable Michael B.        Department of Public Works,    https://msc.fema.gov/portal/        Sep. 3, 2021..........       080046
                                    Denver                 Hancock, Mayor, City and        201 West Colfax Avenue,        advanceSearch.
                                   (20-08-0896P).          County of Denver, 1437 North    Denver, CO 80202.
                                                           Bannock Street, Room 350,
                                                           Denver, CO 80202.
    La Plata.....................  City of Durango        Mr. Jose Madrigal, City of      Planning Department, 1235      https://msc.fema.gov/portal/        Sep. 7, 2021..........       080099
                                   (20-08-0734P).          Durango Manager, 949 East 2nd   Camino Del Rio, Durango, CO    advanceSearch.
                                                           Avenue, Durango, CO 81301.      81301.
    Larimer......................  Unincorporated areas   The Honorable John Kefalas,     Larimer County Engineering     https://msc.fema.gov/portal/        Sep. 7, 2021..........       080101
                                    of Larimer County      Chairman, Larimer County        Department, 200 West Oak       advanceSearch.
                                   (20-08-0812P).          Board of Commissioners, 200     Street, Suite 3000, Fort
                                                           West Oak Street, Suite 2200     Collins, CO 80521.
                                                          Fort Collins, CO 80521.
Florida:
    Charlotte....................  Unincorporated areas   The Honorable Bill Truex,       Charlotte County Community     https://msc.fema.gov/portal/        Oct. 13, 2021.........       120061
                                    of Charlotte County    Chairman, Charlotte County      Development Department,        advanceSearch.
                                   (21-04-2201P).          Board of Commissioners, 18500   18500 Murdock Circle, Port
                                                           Murdock Circle, Suite 536,      Charlotte, FL 33948.
                                                           Port Charlotte, FL 33948.
    Collier......................  City of Naples         The Honorable Teresa Heitmann,  Building Department, 295       https://msc.fema.gov/portal/        Sep. 7, 2021..........       125130
                                   (21-04-0422P).          Mayor, City of Naples, 735      Riverside Circle, Naples, FL   advanceSearch.
                                                           8th Street South, Naples, FL    34102.
                                                           34102.

    Lee..........................  Unincorporated areas   Mr. Roger Desjarlais, Lee       Lee County Building            https://msc.fema.gov/portal/        Sep. 16, 2021.........       125124
                                    of Lee County          County Manager, 2115 2nd        Department, 1500 Monroe        advanceSearch.
                                   (21-04-2302P).          Street, Fort Myers, FL 33901.   Street, Fort Myers, FL
                                                                                33901.
    Pinellas.....................  City of Clearwater     Mr. William Horne, City of      Engineering Department, 100    https://msc.fema.gov/portal/        Sep. 9, 2021..........       125096
                                   (21-04-1867P).          Clearwater Manager, P.O. Box    South Myrtle Avenue, Suite     advanceSearch.
                                                           4748, Clearwater, FL 33756.     220, Clearwater, FL 33756.
Kentucky: Carroll................  Unincorporated areas   The Honorable Harold            Carroll County Solid Waste     https://msc.fema.gov/portal/        Sep. 3, 2021..........       210045
                                    of Carroll County      Tomlinson,Carroll County        Department, 829 Polk Street,   advanceSearch.
                                   (21-04-1755P).          Executive, 440 Main Street,     Carrollton, KY 41008.
                                                           Carrollton, KY 41008.
Massachusetts: Essex.............  Town of Marblehead     Mr. Jason Silva, Town of        Engineering Department, 7      https://msc.fema.gov/portal/        Sep. 17, 2021.........       250091
                                   (21-01-0574P).          Marblehead Administrator, 188   Widger Road, Marblehead, MA    advanceSearch.
                                                           Washington Street,              01945.
                                                           Marblehead, MA 01945.
Mississippi: Panola..............  Unincorporated areas   The Honorable Cole Flint,       Panola County Land             https://msc.fema.gov/portal/        Sep. 29, 2021.........       280125
                                    of Panola County       President, Panola County        Development Commission, 245    advanceSearch.
                                   (21-04-2141P).          Board of Supervisors, 151       Eureka Street, Batesville,
                                                           Public Square, Batesville, MS   MS 38606.
                                                           38606.
New Mexico: Bernalillo...........  Unincorporated areas   The Honorable Charlene E.       Bernalillo County Public       https://msc.fema.gov/portal/        Oct. 12, 2021.........       350001
                                    of Bernalillo County   Pyskoty, Chair, Bernalillo      Works Department, 2400         advanceSearch.
                                   (20-06-2872P).          County Board of                 Broadway Boulevard,
                                                           Commissioners, 1 Civic Plaza    Albuquerque, NM 87102.
                                                           Northwest, Albuquerque, NM
                                                           87102.
Pennsylvania:
    Lackawanna...................  Borough of Moosic      The Honorable James Segilia,    Borough Hall, 715 Main         https://msc.fema.gov/portal/        Oct. 18, 2021.........       420533
                                   (21-03-0726P)           Mayor, Borough of Moosic, 715   Street, Moosic, PA 18507.      advanceSearch.
                                                           Main Street, Moosic, PA
                                                           18507.
    Lackawanna...................  Borough of Old Forge   The Honorable Bob Legg, Mayor,  Borough Hall, 310 South Main   https://msc.fema.gov/portal/        Oct. 18, 2021.........       420535
                                   (21-03-0726P)           Borough of Old Forge, 310       Street, Old Forge, PA 18518.   advanceSearch.
                                                           South Main Street, Old Forge,
                                                           PA 18518.
    Montgomery...................  Township of Hatfield   Mr. Aaron Bibro, Township of    Zoning Department, 1950        https://msc.fema.gov/portal/        Sep. 23, 2021.........       420699
                                   (21-03-0243P)           Hatfield Manager, 1950 School   School Road, Hatfield, PA      advanceSearch.
                                                           Road, Hatfield, PA 19440.       19440.
Texas:
    Bexar........................  Unincorporated areas   The Honorable Nelson Wolff,     Bexar County Public Works      https://msc.fema.gov/portal/        Oct. 4, 2021..........       480035
                                    of Bexar County        Bexar County Judge, 101 West    Department, 1948 Probandt      advanceSearch.
                                   (21-06-0275P).          Nueva Street, 10th Floor, San   Street, San Antonio, TX
                                                           Antonio, TX 78205.              78214.
    Comal........................  City of Bulverde       The Honorable Bill Krawietz,    City Hall, 30360 Cougar Bend,  https://msc.fema.gov/portal/        Oct. 4, 2021..........       481681
                                   (21-06-0275P).          Mayor, City of Bulverde,        Bulverde, TX 78163.            advanceSearch.
                                                           30360 Cougar Bend, Bulverde,
                                                           TX 78163.
    Comal........................  Unincorporated areas   The Honorable Sherman Krause,   Comal County Engineering       https://msc.fema.gov/portal/        Oct. 4, 2021..........       485463
                                    of Comal County        Comal County Judge 100 Main     Department, 195 David Jonas    advanceSearch.
                                   (21-06-0275P).          Plaza, New Braunfels, TX        Drive, New Braunfels, TX
                                                           78130.                          78132.
    Dallas.......................  Town of Sunnyvale      The Honorable Saji George,      Town Hall, 127 North Collins   https://msc.fema.gov/portal/        Oct. 18, 2021.........       480188
                                   (20-06-3713P).          Mayor, Town of Sunnyvale, 127   Road, Sunnyvale, TX 75182.     advanceSearch.
                                                           North Collins Road,
                                                           Sunnyvale, TX 75182.
Virginia: Albemarle..............  Unincorporated areas   The Honorable Ned L. Gallaway,  Albemarle County Community     https://msc.fema.gov/portal/        Sep. 27, 2021.........       510006
                                    of Albemarle County    Chairman, Albemarle County      Development Department, 401    advanceSearch.
                                   (21-03-0029P).          Board of Supervisors, 401       McIntire Road,
                                                           McIntire Road,                  Charlottesville, VA 22902.
                                                           Charlottesville, VA 22902.
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[FR Doc. 2021-14116 Filed 6-30-21; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 84, Number 61 (Friday, March 29, 2019)]
[Rules and Regulations]
[Pages 11885-11887]
[FR Doc No: 2019-06015]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R01-OAR-2018-0791; FRL-9991-35-Region 1]

