[Federal Register Volume 81, Number 175 (Friday, September 9, 2016)]
[Notices]
[Pages 62505-62506]
[FR Doc No: 2016-21686]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0600]

Health Document Submission Requirements for Tobacco Products;
Revised Draft Guidance for Industry; Availability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availability of a revised draft guidance for industry entitled ``Health
Document Submission Requirements for Tobacco Products.'' The revised
draft guidance is intended to assist persons making certain document
submissions to FDA as required by the Family Smoking Prevention and
Tobacco Control Act (Tobacco Control Act).

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
revised draft guidance before it begins work on the final version of
the guidance, submit either electronic or written comments on the draft
guidance by October 11, 2016.

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-2009-D-0600 for ``Health Document Submission Requirements for
Tobacco Products.'' 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 revised 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 20993-2000. Send two self-addressed
adhesive labels to assist that office in processing your requests. 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, Bldg.
71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-2000,
1-877-287-1373, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a revised draft guidance for
industry entitled ``Health Document Submission Requirements for Tobacco
Products.'' We are issuing this draft guidance consistent with our good
guidance practices (GGP) regulation (21 CFR 10.115). The draft
guidance, when finalized, is intended to assist persons making certain
document submissions to FDA as required by the Tobacco Control Act.
    The Tobacco Control Act, enacted on June 22, 2009, amends the FD&C
Act and provides FDA with the authority to regulate the manufacture,
marketing, and distribution of tobacco products to protect the public's
health (Pub. L. 111-31). Among other things, the Tobacco Control Act
adds section 904(a)(4) to the FD&C Act (21 U.S.C. 387d(a)(4)),
requiring each tobacco product manufacturer or importer, or agents
thereof to submit all documents developed after June 22, 2009, that
relate to any ``health, toxicological, behavioral, or physiological
effects of current or future tobacco products, their constituents
(including smoke constituents), ingredients, components, and
additives.''
    The revised draft guidance includes guidance for manufacturers or
importers of products that are newly deemed as tobacco products that
are subject to Chapter IX of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act). Cigarettes, cigarette tobacco, roll-your-own tobacco,
and smokeless tobacco were immediately subject to the tobacco
provisions of the FD&C Act, including section 904(a)(4), and to FDA's
regulatory authority. As for other types of tobacco products, section
901(b) of the FD&C Act (21 U.S.C. 387a) grants FDA authority to deem
those products subject to the law as well. Pursuant to 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, except for accessories of those products, as subject to the
FD&C Act (81 FR 28974). FDA published the final rule on May 10, 2016
(81 FR 28974), and it became effective on August 8, 2016. Manufacturers
and importers of tobacco products that have been deemed subject to the
FD&C Act are now required to comply with Chapter IX of the FD&C Act,
including section 904(a)(4).

II. Significance of Guidance

    FDA is issuing this revised draft guidance consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, represents the current thinking of FDA on health
document submission requirements. 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.

II. Paperwork Reduction Act of 1995

    This revised draft guidance also refers to previously approved
collections of information found in FDA statute. The revised draft
guidance includes information and recommendations for how to provide
health document submissions. The collections of information in section
904(a)(4) of the FD&C Act have been approved under OMB control number
0910-0654.

IV. Electronic Access

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

    Dated: August 31, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21686 Filed 9-8-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: May 29, 2008 (Volume 73, Number 104)]
[Proposed Rules]
[Page 30824-30825]
[DOCID:fr29my08-28]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2008-0456; Airspace Docket No. 08-AAL-15]

Proposed Revision of Class E Airspace; Prospect Creek, AK

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking.

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SUMMARY: This action proposes to revise Class E airspace at Prospect
Creek, AK. Three Special Standard Instrument Approach Procedures
(SIAPs) are being developed for the Prospect Creek Airport at Prospect
Creek, AK. Additionally, two Special SIAPs and a Special textual
Obstacle Departure Procedure (ODP) are being amended. Adoption of this
proposal would result in revision of existing Class E airspace upward
from 700 feet (ft.) and 1,200 ft. above the surface at the Prospect
Creek Airport, Prospect Creek, AK.

DATES: Comments must be received on or before July 14, 2008.

ADDRESSES: Send comments on the proposal to the Docket Management
Facility, U.S. Department of Transportation, 1200 New Jersey Avenue,
SE., West Building Ground Floor, Room W12-140, Washington, DC 20590-
0001. You must identify the docket number FAA-2008-0456/Airspace Docket
No. 08-AAL-15, at the beginning of your comments. You may also submit
comments on the Internet at http://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 a.m.
and 5 p.m., Monday through Friday, except Federal holidays. The Docket
Office (telephone 1-800-647-5527) is on the plaza level of the
Department of Transportation NASSIF Building at the above address.
    An informal docket may also be examined during normal business
hours at the office of the Manager, Safety, Alaska Flight Service
Operations, Federal Aviation Administration, 222 West 7th Avenue, Box
14, Anchorage, AK 99513-7587.

FOR FURTHER INFORMATION CONTACT: Gary Rolf, Federal Aviation
Administration, 222 West 7th Avenue, Box 14, Anchorage, AK 99513-7587;
telephone number<PHONE_NUMBER>; fax:<PHONE_NUMBER>; e-mail:
<EMAIL_ADDRESS>Internet address: http://www.alaska.faa.gov/at.

SUPPLEMENTARY INFORMATION:

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-2008-0456/
Airspace Docket No. 08-AAL-15.'' The postcard will be date/time stamped
and returned to the commenter.
    All communications received on or 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
comments received. All comments submitted will be available for
examination in the public docket both before and after the closing date
for comments. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of Notice of Proposed Rulemakings (NPRMs)

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's Web page at http://
www.faa.gov or the Superintendent of Document's Web page at http://
www.access.gpo.gov/nara/index.html.
    Additionally, any person may obtain a copy of this notice by
submitting a request to the Federal Aviation Administration, Office of
Air Traffic Airspace Management, ATA-400, 800 Independence Avenue, SW.,
Washington, DC 20591 or by calling<PHONE_NUMBER>. Communications must
identify both docket numbers for this notice. Persons interested in
being placed on a mailing list for future NPRMs should contact the
FAA's Office of Rulemaking,<PHONE_NUMBER>, to request a copy of
Advisory Circular No. 11-2A, Notice of Proposed Rulemaking Distribution
System, which describes the application process.

