			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on January 6, 2006

NOTICE OF ACTION TAKEN -- DOCKET OST-2005-22830

________________________________________________________________________
________________________________________________________

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).

Applicant:  TAG Aviation SA						Date Filed:  October 24, 2005

Relief requested:  Exemption from 49 U.S.C. § 41301 to engage in
charter foreign air transportation of persons and property between any
point or points in Swtizerland and any point or points in the United
States, either directly or via intermediate points in other countries,
with or without stopovers, and beyond; and to conduct charters in
accordance with Part 212 of the Department’s rules.  TAG SA proposes
to operate these services using small aircraft.

If renewal, date and citation of last action:  New authority

Applicant representatives:  Gary B. Garofalo & Erin M. Tallardy  (202)
776-3970

DOT Analyst:  Shelita A. Smith<PHONE_NUMBER>

Responsive pleadings:  None filed

DISPOSITION

Action:  Approved 							Action date:  January 6, 2006

Effective dates of exemption authority granted:  January 6, 2006-
January 6, 2008

Basis for approval (bilateral agreement/reciprocity): Air Transport
Agreement with Switzerland

Except to the extent exempted/waived, this authority is subject to the
terms, conditions, and limitations indicated:

    X    Standard exemption conditions (attached)
Foreign air carrier permit   (          )

Special conditions/Partial grant/Denial basis/Remarks:  Based on the
record in this case, we find that TAG SA is financially and
operationally qualified to perform the services authorized above.
However, we are unable to find that TAG SA is substantially owned and
effectively controlled by homeland nationals.  Specifically, the
applicant states that TAG SA is a subsidiary of TAG Holding, a Swiss
company.  TAG Holding is owned 46.63% by a trust, the beneficiaries of
which are citizens of Switzerland, France and Germany.  The remaining
shares are ultimately held by citizens of Saudi Arabia, the U.K., Hong
Kong and by a person of joint Lebanese, Canadian and U.K. citizenship.
Of the nine members of TAG Holding’s board, three hold Swiss
citizenship, two hold French citizenship, two hold British citizenship,
one holds Swedish citizenship, and one holds American citizenship.
Based on this record, we find that there is no evidence that would
suggest that the ownership and control of TAG SA would make grant of
this authority inimical to U.S. aviation policy or interests.  Under the
circumstances present, we find that it is consistent with the public
interest to use our discretion and to waive our ownership and control
standard in this instance.  The carrier is properly licensed by the
Government of Switzerland to perform the proposed services.  By
memorandum December 23, 2005, the FAA advised us that it knew of no
reason why we should act unfavorably on TAG SA’s application.

The authority granted to TAG SA is limited to operations involving
aircraft designed to have a maximum passenger capacity of not more than
60 seats or a maximum payload capacity of not more than 18, 000 pounds.

Action taken by:  Paul L. Gretch, Director

		   Office of International Aviation

________________________________________________________________________
________________________________________________________

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) the applicant is qualified to perform the
proposed operations; (2) our action was consistent with Department
policy; (3) grant of the authority was consistent with the public
interest; and (4) 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/deferred/dismissed, 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:

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

Foreign Carrier Exemption Conditions

In the conduct of the operations authorized, the foreign carrier
applicant(s) shall:

(1)  Not conduct any operations unless it holds a currently effective
authorization from its homeland for such operations, and it has filed a
copy of such authorization with the Department;

(2)  Comply with all applicable requirements of the Federal Aviation
Administration, including, but not limited to, 14 CFR Parts 129, 91, and
36, and with all applicable U.S. Government requirements concerning
security, including, but not limited to, 49 CFR Part 1546 or 1550, as
applicable.  To assure compliance with all applicable U.S. Government
requirements concerning security, the holder shall, before commencing
any new service (including charter flights) from a foreign airport that
would be the holder’s last point of departure for the United States,
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;

(3)  Comply with the requirements for minimum insurance coverage
contained in 14 CFR Part 205, and, prior to the commencement of any
operations under this authority, file evidence of such coverage, in the
form of a completed OST Form 6411, with the Federal Aviation
Administration’s Program Management Branch (AFS-260), Flight Standards
Service (any changes to, or termination of, insurance also shall be
filed with that office);

(4)  Not operate aircraft under this authority unless it complies with
operational safety requirements at least equivalent to Annex 6 of the
Chicago Convention;

