[Federal Register Volume 85, Number 234 (Friday, December 4, 2020)]
[Notices]
[Pages 78336-78337]
[FR Doc No: 2020-26691]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-5739]

Formal Meetings Between the Food and Drug Administration and
Abbreviated New Drug Application Applicants of Complex Products Under
Generic Drug User Fee Amendments; Guidance for Industry; Availability;
Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is correcting
a notice entitled ``Formal Meetings Between the Food and Drug
Administration and Abbreviated New Drug Application Applicants of
Complex Products Under Generic Drug User Fee Amendments; Guidance for
Industry; Availability'' that appeared in the Federal Register of
November 25, 2020. The document announced the availability for a
guidance for industry. The document was published with incorrect
information in the Paperwork Reduction Act of 1995 section. This
document corrects that error.

FOR FURTHER INFORMATION CONTACT: Elizabeth Giaquinto Friedman, Center
for Drug Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 75, Rm. 1670, Silver Spring, MD 20993-0002,
240-402-7930<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Federal Register of November 25, 2020
(85 FR 75336), in FR Doc. 2020-26050, the following correction is made:
    On page 75337, in the third column, under the heading, ``II.
Paperwork Reduction Act of 1995'', the paragraph is corrected to read:
    ``While this guidance contains no collection of information, it
does refer to previously approved FDA collections of information.
Therefore, clearance by the Office of Management and Budget

(OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3521) is not required for this guidance. The previously approved
collections of information are subject to review by OMB under the PRA.
The collections of information for meetings related to generic drug
development have been approved under OMB control number 0910-0797.''

    Dated: November 30, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-26691 Filed 12-3-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 45 (Thursday, March 7, 2013)]
[Notices]
[Pages 14779-14781]
[FR Doc No: 2013-05326]

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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: RP12-1006-000
    Applicants: Colorado Interstate Gas Company LLC
    Description: Operational Purchases and Sales Report of Colorado
Interstate Gas Company LLC
    Filed Date: 8/31/12
    Accession Number: 20120831-5156
    Comments Due: 5 p.m. ET 3/8/13

    Docket Numbers: RP13-596-000
    Applicants: Southern Natural Gas Company, L.L.C.
    Description: Fuel Retention Rates--2013 to be effective 4/1/2013
    Filed Date: 2/28/13
    Accession Number: 20130228-5065
    Comments Due: 5 p.m. ET 3/12/13

    Docket Numbers: RP13-597-000
    Applicants: Millennium Pipeline Company, LLC
    Description: RAM 2013 to be effective 4/1/2013
    Filed Date: 2/28/13
    Accession Number: 20130228-5066
    Comments Due: 5 p.m. ET 3/12/13

    Docket Numbers: RP13-598-000
    Applicants: Elba Express Company, L.L.C.
    Description: Elba Express Pipeline Project--Phase B Compression to
be effective 4/1/2013
    Filed Date: 2/28/13

    Accession Number: 20130228-5067
    Comments Due: 5 p.m. ET 3/12/13

    Docket Numbers: RP13-599-000
    Applicants: El Paso Natural Gas Company, L.L.C.
    Description: Non-Conforming OPASA Filing to be effective 3/1/2013
    Filed Date: 2/28/13
    Accession Number: 20130228-5072
    Comments Due: 5 p.m. ET 3/12/13

    Docket Numbers: RP13-600-000
    Applicants: Natural Gas Pipeline Company of America
    Description: Removal of Agreements to be effective 4/1/2013
    Filed Date: 2/28/13
    Accession Number: 20130228-5073
    Comments Due: 5 p.m. ET 3/12/13

    Docket Numbers: RP13-601-000
    Applicants: High Island Offshore System, L.L.C.
    Description: High Island Offshore System, L.L.C. submits 2013
Annual Fuel Filing for calendar year 2012 activity
    Filed Date: 2/28/13
    Accession Number: 20130228-5084
    Comments Due: 5 p.m. ET 3/12/13

    Docket Numbers: RP13-602-000
    Applicants: Tallgrass Interstate Gas Transmission, L
    Description: Neg Rate Choice Ethanol (fka Nedak) 2013-02-28 to be
effective 2/28/2013
    Filed Date: 2/28/13
    Accession Number: 20130228-5091
    Comments Due: 5 p.m. ET 3/12/13

