[Federal Register Volume 76, Number 158 (Tuesday, August 16, 2011)]
[Notices]
[Pages 50741-50742]
[FR Doc No: 2011-20791]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]

2011 Parenteral Drug Association/Food and Drug Administration
Joint Public Conference; Quality and Compliance in Today's Regulatory
Enforcement Environment

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public conference.

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    The Food and Drug Administration (FDA), in cosponsorship with
Parenteral Drug Association (PDA), is announcing a public conference
entitled ``Quality and Compliance in Today's Regulatory Enforcement
Environment.'' The conference will span 2\1/2\ days and cover current
issues affecting the industry as well as explore strategies and
approaches for ensuring conformance with regulations to facilitate the
development and continuous improvement of safe and effective medical
products. The conference establishes a unique forum to discuss the
foundations, emerging technologies and innovations in regulatory
science, as well as the current quality and compliance areas of
concerns. Meeting participants will hear from FDA and industry speakers
about the requirements and best practices to consider while
implementing robust quality systems in order to deliver the best
quality product.
    Date and Time: The public conference will be held on September 19,
2011, from 7 a.m. to 6 p.m.; September 20, 2011, from 7:30 a.m. to 6:15
p.m.; and September 21, 2011, from 7:30 a.m. to 12:15 p.m.
    Location: The public conference will be held at the Renaissance
Hotel, 999 Ninth St., NW., Washington, DC 20001,<PHONE_NUMBER>, FAX:
202-289-0947.
    Contact: Wanda Neal, Parenteral Drug Association, PDA Global
Headquarters, Bethesda Towers, 4350 East West Hwy., suite 200,
Bethesda, MD 20814,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>    Accommodations: Attendees are responsible for their own
accommodations. To make reservations at the Renaissance Hotel at the
reduced conference rate, contact the Renaissance Hotel (see Location)--
cite the meeting code ``PDA.'' Room rates are: Single: $288, plus 14.5%
state and local taxes and Double: $288, plus 14.5 percent state and
local taxes. Reservations can be made on a space and rate availability
basis.
    Registration: Attendees are encouraged to register at their
earliest convenience. The PDA registration fees cover the cost of
facilities, materials, and refreshments. Seats are limited; please
submit your registration as soon as possible. Conference space will be
filled in order of receipt of registration. Those accepted for the
conference will receive confirmation. Registration will close after the
conference is filled. Onsite registration will be available on a space
available basis on each day of the public conference beginning at 7
a.m. on September 19, 2011. The cost of registration is as follows:

                          Cost of Registration
------------------------------------------------------------------------
                         Affiliation                              Fee
------------------------------------------------------------------------
PDA Members..................................................     $1,895
NonMembers...................................................      2,144
PDA Member Government/Health Authority.......................        700
NonMember Government/Health Authority........................        800
PDA Member Academic..........................................        700
NonMember Academic...........................................        780
PDA Member Students..........................................        280
NonMember Students...........................................        310
------------------------------------------------------------------------

    Please visit PDA's Web site: http://www.pda.org/pdafda2011 to
confirm the prevailing registration fees. (FDA has verified the Web
site address, but FDA is not responsible for any subsequent changes to
the Web site after this document publishes in the Federal Register.)
    If you need special accommodations due to a disability, please
contact Wanda Neal (see Contact), at least 7 days in advance of the
conference.
    Registration Instructions: To register, please submit your name,
affiliation, mailing address, telephone, fax number, and e-mail
address, along with a check or money order payable to ``PDA.'' Mail to:
PDA, Global Headquarters, Bethesda Towers, 4350 East West Hwy., suite
200, Bethesda, MD 20814. To register via the

Internet, go to PDA's Web site: http://www.pda.org/pdafda2011.
    The registrar will also accept payment by major credit cards (VISA/
American Express/MasterCard only). For more information on the meeting,
or for questions on registration, contact PDA (see Contact).
    Transcripts: As soon as a transcript is available, it can be
obtained in either hardcopy or on CD-ROM, after submission of a Freedom
of Information request. Written requests are to be sent to Division of
Freedom of Information (ELEM-1029), Food and Drug Administration, 12420
Parklawn Dr., Element Bldg., Rockville, MD 20857.

SUPPLEMENTARY INFORMATION: The PDA/FDA joint public conference offers
the unique opportunity for participants to join FDA representatives and
industry experts in face-to-face dialogues. Each year, FDA speakers
provide updates on current efforts affecting the development of global
regulatory strategies, while industry professionals from some of
today's leading pharmaceutical companies present case studies on how
they employ global strategies in their daily processes.
    Through a series of sessions and meetings, the conference will
provide participants with the opportunity to hear directly from FDA
experts and representatives of global regulatory authorities on best
practices, including:
     Accountability in a Global Environment--Enforcement and
Supply Chain
     Office of International Programs 101 & Foreign Inspections
     International Conference on Harmonization Q11
     New Regulations--Status Update
     First Cycle Review
     Drug Safety
     Good Inspection Practices--Domestic
     Process Validation
     Emerging Regulations for Positron Emission Tomography
     FDA/Pharmaceutical Inspection Co-operation Scheme
     Standards
     International Compliance Update
     Good Manufacturing Practice Life Cycle
     Supply Chain
    To help ensure the quality of FDA-regulated products, the workshop
helps to achieve objectives set forth in section 406 of the FDA
Modernization Act of 1997 (21 U.S.C. 393) which includes working
closely with stakeholders and maximizing the availability and clarity
of information to stakeholders and the public. The workshop also is
consistent with the Small Business Regulatory Enforcement Fairness Act
of 1996 (Pub. L. 104-121), as outreach activities by Government
Agencies to small businesses.

    Dated: August 11, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-20791 Filed 8-15-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 87, Number 75 (Tuesday, April 19, 2022)]
[Rules and Regulations]
[Pages 23108-23110]
[FR Doc No: 2022-08232]

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SECURITIES AND EXCHANGE COMMISSION

17 CFR Part 232

[Release Nos. 33-11043; 34-94479; 39-2543; IC-34536]

Adoption of Updated EDGAR Filer Manual

AGENCY: Securities and Exchange Commission.

ACTION: Final rule.

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SUMMARY: The Securities and Exchange Commission (``Commission'') is
adopting amendments to Volumes I and II of the Electronic Data
Gathering, Analysis, and Retrieval system (``EDGAR'') Filer Manual
(``Filer Manual'') and related rules and forms. The EDGAR system was
upgraded on March 21, 2022.

DATES: Effective date: April 19, 2022. The incorporation by reference
of the Filer Manual is approved by the Director of the Federal Register
as of April 19, 2022.

