[Federal Register Volume 78, Number 24 (Tuesday, February 5, 2013)]
[Notices]
[Pages 8181-8183]
[FR Doc No: 2013-02455]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2013-0002; Internal Agency Docket No. FEMA-B-1281]

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 May 6, 2013.

ADDRESSES: The Preliminary FIRM, and where applicable, the FIS report
for each community are available for inspection at both the online
location 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 www.msc.fema.gov for comparison.
    You may submit comments, identified by Docket No. FEMA-B-1281, to
Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance
and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC
20472,<PHONE_NUMBER>, or (email<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
FEMA, 500 C Street SW., Washington, DC 20472,<PHONE_NUMBER>, or
(email<EMAIL_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at 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 also 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 http://floodsrp.org/pdfs/srp_fact_sheet.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 and
the respective Community Map Repository address 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
www.msc.fema.gov for comparison.

------------------------------------------------------------------------
                                             Community map repository
               Community                             address
------------------------------------------------------------------------
      Fairbanks North Star Borough, Alaska, and Incorporated Areas
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Maps Available for Inspection Online at: http://www.starr-team.com/starr/RegionalWorkspaces/RegionX/FairbanksMM/Preliminary%20Maps/Forms/AllItems.aspx
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Fairbanks North Star Borough...........  Department of Community
                                          Planning, Borough
                                          Administrative Center, 809
                                          Pioneer Road, Fairbanks, AK
                                          99701.
------------------------------------------------------------------------
            Blackford County, Indiana, and Incorporated Areas
------------------------------------------------------------------------
Maps Available for Inspection Online at: http://www.in.gov/dnr/water/6476.htm
------------------------------------------------------------------------
City of Hartford City..................  Blackford County Area Planning
                                          and Zoning Office, Blackford
                                          County Courthouse, 110 West
                                          Washington Street, Hartford
                                          City, IN 47348.
City of Montpelier.....................  Blackford County Area Planning
                                          and Zoning Office, Blackford
                                          County Courthouse, 110 West
                                          Washington Street, Hartford
                                          City, IN 47348.
Unincorporated Areas of Blackford        Blackford County Area Planning
 County.                                  and Zoning Office, Blackford
                                          County Courthouse, 110 West
                                          Washington Street, Hartford
                                          City, IN 47348.
------------------------------------------------------------------------
            Hamilton County, Indiana, and Incorporated Areas
------------------------------------------------------------------------
Maps Available for Inspection Online at: http://www.in.gov/dnr/water/5775.htm
------------------------------------------------------------------------
City of Carmel.........................  Department of Community
                                          Services, One Civic Square,
                                          Carmel, IN 46032.
City of Noblesville....................  City Hall, Department of
                                          Planning and Zoning, 16 South
                                          10th Street, Noblesville, IN
                                          46060.
City of Westfield......................  City Hall, 130 Penn Street,
                                          Westfield, IN 46074.
Town of Cicero.........................  Utility Office, 150 West
                                          Jackson Street, Cicero, IN
                                          46034.
Town of Fishers........................  Administrative Offices, One
                                          Municipal Drive, Fishers, IN
                                          46038.
Town of Sheridan.......................  Town Hall, 506 South Main
                                          Street, Sheridan, IN 46069.
Unincorporated Areas of Hamilton County  Hamilton County Government and
                                          Judicial Center, One Hamilton
                                          County Square, Noblesville, IN
                                          46060.
------------------------------------------------------------------------
             Madison County, Indiana, and Incorporated Areas
------------------------------------------------------------------------
Maps Available for Inspection Online at: http://www.in.gov/dnr/water/7378.htm
------------------------------------------------------------------------
City of Anderson.......................  City Hall, 120 East Eighth
                                          Street, Anderson, IN 46016.
Town of Chesterfield...................  Town Hall, 17 Veterans
                                          Boulevard, Chesterfield, IN
                                          46017.
Town of Ingalls........................  Town Hall, 247 North Meridian
                                          Street, Ingalls, IN 46048.
Town of Pendleton......................  Town Hall, 100 West State
                                          Street, Pendleton, IN 46064.
Unincorporated Areas of Madison County.  Madison County Government
                                          Center, 16 East 9th Street,
                                          Room 200, Anderson, IN 46016.
------------------------------------------------------------------------
            Kittson County, Minnesota, and Incorporated Areas
------------------------------------------------------------------------
Maps Available for Inspection Online at: http://www.starr-team.com/starr/RegionalWorkspaces/RegionV/KittsonCoMN/SitePages/Home.aspx
------------------------------------------------------------------------
City of Hallock........................  City Hall, 163 South Third
                                          Street, Hallock, MN 56728.
City of Humboldt.......................  City Hall, 204 Ramsey Street,
                                          Humboldt, MN 56731.
City of Kennedy........................  City Office, 414 North Atlantic
                                          Avenue, Suite 100, Kennedy, MN
                                          56733.
City of Lake Bronson...................  City Hall, 112 Main Street,
                                          Lake Bronson, MN 56734.
City of Lancaster......................  City Clerk Office, 100 Second
                                          Street West, Lancaster, MN
                                          56735.
City of St. Vincent....................  City Clerk, 142 South Eighth
                                          Street, St. Vincent, MN 56755.
Unincorporated Areas of Kittson County.  Kittson County Courthouse, 410
                                          Fifth Street South, Suite 104,
                                          Hallock, MN 56728.
------------------------------------------------------------------------
           Broadwater County, Montana, and Incorporated Areas
------------------------------------------------------------------------
Maps Available for Inspection Online at: http://www.bakeraecom.com/index.php/montana/broadwater/
------------------------------------------------------------------------
City of Townsend.......................  110 Broadway Street, Townsend,
                                          MT 59644.
Unincorporated Areas of Broadwater       Broadwater County Treasurer,
 County.                                  515 Broadway Street, Townsend,
                                          MT 59644.
------------------------------------------------------------------------

