[Federal Register Volume 80, Number 222 (Wednesday, November 18, 2015)]
[Notices]
[Pages 72068-72069]
[FR Doc No: 2015-29406]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0530]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
on Tropical Disease Priority Review Vouchers

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995 (the PRA).

DATES: Fax written comments on the collection of information by
December 18, 2015.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-New and
title ``Guidance for Industry on Tropical Disease Priority Review
Vouchers.'' Also include the FDA docket number found in brackets in the
heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Guidance for Industry on Tropical Disease Priority Review Vouchers--OMB
Control Number 0910-NEW

    Section 1102 of the Food and Drug Administration Amendments Act
(FDAAA) adds new section 524 to the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 360n). Section 524 is designed to
encourage development of new drug or biological products for prevention
and treatment of certain tropical diseases affecting millions of people
throughout the world and makes provisions for awarding priority review
vouchers for future applications to sponsors of tropical disease
products. By enacting section 524, Congress intended to stimulate new
drug development for drugs to treat certain tropical diseases for which
there are no or few available treatments by offering additional
incentives for obtaining FDA approval for pharmaceutical treatments for
these diseases. Under section 524, a sponsor of a human drug
application for a

qualified tropical disease may be eligible for a voucher that can be
used to obtain a priority review for any application submitted under
section 505(b)(1) of the FD&C Act (21 U.S.C. 355(b)(1)) or section 351
of the Public Health Service Act (the PHS Act). The guidance explains
to internal and external stakeholders how FDA intends to implement the
provisions of section 524, and provides information on using the
priority review vouchers and on transferring priority review vouchers
to other sponsors.
    Under the guidance, sponsors of certain tropical disease drug
product applications submitted under section 505(b)(1) of the FD&C Act
and section 351 of the PHS Act may request a priority review voucher.
Based on inquiries and discussions with industry about section 524, we
estimate that we will receive annually approximately five requests from
five sponsors, and that each request will take approximately 8 hours to
prepare and submit to FDA.
    The guidance also states that sponsors should notify FDA of their
intent to use a priority review voucher, including the date on which
the sponsor intends to submit the application, at least 90 days before
use. We estimate that we will receive annually approximately five
notifications of intent to use a voucher from five sponsors, and that
each notification will take approximately 8 hours to prepare and submit
to FDA.
    The guidance also permits the transfer of a priority review voucher
from one sponsor to another, and states that each transfer should be
documented with a letter of transfer. We estimate that we will receive
approximately two letters indicating the transfer of a voucher from two
application holders, and two letters from two new voucher owners
acknowledging the transfer, and that it will take approximately 8 hours
to prepare and submit each letter to FDA.
    In the Federal Register of October 20, 2008 (73 FR 62298), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. The comments we received did not pertain to
the information collection that would result from the guidance (that
is, the four types of submissions estimated in table 1).
    FDA estimates the burden of this collection of information as
follows:
    Description of Respondents: Sponsors submitting applications under
section 505(b)(1) of the FD&C Act or section 351 of the PHS Act.

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
    Guidance for Industry on                         Number of
Tropical Disease Priority Review     Number of     responses per   Total annual   Average burden    Total hours
            Vouchers                respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Priority Review Voucher Request.               5               1               5               8              40
Notifications of Intent To Use a               5               1               5               8              40
 Voucher........................
Letters Indicating the Transfer                2               1               2               8              16
 of a Voucher Letter............
Acknowledging the Receipt of a                 2               1               2               8              16
 Transferred Voucher............
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             112
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: November 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-29406 Filed 11-17-15; 8:45 am]
BILLING CODE 4164-01-P


UNITED STATES OF AMERICA

DEPARTMENT OF TRANSPORTATION

OFFICE OF THE SECRETARY

WASHINGTON, DC

Issued by the Department of Transportation on April 1, 2005

   NOTICE OF ACTION TAKEN -- DOCKET OST-2005-20255

________________________________________________________________________
_________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Application of    Chautauqua Airlines, Inc.          filed   1/27/05
for:

XX Exemption for two years under 49 U.S.C. 40109 to provide the
following service:

Scheduled foreign air transportation of persons, property, and mail
between any point or points in the United States and any point or points
in Canada.   Chautauqua Airlines also requests authority to integrate
this authority with its existing certificate and exemption authority.

Applicant rep:   Robert E. Cohn<PHONE_NUMBER>    DOT Analyst:  Gerald
Caolo,<PHONE_NUMBER>

D I S P O S I T I O N

XX  Granted

The above action was effective when taken: April 1, 2005, through  April
1, 2007

Action taken by:   Paul L. Gretch, Director

		    Office of International Aviation

XX  The authority granted is consistent with the aviation agreement
between the United States and Canada.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated:  XX Holder’s
certificates of public convenience and necessity

	   XX  Standard exemption conditions (attached)

________________________________________________________________________
____________

Remarks:  Chautauqua Airlines has previously been found to be a citizen
of the United States and fit, willing, and able to provide scheduled
interstate air transportation of persons, property, and mail as a
certificated air carrier.  The foreign air transportation services
authorized here are not markedly different in terms of aircraft size or
stage length from the carrier's current operations under its existing
authority.  We, therefore, found that Chautauqua Airlines is qualified
to provide the proposed air transportation for the period covered by the
exemption.

