[Federal Register Volume 84, Number 104 (Thursday, May 30, 2019)]
[Notices]
[Pages 25061-25062]
[FR Doc No: 2019-11295]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0429]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Labeling of
Nonprescription Human Drug Products Marketed Without an Approved
Application as Required by the Dietary Supplement and Nonprescription
Drug Consumer Protection Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Fax written comments on the collection of information by July 1,
2019.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0641.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Labeling of Nonprescription Human Drug Products Marketed Without an
Approved Application as Required by the Dietary Supplement and
Nonprescription Drug Consumer Protection Act

OMB Control Number 0910-0641--Extension

    Section 502(x) of the Federal, Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 352(x)), added by the Dietary Supplement and
Nonprescription Drug Consumer Protection Act (Pub. L. 109-462),
requires the label of a nonprescription drug product marketed without
an approved application in the United States to include a domestic
address or domestic telephone number through which a manufacturer,
packer, and distributor may receive a report of a serious adverse event
associated with the product. The guidance document entitled ``Labeling
of Nonprescription Human Drug Products Marketed Without an Approved
Application as Required by the Dietary Supplement and Nonprescription
Drug Consumer Protection Act: Questions and Answers'' explains how FDA
interprets this requirement. The guidance discusses the meaning of
``domestic address'' for purposes of the labeling requirements of
section 502(x) of the FD&C Act, FDA's recommendation for the use of an
introductory statement before the domestic address or phone number that
is required to appear on the product label under section 502(x) of the
FD&C Act, and FDA's intent regarding enforcing the labeling
requirements of section 502(x) of the FD&C Act.
    In the Federal Register of February 11, 2019 (84 FR 3192), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    Description of Respondents: Respondents to this collection of
information are manufacturers, packers, and distributors whose name
(under section 502(b)(1) of the FD&C Act) appears on the label of a
nonprescription drug product marketed in the United States without an
approved application.
    As indicated in table 1 of this document, we estimate that 300
manufacturers will revise approximately 900 labels to add a full
domestic address or a domestic telephone number, and should they choose
to adopt the guidance's recommendation, to add a statement identifying
the purpose of the domestic address or telephone number. We believe
that designing the label change should not take longer than 4 hours per
label. Automated printing of the labels should only require a few
seconds per label.
    We estimate the burden of this collection of information as
follows:

                                  Table 1--Estimated Annual Third-Party Disclosure Burden for New OTC Drug Products \1\
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                                                                                Number of
                              Activity                                  Number of     disclosures per    Total annual    Average burden    Total hours
                                                                       respondents       respondent      disclosures     per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Including a domestic address or phone number and a statement of its             300                3              900                4            3,600
 purpose on OTC drug labeling (section 502(x) of the FD&C Act).....
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or maintenance and operating costs associated with this collection of information.

    Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.

    Dated: May 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-11295 Filed 5-29-19; 8:45 am]
BILLING CODE 4164-01-P


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on September 25, 2003

NOTICE OF ACTION TAKEN -- DOCKET OST 2003-16101

________________________________________________________________________
________________________________________________________

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

Application of    American Eagle Airlines, Inc.,   filed  9/4/03 for:

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

Scheduled foreign air transportation of persons, property, and mail
between Dallas/Ft. Worth, Texas, and Monterrey, Mexico.

Applicant rep:   Carl B. Nelson, Jr.<PHONE_NUMBER>    DOT Analyst:
Linda L. Lundell<PHONE_NUMBER>

D I S P O S I T I O N

XX  Granted, subject to conditions (see below).

The action above was effective when taken:   September 25, 2003, through
 September 25, 2005.

Action taken by:     Paul L. Gretch, Director

  		        Office of International Aviation

XX  Authority granted is consistent with the aviation agreement between
the United States and Mexico.