(5)  Conform to the airworthiness and airman competency requirements of
its Government for international air services;

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

(7)  Agree that operations under this authority constitute a waiver of
sovereign immunity, for the purposes of 28 U.S.C. 1605(a), but only with
respect to those actions or proceedings instituted against it in any
court or other tribunal in the United States that are: (a)  based on its
operations in international air transportation that, according to the
contract of carriage, include a point in the United States as a point of
origin, point of destination, or agreed stopping place, or for which the
contract of carriage was purchased in the United States; or (b)  based
on a claim under any international agreement or treaty cognizable in any
court or other tribunal of the United States.  In this condition, the
term "international air transportation" means "international
transportation" as defined by the Warsaw Convention, except that all
States shall be considered to be High Contracting Parties for the
purpose of this definition;

(8)  Except as specifically authorized by the Department, originate or
terminate all flights to/from the United States in its homeland;

(9)  Comply with the requirements of 14 CFR Part 217, concerning the
reporting of scheduled, nonscheduled, and charter data;

(10) If charter operations are authorized, except as otherwise provided
in the applicable aviation agreement, comply with the Department's rules
governing charters (including 14 CFR Parts 212 and 380); and

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

This authority shall not be effective during any period when the holder
is not in compliance with the conditions imposed above.  Moreover, this
authority cannot be sold or otherwise transferred without explicit
Department approval under Title 49 of the U.S. Code.

 TAG SA’s application was accompanied by a motion under Rule 12 (14
CFR § 302.12) to withhold certain financial information from public
disclosure.  In support of its motion, TAG SA states that the
information is proprietary and commercially sensitive, and that TAG SA
would be adversely affected by its disclosure.  We have reviewed the
documents under the disclosure guidelines of Rule 12 and have determined
that they warrant confidential treatment.  Because of the commercially
sensitive nature of the information, we have determined that the
documents fall within the Freedom of Information Act exemption for
proprietary information and would adversely affect the competitive
position of TAG SA under 49 U.S.C. § 40115.

05/2004


[Federal Register Volume 87, Number 71 (Wednesday, April 13, 2022)]
[Rules and Regulations]
[Pages 21746-21748]
[FR Doc No: 2022-07819]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2022-0250]
RIN 1625-AA00

Safety Zone; Tennessee River, Chattanooga, TN

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
all navigable waters of the Tennessee River from mile marker (MM) 464.0
to 464.5. The temporary safety zone is needed to protect personnel,
vessels, and the marine environment from potential hazards created by
Chattanooga Presents--TN Aquarium 30th Anniversary Fireworks. Entry of
vessels or persons into this zone is prohibited unless specifically
authorized by the Captain of the Port Sector Ohio Valley or a
designated representative.

DATES: This rule is effective from 9 p.m. through 10 p.m. on April 30,
2022.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2022-0250 in the search box and click ``Search.'' Next, in the Document
Type column, select ``Supporting & Related Material.''

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Petty Officer Third Class Benjamin Gardner, Marine Safety
Detatchment Nashville, U.S. Coast Guard; telephone<PHONE_NUMBER>, email
[email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because it is impracticable. We must
establish this safety zone immediately and lack sufficient time to
provide a reasonable comment period and then consider those comments
before issuing the rule.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying this rule would be
contrary to public safety due to the danges associated with fireworks.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The Captain of the Port Sector Ohio
Valley (COTP) has determined that potential hazards associated with the
Chattanooga Presents--TN Aquarium 30th Anniversary Fireworks starting
April 30, 2022, will be a safety concern for anyone within mile marker
(MM) 464.0 to 464.5 on the Tennessee River. This rule is needed to
protect personnel, vessels, and the marine environment in the navigable
waters within the safety zone during the firework display.

IV. Discussion of the Rule

    This rule establishes a temporary safety zone from 9 p.m. through
10 p.m. on April 30, 2022. The safety zone will cover all navigable
waters between MM464.0 to 464.5 on the Tennessee River, extending the
entire width of the river. The duration of the zone is intended to
protect personnel, vessels, and the marine environment in these
navigable waters while the fireworks display is occuring. No vessel or
person will be permitted to enter the safety zone without obtaining
permission from the COTP or a designated representative.
    A designated representative is a commissioned, warrant, or petty
officer of the U.S. Coast Guard assigned to units under the operational
control of USCG Sector Ohio Valley.