The Proposal

    The FAA is considering an amendment to the Code of Federal
Regulations (14 CFR part 71), which would revise the Class E airspace
at the Prospect Creek Airport, in Prospect Creek, AK. The intended
effect of this proposal is to revise Class E airspace upward from 700
ft. and 1,200 ft. above the surface to contain Instrument Flight Rules
(IFR) operations at the Prospect Creek Airport, Prospect Creek, AK.
    The FAA Instrument Flight Procedures Production and Maintenance
Branch has developed three Special SIAPs for the Prospect Creek
Airport. Additionally, two Special SIAPs and a Special textual ODP are
being amended. The new SIAPs are (1) the Area Navigation (RNAV) Global
Positioning System (GPS) Y Runway (RWY) 01, Special, Original (Orig),
(2) the RNAV (GPS) Z RWY 01, Special, Orig and (3) the RNAV (GPS) RWY
19, Special, Orig. The two new SIAPs are (1) the Nondirectional Beacon
(NDB) RWY 01, Special, Amendment (Amdt) 1 and (2) the Simplified
Directional Facility (SDF)/Distance Measuring Equipment (DME), RWY 01,
Special, Orig. These procedures are funded privately and are not
published in the U.S. Terminal Procedures Alaska publication. Class E
controlled airspace extending upward from 700 ft. and 1,200 ft. above
the surface in the Prospect Creek Airport area would be revised by this
action. The proposed airspace is sufficient in size to contain aircraft
executing the instrument procedures at the Prospect Creek Airport,
Prospect Creek, AK.
    The area would be depicted on aeronautical charts for pilot
reference. The coordinates for this airspace docket are based on North
American Datum 83. The Class E airspace areas designated as 700/1200
foot transition areas are published in paragraph 6005 in FAA

Order 7400.9R, Airspace Designations and Reporting Points, signed
August 15, 2007, and effective September 15, 2007, which is
incorporated by reference in 14 CFR 71.1. The Class E airspace
designations listed in this document would be published subsequently in
the Order.
    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 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.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle 1, 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 1, Section 40103, Sovereignty and use of
airspace. Under that section, the FAA is charged with prescribing
regulations to ensure the safe and efficient use of the navigable
airspace. This regulation is within the scope of that authority because
it proposes to create Class E airspace sufficient in size to contain
aircraft executing instrument procedures at the Prospect Creek Airport,
AK, and represents the FAA's continuing effort to safely and
efficiently use the navigable airspace.

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, CLASS B, CLASS C, CLASS D, AND
CLASS E AIRSPACE AREAS; AIRWAYS; ROUTES; AND REPORTING POINTS

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

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

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of Federal
Aviation Administration Order 7400.9R, Airspace Designations and
Reporting Points, signed August 15, 2007, and effective September 15,
2007, is to be amended as follows:
* * * * *

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

* * * * *

AAL AK E5 Prospect Creek, AK [Revised]

Prospect Creek, Prospect Creek Airport, AK
    (Lat. 66[deg]48'50'' N., long. 150[deg]38'37'' W.)

    That airspace extending upward from 700 feet above the surface
within an 11-mile radius of the Prospect Creek Airport, AK, and
extending 2.0 miles either side of a line from 66[deg]55'50'' N.
150[deg]32'43'' W. to 67[deg]02'47'' N. 150[deg]34'16'' W. extending
beyond the 11-mile radius, and 4.5 miles east and 4 miles west of
the 214[deg](T)/241[deg](M) bearing from the Prospect Creek Airport,
AK, extending from the 11-mile radius to 13 miles southwest of the
Prospect Creek Airport, AK; and that airspace extending upward from
1,200 feet above the surface within a 72-mile radius of the Prospect
Creek Airport, AK.
* * * * *

    Issued in Anchorage, AK, on May 16, 2008.
Anthony M. Wylie,
Manager, Alaska Flight Services Information Area Group.
 [FR Doc. E8-11972 Filed 5-28-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 45 (Tuesday, March 8, 2011)]
[Notices]
[Pages 12787-12788]
[FR Doc No: 2011-5242]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Office of Commercial Space Transportation; Notice of Availability
of the Final Environmental Assessment and Finding of No Significant
Impact for Pegasus Launches at Cape Canaveral Air Force Station,
Florida

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

ACTION: Notice of Availability of Final Environmental Assessment and
Finding of No Significant Impact.

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SUMMARY: In accordance with the National Environmental Policy Act of
1969 (NEPA), 42 U.S.C. 4321-4347 (as amended), Council on Environmental
Quality NEPA implementing regulations (40 Code of Federal Regulations
[CFR] parts 1500 to 1508), and FAA Order 1050.1E, Change 1, the FAA is
announcing the availability of the Final Environmental Assessment
(Final EA) and Finding of No Significant Impact (FONSI) for Pegasus
Launches at Cape Canaveral Air Force Station. The Final EA was prepared
to address the potential environmental impacts of the FAA's Proposed
Action for issuing or renewing Launch Operator Licenses to operate
Pegasus launch vehicles at CCAFS. Activities addressed in the Final EA
include carrier aircraft takeoff and landing from a CCAFS runway and
launch of Pegasus vehicle at an altitude of 40,000 feet and
approximately 90 nautical miles offshore over the Atlantic Ocean. The
Final EA tiers from the Final Programmatic Environmental Impact
Statement (PEIS) for Licensing Launches (2001 PEIS) and focuses on
localized and site-specific effects of FAA issuing or renewing Launch
Operator Licenses to operate Pegasus expendable launch vehicles at
CCAFS. The 2001 PEIS, evaluated the launch impacts associated with four
vehicle categories (small, medium, intermediate, and heavy-payload
capacities); three propellant types (solid, liquid, and hybrid
propellant); and three launch scenarios (land, air, and sea). The
Pegasus launch vehicle falls within the parameters of the small-payload
capacity vehicle using solid propellant to launch from

the air. The 2001 PEIS evaluated the impacts of launching 72 small
capacity rockets, including the Pegasus launch vehicle family, over a
10-year period. The estimated annual number of launches ranged from
four to nine launches, with an average of seven annual launches. The
rate of Pegasus launches at CCAFS under the FAA's Proposed Action would
not be expected to exceed the rate of launches analyzed in the 2001
PEIS. The only alternative to the Proposed Action is the No Action
Alternative. Under this Alternative, the FAA would not issue or renew
Launch Operator Licenses to operate Pegasus launch vehicles at CCAFS.
    Resource areas were considered to provide a context for
understanding and assessing the potential environmental effects of the
Proposed Action, with attention focused on key issues. The resources
areas considered in the Final EA included air quality; biological
resources (including fish, wildlife, and plants); compatible land use;
Department of Transportation Section 4(f) resources; hazardous
materials, pollution prevention, and solid waste; historical,
architectural, archaeological, and cultural resources; noise;
socioeconomic impacts; and water quality (including floodplains and
wetlands). Potential cumulative impacts of the Proposed Action were
also addressed in the Final EA.
    After careful and thorough consideration of available data and
information on existing conditions and potential impacts, the FAA has
determined that there will be no significant short-term, long-term, or
cumulative impacts to the environment or surrounding populations from
the issuance or renewal of Launch Operator Licenses to operate Pegasus
launch vehicles at CCAFS. The proposed Federal action is consistent
with existing national environmental policies and objectives as set
forth in Section 101 of NEPA and other applicable environmental
requirements and will not significantly affect the quality of the human
environment within the meaning of NEPA. Therefore, an Environmental
Impact Statement for the Proposed Action is not required and the FAA
issued a FONSI.
    The FAA has posted the Final EA and FONSI on the FAA Office of
Commercial Space Transportation Web site at http://www.faa.gov/about/office_org/headquarters_offices/ast/environmental/review/launch/.

