[Federal Register Volume 85, Number 20 (Thursday, January 30, 2020)]
[Notices]
[Pages 5445-5446]
[FR Doc No: 2020-01705]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-5392]

Interpreting Sameness of Gene Therapy Products Under the Orphan
Drug Regulations; Draft Guidance for Industry; Availability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 Agency) is announcing
the availability of a draft document entitled ``Interpreting Sameness
of Gene Therapy Products Under the Orphan Drug Regulations.'' The draft
guidance document provides FDA's current thinking on the criteria to
determine sameness of human gene therapy products for the purpose of
orphan drug designation and orphan drug exclusivity. The draft guidance
is intended to assist stakeholders, including industry and academic
sponsors who seek orphan drug designation and orphan drug exclusivity,
in the development of gene therapies for rare diseases.

DATES: Submit either electronic or written comments on the draft
guidance by April 29, 2020 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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-2019-D-5392 for ``Interpreting Sameness of Gene Therapy Products
Under the Orphan Drug Regulations.'' 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.govinfo.gov/content/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)).
    Submit written requests for single copies of the draft guidance to
the Office of Communication, Outreach and Development, Center for
Biologics Evaluation and Research (CBER), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist the office in
processing your requests. The draft guidance may also be obtained by
mail by calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.

FOR FURTHER INFORMATION CONTACT: Jenifer Roe, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance document
entitled ``Interpreting Sameness of Gene Therapy Products Under the
Orphan Drug Regulations.'' The draft guidance provides FDA's current
thinking on the criteria to determine sameness of human gene therapy
products for the purpose of orphan drug designation and orphan drug
exclusivity. The draft guidance is intended to assist stakeholders,
including industry and academic sponsors who seek orphan drug
designation and orphan drug exclusivity, in the development of gene
therapies for rare diseases. The draft guidance focuses specifically on
factors FDA intends to consider when determining sameness for gene
therapy products and does not address sameness determinations for other
types of products.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Interpreting
Sameness of Gene Therapy Products Under the Orphan Drug Regulations.''
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 draft guidance refers to previously approved FDA 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. 3501-3521). The collections of
information in 21 CFR part 316 have been approved under OMB control
number 0910-0167, and the collections of information in 21 CFR part 601
have been approved under OMB control number 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: January 27, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-01705 Filed 1-29-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 220 (Wednesday, November 16, 2022)]
[Notices]
[Pages 68779-68781]
[FR Doc No: 2022-24959]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-96298; File No. SR-FINRA-2022-024]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing of Amendment No. 1 and Order
Instituting Proceedings To Determine Whether To Approve or Disapprove
the Proposed Rule Change, As modified by Amendment No. 1, To Amend the
Codes of Arbitration Procedure To Modify the Current Process Relating
to the Expungement of Customer Dispute Information

November 10, 2022.

I. Introduction

    On July 29, 2022, the Financial Industry Regulatory Authority, Inc.
(``FINRA'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change SR-FINRA-2022-024 pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 (``Exchange
Act'') \1\ and Rule 19b-4 \2\ thereunder to modify the current process
relating to the expungement of customer dispute information.\3\ The
proposed rule change was published for public comment in the Federal
Register on August 15, 2022.\4\ On September 27, 2022, FINRA consented
to an extension of the time period in which the Commission must approve
the proposed rule change, disapprove the proposed rule change, or
institute proceedings to determine whether to approve or disapprove the
proposed rule change to November 11, 2022.\5\ On November 10, 2022,
FINRA responded to the comment letters received in response to the
Notice and filed an amendment to modify the proposed rule change
(``Amendment No. 1'').\6\
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See infra note 4. ``Customer dispute information'' includes
complaints, arbitration claims, and court filings made by customers
against broker-dealers and their associated persons. Id. at 50172.
    \4\ Exchange Act Release No. 34-95455 (August 9, 2022), 87 FR
50170 (August 15, 2022) (File No. SR-FINRA-2022-024) (``Notice''),
available at https://www.govinfo.gov/content/pkg/FR-2022-08-15/pdf/2022-17430.pdf.
    \5\ See letter from Mignon McLemore, Associate General Counsel,
Office of General Counsel, FINRA, to Lourdes Gonzalez, Assistant
Chief Counsel, Division of Trading and Markets, Commission, dated
September 27, 2022, available at https://www.finra.org/sites/default/files/2022-09/sr-finra-2022-024-extension1.pdf.
    \6\ See letter from Mignon McLemore, Associate General Counsel,
FINRA, to Vanessa Countryman, Secretary, Commission, dated November
10, 2022 (``FINRA Response''), available at https://www.sec.gov/comments/sr-finra-2022-024/srfinra2022024.htm.
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    The Commission is publishing this order pursuant to Section
19(b)(2)(B) of the Exchange Act \7\ to solicit comments on the proposed
rule change, as modified by Amendment No. 1, and to institute
proceedings to determine whether to approve or disapprove the proposed
rule change, as modified by Amendment No. 1.
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    \7\ 15 U.S.C. 78s(b)(2)(B).
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II. Description of the Proposed Rule Change, as Modified by Amendment
No. 1

A. Background

    The Central Registration Depository (``CRD'') is a licensing and
registration system used by the Commission, state securities
regulators, and self-regulatory organizations (``SROs'') as a source of
regulatory information on, among other things, broker-dealers and their
associated persons. Certain information on CRD is also released to the
public through FINRA's BrokerCheck system.\8\ FINRA stated that it
publishes on BrokerCheck extensive disclosure information, including
customer dispute information for associated persons who are currently
or were formerly registered with FINRA, to help investors make informed
choices about the associated persons and broker-dealer firms with whom
they may conduct business.\9\
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    \8\ A detailed description of the information made available
through BrokerCheck is available at http://www.finra.org/investors/about-brokercheck. See Notice at note 22. The BrokerCheck website is
available at brokercheck.finra.org.
    \9\ See Notice at 50172.
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    FINRA rules allow broker-dealers and their associated persons to
seek expungement of customer dispute information from the CRD and
BrokerCheck systems in certain circumstances.\10\ An associated person
may seek expungement of customer dispute information through the FINRA
arbitration process or by going directly to court without first going
to arbitration.\11\
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    \10\ See, e.g., FINRA Rules 12805 (Expungement of Customer
Dispute Information under Rule 2080), 13805 (Expungement of Customer
Dispute Information under Rule 2080), and 2080 (Obtaining an Order
of Expungement of Customer Dispute Information from the Central
Registration Depository (CRD) System).
    \11\ See id.; see also Notice at 50191.