Air Plan Approval; Massachusetts; Regional Haze Five-Year
Progress Report State Implementation Plan

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving
Massachusetts' Regional Haze Five-Year Progress Report, submitted on
February 9, 2018 as a revision to its State Implementation Plan (SIP).
This SIP revision addresses requirements of the Clean Air Act (CAA) and
EPA's rules that require states to submit periodic reports describing
the progress toward reasonable progress goals (RPGs) established for
regional haze and a determination of adequacy of the State's existing
regional haze SIP. EPA is approving Massachusetts' February 9, 2018 SIP
submittal on the basis that it addresses the progress report and
adequacy determination requirements for the first implementation period
for regional haze.

DATES: This rule is effective on April 29, 2019.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R01-OAR-2018-0791. All documents in the docket

are listed on the https://www.regulations.gov website. Although listed
in the index, some information is not publicly available, i.e., CBI or
other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
internet and will be publicly available only in hard copy form.
Publicly available docket materials are available at https://www.regulations.gov or at the U.S. Environmental Protection Agency, EPA
Region 1 Regional Office, Office of Ecosystem Protection, Air Quality
Planning Unit, 5 Post Office Square--Suite 100, Boston, MA. EPA
requests that if at all possible, you contact the contact listed in the
FOR FURTHER INFORMATION CONTACT section to schedule your inspection.
The Regional Office's official hours of business are Monday through
Friday, 8:30 a.m. to 4:30 p.m., excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: Anne K. McWilliams, Air Quality Unit,
U.S. Environmental Protection Agency, EPA Region 1, 5 Post Office
Square--Suite 100, (Mail code OEP05-2), Boston, MA 02109-3912, tel.
(617) 918-1697, email [email protected].

SUPPLEMENTARY INFORMATION:
    Throughout this document whenever ``we,'' ``us,'' or ``our'' is
used, we mean EPA.

Table of Contents

I. Background and Purpose
II. Public Comment
III. Final Action
IV. Statutory and Executive Order Reviews

I. Background and Purpose

    On February 1, 2019 (84 FR 1021), EPA published a Notice of
Proposed Rulemaking (NPRM) proposing to approve Massachusetts' Regional
Haze Five-Year Progress Report, submitted by the Massachusetts
Department of Environmental Protection (MassDEP) on February 9, 2018. A
detailed discussion of Massachusetts' regional haze progress report and
EPA's rationale for approving the SIP revision were provided in the
NPRM and will not be restated here.

II. Public Comment

    EPA received one comment in response to the NPRM. The comment
discussed subjects outside the scope of a regional haze SIP action,
does not explain (or provide a legal basis for) how the proposed action
should differ in any way, and makes no specific mention of the proposed
action; it is not germane.

III. Final Action

    EPA is approving Massachusetts' Regional Haze Five-Year Progress
Report, submitted by MassDEP on February 9, 2018, as a revision to the
Massachusetts SIP.

IV. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     This action is not an Executive Order 13771 regulatory
action because this action is not significant under Executive Order
12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by May 28, 2019. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Regional haze, Reporting and
recordkeeping requirements, Sulfur oxides, Volatile organic compounds.

    Dated: March 25, 2019.
Deborah Szaro,
Acting Regional Administrator, EPA Region 1.

    Part 52 of chapter I, title 40 of the Code of Federal Regulations
is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart W--Massachusetts

0
2. In Sec.  52.1120 (e), amend the table by adding an entry entitled
``Massachusetts Regional Haze Five-Year Progress Report'' at the end of
the table to read as follows:

Sec.  52.1120   Identification of plan.