    Vessels requiring entry into this safety zone must request
permission from the COTP or a designated representative. To seek entry
into the safety zone, contact the COTP or the COTP's representative by
telephone at<PHONE_NUMBER> or on VHF-FM channel 16.
    Persons and vessels permitted to enter this safety zone must
transit at their slowest safe speed and comply with all lawful
directions issued by the COTP or the designated representative.
    The COTP or a designated representative will inform the public
through Broadcast Notices to Mariners (BNMs), Local Notices to Mariners
(LNMs), and Marine Safety Information Bulletins (MSIBs) about this
safety zone, enforcement period, as well as any changes in the dates
and times of enforcement.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This rule has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, this
rule has not been reviewed by the Office of Management and Budget
(OMB).
    This regulatory action determination is based on the size,
location, duration, and time-of-day of the safety zone. This safety
zone restricts transit on a point five segment of the Tennessee River
for 1 hour on one day. Moreover, the Coast Guard will issue Broadcast
Notices to Mariners (BNMs), Local Notices to Mariners (LNMs), and
Marine Safety Information Bulletins (MSIBs) about this safety zone so
that waterway users may plan accordingly for this short restriction on
transit, and the rule allows vessels to request permission to enter the
zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the National Government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined that this action is one of
a category of actions that do not individually or cumulatively have a
significant effect on the human environment. This rule involves a
safety zone lasting only 1 hour that will prohibit entry between MM
464.0 to 464.5 on the Tennessee River for the fireworks display. It is
categorically excluded from further review under paragraph L60 of
Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1.
Due to the emergency nature of this rulemaking, a Record of
Environmental Consideration is not required.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water) Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No.
0170.1., Revision No. 01.2.Inserting required closing tag for E.

0
2. Add Sec.  165.T08-0250 to read as follows:

Sec.  165.T08-0250  Safety Zone; Tennessee River, Chattanooga, TN.

    (a) Location. The following area is a safety zone: all navigable
waters of the Tennessee River, Mile Markers 464.0 to 464.5, extending
the entire width of the river.
    (b) Periods of enforcement. This section will be enforced from 9
p.m. through 10 p.m. on April 30, 2022.
    (c) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, you may not enter the safety zone described in
paragraph (a) of this section unless authorized by the Captain of the
Port Sector Ohio Valley (COTP) or the COTP's designated representative.
A designated representative is a commissioned, warrant, or petty
officer of the U.S. Coast Guard assigned to units under the operational
control of USCG Sector Ohio Valley.
    (2) Vessels requiring entry into this safety zone must request
permission from the COTP or a designated representative. To seek entry
into the safety zone, contact the COTP or the COTP's representative by
telephone at<PHONE_NUMBER> or on VHF-FM channel 16.
    (3) Persons and vessels permitted to enter this safety zone must
transit at their slowest safe speed and comply with all lawful
directions issued by the COTP or the designated representative.
    (d) Informational broadcasts. The COTP or a designated
representative will inform the public through Broadcast Notices to
Mariners (BNMs), Local Notices to Mariners (LNMs), and Marine Safety
Information Bulletins (MSIBs) about this safety zone, enforcement
period, as well as any changes in the dates and times of enforcement.

    Dated: April 6, 2022.
A.M. Beach,
Captain, U.S. Coast Guard, Captain of the Port Sector Ohio Valley.
[FR Doc. 2022-07819 Filed 4-12-22; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 86, Number 43 (Monday, March 8, 2021)]
[Notices]
[Pages 13410-13411]
[FR Doc No: 2021-04657]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-429, OMB Control No. 3235-0480]

