[Federal Register Volume 85, Number 243 (Thursday, December 17, 2020)]
[Notices]
[Pages 81940-81941]
[FR Doc No: 2020-27710]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2020-0002; Internal Agency Docket No. FEMA-B-2074]

Proposed Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: Comments are requested on proposed flood hazard
determinations, which may include additions or modifications of any
Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area
(SFHA) boundary or zone designation, or regulatory floodway on the
Flood Insurance Rate Maps (FIRMs), and where applicable, in the
supporting Flood Insurance Study (FIS) reports for the communities
listed in the table below. The purpose of this notice is to seek
general information and comment regarding the preliminary FIRM, and
where applicable, the FIS report that the Federal Emergency Management
Agency (FEMA) has provided to the affected communities. 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). In addition, the FIRM and FIS
report, once effective, will be used by insurance agents and others to
calculate appropriate flood insurance premium rates for new buildings
and the contents of those buildings.

DATES: Comments are to be submitted on or before March 17, 2021.

ADDRESSES: The Preliminary FIRM, and where applicable, the FIS report
for each community are available for inspection at both the online
location https://www.fema.gov/preliminaryfloodhazarddata and the
respective Community Map Repository address listed in the tables 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.
    You may submit comments, identified by Docket No. FEMA-B-2074, to
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>
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: FEMA proposes to make flood hazard
determinations for each community listed below, in accordance with
section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C.
4104, and 44 CFR 67.4(a).
    These proposed 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. These flood
hazard determinations are used to meet the floodplain management
requirements of the NFIP and are used to calculate the appropriate
flood insurance premium rates for new buildings built after the FIRM
and FIS report become effective.
    The communities affected by the flood hazard determinations are
provided in the tables below. Any request for reconsideration of the
revised flood hazard information shown on the Preliminary FIRM and FIS
report that satisfies the data requirements outlined in 44 CFR 67.6(b)
is considered an appeal. Comments unrelated to the flood hazard
determinations also will be considered before the FIRM and FIS report
become effective.
    Use of a Scientific Resolution Panel (SRP) is available to
communities in support of the appeal resolution process. SRPs are
independent panels of experts in hydrology, hydraulics, and other
pertinent sciences established to review conflicting scientific and
technical data and provide recommendations for resolution. Use of the
SRP only may be exercised after FEMA and local communities have been
engaged in a collaborative consultation process for at least 60 days
without a mutually acceptable resolution of an appeal. Additional
information regarding the SRP process can be found online at https://www.floodsrp.org/pdfs/srp_overview.pdf.
    The watersheds and/or communities affected are listed in the tables
below. The Preliminary FIRM, and where applicable, FIS report for each
community are available for inspection at both the online location
https://www.fema.gov/preliminaryfloodhazarddata and the respective
Community Map Repository address listed in the tables. For communities
with multiple ongoing Preliminary studies, the studies can be
identified by the unique project number and Preliminary FIRM date
listed in the tables. 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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                                             Community map repository
               Community                             address
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            Charlotte County, Florida and Incorporated Areas
         Project: 14-04-2183S Preliminary Date: October 25, 2019
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City of Punta Gorda....................  City Hall, 326 West Marion
                                          Avenue, Punta Gorda, FL 33950.
Unincorporated Areas of Charlotte        Charlotte County Community
 County.                                  Development Building, 18400
                                          Murdock Circle, Port
                                          Charlotte, FL 33948.
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             Collier County, Florida and Incorporated Areas
        Project: 18-04-0009S Preliminary Date: December 31, 2019
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City of Everglades City................  City Hall, 102 Copeland Avenue
                                          North, Everglades City, FL
                                          34139.
City of Marco Island...................  Growth Management Department,
                                          50 Bald Eagle Drive, Marco
                                          Island, FL 34145.
City of Naples.........................  Building Department, 295
                                          Riverside Circle, Naples, FL
                                          34102.
Unincorporated Areas of Collier County.  Collier County Growth
                                          Management Department, 2800
                                          North Horseshoe Drive, Naples,
                                          FL 34104.
------------------------------------------------------------------------
              Glades County, Florida and Incorporated Areas
        Project: 19-04-0013S Preliminary Date: November 13, 2019
------------------------------------------------------------------------
Unincorporated Areas of Glades County..  Glades County Community
                                          Development Department, 198
                                          6th Street, Moore Haven, FL
                                          33471.
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             Sarasota County, Florida and Incorporated Areas
        Project: 14-04-2183S Preliminary Date: December 31, 2019
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City of North Port.....................  Building Department, 4970 City
                                          Hall Boulevard, North Port, FL
                                          34286.
City of Sarasota.......................  Department of Development
                                          Services, 1565 First Street,
                                          2nd Floor, Sarasota, FL 34236.
City of Venice.........................  Building Department, 401 West
                                          Venice Avenue, Venice, FL
                                          34285.
Town of Longboat Key...................  Planning, Zoning and Building
                                          Department, 501 Bay Isles
                                          Road, Longboat Key, FL 34228.
Unincorporated Areas of Sarasota County  Sarasota County Building
                                          Department, 1001 Sarasota
                                          Center Boulevard, Sarasota, FL
                                          34240.
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[FR Doc. 2020-27710 Filed 12-16-20; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 87, Number 96 (Wednesday, May 18, 2022)]
[Notices]
[Pages 30213-30214]
[FR Doc No: 2022-10677]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2188-271]