* * * * *
    (e) * * *

                                                              Massachusetts Non-Regulatory
--------------------------------------------------------------------------------------------------------------------------------------------------------
     Name of non-regulatory SIP           Applicable geographic or        State submittal date/effective
             provision                       nonattainment area                        date                 EPA approved date \3\       Explanations
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
Massachusetts Regional Haze Five-    Statewide........................  Submitted 2/9/2018...............  3/29/19, [Insert
 Year Progress Report.                                                                                Federal Register
                                                                                citation].
--------------------------------------------------------------------------------------------------------------------------------------------------------
\3\ To determine the EPA effective date for a specific provision listed in this table, consult the Federal Register notice cited in this column for the
  particular provision.

[FR Doc. 2019-06015 Filed 3-28-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 146 (Tuesday, July 30, 2019)]
[Notices]
[Pages 36914-36915]
[FR Doc No: 2019-16124]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2561-055]

Sho-Me Power Electric Cooperative; Notice of Intent To File
License Application, Filing of Pre-Application Document, Approving Use
of the Traditional Licensing Process

    a. Type of Filing: Notice of Intent to File License Application and
Request to Use the Traditional Licensing Process.
    b. Project No.: 2561-055.
    c. Date Filed: May 30, 2019.
    d. Submitted By: Sho-Me Electric Power Cooperative (Sho-Me).
    e. Name of Project: Niangua Hydroelectric Project.
    f. Location: On the Niangua River, in Camden County, Missouri. No
federal lands are occupied by the project works or located within the
project boundary.
    g. Filed Pursuant to: 18 CFR 5.3 of the Commission's regulations.
    h. Potential Applicant Contact: Peter Dawson, Sho-Me Electric Power
Cooperative, P.O. Box D, 301 W Jackson, Marshfield, MO 65706; (417)
859-2615; [email protected]
    i. FERC Contact: Nick Ettema at<PHONE_NUMBER>; or email at
<EMAIL_ADDRESS>    j. Sho-Me filed its request to use the Traditional Licensing
Process on May 30, 2019. Sho-Me provided public notice of its request
on June 7, 2019. In a letter dated July 23, 2019, the Director of the
Division of Hydropower Licensing approved Sho-Me's request to use the
Traditional Licensing Process.
    k. With this notice, we are initiating informal consultation with
the U.S. Fish and Wildlife Service and/or NOAA Fisheries under section
7 of the Endangered Species Act and the joint agency regulations
thereunder at 50 CFR, part 402; and NOAA Fisheries under section 305(b)
of the Magnuson-Stevens Fishery Conservation and Management Act and
implementing regulations at 50 CFR 600.920. We are also initiating
consultation with the Missouri State Historic Preservation Officer, as
required by section 106, National Historic Preservation Act, and the
implementing regulations of the Advisory Council on Historic
Preservation at 36 CFR 800.2.
    l. With this notice, we are designating Sho-Me as the Commission's
non-federal representative for carrying out informal consultation
pursuant to section 7 of the Endangered Species Act; and consultation
pursuant to section 106 of the National Historic Preservation Act.
    m. Sho-Me filed a Pre-Application Document (PAD); including a
proposed process plan and schedule with the Commission, pursuant to 18
CFR 5.6 of the Commission's regulations.
    n. A copy of the PAD is available for review at the Commission in
the Public Reference Room or may be viewed on the Commission's website
(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 at

<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). A copy is also available for inspection and reproduction at
the address in paragraph h.
    o. The licensee states its unequivocal intent to submit an
application for a new license for Project No. 2561. Pursuant to 18 CFR
16.8, 16.9, and 16.10 each application for a new license and any
competing license applications must be filed with the Commission at
least 24 months prior to the expiration of the existing license. All
applications for license for this project must be filed by May 31,
2022.
    p. Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filing and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.

    Dated: July 23, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-16124 Filed 7-29-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 242 (Monday, December 19, 2022)]
[Notices]
[Pages 77671-77674]
[FR Doc No: 2022-27387]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket Nos. NHTSA-2022-0071 and NHTSA-2022-0072; Notice 1]

Diono LLC, Receipt of Petitions for Decision of Inconsequential
Noncompliance

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Receipt of petitions.

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SUMMARY: Diono LLC, (Diono), has determined that certain models of its
child restraint systems do not fully comply with Federal Motor Vehicle
Safety Standard (FMVSS) No. 213, Child Restraint Systems. Diono filed
two noncompliance reports dated June 22, 2022, and later amended one of
the reports on August 10, 2022. Diono subsequently petitioned NHTSA on
July 21, 2022, and July 22, 2022, and later amended one of the
petitions on August

18, 2022, for a decision that the subject noncompliances are
inconsequential as they relate to motor vehicle safety. This document
announces receipt of Diono's petitions.

DATES: Send comments on or before January 18, 2023.

ADDRESSES: Interested persons are invited to submit written data,
views, and arguments on these petitions. Comments must refer to the
docket and notice number cited in the title of this notice and may be
submitted by any of the following methods:
     Mail: Send comments by mail addressed 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.
     Hand Delivery: Deliver comments by hand 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. The Docket Section is open on weekdays from 10 a.m. to 5 p.m.
except for Federal Holidays.
     Electronically: Submit comments electronically by logging
onto the Federal Docket Management System (FDMS) website at https://www.regulations.gov/. Follow the online instructions for submitting
comments.
     Comments may also be faxed to<PHONE_NUMBER>.
    Comments must be written in the English language, and be no greater
than 15 pages in length, although there is no limit to the length of
necessary attachments to the comments. If comments are submitted in
hard copy form, please ensure that two copies are provided. If you wish
to receive confirmation that comments you have submitted by mail were
received, please enclose a stamped, self-addressed postcard with the
comments. Note that all comments received will be posted without change
to https://www.regulations.gov, including any personal information
provided.
    All comments and supporting materials received before the close of
business on the closing date indicated above will be filed in the
docket and will be considered. All comments and supporting materials
received after the closing date will also be filed and will be
considered to the fullest extent possible.
    When the petitions are granted or denied, notice of the decision
will also be published in the Federal Register pursuant to the
authority indicated at the end of this notice.
    All comments, background documentation, and supporting materials
submitted to the docket may be viewed by anyone at the address and
times given above. The documents may also be viewed on the internet at
https://www.regulations.gov by following the online instructions for
accessing the dockets. The docket ID numbers for these petitions are
shown in the heading of this notice.
    DOT's complete Privacy Act Statement is available for review in a
Federal Register notice published on April 11, 2000 (65 FR 19477-78).