FOR FURTHER INFORMATION CONTACT: For questions regarding the amendments
to Volumes I and II of the Filer Manual and related rules, please
contact Rosemary Filou, Deputy Director and Chief Counsel, or E.
Laurita Finch, Senior Special Counsel, in the EDGAR Business Office at
(202) 551-3900. For questions concerning submission form type 497VPSUB,
please contact Andrea Magovern, Assistant Director, in the Division of
Investment Management at<PHONE_NUMBER>. For questions concerning the
payment of filing fees, please contact Luba Dinits in the Office of
Financial Management at<PHONE_NUMBER>. For questions concerning the
structured data requirements for Forms N-3, N-4, and N-6, please
contact Heather Fernandez, Financial Analyst, in the Division of
Investment Management at<PHONE_NUMBER>. For questions regarding non-
broker-dealer filers that are filing pursuant to a Commission
substituted compliance order, please contact Randall Roy, Deputy
Associate Director, at<PHONE_NUMBER>, or Valentina Deng, Special
Counsel, at<PHONE_NUMBER> in the Division of Trading and Markets. For
questions about EX-99.36 Form 7-R, please contact Pamela Carmody in the
Division of Trading and Markets at<PHONE_NUMBER>. For questions
regarding submission form types MA-A and MA-A/A, please contact Mark
Stewart, Attorney-Advisor, in the Office of Municipal Securities, at
(202) 551-4410. For questions regarding Form X-17A-5 Part III, please
contact Rose Wells, Senior Counsel, in the Division of Trading and
Markets, at<PHONE_NUMBER>. For questions concerning taxonomies or
schemas, please contact the Office of Structured Disclosure in the
Division of Economic and Risk Analysis at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: We are adopting an updated Filer Manual,
Volume I: ``General Information,'' Version 40 (March 2022) and Volume
II: ``EDGAR Filing,'' Version 61 (March 2022) and amendments to 17 CFR
232.301 (``Rule 301''). The updated Filer Manual volumes are
incorporated by reference into the Code of Federal Regulations.

I. Background

    The Filer Manual contains technical specifications needed for
filers to make submissions on EDGAR. Filers must comply with the
applicable provisions of the Filer Manual in order to assure the timely
acceptance and processing of filings made in electronic format.\1\
Filers should consult the Filer Manual in conjunction with our rules
governing mandated electronic filings when preparing documents for
electronic submission.
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    \1\ See Rule 301 of Regulation S-T.

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II. Amendment and Functional Enhancement to Volume I of the Filer
Manual

    Volume I of the Filer Manual provides general information regarding
electronic submissions to the Commission on EDGAR. Volume I will be
amended to add a link to the Glossary of Commonly Used Terms, Acronyms,
and Abbreviations. This, together with the guidance already included in
Volume I encouraging users to visit the EDGAR-Information For Filers
homepage on SEC.gov, will provide additional helpful introductory
information to current and prospective EDGAR filers. As noted below,
Volume II will also be revised to remove the Glossary from that volume
and to add a link to the Glossary on SEC.gov.

III. EDGAR System Changes and Associated Modifications to Volume II of
the Filer Manual

    EDGAR is being updated in Release 22.1, and was previously updated
in Releases 21.3.1 and 22.0.2, and corresponding amendments to Volume
II of the Filer Manual will be made to reflect these changes, as
described below.\2\
---------------------------------------------------------------------------

    \2\ Release 22.1 will be deployed on or about March 21, 2022.
---------------------------------------------------------------------------

    On February 23, 2021, the Commission issued a Statement on
Insurance Product Fund Substitution Applications (``Commission
Statement'').\3\ As a result, the substitution by an insurance company
of registered open-end investment companies used as Investment Options
(as defined in the Commission Statement) for variable life insurance
policies or variable annuity contracts will not provide a basis for an
enforcement action if the insurance company does not obtain an order
from the Commission under section 26(c) of the Investment Company Act
(and section 17(b) of the Investment Company Act for certain
substitutions) so long as the terms and conditions of the proposed
substitution are substantially similar to those approved by a prior
order for a substitution pursuant to section 26(c) (and section 17(b))
obtained by the insurance company since January 1, 2004. Pursuant to
the Commission's Statement, EDGAR Release 22.1 will introduce a new
submission form type to EDGARLink Online: 497VPSUB.
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    \3\ See Commission Statement on Insurance Product Fund
Substitution Applications, Release IC-34199 (Feb. 23, 2021) [86 FR
11813 (Feb. 26, 2021)].
---------------------------------------------------------------------------

    On October 13, 2021, the Commission adopted rules and form
amendments to modernize filing fee disclosure and payment methods.\4\
As part of that rulemaking, the Commission added options for electronic
fee payments, and eliminated options for fee payment via paper checks
and money orders in an effort to improve filing fee payment processing.
EDGAR will be updated to allow filers to pay filing fees via credit
card, debit card, and Automated Clearing House (ACH) debit payment
methods. EDGAR will use Treasury's Pay.gov service for filers to
initiate payments in the system, and rely on Pay.gov to perform the
payment processing. The lockbox for the receipt of checks will no
longer be available as of May 31, 2022. Checks received on or after
this date will be returned to the sender.
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    \4\ See Filing Fee Disclosure and Payment Methods Modernization,
Release 33-10997 (Oct. 13, 2021) [86 FR 70166 (Dec. 9, 2021)].
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    On March 11, 2020, the Commission adopted rule and form amendments
regarding variable annuity and variable life insurance contracts to
modernize disclosures by using a layered disclosure approach designed
to provide investors with key information relating to the contract's
terms, benefits, and risks in a concise and more reader-friendly
presentation.\5\ Among other things, to implement the new disclosure
framework, the Commission is requiring investment companies that offer
variable contracts to tag certain disclosures in Forms N-3, N-4, and N-
6 in Inline eXtensible Business Reporting Language (``Inline XBRL'')
beginning January 1, 2023. In conjunction with the amendments, EDGAR
will be updated to support the 2022 Variable Insurance Product (VIP)
Taxonomy.\6\
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    \5\ See Updated Disclosure Requirements and Summary Prospectus
for Variable Annuity and Variable Life Insurance Contracts, Release
33-10765 (March 11, 2020) [85 FR 25964 (May 1, 2020)].
    \6\ See Draft Taxonomies available at https://www.sec.gov/structureddata/dera_taxonomies.
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    The Commission has issued orders granting substituted compliance
with respect to the requirements of Exchange Act Rule 18a-7 which
requires that security-based swap dealers file annual audited financial
statements and reports.\7\ These orders require a security-based swap
dealer applying substituted compliance with respect to these
requirements of Rule 18a-7 to, among other things, simultaneously send
to the Commission a copy of the firm's annual financial statements
filed pursuant to the firm's home-country requirements and the report
of the independent public accountant covering the annual financial
statements. In accordance with these orders, EDGAR is being updated to
allow filers that are not broker-dealers to select the new ``Filing
pursuant to a Commission substituted compliance order'' check box. Such
firms would be permitted to make the entirety of their filing
confidential.
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    \7\ See, e.g., Order Granting Conditional Substituted Compliance
in Connection with Certain Requirements Applicable to Non-U.S.
Security-Based Swap Dealers and Major Security-Based Swap
Participants Subject to Regulation in the United Kingdom, Release
34-92529 (July 30, 2021), 86 FR 43318 (Aug. 6, 2021); Order Granting
Conditional Substituted Compliance in Connection With Certain
Requirements Applicable to Non-U.S. Security-Based Swap Dealers
Subject to Regulation in the Swiss Confederation, Release 24-93284
(Oct. 8, 2021), 86 FR 57455 (Oct. 15, 2021).
---------------------------------------------------------------------------