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B. The Proposed Rule Change

    FINRA is proposing to amend the Code of Arbitration Procedure for
Customer Disputes (``Customer Code'') and the Code of Arbitration
Procedure for Industry Disputes (``Industry Code'') (together,
``Codes'') to modify the current process relating to the expungement of
customer dispute information. The proposed rule change would impose
requirements on expungement requests: (a) filed by an associated person
during an investment-related, customer initiated arbitration
(``customer arbitration''), or filed by a party to the customer
arbitration on behalf of an associated person (``on-behalf-of
request''), or (b) filed by an associated person separate from a
customer arbitration (``straight-in request'').\12\
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    \12\ See Notice at 50170.
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    Specifically, the proposed rule change would: (1) require that a
straight-in request be decided by a three-person panel that is randomly
selected from a roster of experienced public arbitrators with enhanced
expungement training; \13\ (2) prohibit parties to a straight-in
request from agreeing to fewer than three arbitrators to consider their
expungement requests, from striking any of the selected arbitrators,
from stipulating to an arbitrator's removal, or from stipulating to the
use of pre-selected arbitrators; (3) provide notification to state
securities regulators of all expungement requests and a mechanism for
state securities regulators to attend and participate in expungement
hearings in straight-in requests; (4) impose time limits on the filing
of straight-in requests; (5) codify and update the best practices in
the Notice to Arbitrators and Parties on Expanded Expungement Guidance
applicable to all expungement hearings, including amendments to
establish additional requirements for expungement hearings, to
facilitate customer attendance and participation in expungement
hearings, and to codify the panel's \14\ ability to request any
evidence relevant to the expungement request; \15\ (6) require the
unanimous agreement of the panel to issue an award containing
expungement relief; and (7) establish procedural requirements for
filing expungement requests, including for on-behalf-of requests. The
proposed rule change would also amend the Customer Code to specify
procedures for requesting expungement of customer dispute information
during simplified arbitrations.\16\
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    \13\ Among other requirements, public arbitrators are not
employed in the securities industry and do not devote 20 percent or
more of their professional work to the securities industry or to
parties in disputes concerning investment accounts or transactions
or employment relationships within the financial industry. See FINRA
Rules 12100(aa) and 13100(x). Notice at note 3.
    \14\ Under the Codes, the term ``panel'' means the arbitration
panel, whether it consists of one or more arbitrators. See FINRA
Rules 12100(u) and 13100(s). Notice at note 4.
    \15\ See FINRA Dispute Resolution Services, Notice to
Arbitrators and Parties on Expanded Expungement Guidance, https://www.finra.org/arbitration-mediation/notice-arbitrators-and-parties-expanded-expungement-guidance (last updated Sept. 2017).
    \16\ See Notice at 50170.
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    Amendment No. 1 would modify the proposed rule change in three
ways. First, it would amend proposed Rules 12805(c)(3)(A) and
13805(c)(3)(A) to state that all customers whose customer arbitrations,
civil litigations or customer complaints are a subject of the
expungement request are entitled to attend and participate in all
aspects of the prehearing conferences and the expungement hearing.
Second, it would modify proposed Rules 12805(c)(8)(C) and
13805(c)(9)(C) to state that a panel shall not give any evidentiary
weight to a decision by a customer or an authorized representative not
to attend or participate in an expungement hearing when making a
determination of whether expungement is appropriate. Finally, Amendment
No. 1 would modify the proposed rule change to provide that an
associated person shall not file a claim requesting expungement of
customer dispute information from the CRD system if the customer
dispute information is associated with a customer arbitration or civil
litigation in which a panel or court of competent jurisdiction
previously found the associated person liable.\17\
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    \17\ See Amendment No. 1; see also FINRA Response.
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III. Proceedings To Determine Whether To Approve or Disapprove File No.
SR-FINRA-2022-024 and Grounds for Disapproval Under Consideration

    The Commission is instituting proceedings pursuant to Section
19(b)(2)(B) of the Exchange Act to determine whether the proposed rule
change, as modified by Amendment No. 1, should be approved or
disapproved.\18\ Institution of proceedings is appropriate at this time
in view of the legal and policy issues raised by the proposed rule
change, as modified by Amendment No. 1. Institution of proceedings does
not indicate that the Commission has reached any conclusions with
respect to the proposed rule change, as modified by Amendment No. 1.
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    \18\ 15 U.S.C. 78s(b)(2)(B).
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    Pursuant to Section 19(b)(2)(B) of the Exchange Act,\19\ the
Commission is providing notice of the grounds for disapproval under
consideration. The Commission is instituting proceedings to allow for
additional analysis and input concerning whether the proposed rule
change, as modified by Amendment No. 1, is consistent with the Exchange
Act and the rules thereunder.
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    \19\ Id.
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IV. Request for Written Comments

    The Commission requests that interested persons provide written
submissions of their views, data, and arguments with respect to the
issues identified above, as well as any other concerns they may have
with the proposed rule change, as modified by Amendment No. 1. In
particular, the Commission invites the written views of interested
persons concerning whether the proposed rule change, as modified by
Amendment No. 1, is consistent with the Exchange Act and the rules
thereunder.
    Although there do not appear to be any issues relevant to approval
or disapproval that would be facilitated by an oral presentation of
views, data, and arguments, the Commission will consider, pursuant to
Rule 19b-4, any request for an opportunity to make an oral
presentation.\20\
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    \20\ Section 19(b)(2) of the Exchange Act, as amended by the
Securities Acts Amendments of 1975, Public Law 94-29, 89 Stat. 97
(1975), grants the Commission flexibility to determine what type of
proceeding--either oral or notice and opportunity for written
comments--is appropriate for consideration of a particular proposal
by a self-regulatory organization. See Securities Acts Amendments of
1975, Report of the Senate Committee on Banking, Housing and Urban
Affairs to Accompany S. 249, S. Rep. No. 75, 94th Cong., 1st Sess.
30 (1975).
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    Interested persons are invited to submit written data, views, and
arguments regarding whether the proposed rule change, as modified by
Amendment No. 1, should be approved or disapproved by December 7, 2022.
Any person who wishes to file a rebuttal to any other person's
submission must file that rebuttal by December 21, 2022.
    Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File No. SR-FINRA-2022-024 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange

Commission, 100 F Street NE, Washington, DC 20549-1090.

All submissions should refer to File No. SR-FINRA-2022-024. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change, as modified by
Amendment No. 1, that are filed with the Commission, and all written
communications relating to the proposed rule change, as modified by
Amendment No. 1, between the Commission and any person, other than
those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for website viewing and
printing in the Commission's Public Reference Room, 100 F Street NE,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal office of FINRA. All
comments received will be posted without change. Persons submitting
comments are cautioned that we do not redact or edit personal
identifying information from comment submissions. You should submit
only information that you wish to make available publicly. If comments
are received, any rebuttal comments should be submitted on or before
December 21, 2022.
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    \21\ 17 CFR 200.30-3(a)(12); 17 CFR 200.30-3(a)(57).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\21\
J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2022-24959 Filed 11-15-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 93 (Friday, May 13, 2016)]
[Rules and Regulations]
[Pages 29770-29772]
[FR Doc No: 2016-11253]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2016-0250]
RIN 1625-AA87

Security Zone; Tall-Ship CUAUHTEMOC; Thames River, New London
Harbor, New London, CT

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary security zone
around the Tall-Ship CUAUHTEMOC during its transit through the Long
Island Sound Captain of the Port (COTP) Zone, and for the duration of
its mooring on the Thames River in New London Harbor, New London, CT.
This temporary final rule creates a 250-yard radius security zone
encompassing all navigable waters around the Tall-Ship CUAUHTEMOC while
in transit through Sector Long Island Sound's Captain of the Port
(COTP) Zone, and a 100-yard radius temporary security zone while the
vessel is anchored or moored in the Thames River in New London Harbor,
New London, CT. This zone is needed to protect the Tall-Ship CUAUHTEMOC
and its crew from destruction, loss, or injury from sabotage,
subversive acts, or other malicious acts of a similar nature. Persons
or vessels may not enter the security zone without permission of the
COTP or a COTP designated representative.

