[Federal Register: October 4, 2010 (Volume 75, Number 191)]
[Notices]
[Page 61161-61162]
[DOCID:fr04oc10-44]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2010-0057]

Agency Information Collection Activities: Proposed Collection;
Comment Request, OMB No. 1660-0072; Mitigation Grants Program/e-Grants

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice; 60-day notice and request for comments; extension,
without change, of a currently approved information collection; OMB No.
1660-0072; No Form.

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SUMMARY: The Federal Emergency Management Agency, as part of its
continuing effort to reduce paperwork and respondent burden, invites
the general public and other Federal agencies to take this opportunity
to comment on a proposed revision of a currently approved information
collection. In accordance with the Paperwork Reduction Act of 1995,
this Notice seeks comments concerning this collection that is used by:
(1) Applicants and sub-applicants to apply for and report on e-Grant
awards; and (2) the Federal Emergency Management Agency to evaluate,
award, and monitor expenditures and program/project performance for
Flood Mitigation Assistance program, Severe Repetitive Loss, Repetitive
Flood Claim, and Pre-Disaster Mitigation activities.

DATES: Comments must be submitted on or before December 3, 2010.

ADDRESSES: To avoid duplicate submissions to the docket, please use
only one of the following means to submit comments:
    (1) Online. Submit comments at http: //www.regulations.gov under
Docket ID FEMA-2010-0057. Follow the instructions for submitting
comments.
    (2) Mail. Submit written comments to Docket Manager, Office of
Chief Counsel, DHS/FEMA, 500 C Street, SW., Room 835, Washington, DC
20472-3100.
    (3) Facsimile. Submit comments to<PHONE_NUMBER>.
    (4) E-mail. Submit comments to<EMAIL_ADDRESS>Include Docket
ID FEMA-2010-0057 in the subject line.
    All submissions received must include the agency name and Docket
ID. Regardless of the method used for submitting comments or material,
all submissions will be posted, without change, to the Federal
eRulemaking Portal at http://www.regulations.gov, and will include any
personal information you provide. Therefore, submitting this
information makes it public. You may wish to read the Privacy Act
notice that is available via the link in the footer of http://
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Cecelia Rosenberg, Grants Policy
Chief, Federal Insurance and Mitigation Administration,<PHONE_NUMBER>
for additional information. You may contact the Records Management
Division for copies of the proposed collection of information at
facsimile number<PHONE_NUMBER> or e-mail address: FEMA-Information-
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This collection of information is necessary
to implement grants for the Flood Mitigation Assistance (FMA) program,
Severe Repetitive Loss (SRL) program, Repetitive Flood Claims (RFC)
program and the Pre-Disaster Mitigation (PDM) program.
    The FMA program is authorized by section 1366 of the National Flood
Insurance Act of 1968, 42 U.S.C. 4104c, as amended by the National
Flood Insurance Reform Act of 2004 (NFIA), Public Law 108-264. The FMA
program, under 44 CFR Part 79, is designed to award grants so that
measures are taken to reduce or eliminate the long-term risk of flood
damage to buildings, manufactured homes, and other structures insurable
under the National Flood Insurance Program (NFIP).
    The SRL program is authorized by section 1361A of the NFIA of 2004,
42 U.S.C. 4102a, with the goal of reducing flood damages to residential
properties that have experienced severe repetitive losses under flood
insurance coverage. The program under 44 CFR Part 79, focuses on
efforts that will result in the greatest savings to the NFIF in the
shortest period of time.
    The RFC program is authorized by the NFIA of 2004 (Pub. L. 108-
264), 42 U.S.C. 4030. The NFIA authorizes funding annually to award
grants for actions that reduce flood damages to individual properties
for which one or more claim payments for losses have been made.
    The PDM program is authorized by section 203 of the Robert T.
Stafford Disaster Relief and Emergency Assistance Act (the Act), 42
U.S.C. 5133, as amended by section 102 of the Disaster Mitigation Act
of 2000 (DMA), Public Law 106-390, 114 Stat. 1552. The PDM program
provides grants for cost-effective mitigation actions prior to a
disaster event to reduce overall risks to the population and
structures, while also reducing reliance on funding from actual
disaster declarations.
    In accordance with OMB Circular A-102, FEMA requires that all
parties interested in receiving FEMA mitigation grants submit an
application package for grant assistance. The e-Grants system has been
developed and revamped to meet the intent of the e-Government
initiative, authorized by Public Law 106-107. This initiative requires
that all government agencies both streamline grant application
processes and provide for the means to electronically create, review,
and submit a grant application via the Internet.