    EDGAR Release 22.1 will also make general functional enhancements
to EDGAR and require changes to Volume II of the Filer Manual as
follows:
     New exhibit ``EX-99.36 Form 7-R'' (Firm Application) is
being added to the drop down exhibit list for submission form types
SBSE-A and SBSE-A/A. This gives SBSE-A filers, who file Form 7-R with
the Commodity Futures Trading Commission (or its designee), and who are
required to file that form with the Commission, a designated location
to place it when filing on EDGAR. Filers can attach ``EX-99.36 Form 7-
R'' in official HTML, ASCII, or PDF format.
     Appendix B ``Frequently Asked Questions'' (FAQs) has been
modified, and Appendix F ``Glossary of Commonly Used Terms, Acronyms
and Abbreviations'' has been removed. Appendix B is now titled,
``EDGAR--Information for Filers,'' and links to the ``EDGAR Information
for Filers'' web page on SEC.gov, containing a revised Glossary and
updated FAQs, including a ``How Do I?'' guide with step-by-step
instructions concerning filing on EDGAR (available at: https://www.sec.gov/edgar/filer-information/how-do-i).
     Appendix D ``Paper Forms'' has been revised to remove
screen shots of the paper forms. A notice that current and prospective
EDGAR filers can download electronic copies of EDGAR-related forms from
https://www.sec.gov/forms remains.
    The Filer Manual Volume II also has been revised to address
software changes previously made in EDGAR:
     On February 22, 2022, EDGAR Release 22.0.2 introduced the
following change:
     Submission form types MA-A and MA-A/A will be validated to
prevent filers from submitting a form with the incorrect fiscal year.
Filers will not be able to submit their annual amendment in EDGAR for a
fiscal year that has not yet been completed in the ``Fiscal Year

End Information'' field on Item 1, Part I of the form.
     On September 20, 2021, EDGAR Release 21.3 introduced the
following change:
     In Rule 34-87005, Recordkeeping and Reporting Requirements
for Security-Based Swap Dealers, Major Security-Based Swap
Participants, and Broker-Dealers, the Commission adopted a revised
version of Form X-17A-5 Part III. In accordance with these rules, EDGAR
was updated to allow Form X-17A-5 Part III to be filed by two new
classes of registrants (security-based swap dealers and major security-
based swap participants). These changes were deployed in Release 21.3.1
on October 6, 2021.

IV. Amendments to Rule 301 of Regulation S-T

    Along with the adoption of the updated Filer Manual, we are
amending Rule 301 of Regulation S-T to provide for the incorporation by
reference into the Code of Federal Regulations of the current
revisions. This incorporation by reference was approved by the Director
of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51.
    The updated EDGAR Filer Manual is available at https://www.sec.gov/edgar/filer-information/current-edgar-filer-manual. Typically, the
EDGAR Filer Manual is also available for website viewing and printing
in the Commission's Public Reference Room, 100 F Street NE, Room 1580,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Operating conditions may limit access to the
Commission's Public Reference Room.

V. Administrative Law Matters

    Because the Filer Manual, and rule amendments, relate solely to
agency procedures or practice and do not substantially alter the rights
and obligations of non-agency parties, publication for notice and
comment is not required under the Administrative Procedure Act
(``APA'').\8\ It follows that the amendments do not require analysis
under requirements of the Regulatory Flexibility Act \9\ or a report to
Congress under the Small Business Regulatory Enforcement Fairness Act
of 1996.\10\
---------------------------------------------------------------------------

    \8\ 5 U.S.C. 553(b)(A).
    \9\ 5 U.S.C. 601 through 612.
    \10\ 5 U.S.C. 804(3)(C).
---------------------------------------------------------------------------

    The effective date for the updated Filer Manual and related rule
amendments is April 19, 2022. In accordance with the APA,\11\ we find
that there is good cause to establish an effective date less than 30
days after publication of these rules. The Commission believes that
establishing an effective date less than 30 days after publication of
these rules is necessary to coordinate the effectiveness of the updated
Filer Manual with the related system upgrades.
---------------------------------------------------------------------------

    \11\ 5 U.S.C. 553(d)(3).
---------------------------------------------------------------------------

VI. Statutory Basis

    We are adopting the amendments to Regulation S-T under the
authority in Sections 6, 7, 8, 10, and 19(a) of the Securities Act of
1933,\12\ Sections 3, 12, 13, 14, 15, 15B, 23, and 35A of the
Securities Exchange Act of 1934,\13\ Section 319 of the Trust Indenture
Act of 1939,\14\ and Sections 8, 30, 31, and 38 of the Investment
Company Act of 1940.\15\
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    \12\ 15 U.S.C. 77f, 77g, 77h, 77j, and 77s(a).
    \13\ 15 U.S.C. 78c, 78l, 78m, 78n, 78o, 78o-4, 78w, and 78ll.
    \14\ 15 U.S.C. 77sss.
    \15\ 15 U.S.C. 80a-8, 80a-29, 80a-30, and 80a-37.
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List of Subjects in 17 CFR Part 232

    Incorporation by reference, Reporting and recordkeeping
requirements, Securities.

Text of the Amendments

    In accordance with the foregoing, title 17, chapter II of the Code
of Federal Regulations is amended as follows:

PART 232--REGULATION S-T--GENERAL RULES AND REGULATIONS FOR
ELECTRONIC FILINGS

0
1. The general authority citation for part 232 continues to read as
follows:

    Authority: 15 U.S.C. 77c, 77f, 77g, 77h, 77j, 77s(a), 77z-3,
77sss(a), 78c(b), 78l, 78m, 78n, 78o(d), 78w(a), 78ll, 80a-6(c),
80a-8, 80a-29, 80a-30, 80a-37, 7201 et seq.; and 18 U.S.C. 1350,
unless otherwise noted.
* * * * *

0
2. Section 232.301 is revised to read as follows:

Sec.  232.301  EDGAR Filer Manual.