Conditions:  The route integration authority granted Chautauqua Airlines
is subject to the condition that any service provided under this
exemption shall be consistent with all applicable agreements between the
United States and the foreign countries involved.  Furthermore, (a)
nothing in the award of the route integration authority requested should
be construed as conferring upon Chautauqua Airlines rights (including
fifth-freedom intermediate and/or beyond rights) to serve markets where
U.S. carrier entry is limited unless Chautauqua Airlines notifies the
Department of its intent to serve such a market and unless and until the
Department has completed any necessary carrier selection procedures to
determine which carrier(s) should be authorized to exercise such rights;
and (b) should there be a request by any carrier to use the
limited-entry route rights that are included in Chautauqua Airlines’
authority by virtue of the route integration exemption granted here, but
that are not then being used by Chautauqua Airlines, the holding of such
authority by route integration will not be considered as providing any
preference for Chautauqua Airlines in a competitive carrier selection
proceeding to determine which carrier(s) should be entitled to use the
authority at issue.

________________________________________________________________________
______________

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that

(1) our action was consistent with Department policy; (2) grant of the
exemption authority was consistent with the public interest; and (3)
grant of the authority would not constitute a major regulatory action
under the Energy Policy and Conservation Act of 1975.  To the extent not
granted, we denied all requests in the referenced Docket.  We may amend,
modify, or revoke the authority granted in this Notice at any time
without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov//reports/reports_aviation.asp

U.S. Carrier Exemption Conditions

In the conduct of the operations authorized, the U.S. carrier
applicant(s) shall:

(1)  Hold at all times effective operating authority from the government
of each country served;

(2)  Comply with applicable requirements concerning oversales contained
in 14 CFR 250 (for scheduled operations, if authorized);

(3)  Comply with the requirements for reporting data contained in 14 CFR
241;

(4)  Comply with requirements for minimum insurance coverage, and for
certifying that coverage to the Department, contained in 14 CFR 205;

(5)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR 203, concerning
waiver of Warsaw Convention liability limits and defenses;

(6)  Comply with all applicable requirements of the Federal Aviation
Administration and with all applicable U.S. Government requirements
concerning security, including, but not limited to, 49 CFR Part 1544.
To assure compliance with all applicable U.S. Government requirements
concerning security, the holder shall, before commencing any new service
(including charter flights) to or from a foreign airport, contact its
International Principal Security Inspector (IPSI) to advise the IPSI of
its plans and to find out whether the Transportation Security
Administration has determined that security is adequate to allow such
airport(s) to be served; and

(7)  Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department of Transportation, with all applicable orders and regulations
of other U.S. agencies and courts, and with all applicable laws of the
United States.

The authority granted shall be effective only during the period when the
holder is in compliance with the conditions imposed above.

05/2004

 Chuatauqua is a well-established carrier providing extensive service
with aircraft with less than 60 seats (small aircraft). It was recently
awarded Department authority to engage in interstate scheduled
transportation with aircraft with 70 seats.  Chautauqua operates its
regional service on a code-share basis with major U.S. carriers and it
now proposes to use aircraft with 70 passenger seats, in addition to its
commuter service with small aircraft.

 PAGE

 PAGE   2


[Federal Register Volume 86, Number 167 (Wednesday, September 1, 2021)]
[Notices]
[Page 49067]
[FR Doc No: 2021-18908]

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SECURITIES AND EXCHANGE COMMISSION

[Release Nos. 33-10968, 34-92783; File No. 265-28]

Investor Advisory Committee Meeting

AGENCY: Securities and Exchange Commission.

ACTION: Notice of meeting.

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SUMMARY: The Securities and Exchange Commission Investor Advisory
Committee, established pursuant to Section 911 of the Dodd-Frank Wall
Street Reform and Consumer Protection Act of 2010, is providing notice
that it will hold a public meeting. The public is invited to submit
written statements to the Committee.

DATES: The meeting will be held on Thursday, September 9, 2021 from
10:00 a.m. until 3:30 p.m. (ET). Written statements should be received
on or before September 8, 2021.

ADDRESSES: The meeting will be conducted by remote means and/or at the
Commission's headquarters, 100 F St. NE, Washington, DC 20549. The
meeting will be webcast on the Commission's website at www.sec.gov.
Written statements may be submitted by any of the following methods:

Electronic Statements

    [ssquf] Use the Commission's internet submission form (http://www.sec.gov/rules/other.shtml); or
    [ssquf] Send an email message to<EMAIL_ADDRESS>Please
include File No. 265-28 on the subject line; or

Paper Statements

    [ssquf] Send paper statements to Vanessa A. Countryman, Secretary,
Securities and Exchange Commission, 100 F Street NE, Washington, DC
20549-1090.

