[Federal Register Volume 81, Number 248 (Tuesday, December 27, 2016)]
[Notices]
[Pages 95143-95145]
[FR Doc No: 2016-31145]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1495]

Factors to Consider Regarding Benefit-Risk in Medical Device
Product Availability, Compliance, and Enforcement Decisions; 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 the guidance entitled ``Factors to Consider
Regarding Benefit-Risk in Medical Device Product Availability,
Compliance, and Enforcement Decisions.'' This guidance is intended to
provide clarity for FDA staff and industry regarding the benefit and
risk factors FDA may consider in prioritizing resources for compliance
and enforcement efforts to maximize medical device quality and patient
safety. Although product availability and other medical device
compliance and enforcement decisions are generally fact-specific, FDA
believes that explaining how we consider the factors listed in the
guidance will improve the consistency and transparency of these kinds
of decisions. A common understanding of how FDA considers benefit and
risk may better align industry's and FDA's focus on actions that
maximize benefit to patients, improve medical device quality, and
reduce risk to patients. This guidance is in effect at this time.

DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.

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-2016-D-1495 for the guidance entitled ``Factors to Consider
Regarding Benefit-Risk in Medical Device Product Availability,
Compliance, and Enforcement Decisions.'' 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.
    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
``Factors to Consider Regarding Benefit-Risk in Medical Device Product
Availability, Compliance, and Enforcement Decisions'' to the Office of
the Center Director, 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: Ann M. Ferriter, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 3680, Silver Spring, MD 20993, 301-796-
5530.

SUPPLEMENTARY INFORMATION:

I. Background

    The guidance is intended to provide a framework for FDA and
stakeholders that sets forth overarching benefit-risk principles. FDA
may consider the types of benefit-risk factors described in the
guidance--including reliable patient input from a representative
sample--on a case-by-case basis when determining the appropriate
regulatory actions to take and to help ensure that informed and
science-based decisions are made to the greatest extent practicable.
Factors may be weighted differently for different decisions and as the
timeframe allows. FDA intends to use pilots and other evaluation
techniques to help determine how to apply the benefit-risk framework
described in this guidance. Because of the variability in the facts of,
and data available for, each decision, specific factors that will
inform FDA's thinking may vary.
    In addition, the guidance is intended to harmonize FDA's approach
to weighing benefits and risks for medical device product availability,
compliance, and enforcement decisions with FDA's benefit-risk framework
for evaluating medical device marketing and investigational device
exemption applications. The benefit-risk factors in the guidance also
support assessment of medical devices with real world evidence.
    The framework described in the guidance may be applicable to
industry and FDA decisions. The benefit-risk factors may be considered
when device manufacturers evaluate appropriate responses to
nonconforming product or regulatory compliance issues, such as
determining whether to limit the availability of a medical device
(e.g., a voluntary recall or market withdrawal). FDA may consider the
benefit-risk factors during, for example, the evaluation of device
shortage situations, selection of the appropriate regulatory engagement
mechanism following an inspection during which regulatory non-
compliance was observed, evaluation of recalls and consideration of
petitions for variance from those sections of the Quality System
regulation (21 CFR part 820) for which there were inspectional
observations during a premarket approval preapproval inspection.
    The guidance applies to both diagnostic and therapeutic medical
devices subject to, and exempt from, premarket review. The scope of the
guidance excludes medical devices regulated by FDA's Center for
Biologics Evaluation and Research combination products, as defined in
21 CFR 3.2(e), for which the Center for Devices and Radiological Health
(CDRH) is not the lead Center; and electronic products that are not
devices as defined in section 201(h) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 321(h)) as regulated by CDRH
under the Electronic Product Radiation Control provisions in the FD&C
Act and implementing regulations (21 CFR Subchapter J--Radiological
Health). This guidance does not apply to products (e.g., drugs,
biologics, dietary supplements, foods, tobacco products, or cosmetics)
regulated by other FDA Centers.
    In the Federal Register of June 16, 2016 (81 FR 39272), FDA
published a notice of availability for the draft guidance entitled
``Factors to Consider Regarding Benefit-Risk in Medical Device Product
Availability, Compliance, and Enforcement Decisions.'' FDA considered
the comments received on the draft guidance and has revised the
guidance as appropriate in response to the comments.