    Filers must prepare electronic filings in the manner prescribed by
the EDGAR Filer Manual, promulgated by the Commission, which sets forth
the technical formatting requirements for electronic submissions. The
requirements for becoming an EDGAR Filer and updating company data are
set forth in the EDGAR Filer Manual, Volume I: ``General Information,''
Version 40 (March 2022). The requirements for filing on EDGAR are set
forth in the updated EDGAR Filer Manual, Volume II: ``EDGAR Filing,''
Version 61 (March 2022). All of these provisions have been incorporated
by reference into the Code of Federal Regulations, which action was
approved by the Director of the Federal Register in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. You must comply with these
requirements in order for documents to be timely received and accepted.
The EDGAR Filer Manual is available at https://www.sec.gov/edgar/filer-information/current-edgar-filer-manual. Typically, the EDGAR Filer
Manual is also available for website viewing and printing in the
Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10 a.m. and 3
p.m. Operating conditions may limit access to the Commission's Public
Reference Room. You can also inspect the document at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, email [email protected], or
go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    By the Commission.

    Dated: March 21, 2022.
Vanessa A. Countryman,
Secretary.
[FR Doc. 2022-08232 Filed 4-18-22; 8:45 am]
BILLING CODE 8011-01-P


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on June 21, 2002

NOTICE OF ACTION TAKEN -- DOCKET OST 1996-1487

________________________________________________________________________
________________________________________________________

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:  CORPORACION AEROANGELES, S.A. de C.V.
                    Date Filed:  June 5, 2002

Relief requested:  Exemption from 49 USC section 41301 to permit the
applicant to conduct passenger charter operations between Mexico and the
United States, and other passenger charter operations in accordance with
14 CFR Part 212, using small equipment.

Applicant representative(s):  Antonio Ortiz Palero, 011-527-273-11-79

Date of last action:  June 11, 2001, in this Docket.

Responsive pleadings:  None.

	DISPOSITION

Action:  Approved
                                                  Action date:  June 21,
2002

Effective dates of authority granted:  June 21, 2002, through June 21,
2003

Basis for approval (bilateral agreement/reciprocity):  United
States-Mexico Air Transport Services Agreement of August 15, 1960, as
amended and extended (Agreement).

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

     X  Standard exemption conditions.

Special conditions/Partial grant/Denial basis/Remarks:  In the conduct
of these operations, the carrier must adhere to all applicable
provisions of the U.S.-Mexico Agreement.  In the conduct of these
operations, the carrier may only use aircraft capable of carrying no
more than 60 passengers and having a maximum payload capacity of no more
than 18,000 pounds (small equipment).  The above grant includes
authority to conduct Third and Fourth Freedom charter operations.  While
we have subjected, consistent with the provisions of the Agreement,
Mexican carriers conducting charter operations with large aircraft to
prior approval or submission of notice for their Third and Fourth
Freedom charters, we determined that any such requirement was not
necessary on public interest grounds in this case, since the carrier
will be conducting these operations solely with small aircraft.  (Other
charter operations to/from the United States under this authority,
however, are subject to prior approval under 14 CFR Part 212.)  Further,
we are continuing to allow Mexican carriers conducting passenger
charters using small equipment to make stopovers in the United States in
the conduct of such operations.

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) our action was consistent with Department
policy; (2) the applicant was qualified to perform its proposed
operations; (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:

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


[Federal Register Volume 77, Number 35 (Wednesday, February 22, 2012)]
[Notices]
[Pages 10516-10519]
[FR Doc No: 2012-3798]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-1017; FRL-9336-4]

Notice of Receipt of Requests To Voluntarily Cancel Certain
Pesticide Registrations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In accordance with section 6(f)(1) of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), as amended, EPA is issuing a
notice of receipt of requests by registrants to voluntarily cancel
certain pesticide registrations. EPA intends to grant these requests at
the close of the comment period for this announcement unless the Agency
receives substantive comments within the comment period that would
merit its further review of the requests, or unless the registrants
withdraw their requests. If these requests are granted, any sale,
distribution, or use of products listed in this notice will be
permitted after the registration has been cancelled only if such sale,
distribution, or use is consistent with the terms as described in the
final order.

DATES: Comments must be received on or before March 23, 2012.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2009-1017, by one of the following methods:

     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave.
NW., Washington, DC 20460-0001.
    Submit written withdrawal request by mail to: Pesticide Re-
evaluation Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001. ATTN: Jolene Trujillo.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2009-1017. EPA's policy is that all comments received will be included
in the docket without change and may be made available online at http://www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through regulations.gov or email. The
regulations.gov Web site is an ``anonymous access'' system, which means
EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through regulations.gov, your email
address will be automatically captured and included as part of the
comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Jolene Trujillo, Pesticide Re-
evaluation Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. If you have any questions regarding the
information in this notice, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

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

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

II. What action is the Agency taking?

    This notice announces receipt by the Agency of requests from
registrants to cancel 40 pesticide products registered under FIFRA
section 3 or 24(c). These registrations are listed in sequence by
registration number (or company number and 24(c) number) in Tables 1,
2, and 3 of this unit.
    Unless the Agency determines that there are substantive comments
that warrant further review of the requests or the registrants withdraw
their requests, EPA intends to issue orders in the Federal Register
canceling all of the affected registrations.

      Table 1--Registrations With Pending Requests for Cancellation
------------------------------------------------------------------------
       Registration No.             Product name        Chemical name
------------------------------------------------------------------------
004787-00060..................  Cheminova Fipronil   Fipronil.
                                 Technical.
005481-00279..................  PCNB 75% Wettable    Pentachloronitroben
                                 Powder.              zene.