FOR FURTHER INFORMATION CONTACT: Mr. Daniel Czelusniak, Environmental
Program Lead, Office of Commercial Space Transportation, Federal
Aviation Administration, 800 Independence Avenue, SW., Room 325,
Washington, DC 20591, telephone<PHONE_NUMBER>; E-mail
<EMAIL_ADDRESS>
    Issued in Washington, DC, on March 1, 2011.
Michael McElligott,
Manager, Space Systems Development Division.
[FR Doc. 2011-5242 Filed 3-7-11; 8:45 am]
BILLING CODE 4310-13-P


[Federal Register Volume 88, Number 40 (Wednesday, March 1, 2023)]
[Proposed Rules]
[Pages 12872-12875]
[FR Doc No: 2023-04042]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2023-0444; Airspace Docket No. 22-ASO-16]
RIN 2120-AA66

Amendment of VOR Federal Airways V-71 and V-245, Revocation of
VOR Federal Airways V-554 and V-570, and Establishment of RNAV Routes
T-471, T-473, and T-474 in the Vicinity of Natchez, MS

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to amend Very High Frequency (VHF)
Omnidirectional Range (VOR) Federal airways V-71 and V-245, revoke VOR
Federal airways V-554 and V-570, and establish Area Navigation (RNAV)
routes T-471, T-473, and T-474. The FAA is proposing this action due to
the planned decommissioning of the VOR portion of the Natchez, MS
(HEZ), VOR/Distance Measuring Equipment (VOR/DME) navigational aid
(NAVAID). The Natchez VOR is being decommissioned in support of the
FAA's VOR Minimum Operational Network (MON) program.

DATES: Comments must be received on or before April 17, 2023.

ADDRESSES: Send comments identified by FAA Docket No. FAA-2023-0444 and
Airspace Docket No. 22-ASO-16 using any of the following methods:
    * Federal eRulemaking Portal: Go to 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, 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 www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.
    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 the 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 7400.11G, Airspace Designations and Reporting Points,
and subsequent amendments can be viewed online at www.faa.gov/air_traffic/publications/.

FOR FURTHER INFORMATION CONTACT: Colby Abbott, Rules and Regulations
Group, Office of Policy, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

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
the 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 modify the enroute structure as necessary to
preserve the safe and efficient flow of air traffic within the National
Airspace System (NAS).

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 receives 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 delay. The FAA may change this proposal in light
of the comments it receives.

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
Operations office (see ADDRESSES section for address, phone number, and
hours of operations). An informal docket may also be examined during
normal business hours at the office of the Operations Support Group,
Central Service Center, Federal Aviation Administration, 10101 Hillwood
Parkway, Fort Worth, TX 76177.

Incorporation by Reference

    VOR Federal airways are published in paragraph 6010(a) and United
States Area Navigation Routes (T-routes) are published in paragraph
6011 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 7400.11G, dated August 19, 2022, and effective
September 15, 2022. These updates would be published 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 7400.11G lists Class A, B, C, D, and E airspace areas,
air traffic service routes, and reporting points.

Background

    The FAA is planning to decommission the Natchez, MS, VOR in October
2023. The Natchez VOR was one of the candidate VORs identified for
discontinuance by the FAA's VOR MON program and listed in the final
policy statement notice, ``Provision of Navigation Services for the
Next Generation Air Transportation System (NextGen) Transition to
Performance-Based Navigation (PBN) (Plan for Establishing a VOR Minimum
Operational Network),'' published in the Federal Register on July 26,
2016 (81 FR 48694), Docket No. FAA-2011-1082.
    Although the VOR portion of the Natchez, MS, VOR/DME is planned for
decommissioning, the co-located DME portion of the NAVAID is being
retained to support NextGen PBN flight procedure requirements.
    The VOR Federal airways affected by the Natchez VOR decommissioning
are V-71, V-245, V-554, and V-570. With the planned decommissioning of
the Natchez VOR, the remaining ground-based NAVAID coverage in the area
is insufficient to enable the continuity of the affected airways. As
such, the FAA proposes to shorten V-71 and V-245 and revoke V-554 and
V-570.
    To address the proposed modifications and revocations to the
affected Air Traffic Service (ATS) routes, instrument flight rules
(IFR) traffic could use portions of adjacent VOR Federal airways,
including V-9, V-18, and V-212, or receive air traffic control (ATC)
radar vectors to fly around or through the affected area. In addition,
the FAA proposes new RNAV routes T-471, T-473, or T-474 that pilots
equipped with RNAV capabilities could use to navigate point to point
using the existing NAVAIDs and fixes that would remain in place to
support continued operations though the affected area. Visual flight
rules (VFR) pilots who elect to navigate via the affected VOR Federal
airways could also take advantage of the adjacent airways or ATC
services listed previously.
    The FAA proposes to establish RNAV routes T-471, T-473, and T-474
to provide mitigations to the proposed VOR Federal airway amendments
due to the planned Natchez VOR decommissioning. RNAV route T-471 would
mitigate the proposed removal of the V-71 airway segment, RNAV route T-
473 would mitigate portions of the proposed revocations of V-554 and V-
570, and RNAV route T-474 would mitigate the proposed removal of the V-
245 airway segment. The new T-routes would reduce ATC sector workload
and complexity, reduce pilot-to-controller communication, provide RNAV
equipped aircraft an ATS route alternative, and support the FAA's
NextGen efforts to modernize the NAS navigation system from a ground-
based system to a satellite-based system.

The Proposal

    The FAA is proposing to amend 14 CFR part 71 by amending VOR
Federal airways V-71 and V-245, revoking V-554 and V-570, and
establishing RNAV routes T-471, T-473, and T-474. The ATS route
amendments, revocations, and establishments are due to the planned
decommissioning of the Natchez, MS, VOR. The proposed ATS route actions
are described below.
    V-71: V-71 currently extends between the Fighting Tiger, LA, VOR/
Tactical Air Navigation (VORTAC) and the Topeka, KS, VORTAC; between
the Lincoln, NE, VORTAC and the O'Neill, NE, VORTAC; and between the
Pierre, SD, VORTAC and the Williston, ND, VOR/DME. The FAA proposes to
remove the airway segment overlying the Natchez, MS, VOR/DME between
the Fighting Tiger VORTAC and the Monroe, LA, VORTAC. As amended, the
airway would extend between the Monroe VORTAC and the Topeka VORTAC,
between the Lincoln VORTAC and the O'Neill VORTAC, and between the
Pierre VORTAC and the Williston VOR/DME.
    V-245: V-245 currently extends between the Alexandria, LA, VORTAC
and the Bigbee, MS, VORTAC. The FAA proposes to remove the airway
segment overlying the Natchez, MS, VOR/DME between the Alexandria
VORTAC and the Magnolia, MS, VORTAC. As amended, the airway would
extend between the Magnolia VORTAC and the Bigbee VORTAC.
    V-554: V-554 currently extends between the Natchez, MS, VOR/DME and
the Monroe, LA, VORTAC. The FAA proposes to remove the airway in its
entirety.
    V-570: V-570 currently extends between the Alexandria, LA, VORTAC
and the McComb, MS, VORTAC. The FAA proposes to remove the airway in
its entirety.
    T-471: T-471 is a new RNAV route proposed to extend between the
RCOLA, LA, waypoint (WP), located near the Fighting Tiger, LA, VORTAC,
and the Monroe, LA, VORTAC. The proposed T-471 would provide mitigation
for the proposed removal of the V-71 airway segment between the