II. Significant 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 ``Factors to Consider Regarding Benefit-Risk
in Medical Device Product Availability, Compliance, and Enforcement
Decisions.'' 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 interested in obtaining a copy of the guidance may do so by
using the Internet. A search capability for all CDRH guidance documents
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at https://www.regulations.gov. Persons
unable to download an electronic copy of ``Factors to Consider
Regarding Benefit-Risk in Medical Device Product Availability,
Compliance, and Enforcement Decisions'' may send an email request to
<EMAIL_ADDRESS>to receive an electronic copy of the
document. Please use the document number 1500065 to identify the
guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. 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 21 CFR part 7, subpart C, have been
approved under OMB control number 0910-0249. The collections of
information in 21 CFR parts 801 and 809, regarding labeling, have been
approved under OMB control number 0910-0485. The collections of
information in 21 CFR part 803, regarding medical device reporting,
have been approved under OMB control numbers 0910-0291, 0910-0437, and
0910-0471. The collections of information in 21 CFR part 806 have been
approved under OMB control number 0910-0359. The collections of
information in 21 CFR part 807, subpart E, have been approved under OMB
control number 0910-0120. The collections of information in 21 CFR part
810, regarding medical device recall authority, have been approved
under OMB control number 0910-0432. The collections of information in
21 CFR part 812 have been approved under OMB control number 0910-0078.
The collections of information in 21 CFR part 814, subparts B and E,
have been approved under OMB control number 0910-0231. The collections
of information in 21 CFR part 820, regarding the Quality System
regulation, have been approved under OMB control number 0910-0073. The
collections of information in 21 CFR part 822, regarding postmarket
surveillance of medical devices, have been approved under OMB control
number 0910-0449.

    Dated: December 21, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31145 Filed 12-23-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: May 28, 2010 (Volume 75, Number 103)]
[Rules and Regulations]
[Page 29897-29899]
[DOCID:fr28my10-8]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R02-OAR-2010-0131, FRL-9146-4]

Approval and Promulgation of Implementation Plans; New York State
Implementation Plan Revision

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The EPA is approving a proposed revision to the New York State
Implementation Plan (SIP) for ozone concerning the control of volatile
organic compounds. The proposed SIP revision consists of amendments to
Title 6 of the New York Codes, Rules and Regulations Part 235,
``Consumer Products'' and Part 239, ``Portable Fuel Container Spillage
Control.'' The intended effect of this action is to approve control
strategies, required by the Clean Air Act, which will result in
emission reductions that will help achieve attainment of the national
ambient air quality standards for ozone.

DATES: Effective Date: This rule will be effective June 28, 2010.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R02-OAR-2010-0131. All documents in the docket are listed on
the http://www.regulations.gov Web site. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either electronically through
http://www.regulations.gov or in hard copy at the Environmental
Protection Agency, Region 2 Office, Air Programs Branch, 290 Broadway,
25th Floor, New York, NY 10007-1866. This Docket Facility is open from
8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The Docket telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Kirk J. Wieber (wieber.kirk@epa.gov),
Air Programs Branch, Environmental Protection Agency, 290 Broadway,
25th Floor, New York, New York 10007-1866,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. What is the history and time frame for State Implementation Plan
(SIP) submissions?
II. What was included in New York's submittals?
III. What comments did EPA receive in response to its proposal?
IV. What is EPA's conclusion?
V. Statutory and Executive Order Reviews

I. What is the history and time frame for State Implementation Plan
(SIP) submissions?

    EPA's Phase 1 8-hour ozone implementation rule, published on April
30, 2004 (69 FR 23951), referred to as the Phase 1 Rule, specifies that
states must submit attainment demonstrations to EPA by no later than
three years from the effective date of designation, that is, submit
them by June 15, 2007.
    On November 9, 2005, EPA published Phase 2 of the 8-hour ozone
implementation rule (70 FR 71612), referred to as the Phase 2 Rule,
which addressed the control obligations that apply to areas designated
nonattainment for the 8-hour national ambient air quality standard.
Among other things, the Phase 1 and Phase 2 Rules outline the SIP
requirements and deadlines for various requirements in areas designated
as moderate nonattainment. For such areas, reasonably available control
technology (RACT) plans were due by September 2006 (40 CFR
51.912(a)(2)). The rules further require that modeling and attainment
demonstrations, reasonable further progress plans, reasonably available
control measure (RACM) analysis, projection year emission inventories,
motor vehicle emissions budgets and contingency measures were all due
by June 15, 2007 (40 CFR 51.908(a), and (c)).

II. What was included in New York's submittals?

    On October 21, 2009 and November 23, 2009, the New York State
Department of Environmental Conservation (NYSDEC), submitted to EPA
proposed revisions to the SIP which included State adopted revisions to
two regulations which consist of, respectively, Title 6 of the New York
Code of Rules and Regulations (6 NYCRR) Part 235, ``Consumer Products''
with a State effective date of October 15, 2009 and 6 NYCRR Part 239,
``Portable Fuel Container Spillage Control'' with a State effective
date of July 30, 2009. These revisions will provide volatile organic
compound (VOC) emission reductions to address, in part, attainment of
the 1997 8-hour ozone standard in the New York portion of the New York-
Northern New Jersey-Long Island, NY-NJ-CT nonattainment area which is
composed of the five boroughs of New York City and the surrounding
counties of Nassau, Suffolk, Westchester and Rockland. These revisions
will also address, in part, the RACT and RACM requirements by providing
VOC emission reductions statewide.