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

Extension:
    Rule 9b-1

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (``PRA'') (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the existing
collection of information provided for in Rule 9b-1, Options Disclosure
Document (17 CFR 240.9b-1), under the Securities Exchange Act of 1934
(15 U.S.C. 78a et seq.). The Commission plans to submit this existing
collection of information to the Office of Management and Budget
(``OMB'') for extension and approval.
    Rule 9b-1 (17 CFR 240.9b-1) sets forth the categories of
information required to be disclosed in an options disclosure document
(``ODD'') and requires the options markets to file an ODD with the
Commission 60 days prior to the date it is distributed to investors. In
addition, Rule 9b-1 provides that the ODD must be amended if the
information in the document becomes materially inaccurate or incomplete
and that amendments must be filed with the Commission 30 days prior to
the distribution to customers. Finally, Rule 9b-1 requires a broker-
dealer to furnish to each customer an ODD and any amendments prior to
accepting an order to purchase or sell an option on behalf of that
customer or when approving a customer's account for options trading.
    There are 16 options markets \1\ that must comply with Rule 9b-1.
These respondents work together to prepare a single ODD covering
options traded on each market, as well as amendments to the ODD. These
respondents file approximately 3 amendments per year. The staff
calculates that the preparation and filing of amendments should take no
more than eight hours per options market. Thus, the total time burden
for options markets per year is approximately 384 hours (16 options
markets x 8 hours per amendment x 3 amendments). The estimated cost for
an in-house attorney is $420 per hour,\2\ resulting in a total internal
cost of compliance for these respondents of approximately $161,280 per
year (384 hours at $420 per hour).
---------------------------------------------------------------------------

    \1\ The sixteen options markets are as follows: BOX Exchange
LLC, Cboe BZX Exchange, Inc., Cboe C2 Exchange, Inc., Cboe EDGX
Exchange, Inc., Cboe Exchange, Inc., Miami International Securities
Exchange LLC, MIAX Emerald, LLC, MIAX PEARL, LLC, Nasdaq BX, Inc.,
Nasdaq GEMX, LLC, Nasdaq ISE, LLC, Nasdaq MRX, LLC, Nasdaq PHLX LLC,
Nasdaq Options Market (NOM), NYSE Arca, Inc., and NYSE American LLC.
    \2\ SIFMA did its last annual survey in 2013 and will not resume
the survey process. Accordingly, the $420 figure is based on the
2013 figure ($380) adjusted by the inflation rate calculated using
the Bureau of Labor Statistics' CPI Inflation Calculator. The $380
per hour figure for an Attorney is from SIFMA's Management &
Professional Earnings in the Securities Industry 2013, modified by
Commission staff to account for an 1800-hour work-year and
multiplied by 5.35 to account for bonuses, firm size, employee
benefits and overhead.
---------------------------------------------------------------------------

    In addition, approximately 1,020 broker-dealers \3\ must comply
with Rule 9b-1. Each of these respondents will process an average of 3
new customers for options each week and, therefore, will have to
furnish approximately 156 ODDs per year. The postal mailing or
electronic delivery of the ODD takes respondents no more than 30
seconds to complete for an annual time burden for each of these
respondents of approximately 78 minutes or 1.3 hours. Thus, the total
time burden per year for broker-dealers is approximately 1,326 hours
(1,020 broker-dealers x 1.3 hours). The estimated cost for a general
clerk of a broker-dealer is $63 per hour,\4\

resulting in a total internal cost of compliance for these respondents
of approximately $83,538 per year (1,326 hours at $63 per hour).
---------------------------------------------------------------------------

    \3\ The estimate of 1,020 broker-dealers required to comply with
Rule 9b-1 is derived from Item 12 of the Form BD (OMB Control No.
3235-0012). This estimate may be high as it includes broker-dealers
that engage in only a proprietary business, and as a result are not
required to deliver an ODD, as well as those broker-dealers subject
to Rule 9b-1.
    \4\ The $63 figure is based on the 2013 figure ($57) adjusted
for inflation. See supra note 2. The $57 per hour figure for a
General Clerk is from SIFMA's Office Salaries in the Securities
Industry 2013, modified by Commission staff to account for an 1800-
hour work-year and multiplied by 2.93 to account for bonuses, firm
size, employee benefits and overhead. The staff believes that the
ODD would be mailed or electronically delivered to customers by a
general clerk of the broker-dealer or some other equivalent
position.
---------------------------------------------------------------------------

    The total time burden for all respondents under this rule (both
options markets and broker-dealers) is approximately 1,710 hours per
year (384 + 1,326), and the total internal cost of compliance is
approximately $244,818 per year ($161,280 + $83,538).
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information
shall have practical utility; (b) the accuracy of the Commission's
estimates of the burden of the proposed collection of information; (c)
ways to enhance the quality, utility, and clarity of the information
collected; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted in
writing within 60 days of this publication.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    Please direct your written comments to: David Bottom, Director/
Chief Information Officer, Securities and Exchange Commission, c/o
Cynthia Roscoe, 100 F Street NE, Washington, DC 20549, or send an email
to<EMAIL_ADDRESS>
    Dated: March 2, 2021.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-04657 Filed 3-5-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 137 (Friday, July 17, 2015)]
[Notices]
[Pages 42503-42505]
[FR Doc No: 2015-17556]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0967]