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

XX  Holder’s certificates of public convenience and necessity

XX  Standard Exemption Conditions (attached)

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

Special Conditions/Remarks:  The U.S.-Mexico exemption authority granted
is subject to the dormancy notice requirements set forth in condition 7
of Appendix A of Order 88-10-2.   Consistent with our policy, the
dormancy notice period will begin January 6, 2004, American Eagle’s
proposed startup date for these services.

________________________________________________________________________
________________________________________________________

On the basis of data officially noticeable under Rule 24(g) of the
Department’s regulations, we found the applicant qualified to provide
the services authorized.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) grant of the application was consistent with the public
interest; and (3) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
 To the extent not granted, we denied all requests in the referenced
Docket.  We may amend, modify, or revoke the authority granted in this
Notice at any time without hearing at our discretion.

-see next page - 											2

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

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

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

APPENDIX

U.S. Carrier Standard Exemption Conditions

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

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

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

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

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

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

(6)  Comply with all applicable requirements of the Federal Aviation
Administration and with all applicable U.S. Government requirements
concerning security.  To assure compliance with all applicable U.S.
Government requirements concerning security, the holder shall, before
commencing any new service (including charter flights) to or from a
foreign airport, contact its Principal Security Inspector (PSI) to
advise the PSI of its plans and to find out whether the Transportation
Security Administration has determined that security is adequate to
allow such airport(s) to be served; and

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

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

											8/2003

   Under the U.S.-Mexico aviation agreement, only two U.S. carriers may
be designated to serve a given city-pair market.  At the time this
application was filed, both American Airlines, Inc., and Atlantic
Southeast Airlines, Inc. (ASA), held designations to serve the Dallas/Ft
Worth-Monterrey market.  In its application, American Eagle states that
ASA does not currently operate the Dallas/Ft. Worth-Monterrey service,
and that its designation should be revoked.  ASA’s counsel has advised
the Department that ASA’s authority in the Dallas/Ft. Worth-Monterrey
market is dormant.  Thus, one U.S. carrier designation opportunity is
available.


[Federal Register: March 7, 2007 (Volume 72, Number 44)]
[Notices]
[Page 10201-10202]
[DOCID:fr07mr07-88]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL07-38-000]

Maine Public Utilities Commission, Complainant, v. ISO New
England, Inc, Respondent; Notice of Complaint

February 28, 2007.
    Take notice that on February 26, 2007, the Maine Public Utilities
Commission tendered for filing a complaint asking the Commission for an
order finding that Schedule 2 of the ISO New England, Inc., (ISO-NE),
Open Access Transmission Tariff (OATT), is unjust and unreasonable; and
directing ISO-NE to modify Schedule 2 of its OATT as described in the
instant Complaint.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to

the proceeding. Any person wishing to become a party must file a notice
of intervention or motion to intervene, as appropriate. The
Respondent's answer and all interventions, or protests must be filed on
or before the comment date. The Respondent's answer, motions to
intervene, and protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on March 19, 2007.

Magalie R. Salas,
Secretary.
[FR Doc. E7-3976 Filed 3-6-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 82 (Friday, April 28, 2023)]
[Notices]
[Page 26374]
[FR Doc No: 2023-08982]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-97363; File No. SR-NYSECHX-2023-09]

Self-Regulatory Organizations; NYSE Chicago, Inc.; Notice of
Designation of a Longer Period for Commission Action on Proposed Rule
Change To Adopt New NYSE Chicago Rule 29 To Establish Listing Standards
Related to Recovery of Erroneously Awarded Incentive-Based Executive
Compensation