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

James A. Walke,
Acting Deputy Associate Administrator for Mitigation, Department of
Homeland Security, Federal Emergency Management Agency.
[FR Doc. 2013-02455 Filed 2-4-13; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 87, Number 83 (Friday, April 29, 2022)]
[Notices]
[Page 25481]
[FR Doc No: 2022-09282]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: PR22-35-000.
    Applicants: Black Hills Gas Distribution LLC.
    Description: Tariff Amendment: Notice of Cancellation of Statement
of Operating Conditions to be effective 4/23/2022.
    Filed Date: 4/22/22.
    Accession Number: 20220422-5221.
    Comment Date: 5 p.m. ET 5/13/22.

    Docket Numbers: PR22-36-000.
    Applicants: The East Ohio Gas Company.
    Description: Sec.  284.123 Rate Filing: Operating Statment of The
East Ohio Gas Company 4/1/22 to be effective 4/1/2022.
    Filed Date: 4/25/22.
    Accession Number: 20220425-5212.
    Comment Date: 5 pm ET 5/16/22.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: https://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: April 25, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-09282 Filed 4-28-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 183 (Wednesday, September 21, 2011)]
[Notices]
[Pages 58509-58510]
[FR Doc No: 2011-24280]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2010-0108; FRL-9467-8]

Release of Risk and Exposure Assessment Planning Document for the
Review of the National Ambient Air Quality Standards for Lead

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.

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SUMMARY: On June 28, 2011, the EPA made available for public review the
Review of the National Ambient Air Quality Standards for Lead: Risk and
Exposure Assessment Planning Document (REA Planning Document). This
document considers the extent to which information and conclusions
presented in the first external review draft of the Integrated Science
Assessment (ISA) for this review (Lead Integrated Science Assessment
(First External Review Draft) (First Draft ISA) provides support for
the development of quantitative assessments of risk and exposure for
health and/or welfare effects in this review of the national ambient
air quality standards (NAAQS) for lead (Pb).

DATES: Comments should be received on or before October 21, 2011.