    Docket Numbers: RP13-603-000
    Applicants: Guardian Pipeline, L.L.C.
    Description: EPC Semi Annual Adjustment--Spring 2013 to be
effective 4/1/2013
    Filed Date: 2/28/13
    Accession Number: 20130228-5100
    Comments Due: 5 p.m. ET 3/12/13

    Docket Numbers: RP13-604-000
    Applicants: Viking Gas Transmission Company
    Description: LMCRA--Spring 2013 to be effective 4/1/2013
    Filed Date: 2/28/13
    Accession Number: 20130228-5101
    Comments Due: 5 p.m. ET 3/12/13

    Docket Numbers: RP13-605-000
    Applicants: El Paso Natural Gas Company, L.L.C.
    Description: Willcox Lateral Expansion Tariff Compliance Filing to
be effective 4/1/2013
    Filed Date: 2/28/13
    Accession Number: 20130228-5116
    Comments Due: 5 p.m. ET 3/12/13

    Docket Numbers: RP13-606-000
    Applicants: Columbia Gas Transmission, LLC
    Description: LNG Settlement--Pro-Forma to be effective 12/31/9998
    Filed Date: 2/28/13
    Accession Number: 20130228-5150
    Comments Due: 5 p.m. ET 3/12/13

    Docket Numbers: RP13-607-000
    Applicants: Northern Natural Gas Company
    Description: 20130228 Negotiated Rate to be effective 3/1/2013
    Filed Date: 2/28/13
    Accession Number: 20130228-5157
    Comments Due: 5 p.m. ET 3/12/13

    Docket Numbers: RP13-608-000
    Applicants: American Midstream (Midla), LLC
    Description: Midla Non-Conforming Agreements to be effective 3/1/
2013
    Filed Date: 2/28/13
    Accession Number: 20130228-5165
    Comments Due: 5 p.m. ET 3/12/13

    Docket Numbers: RP13-609-000
    Applicants: Tennessee Gas Pipeline Company, L.L.C.
    Description: Fuel Tracker 2013 to be effective 4/1/2013
    Filed Date: 2/28/13
    Accession Number: 20130228-5185
    Comments Due: 5 p.m. ET 3/12/13

    Docket Numbers: RP13-610-000
    Applicants: Rockies Express Pipeline LLC
    Description: Rockies Express Pipeline LLC submits tariff filing per
154.204: 2013 Annual FL&U Percentage Adjustment to be effective 4/1/
2013
    Filed Date: 2/28/13
    Accession Number: 20130228-5204
    Comments Due: 5 p.m. ET 3/12/13

    Docket Numbers: RP13-611-000
    Applicants: Transwestern Pipeline Company, LLC
    Description: 2013 TW Settlement Fuel Filing to be effective 4/1/
2013
    Filed Date: 2/28/13
    Accession Number: 20130228-5261
    Comments Due: 5 p.m. ET 3/12/13

    Docket Numbers: RP13-612-000
    Applicants: Dominion Cove Point LNG, LP
    Description: DCP--2013 Annual EPCA to be effective 4/1/2013
    Filed Date: 2/28/13
    Accession Number: 20130228-5292
    Comments Due: 5 p.m. ET 3/12/13

    Docket Numbers: RP13-613-000
    Applicants: Dominion Cove Point LNG, LP
    Description: DCP--2013 Annual Fuel Retainage to be effective 4/1/
2013
    Filed Date: 2/28/13
    Accession Number: 20130228-5297
    Comments Due: 5 p.m. ET 3/12/13

    Docket Numbers: RP13-614-000
    Applicants: ANR Pipeline Company
    Description: Marshfield Reduction Phase IV to be effective 4/1/2013
    Filed Date: 2/28/13
    Accession Number: 20130228-5330
    Comments Due: 5 p.m. ET 3/12/13

    Docket Numbers: RP13-615-000
    Applicants: Cheniere Creole Trail Pipeline, L.P.
    Description: Transportation Retainage Adjustment to be effective 4/
1/2013
    Filed Date: 2/28/13
    Accession Number: 20130228-5357
    Comments Due: 5 p.m. ET 3/12/13

    Docket Numbers: RP13-616-000
    Applicants: Kern River Gas Transmission Company
    Description: 2013 Daggett Surcharge to be effective 4/1/2013
    Filed Date: 3/1/13
    Accession Number: 20130301-5002
    Comments Due: 5 p.m. ET 3/13/13