III. What comments did EPA receive in response to its proposal?

    On March 2, 2010 (75 FR 9373), EPA proposed to approve the proposed
revisions to the New York SIP for ozone concerning the amendments to 6
NYCRR Parts 235 and 239. The reader is referred to that proposal for a
more detailed discussion of this action. No comments were received in
response to that proposal.

IV. What is EPA's conclusion?

    EPA has evaluated New York's submittal for consistency with the
Clean Air Act, EPA regulations, and EPA policy. EPA has determined that
the revisions made to Part 235 and Part 239 of Title 6 of the New York
Codes, Rules and Regulations, entitled, ``Consumer Products'' and
``Portable Fuel Container Spillage Control,'' respectively, meet the

SIP revision requirements of the Clean Air Act with the following
exceptions.
    The provisions related to innovative products exemptions in subpart
239-5, variances in subpart 239-7 and alternate test methods in subpart
239-8 do not explicitly require submission of an innovative product
exemption, variance or alternative test method to EPA for approval into
the SIP. Since the rule does not explicitly state that innovative
product exemptions, variances or alternative test methods have to be
submitted to EPA for approval in the SIP, there is the possibility that
such exemptions, variances and alternatives will not be submitted for
review and approval into the SIP and therefore will not, even though
approved by the State, become federally enforceable. Failure to submit
such exemptions, variances or alternatives to EPA for review and
approval can lead to sources not understanding that the original rule
still applies and can be enforced by the United States. In order to be
federally enforceable, any exemption, variance or alternative test
method approved by NYSDEC must be approved by EPA into the SIP.
    Therefore, EPA is approving the proposed revisions to Part 239,
``Portable Fuel Container Spillage Control'' with a State effective
date of July 30, 2009, as part of the New York SIP with the
understanding that the specific application of provisions associated
with innovative product exemptions, variances, and alternate test
methods, pursuant to Part 239, must be submitted to EPA as SIP
revisions. EPA is also approving the proposed revisions to Part 235,
``Consumer Products'' with a State effective date of October 15, 2009,
as part of the New York SIP.

V. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by July 27, 2010. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Ozone, Reporting and
recordkeeping requirements, Volatile organic compounds.

    Dated: April 27, 2010.
Judith A. Enck,
Regional Administrator, Region 2.

0
Chapter I, title 40 of the Code of Federal Regulations is amended as
follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

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

Subpart HH--New York

0
2. Section 52.1670 is amended by adding new paragraph (c)(114) to read
as follows:

Sec.  52.1670  Identification of plans.

* * * * *
    (c) * * *
    (114) On October 21, 2009 and November 23, 2009, the New York State
Department of Environmental Conservation (NYSDEC), submitted to EPA
proposed revisions to the SIP concerning control strategies which will
result in volatile organic compound emission reductions that will help
achieve attainment of the national ambient air quality standards for
ozone.
    (i) Incorporation by reference:
    (A) Title 6 of the New York Code of Rules and Regulations, Part
235, ``Consumer Products,'' with an effective date of October 15, 2009
and Part 239, ``Portable Fuel Container Spillage Control,'' with an
effective date of July 30, 2009.
    (ii) Additional information:
    (A) Letters dated October 21, 2009 and November 23, 2009 from
Assistant Commissioner J. Jared Snyder, NYSDEC, to George Pavlou,
Acting Regional

Administrator, EPA Region 2, submitting the SIP revision for parts 235
and 239 respectively.

0
3. In Sec.  52.1679, the table is amended by revising the entries for
Title 6, Part 235 and Part 239 to read as follows:

Sec.  52.1679  EPA-approved New York State regulations.

----------------------------------------------------------------------------------------------------------------
                                    State
   New York State regulation      effective     Latest EPA approval                    Comments
                                     date              date
----------------------------------------------------------------------------------------------------------------

                                 ...........  ......................  ..........................................
Part 235, Consumer Products....     10/15/09  5/28/10 [Insert FR      ..........................................
                                               page citation].

                                 ...........  ......................  ..........................................
Part 239, Portable Fuel              7/30/09  5/28/10 [insert FR      The specific application of provisions
 Container Spillage Control.                   page citation].         associated with alternate test methods,
                                                                       variances and innovative products, must
                                                                       be submitted to EPA as SIP revisions.

                                 ...........  ......................  ..........................................
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2010-12917 Filed 5-27-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 197 (Thursday, October 10, 2019)]
[Notices]
[Pages 54728-54729]
[FR Doc No: 2019-22130]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2019-0083]

Public Meeting Regarding NHTSA's Research Portfolio

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

ACTION: Notice of public meeting.

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SUMMARY: NHTSA is announcing a public meeting where the Agency's
Vehicle Safety Research and Behavioral Safety Research offices will
present information on activities related to the Agency's research
programs. Representatives from across the two research offices will
present the information and accept questions from the audience after
presentations.