005481-00419..................  PCNB 75W Turf and    Pentachloronitroben
                                 Ornamental Soil      zene.
                                 Fungicide.
005481-00438..................  80% PCNB...........  Pentachloronitroben
                                                      zene.
005481-00441..................  PCNB 75 DG.........  Pentachloronitroben
                                                      zene.
005481-00453..................  PCNB 75 WSP........  Pentachloronitroben
                                                      zene.
005481-00457..................  Turfpro WSP Turf &   Pentachloronitroben
                                 Ornamental Soil      zene.
                                 Fungicide.
005481-08981..................  Terraclor 75%        Pentachloronitroben
                                 Wettable Powder.     zene.
005481-08983..................  Terrachlor           Pentachloronitroben
                                 Technical.           zene.
005481-08990..................  Terrachlor 90% Dust  Pentachloronitroben
                                 Concentrate.         zene.
005481-08996..................  Terrazan PCNB        Pentachloronitroben
                                 Technical 99%.       zene.
005481-08999..................  Terrachlor           Pentachloronitroben
                                 Technical 96.        zene.
005481-09034..................  Gustafson            Pentachloronitroben
                                 Terrachlor 80%       zene.
                                 Dust Concentrate.
005481-09036..................  RTU PCNB Seed        Pentachloronitroben
                                 Protectant.          zene.
005481-09037..................  Gustafson Apron-     Pentachloronitroben
                                 Terrachlor Dust      zene Metalaxyl.
                                 Seed Treatment.
005481-09038..................  Terra-Coat WP......  Pentachloronitroben
                                                      zene.
005905-00497..................  5 lb. Dimethoate     Dimethoate.
                                 Systemic
                                 Insecticide.
006836-00159..................  LFQ-30.............  Poly(oxy-1,2-
                                                      ethanediyl
                                                      (dimethylimino)-
                                                      1,2-ethanediyl
                                                      (dimethylimino) -
                                                      1,2-ethanediyl
                                                      dichloride).
009444-00170..................  CB-38-2 For Insect   Pyrethrins,
                                 Control.             Piperonyl
                                                      Butoxide.
010807-00101..................  Repco-Tox Space      Resmethrin.
                                 Spray Insecticide.
010807-00107..................  Fog Kill Oil Base    Resmethrin.
                                 Insecticide.
010807-00110..................  Aqua-Kill            Resmethrin.
                                 Insecticide.
028293-00160..................  Unicorn House and    Phenothrin,
                                 Carpet Spray 11.     Tetramethrin.
066222-00026..................  Pramitol 2.5%        Prometon.
                                 Liquid Vegetation
                                 Killer.
067760-00107..................  Rhyme TC             Fipronil.
                                 Termiticide/
                                 Insecticide.
082542-00019..................  Technical            Propiconazole.
                                 Propiconazole.
082542-00020..................  Propiconazole 41.8%  Propiconazole.
                                 EC Fungicide.
083851-00016..................  Amitide Imazapyr     Imazapyr.
                                 Technical 98%.
086068-00001..................  Texcan Glyphosate    Glyphosate.
                                 Technical.
086068-00002..................  Texcan 62%           Glyphosate-
                                 Glyphosate MUP.      isopropylammonium.
------------------------------------------------------------------------

  Table 2--Registrations Containing Fenarimol With Pending Requests for
                              Cancellation
------------------------------------------------------------------------
       Registration No.            Product name        Chemical name
------------------------------------------------------------------------
010163-00273..................  Rubigan E.C......  Fenarimol.
010163-00274..................  Rubigan A.S. Turf  Fenarimol.
                                 and Ornamental.
010163-00275..................  Rubigan A.S......  Fenarimol.
010163-00276..................  Rubigan Technical  Fenarimol.
010163-00290..................  Riverdale          Fenarimol.
                                 Patchwork.
010163-00302..................  Fenarimol          Fenarimol.
                                 Technical.
OR030037......................  Rubigan E.C......  Fenarimol.
------------------------------------------------------------------------

  Table 3--Registrations Containing Chloroneb With Pending Requests for
                              Cancellation
------------------------------------------------------------------------
       Registration No.            Product name        Chemical name
------------------------------------------------------------------------
002217-00692..................  Gordon's           Chloroneb.
                                 Professional
                                 Turf Products
                                 Teremec SP Turf
                                 Fungicide.
009198-00182..................  Andersons Golf     Chloroneb.
                                 Products
                                 Fungicide V.
009198-00204..................  Andersons Golf     Chloroneb,
                                 Products           Thiophanate-methyl.
                                 Fungicide IX.
------------------------------------------------------------------------

    Table 4 of this unit includes the names and addresses of record for
all registrants of the products in Tables 1, 2, and 3 of this unit, in
sequence by EPA company number. This number corresponds to the first
part of the EPA registration numbers of the products listed in this
unit.

         Table 4--Registrants Requesting Voluntary Cancellation
------------------------------------------------------------------------
           EPA company number                Company name and address
------------------------------------------------------------------------
2217...................................  PBI/Gordon Corp., 1217 West
                                          12th St., P.O. Box 014090,
                                          Kansas City, MO 64101.
4787...................................  Cheminova A/S, Agent:
                                          Cheminova, Inc., 1600 Wilson
                                          Blvd., Suite 700, Arlington,
                                          VA 22209.
5481...................................  Amvac Chemical Corporation,
                                          4695 MacArthur Ct., Suite
                                          1200, Newport Beach, CA 92660-
                                          1706.
5905...................................  Helena Chemical Co., Agent
                                          Helena Products Group, 7664
                                          Smythe Farm Rd., Memphis, TN
                                          38120.

6836...................................  Lonza Inc., 90 Boroline Rd.,
                                          Allendale, NJ 07401.
9198...................................  The Andersons Lawn Fertilizer
                                          Division Inc., 521 Illinois
                                          Ave., P.O. Box 119, Maumee, OH
                                          43537.
9444...................................  Waterbury Companies Inc.,
                                          Agent: FMC Corporation, 1101
                                          Penn. Ave. NW., Suite 325,
                                          Washington, DC 20004.
10163; OR030037........................  Gowan Company, P.O. Box 5569,
                                          Yuma, AZ 85366.
10807..................................  Amrep Inc., 990 Industrial Park
                                          Dr., Marietta, GA 30062.
28293..................................  Phaeton Corporation, Agent:
                                          Registrations By Design Inc.,
                                          P.O. Box 1019, Salem, VA
                                          24153.
66222..................................  Makhteshim-Agan of North
                                          America Inc., Agent: Pyxis
                                          Regulatory Consulting, Inc.,
                                          4110 136th St. NW., Gig
                                          Harbor, WA 98332.
67760..................................  Cheminova, Inc., Agent:
                                          Cheminova, Inc., 1600 Wilson
                                          Blvd., Suite 700, Arlington,
                                          VA 22209.
82542..................................  Source Dynamics LLC., 10039 E.
                                          Troon North Dr., Scottsdale,
                                          AZ 85262.
83851..................................  Amitide, LLC, 21 Hubble,
                                          Irvine, CA 92618.
86068..................................  Texcan Investments & Marketing
                                          Company Inc., Agent: Pyxis
                                          Regulatory Consulting, Inc.,
                                          4110 136th St., NW., Gig
                                          Harbor, WA 98332.
------------------------------------------------------------------------

III. What is the Agency's authority for taking this action?

    Section 6(f)(1) of FIFRA provides that a registrant of a pesticide
product may at any time request that any of its pesticide registrations
be cancelled. FIFRA further provides that, before acting on the
request, EPA must publish a notice of receipt of any such request in
the Federal Register.
    Section 6(f)(1)(B) of FIFRA requires that before acting on a
request for voluntary cancellation, EPA must provide a 30-day public
comment period on the request for voluntary cancellation or use
termination. In addition, FIFRA section 6(f)(1)(C) requires that EPA
provide a 180-day comment period on a request for voluntary
cancellation or termination of any minor agricultural use before
granting the request, unless:
    1. The registrants request a waiver of the comment period, or
    2. The EPA Administrator determines that continued use of the
pesticide would pose an unreasonable adverse effect on the environment.
    The registrants in Table 4 of Unit II. have requested that EPA
waive the 180-day comment period. Accordingly, EPA will provide a 30-
day comment period on the proposed requests.

