[Federal Register Volume 84, Number 109 (Thursday, June 6, 2019)]
[Notices]
[Pages 26462-26464]
[FR Doc No: 2019-11799]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-85990; File No. SR-NYSE-2019-32]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing of Proposed Rule Change To Amend Rule 123D

May 31, 2019
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on May 24, 2019, New York Stock Exchange LLC (``NYSE'' or the
``Exchange'') 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
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Rule 123D to permit the Exchange to

declare a regulatory halt in a security that traded in the over-the-
counter market prior to the initial pricing on the Exchange. The
proposed rule change is available on the Exchange's website at
www.nyse.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 self-regulatory organization
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 those 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 amend Rule 123D to permit the Exchange to
declare a regulatory halt in a security that traded in the over-the-
counter market prior to the initial pricing on the Exchange.
Proposed Rule Change
    Current Rule 123D(d) permits the Exchange to declare a regulatory
halt in a security that is the subject of an initial pricing on the
Exchange of a security that has not been listed on a national
securities exchange or traded in the over-the-counter market pursuant
to FINRA Form 211 (the ``OTC market'') immediately prior to the initial
pricing. Accordingly, the Exchange has authority to declare a
regulatory halt for any initial listing that is not a transfer from
either another national securities exchange or the OTC market.
Regulatory halts under the rule terminate when the DMM opens the
security.
    The Exchange proposes to delete the clause ``or traded in the over-
the-counter market pursuant to FINRA Form 211'' before ``immediately
prior to the initial pricing.'' The proposed amendment would thus
enable the Exchange to declare a regulatory halt for a security that is
having its initial listing on the Exchange that was traded in the OTC
market immediately prior to its initial pricing on the Exchange.
    The Exchange believes that it would be consistent with the
protection of investors and the public interest for the Exchange, as a
primary listing exchange, to have to authority to declare a regulatory
halt for security that was previously traded in the OTC market prior to
its initial pricing on the Exchange. An OTC market security that will
be listed on a primary listing exchange will be removed from the OTC
trading list on the day prior to its initial pricing on the Exchange.
However, on the day of its initial listing, such security can trade on
an unlisted trading permit (``UTP'') basis before the first transaction
on the primary listing exchange. The Exchange believes that permitting
the Exchange to declare a regulatory halt in such securities before
trading on the Exchange begins would avoid potential price disparities
or anomalies that may occur during any UTP trading before the first
transaction on the primary listing exchange. More specifically, the
Exchange believes that quoting and trading in the pre-market of an OTC
transfer can be erratic and investors may be harmed if their securities
trade during this period. The Exchange believes that the proposed
limited authority to declare a regulatory halt in the hours prior to
the OTC transfer pricing on the Exchange would mitigate any potential
price disparities and contribute to a fair and orderly market once the
security opens on the Exchange. The Exchange believes that such
authority would be consistent with the protection of investors and the
public interest.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\3\ in general, and furthers the
objectives of Section 6(b)(5) of the Act,\4\ in particular, because it
is designed to prevent fraudulent and manipulative acts and practices,
promote just and equitable principles of trade, remove impediments to
and perfect the mechanism of a free and open market and a national
market system, and protect investors and the public interest.
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    \3\ 15 U.S.C. 78f(b).
    \4\ 15 U.S.C. 78f(b)(5).
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    The Exchange believes that the proposed amendment to Rule 123D to
provide authority to declare a regulatory halt in a security that is an
OTC transfer would remove impediments to and perfect the mechanism of a
free and open market and a national market system by providing the
Exchange with authority to halt trading across all markets for a
security that has traded in the OTC market and not previously listed on
the Exchange, but for which a regulatory halt would promote fair and
orderly markets. The Exchange believes that permitting the Exchange to
declare a regulatory halt in such securities before trading on the
Exchange begins would avoid potential price disparities or anomalies
that may occur during any UTP trading before the first transaction on
the primary listing exchange. More specifically, the Exchange believes
that quoting and trading in the pre-market of an OTC transfer can be
erratic and investors may be harmed if their securities trade during
this period. The Exchange therefore believes that having the authority
to declare a regulatory halt for a security that is the subject of an
OTC transfer is consistent with the protection of investors and the
public interest and would promote fair and orderly markets by helping
to protect against volatility in pricing before the initial transaction
on the primary listing exchange.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The Exchange believes that
the benefit to investors to halt trading in a security that transfers
from an OTC market to a primary listing exchange outweighs any burden
on competition that may result from a regulatory halt in such security
before the initial listing on the primary listing exchange. The
proposed rule change is consistent with existing authority for the
Exchange to declare a regulatory halt in trading of a security before
the initial pricing on the Exchange and would extend that authority to
a transfer from the OTC market.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:

    (A) By order approve or disapprove the proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change 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 Number SR-NYSE-2019-32 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 Number SR-NYSE-2019-32. 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 website (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 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 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NYSE-2019-32, and should be submitted on
or before June 27, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\5\
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    \5\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-11799 Filed 6-5-19; 8:45 am]
 BILLING CODE 8011-01-P


FAXBACK 136019445.1993(04)USE OF PAINT FILTER LIQUIDS TEST TO DETERMINE FREE LIQUIDS IN A WASTEUnited States Environmental Protection AgencyApril 19, 1993Mr. Raymond D. HileyGoodwin, Procter & HoarCounsellors at LawExchange PlaceBoston, Massachusetts 02109-2881Dear Mr. Hiley:Thank you for your letter of March 24, 1993 concerning thedetermination of the corrosivity characteristic. The Paint FilterLiquids Test (Method 9095 in SW-846) was developed to determinefree liquids in a waste. It was never intended for use indetermining if a waste contains any bound or absorbed liquid or ifsuch liquid is aqueous. The Office of Solid Waste is looking at the issue of whatconstitutes a liquid for characteristic testing. We will shortly beproposing revisions to the Third Edition of "Test Methods forEvaluating Solid Waste" (SW-846) in the Federal Register. In thisproposal, we hope to clarify the meaning of liquid forcharacteristic testing. After this rule is proposed in the FederalRegister, we would happy to sent you a copy of the notice. The guidance on the use of Method 9095 provided in theFebruary 16, 1990 letter to Mr. Robert D. Wyatt would still be ourbest advice to you until rules have been promulgated defining themeaning of "liquid" and "aqueous" for characteristic testing. As you have correctly stated, under the present regulations anaqueous phase must be present in the sample in order to determinethe corrosivity characteristic by pH measurement. This is becauseit is technically impossible to determine pH in liquids where wateris not present. I hope that this information will be of use to your analyticalprogram. If you have any questions, please feel free to call OllieFordham of our Methods Section at<PHONE_NUMBER>.Sincerely,Sylvia K. LowranceDirectorOffice of Solid Waste