All submissions should refer to File No. 265-28. This file number
should be included on the subject line if email is used. To help us
process and review your statement more efficiently, please use only one
method.
    Statements also will be available for website viewing and printing
in the Commission's Public Reference Room, 100 F Street NE, Room 1503,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. All statements received will be posted without
change. Persons submitting comments are cautioned that we do not redact
or edit personal identifying information from comment submissions. You
should submit only information that you wish to make available
publicly.

FOR FURTHER INFORMATION CONTACT: Marc Oorloff Sharma, Chief Counsel,
Office of the Investor Advocate, at<PHONE_NUMBER>, Securities and
Exchange Commission, 100 F Street NE, Washington, DC 20549.

SUPPLEMENTARY INFORMATION: The meeting will be open to the public,
except during that portion of the meeting reserved for an
administrative work session during lunch. Persons needing special
accommodations to take part because of a disability should notify the
contact person listed in the section above entitled FOR FURTHER
INFORMATION CONTACT. The agenda for the meeting includes: Welcome
remarks; approval of previous meeting minutes; a panel discussion
entitled ``Reimagining Investor Protection in a Digital World: the
Behavioral Design of Online Trading Platforms''; a panel discussion
regarding competition and regulatory reform at the PCAOB; a discussion
of a recommendation regarding 10b5-1 plans; a discussion of a
recommendation regarding SPACs; subcommittee reports; and a non-public
administrative session.

    Dated: August 27, 2021.
Vanessa A. Countryman,
Secretary.
[FR Doc. 2021-18908 Filed 8-31-21; 8:45 am]
BILLING CODE P


[Federal Register Volume 81, Number 112 (Friday, June 10, 2016)]
[Notices]
[Pages 37626-37627]
[FR Doc No: 2016-13812]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2016-0002]

Final Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final notice.

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SUMMARY: Flood hazard determinations, which may include additions or
modifications of Base Flood Elevations (BFEs), base flood depths,
Special Flood Hazard Area (SFHA) boundaries or zone designations, or
regulatory floodways on the Flood Insurance Rate Maps (FIRMs) and where
applicable, in the supporting Flood Insurance Study (FIS) reports have
been made final for the communities listed in the table below.
    The FIRM and FIS report are the basis of the floodplain management
measures that a 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 Federal Emergency Management Agency's (FEMA's)
National Flood Insurance Program (NFIP). In addition, the FIRM and FIS
report are used by insurance agents and others to calculate appropriate
flood insurance premium rates for buildings and the contents of those
buildings.

DATES: The effective date of June 15, 2016 which has been established
for the FIRM and, where applicable, the supporting FIS report showing
the new or modified flood hazard information for each community.

ADDRESSES: The FIRM, and if applicable, the FIS report containing the
final flood hazard information for each community is available for
inspection at the respective Community Map Repository address listed in
the tables below and will be available online through the FEMA Map
Service Center at www.msc.fema.gov by the effective date indicated
above.

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services 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: The Federal Emergency Management Agency
(FEMA) makes the final determinations listed below for the new or
modified flood hazard information for each community listed.
Notification of these changes has been published in newspapers of local
circulation and 90 days have elapsed since that publication. The Deputy
Associate Administrator for Mitigation has resolved any appeals
resulting from this notification.
    This final notice is issued in accordance with section 110 of the
Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part
67. FEMA has developed criteria for floodplain management in floodprone
areas in accordance with 44 CFR part 60.
    Interested lessees and owners of real property are encouraged to
review the new or revised FIRM and FIS report available at the address
cited below for each community or online through the FEMA Map Service
Center at www.msc.fema.gov.
    The flood hazard determinations are made final in the watersheds
and/or communities listed in the table below.

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

    Dated: May 19, 2016.
Roy E. Wright,
Deputy Associate Administrator for Insurance and Mitigation, Department
of Homeland Security, Federal Emergency Management Agency.
    I. Non-watershed-based studies:

------------------------------------------------------------------------
                                             Community map repository
               Community                             address
------------------------------------------------------------------------
             Douglas County, Nevada, and Incorporated Areas
------------------------------------------------------------------------
                         Docket No.: FEMA-B-1535
------------------------------------------------------------------------
Unincorporated Areas of Douglas County.  Community Development, 1594
                                          Esmeralda Avenue, Minden, NV
                                          89423.
------------------------------------------------------------------------

[FR Doc. 2016-13812 Filed 6-9-16; 8:45 am]
 BILLING CODE 9110-12-P


[Federal Register Volume 85, Number 117 (Wednesday, June 17, 2020)]
[Notices]
[Page 36577]
[FR Doc No: 2020-13022]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER20-1980-000]

Cedar Springs Wind, 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 Cedar Springs
Wind, 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 1, 2020.
    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: June 11, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-13022 Filed 6-16-20; 8:45 am]
BILLING CODE 6717-01-P