DATES: This rule is effective without actual notice from May 13, 2016
until May 14, 2016. For the purposes of enforcement, actual notice will
be used from May 1, 2016 until May 13, 2016.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2016-0250 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Petty Officer Jay TerVeen, Prevention Department, Coast
Guard Sector Long Island Sound; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

COTP Captain of the Port
DHS Department of Homeland Security

FR Federal Register
NPRM Notice of Proposed Rulemaking

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because an NPRM would be impracticable and
contrary to the public interest. Consequently, the Coast Guard did not
have enough time to draft, publish, and receive public comment on this
rulemaking via an NPRM and still publish a final rule before the event
was scheduled to take place. Delaying this rulemaking by waiting for a
comment period to run would also reduce the Coast Guard's ability to
fulfill its statutory missions to protect and secure the ports and
waterways of the United States.
    Under 5 U.S.C. 553(d)(3), and for the same reasons as stated above,
the Coast Guard finds that good cause exists for making this rule
effective less than 30 days after publication in the Federal Register.
Delaying the effective date of this rule would be contrary to public
interest because immediate action is needed to respond to the potential
security threats associated with having the Tall-Ship CUAUHTEMOC in
U.S. Waters.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under the authority in 33
U.S.C. 1231. The Captain of the Port Long of Island Sound (COTP) has
determined that vessels, within a 250-yard radius of the Tall-Ship
CUAUHTEMOC while it is transiting and a 100-yard radius while it is
moored, pose a potential security risk.

IV. Discussion of the Rule

    This rule establishes a security zone from May 1, 2016 through May
14, 2016 for the Tall-Ship CUAUHTEMOC. This zone is needed to protect
the Tall-Ship CUAUHTEMOC and its crew from destruction, loss, or injury
from sabotage, subversive acts, or other malicious acts of a similar
nature.
    This rule prevents vessels from entering, transiting, mooring, or
anchoring within the security zone unless authorized by the COTP or
designated representative. The Coast Guard has determined that this
security zone will not have a significant impact on vessel traffic due
to its temporary nature, limited size, and the fact that vessels are
allowed to transit the navigable waters outside of the security zone.
    The Coast Guard will notify the public and local mariners of this
safety zone through appropriate means, which may include, but are not
limited to, publication in the Federal Register, the Local Notice to
Mariners, and Broadcast Notice to Mariners.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on these statutes and Executive Order and we discuss First
Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13563 emphasizes the importance of
quantifying both costs and benefits, of reducing costs, of harmonizing
rules, and of promoting flexibility. This rule has not been designated
a ``significant regulatory action,'' under Executive Orders 12866.
Accordingly, it has not been reviewed by the Office of Management and
Budget.
    The Coast Guard determined that this rulemaking is not a
significant regulatory action for the following reasons: (1) The
enforcement of this security zone will be relatively short in duration;
(2) persons or vessels desiring to enter the security zone may do so
with permission from the COTP Sector LIS or a designated
representative; (3) this security zone is designed in a way to limit
impacts on vessel traffic, permitting vessels to navigate in other
portions of the waterway not designated as a security zone; and (4) the
Coast Guard will notify the public of the enforcement of this rule via
appropriate means, such as via Local Notice to Mariners and Broadcast
Notice to Mariners to increase public awareness of this security zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this proposed rule or any
policy or action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism

principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
(DHS) Management Directive 023-01 and Commandant Instruction Manual
(CIM) M16475.lD, which guide the Coast Guard in complying with the
National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-
4370f), and have concluded that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on the human environment. This rule involves the establishment
of a temporary security zone and is categorically excluded from further
review under, paragraph 34(g) of figure 2-1 of the Commandant
Instruction. An environmental analysis checklist and a categorical
exclusion determination will be available in the docket where indicated
under ADDRESSES.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-
1, 6.04-6, and 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. Add Sec.  165.T01-0250 to read as follows:

Sec.  165.T01-0250  Security Zone; Tall-Ship CUAUHTEMOC; Thames River,
New London Harbor, New London, CT.

    (a) Location. The following areas are designated as security zones:
    (1) All navigable waters within the Sector Long Island Sound
Captain of the Port (COTP) Zone, extending from the surface to the
bottom, within a 250-yard radius of the Tall-Ship CUAUHTEMOC.
    (2) All navigable waters within the Thames River in New London
Harbor, New London, CT, extending from the surface to the riverbed
within a 100-yard radius of the Tall-Ship CUAUHTEMOC while it moored or
anchored in the Thames River in New London Harbor, New London, CT.
    (b) Enforcement Period. This section will be enforced from May 1,
2016 through May 14, 2016, unless terminated sooner by the COTP.
    (c) Regulations. (1) The general regulations contained in 33 CFR
165.33 apply. During the enforcement period, entry into, transit
through, remaining within, mooring or anchoring within this temporary
security zone is prohibited unless authorized by the Captain of the
Port (COTP) or the designated representative.
    (2) Vessel operators given permission to enter or operate in the
temporary security zone must comply with all directions given to them
by the COTP or the designated representatives. Those vessels may be
required to be at anchor or moored to a waterfront facility.
    (3) The ``designated representative'' is any Coast Guard
commissioned, warrant, or petty officer who has been designated by the
COTP to act on his behalf. The on-scene representative may be on a
Coast Guard vessel, or onboard a federal, state, or local agency vessel
that is authorized to act in support of the Coast Guard.
    (4) Vessel operators desiring to enter or operate within the
temporary security zone shall telephone the COTP at<PHONE_NUMBER>, or
his designated representative via VHF channel 16 to obtain permission
to do so.

    Dated: April 19, 2016.
E.J. Cubanski, III,
Captain, U.S. Coast Guard, Captain of the Port Sector Long Island
Sound.
[FR Doc. 2016-11253 Filed 5-12-16; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 79, Number 126 (Tuesday, July 1, 2014)]
[Notices]
[Pages 37339-37340]
[FR Doc No: 2014-15457]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2014-0515]

Public Workshop Related to the International Maritime
Organization's Development of a Mandatory Code for Ships Operating in
Polar Waters.

AGENCY: Coast Guard, DHS.

ACTION: Notice of meeting; request for comments.

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

SUMMARY: The Coast Guard will hold a public workshop in Seattle, WA on
topics related to the development of a mandatory code for ships
operating in polar waters (Polar Code) by the International Maritime
Organization (IMO). Various topics will be discussed including
application and certification under the Polar Code; and regulations for
hull design, equipment, operations, and environmental protection. This
workshop is intended to be an interactive exchange of information
between policymakers, industry experts, and interested members of the
public.

DATES: The public workshop will be held on Thursday, August 14, 2014
from 9 a.m. to 4 p.m., Pacific Time. This workshop is open to the
public. Please note that the workshop has a limited number of seats and
may close early if all business is finished.
    The comment period for the docket closes September 1, 2014. All
comments and related material submitted after the meeting must either
be submitted to our online docket via http://www.regulations.gov on or
before September 1, 2014, or reach the Docket Management Facility by
that date.