Northwestern Corporation; Notice of Application Accepted for
Filing and Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Application Type: Temporary Variance of Article 403.
    b. Project No: 2188-271.
    c. Date Filed: April 29, 2022.
    d. Applicant: Northwestern Corporation (licensee).
    e. Name of Project: Missouri-Madison Hydroelectric Project.
    f. Location: The project consists of nine hydroelectric
developments located on the Madison and Missouri Rivers in Gallatin,
Madison, Lewis and Clark, and Cascade counties, Montana.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: Mary Gail Sullivan, Director, Environmental
and Lands, Northwestern Corporation, 11 East Park Street, Butte,
Montana, 59701,<PHONE_NUMBER>, [email protected].
    i. FERC Contact: Holly Frank,<PHONE_NUMBER>, [email protected].
    j. Deadline for filing comments, motions to intervene, and
protests: June 13, 2022.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, and protests using the Commission's
eFiling system at http://www.ferc.gov/docs-filing/efiling.asp.
Commenters can submit brief comments up to 6,000 characters, without
prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact
information at the end of your comments. For assistance, please contact
FERC Online Support at [email protected],<PHONE_NUMBER> (toll
free), or<PHONE_NUMBER> (TTY). In lieu of electronic filing, you may
submit a paper copy. Submissions sent via the U.S. Postal Service must
be addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street NE, Room 1A, Washington, DC 20426.
Submissions sent via any other carrier must be addressed to: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, Maryland 20852. The first page of any filing should
include the docket number P-2188-271. Comments emailed to Commission
staff are not considered part of the Commission record.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person whose name appears on the official service
list for the project. Further, if an intervenor files comments or
documents with the Commission relating to the merits of an issue that
may affect the responsibilities of a particular resource agency, they
must also serve a copy of the document on that resource agency.
    k. Description of Request: The licensee requests a temporary
variance from the minimum flow requirements for the Hebgen and Madison
developments, to occur from June 15, 2022 to April 15, 2023, due to the
severe drought conditions in the Madison River watershed. Section (3)
of Article 403 for the Hebgen Development requires the licensee to
limit changes in outflow from Hebgen Dam to no more than 10 percent per
day for the entire year. The licensee requests a temporary variance
allowing changes in outflow from Hebgen Dam to no more than 5 percent
hourly for flow increases; the 10 percent daily limit would remain
unchanged for flow decreases. Section (5) of Article 403 for the
Madison Development requires ramping rates for flows in the Madison
bypass reach, such that flows must not be reduced by more than 100 cfs
per hour from 600 cfs to minimum flow (which varies seasonally between
80-200 cfs, as required in Section (4) of Article 403 for the Madison
Development), and not increased by more than 100 cfs per hour when
flows are 600 cfs or less (except when needed to meet the 1,100-cfs
minimum flow below the powerhouse as required in Section (2) of Article
403 for the Madison Development, or to avoid overfilling Ennis Lake).
The licensee will maintain the required ramping rate for flow
reductions to minimize biological effects, but requests a temporary
variance to remove the ramping rate of 100 cfs per hour for flow
increases when the bypass flow is less than 600 cfs. The temporary
variance would allow the licensee to make larger flow changes more
quickly, which contributes to water conservation goals by limiting
small increases of Hebgen and Madison dam outflows over longer
durations in advance of forecasted needs of increased water downstream.
The proposed temporary variance measures, in combination with the
temporary minimum flow reductions