Fighting Tiger VORTAC and the Monroe VORTAC. This new route would
provide RNAV routing from the Baton Rouge, LA, area northwestward to
the Monroe, LA, area. The full T-471 route description is listed in the
amendments to part 71 as set forth below.
    T-473: T-473 is a new RNAV route proposed to extend between the
ICEKI, MS, WP and the Monroe, LA, VORTAC. The proposed T-473 would
provide mitigation for the proposed revocation of V-570 between the Mc
Comb VORTAC and the Natchez VOR/DME and for the proposed revocation of
V-554 between the Natchez VOR/DME and Monroe VORTAC. This new route
would provide RNAV routing from the McComb, MS, area northwestward to
the Monroe, LA, area. The full T-473 route description is listed in the
amendments to part 71 as set forth below.
    T-474: T-474 is a new RNAV route proposed to extend between the
Alexandria, LA, VORTAC and the Magnolia, MS, VORTAC. The proposed T-474
would provide mitigation to the proposed removal of the V-245 airway
segment between the Alexandria VORTAC and the Magnolia VORTAC. This new
T-route would provide RNAV routing from the Alexandria, LA, area
northeastward to the Magnolia, MS, area. The full T-474 route
description is listed in the amendments to part 71 as set forth below.
    All NAVAID radials listed in the V-71 description below are
unchanged and stated in degrees True north.

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
7400.11G, Airspace Designations and Reporting Points, dated August 19,
2022, and effective September 15, 2022, is amended as follows:

Paragraph 6010(a) Domestic VOR Federal Airways.

* * * * *

V-71 [Amended]

    From Monroe, LA; El Dorado, AR; Hot Springs, AR; INT Hot Springs
358[deg] and Harrison, AR, 176[deg] radials; Harrison; Springfield,
MO; Butler, MO; to Topeka, KS. From Lincoln, NE; Columbus, NE; to
O'Neill, NE. From Pierre, SD; Bismarck, ND; to Williston, ND.
* * * * *

V-245 [Amended]

    From Magnolia, MS; to Bigbee, MS.
* * * * *

V-554 [Removed]

* * * * *

V-570 [Removed]

* * * * *

Paragraph 6011 United States Area Navigation Routes.

* * * * *

T-471 RCOLA, LA to Monroe, LA (MLU) [New]

RCOLA, LA                                    WP                             (Lat. 30[deg]29'06.52'' N, long. 091[deg]17'37.96'' W)
NTCHZ, MS                                    WP                             (Lat. 31[deg]37'05.81'' N, long. 091[deg]17'58.18'' W)
Monroe, LA (MLU)                             VORTAC                         (Lat. 32[deg]31'00.77'' N, long. 092[deg]02'09.65'' W)

                                                                      * * * * * * *
T-473 ICEKI, MS to Monroe, LA (MLU) [New]

ICEKI, MS                                    WP                             (Lat. 31[deg]18'16.12'' N, long. 090[deg]15'28.85'' W)
NTCHZ, MS                                    WP                             (Lat. 31[deg]37'05.81'' N, long. 091[deg]17'58.18'' W)
TULLO, LA                                    WP                             (Lat. 31[deg]58'47.77'' N, long. 091[deg]48'24.56'' W)
Monroe, LA (MLU)                             VORTAC                         (Lat. 32[deg]31'00.77'' N, long. 092[deg]02'09.65'' W)

                                                                      * * * * * * *
T-474 Alexandria, LA (AEX) to Magnolia, MS (MHZ) [New]

Alexandria, LA (AEX)                         VORTAC                         (Lat. 31[deg]15'24.23'' N, long. 092[deg]30'03.50'' W)
NTCHZ, MS                                    WP                             (Lat. 31[deg]37'05.81'' N, long. 091[deg]17'58.18'' W)
Magnolia, MS (MHZ)                           VORTAC                         (Lat. 32[deg]26'02.65'' N, long. 090[deg]05'59.18'' W)

* * * * *

    Issued in Washington, DC, on February 22, 2023.
Brian Konie,
Acting Manager, Airspace Rules and Regulations.
[FR Doc. 2023-04042 Filed 2-28-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 132 (Tuesday, July 12, 2022)]
[Notices]
[Pages 41326-41327]
[FR Doc No: 2022-14828]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2022-0206]

Recertification of Cook Inlet Regional Citizens' Advisory Council

AGENCY: Coast Guard, DHS.

ACTION: Notice of recertification.

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SUMMARY: The Coast Guard announces the recertification of the Cook
Inlet Regional Citizens' Advisory Council (CIRCAC) as an alternative
voluntary advisory group for Cook Inlet, Alaska. This certification
allows the CIRCAC to monitor the activities of terminal facilities and
crude oil tankers under the Cook Inlet Program established by the Oil
Terminal and Oil Tanker Environmental Oversight and Monitoring Act of
1990.

DATES: This recertification is effective for the period from September
1, 2022 through August 31, 2023.

FOR FURTHER INFORMATION CONTACT: For information about this document,
call or email LT Lauren Bloch, Seventeenth Coast Guard District (dpi),
by phone at<PHONE_NUMBER> or email at [email protected].

SUPPLEMENTARY INFORMATION:

Background and Purpose

    The Coast Guard published guidelines on December 31, 1992 (57 FR
62600), to assist groups seeking recertification under the Oil Terminal
and Oil Tanker Environmental Oversight and Monitoring Act of 1990 (33
U.S.C. 2732) (the Act). The Coast Guard issued a policy statement on
July 7, 1993 (58 FR 36504), to clarify the factors that the Coast Guard
would be considering in making its determination as to whether advisory
groups should be certified in accordance with the Act, and the
procedures which the Coast Guard would follow in meeting its
certification responsibilities under the Act.
    Most recently, on September 16, 2002 (67 FR 58440), the Coast Guard
changed its policy on recertification procedures for regional citizen's
advisory council by requiring applicants to provide comprehensive
information every three years. For each of the two years between the
triennial application procedures, applicants submit a letter requesting
recertification that includes a description of any substantive changes
to the information provided at the previous triennial recertification.
Further, public comment is only solicited during the triennial
comprehensive review.

Recertification

    By letter dated June 29, 2022, the Commander, Seventeenth Coast
Guard District, certified that the CIRCAC qualifies as an alternative
voluntary advisory group under 33 U.S.C. 2732(o). This recertification
terminates on August 31, 2023.

    Dated: July 1, 2022.
Nathan A. Moore,
Rear Admiral, U.S. Coast Guard, Commander, Seventeenth Coast Guard
District.
[FR Doc. 2022-14828 Filed 7-11-22; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 80, Number 30 (Friday, February 13, 2015)]
[Notices]
[Pages 8088-8089]
[FR Doc No: 2015-03001]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-P-1055]

Determination That SUBUTEX (Buprenorphine Hydrochloride)
Sublingual Tablets, Equivalent 2 Milligrams Base and Equivalent 8
Milligrams Base, Were Not Withdrawn From Sale for Reasons of Safety or
Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined that
SUBUTEX (buprenorphine hydrochloride (HCl)) Sublingual Tablets,
Equivalent (Eq) 2 milligrams (mg) base and Eq 8 mg base, were not
withdrawn from sale for reasons of safety or effectiveness. This
determination means that FDA will not begin procedures to withdraw
approval of abbreviated new drug applications (ANDAs) that refer to
SUBUTEX, and it will allow FDA to continue to approve ANDAs that refer
to SUBUTEX as long as they meet relevant legal and regulatory
requirements.