ADDRESSES: The public workshop will be held at the Henry M. Jackson
Federal Building, 915 2nd Avenue, North Auditorium, 4th floor, Seattle,
WA 98174-1076. Due to building security requirements, each visitor must
present a valid government-issued photo identification (for example, a
driver's license) in order to gain entrance to the building. To
facilitate the security process related to building access, or to
request reasonable accommodation, those who plan to attend should
contact the meeting coordinator, Lieutenant Andrew Gibbons (see FOR
FURTHER INFORMATION CONTACT) not later than August 1, 2014. The Coast
Guard may not be able to accommodate requests made after August 1,
2014.
    Submit comments using one of the listed methods, and see
SUPPLEMENTARY INFORMATION for more information on public comments.
     Online--http://www.regulations.gov following Web site
instructions.
     Fax--202-493-2251.
     Mail or hand deliver--Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001. Hours
for hand delivery are 9 a.m. to 5 p.m., Monday through Friday, except
Federal holidays (telephone<PHONE_NUMBER>).

FOR FURTHER INFORMATION CONTACT: If you have questions concerning the
workshop, please call or email Lieutenant Andrew Gibbons, U.S. Coast
Guard; telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>If you
have questions on viewing or submitting material to the docket, call
Cheryl Collins, Program Manager, Docket Operations, telephone 202-366-
9826, toll free 1-800-647-5527.

SUPPLEMENTARY INFORMATION:

Discussion

    This workshop is intended to be an interactive exchange of
information between policymakers, industry experts, and interested
members of the public. The primary topics that will be considered at
the public meeting include:
     General overview of the draft Polar Code;
     Overview of draft amendments to the International
Convention for the Safety of Life at Sea (SOLAS);
     Overview of draft amendments to the International
Convention for the Prevention of Pollution from Ships (MARPOL);
     Application, certification, and documentation.
    This workshop is scheduled following progress at IMO during recent
meetings of the Maritime Safety Committee (MSC); Marine Environment
Protection Committee (MEPC); and subcommittees on the Human Element,
Training, and Watchkeeping; Navigation, Communication, and Search and
Rescue; and Ship Design and Construction. The public workshop will also
provide the opportunity for comment as the Coast Guard prepares for
upcoming meetings in October 2014 and November 2014 of MEPC and MSC at
IMO.
    You may view the draft Polar Code, draft SOLAS amendments, draft
MARPOL amendments, and public comments submitted thus far in our online
docket. Please see below for more information on viewing comments and
documents. Comments submitted to the docket and informal public
comments during the workshop are encouraged.
    Please note that the workshop has a limited number of seats and may
close early if all business is finished.
    Members of the public may attend this workshop up to the seating
capacity of the room. To facilitate the security process related to
building access, or to request reasonable accommodation, those who plan
to attend should contact the meeting coordinator, Lieutenant Andrew
Gibbons (see FOR FURTHER INFORMATION CONTACT) not later than Friday
August 1, 2014. We may not be able to accommodate requests made after
August 1, 2014.
    Members of the public are encouraged to participate and join in
discussions, subject to the discretion of the moderator. If you bring
written comments to the meeting, you may submit them to Coast Guard
personnel specified at the meeting to receive written comments. These
comments will be submitted to our online public docket.
    Comments should be marked with docket number USCG-2014-0515 and
should provide a reason for each suggestion or recommendation. You
should provide personal contact information so that we can contact you
if we have questions regarding your comments; but please note that all
comments will be posted to the online docket without change and that
any personal information you include can be searchable online (see the
Federal Register Privacy Act notice regarding our public dockets, 73 FR
3316, Jan. 17, 2008).
    Mailed or hand-delivered comments should be in an unbound 8\1/2\ x
11 inch format suitable for reproduction. The Docket Management
Facility will acknowledge receipt of mailed comments if you enclose a
stamped, self-addressed postcard or envelope with your submission.
    Documents mentioned in this notice, and all public comments, are in
our online docket at http://www.regulations.gov and can be viewed by
following the Web site's instructions. You can also view the docket at
the Docket Management Facility (see the mailing address under
ADDRESSES) between 9 a.m. and 5 p.m., Monday through Friday, except
Federal holidays.
    For information on facilities or services for individuals with
disabilities or to request special assistance at the meeting, contact
Lieutenant Andrew Gibbons (see FOR FURTHER INFORMATION CONTACT).
    This notice is issued under the authority of 5 U.S.C. 552(a).

    Dated: June 25, 2014.
J. G. Lantz,
Director of Commercial Regulations and Standards, U.S. Coast Guard.
[FR Doc. 2014-15457 Filed 6-30-14; 8:45 am]
BILLING CODE 9110-04-P


Exhibit 1A
1997 EIGHT-HOUR OZONE STANDARD MAINTENANCE PLANNING ASSUMPTIONS & MODELING INPUTS
General Methods and Assumptions
   1) Modeling Methodology:  Use the MOVES model in inventory mode to determine the total NOx and VOC emissions in the 20-county nonattainment area.
   2) Analysis Years: 2008, 2024
   3) Modeling Start Date: July 2011.  This start date is defined by the ARC as the initiation of the first model run for the support of SIP development.
Travel Demand Modeling Assumptions
   1) Calibration Year: 2000 (with some 2005 interim validations and benchmarking thereafter)
   2) Social/Economic Data: Produced as part of PLAN 2040
   3) All other modeling assumptions consistent with those approved in the PLAN 2040 documentation
Emissions Modeling Assumptions
   1) Emissions Model: MOVES2010a  -  Database: MOVES20100830
         a. Emissions Process  -  use MOVES in inventory mode for a July day
                 i. For the attainment inventory and maintenance inventory
                 ii. As the basis for the 2024 motor vehicle emissions budget
         b. Run separately for the 13-county and 7-county portions of the nonattainment area
                 i. 13-county area activity, vehicle population and other inputs area assigned to Fulton County while running MOVES
                 ii. 7-county area activity, vehicle population and other inputs are assigned to Bartow County while running MOVES
   2) MOVES Inputs
         a. Road Type Distribution  -  Processed from the travel demand model, GDOT HPMS counts and MOVES defaults.  Summarizes VMT fraction by road type and source type for the 13 and 7 counties separately.
         b. Source Type Population
                 i. Started with 2002 R.L. Polk & Co. registration data for the Atlanta nonattainment counties, as well as the Georgia Department of Revenue's registration data for 2003 and 2007.
                 ii. Vehicles by type were grown from 2002 to 2007 using different growth factors by vehicle type based on either Census person population estimates or on Georgia 2007 registration data.  Methodology developed by EPD for inputs to the SMOKE-MOVES Integration Tool.
                 iii. 2024 data grown from 2007 based on the ratio of MPO future year people population estimates
                 iv. Since the population of vehicle type 62 (combination long-haul trucks) can easily be underrepresented in areas with lots of through traffic, the vehicle population for MOVES source type 62 was revised using MOVES default VMT/VPOP ratios and VMT for HPMS type 60 data
         c. Vehicle Type VMT
                 i. HPMS VTypeYear - Processed from the travel demand model, GDOT HPMS Counts, and an EPA daily to annual VMT converter.  Assigns total annual VMT by HPMS vehicle type.
                 ii. Month VMT Fraction: MOVES defaults
                 iii. Day VMT Fraction: MOVES defaults
                 iv. Hour VMT Fraction:  Derived from the travel demand model by source and road type.  The fractions are determined separately for the 13 and 7 county areas.
         d. I/M Programs and Stage II Refueling Vapor Recovery  -  Applied to the 13-county area only (See Appendix A)
         e. Age Distribution  -  MOBILE6 age distributions converted to MOVES format using the EPA converter.  MOBILE6 distributions were derived from 2002 R.L. Polk & Co. registration data for the 13 and 7 county areas separately for all vehicle types, except for HDV8B where MOBILE6 defaults were used.
         f. Average Speed Distribution  -  Processed from the travel demand model with HPMS VMT Adjustment factors applied.  Calculates VHT by hour by speed bin by source.  The distribution is determined separately for the 13 and 7 county areas.
         g. Ramp Fraction  -  Processed from the travel demand model.  Calculates VMT by freeway and ramps by area type.  The fraction is determined separately for the 13 and 7 county areas.
         h. Fuel  -  MOVES defaults for a July weekday for Fulton (13-county) and Bartow (7-county)
         i. Meteorology  -  2008 data
   3) VMT HPMS Adjustment Factors
         a. Calculated for the year 2000 (See Appendix B)
         b. HPMS adjustment in base year of calibration in accordance with  Section 93.122(b)(3) of the Transportation Conformity Rule which recommends that HPMS adjustment factors be developed to reconcile travel model estimates of VMT in base year of validation to HPMS estimates for the same period
         c. Summer (seasonal) adjustment to convert from average annual VMT to summer-season VMT
         d. Factors applied to VMT estimates generated by ARC travel demand model for 13-county portion and 7-county portion of 20-county modeling domain, separately
         a. Factors aggregated up to MOVES road types from base HPMS functional classifications
   4) Off-Model Calculations
         a. Senior I/M Exemption (emissions debit)
                 i. The Senior I/M Exemption calculated for year 2002 is conservatively high and will be added to the regional emission inventories for each analysis year
   5) TCMs
         a. No additional credit is taken in the emissions modeling process for SIP TCMs