Public Meeting on Patient-Focused Drug Development for
Huntington's and Parkinson's Diseases

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
a public meeting and an opportunity for public comment on Patient-
Focused Drug Development for Huntington's disease and Parkinson's
disease. Patient-Focused Drug Development is part of FDA's performance
commitments made as part of the fifth authorization of the Prescription
Drug User Fee Act (PDUFA V). The public meeting is intended to allow
FDA to obtain patient perspectives on the impact of Huntington's
disease and Parkinson's disease on daily life and patient views on
treatment approaches. Although these are both neurological diseases,
since they are quite distinct, FDA will structure this public meeting
into two distinct sessions. The morning session, scheduled from 9 a.m.
to 1 p.m., will be

devoted to hearing patient perspectives on the impact of Huntington's
disease on daily life and their views on currently available treatment
approaches. The afternoon session, scheduled from 1 p.m. to 5 p.m.,
will be devoted to obtaining patient perspectives on the impact of
Parkinson's disease on daily life and patient views on currently
available treatment approaches.

DATES: The public meeting will be held on September 22, 2015, from 9
a.m. to 5 p.m. Registration to attend the meeting must be received by
September 14, 2015 (see SUPPLEMENTARY INFORMATION for instructions).
Register here to attend the meeting: https://pfddhuntingtonparkinson.eventbrite.com. Submit electronic or written
comments to the public docket by November 23, 2015.

ADDRESSES: The meeting will be held at the FDA White Oak Campus, 10903
New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993-0002. Participants must enter through
Building 1 and undergo security screening. For more information on
parking and security procedures, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Submit electronic comments to http://www.regulations.gov. Submit
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD
20852. All comments should be identified with the docket number found
in brackets in the heading of this document.
    FDA will post the agenda approximately 5 days before the meeting
at: http://www.fda.gov/Drugs/NewsEvents/ucm451807.htm.

FOR FURTHER INFORMATION CONTACT: Graham Thompson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993, 301-796-
5003, FAX:<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background on Patient-Focused Drug Development

    FDA has selected Huntington's disease (HD) and Parkinson's disease
(PD) as the focus of a public meeting under Patient-Focused Drug
Development, an initiative that involves obtaining a better
understanding of patient perspectives on the severity of a disease and
the available therapies for these conditions. Patient-Focused Drug
Development is being conducted to fulfill FDA performance commitments
that are part of the reauthorization of PDUFA under Title I of the Food
and Drug Safety and Innovation Act (Pub. L. 112-144). The full set of
performance commitments is available at http://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm270412.pdf.
    FDA committed to obtain the patient perspective on 20 disease areas
during the course of PDUFA V. For each disease area, the Agency will
conduct a public meeting to discuss the disease and its impact on
patients' daily lives, the types of treatment benefit that matter most
to patients, and patients' perspectives on the adequacy of the
available therapies. These meetings will include participation of FDA
review divisions, the relevant patient communities, and other
interested stakeholders.
    On April 11, 2013, FDA published a notice (78 FR 21613) in the
Federal Register announcing the disease areas for meetings in fiscal
years (FY) 2013 to 2015, the first 3 years of the 5-year PDUFA V time
frame. The Agency used several criteria outlined in that notice to
develop the list of disease areas. FDA obtained public comment on the
Agency's proposed criteria and potential disease areas through a public
docket and a public meeting that was convened on October 25, 2012. In
selecting the set of disease areas, FDA carefully considered the public
comments received and the perspectives of review divisions at FDA. By
the end of FY 2015, FDA will initiate a second public process for
determining the disease areas for FYs 2016 to 2017. More information,
including the list of disease areas and a general schedule of meetings,
is posted at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm326192.htm.

