[Federal Register Volume 82, Number 10 (Tuesday, January 17, 2017)]
[Notices]
[Pages 4893-4894]
[FR Doc No: 2017-00773]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-0120]

Interpretation of and Compliance Policy for Certain Label
Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic
Act Requirements to Vape Shops; Draft Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a draft guidance for industry entitled ``Interpretation
of and Compliance Policy for Certain Label Requirement; Applicability
of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape
Shops.'' This draft guidance provides FDA's interpretation of, and a
compliance policy for, the requirement that the label of tobacco
products contain an accurate statement of the percentage of foreign and
domestic grown tobacco under the Federal Food, Drug, and Cosmetic Act
(the FD&C Act). This draft guidance document is also intended to assist
retailers who sell newly deemed products by explaining whether engaging
in certain activities subjects such establishments to additional
requirements of the FD&C Act and the limited circumstances under which
FDA does not intend to enforce compliance.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment of this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by February 16, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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-2017-D-0120 for ``Interpretation of and Compliance Policy for
Certain Label Requirement; Applicability of Certain Federal Food, Drug,
and Cosmetic Act Requirements to Vape Shops.'' Received comments will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://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 https://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 https://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 draft guidance to
the Center for Tobacco Products, Food and Drug Administration, Document
Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a fax number to which
the guidance document may be sent. See the SUPPLEMENTARY INFORMATION
section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Katherine Collins, Center for Tobacco
Products, Food and Drug Administration, Document Control Center, 10903
New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002,
1-877-287-1373, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a draft guidance for industry
entitled ``Interpretation of and Compliance Policy for Certain Label
Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic
Act Requirements to Vape Shops.''
    This draft guidance document, when finalized, will provide FDA's
interpretation of, and a compliance policy for, the label requirement
under section 903(a)(2)(C) of the FD&C Act (21 U.S.C. 387c(a)(2)(C)).
This draft guidance document, when finalized, is also intended to
assist retailers who sell newly deemed products by explaining whether
engaging in certain activities subjects such establishments to
additional requirements of the FD&C Act and the limited circumstances
under which FDA does not intend to enforce compliance.
    The Family Smoking Prevention and Tobacco Control Act (Pub. L. 111-
31) (Tobacco Control Act), enacted on June 22, 2009, amends section 904
of the FD&C Act (21 U.S.C. 387d) and provides FDA with the authority to
regulate the manufacture, marketing, and distribution of tobacco
products to protect the public health generally and to reduce tobacco
use by minors.
    Cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless
tobacco were immediately covered by FDA's tobacco product authorities
in chapter IX of the FD&C Act, when the Tobacco Control Act went into
effect. As for other types of tobacco products, section 901(b) of the
FD&C Act (21 U.S.C. 387a(b)) grants FDA authority to deem those
products subject to chapter IX of the FD&C Act. Under that authority,
FDA issued a rule deeming all other products that meet the statutory
definition of ``tobacco product,'' set forth in section 201(rr) of the
FD&C Act (21 U.S.C. 321(rr)), except for accessories of those products,
as subject to chapter IX of the FD&C Act (81 FR 28974). FDA published
the final rule on May 10, 2016, and it became effective on August 8,
2016.
    Section 903(a)(2)(C) of the FD&C Act provides that a tobacco
product in package form is misbranded unless its label contains ``an
accurate statement of the percentage of tobacco used in the product
that is domestically grown tobacco and the percentage that is foreign
grown tobacco.'' The draft guidance provides FDA's interpretation of,
and a compliance policy for, this label requirement.
    Retail establishments, such as vape shops, which engage in certain
activities may also be subject to certain requirements of the FD&C Act
that apply to tobacco product manufacturers and to establishments that
engage in the manufacture, preparation, compounding, or processing of
tobacco product. These activities may also include modifying a product
so that it is a new tobacco product requiring compliance with the
premarket authorization requirements. This draft guidance explains
which activities subject vape shops to these FD&C Act requirements and
the limited circumstances under which FDA does not intend to enforce
compliance.

II. Significance of Guidance

    FDA is issuing this draft guidance consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA. It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

III. Electronic Access

    Persons with access to the Internet may obtain an electronic
version of the draft guidance at either https://www.regulations.gov or
http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm.

    Dated: January 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00773 Filed 1-13-17; 8:45 am]
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[Federal Register Volume 85, Number 89 (Thursday, May 7, 2020)]
[Proposed Rules]
[Pages 27184-27186]
[FR Doc No: 2020-09476]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2020-0354; Airspace Docket No. 20-ASW-3]
RIN 2120-AA66

Proposed Amendment of Class E Airspace; Kountze/Silsbee, TX

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to amend the Class E airspace extending
upward from 700 feet above the surface at Hawthorne Field, Kountze/
Silsbee, TX. The FAA is proposing this action as the result of an
airspace review caused by the decommissioning of the Hardin County non-
directional beacon (NDB) which provided navigation information for the
instrument procedures at this airport. The geographic coordinates of
the airport would also be updated to coincide with the FAA's
aeronautical database. Airspace redesign is necessary for the safety
and management of instrument flight rules (IFR) operations at this
airport.