APPENDIX A  -  I/M Program
   1) Exhaust and Evaporative (OBD and gas cap pressure test) for 1996 and newer vehicles
         a. Began in 1982
         b. Annual inspection required
         c. Computerized test and repair OBD  -  Exhaust
         d. Computerized test and repair OBD & GC - Evaporative
         e. Applies to all LDG vehicle types
         f. Three year grace period
         g. 3% waiver rate for all vehicles  -  Exhaust test
         h. 0% waiver rate for all vehicles  -  Evaporative test
         i. 97% compliance
   2) Exhaust and Evaporative test for 1975  -  1995 vehicles
         a. Began in 1982
         b. Annual inspection required
         c. Computerized test and repair ASM 2525/5015 Phase-in  -  Exhaust
         d. Computerized test and repair GC  -  Evaporative
         e. Applies to all LDG vehicle types
         f. 3% waiver rate for all vehicles  -  Exhaust
         g. 0% waiver rate for all vehicles  -  Evaporative
         h. 97% compliance
         i. 25 year and older model years are exempt
   3) Stage II Refueling and Vapor Recovery
         a. Started in 1992
         b. Three phase in years
         c. 81% efficiency

Appendix B  -  VMT Adjustment Factors
                         Ozone VMT Adjustment Factors
                             Functional Class Name
                          Functional Classifications
                           Factor for 13 County Area
                           Factor for 7 County Area
                            Interstates / Freeways
                                   1, 11, 12
                                     1.05
                                     0.89
                                   Arterials
                                 2, 6, 14, 16
                                     0.98
                                     0.99
                                  Collectors
                                   7, 8, 17
                                     1.07
                                     1.81
                                     Local
                                     9, 19
                                     0.87
                                     1.10

Exhibit 1B
1997 ANNUAL PM2.5 STANDARD MAINTENANCE PLANNING ASSUMPTIONS & MODELING INPUTS
General Methods and Assumptions
   1) Modeling Methodology
         a. 20-County Portion  -  Use the MOVES model in inventory mode to determine the total NOx and PM2.5 emissions
         b. Putnam Partial County Portion  -  Use an off-travel model technique to determine emissions in MOVES
   2) Conformity Test
         a. No Greater than Base Year interim emissions test for analysis years prior to 2024
                 i. 2002 base year
                 ii. Base year emissions to be developed as part of the conformity analysis provided in preamble to the eight-hour ozone and PM2.5 Transportation Conformity Rule.  Base year emissions will be established using the same modeling methodology presented above.
   3) Conformity Analysis Years: 2002, 2008, 2024
   4) Modeling Start Date: July 2011.  This start date is defined by the ARC as the initiation of the first model run for the support of SIP development.
Travel Demand Modeling Assumptions
   1) Calibration Year: 2000 (with some 2005 interim validations and benchmarking thereafter)
   2) Social/Economic Data: Produced as part of PLAN 2040
   3) All other modeling assumptions consistent with those approved in the PLAN 2040 documentation
Emissions Modeling Assumptions
   1) Emissions Model: MOVES2010a  -  Database: MOVES20100830
         a. Emissions Process  -  using MOVES in Inventory mode
                 i. Run an entire year
                 ii. Run an annualized average day, which is used as the basis for the 2024 motor vehicle emission budget
         b. Run separately for the 13-county and 7-county portions of the nonattainment area
                 i. 13-county area activity, vehicle population, and other inputs are assigned to Fulton County while running MOVES
                 ii. 7-county area activity, vehicle population, and other inputs are assigned to Bartow County while running MOVES
   1) MOVES Inputs
         a. Road Type Distribution  -  Processed from the travel demand model, GDOT HPMS counts and MOVES defaults.  Summarizes VMT fraction by road type and source type for the 13 and 7 counties separately.
         b. Source Type Population
                 i. Started with 2002 R.L. Polk & Co. registration data for the Atlanta nonattainment counties, as well as the Georgia Department of Revenue's registration data for 2003 and 2007
                 ii. Vehicles by type were grown from 2002 to 2007 using different growth factors by vehicle type based on either Census person population estimates or on Georgia 2007 registration data.  Methodology developed by EPD for inputs to the SMOKE-MOVES Integration Tool
                 iii. 2024 data grown from 2007 based on the ratio of MPO future year people population estimates
                 iv. Since the population of vehicle type 62 (combination long-haul trucks) can easily be underrepresented in areas with lots of through traffic, the vehicle population for MOVES source type 62 was revised using MOVES default VMT/VPOP ratios and VMT for HPMS type 60 data
                 v. 2024 Putnam County data grown from 2007 based on the ratio of Georgia Office of Planning and Budget future people population estimates
         c. Vehicle Type VMT
                 i. HPMS VTypeYear - Processed from the travel demand model, GDOT HPMS Counts, and an EPA daily to annual VMT converter.  Assigns total annual VMT by HPMS vehicle type
                 ii. Month VMT Fraction: MOVES defaults
                 iii. Day VMT Fraction: MOVES defaults
                 iv. Hour VMT Fraction: Derived from the travel demand model by source and road type.  Determined separately for the 13 and 7 county areas.
         d. I/M Programs and Stage II Refueling Vapor Recovery  -  Applied to 13 county area only (See Appendix A)
         e. Age Distribution  -  MOBILE6 age distributions converted to MOVES format using EPA converter.  MOBILE6 distributions were derived from 2002 R.L. Polk & Co. registration data for the 13 and 7 county areas separately for all vehicle types, except for HDV8B where MOBILE6 defaults were used.
         f. Average Speed Distribution  -  Processed from the travel demand model with HPMS VMT Adjustment factors applied.  Calculates VHT by hour by speed bin by source.  Determined separately for the 13 and 7 county areas.
         g. Ramp Fraction  -  Processed from the travel demand model.  Calculates VMT by freeway and ramps by area type.  Determined separately for the 13 and 7 county areas.
         h. Fuel  -  Annualized MOVES defaults for Fulton (13-county) and Bartow (7-county)
         i. Meteorology  -  2008 data
   2) VMT HPMS Adjustment Factors
         a. Calculated for year 2000  (See Appendix B)
         b. HPMS adjustment in base year of calibration in accordance with  Section 93.122(b)(3) of the Transportation Conformity Rule which recommends that HPMS adjustment factors be developed to reconcile travel model estimates of VMT in base year of validation to HPMS estimates for the same period
         c. Factors applied to VMT estimates generated by ARC travel demand model for 13-county portion and 7-county portion of 20-county modeling domain, separately.
         d. Factors aggregated up to MOVES road types from base HPMS functional classifications
   3) Off-Model Calculations
         a. Senior I/M Exemption (emissions debit)
                 i. The Senior I/M Exemption calculated for year 2002 is conservatively high and will be added to the regional emission inventories for each analysis year.
         b. Putnam Partial Nonattainment Area
                 i. Total MOVES inventory-mode derived emissions in Putnam County were scaled down to the nonattainment area's contribution based on the ratio of human population in the nonattainment area to the entire county.
                 ii. VMT in Putnam County is estimated using historical VMT estimates from GDOT's 445 Reports
                 iii. Congested flow speeds for Putnam County are taken from the 7-county portion of the ARC travel demand model for each analysis year
   4) TCMs
         a. No additional credit is taken in the emissions modeling process for SIP TCMs
APPENDIX A  -  I/M Program
   1) Exhaust and Evaporative (OBD and gas cap pressure test) for 1996 and newer vehicles
         a. Began in 1982
         b. Annual inspection required
         c. Computerized test and repair OBD  -  Exhaust
         d. Computerized test and repair OBD & GC - Evaporative
         e. Applies to all LDG vehicle types
         f. Three year grace period
         g. 3% waiver rate for all vehicles  -  Exhaust test
         h. 0% waiver rate for all vehicles  -  Evaporative test
         i. 97% compliance
   2) Exhaust and Evaporative test for 1975  -  1995 vehicles
         a. Began in 1982
         b. Annual inspection required
         c. Computerized test and repair ASM 2525/5015 Phase-in  -  Exhaust
         d. Computerized test and repair GC  -  Evaporative
         e. Applies to all LDG vehicle types
         f. 3% waiver rate for all vehicles  -  Exhaust
         g. 0% waiver rate for all vehicles  -  Evaporative
         h. 97% compliance
         i. 25 year and older model years are exempt
   3) Stage II Refueling and Vapor Recovery
         a. Started in 1992
         b. Three phase in years
         c. 81% efficiency