II. Public Meeting Information

A. Purpose and Scope of the Meeting

    The purpose of this Patient-Focused Drug Development meeting is to
obtain input on the symptoms and other impacts of HD and PD that matter
most to patients, as well as perspectives on current approaches to
treating these conditions. HD is a fatal genetic disorder that causes
the progressive degeneration of nerve cells in the brain, resulting in
uncontrolled movements, loss of intellectual faculties, and emotional
disturbance. Each child of an HD parent has a 50-50 chance of
inheriting the HD gene, and a person who inherits the HD gene will
eventually develop the disease. Physicians may prescribe a number of
medications to help control emotional and movement problems associated
with HD. While medicines may help keep these clinical symptoms under
control, there is no current treatment to stop or reverse the course of
the disease.
    PD belongs to a group of conditions called motor system disorders,
which are the result of the loss of dopamine-producing brain cells. As
nerve cells become impaired or die, individuals begin to experience
tremor, muscle rigidity or stiffness, slowing of movement, and impaired
balance and coordination. The cause of PD is unknown, but factors such
as genetics and environmental triggers may play a role. Although there
is no cure for PD, medications can help manage the levels of dopamine
and other neurotransmitters in the brain to improve symptoms. Deep
brain stimulation is a surgery that may also be used to manage symptoms
if medications are not effective.
    The questions that will be asked of patients and patient
stakeholders at the meeting are listed in this section, organized by
topic. For each topic, a brief initial patient panel discussion will
begin the dialogue. This will be followed by a facilitated discussion
inviting comments from other patient and patient stakeholder
participants. In addition to input generated through this public
meeting, FDA is interested in receiving patient input addressing these
questions through written comments, which can be submitted to the
public docket (see ADDRESSES).

B. Huntington's Disease Discussion Questions

Topic 1: Disease Symptoms and Daily Impacts That Matter Most to
Patients
    1. Of all the symptoms that you experience because of your
condition, which one to three symptoms have the most significant impact
on your life? (Examples may include: ability to control movements,
balance/coordination, difficulty concentrating, sleeping, mood/
behavior, etc.)
    2. Are there specific activities that are important to you but that
you cannot do at all or as fully as you would like because of your
condition? (Examples of activities may include sleeping through the
night, daily bathing/showering, cooking, eating, dressing, shopping,
etc.)
     How do your symptoms affect your daily life on the best
days? On the worst days?
    3. How has your condition and its symptoms changed over time?

     Do your symptoms come and go? If so, do you know of
anything that makes your symptoms better? Worse?
    4. How has your condition affected your social interactions,
including relationships with family and friends?
    5. How has your condition affected your mood (for example:
depression, apathy, patience/tolerance for frustration)?
Topic 2: Patients' Perspectives on Current Approaches To Treating HD
    1. What are you currently doing to help treat your condition or its
symptoms? (Examples may include prescription medicines, over-the-
counter products, and other therapies including non-drug therapies such
as diet modification and exercise.)
    (a) What specific symptoms do your treatments address?
    (b) How has your treatment regimen changed over time, and why?
    2. How well does your current treatment regimen treat the most
significant symptoms of your disease?
    (a) How well do these treatments improve your ability to do
specific activities that are important to you in your daily life?
    (b) How well have these treatments worked for you as your condition
has changed over time?
    3. What are the most significant downsides to your current
treatments, and how do they affect your daily life? (Examples of
downsides may include bothersome side effects, interacts with other
medications, need to visit your doctor more frequently, etc.)
    4. Assuming there is no complete cure for your condition, what
would you look for in an ideal treatment for your condition or a
specific aspect of your condition?

C. Parkinson's Disease Discussion Questions

Topic 1: Disease Symptoms and Daily Impacts That Matter Most to
Patients
    1. Of all the symptoms that you experience because of your
condition, which one to three symptoms have the most significant impact
on your life? (Examples may include difficulty moving, pain,
constipation, difficulty concentrating or remembering, daytime
sleepiness, etc.)
    2. Are there specific activities that are important to you but that
you cannot do at all or as fully as you would like because of your
condition? (Examples of activities may include daily hygiene, feeding,
dressing, etc.)
     How do your symptoms affect your daily life on the best
days? On the worst days?
    3. How has your ability to cope with symptoms changed over time?
     Do your symptoms come and go? If so, do you know of
anything that makes your symptoms better? Worse?
    4. What worries you most about your condition?
    5. How has your condition affected your social interactions,
including relationships with family and friends?
Topic 2: Patients' Perspectives on Current Approaches To Treating PD
    1. What are you currently doing to help treat your condition or its
symptoms? (Examples may include prescription medicines, over-the-
counter products, and other therapies including non-drug therapies such
as diet modification and exercise.)
     What specific symptoms do your treatments address (for
example: depression, constipation, memory difficulty, sleepiness,
ability to move)?
    2. How well does your current treatment regimen treat the most
significant symptoms of your disease?
     How well do these treatments improve your ability to do
specific activities that are important to you in your daily life?
    3. What are the most significant downsides to your current
treatments, and how do they affect your daily life? (Examples of
downsides may include bothersome side effects, need to visit your
doctor or take medications frequently, cause sleepiness, etc.)
    4. Assuming there is no complete cure for your condition, what
would you look for in an ideal treatment for your condition or a
specific aspect of your condition?