FOR FURTHER INFORMATION CONTACT: Paloma Lampert, General Engineer,
NHTSA, Office of Vehicle Safety Compliance,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    I. Overview: Diono determined that certain Diono Everett NXT
Booster Seats do not fully comply with paragraph S5.5.2(e) of FMVSS No.
213, Child Restraint Systems (49 CFR 571.213) because they do not
contain the certification statement.
    Diono filed an original noncompliance report dated June 22, 2022,
pursuant to 49 CFR part 573, Defect and Noncompliance Responsibility
and Reports. Diono petitioned NHTSA on July 22, 2022, for an exemption
from the notification and remedy requirements of 49 U.S.C. Chapter 301
on the basis that this noncompliance is inconsequential as it relates
to motor vehicle safety, pursuant to 49 U.S.C. 30118(d) and 30120(h)
and 49 CFR part 556, Exemption for Inconsequential Defect or
Noncompliance.
    Diono also determined that certain Cambria, Monterey, Radian,
Everett, and Solana, model child restraints do not fully comply with
paragraphs S5.5.2, S5.5.2(m)(ii), S<IP_ADDRESS>(ii), and S5.8.2, of FMVSS
No. 213, Child Restraint Systems (49 CFR 571.213).
    Diono filed an original noncompliance report dated June 22, 2022,
and later amended it on August 10, 2022, pursuant to 49 CFR part 573,
Defect and Noncompliance Responsibility and Reports. Diono petitioned
NHTSA on July 21, 2022, and later amended it on August 18, 2022, for an
exemption from the notification and remedy requirements of 49 U.S.C.
chapter 301 on the basis that this noncompliance is inconsequential as
it relates to motor vehicle safety, pursuant to 49 U.S.C. 30118(d) and
30120(h) and 49 CFR part 556, Exemption for Inconsequential Defect or
Noncompliance.
    This notice of receipt of Diono's petitions is published under 49
U.S.C. 30118 and 30120 and does not represent any agency decision or
another exercise of judgment concerning the merits of the petitions.
    II. Child Restraint Systems Involved: Approximately 2,642 Diono
Everett NXT Booster Seats, manufactured between October 1, 2020, and
March 31, 2021, are potentially involved because they do not comply
with S5.5.2(e) of FMVSS No. 213.
    In addition, approximately 697,286 Cambria 2, Monterey XT, Monterey
4DXT, Monterey 5, Radian 3R, Radian 3RX, Radian 3RXT, Radian 3QX,
Radian 3QXT, Radian 3QXT+, Radian 3RXT Safe+, Everett NXT,\1\ Solana,
and Solana 2, child seat restraints manufactured between July 12, 2021,
and July 21, 2022, are potentially involved.
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    \1\ According to Diono's petition, the Everett NXT model does
not comply with S<IP_ADDRESS>(ii) and S5.8.2 whereas the other models
listed also do not comply with S5.5.2 and S5.5.2(m)(ii) because the
required information is not printed on black text with white
background.
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    III. Noncompliances: Diono explains that the labels on the subject
Everett NXT Booster Seats are missing the statement ``This child
restraint system conforms to all applicable Federal motor vehicle
safety standards,'' and therefore the Everett NXT Booster Seats do not
fully comply with S5.5.2(e) of FMVSS No. 213.
    The subject Cambria 2, Monterey XT, Monterey 4DXT, Monterey 5,
Radian 3R, Radian 3RX, Radian 3RXT, Radian 3QX, Radian 3QXT, Radian
3QXT+, Radian 3RXT Safe+, Solana, and Solana 2 child restraints are
affixed with labels that were printed with white text on a black
background rather than black text on a white background, and therefore,
do not fully comply with S5.5.2 of FMVSS No. 213.
    The subject Cambria 2, Monterey XT, Monterey 4DXT, Radian 3R,
Radian 3RX, Radian 3RXT, Radian 3QX, Radian 3QXT, Everett NXT, Solana,
and Solana 2 child restraints were sold with printed instructions that
provided an incorrect web address to access the electronic registration
form, and therefore, do not fully comply with S5.6.1(7)(ii) and S5.8.2
of FMVSS No. 213.
    IV. Rule Requirements: Paragraphs S5.5.2, S5.5.2(e), S5.5.2(m)(ii),
S<IP_ADDRESS>(ii) and S5.8.2 of FMVSS No. 213 include the requirements
relevant to the petitions. Among other required information, each add-
on child restraint must be permanently labeled on a white background
with black text with the following statements:
     ``This child restraint system conforms to all applicable
Federal motor vehicle safety standards.''
     ``Child restraints could be recalled for safety reasons.
You must register this restraint to be reached in a recall. Send