Appendix B  -  VMT Adjustment Factors
                         PM2.5 VMT Adjustment Factors
                             Functional Class Name
                          Functional Classifications
                           Factor for 13 County Area
                           Factor for 7 County Area
                            Interstates / Freeways
                                   1, 11, 12
                                     1.02
                                     0.85
                                   Arterials
                                 2, 6, 14, 16
                                     0.99
                                     0.97
                                  Collectors
                                   7, 8, 17
                                     1.09
                                     1.80
                                     Local
                                     9, 19
                                     0.89
                                     1.09

Exhibit 1C
PLAN2040 Population and Employment Planning Assumptions
The ARC will be conducting a conformity analysis under the PM2.5 standard as part of the conformity determination for the PLAN 2040 RTP / FY 2012-2017 TIP for the 20 county nonattainment area.
Below is a detailed listing of the procedures and planning assumptions for the upcoming conformity analysis of the PLAN 2040 RTP.
ARC periodically revises its population and employment forecasts based on best available current information. Each revision is a two-step process. First, new region-level forecasts are produced. These then become region-level controls for census tract and traffic analysis zone (TAZ) forecasts.

The most current region-level control forecasts (PLAN 2040) were completed in spring of 2009. The accompanying table summarizes the new population and employment controls for the updated, 20-county study area.

ARC staff was assisted in the development of these regional forecasts by a Technical Advisory Committee (TAC) of nationally known, local experts on the Atlanta Regional Economy. Chair of the Committee was Dr. Donald Ratajczak, Regents Professor Emeritus of Economics at Georgia State University. Dr. Ratajczak served as director of the Economic Forecasting Center in the J. Mack Robinson College of Business at Georgia State University from 1973 until June 2000 and as a professor of economics in the Andrew Young School of Policy Studies until he retired in 2000. The committee recommended the final adopted forecasts for use by the Commission in 2009.

The second step in the forecasting process uses mathematical models to disaggregate the region-level control population and employment forecasts to "small areas": the Superdistrict, census tract and traffic analysis zone (TAZ) level. TAZs are nested within census tracts. Census tracts nest within superdistricts. The mathematical models underlying the region-level controls have evolved and become more complex, but ARC's basic approach is the same today as in 1975.

The TAZ Disaggregator (TAZ-D) model has been used in Plan2040 to disaggregate the regional controls to small areas. This model runs annually and iteratively (unlike the five-year iterative sequence of the previous model small area model, DRAM/EMPAL). The process is fully integrated with the ARC travel demand model, as impedances (travel costs) from the travel model are a significant influence layer for spatial allocation of population and job growth.

Population and job levels from each successive single-year forecast become the base for forecasts in the next model year. First, the Cube/TP+ model analyze base year traffic patterns and produces accessibility measures (impedances or travel costs) within the 20-county forecasted area. Then, the TAZ-D model uses the composite impedances; Superdistrict-level distribution of base-year population, employment and land use; and other spatial influence layers (e.g. like land use, interchange locations, major arterials, transit stations, etc.) to develop grid-level forecasts one year into the future. The size of the grid areas in the TAZ-D model vary by geographic area of the region, as do the weights assigned to various spatial influence factors for growth. The Unified Growth Policy Map (UGPM) was used by the TAZ-D as the baseline source to generate household and job density and/or intensity levels to allocate future growth. The grid-level forecasts are then aggregated back up to the TAZ, tract, and superdistrict levels. The TAZ-level forecasts then become the input used by the Cube/TP+ model to produce the impedances measure that drives the next iteration of the integrated model run.

All these models are carefully calibrated based on the best and most current data available. Data used in the current effort include 2000 United States Census results, ARC annual estimates of population (using the building permit method from 2000 Census base) for superdistricts and census tracts, ARC annual estimates of employment by industry for superdistricts, tracts and TAZs from the state of Georgia unemployment insurance base file. National forecasts of employment and population were derived from the REMI Policy Insight+ model. The results of ARC travel surveys included the SMARTRAQ household travel survey, transit on-board survey, Hartsfield air passenger survey, travel time studies, speed studies, and others. Highway projects and the schedule for their completion (primary inputs to the Cube/TP+ model) are developed as part of an extensive discussion between ARC staff, local planners, Georgia Department of Transportation and various federal agencies.

The area modeled by ARC for transportation/air quality purposes expanded from ten (10) to twenty (20) counties over the last 15 years. The 2010 Census and federal conformity analysis requirements may result in further expansion of the nonattainment area. To meet current and future data needs, ARC produced employment estimates by county and census block group for the state of Georgia beginning in 2008, and continues to produce these estimates annually. The counties covered by land-use data produced in the LandPro program is expanded as needed. ARC's population estimates' program area will be expanded as required, from the current 20 counties, using the 2010 Census as a data baseline.