III. Meeting Attendance and Participation

    If you wish to attend this meeting, visit https://pfddhuntingtonparkinson.eventbrite.com. Please register by September
14, 2015. If you are unable to attend the meeting in person, you can
register to view a live webcast of the meeting. When you register, you
can indicate whether you plan to attend the morning session on HD, the
afternoon session on PD, or both. You will also be asked to indicate in
your registration if you plan to attend in person or via the webcast.
Seating will be limited, so early registration is recommended.
Registration is free and will be on a first-come, first-served basis.
However, FDA may limit the number of participants from each
organization based on space limitations. Registrants will receive
confirmation once they have been accepted. Onsite registration on the
day of the meeting will be based on space availability. If you need
special accommodations because of a disability, please contact Graham
Thompson (see FOR FURTHER INFORMATION CONTACT) at least 7 days before
the meeting.
    Patients who are interested in presenting comments as part of the
initial panel discussions will be asked to indicate in their
registration which topic(s) they wish to address. These patients also
must send to<EMAIL_ADDRESS>a brief summary of responses to
the topic questions by September 8, 2015. Panelists will be notified of
their selection approximately 7 days before the public meeting. We will
try to accommodate all patients and patient stakeholders who wish to
speak, either through the panel discussion or audience participation;
however, the duration of comments may be limited by time constraints.

IV. Comments

    Regardless if you attend the public meeting, you can submit
electronic or written responses to the questions pertaining to HD
Topics 1 and 2 and PD Topics 1 and 2 to the public docket (see
ADDRESSES) by November 23, 2015. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at http://www.regulations.gov.

V. Transcripts

    As soon as a transcript is available, FDA will post it at http://www.fda.gov/Drugs/NewsEvents/ucm451807.htm.

    Dated: July 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-17556 Filed 7-16-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 91 (Monday, May 12, 2014)]
[Notices]
[Page 26962]
[FR Doc No: 2014-10804]

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ENVIRONMENTAL PROTECTION AGENCY

[CERCLA-04-2014-3756: FRL 9910-60-OSWER]

Chemfax Inc. Superfund Site; Gulfport, Harrison County,
Mississippi; Notice of Settlement

AGENCY: Environmental Protection Agency.

ACTION: Notice of settlement.

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

SUMMARY: Under 122(h) of the Comprehensive Environmental Response,
Compensation and Liability Act (CERCLA), the United States
Environmental Protection Agency has entered into a settlement with the
State of Mississippi concerning the Chemfax Inc. Superfund Site located
in Gulfport, Harrison County, Mississippi. The settlement addresses
costs from a fund-lead Removal Action taken by the EPA, a fund lead RI/
FS and various enforcement work performed at the Site.

DATES: The Agency will consider public comments on the settlement until
June 11, 2014. The Agency will consider all comments received and may
modify or withdraw its consent to the settlement if comments received
disclose facts or considerations which indicate that the amended
settlement is inappropriate, improper, or inadequate.

ADDRESSES: Copies of the settlement are available from the Agency by
contacting Ms. Paula V. Painter, Environmental Protection Specialist
using the contact information provided in this notice. Comments may
also be submitted by referencing the Site's name through one of the
following methods:
     Internet: www.epa.gov/region4/superfund/programs/enforcement/enforcement.html.
     U.S. Mail: U.S. Environmental Protection Agency, Superfund
Division, Attn: Paula V. Painter, 61 Forsyth Street SW., Atlanta,
Georgia 30303.
     Email<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Paula V. Painter at 404/562-8887.

    Dated: April 21, 2014.
Anita L. Davis,
Chief, Superfund Enforcement & Information Management Branch, Superfund
Division.
[FR Doc. 2014-10804 Filed 5-9-14; 8:45 am]
BILLING CODE 6560-50-P