[Federal Register Volume 83, Number 7 (Wednesday, January 10, 2018)]
[Notices]
[Pages 1260-1261]
[FR Doc No: 2018-00238]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0085]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Guidance for Industry: Cooperative
Manufacturing Arrangements for Licensed Biologics

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Fax written comments on the collection of information by
February 9, 2018.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0629.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Guidance for Industry: Cooperative Manufacturing Arrangements for
Licensed Biologics

OMB Control Number 0910-0629--Extension

    This information collection supports the Agency guidance document
entitled, ``Guidance for Industry: Cooperative Manufacturing for
Licensed Biologics'' (available at: https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/General/ucm069908.pdf). The guidance

document provides information concerning cooperative manufacturing
arrangements applicable to biological products subject to licensure
under section 351 of the Public Health Service Act (42 U.S.C. 262). The
guidance addresses several types of manufacturing arrangements (i.e.,
short supply arrangements, divided manufacturing arrangements, shared
manufacturing arrangements, and contract manufacturing arrangements)
and describes certain reporting and recordkeeping responsibilities
associated with these arrangements, including the following: (1)
Notification of all important proposed changes to production and
facilities; (2) notification of results of tests and investigations
regarding or possibly impacting the product; (3) notification of
products manufactured in a contract facility; and (4) standard
operating procedures.
1. Notification of All Important Proposed Changes to Production and
Facilities
    Each licensed manufacturer in a divided manufacturing arrangement
or shared manufacturing arrangement must notify the appropriate FDA
Center regarding proposed changes in the manufacture, testing, or
specifications of its product, in accordance with Sec.  601.12 (21 CFR
601.12). In the guidance, we recommend that each licensed manufacturer
that proposes such a change should also inform other participating
licensed manufacturer(s) of the proposed change.
    For contract manufacturing arrangements, we recommend that the
contract manufacturer should share with the license manufacturer all
important proposed changes to production and facilities (including
introduction of new products or at inspection). The license holder is
responsible for reporting these changes to FDA (Sec.  601.12).
2. Notification of Results of Tests and Investigations Regarding or
Possibly Impacting the Product
    In the guidance, we recommend the following for contract
manufacturing arrangements:
     The contract manufacturer should fully inform the license
manufacturer of the results of all tests and investigations regarding
or possibly having an impact on the product; and
     The license manufacturer should obtain assurance from the
contractor that any FDA list of inspectional observations will be
shared with the license manufacturer to allow evaluation of its impact
on the purity, potency, and safety of the license manufacturer's
product.
3. Notification of Products Manufactured in a Contract Facility
    In the guidance, we recommend for contract manufacturing
arrangements that a license manufacturer cross reference a contract
manufacturing facility's master files only in circumstances involving
certain proprietary information of the contract manufacturer, such as a
list of all products manufactured in a contract facility. In this
situation, the license manufacturer should be kept informed of the
types or categories of all products manufactured in the contract
facility.
4. Standard Operating Procedures
    In the guidance, we remind the license manufacturer that the
license manufacturer assumes responsibility for compliance with the
applicable product and establishment standards (21 CFR 600.3(t)).
Therefore, if the license manufacturer enters into an agreement with a
contract manufacturing facility, the license manufacturer must ensure
that the facility complies with the applicable standards. An agreement
between a license manufacturer and a contract manufacturing facility
normally includes procedures to regularly assess the contract
manufacturing facility's compliance. These procedures may include, but
are not limited to, review of records and manufacturing deviations and
defects, and periodic audits.
    For shared manufacturing arrangements, each manufacturer must
submit a separate biologics license application describing the
manufacturing facilities and operations applicable to the preparation
of that manufacturer's biological substance or product (Sec.
601.2(a)). In the guidance, we state that we expect the manufacturer
that prepares, or is responsible for the preparation of, the product in
final form for commercial distribution to assume primary responsibility
for providing data demonstrating the safety, purity, and potency of the
final product. We also state that we expect the licensed finished
product manufacturer to be primarily responsible for any postapproval
obligations, such as postmarketing clinical trials, additional product
stability studies, complaint handling, recalls, postmarket reporting of
the dissemination of advertising and promotional labeling materials as
required under Sec.  601.12(f)(4), and adverse experience reporting. We
recommend that the final product manufacturer establish a procedure
with the other participating manufacturer(s) to obtain information in
these areas.
    Description of Respondents: Respondents to the information
collection are participating licensed manufacturers, final product
manufacturers, and contract manufacturers associated with cooperative
manufacturing arrangements subject to the associated regulations
discussed in the guidance.
    In the Federal Register of August 7, 2017 (82 FR 36797), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. We received no comments.
    Burden Estimate: We believe that the information collection
provisions in the guidance do not create a new burden for respondents.
We believe the reporting and recordkeeping provisions are part of usual
and customary business practices. Licensed manufacturers would have
contractual agreements with participating licensed manufacturers, final
product manufacturers, and contract manufacturers, as applicable for
the type of cooperative manufacturing arrangement, to address all these
information collection provisions.
    The guidance also refers to previously approved collections of
information found in FDA regulations at parts 201, 207, 211, 600, 601,
606, 607, 610, 660, 801, 803, 807, 809, and 820 (21 CFR parts 201, 207,
211, 600, 601, 606, 607, 610, 660, 801, 803, 807, 809, and 820). The
collections of information in parts 606 and 610 have been approved
under OMB control numbers 0910-0116, 0910-0458, and 0910-0206; part 600
has been approved under OMB control numbers 0910-0308 and 0910-0458;
parts 601 and 660 have been approved under OMB control number 0910-
0338; part 803 has been approved under OMB control number 0910-0437;
part 211 has been approved under OMB control number 0910-0139; part 820
has been approved under OMB control number 0910-0073; parts 207, 607,
and 807 have been approved under OMB control numbers 0910-0045, 0910-
0052, and 0910-0625; and parts 201, 801, and 809 have been approved
under OMB control numbers 0910-0537, 0910-0572, and 0910-0485.

    Dated: January 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00238 Filed 1-9-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: August 27, 2010 (Volume 75, Number 166)]
[Proposed Rules]
[Page 52691-52692]
[DOCID:fr27au10-19]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 2

[EPA-HQ-OAR-2009-0924; FRL-9193-7]
RIN 2060-AQ04

Supplemental Proposal to the Proposed Confidentiality
Determinations for Data Required Under the Mandatory Greenhouse Gas
Reporting Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Extension of public comment period.

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SUMMARY: On July 27, 2010, EPA published a Supplemental Proposal that
proposed confidentiality determinations for certain data elements
contained in proposed revisions to the Mandatory Greenhouse Gas
Reporting Rule. In this action, EPA is extending the comment period for
the Supplemental Proposal until September 7, 2010.