IV. Procedures for Withdrawal of Request

    Registrants who choose to withdraw a request for cancellation
should submit such withdrawal in writing to the person listed under FOR
FURTHER INFORMATION CONTACT. If the products have been subject to a
previous cancellation action, the effective date of cancellation and
all other provisions of any earlier cancellation action are
controlling.

V. Provisions for Disposition of Existing Stocks

    Existing stocks are those stocks of registered pesticide products
that are currently in the United States and that were packaged,
labeled, and released for shipment prior to the effective date of the
cancellation action. Because the Agency has identified no significant
potential risk concerns associated with these pesticide products, upon
cancellation of the products identified in Tables 1, 2, and 3 of Unit
II., EPA will allow existing stocks provisions as follows:

A. Registrations Listed in Table 1 of Unit II

    The Agency anticipates allowing registrants to sell and distribute
existing stocks of these products for 1 year after publication of the
Cancellation Order in the Federal Register. Thereafter, registrants
will be prohibited from selling or distributing the pesticides
identified in Table 1 of Unit II., except for export consistent with
FIFRA section 17 or for proper disposal. Persons other than registrants
will generally be allowed to sell, distribute, or use existing stocks
until such stocks are exhausted, provided that such sale, distribution,
or use is consistent with the terms of the previously approved labeling
on, or that accompanied, the cancelled products.

B. Registrations Listed in Table 2 of Unit II

    The effective date of cancellation of these products is July 31,
2013. The registrants will be allowed to sell and distribute existing
stocks of products containing Fenarimol until July 31, 2013.
Thereafter, registrants will be prohibited from selling or distributing
these pesticide products, except for export consistent with FIFRA
section 17 or for proper disposal.
    Persons other than the registrant will be allowed to sell and
distribute existing stocks through July 31, 2015. After this date,
remaining existing stocks of products containing Fenarimol labeled for
all uses, already in the hands of users may be used until exhausted,
provided that such use complies with the EPA-approved label and
labeling of the product.

C. Registrations Listed in Table 3 of Unit II. Except No.<PHONE_NUMBER>2

    The registrant will be allowed to sell and distribute existing
stocks until December 31, 2013. Thereafter, registrants will be
prohibited from selling or distributing these pesticide products,
except for export consistent with FIFRA section 17 or for proper
disposal.
    Persons other than registrants will generally be allowed to sell,
distribute, or use existing stocks until such stocks are exhausted,
provided that such sale, distribution, or use is consistent with the
terms of the previously approved labeling on, or that accompanied, the
cancelled products.

D. Registration No.<PHONE_NUMBER>2

    The effective date of cancellation of this product is December 31,
2013. The registrant may continue to sell or distribute existing stocks
of chloroneb for one year from the date of the cancellation.
Thereafter, registrants will be prohibited from selling or distributing
this pesticide product, except for export consistent with FIFRA section
17 or for proper disposal. Persons other than registrants will
generally be allowed to sell, distribute, or use existing stocks until
such stocks are exhausted, provided that such sale, distribution, or
use is consistent with the terms of the previously approved labeling
on, or that accompanied, the cancelled products.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: February 8, 2012.
Michael Goodis,
Acting Director, Pesticide Re-evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2012-3798 Filed 2-21-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 84 (Monday, May 2, 2011)]
[Rules and Regulations]
[Page 24372]
[FR Doc No: 2011-10514]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2011-0287]

Drawbridge Operation Regulation; Mispillion River, Milford, DE

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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

SUMMARY: The Commander, District Fifth Coast Guard District, has issued
a temporary deviation from the regulation governing the operation of
the Route 1/Rehoboth Blvd Bascule Bridge across the Mispillion River,
mile 11.0, at Milford, DE. This deviation allows the bridge to remain
in the closed position for two months to accommodate the necessary
bridge cleaning and painting of the bridge.

DATES: This deviation is effective from 12 a.m. on May 13, 2011 through
11:59 p.m. on July 17, 2011.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket are part of docket USCG-2011-0287 and are available online
by going to http://www.regulations.gov, inserting USCG-2011-0287 in the
``Keyword'' box and then clicking ``Search''. They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or e-mail Lindsey Middleton, Bridge Management Specialist, Coast
Guard; telephone<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>If
you have questions on viewing the docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Marinis Bros. Inc., (Marinis) on behalf of
Delaware Department of Transportation, has requested a temporary
deviation from the current operating regulation of the Route 1/Rehoboth
Blvd Bascule Bridge across the Mispillion River, mile 11.0, at Milford,
DE. The vertical clearance of this bridge is five feet at mean high
water (MHW) in the closed position and unlimited in the open position.
During this deviation period, the vertical clearance will be limited to
four feet at MHW due to the scaffolding that will be used for the
maintenance of the bridge. Vessels that are able to pass through the
bridge may do so at anytime. The bridge is able to open for emergencies
if at least five business days are given. There are no alternate routes
available to vessels.
    The current operating schedule for the bridge is set out in 33 CFR
117.241. The regulation requires the bridge to open on signal if at
least 24 hours notice is given. The requested deviation is to
accommodate painting and cleaning of the bridge. To carry out the
bridge maintenance safely and successfully, the draw of the bridge will
be maintained in the closed-to-navigation position from 12 a.m. on May
13, 2011 through 11:59 p.m. on July 17, 2011.
    Logs from the past two years have shown that there are minimal
openings during the period of time this deviation will be enforced. The
majority of vessel traffic is recreational boaters. Most, if not all,
of the past openings have been requested by one specific resident of
the area. The Coast Guard and Marinis have been in contact with this
resident and have worked together to accommodate any necessary bridge
openings during the temporary deviation. The Coast Guard will inform
the users of the waterway through our Local and Broadcast Notices to
Mariners so that mariners can arrange their transits to minimize any
impact caused by the temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: April 18, 2011.
Waverly W. Gregory, Jr.,
Chief, Bridge Administration Branch, Fifth Coast Guard District.
[FR Doc. 2011-10514 Filed 4-29-11; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 79, Number 74 (Thursday, April 17, 2014)]
[Notices]
[Pages 21825-21826]
[FR Doc No: 2014-08689]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-71936; File No. SR-BYX-2014-006]

Self-Regulatory Organizations; BATS Y-Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change Related to
Fees for Use of BATS Y-Exchange, Inc.