FOR FURTHER INFORMATION CONTACT: Ayako Sato, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6228, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA sponsors must,
with certain exceptions, show that the drug for which they are seeking
approval contains the same active ingredient in the same strength and
dosage form as the ``listed drug,'' which is a version of the drug that
was previously approved. Sponsors of ANDAs do not have to repeat the
extensive clinical testing otherwise necessary to gain approval of a
new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products with Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, a drug is removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
    Under Sec.  314.161(a) (21 CFR 314.161(a)), the Agency must
determine whether a listed drug was withdrawn from sale for reasons of
safety or effectiveness: (1) Before an ANDA that refers to that listed
drug may be approved, (2) whenever a listed drug is voluntarily
withdrawn from sale and ANDAs that refer to the listed drug have been
approved, and (3) when a person petitions for such a determination
under 21 CFR 10.25(a) and 10.30.
    SUBUTEX (buprenorphine HCl) Sublingual Tablets is the subject of
NDA 20-732, held by Reckitt Benckiser Pharmaceuticals, Inc. (Reckitt).
It was approved on October 8, 2002. After Reckitt discontinued
marketing SUBUTEX in 2011, FDA moved SUBUTEX to the ``Discontinued Drug
Product List'' section of the Orange Book. Another buprenorphine-
containing product, SUBOXONE (buprenorphine HCl and naloxone HCl)
Sublingual Tablets, is the subject of NDA 20-733, also held by Reckitt.
It was originally approved on October 8, 2002, and later approved in
another dosage form (sublingual film) on August 30, 2010, under NDA 22-
410. In March 2013, Reckitt discontinued marketing the sublingual
tablet dosage form of SUBOXONE.\1\ All three products are approved for
treatment of opioid dependence.\2\
---------------------------------------------------------------------------

    \1\ On September 27, 2012, after Reckitt publicly announced that
it was planning to discontinue the product, Lachman Consultant
Services Inc. (Lachman) submitted a citizen petition requesting that
the Agency determine whether SUBOXONE Sublingual Tablets were
withdrawn from sale for reasons of safety or effectiveness (Docket
No. FDA-2012-P-1034). After considering Lachman's citizen petition
and reviewing our records, including the analysis that the Agency
prepared in connection with Reckitt's citizen petition (Docket No.
FDA-2012-P-1028), FDA determined that SUBOXONE Sublingual Tablets
was not discontinued for reasons of safety or effectiveness (78 FR
34108).
    \2\ On September 25, 2012, Reckitt submitted a citizen petition
requesting that FDA not approve any new drug application or
abbreviated new drug application (ANDA) for a buprenorphine product
for treatment of opioid dependence unless the applications and
products met certain criteria. On February 22, 2013, FDA denied
Reckitt's petition (Docket No. FDA-2012-P-1028).
---------------------------------------------------------------------------

    Actavis Elizabeth LLC submitted a citizen petition dated August 16,
2013 (Docket No. FDA-2013-P-1055), under 21 CFR 10.30, requesting that
FDA determine whether SUBUTEX was withdrawn from sale for reasons of
safety or effectiveness. The petition contains no data or other
information suggesting that SUBUTEX was withdrawn for reasons of safety
or effectiveness.
    We have carefully reviewed our records concerning the withdrawal of
SUBUTEX from sale. Based on the information we have at this time, FDA
has determined under Sec.  314.161 that SUBUTEX was not withdrawn for
reasons of safety or effectiveness.
    The buprenorphine in both SUBUTEX and SUBOXONE is a mu opioid
partial agonist that can precipitate withdrawal in patients physically
dependent on full opioid agonists. That is, the relative reduction in
activity at the mu receptor when buprenorphine replaces a full opioid
agonist can cause symptoms of opioid withdrawal. SUBOXONE also contains
naloxone. Naloxone is a potent

opioid antagonist with high affinity for the mu opioid receptor. The
naloxone is intended to be inactive when SUBOXONE is used
appropriately, but to precipitate more severe withdrawal symptoms if
the product is crushed and injected by an individual dependent on full
opioid agonists. A variety of factors such as degree of opioid
dependence, relative amount of buprenorphine exposure, and route of
administration influence the antagonist effect of naloxone. As a
result, buprenorphine/naloxone combination products may not have the
same effect on non-dependent opioid abusers or abusers of
buprenorphine. As stated in the approved SUBOXONE labeling in section
12.2, ``naloxone in buprenorphine/naloxone tablets may deter injection
of buprenorphine/naloxone tablets by persons with active substantial
heroin or other full mu-opioid dependence,'' but ``some opioid-
dependent persons, particularly those with a low level of full mu-
opioid physical dependence or those whose opioid physical dependence is
predominantly to buprenorphine, abuse buprenorphine/naloxone
combinations by the intravenous or intranasal route.''
    SUBUTEX has important therapeutic benefits for certain patient
populations that may not tolerate or should not be exposed to the
naloxone in SUBOXONE. Specifically, as explained in section 5.11 of the
approved labeling for SUBOXONE, ``[b]uprenorphine/naloxone products are
not recommended in patients with severe hepatic [liver] impairment and
may not be appropriate for patients with moderate hepatic impairment.''
Section 5.11 further states that ``hepatic impairment results in a
reduced clearance of naloxone to a much greater extent than
buprenorphine,'' and thus, ``patients with severe hepatic impairment
will be exposed to substantially higher levels of naloxone than
patients with normal hepatic function.'' SUBUTEX also is preferred to
SUBOXONE for patients transitioning from treatment with methadone or
other long-acting opioid products because they are at higher risk for
precipitated and prolonged withdrawal, and the naloxone in
buprenorphine/naloxone combination products may cause worse withdrawal
in this population.
    Although Reckitt has publicly stated that SUBUTEX ``creates a
greater risk of misuse, abuse, and diversion'' than SUBOXONE (please
refer to letter from Reckitt to Health Care Providers, available at
http://buprenorphine.samhsa.gov/SubutexDiscontinuation9-16-11.pdf),
Reckitt has not submitted any data, information, or analysis to support
this claim. Based on our independent review of the available data and
the published studies on the relative abuse liability of SUBUTEX and
SUBOXONE, we do not have sufficient information at this time to
determine that SUBUTEX poses an increased potential for abuse or misuse
relative to SUBOXONE. Furthermore, as discussed previously, SUBUTEX has
important therapeutic benefits for certain patient populations that may
not tolerate or should not be exposed to the naloxone in SUBOXONE.
    For these reasons, based on the data and information available to
the Agency at this time, we find that the benefits of SUBUTEX continue
to outweigh the risks. Therefore, we conclude that SUBUTEX was not
withdrawn from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list SUBUTEX in the
``Discontinued Drug Product List'' section of the Orange Book. The
``Discontinued Drug Product List'' delineates, among other items, drug
products that have been discontinued from marketing for reasons other
than safety or effectiveness. FDA will not begin procedures to withdraw
approval of ANDAs that refer to SUBUTEX. Such ANDAs may continue to be
approved by the Agency as long as they meet all other legal and
regulatory requirements for the approval of ANDAs.