DATES: Comments. This document extends the comment period for the
Supplemental Proposal to the Proposed Confidentiality Determinations
for Data Required under the Mandatory

Greenhouse Gas Reporting Rule (75 FR 43889). Comments must be received
on or before September 7, 2010.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2009-0924, by one of the following methods:
    Federal eRulemaking Portal: http://www.regulations.gov. Follow the
online instructions for submitting comments.
    E-mail<EMAIL_ADDRESS>    Fax:<PHONE_NUMBER>.
    Mail: Environmental Protection Agency, EPA Docket Center (EPA/DC),
Mailcode 6102T, Attention Docket ID No. EPA-HQ-OAR-2009-0924, 1200
Pennsylvania Avenue, NW., Washington, DC 20460.
    Hand Delivery: EPA Docket Center, Public Reading Room, EPA West
Building, Room 3334, 1301 Constitution Avenue, NW., Washington, DC
20004. Such deliveries are only accepted during the Docket's normal
hours of operation, and special arrangements should be made for
deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2009-0924. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
confidential business information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://
www.regulations.gov or e-mail. The http://www.regulations.gov 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 e-mail comment directly to EPA without
going through http://www.regulations.gov your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.
    Docket: All documents in the docket are listed in the http://
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the Air Docket, EPA/
DC, EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC.
This Docket Facility is open from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
Public Reading Room is<PHONE_NUMBER>, and the telephone number for the
Air Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Carole Cook, Climate Change Division,
Office of Atmospheric Programs (MC-6207J), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone
number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>For technical information, contact the Greenhouse Gas
Reporting Rule Hotline at: http://www.epa.gov/climatechange/emissions/
ghgrule_contactus.htm. Alternatively, contact Carole Cook at 202-343-
9263.

SUPPLEMENTARY INFORMATION: Additional Information on Submitting
Comments: To expedite review of your comments by Agency staff, you are
encouraged to send a separate copy of your comments, in addition to the
copy you submit to the official docket, to Carole Cook, U.S. EPA,
Office of Atmospheric Programs, Climate Change Division, Mail Code
6207-J, Washington, DC, 20460, telephone<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>    Background on Today's Action: In this action, EPA is extending the
public comment period on the July 27, 2010 Supplemental Proposal to the
Proposed Confidentiality Determinations for Data Required Under the
Mandatory Greenhouse Gas Reporting Rule (``Supplemental CBI Proposal,''
75 FR 43889). EPA is extending the comment period for the Supplemental
CBI Proposal to September 7, 2010.
    On July 7, 2010, EPA published the Proposed Confidentiality
Determinations for Data Required Under the Mandatory Greenhouse Gas
Reporting Rule and Proposed Amendment to Special Rules Governing
Certain Information Obtained Under the Clean Air Act (``CBI Proposal,''
75 FR 39094). The comment period for the CBI Proposal ends on September
7, 2010.
    On July 27, 2010, EPA published the Supplemental CBI Proposal; the
comment period for the Supplemental CBI Proposal would have ended on
August 26, 2010.
    EPA received comments requesting an extension of the public comment
period for the Supplemental CBI Proposal to September 7, 2010.
Commenters noted that the CBI Proposal and the Supplemental CBI
Proposal both concern the confidentiality of data collected under the
Greenhouse Gas Reporting Program. Commenters also noted how comments on
the two proposals might be easily consolidated into one document.
Therefore, to facilitate submission of public comments, EPA is
extending the comment period for the Supplemental CBI Proposal to
September 7, 2010 so that the comment period for both actions ends on
the same day.

List of Subjects in 40 CFR Part 2

    Environmental protection, Administrative practice and procedure,
Reporting and recordkeeping requirements.

    Dated: August 23, 2010.
Dina Kruger,
Acting Director, Office of Atmospheric Programs.
[FR Doc. 2010-21385 Filed 8-26-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 114 (Tuesday, June 14, 2016)]
[Notices]
[Pages 38704-38705]
[FR Doc No: 2016-14037]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2015-0814; FRL-9946-13]

Pesticides; Draft Guidance for Pesticide Registrants on the
Determination of Minor Use

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.

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SUMMARY: The Agency is announcing the availability of and seeking
public comment on a draft Pesticide Registration Notice (PR Notice)
entitled ``Determination of Minor Use under Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), section 2(ll).'' PR Notices are
issued by the Office of Pesticide Programs (OPP) to inform pesticide
registrants and other interested persons about important policies,
procedures, and registration related decisions, and serve to provide
guidance to pesticide registrants and OPP personnel. This draft PR
Notice would update section 5 of PR Notice 97-2 and provide guidance to
the registrant as to how the EPA determines a ``minor use.'' EPA seeks
to identify and encourage the registration of pesticides for minor uses
to protect communities from harmful pests. This draft PR Notice revises
the method used by EPA for evaluating ``sufficient economic incentive''
under FIFRA. The draft PR Notice explains how qualitative information
may be used to inform the quantitative analysis, interpret the results,
and clarifies that the most recent United States Department of
Agriculture (USDA) Census of Agriculture is the appropriate source for
data on acreage in the United States to establish a minor use under the
acreage definition in FIFRA 2(ll)(1).

DATES: Comments must be received on or before August 15, 2016.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2015-0814, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Derek Berwald, Biological and Economic
Analysis Division, MC 7503P, 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?

    You may be potentially affected by this action if you are
responsible for the initial or continuing registration of pesticides.
Entities that register pesticides with EPA's Office of Pesticide
Programs typically fall under the North American Industry
Classification System (NAICS) Code 325300--Pesticide, Fertilizer, and
Other Agricultural Chemical Manufacturing. This action may also be of
interest to persons using pesticides on sites that may be considered
``minor'' including persons engaged in crop and livestock production,
and persons engaged in pest control in residential, commercial, and
municipal areas including control of public health pests, and to the
public in general. Since many entities may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action.

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 preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

C. How can I get copies of this document and other related information?

    A copy of the draft PR Notice is available in the docket under
docket identification (ID) number EPA-HQ-OPP-2015-0814.