April 11, 2014.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on April 8, 2014, BATS Y-Exchange, Inc. (the ``Exchange'' or
``BYX'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Exchange. The Exchange
has designated the proposed rule change as one establishing or changing
a member due, fee, or other charge imposed by the Exchange under
Section 19(b)(3)(A)(ii) of the Act \3\ and Rule 19b-4(f)(2)
thereunder,\4\ which renders the proposed rule change effective upon
filing with the Commission. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange filed a proposal to amend the fee schedule applicable
to Members \5\ and non-members of the Exchange pursuant to BYX Rules
15.1(a) and (c). Changes to the fee schedule pursuant to this proposal
are effective upon filing.
---------------------------------------------------------------------------

    \5\ A Member is defined as ``any registered broker or dealer
that has been admitted to membership in the Exchange.'' See Exchange
Rule 1.5(n).
---------------------------------------------------------------------------

    The text of the proposed rule change is available at the Exchange's
Web site at http://www.batstrading.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
Sections A, B, and C below, of the most significant parts of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to modify its fee schedule applicable to use
of the Exchange in order to modify the way that, for purposes of tiered
pricing, the Exchange calculates ADAV and average daily TCV (as such
terms are defined below). Currently, the Exchange determines the
liquidity adding fee that it charges Members pursuant to the Exchange's
tiered pricing structure by excluding from the calculation of ADAV \6\
and average daily TCV \7\ any day that an Exchange Outage occurs. An
Exchange Outage is defined as any day that trading is not available on
the Exchange for more than sixty (60) minutes during regular trading
hours \8\ but continues on other markets during such time.\9\ The
Exchange proposes to modify the definition of Exchange Outage to
include situations where the Exchange experiences a systems disruption
that lasts for more than 60 minutes during regular trading hours, even
if such disruption would not be categorized as a complete outage of the
Exchange's system, and to rename it as an ``Exchange System
Disruption.'' \10\ As an example, an Exchange System Disruption may
occur where a certain group of securities (i.e., securities in a select
symbol range such as A through C) traded on the Exchange is unavailable
for trading due to an Exchange system issue. Similarly, the Exchange
may be able to perform certain functions with respect to accepting and
processing orders, but may have a failure to another significant
process, such as routing to other market centers, that would lead
Members that rely on such process to avoid utilizing the Exchange until
the Exchange's entire system was operational.
---------------------------------------------------------------------------

    \6\ As provided in the fee schedule, ``ADAV'' means average
daily volume calculated as the number of shares added per day on a
monthly basis; routed shares are not included in ADAV calculation.
    \7\ As provided in the fee schedule, ``TCV'' means total
consolidated volume calculated as the volume reported by all
exchanges and trade reporting facilities to a consolidated
transaction reporting plan for the month for which the fees apply.
    \8\ The term ``regular trading hours'' means the ``time between
9:30 a.m. and 4:00 p.m. Eastern Time.'' See Exchange Rule 1.5(w).
    \9\ The Exchange notes that it also excludes the last Friday of
June from the calculation of ADAV and average daily TCV. The last
day of June is the day that Russell Investments reconstitutes its
family of indexes (``Russell Reconstitution''), resulting in
particularly high trading volumes, much of which the Exchange
believes derives from market participants who are not generally as
active entering the market to rebalance their holdings in-line with
the Russell Reconstitution.
    \10\ See SR-BATS-2014-010 (proposing to exclude Exchange System
Disruptions from the definitions of ADAV, ADV and average TCV).
---------------------------------------------------------------------------

    The Exchange believes that this modification is reasonable because
the intent of the current Exchange Outage exclusion has always been to
avoid penalizing Members that might otherwise qualify for certain
tiered pricing but that, because of a significant Exchange system
problem, did not participate on the Exchange to the extent that they
might have otherwise participated. The Exchange believes that certain
systems disruptions could preclude some Members from submitting orders
to the Exchange even if such issue is not actually a complete systems
outage. The Exchange notes that it is not proposing to modify any of
the existing fees or the percentage thresholds at which a Member may
qualify for certain fee reductions pursuant to the tiered pricing
structure. Rather, as mentioned above, the Exchange is proposing to
modify its fee schedule to exclude trading activity occurring on any
day that the Exchange experiences an Exchange System Disruption.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder that are applicable to a national securities exchange, and,
in particular, with the requirements of Section 6 of the Act.\11\
Specifically, the Exchange believes that the proposed rule change is
consistent with Section 6(b)(4) of the Act,\12\ in that it provides for
the equitable allocation of reasonable dues, fees and other charges
among members and other