April 24, 2023.
    On February 22, 2023, NYSE Chicago, Inc. (``NYSE Chicago'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to adopt new Rule 29 to require issuers to develop
and implement a policy providing for the recovery of erroneously
awarded incentive-based compensation received by current or former
executive officers. The proposed rule change was published for comment
in the Federal Register on March 13, 2023.\3\ The Commission has
received no comments on the proposal.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 97052 (March 7,
2023), 88 FR 15476.
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    Section 19(b)(2) of the Act \4\ provides that within 45 days of the
publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day after publication of the notice for this proposed rule change
is April 27, 2023. The Commission is extending this 45-day time period.
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    \4\ 15 U.S.C. 78s(b)(2).
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    The Commission finds it appropriate to designate a longer period
within which to take action on the proposed rule change so that it has
sufficient time to consider the proposed rule change. Accordingly, the
Commission, pursuant to section 19(b)(2) of the Act,\5\ designates June
11, 2023, as the date by which the Commission shall either approve or
disapprove, or institute proceedings to determine whether to
disapprove, the proposed rule change (File No. SR-NYSECHX-2023-09).
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    \5\ 15 U.S.C. 78s(b)(2).
    \6\ 17 CFR 200.30-3(a)(31).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-08982 Filed 4-27-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 4 (Friday, January 6, 2012)]
[Notices]
[Pages 791-793]
[FR Doc No: 2011-33848]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2011-1016; FRL-9331-5]

Kasugamycin; Receipt of Application for Emergency Exemption for
Use on Apples in Michigan, Solicitation of Public Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA has received a specific exemption request from the
Michigan Department of Agriculture to use the pesticide Kasugamycin
(CAS No. 6980-18-3) to treat up to 10,000 acres of apples to control
fire blight. The applicant proposes the use of a new chemical which has
not been registered by the EPA. EPA is soliciting public comment before
making the decision whether or not to grant the exemption.

DATES: Comments must be received on or before February 6, 2012.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2011-1016, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave.
NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2011-1016. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or
email. The regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an email
comment directly to EPA without going through regulations.gov, your
email address will be automatically captured and included as part of
the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Keri Grinstead, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; fax 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 an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

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

    1. Submitting CBI. Do not submit this information to EPA through
www.regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the
pesticide(s) discussed in this document, compared to the general
population.

II. What action is the agency taking?

    Under section 18 of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) (7 U.S.C. 136p), at the discretion of the
Administrator, a Federal or State agency may be exempted from any
provision of FIFRA if the Administrator determines that emergency
conditions exist which require the exemption. Michigan Department of
Agriculture has requested the Administrator to issue a specific
exemption for the use of kasugamycin on apples to control fire blight.
Information in accordance with 40 CFR part 166 was submitted as part of
this request.
    As part of this request, the applicant asserts that kasugamycin is
needed to control streptomycin-resistant strains of Erwinia amylovora,
the causal pathogen of fire blight, due to the lack of available
alternatives and effective control practices.
    The Applicant proposes to make no more than three applications of
Kasumin 2L on not more than 10,000 acres of apples between April 1 and
May 31, 2012 in Berrien, Cass, Grand Traverse, Ionia, Kent, Montcalm,
Newaygo, Oceana, Ottawa, and Van Buren counties. As currently proposed,
the maximum amount of the product to be applied would be 30,000
gallons.
    This notice does not constitute a decision by EPA on the
application itself. The regulations governing section 18 of FIFRA
require publication of a notice of receipt of an application for a
specific exemption proposing use of a new chemical (i.e., an active
ingredient) which has not been registered by EPA.
    The notice provides an opportunity for public comment on the
application.
    The Agency, will review and consider all comments received during
the comment period in determining whether to issue the specific
exemption requested by the Michigan Department of Agriculture.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: December 22, 2011.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2011-33848 Filed 1-5-12; 8:45 am]
BILLING CODE P


P-20-0069 Sanitized Support Documents Index:
 P-20-0069 Sanitized Determination Document (linked)
 P-20-0069 Sanitized CHEM Report (attached)
 P-20-0069 Sanitized ECO Report (attached)
 P-20-0069 Sanitized ENG Report (attached)
 P-20-0069 Sanitized EXP Report (attached)
 P-20-0069 Sanitized Fate Report (attached)
 P-20-0069 Sanitized HLTH Report_POST-FOCUS FINAL (attached)