ADDRESSES: This document is available primarily via the Internet at the
following Web site: http://www.epa.gov/ttn/naaqs/standards/pb/s_pb_index.html. Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2010-0108, by one of the following methods:
     http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>1.
     Mail: EPA-HQ-OAR-2010-0108, Environmental Protection
Agency, Mail code 6102T, 1200 Pennsylvania Ave., NW., Washington, DC
20460. Please include a total of two copies.
     Hand Delivery: Environmental Protection Agency, EPA West,
Room 3334, 1301 Constitution Ave., NW., Washington, DC. Such deliveries
are only accepted during the Docket's normal hours of operation, and
special arrangements should be made for deliveries of boxed
information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2010-0108. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov (or e-mail). The http://www.regulations.gov website
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket, visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the Air and Radiation
Docket and Information Center, EPA/DC, EPA West, Room 3334, 1301
Constitution Ave., NW., Washington, DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the Air and Radiation Docket and
Information Center is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Dr. Zachary Pekar, Office of Air
Quality Planning and Standards (Mail code C539-07), U.S. Environmental
Protection Agency, Research Triangle Park, NC 27711; telephone number:
919-541-3704; fax number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>For further information on the ecological risk
assessment chapter, contact Dr. Travis Smith, Office of Air Quality
Planning and Standards (Mail code C539-07), U.S. Environmental
Protection Agency, Research Triangle Park, NC 27711; telephone number:
919-541-2035; fax number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
http://www.regulations.gov or e-mail. Clearly mark the part or all of
the information that you claim to be CBI. For CBI information in a disk
or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM
as CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for Preparing Your Comments. When submitting comments,
remember to:
     Identify the rulemaking by docket number and other
identifying information (subject heading, Federal Register date and
page number).
     Follow directions--The agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
     Explain why you agree or disagree; suggest alternatives
and substitute language for your requested changes.
     Describe any assumptions and provide any technical
information and/or data that you used.
     If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow for it to be
reproduced.
     Provide specific examples to illustrate your concerns, and
suggest alternatives.

     Explain your views as clearly as possible, avoiding the
use of profanity or personal threats.
     Make sure to submit your comments by the comment period
deadline identified.

II. Information Specific to This Document

    Two sections of the Clean Air Act govern the establishment and
revision of the NAAQS. Section 108 (42 U.S.C. 7408) directs the
Administrator to identify and list certain air pollutants and then to
issue air quality criteria for those pollutants. The Administrator is
to list those air pollutants that in her ``judgment, cause or
contribute to air pollution which may reasonably be anticipated to
endanger public health or welfare;'' ``the presence of which in the
ambient air results from numerous or diverse mobile or stationary
sources;'' and ``for which * * * [the Administrator] plans to issue air
quality criteria * * *'' Air quality criteria are intended to
``accurately reflect the latest scientific knowledge useful in
indicating the kind and extent of all identifiable effects on public
health or welfare which may be expected from the presence of [a]
pollutant in the ambient air * * * '' 42 U.S.C. 7408(b). Under section
109 (42 U.S.C. 7409), EPA establishes primary (health-based) and
secondary (welfare-based) NAAQS for pollutants for which air quality
criteria are issued. Section 109(d) requires periodic review and, if
appropriate, revision of existing air quality criteria. The revised air
quality criteria reflect advances in scientific knowledge on the
effects of the pollutant on public health or welfare. The EPA is also
required to periodically review and revise the NAAQS, if appropriate,
based on the revised criteria. Section 109(d)(2) requires that an
independent scientific review committee ``shall complete a review of
the criteria * * * and the national primary and secondary ambient air
quality standards * * * and shall recommend to the Administrator any
new * * * standards and revisions of existing criteria and standards as
may be appropriate. * * *'' Since the early 1980's, this independent
review function has been performed by the Clean Air Scientific Advisory
Committee (CASAC).
    Presently, EPA is reviewing the NAAQS for Pb.\1\ The First Draft
ISA was released in early May (76 FR 26284) and reviewed by CASAC at a
public meeting announced in a separate notice (76 FR 36120). The
document that is the subject of today's notice considers the extent to
which information and conclusions presented in the First Draft ISA
provide support for the development of quantitative assessments of risk
and exposure for health and/or welfare effects. This document is
available on the EPA's Technology Transfer Network Web site at http://www.epa.gov/ttn/naaqs/standards/pb/s_pb_index.html. The document is
accessible in the ``Documents from Current Review'' section under
``Planning Documents.''
---------------------------------------------------------------------------

    \1\ The EPA's call for information for this review was issued on
February 26, 2010 (75 FR 8934).
---------------------------------------------------------------------------

    The REA Planning Document has been made available for consultation
with CASAC and for public comment. Comments should be submitted to the
docket, as described above. The CASAC consultation on this planning
document occurred on July 21, 2011. A separate Federal Register notice
published on June 21, 2011 (76 FR 36120) provided additional details
about this meeting and the process for participation. The document that
is the subject of today's notice does not represent and should not be
construed to represent any final EPA policy, viewpoint, or
determination.