your name, address, email address if available [preceding four words
are optional], and the restraint's model number and manufacturing date
to (insert address) or call (insert a U.S. telephone number) or
register online at (insert website for electronic registration form).
For recall information, call the U.S. Government's Vehicle Safety
Hotline at 1-888-327-4236 (TTY: 1-800-424-9153), or go to http://www.NHTSA.gov.''
    The written instructions required to be provided with each child
seat restraint must include the statement provided by S<IP_ADDRESS>(i) or
S<IP_ADDRESS>(ii). If a manufacturer opts to provide a website on the
registration card, the manufacturer must include the statement given in
S<IP_ADDRESS>(ii) which states: ``Child restraints could be recalled for
safety reasons. You must register this restraint to be reached in a
recall. Send your name, address, email address if available (preceding
four words are optional), and the restraint's model number and
manufacturing date to (insert address) or call (insert telephone
number) or register online at (insert website for electronic
registration form). For recall information, call the U.S. Government's
Vehicle Safety Hotline at 1-888-327-4236 (TTY: 1-800-424-9153), or go
to http://www.NHTSA.gov.'' S5.8.2 specifies that the electronic
registration form must be accessed directly by the web address that the
manufacturer printed on the attached registration form and the form
must appear on screen without any further keystrokes on the keyboard or
clicks of the mouse.
    V. Summary of Diono's Petitions: The following views and arguments
presented in this section, ``V. Summary of Diono's Petitions,'' are the
views and arguments provided by Diono. They have not been evaluated by
the Agency and do not reflect the views of the Agency. Diono describes
the subject noncompliances and contends that the noncompliances are
inconsequential as they relate to motor vehicle safety.
    Diono Everett NXT Booster Seats:
    Diono explains that while the Diono Everett NXT Booster Seats do
not contain one of the statements required by S5.5.2, the noncompliance
is inconsequential because the instruction manual provided with them
does contain the missing statement, and consumers can contact Diono's
customer service department if they have any questions about product
safety or compliance with FMVSSs. Therefore, Diono argues that
consumers have an ``adequate and alternative means of being informed of
the compliance status.'' Diono references NHTSA's decision on a
petition submitted by Mazda, in which the noncompliance was deemed
consequential; however, Diono contends that NHTSA's reasoning
(noncompliances pertaining to labelling are inconsequential when they
do not cause any misunderstanding, especially where other sources of
correct information are available) supports the granting of the subject
petition.
    Furthermore, Diono believes that it is unlikely consumers would
conclude that the subject Diono Everett NXT Booster Seats do not comply
FMVSS No. 213, ``given that no child restraint can be legally sold in
the United States without such compliance.'' Diono contends that
consumers would instead ``assume that products on the market meet
mandatory safety standards, whatever those standards might be.''
    Cambria, Monterey, Radian, Everett, and Solana Models
    Diono believes that the noncompliant text and background colors
used on the labels affixed to the subject Cambria, Monterey, Radian,
and Solana model child restraint systems are inconsequential to motor
vehicle safety because Diono claims that the colors used still fulfill
the purpose of the requirement. Diono states that the noncompliant
labels use the same black and white contrast that is required but in
reverse and the purpose of the requirement to conspicuously provide the
information on the label is fulfilled.
    Diono states that ``[t]o ensure compliance with the regulation and
before manufacture of the affected child restraints, Diono proactively
had all labels reviewed and approved by Calspan Corporation.'' Diono
included copies of the reports prepared by Calspan with its petition as
Exhibits B through O. Diono states that Calspan concluded that the
affected labels complied with FMVSS No. 213 and contends that
``Calspan's finding that the affected labels complied with FMVSS [No.]
213 supports the conclusion that Diono's particular use of the chosen
colors provides the necessary level of conspicuity.''
    Diono also states that it has corrected future production to use a
label with the black text on white background, as required by S5.5.2.
Diono notes that NHTSA has denied a petition submitted by Baby Jogger,
LLC, concerning a similar noncompliance; however, Diono states that the
labels at issue in that petition were difficult to read and ``did not
fully comply with numerous other provisions of S5.5.2 concerning font,
capitalization, and incorrect sequencing of text and warnings.'' Unlike
the noncompliant labels in Baby Jogger, LLC's petition, Diono believes
that its noncompliant labels should be found inconsequential to motor
vehicle safety because all the required information is still present
and the label is ``conspicuous and legible.''
    In both petitions, Diono states that NHTSA has previously explained
that it might consider a labeling noncompliance to be inconsequential
in situations where the label has a misspelled word, or is printed in
the wrong format or wrong type size if the noncompliance does not cause
any misunderstanding, especially where other sources of correct
information are available.\2\ Furthermore, Diono states that it has not
received any reports or inquiries regarding the subject noncompliances.
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    \2\ Diono cites Mazda North American Operations; Denial of
Petition for Inconsequentiality; 86 FR 7170-01 (Jan. 26, 2021).
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    Diono also determined that the written instructions sold with the
affected child restraint systems provided a web address that did not
directly access the electronic registration form. Diono explained that
the noncompliance occurred because ``an IT contractor who was updating
Diono's website failed to comply with the requirement not to disturb
the registration page.'' Diono says that it has corrected the issue by
redirecting the provided web address to allow the consumer to access
the registration form as required. Diono believes that this
noncompliance does not ``negatively impact motor vehicle safety because
the availability of an electronic registration form on the website (1)
is voluntary by regulation and (2) could still be located and completed
by consumers in an effective manner.'' Diono further explains that
consumers affected by this noncompliance were still able to navigate to
Diono's home web page via the incorrect web address where the consumer
could access the link to the registration form.
    According to Diono, the purpose of the requirement to provide a web
address to access the registration was still fulfilled ``even if the
manner by which consumers temporarily did this did not fully comply''
with the requirements provided in FMVSS No. 213. Diono notes that it
was ``actively receiving electronic registrations through its website
throughout the time period at issue.'' Therefore, Diono states that
consumers were ``consistently able to redirect themselves to the
appropriate registration link and effectuate registration.'' Diono says
that it did not receive any reports that consumers were unable to
register their child restraint system.