II. What guidance does this PR notice provide?

    FIFRA defines a minor use of a pesticide as either (1) a use on a
crop grown on 300,000 acres or less in the United States or (2) a use
that lacks sufficient economic incentive to seek or maintain a
registration but has private or social value. This draft PR Notice
provides guidance to the registrant concerning the method used to
determine if a use site is a ``minor use'' as defined by FIFRA 2(ll).
In particular, the draft PR Notice describes the method for determining
if the use ``does not provide sufficient economic incentive.'' To date,
EPA's interpretation of economic minor use in section 2(ll)(2) has been
shaped by guidance provided in PR Notice 97-2. However, the approach
outlined in PR Notice 97-2 ignores critical factors that influence the
incentives for registration.
    This draft PR Notice describes the revised approach to evaluate
``sufficient economic incentive'' which addresses these factors. It
explicitly considers (1) the difference in time between incurring costs
of generating data for registration and obtaining revenue from product
sales, (2) the multiple years over which revenue is generated, and (3)
the costs of producing and distributing the product. The draft PR
Notice provides suggestions about the data that can be used to conduct
the analysis. Finally, the draft PR Notice explains how qualitative
information may be used to inform the quantitative analysis and
interpret the results. It also clarifies that the most recent USDA
Census of Agriculture is the appropriate source for data on acreage in
the United States to establish a minor use under the acreage definition
in FIFRA section 2(ll)(1).
    Registrants will typically seek to demonstrate a site is a minor
use in the context of requesting an extension of the

exclusive use period for data submitted in support of a registration
under FIFRA section 3(c)(1)(F)(ii) or a new exclusive use period for
data submitted to support a registration under FIFRA section
3(c)(1)(F)(vi). These clauses are intended to provide incentives to
registrants to obtain registrations for uses that might otherwise go
unfulfilled because they offer low returns because of low demand.
    The information collection activities associated with the
activities described in this PR Notice are already approved by the
Office of Management and Budget (OMB) under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq. The corresponding Information Collection
Request (ICR) document for the Application for New and Amended
Pesticide Registration has been assigned EPA ICR number 0277.16 and is
approved OMB control number 2070-0060.

III. Do PR Notices contain binding requirements?

    The PR Notice about the determination of a minor use is intended to
provide guidance to EPA personnel and decision-makers and to pesticide
registrants. While the requirements in the statutes and Agency
regulations are binding on EPA and the applicants, this PR Notice is
not binding on either EPA or pesticide registrants, and EPA may depart
from the guidance where circumstances warrant and without prior notice.
Likewise, pesticide registrants may assert that the guidance is not
appropriate generally or not applicable to a specific pesticide or
situation.

    Authority:  7 U.S.C. 136 et seq.

    Dated: May 31, 2016.
Jack E. Housenger,
Director, Office of Pesticide Programs.
[FR Doc. 2016-14037 Filed 6-13-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 196 (Thursday, October 14, 2021)]
[Notices]
[Page 57190]
[FR Doc No: 2021-22355]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3572-EM; Docket ID FEMA-2021-0001]

New York; Amendment No. 1 to Notice of an Emergency Declaration

AGENCY: Federal Emergency Management Agency (FEMA), Homeland Security
(DHS).

ACTION: Notice.

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

SUMMARY: This notice amends the notice of an emergency declaration for
the State of New York (FEMA-3572-EM), dated September 2, 2021, and
related determinations.

DATES: This amendment was issued September 8, 2021.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that the incident
period for this emergency is closed effective September 3, 2021.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2021-22355 Filed 10-13-21; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 79, Number 21 (Friday, January 31, 2014)]
[Rules and Regulations]
[Pages 5249-5251]
[FR Doc No: 2014-01466]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0525; Directorate Identifier 2011-SW-063-AD;
Amendment 39-17730; AD 2014-02-02]
RIN 2120-AA64

Airworthiness Directives; Bell Helicopter Textron Canada Limited
(Bell) Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for Bell
Model 206L, L-1, L-3, and L-4 helicopters. This AD requires measuring
each main rotor (M/R) blade spar space to determine whether it is
oversized and reidentifying the M/R blade and

reducing the life limit of the blade if the spar spacer is oversized.
This AD was prompted by the manufacture of certain blades with an
oversized spar spacer and the determination to reduce the life limits
of those blades. The actions of this AD are intended to prevent failure
of an M/R blade and subsequent loss of control of the helicopter.

DATES: This AD is effective March 7, 2014.
    The Director of the Federal Register approved the incorporation by
reference of a certain document listed in this AD as of March 7, 2014.

ADDRESSES: For service information identified in this AD, contact Bell
Helicopter Textron Canada Limited, 12,800 Rue de l'Avenir, Mirabel,
Quebec J7J1R4; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax (450)
433-0272; or at http://www.bellcustomer.com/files/. You may review the
referenced service information at the FAA, Office of the Regional
Counsel, Southwest Region, 2601 Meacham Blvd., Room 663, Fort Worth,
Texas 76137.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the Docket Operations Office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the Transport Canada Civil
Aviation (TCCA) AD, any incorporated-by-reference service information,
the economic evaluation, any comments received, and other information.
The street address for the Docket Operations Office (phone: 800-647-
5527) is U.S. Department of Transportation, Docket Operations Office,
M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue
SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Sharon Miles, Aerospace Engineer, FAA,
Rotorcraft Directorate, Regulations and Policy Group, 2601 Meacham
Blvd., Fort Worth, Texas 76137, telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    On June 20, 2013, at 78 FR 37152, the Federal Register published
our notice of proposed rulemaking (NPRM), which proposed to amend 14
CFR part 39 by adding an AD that would apply to Bell Model 206L, L-1,
L-3, and L-4 helicopters. The NPRM proposed measuring the M/R blade
spar spacer. If a blade is fitted with an oversized spacer, the NPRM
proposed reidentifying the blade, reducing the life limit for the blade
from 3,600 hours time-in-service (TIS) to 2,300 hours TIS, and making
an entry on the component history card or equivalent record. The
proposed requirements were intended to prevent failure of an M/R blade
and subsequent loss of control of the helicopter.
    The NPRM was prompted by AD No. CF-2011-43, dated November 10,
2011, issued by TCCA, which is the aviation authority for Canada, to
correct an unsafe condition for Bell Model 206L, L-1, L-3, and L-4
helicopters. TCCA advises that, during manufacturing, some M/R blades
were inadvertently fitted with oversized spar spacers, which reduces
the life of the blades from 3600 to 2300 hours ``air time.'' As a
result, TCCA has mandated procedures to reidentify blades that have
oversized spar spacers with new part numbers and reduce the life limit
for such blades.

Comments

    After our NPRM (78 FR 37152, June 30, 2013), was published, we
received comments from one commenter.

Request

    The one commenter stated that Bell has released Revision A of Alert
Service Bulletin (ASB) No. 206L-09-163, dated April 19, 2012, and
requested that both the original ASB and Revision A be included in the
final AD.
    We agree that the AD should reference Revision A of the ASB. This
revision only updates Bell's warranty information and does not change
the technical aspects or the corrective actions. Thus, performing the
actions in either the original ASB or Revision A before the effective
date of this AD would constitute prior compliance with this AD.