DATES: NHTSA will hold the public meeting on November 20-21, 2019, from
8:30 a.m. to 4:00 p.m., Eastern Standard Time on November 20, and 8:30
a.m. to 12 p.m., Eastern Standard Time on November 21. Check-in
(through security) will begin at 7:30 a.m. both days. Attendees should
arrive early enough to enable them to go through security by 8:20 a.m.
The public docket will remain open for 90 days following the conclusion
of the public meeting.

ADDRESSES: The public meeting will be held at the DOT headquarters
building located at 1200 New Jersey Avenue SE, Washington, DC 20590
(Green Line Navy Yard/Ballbark Metro station) in the West Building
Atrium. This facility is accessible to individuals with disabilities.
The meeting will also be recorded and made available after the event
for offline viewing (no planned live broadcast) at https://www.nhtsa.gov/events-and-public-meetings.

FOR FURTHER INFORMATION CONTACT: If you have questions about the public
meeting, please contact Lisa Floyd at<PHONE_NUMBER>, by email at
<EMAIL_ADDRESS>or by US Mail at NHTSA's Department of
Transportation, 1200 New Jersey Ave. SE, Washington, DC 20590.

SUPPLEMENTARY INFORMATION: Registration is recommended for all
attendees. Attendees should register at https://www.surveymonkey.com/r/NHTSAResearchPortfolio2019 by November 13, 2019. Please provide name,
affiliation, email, and indicate whether you need special
accommodations. Space is limited, so advance registration is highly
encouraged.
    NHTSA DOT is committed to providing equal access to this meeting
for all participants. If you need accommodation because of a
disability, please contact Lisa Floyd at<PHONE_NUMBER>, or via email at
<EMAIL_ADDRESS>with your request by close of business November 13,
2019. Should it be necessary to cancel or reschedule the meeting due to
inclement weather or emergency, NHTSA will take all available measures
to notify registered participants as soon as possible.
    NHTSA will conduct the public meeting informally, and technical
rules of evidence will not apply. We will arrange for a written
transcript of the meeting and keep the official record open for 90 days
after the meeting to allow submission of public comments and
supplemental information. You may make arrangements for copies of the
transcripts directly with the court reporter, and the transcript will
also be

posted in the docket when it becomes available.
    Written Comments: Written comments can be submitted during the 90-
day comment period. Please submit all written comments no later than
February 20, 2019, following the close of the public meeting by any of
the following methods:
     Federal Rulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility: US Department of
Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: 1200 New Jersey Avenue SE, West
Building Ground Floor, Room W12-140, Washington, DC 20590-0001, between
9 a.m. and 5 p.m. ET, Monday through Friday, except Federal Holidays.
     Fax:<PHONE_NUMBER>.
    Instructions: All submissions must include the agency name and
docket number. Note that all comments received will be posted without
change to http://www.regulations.gov, including any personal
information provided. Please see the Privacy Act discussion below.
    Docket: For access to the docket go to http://www.regulations.gov
at any time or to 1200 New Jersey Avenue SE, West Building, Ground
Floor, Room W12-140, Washington, DC 20590 between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal Holidays. Telephone: 202-366-
9826.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (Volume 65, Number 70; Pages 19477-78), or you may visit
http://www.regulations.gov/privacy.html.
    Confidential Business Information: If you wish to submit any
information under a claim of confidentiality, you should submit three
copies of your complete submission, including the information you claim
to be confidential business information to the Chief Counsel, NHTSA, at
1200 New Jersey Avenue SE, Washington, DC 20590. In addition, you
should submit two copies, from which you have deleted the claimed
confidential business information, to Docket Management at the address
given above. When you send a comment containing information claimed to
be confidential business information, you should submit a cover letter
setting forth the information specified in our confidential business
information regulation (49 CFR part 512).
    Background: Each year, NHTSA executes a broad array of research
programs in support of agency priorities. The Agency's research
portfolio covers program areas pertaining to vehicle safety, including
safety countermeasures implemented through the vehicle, components,
operation and use, among others, and behavioral safety, which includes
safety countermeasures that pertain to the behavior and actions of the
driver, occupant, and other road users.
    The public meeting is intended to provide public outreach regarding
research activities at NHTSA for both vehicle and behavioral safety,
including expected near term deliverables. NHTSA technical research
staff will discuss projects underway and allow time for meeting
attendees to ask questions. There will be display information available
and posters illustrating select research activities and staff available
for discussion.
    The Agency invites comments on the information presented regarding
research priorities, research goals, and additional research gaps/needs
the public may believe NHTSA should be addressing. Select project work
may be posted to the docket for which comments are also welcome. Slides
presented at the public meeting will be posted to the docket
subsequently for public viewing and a recording of the meeting will be
made available after the event for offline viewing (no planned live
broadcast).