completed in April 2022, would reduce the drafting of Hebgen Reservoir
and support higher Hebgen Reservoir elevations longer into the
recreation season. The duration of the temporary variance, from June
15, 2022 to April 15, 2023, would allow for water savings that ensure
water availability through the pulse flow season to protect fishery
resources in the lower Madison River and allow for flow changes during
the fall/winter period.
    l. Locations of the Application: This filing may be viewed on the
Commission's website at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. You may also register
online at http://www.ferc.gov/docs-filing/esubscription.asp to be
notified via email of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or email
[email protected], for TTY, call<PHONE_NUMBER>. Agencies may
obtain copies of the application directly from the applicant.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214, respectively. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    o. Filing and Service of Documents: Any filing must (1) bear in all
capital letters the title ``COMMENTS'', ``PROTEST'', or ``MOTION TO
INTERVENE'' as applicable; (2) set forth in the heading the name of the
applicant and the project number of the application to which the filing
responds; (3) furnish the name, address, and telephone number of the
person commenting, protesting or intervening; and (4) otherwise comply
with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis. Any filing made by an intervenor must be accompanied
by proof of service on all persons listed in the service list prepared
by the Commission in this proceeding, in accordance with 18 CFR
385.2010.

    Dated: May 12, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-10677 Filed 5-17-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 173 (Friday, September 8, 2023)]
[Notices]
[Pages 62090-62091]
[FR Doc No: 2023-19419]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-3518]

Endogenous Cushing's Syndrome: Developing Drugs for Treatment;
Draft 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 draft guidance for industry entitled ``Endogenous
Cushing's Syndrome: Developing Drugs for Treatment.'' The purpose of
this guidance is to provide recommendations to sponsors regarding
clinical trial designs for drugs intended for the treatment of adults
with endogenous Cushing's syndrome for whom surgery is not an option or
has not been curative. This draft guidance is intended to focus
continued discussions among FDA's Division of General Endocrinology,
pharmaceutical sponsors, the academic community, and the public.

DATES: Submit either electronic or written comments on the draft
guidance by November 7, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2023-D-3518 for ``Endogenous Cushing's Syndrome: Developing Drugs
for Treatment.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft 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. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Naomi Lowy, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Endogenous Cushing's Syndrome: Developing Drugs for
Treatment.'' The purpose of this guidance is to provide recommendations
to sponsors regarding clinical trial designs for drugs intended for the
treatment of adults with endogenous Cushing's syndrome for whom surgery
is not an option or has not been curative. This draft guidance is
intended to focus continued discussions among FDA's Division of General
Endocrinology, pharmaceutical sponsors, the academic community, and the
public. This is the first guidance drafted by FDA on this topic.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Endogenous
Cushing's Syndrome:

Developing Drugs for Treatment.'' 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

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in 21 CFR part 312 relating to the submissions of investigational new
drug applications have been approved under OMB control number 0910-
0014. The collections of information in 21 CFR part 314 relating to the
submissions of new drug applications and abbreviated new drug
applications have been approved under OMB control number 0910-0001.

III. Electronic Access

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

    Dated: September 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-19419 Filed 9-7-23; 8:45 am]
BILLING CODE 4164-01-P