FAA's Determination

    These helicopters have been approved by TCCA and are approved for
operation in the United States. Pursuant to our bilateral agreement
with Canada, TCCA, its technical representative, has notified us of the
unsafe condition described in the TCCA AD. We are issuing this AD
because we evaluated all information provided by TCCA, reviewed the
relevant information, considered the comment received, and determined
the unsafe condition exists and is likely to exist or develop on other
helicopters of these same type designs and that air safety and the
public interest require adopting the AD requirements as proposed with
the change previously described. Also, under paragraph (f) of the NPRM,
the TCCA AD is incorrectly referenced as No. ``CF-2011-41.'' We have
corrected paragraph (f) in this AD to correctly identify the TCCA AD as
``CF-2011-43.'' These changes are consistent with the intent of the
proposals in the NPRM and will not increase the economic burden on any
operator nor increase the scope of this AD.

Differences Between this AD and the TCCA AD

    TCCA requires compliance time within 100 hours air time or 30 days.
This AD requires compliance within 100 hours TIS.

Related Service Information

    Bell issued ASB No. 206L-09-163, dated November 13, 2009, which
specifies inspecting certain M/R blades for oversized spar spacers and
reidentifying and reducing the life limit of any blade with an
oversized spar spacer from 3600 to 2300 flight hours. On April 19,
2012, Bell issued ASB No. 206L-09-163, Revision A, dated April 19,
2012, to update the warranty information.

Costs of Compliance

    We estimate that this AD will affect 688 helicopters of U.S.
Registry.
    We estimate that operators may incur the following costs in order
to comply with this AD. It will take about 2.5 work hours to measure
the spar spacer and reidentify the blade at $85 per work hour for a
total cost of $213 per helicopter.
    According to Bell's service information some of the costs of this
AD may be covered under warranty, thereby reducing the cost to affected
individuals. We do not control warranty coverage by Bell. Accordingly,
we have included all costs in our cost estimate.

Authority for this Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on

helicopters identified in this rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have 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.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866;
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979);
    (3) Will not affect intrastate aviation in Alaska to the extent
that it justifies making a regulatory distinction; and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared an economic evaluation of the estimated costs to comply
with this AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

    2014-02-02 Bell Helicopter Textron Canada Limited: Amendment 39-
17730; Docket No. FAA-2013-0525; Directorate Identifier 2011-SW-063-
AD.

(a) Applicability

    This AD applies to Model 206L, L-1, L-3, and L-4 helicopters
with a main rotor (M/R) blade, part number (P/N) 206-015-001-115, -
117, -119, or -121, with a serial number (S/N) listed in Table 1 or
2 of Bell Helicopter Alert Service Bulletin [No. 206L-09-163,
Revision A, dated April 19, 2012 (ASB), certificated in any
category.

(b) Unsafe Condition

    This AD defines the unsafe condition as the manufacture of an M/
R blade with an oversized spar spacer. This condition could result
in failure of an M/R blade and subsequent loss of control of the
helicopter.

(c) Effective Date

    This AD becomes effective March 7, 2014.

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(e) Actions Required

    Within 100 hours time-in-service (TIS):
    (1) For each M/R blade with an S/N listed in Table 1 of the ASB,
measure the M/R blade spar spacer by following the Accomplishment
Instructions, Part II A), paragraphs 1 through 3, of the ASB. If the
spar spacer measures more than 1.018 inches (25.86 millimeters),
reidentify the blade by following Part II A, paragraph 5.a. and
Table 3, of the ASB.
    (2) For each M/R blade with an S/N listed in Table 2 of the ASB,
measure the M/R blade spar spacer by following the Accomplishment
Instructions, Part II B, paragraphs 1 through 3, of the ASB. If the
spar spacer measures more than 1.018 inches (25.86 millimeters),
reidentify the blade by following Part II B, paragraph 5 and Table
4, of the ASB.
    (3) For each reidentified blade, reduce the life limit from
3,600 hours TIS to 2,300 hours TIS, and make an entry on the
component history card or equivalent record.
    (4) Before further flight, remove any blade that exceeds the new
retirement life of 2,300 hours TIS.

(f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Group, FAA, may approve AMOCs
for this AD. Send your proposal to: Sharon Miles, Aerospace
Engineer, FAA, Rotorcraft Directorate, Regulations and Policy Group,
2601 Meacham Blvd., Fort Worth, Texas 76137, telephone (817) 222-
5110, email<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office before operating any aircraft
complying with this AD through an AMOC.

(g) Additional Information

    The subject of this AD is addressed in Transport Canada Civil
Aviation (TCCA) AD CF-2011-43, dated November 10, 2011. You may view
the TCCA AD on the internet at http://www.regulations.gov in Docket
No. FAA-2013-0525.

 (h) Subject

    Joint Aircraft Service Component (JASC) Code: 6210 Main Rotor
Blades.

 (i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Bell Helicopter Alert Service Bulletin No. 206L-09-163,
Revision A, dated April 19, 2012.
    (ii) Reserved.
    (3) For Bell Helicopter service information identified in this
AD, contact Bell Helicopter Textron Canada Limited, 12,800 Rue de
l'Avenir, Mirabel, Quebec J7J1R4; telephone<PHONE_NUMBER> or (800)
363-8023; fax<PHONE_NUMBER>; or at http://www.bellcustomer.com/files/.
    (4) You may view this service information at FAA, Office of the
Regional Counsel, Southwest Region, 2601 Meacham Blvd., Room 663,
Fort Worth, Texas 76137. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Fort Worth, Texas, on January 15, 2014.
Lance T. Gant,
Acting Directorate Manager, Rotorcraft Directorate, Aircraft
Certification Service.
[FR Doc. 2014-01466 Filed 1-30-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 96 (Monday, May 18, 2020)]
[Notices]
[Pages 29778-29779]
[FR Doc No: 2020-10621]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. FAA-2020-27]

Petition for Exemption; Summary of Petition Received; Airlines
for America

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Federal Aviation Regulations. The
purpose of this notice is to improve the public's awareness of, and
participation in, the FAA's exemption process. Neither publication of
this notice nor the inclusion or omission of information in the summary
is intended to affect the legal status of the petition or its final
disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before May 26, 2020.

ADDRESSES: Send comments identified by docket number FAA-FAA-2020-0307
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation, 1200 New Jersey Avenue SE, Room W12-140,
West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to http://www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
http://www.dot.gov/privacy.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE,
Washington, DC 20590-0001, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Alphonso Pendergrass, Office of
Rulemaking, Federal Aviation Administration, telephone<PHONE_NUMBER>,
800 Independence Avenue SW, Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on May 13, 2020.
Brandon Roberts,
Acting Executive Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2020-0307
    Petitioner: Airlines for America
    Section(s) of 14 CFR Affected: 121.407(c)(2), 121.409(b)(2)(i),
121.417(c)(2)(i)(C)-(D) and (E)(4), 121.424(a)(1), 121.427(b)(2)(i)-
(iii), (e)(1)(ii) and (e)(2), 121.441(b)(1), and 121.805(b)(5)(iii)
    Description of Relief Sought: The petitioner requests extension of
exemption 18512 to allow certificate holders to use alternative methods
to conduct certain required crewmember emergency procedures during
recurrent, conversion, and upgrade training, checking, and evaluation
until November 30, 2020.