    Issued in Washington, DC under authority delegated by 49 CFR
1.95.
Cem Hatipoglu,
Associate Administrator for Vehicle Safety Research.
[FR Doc. 2019-22130 Filed 10-9-19; 8:45 am]
 BILLING CODE 4910-59-P


[Federal Register Volume 85, Number 211 (Friday, October 30, 2020)]
[Notices]
[Page 68869]
[FR Doc No: 2020-24100]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2487-048]

Hydro Power, Inc., Albany Engineering Corporation; Notice of
Application for Transfer of License and Soliciting Comments, Motions To
Intervene, and Protests

    On September 22, 2020, Hydro Power, Inc. (transferor) and Albany
Engineering Corporation (transferee) filed a joint application for the
transfer of license of the Hoosick Falls Hydroelectric Project No.
2487. The project is located on the Hoosick Falls, Rensselaer County,
New York.
    The applicants seek Commission approval to transfer the license for
the Hoosick Falls Hydroelectric Project from the transferor to the
transferee.
    Applicants Contact: For transferor and transferee: Mr. James A.
Besha, P.E., Albany Engineering Corporation, 5 Washington Square,
Albany, NY 12205, Phone:<PHONE_NUMBER> Ext. 402, Fax:<PHONE_NUMBER>,
Email<EMAIL_ADDRESS>    FERC Contact: Anumzziatta Purchiaroni,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    Deadline for filing comments, motions to intervene, and protests:
30 days from the date that the Commission issues this notice. The
Commission strongly encourages electronic filing. Please file comments,
motions to intervene, and protests using the Commission's eFiling
system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can
submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information
at the end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>(866) 208-3676 (toll free), or
(202) 502-8659 (TTY).
    In lieu of electronic filing, you may submit a paper copy.
Submissions sent via U.S. Postal Service must be addressed to, Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First
Street NE, Room 1A, Washington, DC 20426. Submissions sent via any
other carrier must be addressed to, Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville,
Maryland 20852. The first page of any filing should include docket
number P-2487-048. Comments emailed to Commission staff are not
considered part of the Commission record.

    Dated: October 26, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-24100 Filed 10-29-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 209 (Tuesday, October 29, 2019)]
[Proposed Rules]
[Pages 57838-57840]
[FR Doc No: 2019-23515]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 62

[EPA-R03-OAR-2019-0537; FRL-10001-55-Region 3]

Approval and Promulgation of State Plans for Designated
Facilities and Pollutants; Virginia; Emission Standards for Existing
Municipal Solid Waste Landfills

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a Clean Air Act (CAA) section 111(d) plan submitted by the
Virginia Department of Environmental Quality (VADEQ). This plan was
submitted to fulfill the requirements of the CAA and in

response to EPA's promulgation of Emissions Guidelines and Compliance
Times for municipal solid waste (MSW) landfills. The Virginia plan
establishes emission limits for existing MSW landfills, and provides
for the implementation and enforcement of those limits.

DATES: Written comments must be received on or before November 29,
2019.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R03-
OAR-2019-0537 at https://www.regulations.gov, or via email to
[email protected]. For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be confidential business information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Cynthia Stahl, Permits Branch (3AD10),
Air and Radiation Division, U.S. Environmental Protection Agency,
Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103. The
telephone number is<PHONE_NUMBER>. Ms. Stahl can also be reached via
electronic mail at [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On August 29, 2016, EPA finalized Standards of Performance for MSW
landfills and Emission Guidelines and Compliance Times for MSW
Landfills in 40 CFR part 60 subpart XXX and Cf, respectively. 81 FR
59332 and 81 FR 59313. These actions were taken under section 111 of
the CAA.
    Section 111(d) of the CAA requires EPA to establish a procedure for
a state to submit a plan to EPA which establishes standards of
performance for any air pollutant: (1) For which air quality criteria
have not been issued or which is not included on a list published under
CAA section 108 or emitted from a source category which is regulated
under CAA section 112 but; (2) to which a standard of performance under
CAA section 111 would apply if such existing source were a new source.
EPA established these requirements for state plan submittal in 40 CFR
part 60, subpart B. State submittals under CAA sections 111(d) must be
consistent with the relevant emission guidelines, in this instance 40
CFR part 60, subpart Cf, and the requirements of 40 CFR part 60,
subpart B and part 62, subpart A.
    On August 29, 2019, the Virginia Department of Environmental
Quality (VADEQ) submitted to EPA a formal section 111(d) plan for
existing municipal solid waste landfills. The submitted section 111(d)
plan was in response to the August 29, 2016 promulgation of Federal New
Source Performance Standards (NSPS) and emission guidelines
requirements for MSW landfills, 40 CFR part 60, subparts XXX and Cf,
respectively (76 FR 15372).