Collection of Information

    Title: Mitigation Grant Program/eGrants.
    Type of Information Collection: Extension, without change, of a
currently approved information collection.
    OMB Number: 1660-0072.
    Form Titles and Numbers: No Forms.
    Abstract: The FEMA mitigation grant programs--Flood Mitigation
Assistance, Severe Repetitive Loss, Repetitive Flood Claims, and Pre-
Disaster Mitigation--all utilize an automated grant application and
management system known as e-Grants to apply for these grants. These
programs provide funding to allow for the reduction or elimination of
the risks to life and property from hazards. The e-Grants system also
provides the mechanism to provide quarterly reports of the financial
status of the project and the final closeout report.
    Affected Public: State, local and Tribal Governments.
    Estimated Total Annual Burden Hours: 43,848 Hours.

                                                       Estimated Annualized Burden Hours and Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                               No. of                 Avg. burden     Total                     Total
                                                                  No. of     responses    Total no.       per         annual    Avg. hourly     annual
         Type of respondent            Form name/Form number   respondents      per           of        response   burden  (in   wage rate    respondent
                                                                             respondent   responses    (in hours)     hours)                     cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                FMA:           ...........  ...........  ...........  ...........  ...........  ...........  ...........
State, local or Tribal Government...   Benefit-Cost                     56            2          112            5          560       $43.54      $24,382
                                       Determination.
State, local or Tribal Government...   Environmental Review..           56            2          112          7.5          840        43.54       36,574
State, local or Tribal Government...   Project Narrative-               56            4          224           12        2,688        43.54      117,036
                                       Subgrant Application.
                                                              ------------------------------------------------------------------------------------------
     Subtotal.......................                                    56  ...........          448  ...........        4,088  ...........      177,992
                                                              ------------------------------------------------------------------------------------------
                                                RFC:
State, local or Tribal Government...  Benefit-Cost                      56            1           56            5          280        43.54       12,191
                                       Determination.
State, local or Tribal Government...  Environmental Review...           56            1           56          7.5          420        43.54       18,287
 State, local or Tribal Government..  Project Narrative-                56            2          112           12        1,344        43.54       58,518
                                       Subgrant Application.
                                                              ------------------------------------------------------------------------------------------
    Subtotal........................                                    56  ...........          224  ...........        2,044  ...........       88,996
                                                SRL:
State, local or Tribal Government...  Benefit-Cost                      56            7          392            5         1960        43.54       85,338
                                       Determination.
State, local or Tribal Government...  Environmental Review...           56            7          392          7.5        2,940        43.54      128,008
 State, local or Tribal Government..  Project Narrative-                56            8          448           12        5,376        43.54      234,071
                                       Subgrant Application.
                                                              ------------------------------------------------------------------------------------------
    Subtotal........................                                    56  ...........        1,232  ...........       10,276  ...........      447,417
                                                PDM:
State, local or Tribal Government...  Benefit-Cost                      56           20        1,120            5        5,600        43.54      243,824
                                       Determination.
State, local or Tribal Government...  Environmental Review...           56           20        1,120          7.5        8,400        43.54      365,736
 State, local or Tribal Government..  Project Narrative-                56           20        1,120           12       13,440        43.54      585,178
                                       Subgrant Application.
                                                              ------------------------------------------------------------------------------------------
    Subtotal........................  .......................           56  ...........        3,360  ...........       27,440  ...........    1,194,738
                                                              ------------------------------------------------------------------------------------------
        Total.......................  .......................           56  ...........        5,264  ...........       43,848  ...........    1,909,143
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Estimated Cost: There are no operation and maintenance, or capital
and start-up costs associated with this collection of information.

Comments

    Comments may be submitted as indicated in the ADDRESSES caption
above. Comments are solicited to: (a) Evaluate whether the proposed
data collection is necessary for the proper performance of the agency,
including whether the information shall have practical utility; (b)
evaluate 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; (c) enhance the quality, utility, and
clarity of the information to be collected; and (d) minimize the burden
of the collection of information on those who are to respond, including
through 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.

Lesia M. Banks,
Director, Records Management Division, Mission Support Bureau, Federal
Emergency Management Agency, Department of Homeland Security.
[FR Doc. 2010-24768 Filed 10-1-10; 8:45 am]
BILLING CODE 9110-13-P


[Federal Register: April 5, 2010 (Volume 75, Number 64)]
[Notices]
[Page 17196-17197]
[DOCID:fr05ap10-107]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61800; File No. SR-DTC-2010-03]

Self-Regulatory Organizations; The Depository Trust Company;
Order Granting Approval of a Proposed Rule Change To Eliminate the
Option To Receive a Physical Certificate From DTC for Unsponsored
American Depositary Receipts That Are Part of the Fast Automated
Transfer Program

March 30, 2010.