[FR Doc. 2020-10621 Filed 5-15-20; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 40 (Wednesday, March 3, 2021)]
[Rules and Regulations]
[Pages 12260-12263]
[FR Doc No: 2021-03124]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 49

[EPA-R01-OAR-2020-0374; FRL-10018-74-Region 1]

Approval and Promulgation of Air Quality Implementation Plan;
Mashantucket Pequot Tribal Nation

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) approves the
Mashantucket Pequot Tribal Nation's (MPTN or the Tribe) Tribal
Implementation Plan (TIP) under the Clean Air Act (CAA) to regulate air
pollution within the exterior boundaries of the Tribe's reservation.
The TIP is one of two CAA regulatory programs that comprise the Tribe's
Clean Air Program (CAP). EPA approved the Tribe for treatment in the
same manner as a State (Treatment as State or TAS) for purposes of
administering New Source Review (NSR) and Title V operating permits
under the CAA on July 10, 2008. In this action we act only on those
portions of MPTN's CAP that constitute a TIP containing severable
elements of

an implementation plan under CAA section 110(a). The TIP includes
permitting requirements for major and minor sources of air pollution.
The purpose of the TIP is to enable the Tribe to attain and maintain
the National Ambient Air Quality Standards (NAAQS) within the exterior
boundaries of its reservation by establishing a federally enforceable
preconstruction permitting program.

DATES: This rule is effective on April 2, 2021.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R01-OAR-2020-0374. All documents in the docket
are listed on the https://www.regulations.gov website. Although listed
in the index, some information is not publicly available, i.e., 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 at https://www.regulations.gov or at the U.S. Environmental Protection Agency, EPA
Region 1 Regional Office, Air and Radiation Division, 5 Post Office
Square--Suite 100, Boston, MA. EPA requests that if at all possible,
you contact the contact listed in the FOR FURTHER INFORMATION CONTACT
section to schedule your inspection. The Regional Office's official
hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m.,
excluding legal holidays and facility closures due to COVID-19.

FOR FURTHER INFORMATION CONTACT: Patrick Bird, Air Permits, Toxics and
Indoor Programs Branch, U.S. Environmental Protection Agency, Region 1,
5 Post Office Square, Mail Code: 05-2, Boston, MA 02109-0287.
Telephone:<PHONE_NUMBER>. Fax:<PHONE_NUMBER>. Email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA.

Table of Contents

I. Background and Purpose
II. Response to Comments
III. Final Action
IV. Incorporation by Reference
V. Statutory and Executive Order Reviews

I. Background and Purpose

    On September 9, 2020 (85 FR 55628), EPA published a Notice of
Proposed Rulemaking (NPRM) for a TIP submitted by the MPTN for approval
under section 110 of the CAA. The TIP addresses attainment and
maintenance of the National Ambient Air Quality Standards (NAAQS) by
establishing a federally enforceable preconstruction permitting program
within the exterior boundaries of the Tribe's reservation. It also
allows for sources that otherwise would have the potential to emit
hazardous air pollutants or regulated NSR pollutants in amounts at or
above those for major sources to request federally enforceable permit
limitations that restrict emissions to below those of a major source.
    The MPTN is an Indian Tribe federally recognized in 1983 by
Congressional legislation (Pub. L. 98-134, sec. 9, Oct. 1St, 1983 97
Stat 855, Title 25 U.S.C.A. 1751-1760). The Secretary of the Interior
recognizes the ``Mashantucket Pequot Tribe of Connecticut'' (73 FR
18553, 18554, April 4, 2008). MPTN's CAP was established by Tribal
Council Resolution in 2005 (TCR102600-01 of 02). On July 10, 2008, EPA
determined that the Tribe is eligible for TAS for these purposes.
    The MPTN formally submitted the applicable elements of its TIP to
EPA Region 1 on December 7, 2018. Having found that the MPTN is
eligible for TAS to implement these regulatory programs, EPA is now
approving the Tribe's TIP. We intend to act on the Tribe's title V
operating permit program in separate notice and comment processes, as
appropriate.
    The rationale for EPA's proposed approval of the MTPN TIP is
explained in the NPRM and will not be restated here. No adverse public
comments were received on the NPRM.

II. Response to Comments

    EPA received three comments during the comment period, all of which
supported EPA's proposed action. As such, these comments do not require
further response to finalize the action as proposed.

III. Final Action

    EPA is approving the MPTN's TIP under the Clean Air Act to regulate
air pollution within the exterior boundaries of the Tribe's
reservation. In this action we act only on those portions of MPTN's CAP
that constitute a TIP containing severable elements of an
implementation plan under CAA section 110(a). The TIP includes
permitting requirements for major and minor sources of air pollution.
Specifically, we are approving the following sections of the MPTN's air
quality regulations. Title 12, Subtitle 12.1, Sec.  2--Applicability
(with effective date); Title 12, Subtitle 12.1, Sec.  4--Definitions;
and Title 12, Subtitle 12.2--New Source Review--MPTN TIP.

IV. Incorporation by Reference

    In this rule, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, EPA is finalizing the incorporation by reference of the MPTN
rules discussed in section I. and III. of this preamble. EPA has made,
and will continue to make, these documents generally available through
https://www.regulations.gov and at the EPA Region 1 Office (please
contact the person identified in the FOR FURTHER INFORMATION CONTACT
section of this preamble for more information).

V. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
TIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing TIP submissions, EPA's role is to approve tribal
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this final action merely approves tribal law as meeting
Federal requirements and does not impose additional requirements beyond
those imposed by tribal law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);

     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. Section 804, however, exempts from section 801 the
following types of rules: Rules of particular applicability; rules
relating to agency management or personnel; and rules of agency
organization, procedure, or practice that do not substantially affect
the rights or obligations of non-agency parties, 5 U.S.C. 804(3).
Because this is a rule of particular applicability, EPA is not required
to submit a rule report regarding this action under section 801.
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by May 3, 2021. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 49

    Environmental protection, Administrative practice and procedure,
Air pollution control, Incorporation by reference, Indians,
Intergovernmental relations, Reporting and recordkeeping requirements.

    Authority:  42 U.S.C. 7401 et seq.

    Dated: February 10, 2021.
Deborah Szaro,
Acting Regional Administrator, EPA Region 1.
    Part 49 of chapter I, title 40 of the Code of Federal Regulations
is amended as follows:

PART 49--INDIAN COUNTRY: AIR QUALITY PLANNING AND MANAGEMENT

0
1. The authority citation for part 49 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart D--Implementation Plans for Tribes--Region 1

0
2. Subpart D of Part 49 is amended by adding an undesignated center
heading and Sec.  49.202, after Sec.  49.201, to read as follows:

Implementation Plan for the Mashantucket Pequot Tribal Nation.