II. Summary of the Plan and EPA Analysis

    EPA has reviewed the Virginia section 111(d) plan submittal in the
context of the requirements of 40 CFR part 60, subparts B and Cf, and
part 62, subpart A. In this action, EPA is proposing to determine that
the submitted section 111(d) plan meets the above-cited requirements.
Included within the section 111(d) plan are regulations under the
Virginia state rule 9VAC5 Chapter 40 Article 43.1, entitled ``Emission
Standards for Municipal Solid Waste Landfills.'' In this action, EPA is
proposing to incorporate by reference (IBR) Virginia state rule 9VAC5
Chapter 40 Article 43.1, which became effective in the Commonwealth of
Virginia on February 22, 2017. A detailed explanation of the rationale
behind this proposed approval is available in the Technical Support
Document (TSD).

III. Proposed Action

    EPA is proposing to approve the Virginia section 111(d) plan for
MSW landfills submitted pursuant to 40 CFR part 60, subpart Cf.
Therefore, EPA is proposing to amend 40 CFR part 62, subpart XX to
reflect this action. This approval is based on the rationale previously
discussed and in further detail in the TSD associated with this action.
The scope of the proposed approval of the section 111(d) plan is
limited to the provisions of 40 CFR parts 60 and 62 for existing MSW
landfills, as referenced in the emission guidelines, subpart Cf.
    The EPA Administrator continues to retain authority for approval of
alternative methods to determine the nonmethane organic compound
concentration or a site-specific methane generation rate constant (k),
as stipulated in 40 CFR 60.30f(c), as well as in Part 1,
``Discretionary Authority,'' of Virginia's 111(d) plan submittal.

IV. Incorporation by Reference

    In this document, EPA is proposing to include in a final EPA rule
regulatory text that includes incorporation by reference of the state
plan. In accordance with requirements of 1 CFR 51.5, EPA is proposing
to incorporate by reference VADEQ rules regarding MSW landfills
discussed in section II of this preamble. EPA has made, and will
continue to make, these materials generally available through the
docket for this action, EPA-R03-OAR-2019-0537, at https://www.regulations.gov and at the EPA Region III Office (please contact
the person identified in the FOR FURTHER INFORMATION CONTACT section of
this preamble for more information).

V. Statutory and Executive Order Reviews

    In reviewing state plan submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the CAA. Accordingly,
this action merely approves state law as meeting Federal requirements
and does not impose additional requirements beyond those imposed by
state law. For that reason, this proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because this action is not significant under
Executive Order 12866.
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described

in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this proposed approval of Virginia's state plan
submittal for existing MSW landfills does not have tribal implications
as specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the state plan is not approved to apply in Indian country
located in the state, and EPA notes that it will not impose substantial
direct costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 62

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Landfills, Methane, Ozone,
Reporting and recordkeeping requirements, Sulfur oxides, Volatile
organic compounds.

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

    Dated: October 18, 2019.
Cosmo Servidio,
Regional Administrator, Region III.
[FR Doc. 2019-23515 Filed 10-28-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: November 5, 2008 (Volume 73, Number 215)]
[Notices]
[Page 65867]
[DOCID:fr05no08-67]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-1806-DR]

Florida; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Florida (FEMA-1806-DR), dated October 27,
2008, and related determinations.

DATES: Effective Date: October 27, 2008.

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

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated October 27, 2008, the President declared a major disaster under
the authority of the Robert T. Stafford Disaster Relief and Emergency
Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as follows:

    I have determined that the damage in certain areas of the State
of Florida resulting from Hurricane Gustav during the period of
August 31 to September 7, 2008, is of sufficient severity and
magnitude to warrant a major disaster declaration under the Robert
T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C.
5121-5207 (the Stafford Act). Therefore, I declare that such a major
disaster exists in the State of Florida.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Public Assistance in the
designated areas, Hazard Mitigation throughout the State, and any
other forms of assistance under the Stafford Act that you deem
appropriate. Consistent with the requirement that Federal assistance
be supplemental, any Federal funds provided under the Stafford Act
for Hazard Mitigation will be limited to 75 percent of the total
eligible costs. Federal funds provided under the Stafford Act for
Public Assistance also will be limited to 75 percent of the total
eligible costs, except for any particular projects that are eligible
for a higher Federal cost-sharing percentage under the FEMA Public
Assistance Pilot Program instituted pursuant to 6 U.S.C. 777. If
Other Needs Assistance under Section 408 of the Stafford Act is
later requested and warranted, Federal funding under that program
also will be limited to 75 percent of the total eligible costs.
    Further, you are authorized to make changes to this declaration
to the extent allowable under the Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Jeffery L. Bryant, of FEMA is
appointed to act as the Federal Coordinating Officer for this declared
disaster.
    The following areas of the State of Florida have been designated as
adversely affected by this declared major disaster:

    Bay, Escambia, Franklin, Gulf, Okaloosa, and Santa Rosa Counties
for Public Assistance.
    All counties within the State of Florida are eligible to apply
for assistance under the Hazard Mitigation Grant Program.

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.