    Dated: February 9, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03001 Filed 2-12-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: May 3, 2007 (Volume 72, Number 85)]
[Notices]
[Page 24635-24636]
[DOCID:fr03my07-105]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange

Commission, Office of Filings and Information Services, Washington, DC
20549.

Extension:
    Rule 19d-3, SEC File No. 270-245, OMB Control No. 3235-0204.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.) the Securities and Exchange Commission
(``Commission'') intends to submit to the Office of Management and
Budget a request for extension of the previously approved collection of
information discussed below.
     Rule 19d-3 (17 CFR 240.19d-3)--Applications for Review of
Final Disciplinary Sanctions, Denials of Membership, Participation or
Association, or Prohibitions or Limitations of Access to Services
Imposed by Self-Regulatory Organizations.
    Rule 19d-3 under the Securities Exchange Act of 1934 (17 U.S.C. 78a
et seq.) prescribes the form and content of applications to the
Commission by persons desiring stays of final disciplinary sanctions
and summary action of self-regulatory organizations (``SROs'') for
which the Commission is the appropriate regulatory agency. The
Commission uses the information provided in the application filed
pursuant to Rule 19d-3 to review final actions taken by SROs including:
(1) Disciplinary sanctions; (2) denials of membership, participation or
association; and (3) prohibitions on or limitations of access to SRO
services.
    It is estimated that approximately 15 respondents will utilize this
application procedure annually, with a total burden of 270 hours, for
all respondents to complete all submissions. This figure is based upon
past submissions. The staff estimates that the average number of hours
necessary to comply with the requirements of Rule 19d-3 is 18 hours.
The average cost per hour, to complete each submission, is
approximately $101. Therefore, the total cost of compliance for all
respondents is $27,270. (15 submissions x 18 hours x $101 per hour).
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information shall
have practical utility; (b) the accuracy of the agency's estimates of
the burden of the proposed collection of information; (c) ways to
enhance the quality, utility and clarity of the information to be
collected; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted in
writing within 60 days of this publication.
    Direct your written comments to R. Corey Booth, Director/Chief
Information Officer, Securities and Exchange Commission, C/O Shirley
Martinson, 6432 General Green Way, Alexandria, VA 22312 or send an e-
mail to<EMAIL_ADDRESS>Comments must be submitted to OMB within
60 days of this notice.

    Dated: April 24, 2007.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-8428 Filed 5-2-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 87, Number 147 (Tuesday, August 2, 2022)]
[Notices]
[Pages 47238-47239]
[FR Doc No: 2022-16480]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-537, OMB Control No. 3235-0597]

Submission for OMB Review; Comment Request: Extension: Rule 31
and Form R31

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

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (``PRA'') (44 U.S.C. 3501 et seq.), the Securities and
Exchange Commission (``Commission'') has submitted to the Office of
Management and Budget (``OMB'') a request for extension of the
previously approved collection of information provided for in Rule 31
(17 CFR 240.31) and Form R31 (17 CFR 249.11) under the Securities
Exchange Act of 1934 (15 U.S.C. 78ee) (``Exchange Act'').
    Section 31 of the Exchange Act requires the Commission to collect
fees and assessments from national securities exchanges and national
securities associations (collectively, ``self-regulatory
organizations'' or ``SROs'') based on the volume of their securities
transactions. To collect the proper amounts, the Commission adopted
Rule 31 and Form R31 under the Exchange Act whereby each SRO must
report to the Commission the volume of its securities transactions and
the Commission, based on those data, calculates the amount of fees and
assessments that each SRO owes pursuant to Section 31. Rule 31 and Form
R31 require each SRO to provide these data on a monthly basis.
    Currently, there are 27 respondents under Rule 31 that are subject
to the collection of information requirements of Rule 31: 24 national
securities exchanges, one national securities association, and two
registered clearing agencies that are required to provide certain data
in their possession needed by the SROs to complete Form R31, although
these two clearing agencies are not themselves required to complete and
submit Form R31.\1\ The Commission estimates that the total burden for
all 27 respondents is 432 hours per year. The Commission estimates
that, based on previous and current experience, three additional
national securities exchanges will become registered and subject to the
reporting requirements of Rule 31 over the course of the authorization
period and collectively incur a burden of 18 hours per year. Thus, the
Commission estimates the collective burden for all respondents
(existing and new added together) to be 450 hours per year. The SEC
does not believe that the 27 existing or 3 expected new respondents
will have to incur any capital or start-up costs, or any additional
operational or maintenance costs (other than as already discussed in
this paragraph), to comply with the collection of information
requirements imposed by Rule 31 and Form R31. The SEC estimates that
the average annual cost to the SEC of processing all of these filings
would be $20,307.48 (90.1 hours at an average of $225.39 per hour).
---------------------------------------------------------------------------

    \1\ Since the last renewal period, when there was one security
futures exchange that reported transactions, that exchanged has
ceased operation. Therefore, currently, no security futures
exchanges report any transaction in security futures on Form R31.

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

    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    The public may view background documentation for this information
collection at the following website: >www.reginfo.gov<. Find this
particular information collection by selecting ``Currently under 30-day
Review--Open for Public Comments'' or by using the search function.
Written comments and recommendations for the proposed information
collection should be sent by September 1, 2022 to (i)
>[email protected]< and (ii) David Bottom,
Director/Chief Information Officer, Securities and Exchange Commission,
c/o John Pezzullo, 100 F Street NE, Washington, DC 20549, or by sending
an email to: [email protected].

    Dated: July 27, 2022.
J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2022-16480 Filed 8-1-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 237 (Tuesday, December 11, 2018)]
[Notices]
[Page 63636]
[FR Doc No: 2018-26731]

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ENVIRONMENTAL PROTECTION AGENCY

[9986-19-OEI]

Cross-Media Electronic Reporting: Authorized Program Revision
Approval, State of Kansas

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces EPA's approval of the State of Kansas'
request to revise/modify certain of its EPA-authorized programs to
allow electronic reporting.

DATES: EPA approves the authorized program revisions/modifications as
of December 11, 2018.