    Docket Numbers: RP13-617-000
    Applicants: Columbia Gas Transmission, LLC
    Description: Firm to IPP Pooling Modifications to be effective 4/1/
2013
    Filed Date: 3/1/13
    Accession Number: 20130301-5027
    Comments Due: 5 p.m. ET 3/13/13

    Docket Numbers: RP13-618-000
    Applicants: Transcontinental Gas Pipe Line Company,
    Description: Annual Electric Power Tracker Filing effective April
1, 2013 to be effective 4/1/2013
    Filed Date: 3/1/13
    Accession Number: 20130301-5038
    Comments Due: 5 p.m. ET 3/13/13

    Docket Numbers: RP13-619-000
    Applicants: Big Sandy Pipeline, LLC
    Description: Big Sandy Pipeline, LLC submits tariff filing per
154.204: Troublesome Creek 1009027 Negotiated Rate to be effective 4/1/
2013
    Filed Date: 3/1/13
    Accession Number: 20130301-5039
    Comments Due: 5 p.m. ET 3/13/13

    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.

Filings in Existing Proceedings

    Docket Numbers: RP11-65-003
    Applicants: Trans-Union Interstate Pipeline, L.P.
    Description: Order 587-V Compliance Filing to Modify Tariff
(2.14.13) to be effective 12/1/2012
    Filed Date: 2/14/13
    Accession Number: 20130214-5054
    Comments Due: 5 p.m. ET 3/5/13

    Docket Numbers: RP12-955-003
    Applicants: CenterPoint Energy--Mississippi River T

    Description: MRT Rate Case Motion Rate Filing to be effective 3/1/
2013
    Filed Date: 2/28/13
    Accession Number: 20130228-5103
    Comments Due: 5 p.m. ET 3/12/13

    Docket Numbers: RP12-993-002
    Applicants: Transcontinental Gas Pipe Line Company,
    Description: Compliance Filing to Update Suspended Tariff Records
in Docket No. RP12-993 to be effective 3/1/2013
    Filed Date: 2/28/13
    Accession Number: 20130228-5346
    Comments Due: 5 p.m. ET 3/12/13

    Docket Numbers: RP13-147-002
    Applicants: WestGas InterState, Inc.
    Description: 20130228--Compliance Filing to be effective 12/1/2012
    Filed Date: 2/28/13
    Accession Number: 20130228-5366
    Comments Due: 5 p.m. ET 3/12/13

    Docket Numbers: RP13-588-001
    Applicants: Natural Gas Pipeline Company of America
    Description: Interstate Power Amended Negotiated Rate Filing to be
effective 3/1/2013
    Filed Date: 2/28/13
    Accession Number: 20130228-5152
    Comments Due: 5 p.m. ET 3/12/13

    Docket Numbers: RP13-147-003
    Applicants: WestGas InterState, Inc.
    Description: 20130301--Compliance Filing to be effective 12/1/2012
    Filed Date: 3/1/13
    Accession Number: 20130301-5003
    Comments Due: 5 p.m. ET 3/13/13

    Any person desiring to protest in any the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5:00 p.m. Eastern time on the specified
comment date.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, and service can be found at:
http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other
information, call<PHONE_NUMBER> (toll free). For TTY, call (202) 502-
8659.

    Dated: March 1, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary
[FR Doc. 2013-05326 Filed 3-6-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: August 31, 2007 (Volume 72, Number 169)]
[Notice]
[Page 50365-50366]
[DOCID:fr31au07-98]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 459-187]

Union Electric Company dba Ameren EU; Notice of Amendment of
License and Soliciting Comments, Motions To Intervene, and Protests

August 23, 2007.
    Take notice that the following application has been filed with the
Commission and is available for public inspection:
    a. Application Type: Non-Project Use of Project Lands and Waters.
    b. Project No: 459-187.
    c. Date filed: August 14, 2007.
    d. Applicant: Ameren UE.
    e. Name of Project: Osage Project.
    f. Location: The project is located on the Osage River, in Benton,
Camden, Miller, and Morgan Counties, Missouri. The project is located
immediately downstream from the U.S. Army Corps of Engineers' (Corps)
Harry S. Truman Dam and occupies 1.6 acres of inundated federal lands
administered by the Bureau of Land Management.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r)
and sections 799 and 801.
    h. Applicant Contact: Mr. Jeff Green, Supervisor, P.O. Box 993,
Lake Ozark, MO 65049 phone number<PHONE_NUMBER> or e-mail--
<EMAIL_ADDRESS>    i. FERC Contact: Rebecca Martin at<PHONE_NUMBER>, or e-mail
<EMAIL_ADDRESS>