Sec.  49.202   Identification of Plan

    (a) Purpose and scope. This section contains the implementation
plan for the Mashantucket Pequot Tribal Nation. This plan consists of
permitting requirements for major and minor sources of air pollution
submitted by the Tribe on December 7, 2018, applicable to lands within
the exterior boundaries of the Mashantucket Pequot Tribal Nation's
reservation.
    (b) Incorporation by reference. (1) Material listed in paragraph
(c) of this section was approved for incorporation by reference by the
Director of the Federal Register in accordance with 5 U.S.C. 552(a) and
1 CFR part 51. Material is incorporated as it exists on the date of the
approval, and notice of any change in the material will be published in
the Federal Register. Entries in paragraph (c) of this section with EPA
approval dates after January 6, 2021, will be incorporated by reference
in the next update to the TIP compilation.
    (2) EPA Region 1 certifies that the rules/regulations provided by
EPA in the TIP compilation at the addresses in paragraph (b)(3) of this
section are an exact duplicate of the officially promulgated tribal
rules/regulations which have been approved as part of the Tribal
Implementation Plan as of January 6, 2021.
    (3) Copies of the materials incorporated by reference may be
inspected at the EPA Region 1 Office, 5 Post Office Square, Suite 100,
Boston, MA 02109-3912 and at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, email<EMAIL_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.
    (c) EPA-approved regulations.

                                  Table 1 to Paragraph (c)--EPA-Approved Mashantucket Pequot Tribal Nation Regulations
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Tribal
            Tribal citation                          Title/subject               effective date      EPA approval date              Explanations
--------------------------------------------------------------------------------------------------------------------------------------------------------
Resolution Number TCR101118-04 of 06    RESOLUTION NUMBER TCR101118-04 of 06 OF      10/11/2018  3/3/2021 [Insert Federal
 of the Mashantucket Pequot Tribe.       THE MASHANTUCKET PEQUOT TRIBAL                           Register citation].
                                         COUNCIL, THE GOVERNING BODY OF THE
                                         MASHANTUCKET PEQUOT TRIBE, Approves
                                         the MPTN Air Quality Program,
                                         Submission of the Tribal
                                         Implementation Plan and Requests
                                         Delegation of the Title V Program.
MPTN Land Use Regulations, Title 12     MPTN Land Use Regulations, Title 12 Air      10/11/2018  3/3/2021[Insert Federal   MPTN only submitted, and EPA
 Air Quality Regulations.                Quality Regulations.                                     Register citation].       only approved, applicable
                                                                                TIP References: Subtitle
                                                                                12.1, Sec.   2
                                                                                ``Applicability'' and Sec.
                                                                                4 ``Definitions''; and
                                                                                Subtitle 12.2 ``New Source
                                                                                Review--MPTN TIP.''
--------------------------------------------------------------------------------------------------------------------------------------------------------

[FR Doc. 2021-03124 Filed 3-2-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 230 (Friday, December 1, 2023)]
[Proposed Rules]
[Pages 83874-83875]
[FR Doc No: 2023-26356]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2023-2222; Airspace Docket No. 23-AGL-32]
RIN 2120-AA66

Establishment of Class E Airspace; Redfield, SD

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to establish Class E airspace at
Redfield, SD. The FAA is proposing this action due to the development
of new public instrument procedures and to support instrument flight
rule (IFR) operations.

DATES: Comments must be received on or before January 16, 2024.

ADDRESSES: Send comments identified by FAA Docket No. FAA-2023-2222 and
Airspace Docket No. 23-AGL-32 using any of the following methods:
    * Federal eRulemaking Portal: Go to www.regulations.gov and follow
the online instruction for sending your comments electronically.
    * Mail: Send comments to Docket Operations, M-30; U.S. Department
of Transportation, 1200 New Jersey Avenue SE, Room W12-140, West
Building Ground Floor, Washington, DC 20590-0001.
    * Hand Delivery or Courier: Take comments to Docket Operations in
Room W12-140 of the West Building Ground Floor at 1200 New Jersey
Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.
    * Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Docket: Background documents or comments received may be read at
www.regulations.gov at any time. Follow the online instructions for
accessing the docket or go to Docket Operations in Room W12-140 of the
West Building Ground Floor at 1200 New Jersey Avenue SE, Washington,
DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.
    FAA Order JO 7400.11H, Airspace Designations and Reporting Points,
and subsequent amendments can be viewed online at www.faa.gov/air_traffic/publications/. You may also contact the Rules and
Regulations Group, Office of Policy, Federal Aviation Administration,
800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

FOR FURTHER INFORMATION CONTACT: Jeffrey Claypool, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would establish the Class E airspace extending upward from 700
feet above the surface at Redfield Municipal Airport, Redfield, SD, to
support IFR operations at this airport.

Comments Invited

    The FAA invites interested persons to participate in this
rulemaking by submitting written comments, data, or views. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal. The most
helpful comments reference a specific portion of the proposal, explain
the reason for any recommended change, and include supporting data. To
ensure the docket does not contain duplicate comments, commenters
should submit only one time if comments are filed electronically, or
commenters should send only one copy of written comments if comments
are filed in writing.
    The FAA will file in the docket all comments it receives, as well
as a report

summarizing each substantive public contact with FAA personnel
concerning this proposed rulemaking. Before acting on this proposal,
the FAA will consider all comments it received on or before the closing
date for comments. The FAA will consider comments filed after the
comment period has closed if it is possible to do so without incurring
expense or dely. The FAA may change this proposal in light of the
comments it receives.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT post these
comments, without edit, including any personal information the
commenter provides, to www.regulations.gov as described in the system
of records notice (DOT/ALL-14FDMS), which can be reviewed at
www.dot.gov/privacy.

Availability of Rulemaking Documents

    An electronic copy of this document may be downloaded through the
internet at www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at
www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address, phone number, and
hours of operations). An informal docket may also be examined during
normal business hours at the Federal Aviation Administration, Air
Traffic Organization, Central Service Center, Operations Support Group,
10101 Hillwood Parkway, Fort Worth, TX 76177.

Incorporation by Reference

    Class E airspace is published in paragraph 6005 of FAA Order JO
7400.11, Airspace Designations and Reporting Points, which is
incorporated by reference in 14 CFR 71.1 on an annual basis. This
document proposes to amend the current version of that order, FAA Order
JO 7400.11H, dated August 11, 2023, and effective September 15, 2023.
These updates would be published subsequently in the next update to FAA
Order JO 7400.11. That order is publicly available as listed in the
ADDRESSES section of this document.
    FAA Order JO 7400.11H lists Class A, B, C, D, and E airspace areas,
air traffic service routes, and reporting points.