FOR FURTHER INFORMATION CONTACT: Devon Martin, U.S. Environmental
Protection Agency, Office of Environmental Information, Mail Stop
2824T, 1200 Pennsylvania Avenue NW, Washington, DC 20460, (202) 566-
2603<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On October 13, 2005, the final Cross-Media
Electronic Reporting Rule (CROMERR) was published in the Federal
Register (70 FR 59848) and codified as part 3 of title 40 of the CFR.
CROMERR establishes electronic reporting as an acceptable regulatory
alternative to paper reporting and establishes requirements to assure
that electronic documents are as legally dependable as their paper
counterparts. Subpart D of CROMERR requires that state, tribal or local
government agencies that receive, or wish to begin receiving,
electronic reports under their EPA-authorized programs must apply to
EPA for a revision or modification of those programs and obtain EPA
approval. Subpart D provides standards for such approvals based on
consideration of the electronic document receiving systems that the
state, tribe, or local government will use to implement the electronic
reporting. Additionally, Sec.  3.1000(b) through (e) of 40 CFR part 3,
subpart D provides special procedures for program revisions and
modifications to allow electronic reporting, to be used at the option
of the state, tribe or local government in place of procedures
available under existing program-specific authorization regulations. An
application submitted under the subpart D procedures must show that the
state, tribe or local government has sufficient legal authority to
implement the electronic reporting components of the programs covered
by the application and will use electronic document receiving systems
that meet the applicable subpart D requirements.
    On September 11, 2018, the Kansas Department of Health and
Environment (KDHE) submitted an application titled ``Kansas
Environmental Information Management System'' for revisions/
modifications to its EPA-approved programs under title 40 CFR to allow
new electronic reporting. EPA reviewed KDHE's request to revise/modify
its EPA-authorized programs and, based on this review, EPA determined
that the application met the standards for approval of authorized
program revisions/modifications set out in 40 CFR part 3, subpart D. In
accordance with 40 CFR 3.1000(d), this notice of EPA's decision to
approve Kansas' request to revise/modify its following EPA-authorized
programs to allow electronic reporting under 40 CFR parts 50-52, 60-65,
and 70, is being published in the Federal Register:
    Part 52--Approval and Promulgation of Implementation Plans;
    Part 60--Standards of Performance For New Stationary Sources;
    Part 62--Approval and Promulgation of State Plans for Designated
Facilities and Pollutants;
    Part 63--National Emission Standards for Hazardous Air Pollutants
for Source Categories; and
    Part 70--State Operating Permit Programs.
    KDHE was notified of EPA's determination to approve its application
with respect to the authorized programs listed above.

Matthew Leopard,
Director, Office of Information Management.
[FR Doc. 2018-26731 Filed 12-10-18; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 104 (Thursday, May 30, 2019)]
[Notices]
[Pages 25117-25118]
[FR Doc No: 2019-11208]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2018-0054; Notice 2]

General Motors, LLC, Grant of Petition for Decision of
Inconsequential Noncompliance

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Grant of petition.

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SUMMARY: General Motors, LLC (GM), has determined that certain model
year (MY) 2018 Buick Regal motor vehicles do not fully comply with
Federal Motor Vehicle Safety Standard (FMVSS) No. 110, Tire Selection
and Rims and Motor Home/Recreation Vehicle Trailer Load Carrying
Capacity Information for Motor Vehicles with a GVWR of 4,536 kilograms
(10,000 pounds) or Less. GM filed a noncompliance report dated April 4,
2018, and subsequently petitioned NHTSA on April 27, 2018, for a
decision that the subject noncompliance is inconsequential as it
relates to motor vehicle safety. This document announces the grant of
GM's petition.

FOR FURTHER INFORMATION CONTACT: Kerrin Bressant, Office of Vehicle
Safety Compliance, the National Highway Traffic Safety Administration
(NHTSA), telephone<PHONE_NUMBER>, facsimile<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Overview

    GM has determined that certain MY 2018 Buick Regal motor vehicles
do not fully comply with paragraph S4.3 of Federal Motor Vehicle Safety
Standard (FMVSS) No. 110, Tire Selection and Rims and Motor Home/
Recreation Vehicle Trailer Load Carrying Capacity Information for Motor
Vehicles with a GVWR of 4,536 kilograms (10,000 pounds) or Less (49 CFR
571.110). GM filed a noncompliance report dated April 4, 2018, pursuant
to 49 CFR part 573, Defect and Noncompliance Responsibility and
Reports. GM also petitioned NHTSA on April 27, 2018, pursuant to 49
U.S.C. 30118(d) and 30120(h) and 49 CFR part 556, for an exemption from
the notification and remedy requirements of 49 U.S.C. Chapter 301 on
the basis that this noncompliance is inconsequential as it relates to
motor vehicle safety.
    Notice of receipt of GM's petition was published, with a 30-day
public comment period on May 24, 2018, in the Federal Register (83 FR
24162). No Comments were received.

II. Vehicles Involved

    Approximately 1,029 MY 2018 Buick Regal motor vehicles manufactured
between August 22, 2017, and February 15, 2018, are potentially
involved.

III. Noncompliance

    GM explains that the noncompliance is that the subject vehicles
were equipped with tire placards that incorrectly state the spare tire
size and cold tire pressure. Specifically, the tire placards state that
the spare tire size is ``None'' when in fact it should have been
``T125/70R17'' and omitted the cold tire pressure for the spare tire
when it should have read ``420 kPa, 60 psi,'' as required by paragraph
S4.3 of FMVSS No. 110.

IV. Rule Requirements

    Paragraph S4.3 of FMVSS No. 110 includes the requirements relevant
to this petition. Each vehicle, except for a trailer or incomplete
vehicle, shall show the original spare tire size designation and
recommended cold tire inflation pressure on a placard permanently
affixed to the vehicle on the driver's side B-pillar.

V. Summary of GM's Petition

    GM described the subject noncompliance and stated its belief that
the noncompliance is inconsequential as it relates to motor vehicle
safety.
    In support of its petition, GM submitted the following reasoning:
    1. There is no issue with the spare tire itself, it's safe and
nondefective. The only issue here is that certain information about the
spare tire is not listed on the vehicle placard. But that is
inconsequential because that information is provided in other
locations.
    2. Specifically, the spare tire information is located in at least
three places: (1) On the sidewall of the spare tire; (2) in the owner's
manual, which the vehicle placard specifically directs the customer to
for additional information; and (3) on the Monroney label.
    3. There is no issue with the road tires and the information on the
vehicle placard for the road tires is correct.
    4. In the event of a flat tire, the customer will have a spare tire
that is labeled with the proper inflation pressure and has a sufficient
load rating for the vehicle. It will be immediately apparent to any
customer potentially confused by the ``none'' language that the vehicle
has a spare tire when they lift the liftgate as explained in the
owner's manual. In addition, the fact that the vehicle has a spare tire
is explained on the Monroney label.
    5. The spare-tire size and pressure information is readily
available from additional sources (e.g., any automotive dealer or tire
replacement facility), and on GM's or the tire retailer's website.
    6. Most, if not all, temporary spare tires have the same cold tire
pressure, which is 60 psi. The 60 psi pressure is an industry standard
and it is set by at least two governing bodies, the U.S. Tire and Rim
Association and the European Tire Rim Technical Organization.
    7. All other information on the vehicle placard is correct.
    8. NHTSA has previously granted similar inconsequential petitions
with respect to FMVSS No. 110 noncompliances.
    9. GM is not aware of any field or owner complaints associated with
this issue. GM is also not aware of any crashes or injuries associated
with this condition.
    GM's complete petition and all supporting documents are available
by logging onto the Federal Docket Management System (FDMS) website at
https://www.regulations.gov and by following the online search
instructions to locate the docket number as listed in the title of this
notice.