    Diono further contends that ``it is not unusual for any business to
experience extended, unexpected and even undiagnosed downtime or
impaired function of pages on its website, which it learns of only when
reported, and promptly remedies.'' Diono states that consumers are able
to effectively navigate websites to find the intended web page, which
it says, ``may complicate the supplier's ability to recognize such
issues in the first place.'' Moreover, Diono states, ``If technical
difficulties with a supplier's registration website were consequential
to motor vehicle safety, a motor vehicle equipment supplier would need
to file a Part 573 report every time their website experienced a
material service interruption or had a miscommunication with its web
development team.''
    Diono concludes by stating its belief that the subject
noncompliances are inconsequential as they relate to motor vehicle
safety and its petitions to be exempted from providing notification of
the noncompliance, as required by 49 U.S.C. 30118, and a remedy for the
noncompliance, as required by 49 U.S.C. 30120, should be granted.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners, purchasers, and dealers of a defect or noncompliance
and to remedy the defect or noncompliance. Therefore, any decision on
these petitions only applies to the subject child restraints that Diono
no longer controlled at the time it determined that the noncompliances
existed. However, any decision on these petitions does not relieve
child restraint distributors and dealers of the prohibitions on the
sale, offer for sale, or introduction or delivery for introduction into
interstate commerce of the noncompliant child restraint systems under
their control after Diono notified them that the subject noncompliances
existed.

(Authority: 49 U.S.C. 30118, 30120: delegations of authority at 49
CFR 1.95 and 501.8)

Otto G. Matheke III,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2022-27387 Filed 12-16-22; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 81, Number 107 (Friday, June 3, 2016)]
[Notices]
[Pages 35776-35777]
[FR Doc No: 2016-13167]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-0268]

Individual Patient Expanded Access Applications: Form FDA 3926;
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a guidance for industry entitled ``Individual
Patient Expanded Access Applications: Form FDA 3926.'' The guidance
describes Form FDA 3926 (Individual Patient Expanded Access--
Investigational New Drug Application (IND)), which is available for
licensed physicians to use for expanded access requests for individual
patient INDs. Individual patient expanded access allows for the use of
an investigational new drug outside of a clinical investigation, or the
use of an approved drug where availability is limited by a risk
evaluation and mitigation strategy (REMS), for an individual patient
who has a serious or immediately life-threatening disease or condition
when there is no comparable or satisfactory alternative therapy to
diagnose, monitor, or treat the disease or condition. Form FDA 3926
provides a streamlined alternative for submitting an IND for use in
cases of individual patient expanded access, including for emergency
use. This guidance finalizes the draft guidance issued in February
2015.

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

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. 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 http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2015-D-0268 for ``Individual Patient Expanded Access Applications:
Form FDA 3926; Guidance for Industry; Availability.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of 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 to 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: Larry Lim, Center for Drug Evaluation
and Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Bldg., Rm. 4134, Silver Spring, MD 20993,<PHONE_NUMBER>; 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 guidance for industry
entitled

``Individual Patient Expanded Access Applications: Form FDA 3926.'' The
guidance describes Form FDA 3926, which is available for licensed
physicians to use for expanded access requests for individual patient
INDs. FDA's current expanded access regulations (21 CFR part 312,
subpart I) went into effect on October 13, 2009 (74 FR 40900). Expanded
access refers to the use of an investigational drug when the primary
purpose is to diagnose, monitor, or treat a patient rather than to
obtain the kind of information about the drug that is generally derived
from clinical trials. Under the regulations, there are three categories
of expanded access: (1) Expanded access for individual patients,
including for emergency use; (2) expanded access for intermediate-size
patient populations (generally smaller than those typical of a
treatment IND or treatment protocol--a treatment protocol is submitted
as a protocol amendment to an existing IND by the sponsor of the
existing IND); and (3) expanded access for widespread treatment use
through a treatment protocol or treatment IND (designed for use in
larger patient populations). The regulations are intended to facilitate
the availability of investigational new drugs outside of a clinical
investigation, or approved drugs where availability is limited by a
REMS, to patients with serious or immediately life-threatening diseases
or conditions when there is no comparable or satisfactory alternative
therapy to diagnose, monitor, or treat the disease or condition.
    Elsewhere in this issue of the Federal Register, FDA is announcing
the availability of a guidance for industry entitled ``Expanded Access
to Investigational Drugs for Treatment Use--Questions and Answers,''
which provides answers to questions concerning the implementation of
FDA's regulations on expanded access to investigational drugs for
treatment use (21 CFR part 312, subpart I). (FDA's guidance documents
are available at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. FDA has
verified the Web site addresses throughout this document, as of the
date this document publishes in the Federal Register, but Web sites are
subject to change over time.)
    Additionally, in this issue of the Federal Register, FDA is
announcing the availability of a guidance for industry entitled
``Charging for Investigational Drugs Under an IND--Questions and
Answers,'' which provides information about the implementation of FDA's
regulation on charging for investigational drugs under an IND,
including investigational drugs made available for expanded access use.
    FDA may permit expanded access to an investigational new drug
outside of a clinical investigation, or to an approved drug where
availability is limited by a REMS, for an individual patient when the
applicable criteria in Sec.  312.305(a) (which apply to all types of
expanded access) and in Sec.  312.310(a) (which apply specifically to
individual patient expanded access, including for emergency use) are
met. In addition, Sec.  312.305(b) sets forth the submission
requirements for all types of expanded access use requests. One of the
requirements under Sec.  312.305(b)(2) is that a ``cover sheet'' must
be included ``meeting the requirements of Sec.  312.23(a).'' This
provision applies to several types of submissions under part 312,
ranging from commercial INDs under Sec.  312.23 that involve large
groups of patients enrolled in clinical trials to requests from
physicians to use an investigational drug for an individual patient.
Form FDA 1571 is currently used by sponsors for all types of IND
submissions. However, FDA is concerned that physicians requesting
expanded access for an individual patient may have encountered
difficulty in completing Form FDA 1571 and providing the associated
documents because Form FDA 1571 is not tailored to requests for
individual patient expanded access.
    To streamline the submission process for individual patient
expanded access INDs, FDA developed Form FDA 3926, which is available
for licensed physicians to use to request expanded access to an
investigational drug outside of a clinical investigation, or to an
approved drug where availability is limited by a REMS, for an
individual patient who has a serious or immediately life-threatening
disease or condition when there is no comparable or satisfactory
alternative therapy to diagnose, monitor, or treat the disease or
condition.
    In an emergency situation that requires the patient to be treated
before a written submission can be made, the request to use the
investigational drug for individual patient expanded access may be made
by telephone (or other rapid means of communication) to the appropriate
FDA review division. Authorization of the emergency use may be given by
an FDA official by telephone, provided the physician explains how the
expanded access use will meet the requirements of Sec. Sec.  312.305
and 312.310 and agrees to submit an expanded access request within 15
working days of FDA's initial authorization of the expanded access use
(Sec.  312.310(d)). The physician may choose to use Form FDA 3926 for
the expanded access application.
    In the Federal Register of February 10, 2015 (80 FR 7318), FDA
announced the availability of the draft guidance. FDA received several
comments on the draft guidance and those comments were considered as
the guidance was finalized. Both the guidance and Form FDA 3926 were
revised based on public comments and editorial changes were made
primarily for clarification. One notable change includes the ability to
use Form FDA 3926 for subsequent submissions to an existing individual
patient expanded access IND.
    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 the use of Form FDA 3926 by licensed
physicians to submit requests for individual patient expanded access
INDs. It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collection of information in this guidance was approved under OMB
control number 0910-0814.
    This guidance also refers to previously approved collections of
information found in FDA regulations. The collections of information in
21 CFR part 312 have been approved under OMB control number 0910-0014.