    j. Deadline for filing comments and or motions: September 24, 2007.
    All documents (original and eight copies) should be filed with: The
Secretary, Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington DC, 20426. Please include the project number (P-459-187) 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 under the ``e-Filing'' link. The Commission strongly encourages e-
filings.
    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. A copy
of any motion to intervene must also be served upon each representative
of the Applicant specified in the particular application.
    k. Description of Application: The licensee requests permission to
allow the Breezes Condominiums to construct eight boat docks with 112
slips along 1,000 feet of shoreline. The property is located along U.S.
Business Highway 54 and inside the 1 mile marker (river mile),
approximately 1,100 feet upstream and west of Bagnell Dam.
    l. Location of Application: A copy of the application is available
for inspection and reproduction at the Commission's Public Reference
Room, located at 888 First Street, NE., Room 2A, Washington, DC 20426,
or by calling<PHONE_NUMBER>. This filing may also be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. You may also register
online at http://www.ferc.gov/docs-filing/esubscription.asp to be
notified via e-mail of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or e-mail
<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. 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,
385.211, 385.214. 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 application. A copy of the
application 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.
    q. 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.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-17255 Filed 8-30-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: November 4, 2010 (Volume 75, Number 213)]
[Notices]
[Page 67992]
[DOCID:fr04no10-60]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2008-0017]

Voluntary Private Sector Accreditation and Certification
Preparedness Program

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice of closing date for public comments.

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SUMMARY: The Department of Homeland Security (DHS) published a notice
in the Federal Register on October 1, 2010, requesting comments on an
initial small business plan to address small business concerns in the
Voluntary Private Sector Accreditation and Certification Preparedness
Program (PS-Prep Program). That notice did not contain a closing date
for the comment period. This notice provides a closing date.

DATES: Submit comments on or before December 6, 2010.

ADDRESSES: DHS will review any comments received for small business
considerations or the PS-Prep Program generally and, when merited, will
publish a Federal Register notice providing the results of that review.
    Those interested may submit comments, identified by Docket ID FEMA-
2008-0017, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. (Note: This process
applies to all government requests for comments--even though as in the
case of the PS-Prep Program, they may not be for regulatory purposes.)
     Fax:<PHONE_NUMBER>.
     Mail/Hand Delivery/Courier: Office of Chief Counsel,
Federal Emergency Management Agency, 500 C Street, SW., Room 840,
Washington, DC 20472-3100.
    All submissions received must include the agency name and Docket ID
FEMA-2008-0017. All submissions will be posted, without change, to the
Federal eRulemaking Portal at http://www.regulations.gov, and will
include any personal information you provide. Because comments are made
available to the public, submitters should take caution to not include
any sensitive, personal information, trade secret, or any commercial or
financial information which is obtained from any person and which is
deemed privileged or confidential. Submitters may wish to read the
Privacy Act notice available on the Privacy Notice link located at the
bottom of http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments received, go to the Federal eRulemaking Portal at http://
www.regulations.gov. Submitted comments may also be inspected at FEMA,
Office of Chief Counsel, 500 C Street, SW., Room 840, Washington, DC
20472-3100.

FOR FURTHER INFORMATION CONTACT: Mr. Marcus Pollock, National
Integration Center, Federal Emergency Management Agency, 500 C Street,
SW., Washington, DC 20472-3100; phone:<PHONE_NUMBER>; e-mail: FEMA-
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On October 1, 2010, DHS published a notice
in the Federal Register at 75 FR 60773 announcing an initial plan to
address small business concerns in the PS-Prep Program. That notice (1)
presented the plan for small business preparedness, and (2) invited
public comment on the plan. However, the notice that published on
October 1, 2010 did not include a closing date for the submission of
public comments. This notice corrects that error by providing a closing
date of December 6, 2010 for the submission of public comments.

    Authority: 6 U.S.C. 321m(b)(2)(D).

    Dated: October 22, 2010.
W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2010-27828 Filed 11-3-10; 8:45 am]
BILLING CODE 9111-46-P