VI. NHTSA's Analysis

    The intent of FMVSS No. 110 is to ensure that vehicles are equipped
with tires appropriate to handle maximum vehicle loads and to prevent
overloading.
    GM explained that the subject vehicles are equipped with tire and

loading information labels that do not provide the cold tire pressure
or original size information for the spare tire, and instead,
incorrectly indicated that there is no spare tire.
    The agency agrees with GM that the subject noncompliance is
inconsequential to motor vehicle safety. Even though the subject
vehicles have erroneously marked tire placard labels, the subject
vehicles are equipped with the appropriate matched spare tire and rim
combination, and that when properly mounted on the subject vehicles,
would allow the vehicles to be operated safely within the
manufacturer's specified performance and loading limits. The agency
agrees with GM, that should a customer question whether the vehicle
comes equipped with a spare tire or what the cold tire pressure is for
the spare tire, most customers would consult the Owner's Manual, which
would direct the customer to the spare tire location as well as provide
the recommended tire pressure. Should the Owner's Manual be
unavailable, the customer would be able to lift the liftgate and see
that there is a spare tire or contact any authorized dealer or tire
replacement facility for assistance.

VII. NHTSA's Decision

    In consideration of the foregoing, NHTSA finds that GM has met its
burden of persuasion that the FMVSS No. 110 noncompliance is
inconsequential as it relates to motor vehicle safety. Accordingly,
GM's petition is hereby granted and GM is exempted from the obligation
of providing notification of, and a remedy for, the noncompliance under
49 U.S.C. 30118 and 30120.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners, purchasers, and dealers of a defect or noncompliance
and to remedy the defect or noncompliance. Therefore, this decision
only applies to the subject vehicles that GM no longer controlled at
the time it determined that the noncompliance existed. However, the
granting of this petition does not relieve vehicle distributors and
dealers of the prohibitions on the sale, offer for sale, or
introduction or delivery for introduction into interstate commerce of
the noncompliant vehicles under their control after GM notified them
that the subject noncompliance existed.

    Authority: (49 U.S.C. 30118, 30120: delegations of authority at
49 CFR 1.95 and 501.8)

Otto G. Matheke III,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2019-11208 Filed 5-29-19; 8:45 am]
 BILLING CODE 4910-59-P


[Federal Register: September 2, 2010 (Volume 75, Number 170)]
[Notices]
[Page 53978]
[DOCID:fr02se10-76]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1925-DR; Docket ID FEMA-2010-0002]

Kentucky; Amendment No. 5 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the Commonwealth of Kentucky (FEMA-1925-DR), dated July 23, 2010,
and related determinations.

DATES: Effective Date: August 19, 2010.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Recovery Directorate,
Federal Emergency Management Agency, 500 C Street, SW., Washington, DC
20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Terry L.
Quarles, of FEMA is appointed to act as the Federal Coordinating
Officer for this disaster.
    This action terminates the appointment of Douglas G. Mayne as
Federal Coordinating Officer for this disaster.

(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.)

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2010-21901 Filed 9-1-10; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 84, Number 89 (Wednesday, May 8, 2019)]
[Notices]
[Pages 20140-20142]
[FR Doc No: 2019-09381]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-7011]

Laser Products--Conformance With IEC 60825-1 Ed. 3 and IEC 60601-
2-22 Ed. 3.1 (Laser Notice No. 56); Guidance for Industry and Food and
Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Laser
Products--Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1
(Laser Notice No. 56).'' This guidance describes the Agency's approach
regarding compliance with FDA's performance standards for laser
products. FDA believes that under the circumstances described in this
guidance, conformance with certain International Electrotechnical
Commission (IEC) standards would provide adequate protection of the
public health and safety for laser products similar to performance
standards in FDA's regulations. Accordingly, for laser product
manufacturers that comply with the comparable clauses in IEC standards
specified in the guidance, FDA does not intend to enforce the specified
laser performance standards in FDA's regulations.

DATES: The announcement of the guidance is published in the Federal
Register on May 8, 2019.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time 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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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-7011 for ``Laser Products--Conformance with IEC 60825-1 Ed.
3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56).'' 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 Dockets Management Staff 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 Dockets Management Staff. 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:
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Laser Products--Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22
Ed. 3.1 (Laser Notice No. 56)'' to the Office of Policy, Guidance and
Policy Development, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Patrick Hintz, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4228, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA recognizes that the IEC is a global organization that prepares
and publishes international standards for electrical, electronic, and
related technologies, including laser products. This means that
manufacturers distributing products in the United States and other
countries might have to ensure conformance of their products with IEC
standards as well as comply with FDA regulatory requirements. Complying
with FDA regulations and conforming to the identified IEC standards may
cause manufacturers to duplicate their efforts.
    FDA acknowledges the advantages of a universal set of device-
specific criteria and requirements. Moreover, FDA believes that under
the circumstances described in this guidance, conformance with certain
IEC standards would provide adequate protection of the public health
and safety for laser products similar to FDA's performance standards in
Sec. Sec.  [thinsp]1040.10 and 1040.11 (21 CFR 1040.10 and 1040.11).
FDA eventually intends to amend its standards for laser products at
Sec. Sec.  [thinsp]1040.10 and 1040.11 to harmonize many of its
requirements with those of the IEC because FDA acknowledges the
advantages of one set of criteria and requirements worldwide. Until
these requirements are harmonized, for laser product manufacturers that
comply with the comparable clauses in IEC 60825-1 Ed. 3 and IEC 60601-
2-22 Ed. 3.1, FDA does not intend to enforce the comparable
requirements in Sec. Sec.  1040.10 and 1040.11.
    On June 24, 2007, FDA's Center for Devices and Radiological Health
(CDRH) published a guidance entitled ``Laser Products--Conformance with
IEC 60825-1 and IEC 60601-2-22; Guidance for Industry and FDA Staff
(Laser Notice No. 50)'' (https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/laser-products-conformance-iec-60825-1-and-iec-60601-2-22-laser-notice-no-50). Laser Notice No. 56 will not replace the recommendations provided
in that 2007 guidance, and manufacturers can follow either Laser Notice
No. 50 or 56.
    FDA considered comments received on the draft guidance that
appeared in the Federal Register of January 19, 2018 (83 FR 2789). FDA
revised the guidance as appropriate in response to the comments.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Laser Products--Conformance with IEC
60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56).'' 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. This guidance
is not subject to Executive Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance document is also available at https://www.regulations.gov.
Persons unable to download an electronic copy of ``Laser Products--
Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser
Notice No. 56)'' may send an email request to<EMAIL_ADDRESS>to receive an electronic copy of the document. Please use the document
number 1500024 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in
the following FDA regulations have been approved by OMB as listed in
the following table:

------------------------------------------------------------------------
                                                            OMB control
         21 CFR parts                    Topic                  No.
------------------------------------------------------------------------
1002, 1010, 1040.............  Reporting and                   0910-0025
                                Recordkeeping for
                                Electronic Products--
                                General Requirements.
------------------------------------------------------------------------

    Dated: May 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-09381 Filed 5-7-19; 8:45 am]
 BILLING CODE 4164-01-P