    Dated: September 15, 2011.
Mary Henigin,
Acting Director, Office of Air Quality Planning and Standards.
[FR Doc. 2011-24280 Filed 9-20-11; 8:45 am]
BILLING CODE 6560-60-P


[Federal Register Volume 85, Number 94 (Thursday, May 14, 2020)]
[Notices]
[Pages 28955-28958]
[FR Doc No: 2020-10359]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0275]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Certification to Accompany Drug, Biological Product,
and Device Applications or Submissions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the requirements for certain FDA
applications or submissions to be accompanied by a certification, Form
FDA 3674, to ensure all applicable statutory requirements have been
met.

DATES: Submit either electronic or written comments on the collection
of information by July 13, 2020.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before July 13, 2020. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of July 13, 2020. Comments received by
mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

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-2011-N-0275 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Certification to Accompany Drug,
Biological Product, and Device Applications or Submissions.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party.

Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires
Federal Agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information, including each
proposed extension of an existing collection of information, before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Certification To Accompany Drug, Biological Product, and Device
Applications or Submissions (Form FDA 3674)

OMB Control Number 0910-0616--Extension

    The information required under section 402(j)(5)(B) of the Public
Health Service Act (PHS Act) (42 U.S.C. 282(j)(5)(B)) is submitted in
the form of a certification, Form FDA 3674, which accompanies
applications and submissions currently submitted to FDA and already
approved by OMB. The OMB control numbers and expiration dates for those
applications and submissions are: 21 CFR parts 312 and 314 (human
drugs), OMB control number 0910-0014, expiring March 31, 2022, and OMB
control number 0910-0001, expiring March 31, 2021; 21 CFR parts 312 and
601 (biological products), OMB control number 0910-0014, expiring March
31, 2022, and OMB control number 0910-0338, expiring February 28, 2023;
21 CFR parts 807 and 814 (devices), OMB control number 0910-0120,
expiring June 30, 2020, and OMB control number 0910-0231, expiring
March 31, 2023.
    Title VIII of the Food and Drug Administration Amendments Act of
2007 (FDAAA) (Pub. L. 110-85) amended the PHS Act by adding section
402(j). The provisions broadened the scope of clinical trials subject
to submitting information and required additional information to be
submitted to the clinical trials databank (https://clinicaltrials.gov/)
(FDA has verified the website address, but FDA is not responsible for
any subsequent changes to the website after this document publishes in
the Federal Register) previously established by the National Institutes
of Health (NIH)/National Library of Medicine. This includes expanded
information on applicable clinical trials and summary information on
the results of certain clinical trials. The provisions include
responsibilities for FDA as well as several amendments to the Federal
Food, Drug, and Cosmetic Act (the FD&C Act).
    One provision, section 402(j)(5)(B) of the PHS Act, requires that a
certification accompany human drug, biological, and device product
submissions made to FDA. Specifically, at the time of submission of an
application under sections 505, 515, or 520(m) of the FD&C Act (21
U.S.C. 355, 360e, or 360j(m)), or under section 351 of the PHS Act (42
U.S.C. 262), or submission of a report under section 510(k) of the FD&C
Act (21 U.S.C. 360(k)), such application or submission must be
accompanied by a certification, Form FDA 3674, that all applicable
requirements of section 402(j) of the PHS Act have been met. Where
available, such certification must include the appropriate National
Clinical Trial (NCT) numbers that are assigned upon submission of
required information to the NIH databank at https://clinicaltrials.gov/.
    The proposed extension of the collection of information is
necessary to satisfy the previously mentioned statutory requirement.
The importance of obtaining these data relates to adherence to the
legal requirements for submissions to the clinical trials registry and
results data bank and ensuring that individuals and organizations
submitting applications or reports to FDA under the listed provisions
of the FD&C Act or the PHS Act adhere to the appropriate legal and
regulatory requirements for certifying to having complied with those
requirements. The failure to submit the certification required by
section 402(j)(5)(B) of the PHS Act, and the knowing submission of a
false certification, are both prohibited acts under section 301 of the
FD&C Act (21 U.S.C. 331). Violations are subject to civil money
penalties. Form FDA 3674 provides a convenient mechanism for sponsors/
applicants/submitters to satisfy the certification requirements of the
statutory provision.
    To assist sponsors/applicants/submitters in understanding the
statutory requirements associated with Form FDA 3674, we have provided
a guidance available at: https://www.fda.gov/RegulatoryInformation/Guidances/ucm125335.htm. This guidance recommends the applications and
submissions FDA considers should be accompanied by the certification
form, Form FDA 3674. The applications and submissions identified in the
guidance are reflected in the burden analysis. FDA last updated this
guidance in 2017.
    Investigational New Drug Applications. FDA's Center for Drug
Evaluation and Research (CDER) received 1,661 investigational new drug
applications (INDs) and 11,328 clinical protocol IND amendments in
calendar year (CY) 2019. CDER anticipates that IND and clinical
protocol amendment submission rates will remain at or near this level
in the near future.
    FDA's Center for Biologics Evaluation and Research (CBER) received
639 new INDs and 581 clinical protocol IND amendments in CY 2019. CBER
anticipates that IND and clinical protocol amendment submission rates
will remain at or near this level in the near future. The estimated
total number of submissions (new INDs and new protocol submissions)
subject to mandatory certification requirements under section
402(j)(5)(B) of the PHS Act, is 12,989 for CDER plus 1,220 for CBER, or
14,209 submissions per year. The minutes per response is the estimated
number of minutes that a respondent would spend preparing the
information to be submitted to FDA under section 402(j)(5)(B) of the
PHS Act, including the time it takes to enter the necessary information
on the form.
    Based on its experience with current submissions, FDA estimates
that approximately 15 minutes on average would be needed per response
for certifications that accompany IND applications and clinical
protocol amendment submissions. It is assumed that most submissions to
investigational applications will reference only a few protocols for
which the sponsor/applicant/submitter has obtained a NCT number from
https://clinicaltrials.gov/ prior to making the submission to FDA. It
is also assumed that the sponsor/applicant/submitter has electronic
capabilities allowing them to retrieve the information necessary to
complete the form in an efficient manner.
    Marketing Applications/Submissions. In CY 2019, CDER and CBER
received 252 new drug applications (NDA)/biologics license applications
(BLA)/premarket approvals (PMA)/