I. Introduction

    On January 19, 2010, The Depository Trust Company (``DTC'') filed
with the Securities and Exchange Commission (``Commission'') proposed
rule change SR-DTC-2010-03 pursuant to section 19(b)(1) of the
Securities Exchange Act of 1934 (``Act'').\1\ Notice of the proposal
was published in the Federal Register on February 22, 2010.\2\ The
Commission received no comment letters. For the reasons discussed
below, the Commission is granting approval of the proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ Securities Exchange Act Release No. 61507 (February 5,
2010), 75 FR 7641 (February 22, 2010).
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II. Description

    An ADR is a security that trades in the United States but
represents a specified number of shares in a foreign corporation. ADRs
are issued in the U.S. by depositary banks. An ADR issuance is
``unsponsored'' when there is no formal agreement between the
depositary bank(s) issuing the ADR and the foreign company whose
underlying shares are the basis for the ADR. Because in unsponsored
programs there is no agreement between the issuer and a specific
depositary, more than one depositary can be involved in the issuance
and cancellation of ADR programs. Unsponsored ADRs trade in the over-
the-counter market.
    Currently, in order to deposit an unsponsored ADR at DTC, a
depositary bank that is also a DTC participant will have its transfer
agent create a certificate for the new issue ADR, which is then
deposited at DTC by the depositary bank. In an effort to eliminate some
of the risks and costs related to the processing of securities
certificates,\3\ DTC recently made unsponsored ADRs eligible for DTC's
Fast Automated Securities Transfer Program (``FAST'').\4\
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    \3\ The costs and risks associated with physical certificates
include, among other things, those associated with safekeeping,
transfer, shipping and insurance costs.
    \4\ FAST was designed to eliminate some of the risks and costs
related to the creation, movement, processing, and storage of
securities certificates. Under the FAST program, FAST transfer
agents hold FAST eligible securities in the name of Cede & Co. in
custody and for the benefit of DTC. As additional securities are
deposited or withdrawn from DTC, the FAST transfer agents adjust the
size of DTC's position as appropriate and electronically confirm
theses changes with DTC. For more information relating to FAST, see
Securities Exchange Act Release Nos. 13342 (March 8, 1977) [File No.
SR-DTC-76-3]; 14997 (July 26, 1978) [File No. SR-DTC-78-11]; 21401
(October 16, 1984) [File No. SR-DTC-84-8]; 31941 (March 3, 1993)
[SR-DTC-92-15]; and 46956 (December 6, 2002) [File No. SR-DTC-2002-
15].
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    DTC's withdrawal-by-transfer (``WT'') service allows a participant
to instruct DTC to have securities assets that are held in the
participant's DTC account reregistered in the name of the participant,
an investor, or a third party. Upon receipt of a WT instruction from a
participant, DTC either sends a certificate to the transfer agent for
reregistration in the name of the person or entity identified in the WT
instruction or instructs the transfer agent to debit DTC's FAST
position and to issue securities in the name of the person or entity
identified in the WT instruction.
    As part of DTC's response to an industry effort to reduce the
number of securities certificates in the U.S. market (sometimes
referred to as ``dematerialization''),\5\ DTC initiated a program of
steadily increasing its fees for WTs and other withdrawals to create
strong disincentives for the use of physical certificates. Consistent
with that program, DTC is now eliminating participants' ability to use
the WT service to have physical certificates issued for unsponsored
ADRs that are a part of the FAST Program. DTC believes that this
modification of its WT service reaffirms its goals of reducing the
number of securities certificates in the U.S. markets. DTC participants
will continue to have the ability to request a physical certificate
directly from the transfer agent by using the DWAC process.\6\
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    \5\ For more information on dematerialization, see Securities
Exchange Act Release No. 49405 (March 11, 2004), 69 FR 12922 (March
18, 2004), (File No. S7-13-04).
    \6\ For more information about the DWAC service, see Securities
Exchange Act Release No. 30283 (January 23, 1992), 57 FR 3658
(January 30, 1992) (SR-DTC-91-16) (order granting approval of the
DWAC service).
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III. Discussion