The Proposal

    The FAA is proposing to amend 14 CFR part 71 by establishing Class
E airspace extending upward from 700 feet above the surface to within a
6.3-mile radius of Redfield Municipal Airport, Redfield, SD.
    The FAA is proposing this action due to the development of new
public instrument procedures and to support instrument flight rule
(IFR) operations.

Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this proposed rule, when promulgated, will not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority:  49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO
7400.11H, Airspace Designations and Reporting Points, dated August 11,
2023, and effective September 15, 2023, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

AGL SD E5 Redfield, SD [Establish]

Redfield Municipal Airport, SD
    (Lat 44[deg]51'24'' N, long 98[deg]31'52'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.3-mile radius of Redfield Municipal Airport.
* * * * *

    Issued in Fort Worth, Texas, on November 27, 2023.
Martin A. Skinner,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2023-26356 Filed 11-30-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 191 (Friday, October 2, 2015)]
[Notices]
[Pages 59787-59788]
[FR Doc No: 2015-25121]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0684]

Identification of Alternative In Vitro Bioequivalence Pathways
Which Can Reliably Ensure In Vivo Bioequivalence of Product Performance
and Quality of Non-Systemically Absorbed Drug Products for Animals;
Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Request for comments; reopening of the comment period.

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

SUMMARY: The Food and Drug Administration (FDA) is reopening the

comment period related to the use of in vitro methods as a mechanism
for assessing the in vivo product bioequivalence (BE) of
nonsystemically absorbed drug products intended for use in veterinary
species, published in the Federal Register of March 18, 2015 (80 FR
14146). FDA is reopening the comment period to receive new information.

DATES: Submit either electronic or written comments by November 2,
2015.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2015-N-0684 for Identification of Alternative In Vitro
Bioequivalence Pathways Which Can Reliably Ensure In Vivo
Bioequivalence of Product Performance and Quality of Non-Systemically
Absorbed Drug Products for Animals; Reopening of the Comment Period.
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the guidance to the
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine,
Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: John Harshman, CVM, Food and Drug
Administration, HFV-170, MPN2, 7500 Standish Place, Rockville, MD
20855,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 18, 2015 (80 FR 14146), FDA
announced a public meeting to discuss the use of in vitro methods as a
mechanism for assessing the in vivo product bioequivalence of
nonsystemically absorbed drug products intended for use in veterinary
species. In the same notice, FDA said that it is seeking additional
public comment to the docket. Interested persons were originally given
until May 18, 2015, to comment on this issue. Following publication of
that notice, FDA received a request to allow interested persons
additional time to comment. In response to that request, FDA published
a Federal Register notice on June 10, 2015, reopening the comment
period for 60 days, until August 10, 2015.

II. Request for Comments

    Following publication of the June 10, 2015, notice reopening the
comment period for 60 days, FDA received a request to allow interested
persons an additional 30 days to comment. FDA has considered the
request and is reopening the comment period for 30 days, until November
2, 2015.

    Dated: September 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-25121 Filed 10-1-15; 8:45 am]
 BILLING CODE 4164-01-P


Note to Docket RCRA 2003 0023 From: Ross Elliott, Office of Solid Waste Date: 19 November 2003 Re: EPA Meeting With Vanadium Producers and Reclaimers Association ( VPRA)

On November 19, 2003, staff and management from EPA's Office of Solid Waste met with VPRA to discuss the status of the Notice of Data Availability ( NODA) published on October 23, 2003 ( 68 FR 59935). During the meeting, representatives from VPRA asked clarifying questions about the published NODA, in advance of their submittal of comments. VPRA representatives also asked questions related to their pending rulemaking petition, possible future agency actions, and the extension of the comment period for the NODA.

In attendance at the meeting were:

EPA/ Office of Solid Waste:

Robert Dellinger, Director, Hazardous Waste Identification Division Gail Cooper, Chief, Waste Identification Branch Dave Cozzie, Acting Associate Division Director, Economics, Methods, and Risk Assessment Division John Austin, Waste Treatment Branch Scott Rauenzhan, Waste Treatment Branch Greg Helms, Hazardous Waste Identification Division Ross Elliott, Waste Identification Branch VPRA:

John Hilbert III James Allen Bob Phelan Dale Scherger, Scherger Associates Allan Orr, Gulf Chemical and Metallurgical Corp.


[Federal Register Volume 87, Number 32 (Wednesday, February 16, 2022)]
[Notices]
[Page 8922]
[FR Doc No: 2022-03287]

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

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2022-0010]

Petition for Waiver of Compliance

    Under part 211 of title 49 Code of Federal Regulations (CFR), this
document provides the public notice that on January 28, 2022, the
Western Maryland Scenic Railroad (WMSX) petitioned the Federal Railroad
Administration (FRA) for a waiver of compliance from certain provisions
of the Federal railroad safety regulations contained at 49 CFR parts
215 (Railroad Freight Car Safety Standards) and 224 (Reflectorization
of Rail Freight Rolling Stock). FRA assigned the petition Docket Number
FRA-2022-0010.
    Specifically, WMSX requested a special approval pursuant to 49 CFR
215.203, Restricted cars, for a total of 6 cars, comprised of 1 tank
car (WMSX 8959) and 5 coal hopper cars (WMSX 806641, WMSX 823059, WMSX
823059, WMSX 834314, and WMSX 834623) that are or are approaching more
than 50 years from the date of original construction. WMSX also
requests relief from 49 CFR 215.303, Stenciling of restricted cars, and
224.101, General requirements. WMSX seeks to operate the cars as
historic artifacts in conjunction with, but not on, tourist and
excursion trains. In support of its request, WMSX states that the
relief would enable the cars to maintain historic integrity and that
the cars would not exceed 10 miles per hour and not be interchanged.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment and a public hearing, they
should notify FRA, in writing, before the end of the comment period and
specify the basis for their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted at http://www.regulations.gov. Follow the online instructions for submitting
comments.
    Communications received by April 4, 2022 will be considered by FRA
before final action is taken. Comments received after that date will be
considered if practicable. Anyone can search the electronic form of any
written communications and comments received into any of our dockets by
the name of the individual submitting the comment (or signing the
document, if submitted on behalf of an association, business, labor
union, etc.). Under 5 U.S.C. 553(c), the U.S. Department of
Transportation (DOT) solicits comments from the public to better inform
its processes. DOT posts these comments, without edit, including any
personal information the commenter provides, to www.regulations.gov, as
described in the system of records notice (DOT/ALL-14 FDMS), which can
be reviewed at https://www.transportation.gov/privacy. See also https://www.regulations.gov/privacy-notice for the privacy notice of
regulations.gov.

    Issued in Washington, DC.
John Karl Alexy,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2022-03287 Filed 2-15-22; 8:45 am]
BILLING CODE 4910-06-P