resubmissions and 701 NDA/BLA amendments for which certifications are
needed. CDER and CBER received 295 efficacy supplements/resubmissions
to previously approved NDAs/BLAs in CY 2019. CDER and CBER received 893
abbreviated new drug applications (ANDAs) in CY 2019. CDER received 765
bioequivalence amendments/supplements in CY 2019. CDER and CBER
anticipate that new drug/biologic applications/resubmissions and
efficacy supplement submission rates will remain at or near this level
in the near future.
    FDA's Center for Devices and Radiological Health (CDRH) received a
total of 324 new applications for PMA, 510(k) submissions containing
clinical information, PMA supplements, applications for humanitarian
device exemptions (HDE) and amendments in CY 2019. CDRH anticipates
that application, amendment, supplement, and annual report submission
rates will remain at or near this level in the near future.
    Based on its experience reviewing NDAs, BLAs, PMAs, HDEs, 510(k)s,
and ANDAs and experience with current submissions of Form FDA 3674, FDA
estimates that approximately 45 minutes on average would be needed per
response for certifications which accompany NDA, BLA, PMA, HDE, 510(k),
and ANDA marketing applications and submissions. It is assumed that the
sponsor/applicant/submitter has electronic capabilities allowing them
to retrieve the information necessary to complete the form in an
efficient manner.
    FDA estimates the burden of this collection of information as
follows:

                                                      Table 1--Estimated Annual Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                       Number of         Number of
                                      respondents       respondents      Number of     Total annual
       FDA; center activity         (investigational    (marketing     responses per     responses       Average  burden per  response      Total hours
                                     applications)     applications)    respondent
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                          CDER
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Applications (IND)...........              1,661  ..............               1           1,661  0.25 (15 minutes).................             415
Clinical Protocol Amendments                  11,328  ..............               1          11,328  0.25 (15 minutes).................           2,832
 (IND).
New Marketing Applications/        .................             220               1             220  0.75 (45 minutes).................             165
 Resubmissions (NDA/BLA).
Clinical Amendments to Marketing   .................             701               1             701  0.75 (45 minutes).................             526
 Applications.
Efficacy Supplements/              .................             257               1             257  0.75 (45 minutes).................             193
 Resubmissions.
Abbreviated New Drug Applications  .................             892               1             892  0.75 (45 minutes).................             669
 (ANDA)--Original Applications.
ANDA Bioequivalence Supplements/   .................             765               1             765  0.75 (45 minutes).................             573
 Amendments.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                          CBER
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Applications (IND)...........                639  ..............               1             639  0.25 (15 minutes).................             160
Clinical Protocol Amendments                     581  ..............               1             581  0.25 (15 minutes).................             145
 (IND).
New Marketing Applications/        .................              32               1              32  0.75 (45 minutes).................              24
 Resubmissions (NDA/BLA/PMA).
Clinical Amendments to Marketing   .................               0               1               0  0.75 (45 minutes).................               0
 Applications.
Efficacy Supplements/              .................              38               1              38  0.75 (45 minutes).................              28
 Resubmissions (BLA only).
Abbreviated New Drug Applications  .................               1               1               1  0.75 (45 minutes).................               1
 (ANDA)--Original Applications.
ANDA Bioequivalence Supplements/   .................               0               1               0  0.75 (45 minutes).................               0
 Amendments.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                          CDRH
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Marketing Applications         .................             324               1             324  0.75 (45 minutes).................             243
 (includes PMAs, HDEs,
 Supplements and 510(k)s expected
 to contain clinical data).
    Total........................  .................  ..............  ..............  ..............  ..................................           5,974
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: May 6, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-10359 Filed 5-13-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 216 (Friday, November 6, 2020)]
[Notices]
[Pages 71135-71136]
[FR Doc No: 2020-24716]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. FAA-2020-1052]

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Reporting of
Information Using Special Airworthiness Information Bulletin

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. The collection involves a voluntary request for information
on a specific safety concern. The information to be collected will be
used to help the FAA in an ongoing investigation to determine the cause
of a specific condition, or whether the condition is likely to exist or
develop on other aircraft, aircraft engines, propellers, or appliances
of the same type design.

DATES: Written comments should be submitted by January 5, 2021.

ADDRESSES: Please send written comments:

By Electronic Docket: https://www.regulations.gov (Enter docket number
into search field)
By mail: Stephen Kocmoud, 10101 Hillwood Parkway, Fort Worth, TX 76177-
1524
By fax:<PHONE_NUMBER>

FOR FURTHER INFORMATION CONTACT: Stephen Kocmoud by email at:
<EMAIL_ADDRESS>phone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.
    OMB Control Number: 2120-0731.
    Title: Reporting of Information Using Special Airworthiness
Information Bulletin.
    Form Numbers: None.
    Type of Review: Renewal of an information collection.
    Background: A special airworthiness information bulletin (SAIB) is
an important tool that helps the FAA to gather information to determine
whether an airworthiness directive is necessary. An SAIB alerts,
educates, and make recommendations to the aviation community and
individual aircraft owners and operators about ways to improve the
safety of a product. It contains non-regulatory information and

guidance that is advisory and may include recommended actions or
inspections with a request for voluntary reporting of inspection
results.
    Respondents: Respondents may include mechanics, type clubs, owners
and operators of aircraft.
    Frequency: Information is collected as needed to acquire additional
information on a specific condition.
    Estimated Average Burden per Response: 5 minutes.
    Estimated Total Annual Burden: 447 hours.

    Issued in Washington, DC.
Joy Wolf,
Management & Program Analyst for Regulatory and Guidance Processing.
[FR Doc. 2020-24716 Filed 11-5-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 249 (Tuesday, December 29, 2020)]
[Notices]
[Page 85628]
[FR Doc No: 2020-28719]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER21-685-000]

Trieve, LLC; Supplemental Notice That Initial Market-Based Rate
Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of
Centerfield Cooper Solar, LLC's application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is January 11, 2021.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at<EMAIL_ADDRESS>or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.

    Dated: December 21, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-28719 Filed 12-28-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 118 (Tuesday, June 19, 2012)]
[Notices]
[Page 36529]
[FR Doc No: 2012-14882]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER12-1925-000]

Patton Wind Farm, LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Patton Wind Farm, LLC's application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is July 5, 2012.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive email notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please email<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: June 13, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-14882 Filed 6-18-12; 8:45 am]
BILLING CODE 6717-01-P