III. Electronic Access

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

    Dated: May 31, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-13167 Filed 6-2-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: February 2, 2007 (Volume 72, Number 22)]
[Notices]
[Page 5036-5037]
[DOCID:fr02fe07-45]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Application for Amendment of Shoreline Management Plan
and Soliciting Comments, Motions To Intervene, and Protests

January 26, 2007.
    Take notice that the following application has been filed with the
Commission and is available for public inspection:
    a. Application Type: Amendment of Shoreline Management Plan.
    b. Project No: 2210-148.
    c. Date Filed: January 23, 2007.
    d. Applicant: Appalachian Power Company (APC).
    e. Name of Project: Smith Mountain Pumped Storage Project.
    f. Location: The project is located on the Roanoke River, in
Bedford, Pittsylvania, Franklin, and Roanoke Counties, Virginia.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a), 825(r)
and 799 and 801.
    h. Applicant Contact: Frank M. Simms, Hydro Generation Department,
American Electric Power, P.O. Box 2021, Roanoke, VA 24022-2121, (540)
985-2875.
    i. FERC Contact: Any questions on this notice should be addressed
to Mrs. Heather Campbell at<PHONE_NUMBER>, or e-mail address:
<EMAIL_ADDRESS>or Mr. Bob Fletcher at<PHONE_NUMBER>, or e-

mail address<EMAIL_ADDRESS>    j. Deadline for filing comments and or motions: February 16, 2006.
    All documents (original and eight copies) should be filed with: Ms.
Magalie R. Salas, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426. Please include the project
number (P-2210-148) on any comments or motions filed. 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 at http://www.ferc.gov under

the ``e-Filing'' link. The Commission strongly encourages e-filings.
    k. Description of Request: The licensee requests to amend the July
5, 2005 Order Modifying and Approving Shoreline Management Plan (112
FERC ] 61,026) to revise ordering paragraph (D) to state: ``All in-
water construction, within areas identified as `Conservation/
Environmental' or `Impact Minimization Zone' within the Shoreline
Management Plan as currently exists or as modified in the future shall
be prohibited from February 15 through June 15. In-water construction
will be permitted in all other areas identified within the Shoreline
Management Plan. During the period from April 15 through June 15, the
licensee shall ensure that prior to the work taking place, the
locations of the proposed work be inspected for the presence of
largemouth bass nests. If a largemouth bass nest is detected where the
work is to take place, the work shall

be modified to not disturb the nest or the work delayed until after
June 15.''
    l. Location of the Application: This filing is available for review
at the Commission in the Public Reference Room, 888 First Street, NE.,
Room 2A, Washington, DC 20426 or may be viewed on the Commission's Web
site at http://www.ferc.gov using the ``e-library'' link. Enter the

docket number excluding the last three digits in the docket number
field to access the document. For assistance, call toll-free 1-866-208-
3676 or e-mail<EMAIL_ADDRESS>For TTY, call (202) 502-
8659. A copy is also available for inspection and reproduction at the
address in item h. above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Responsive Documents: Any filings must
bear in all capital letters the title ``COMMENTS'', ``RECOMMENDATIONS
FOR TERMS AND CONDITIONS'', ``PROTEST'', or ``MOTION TO INTERVENE'', as
applicable, and the Project Number of the particular application to
which the filing refers. A copy of any motion to intervene must also be
served upon each representative of the Applicant specified in the
particular application.
    p. Agency Comments: Federal, State, and local agencies are invited
to file comments on the described applications. Copies of the
applications may be obtained by agencies directly from the Applicant.
If an agency does not file comments within the time specified for
filing comments, it will be presumed to have no comments. One copy of
an agency's comments must also be sent to the Applicant's
representatives.

Magalie R. Salas,
Secretary.
 [FR Doc. E7-1670 Filed 2-1-07; 8:45 am]

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[Federal Register Volume 88, Number 138 (Thursday, July 20, 2023)]
[Notices]
[Pages 46803-46804]
[FR Doc No: 2023-15410]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2023-0018]

National Advisory Council

AGENCY: Federal Emergency Management Agency, Department of Homeland
Security.

ACTION: Committee management; request for applicants for appointment to
a subcommittee of the National Advisory Council (NAC).