R. David Paulison,
Administrator, Federal Emergency Management Agency.
[FR Doc. E8-26298 Filed 11-4-08; 8:45 am]

BILLING CODE 9111-23-P


[Federal Register Volume 85, Number 102 (Wednesday, May 27, 2020)]
[Rules and Regulations]
[Pages 31670-31671]
[FR Doc No: 2020-11232]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2019-0874; Airspace Docket No. 18-ANM-6]
RIN 2120-AA66

Amendment of Class E Airspace; Dillon, MT

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends Class E airspace, designated as a surface
area, at Dillon Airport, Dillon, MT. This action reduces the radius of
the airspace and adds an extension to the northeast of the airport.
This action also amends the Class E airspace extending upward from 700
feet above the surface, the action reduces the circular radius around
the airport and adds an extension to the southwest of the airport and
an extension to the north of the airport. Additionally, this action
amends the Class E airspace extending upward from 1,200 feet above the
surface. The action significantly reduces the dimensions of the area to
properly size it to contain IFR aircraft transitioning to/from the
terminal or en route environments. Lastly, this action implements an
administrative correction to the Class E airspace designated as a
surface area.

DATES: Effective 0901 UTC, September 10, 2020. The Director of the
Federal Register approves this incorporation by reference action under
Title 1 Code of Federal Regulations part 51, subject to the annual
revision of FAA Order 7400.11 and publication of conforming amendments.

ADDRESSES: 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: Matthew Van Der Wal, Federal Aviation
Administration, Western Service Center, Operations Support Group, 2200
S 216th Street, Des Moines, WA 98198; 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 amends Class E airspace at Dillon Airport, Dillon, MT, to ensure
the safety and management of Instrument Flight Rules (IFR) operations
at the airport.

History

    The FAA published a notice of proposed rulemaking in the Federal
Register (85 FR 13080; March 6, 2020) for Docket No. FAA-2019-0874 to
amend Class E airspace at Dillon Airport, Dillon, MT. Interested
parties were invited to participate in this rulemaking effort by
submitting written comments on the proposal to the FAA. No comments
were received.
    After the NPRM comment period closed, the FAA identified an error
in the proposed Class E airspace extending upward from 1,200 feet above
the surface. The proposal stated the area should be reduced from a 45-
mile radius

to an 8-mile radius of the airport. However, to properly contain IFR
aircraft transitioning to/from the terminal or en route environment,
this area should be reduced to a 25-mile radius of the airport. The
Final Rule includes a correction to the airspace area.
    Class E2 and E5 airspace designations are published in paragraphs
6002 and 6005, respectively, 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 designation listed in
this document will be published subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends 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 Rule

    This amendment to Title 14 Code of Federal Regulations (14 CFR)
part 71 amends the Class E airspace, designated as a surface area, at
Dillon Airport, Dillon, MT. The action reduces the area from a 6.1-mile
radius to a 5.2-mile radius of the airport and adds an extension
northeast of the airport. This area is described as follows: That
airspace extending upward from the surface within a 5.2-mile radius of
the airport, and with 2.4 miles each side of the 026[deg] bearing from
the airport, extending from the 5.2-mile radius to 6.8 miles northeast
of Dillon Airport.
    Also, this action amends Class E airspace extending upward from 700
feet above the surface. This area is reconfigured a 9.2-mile radius of
the airport to a 5.2-mile radius of the airport, with extensions
southwest and north of the airport. This area is described as follows:
That airspace extending upward from 700 feet above the surface within a
5.2-mile radius of the airport, and within 3 miles each side of the
205[deg] bearing from the airport, extending from the 5.2-mile radius
to 9.9 miles southwest of the airport, and within eight miles west and
four miles east of the 005[deg] bearing from the airport, extending
from the 5.2-mile radius to 16 miles north of Dillon Airport.
    Additionally, this action amends the Class E airspace extending
upward from 1,200 feet above the surface from a 45-mile radius to a 25-
mile radius of the airport.
    Lastly, this action implements an administrative correction to the
Class E airspace designated as a surface area. This area is full time
and the following two sentences do not accurately represent the time of
use and are removed: ``This Class E airspace area is effective during
specific dates and times established in advance by a Notice to Airmen.
The effective date and time will thereafter be continuously published
in the Airport/Facility Directory.''
    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

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 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 6002 Class E Airspace Areas Designated as Surface Areas.

* * * * *

ANM MT E2 Dillon, MT [Amended]

Dillon Airport, MT
    (Lat. 45[deg]15'19'' N, long. 112[deg]33'09'' W)

    That airspace extending upward from the surface within a 5.2-
mile radius of the airport, and within 2.4 miles each side of the
026[deg] bearing from the airport, extending from the 5.2-mile
radius to 6.8 miles northeast of Dillon Airport.