persons using any facility or system which the Exchange operates or
controls. The Exchange notes that it operates in a highly competitive
market in which market participants can readily direct order flow to
competing venues if they deem fee levels at a particular venue to be
excessive.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78f.
    \12\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The Exchange believes that its proposal is reasonable because, as
explained above, it will help provide Members with a greater level of
certainty as to their level of costs for trading in any month where the
Exchange experiences an Exchange System Disruption on one or more
trading days. The Exchange is not proposing to amend the thresholds a
Member must achieve to become eligible for, or the dollar value
associated with, the Exchange's tiered fees. By eliminating the
inclusion of a trading day on which an Exchange System Disruption
occurs the Exchange would almost certainly be excluding a day that
would otherwise lower a Member's ADAV as a percentage of average daily
TCV. Thus, the proposed change will make the majority of Members more
likely to meet the minimum or higher tier thresholds, incentivizing
Members to increase their participation on the Exchange in order to
meet the next highest tier. In addition, the Exchange believes that the
proposed changes to its fee schedule are equitably allocated among
Exchange constituents and not unfairly discriminatory as the
methodology for calculating ADAV and TCV will apply equally to all
Members. While, although unlikely, certain Members may have a higher
ADAV as a percentage of average daily TCV with their activity included
from days where the Exchange experiences an Exchange System Disruption,
the proposal will make all Members' cost of trading on the Exchange
more predictable, regardless of how the proposal affects their ADAV as
a percentage of average daily TCV.
    Volume-based tiers such as the liquidity adding tiers maintained by
the Exchange have been widely adopted, and are equitable and not
unfairly discriminatory because they are open to all members on an
equal basis and provide higher rebates or lower fees that are
reasonably related to the value to an exchange's market quality
associated with higher levels of market activity, such as higher levels
of liquidity provision and introduction of higher volumes of orders
into the price and volume discovery process. Accordingly, the Exchange
believes that the proposal is equitably allocated and not unfairly
discriminatory because it is consistent with the overall goals of
enhancing market quality. Further, the Exchange believes that a tiered
pricing model not significantly altered by a day of atypical trading
behavior which allows Members to predictably calculate what their costs
associated with trading activity on the Exchange will be is reasonable,
fair and equitable and not unreasonably discriminatory as it is uniform
in application amongst Members and should enable such participants to
operate their business without concern of unpredictable and potentially
significant changes in expenses.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act, as amended. The
proposed change will help to promote intramarket competition by
avoiding a penalty to Members for days when trading on the Exchange is
disrupted for a significant portion of the day. As stated above, the
Exchange notes that it operates in a highly competitive market in which
market participants can readily direct order flow to competing venues
if the deem fee structures to be unreasonable or excessive.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    The Exchange has neither solicited nor received written comments on
the proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \13\ and paragraph (f) of Rule 19b-4
thereunder.\14\ At any time within 60 days of the filing of the
proposed rule change, the Commission summarily may temporarily suspend
such rule change if it appears to the Commission that such action is
necessary or appropriate in the public interest, for the protection of
investors, or otherwise in furtherance of the purposes of the Act. If
the Commission takes such action, the Commission shall institute
proceedings to determine whether the proposed rule should be approved
or disapproved.
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    \13\ 15 U.S.C. 78s(b)(3)(A).
    \14\ 17 CFR 240.19b-4(f).
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IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposal is
consistent with the Act. Comments may be submitted by any of the
following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File No. SR-BYX-2014-006 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

All submissions should refer to File No. SR-BYX-2014-006. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing will also be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File No. SR-BYX-2014-006 and should be
submitted on or before May 8, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
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    \15\ 17 CFR 200.30-3(a)(12).
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Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2014-08689 Filed 4-16-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 50 (Thursday, March 14, 2019)]
[Notices]
[Pages 9411-9412]
[FR Doc No: 2019-04696]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. FAA-2019-0159]

Agency Information Collection Activities: Requests for Comments;
Clearance of a Renewed Approval of Information Collection: B4UFLY
Smartphone App

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. The collection involves the B4UFLY smartphone app that
provides situational awareness of flight restrictions--including
locations of airports, restricted airspace, special use airspace, and
temporary flight restrictions--based on a user's current or planned
flight location. In order to maintain NAS safety in proximity to
airports, authorization is now required from recreational Unmanned
Aircraft System (UAS) pilots to operate in controlled airspace The data
collected will assist the FAA with determining the best processes to
authorize recreational UAS pilots and inform air

traffic control personnel of a UAS pilot's intended flight in order to
assess whether the UAS may disrupt or endanger manned air traffic.

DATES: Written comments should be submitted by May 13, 2019.

ADDRESSES: Please send written comments:
    By Electronic Docket: www.regulations.gov (Enter docket number into
search field).
    By mail: Jessica A. Orquina, 470 L'Enfant Plaza SW, Suite 7225,
Washington, DC 20024.

FOR FURTHER INFORMATION CONTACT: Bonnie Reichert by email at:
<EMAIL_ADDRESS>phone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.
    OMB Control Number: 2120-0764.
    Title: B4UFLY Smartphone App.
    Form Numbers: There are no forms associated with this collection.
    Type of Review: Renewal of an information collection.
    Background: Public Law 112-95, Section 336 which requires model
aircraft operators to notify the airport operator and air traffic
control tower (if one is located at the airport) prior to operating
within 5 miles of an airport. The FAA's B4UFLY smartphone app provides
situational awareness of flight restrictions-- including locations of
airports, restricted airspace, special use airspaces, and temporary
flight restrictions--based on a user's current or planned flight
location. In order to maintain NAS safety in proximity to airports, air
traffic control personnel would need certain basic information about a
UAS operator's intended flight in order to assess whether the UAS may
disrupt or endanger manned air traffic. The data collected will assist
the FAA with determining the best processes to authorize recreational
UAS pilots and inform air traffic control personnel of a UAS pilot's
intended flight in order to assess whether the UAS may disrupt or
endanger manned air traffic.
    Respondents: Approximately 640,060 users.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: Approximately 2 minutes.
    Estimated Total Annual Burden: Approximately 100 minutes for light
usage per user. Approximately 5 hours per user for heavier usage.

    Issued in Oklahoma City, OK, on March 6, 2019.
Bonnie Reichert,
Project Manager, UAS Program Office Division, Office of Information and
Technology, Enterprise Program Management Services, AEM-210.
[FR Doc. 2019-04696 Filed 3-13-19; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 51 (Thursday, March 16, 2023)]
[Notices]
[Page 16266]
[FR Doc No: 2023-05364]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0026]

Issuance of Priority Review Voucher; Rare Pediatric Disease
Product

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of a priority review voucher to the sponsor of a rare
pediatric disease product application. The Federal Food, Drug, and
Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration
Safety and Innovation Act (FDASIA), authorizes FDA to award priority
review vouchers to sponsors of approved rare pediatric disease product
applications that meet certain criteria. FDA is required to publish
notice of the award of the priority review voucher. FDA has determined
that SKYCLARYS (omaveloxolone), approved February 28, 2023, and
manufactured by Reata Pharmaceuticals, Inc., meets the criteria for a
priority review voucher.

FOR FURTHER INFORMATION CONTACT: Cathryn Lee, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>, email:
[email protected].

SUPPLEMENTARY INFORMATION: FDA is announcing the issuance of a priority
review voucher to the sponsor of an approved rare pediatric disease
product application. Under section 529 of the FD&C Act (21 U.S.C.
360ff), which was added by FDASIA, FDA will award priority review
vouchers to sponsors of approved rare pediatric disease product
applications that meet certain criteria. FDA has determined that
SKYCLARYS (omaveloxolone), manufactured by Reata Pharmaceuticals, Inc.,
meets the criteria for a priority review voucher.
    SKYCLARYS (omaveloxolone) capsule is for the treatment of
Friedreich's ataxia in adults and adolescents aged 16 years and older.
    For further information about the Rare Pediatric Disease Priority
Review Voucher Program and for a link to the full text of section 529
of the FD&C Act, go to https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm. For further
information about SKYCLARYS (omaveloxolone), go to the ``[email protected]''
website at https://www.accessdata.fda.gov/scripts/cder/daf/.

    Dated: March 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-05364 Filed 3-15-23; 8:45 am]
BILLING CODE 4164-01-P