ARC produced tract-level 2010 estimates of population and 2009 small-area estimates of employment for the 20-county study area to support initial iterations of the TAZ-D model. Development of the annual estimates and of the year 2000 calibration database for the nonmember counties was coordinated with the affected county governments and the Regional Development Centers of which they are members.

Post processing adjustments are made to the ARC forecasts to account for expected large scale changes and policy priorities that would not be reflected in historical data. Events such as expected construction of a new highway or policy input restricting development within the region are accounted for directly in the models with the spatial influence layers or density limitations. Factors such as expected job and household growth from the completion of a major development project (i.e. Atlantic Station) or transit-oriented development are incorporated as post processing adjustments to the model output.

The forecasts will be used as part of the 2011 RTP (Plan2040/FY 2012-2017 TIP), scheduled for adoption in August 2011.


[Federal Register Volume 84, Number 197 (Thursday, October 10, 2019)]
[Rules and Regulations]
[Pages 54520-54522]
[FR Doc No: 2019-22123]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 64

[Docket ID FEMA-2019-0003; Internal Agency Docket No. FEMA-8601]

Suspension of Community Eligibility

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final rule.

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SUMMARY: This rule identifies communities where the sale of flood
insurance has been authorized under the National Flood Insurance
Program (NFIP) that are scheduled for suspension on the effective dates
listed within this rule because of noncompliance with the floodplain
management requirements of the program. If the Federal Emergency
Management Agency (FEMA) receives documentation that the community has
adopted the required floodplain management measures prior to the
effective suspension date given in this rule, the suspension will not
occur and a notice of this will be provided by publication in the
Federal Register on a subsequent date. Also, information identifying
the current participation status of a community can be obtained from
FEMA's Community Status Book (CSB). The CSB is available at https://www.fema.gov/national-flood-insurance-program-community-status-book.

DATES: The effective date of each community's scheduled suspension is
the third date (``Susp.'') listed in the third column of the following
tables.

FOR FURTHER INFORMATION CONTACT: If you want to determine whether a
particular community was suspended on the suspension date or for
further information, contact Adrienne L. Sheldon, PE, CFM, Federal
Insurance and Mitigation Administration, Federal Emergency Management
Agency, 400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The NFIP enables property owners to purchase
Federal flood insurance that is not otherwise generally available from
private insurers. In return, communities agree to adopt and administer
local floodplain management measures aimed at protecting lives and new
construction from future flooding. Section 1315 of the National Flood
Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale
of NFIP flood insurance unless an appropriate public body adopts
adequate floodplain management measures with effective enforcement
measures. The communities listed in this document no longer meet that
statutory requirement for compliance with program regulations, 44 CFR
part 59. Accordingly, the communities will be suspended on the
effective date in the third column. As of that date, flood insurance
will no longer be available in

the community. We recognize that some of these communities may adopt
and submit the required documentation of legally enforceable floodplain
management measures after this rule is published but prior to the
actual suspension date. These communities will not be suspended and
will continue to be eligible for the sale of NFIP flood insurance. A
notice withdrawing the suspension of such communities will be published
in the Federal Register.
    In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that
identifies the Special Flood Hazard Areas (SFHAs) in these communities.
The date of the FIRM, if one has been published, is indicated in the
fourth column of the table. No direct Federal financial assistance
(except assistance pursuant to the Robert T. Stafford Disaster Relief
and Emergency Assistance Act not in connection with a flood) may be
provided for construction or acquisition of buildings in identified
SFHAs for communities not participating in the NFIP and identified for
more than a year on FEMA's initial FIRM for the community as having
flood-prone areas (section 202(a) of the Flood Disaster Protection Act
of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against
certain types of Federal assistance becomes effective for the
communities listed on the date shown in the last column. The
Administrator finds that notice and public comment procedures under 5
U.S.C. 553(b), are impracticable and unnecessary because communities
listed in this final rule have been adequately notified.
    Each community receives 6-month, 90-day, and 30-day notification
letters addressed to the Chief Executive Officer stating that the
community will be suspended unless the required floodplain management
measures are met prior to the effective suspension date. Since these
notifications were made, this final rule may take effect within less
than 30 days.
    National Environmental Policy Act. FEMA has determined that the
community suspension(s) included in this rule is a non-discretionary
action and therefore the National Environmental Policy Act of 1969 (42
U.S.C. 4321 et seq.) does not apply.
    Regulatory Flexibility Act. The Administrator has determined that
this rule is exempt from the requirements of the Regulatory Flexibility
Act because the National Flood Insurance Act of 1968, as amended,
Section 1315, 42 U.S.C. 4022, prohibits flood insurance coverage unless
an appropriate public body adopts adequate floodplain management
measures with effective enforcement measures. The communities listed no
longer comply with the statutory requirements, and after the effective
date, flood insurance will no longer be available in the communities
unless remedial action takes place.
    Regulatory Classification. This final rule is not a significant
regulatory action under the criteria of section 3(f) of Executive Order
12866 of September 30, 1993, Regulatory Planning and Review, 58 FR
51735.
    Executive Order 13132, Federalism. This rule involves no policies
that have federalism implications under Executive Order 13132.
    Executive Order 12988, Civil Justice Reform. This rule meets the
applicable standards of Executive Order 12988.
    Paperwork Reduction Act. This rule does not involve any collection
of information for purposes of the Paperwork Reduction Act, 44 U.S.C.
3501 et seq.

List of Subjects in 44 CFR Part 64

    Flood insurance, Floodplains.

    Accordingly, 44 CFR part 64 is amended as follows:

PART 64--[AMENDED]

0
1. The authority citation for part 64 continues to read as follows:

    Authority:  42 U.S.C. 4001 et seq., Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp.; p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp.; p. 376.

Sec.  64.6  [Amended]

0
2. The tables published under the authority of Sec.  64.6 are amended
as follows:

----------------------------------------------------------------------------------------------------------------
                                                Effective date
                                                authorization/
                                  Community    cancellation of     Current effective map   Date certain Federal
       State and location            No.        sale of flood              date            assistance no longer
                                                 insurance in                               available  in SFHAs
                                                  community
----------------------------------------------------------------------------------------------------------------
           Region IV
Mississippi:

    Columbia, City of, Marion        280111  February 6, 1975,    October 18, 2019......  October 18, 2019
     County.                                  Emerg; September
                                              28, 1979, Reg;
                                              October 18, 2019,
                                              Susp.
    Lamar County,                    280304  April 16, 1979,      ......do..............   Do.
     Unincorporated Areas.                    Emerg; April 2,
                                              1990, Reg; October
                                              18, 2019, Susp.
    Marion County,                   280230  March 18, 1975,      ......do..............   Do.
     Unincorporated Areas.                    Emerg; September
                                              28, 1979, Reg;
                                              October 18, 2019,
                                              Susp.
    Tylertown, Town of,              280175  February 27, 1975,   ......do..............   Do.
     Walthall County.                         Emerg; September
                                              30, 1988, Reg;
                                              October 18, 2019,
                                              Susp.
    Walthall County,                 280307  May 20, 1980,        ......do..............   Do.
     Unincorporated Areas.                    Emerg; August 1,
                                              1986, Reg; October
                                              18, 2019, Susp.
South Carolina:

    Hardeeville, City of,            450113  May 27, 1975,        ......do..............   Do.
     Beaufort and Jasper                      Emerg; September
     Counties.                                1, 1987, Reg;
                                              October 18, 2019,
                                              Susp.
    Jasper County,                   450112  June 10, 1975,       ......do..............   Do.
     Unincorporated Areas.                    Emerg; September
                                              29, 1986, Reg;
                                              October 18, 2019,
                                              Susp.
           Region VI
Texas:

    Austin County,                   480704  November 21, 1975,   ......do..............   Do.
     Unincorporated Areas.                    Emerg; January 17,
                                              1990, Reg; October
                                              18, 2019, Susp.
    San Felipe, Town of, Austin      480705  April 7, 1976,       ......do..............   Do.
     County.                                  Emerg; January 3,
                                              1986, Reg; October
                                              18, 2019, Susp.
    Sealy, City of, Austin           480017  July 31, 1975,       ......do..............   Do.
     County.                                  Emerg; January 17,
                                              1990, Reg; October
                                              18, 2019, Susp.
            Region X
Oregon:

    Depoe Bay, City of, Lincoln      410283  January 11, 1979,    ......do..............   Do.
     County.                                  Emerg; October 15,
                                              1980, Reg; October
                                              18, 2019, Susp.
    Lincoln County,                  410129  February 16, 1973,   ......do..............   Do.
     Unincorporated Areas.                    Emerg; September
                                              3, 1980, Reg;
                                              October 18, 2019,
                                              Susp.

    Marion County,                   410154  December 10, 1971,   ......do..............   Do.
     Unincorporated Areas.                    Emerg; August 15,
                                              1979, Reg; October
                                              18, 2019, Susp.
    Newport, City of, Lincoln        410131  October 18, 1974,    ......do..............   Do.
     County.                                  Emerg; April 15,
                                              1980, Reg; October
                                              18, 2019, Susp.
    Salem, City of, Marion and       410167  December 3, 1971,    ......do..............   Do.
     Polk Counties..                          Emerg; June 15,
                                              1979, Reg; October
                                              18, 2019, Susp.
    Siletz, City of, Lincoln         410132  May 30, 1975,        October 18, 2019......  October 18, 2019.
     County..                                 Emerg; March 1,
                                              1979, Reg; October
                                              18, 2019, Susp.
    Toledo, City of, Lincoln         410133  April 19, 1973,      ......do..............   Do.
     County..                                 Emerg; March 1,
                                              1979, Reg; October
                                              18, 2019, Susp.
    Turner, City of, Marion          410171  August 1, 1975,      ......do..............   Do.
     County..                                 Emerg; April 2,
                                              1979, Reg; October
                                              18, 2019, Susp.
    Waldport, City of, Lincoln       410134  November 1, 1974,    ......do..............   Do.
     County..                                 Emerg; March 15,
                                              1979, Reg; October
                                              18, 2019, Susp.
    Yachats, City of, Lincoln        410135  July 18, 1975,       ......do..............   Do.
     County..                                 Emerg; March 1,
                                              1979, Reg; October
                                              18, 2019, Susp.
----------------------------------------------------------------------------------------------------------------
*......do = Ditto.
Code for reading third column: Emerg.--Emergency; Reg.--Regular; Susp.--Suspension.

    Dated: October 3, 2019.
Katherine B. Fox,
Assistant Administrator for Mitigation, Federal Insurance and
Mitigation Administration--FEMA Resilience, Department of Homeland
Security, Federal Emergency Management Agency.
[FR Doc. 2019-22123 Filed 10-9-19; 8:45 am]
BILLING CODE 9110-12-P


Telephone log

12/7/2009

Call from Margaret Sheppard, EPA

To:	Harry Eustice, GM<PHONE_NUMBER>

I returned Mr. Eustice’s voicemail message.  He wanted to know:

1) When will SAE’s presentation go up?

2) He agrees with the comment from Michael of BMW on the presentation summary.  He may have comment of his own.

I also mentioned that EPA may reopen public comment period once final standards are available.  We may well get a request to reopen in the next week or two.


[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)]
[Notices]
[Pages 6497-6498]
[FR Doc No: 2017-01140]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2611-084]

Hydro Kennebec, LLC; Notice of Application To Extend Interim
Species Protection Plan for Three Years and Soliciting Comments,
Motions To Intervene and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Application Type: Amendment of License.
    b. Project No: 2611-084.
    c. Date Filed: December 23, 2016.
    d. Applicant: Hydro Kennebec, LLC.
    e. Name of Project: Hydro Kennebec.
    f. Location: The project is located on the Kennebec River in
Kennebec and Somerset counties, Maine.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: Kelly Maloney, Hydro Kennebec LLC, 150 Main
Street, Lewiston, ME 04340,<PHONE_NUMBER>.
    i. FERC Contact: Mr. Mark Pawlowski<PHONE_NUMBER>,
<EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene, and
protests: February 13, 2017.
    All documents may be filed electronically via the Internet. See, 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site at http://www.ferc.gov/docs-filing/efiling.asp. If unable to be
filed electronically, documents may be paper-filed. To paper-file, an
original and seven copies should be mailed to: Secretary, Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426. 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.
    Please include the project number, P-2611-084, on any comments,
motions, or protests filed.
    k. Description of Request: Hydro Kennebec, LLC, licensee for the
Hydro Kennebec Project, seeks Commission approval to extend the
expiration date of its approved Interim Species Passage Plan (ISPP).
The Commission approved the ISPP on February 28, 2013, with an
expiration date of December 31, 2016. Hydro Kennebec, LLC wants to keep
the plan in effect for three more years so that it expires on December
31, 2019 (the same date approved ISPPs expire for the Lockwood,
Shawmut, and Weston Projects, which are also located on the Kennebec
River).
    l. Locations of the Application: A copy of the application is
available for review at the Commission in the Public Reference Room or
may be viewed on the Commission's Web site at http://www.ferc.gov using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). A copy is also available for inspection and reproduction at
the address in item (h) above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Responsive Documents: Any filing must (1)
bear in all capital letters the title ``COMMENTS,'' ``PROTESTS,'' or
``MOTION TO INTERVENE'' as applicable; (2) set forth in the heading the
name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person protesting or intervening; and (4) otherwise
comply with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis and otherwise comply with the requirements of 18 CFR
4.34(b). Agencies may obtain copies of the application directly from
the applicant. A copy of any protest or motion to intervene must be
served upon each representative of the applicant specified in the
particular application. If an intervener files comments or documents
with the Commission relating to the merits of an issue that may affect
the responsibilities of a particular resource

agency, they must also serve a copy of the document on that resource
agency. A copy of all other filings in reference to this application
must be accompanied by proof of service on all persons listed in the
service list prepared by the Commission in this proceeding, in
accordance with 18 CFR 4.34(b) and 385.2010.

    Dated: January 12, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-01140 Filed 1-18-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 164 (Monday, August 25, 2014)]
[Notices]
[Pages 50644-50645]
[FR Doc No: 2014-20126]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER14-2672-000]

EDF Energy Services, LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
EDF Energy Services, LLC's application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for

blanket authorization, under 18 CFR part 34, of future issuances of
securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is September 8, 2014.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the Web site that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: August 19, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-20126 Filed 8-22-14; 8:45 am]
BILLING CODE 6717-01-P