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SUMMARY: The Federal Emergency Management Agency (FEMA) requests that
qualified individuals interested in serving on a subcommittee of the
FEMA National Advisory Council (NAC) to provide advice regarding
Preliminary Damage Assessments, apply for appointment as identified in
this notice. Appointed members will serve on the subcommittee only and
will not be members of the NAC.

DATES: FEMA will accept applications until 11:59 p.m. ET on August 10,
2023.

ADDRESSES: The only method for application package submission is by
email. Application packages by U.S. Mail will not be considered. Please
submit using the following method:
     Email: Manuel Barrios, Alternate Designated Federal
Officer, Recovery Directorate, Office of Response and Recovery, FEMA,
[email protected].
     Save materials in one file using the naming convention,
``[Last Name]_[First Name]_PDA Application'' and attach to the email.
    FEMA will send applicants an email that confirms receipt of your
application and will notify you of the final status of your application
once FEMA selects members.

FOR FURTHER INFORMATION CONTACT: Manuel Barrios, Alternate Designated
Federal Officer, Recovery Directorate, Office of Response and Recovery,
FEMA,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION: The NAC is an advisory committee established
in accordance with the provisions of the Federal Advisory Committee Act
(FACA), 5 U.S.C. ch. 10. As required by the Post-Katrina Emergency
Management Reform Act of 2006 (PKEMRA), the Secretary of Homeland
Security established the NAC to ensure effective and ongoing
coordination of federal preparedness, protection, response, recovery,
and mitigation for natural disasters, acts of terrorism, and other man-
made disasters. Appointees may be designated as a Special Government
Employee (SGE) as defined in section 202(a) of title 18, U.S.C., or as
a Representative member. SGEs speak in a personal capacity as experts
in their field and Representative members speak for the stakeholder
group they represent.
    The Preliminary Damage Assessment (PDA), National Defense
Authorization Act for Fiscal Year 2023, Public Law 117-263, Sec. 5603,
was signed into law on Dec. 23, 2022. The Act requires FEMA to convene
an advisory panel consisting of emergency management personnel employed
by State, local, Territorial, or Tribal authorities, and the
representative organizations of such personnel, to assist the agency in
improving critical components of the preliminary damage assessment
process. This advisory panel will consider: (1) establishing a training
regime to ensure preliminary damage assessments are conducted and
reviewed under consistent guidelines; (2) utilizing a common
technological platform to integrate data collected by state and local
governments with data collected by the agency; and (3) assessing
instruction materials provided by the agency for omissions of pertinent
information or language that conflicts with other statutory
requirements. The advisory panel will also identify opportunities for
streamlining the consideration of preliminary damage assessments by the
agency, including eliminating duplicative paperwork requirements and
ensuring consistent communication and decision making among agency
staff.
    To serve on this advisory panel, FEMA will select:
    (1) At least one representative from each of the ten (10) FEMA
Regions

selected from emergency management personnel employed by State, local,
Tribal, or Territorial authorities within each region.
    (2) At least two representatives from national emergency management
organizations.
    (3) Such other members as the Administrator shall deem appropriate.
    To the furthest extent practicable, representation on the advisory
panel shall include emergency management personnel from both urban and
rural jurisdictions. Members will not receive compensation for their
service. Members may be required to file a confidential financial
disclosure and complete ethics training provided by FEMA.
    FEMA is requesting that individuals who are interested in and
qualified to serve on the advisory panel apply for appointment.
Appointments will be for a one-year term, with the possibility of
renewal, which will begin Sept. 1, 2023.
    To apply, please submit an application package to Manuel Barrios as
listed in the ADDRESSES section of this notice. There is no application
form, but each application package MUST include the following
information:
     Cover letter, addressed to the Office of Response and
Recovery, that includes current position title and employer or
organization you represent, home and work mailing addresses, preferred
telephone number, and email address; the discipline area position(s)
for which you would like consideration; and why you are interested in
serving on the PDA Advisory Panel.
     A summary of the most important accomplishments that
qualify you to serve in the form of three to five (3-5) bullets, in
fewer than 75 words total.
     Three (3) peer or supervisor references including full
name, position title, employer or organization, preferred telephone
number and email address. References must be able to attest to the
qualifications and accomplishments you have listed.
     Resume or Curriculum Vitae (CV).
    Your application package must be less than eight (8) total pages to
be considered by FEMA. Information contained in your application
package should clearly indicate your qualifications. FEMA will not
consider incomplete applications. FEMA will review the information
contained in application packages and make selections based on the
requirements listed above, expertise in the subject matter area, and
ability to meet membership expectations. FEMA will also consider
overall composition, including diversity (including, but not limited to
geographic, demographic, and experience) and mix of officials,
emergency managers, and emergency response providers from State, local,
Tribal, and Territorial governments, when selecting members.
    DHS is committed to pursuing opportunities, consistent with
applicable law, to compose a panel that reflects the diversity of the
United States. DHS does not discriminate based on race, color,
religion, sex, national origin, sexual orientation, gender identity,
marital status, political affiliation, disability and genetic
information, age, membership in an employee organization, or other non-
merit factor. DHS strives to achieve a widely diverse candidate pool
for all its recruitment actions. Federally registered lobbyists may not
apply.
    Expectations: Appointees to this volunteer service opportunity are
expected to fully participate in meetings, work with fellow members as
a team, and maintain a high degree of integrity. The NAC Bylaws contain
more information and can be found at: https://www.fema.gov/sites/default/files/documents/fema_nac-bylaws-041223.pdf. FEMA estimates a
four (4) hour minimum time commitment per month for regular
communications, special activities, and subcommittee participation.
Some selected members will serve in leadership roles and participate in
additional meetings and activities. Members may be invited to attend
in-person meetings of the NAC up to twice per year, typically three (3)
days for each meeting. FEMA does not pay members for their time, but
may reimburse travel expenses such as airfare, lodging, meals,
incidentals, and other transportation costs within Federal Travel
Regulations when pre-approved by the Designated Federal Officer.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2023-15410 Filed 7-19-23; 8:45 am]
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