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

* * * * *

ANM MT E5 Dillon, MT [Amended]

Dillon Airport, MT
    (Lat. 45[deg]15'19'' N, long. 112[deg]33'09'' W)

    That airspace extending upward from 700 feet above the surface
within a 5.2-mile radius of the airport, and within 3 miles each
side of the 205[deg] bearing from the airport, extending from the
5.2-mile radius to 9.9 miles southwest of the airport, and that
airspace within 8 miles west and 4 miles east of the 005[deg]
bearing from the airport, extending from the 5.2-mile radius to 16
miles north of the airport; and that airspace extending upward from
1,200 feet above the surface within a 25-mile radius of Dillon
Airport.

    Issued in Seattle, Washington, on May 20, 2020.
Shawn M. Kozica
Group Manager, Western Service Center, Operations Support Group.
[FR Doc. 2020-11232 Filed 5-26-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: February 12, 2008 (Volume 73, Number 29)]
[Notices]
[Page 8103-8104]
[DOCID:fr12fe08-81]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[U.S. DOT Docket Number NHTSA-2008-0027]

Reports, Forms, and Recordkeeping Requirements

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

ACTION: Request for public comment on proposed collection of
information.

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

SUMMARY: Before a Federal agency can collect certain information from
the public, it must receive approval from the Office of Management and
Budget (OMB). Under procedures established by the Paperwork Reduction
Act of 1995, before seeking OMB approval, Federal agencies must solicit
public comment on proposed collections of information, including
extensions and reinstatement of previously approved collections. This
document describes one collection of information for which NHTSA
intends to seek OMB approval.

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

ADDRESSES: You may submit comments [identified by DOT Docket No. NHTSA-
2008-0027] by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov.
 Follow the online instructions for submitting

comments.
     Mail: Docket Management Facility: U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., between 9 a.m. and 5 p.m. ET,
Monday through Friday, except Federal holidays. Telephone: 1-800-647-
5527.
     Fax:<PHONE_NUMBER>.
    Instructions: All submissions must include the agency name and
docket number for this proposed collection of information. Note that
all comments received will be posted without change to http://www.regulations.gov
, including any personal information provided.

Please see the Privacy Act heading below.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78) or you may visit http://DocketInfo.dot.gov
.

    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov or the street

address listed above. Follow the online instructions for accessing the
dockets.

FOR FURTHER INFORMATION CONTACT: Complete copies of each request for
collection of information may be obtained at no charge from Kenneth
Hardie, NHTSA 1200 New Jersey Avenue, SE., W43-458 NVS-121, Washington,
DC 20590. Mr. Kenneth Hardie's telephone number is<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995,
before an agency submits a proposed collection of information to OMB
for approval, it must first publish a document in the Federal Register
providing a 60-day comment period and otherwise consult with members of
the public and affected agencies concerning each proposed collection of
information. The OMB has promulgated regulations describing what must
be included in such a document. Under OMB's regulation (at 5CFR
1320.8(d)), an agency must ask for public comment on the following:
    (i) whether the proposed collection of information is necessary for
the proper performance of the functions of the agency, including
whether the information will have practical utility;
    (ii) the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used;
    (iii) how to enhance the quality, utility, and clarity of the
information to be collected;
    (iv) how to minimize the burden of the collection of information on
those who are to respond, including the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses.
    In compliance with these requirements, NHTSA asks for public
comments on the following proposed collections of information:
    Title: Replaceable Light Source Dimensional Information Collection,
49 CFR Part 564
    OMB Number: 2127-0563.
    Type of Request: Extension of a currently approved collection.
    Affected Public: Business or other for profit organizations.
    Abstract: The information to be collected is in response to 49 CFR
Part 564--Replaceable Light Source Information. Manufacturers of
modified or original equipment light sources desiring to use newly
designed replaceable light sources in headlamps are required to submit
manufacturing specifications (dimensional, electrical specification,
and marking/designation information) to the agency. After a short
agency review to assure completeness, the information is placed in the
Part 564--Replaceable Light Source Information Docket. The Part 564
Docket is a public docket available for use by any manufacturer who
desired to manufacture headlamp light sources for highway motor
vehicles. In Federal Motor Vehicle Safety Standard (FMVSS)

No. 108; Lamps, reflective devices and associated equipment, Part 564
submissions are referenced as being the source of information regarding
the performance and interchangeability information for legal headlamp
light sources, whether original equipment or replacement equipment.
Thus, the submitted information about headlamp light sources becomes
the basis for certification of compliance with FMVSS No. 108.
    Estimated Total Annual Burden: 28.
    Estimated Number of Respondents: 7.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the function of
the Department, including whether the information will have practical
utility; the accuracy of the Department's estimate of the burden of the
proposed information collected; ways to enhance the quality, utility
and clarity of the information to be collected; and ways to minimize
the burden of the collection of information on respondents, including
the use of automated collection techniques or other forms of
information technology.

    Issued: February 5, 2008.
Stephen R. Kratzke,
Associate Administrator for Rulemaking.
[FR Doc. 08-611 Filed 2-11-08; 8:45 am]

BILLING CODE 4910-59-M