DATES: Comments must be received on or before June 22, 2020.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590; telephone
(202) 366-9826, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2020-0354/Airspace Docket No. 20-ASW-3 at the beginning of your
comments. You may also submit comments through the internet at https://www.regulations.gov. You may review the public docket containing the
proposal, any comments received, and any final disposition in person in
the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through
Friday, except federal holidays.
    FAA Order 7400.11D, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA

Order 7400.11D at NARA, email<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

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 amend the Class E airspace extending upward from 700 feet
above the surface at Hawthorne Field, Kountze/Silsbee, TX, to support
IFR operations at this airport.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2020-0354/
Airspace Docket No. 20-ASW-3.'' The postcard will be date/time stamped
and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at https://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at https://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 and phone number)
between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. 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.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11D, Airspace
Designations and Reporting Points, dated August 8, 2019, and effective
September 15, 2019. FAA Order 7400.11D is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11D lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 by amending the Class E airspace area
extending upward from 700 feet above the surface to within a 6.4-mile
(decreased from 6.6-mile) radius at Hawthorne Field, Kountze/Silsbee,
TX; updating the header of the airspace legal description to read
Kountze/Silsbee, TX (previously Kountze-Silsbee, TX) to coincide with
the FAA's aeronautical database; removing the city associated with the
airport to comply with changes to FAA Order 7400.2M, Procedures for
Handling Airspace Matters; and updating the geographic coordinates of
the airport to coincide with the FAA's aeronautical database.
    These actions are the result of an airspace review caused by the
decommissioning of the Hardin County NDB which provided navigation
information for the instrument procedures at these airports.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.11D, dated August 8, 2019, and effective September 15,
2019, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designations listed in this document will be published
subsequently in the Order.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. 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 rule, when promulgated, would 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

    Accordingly, pursuant to the authority delegated to me, 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 7400.11D,
Airspace Designations and Reporting Points, dated August 8, 2019, and
effective September 15, 2019, is amended as follows:

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

* * * * *

ASW TX E5 Kountze/Silsbee, TX [Amended]

Hawthorne Field, TX
    (Lat. 30[deg]20'11'' N, long. 94[deg]15'27'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.4-mile radius of Hawthorne Field.

    Issued in Fort Worth, Texas, on April 27, 2020.
Steven Phillips,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2020-09476 Filed 5-6-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 155 (Thursday, August 11, 2016)]
[Proposed Rules]
[Pages 53100-53101]
[FR Doc No: 2016-18432]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 271

[EPA-R06-RCRA-2016-0176; FRL-9950-12-Region 6]

Arkansas: Final Authorization of State Hazardous Waste Management
Program Revisions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The State of Arkansas has applied to EPA for Final
authorization of the changes to its hazardous waste program under the
Resource Conservation and Recovery Act (RCRA). EPA proposes to grant
Final authorization to the State of Arkansas. In the ``Rules and
Regulations'' section

of this Federal Register, EPA is authorizing the changes by direct
final rule. EPA did not make a proposal prior to the direct final rule
because we believe this action is not controversial and do not expect
comments that oppose it. We have explained the reasons for this
authorization in the preamble to the direct final rule. Unless we get
written comments which oppose this authorization during the comment
period, the direct final rule will become effective 60 days after
publication and we will not take further action on this proposal. If we
receive comments that oppose this action, we will withdraw the direct
final rule and it will not take effect. We will then respond to public
comments in a later final rule based on this proposal. You may not have
another opportunity for comment. If you want to comment on this action,
you must do so at this time.

DATES: Send your written comments by September 12, 2016.

ADDRESSES: Submit any comments identified by Docket ID No. EPA-R06-
RCRA-2016-0176, by one of the following methods:
    1. Federal eRulemaking Portal: http://www.regulations.gov. Follow
the on-line instructions for submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Mail: Alima Patterson, Region 6, Regional Authorization
Coordinator, State/Tribal Oversight Section (6PD-O), Multimedia
Planning and Permitting Division, EPA Region 6, 1445 Ross Avenue,
Dallas, Texas 75202-2733.
    4. Hand Delivery or Courier. Deliver your comments to Alima
Patterson, Region 6, Regional Authorization Coordinator, Permit Section
(RPM), Multimedia Planning and Permitting Division, EPA Region 6, 1445
Ross Avenue, Dallas, Texas 75202-2733.
    Instructions: Do not submit information that you consider to be CBI
or otherwise protected through regulations.gov, or email. Direct your
comment to Docket No. EPA-R06-RCRA-2016-0176. The Federal
regulations.gov Web site is an ``anonymous access'' system, which means
the 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 the 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 public docket and made available on the
Internet. If you submit an electronic comment, the 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 the EPA cannot read
your comment due to technical difficulties and cannot contact you for
clarification, the 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. You can view and
copy Arkansas's application and associated publicly available materials
from 8:30 a.m. to 4 p.m. Monday through Friday at the following
locations: Arkansas Department of Environmental Quality, 8101
Interstate 30, Little Rock, Arkansas 72219-8913,<PHONE_NUMBER>.
Interested persons wanting to examine these documents should make an
appointment with the office at least two weeks in advance.

FOR FURTHER INFORMATION CONTACT: Alima Patterson, Region 6, Regional
Authorization Coordinator, RCRA Permits Section (RPM), Multimedia
Planning and Permitting Division, EPA Region 6, 1445 Ross Avenue,
Dallas, Texas 75202-2733,<PHONE_NUMBER> and Email address
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    For additional information, please see the direct final published
in the ``Rules and Regulations'' section of today's Federal Register.

    Dated: July 14, 2016.
Ron Curry,
Regional Administrator, Region 6.
[FR Doc. 2016-18432 Filed 8-10-16; 8:45 am]
 BILLING CODE 6560-50-P