    Section 17A(b)(3)(F) of the Act requires, among other things, that
the rules of a clearing agency be designed to promote the prompt and
accurate clearance and settlement of securities transactions, assure
the safeguarding of securities and funds which are in the custody or
control of the clearing agency or for which it is responsible, to
foster cooperation and coordination with persons engaged in the
clearance and settlement of securities transactions, to remove
impediments to and perfect the mechanism of a national system for the
prompt and accurate clearance and settlement of securities
transactions, and, in general, to protect investors and the public
interest.\7\ The rule change modifies a DTC service by discontinuing
the WT services for unsponsored ADRs that are part of the FAST program,
which should in turn decrease the use of securities certificates. As a
result, DTC's rule change, as approved, should make processing
securities transactions more safe and efficient by discouraging the use
of securities certificates, which increase the risks and costs
associated with processing securities transactions.
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    \7\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    Accordingly, for the reasons stated above the Commission believes
that the rule change is consistent with DTC's obligation under Section
17A of the Exchange Act, as amended, and the rules and regulations
thereunder.

IV. Conclusion

    On the basis of the foregoing, the Commission finds that the
proposed rule change is consistent with the requirements of the Act and
in particular with the requirements of Section 17A of the Act and the
rules and regulations thereunder.
    It is therefore ordered, pursuant to Section 19(b)(2) of the Act,
that the

proposed rule change (File No. SR-DTC-2010-03) be and hereby is
approved.

    For the Commission by the Division of Trading and Markets,
pursuant to delegated authority.\8\
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    \8\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-7553 Filed 4-2-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: July 8, 2010 (Volume 75, Number 130)]
[Notices]
[Page 39224-39225]
[DOCID:fr08jy10-61]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 4093-031]

PK Ventures, Inc.; Notice of Intent To File License Application,
Filing of Pre-Application Document, and Approving Use of the
Traditional Licensing Process

June 30, 2010.
    a. Type of Filing: Notice of Intent to File License Application and
Request to Use the Traditional Licensing Process.
    b. Project No.: 4093-031.
    c. Dated Filed: April 30, 2010.
    d. Submitted By: PK Ventures, Inc.
    e. Name of Project: Bynum Hydroelectric Project.
    f. Location: On the Haw River, in Chatham County, North Carolina.
No Federal lands are occupied by the project works or located within
the project boundary.
    g. Filed Pursuant to: 18 CFR 5.3 of the Commission's regulations.
    h. Potential Applicant Contact: Robert L Rose, President, P.O. Box
35236, Sarasota, FL 34242;<PHONE_NUMBER>; e-mail_
<EMAIL_ADDRESS>    i. FERC Contact: Sean Murphy at<PHONE_NUMBER>; or e-mail at
<EMAIL_ADDRESS>    j. PK Ventures, Inc. filed its request to use the Traditional
Licensing Process on April 30, 2010. PK Ventures, Inc. provided public
notice of its request on May 22, 2010. In a letter dated June 30, 2010,
the Director of the Office of Energy Projects approved PK Ventures,
Inc.'s request to use the Traditional Licensing Process.
    k. With this notice, we are initiating informal consultation with:
(a) The U.S. Fish and Wildlife Service and/or NOAA Fisheries under
section 7 of the Endangered Species Act and the joint agency
regulations thereunder at 50 CFR, Part 402; (b) NOAA Fisheries under
section 305(b) of the Magnuson-Stevens Fishery Conservation and
Management Act and implementing regulations at 50 CFR 600.920; and (c)
the North Carolina State Historic Preservation Officer, as required by
section 106, National Historical Preservation Act, and the implementing
regulations of the Advisory Council on Historic Preservation at 36 CFR
800.2.
    l. PK Ventures, Inc. filed a Pre-Application Document (PAD;
including a proposed process plan and schedule) with the Commission,
pursuant to 18 CFR 5.6 of the Commission's regulations.
    m. A copy of the PAD is available for review at the Commission in
the Public Reference Room or may be viewed on the Commission's Web site
(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, contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at 1-866-208-3676, of for TTY,
(202) 502-8659. A copy is also available for inspection and
reproduction at the address in paragraph h.
    n. The licensee states its unequivocal intent to submit an
application for a new license for Project No. 4093.

Pursuant to 18 CFR 16.8, 16.9, and 16.10 each application for a new
license and any competing license applications must be filed with the
Commission at least 24 months prior to the expiration of the existing
license. All applications for license for this project must be filed by
April 30, 2013.
    o. Register online at http://www.ferc.gov/docs-filing/
esubscription.asp to be notified via e-mail of new filing and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-16558 Filed 7-7-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 37 (Friday, February 26, 2021)]
[Notices]
[Pages 11823-11824]
[FR Doc No: 2021-04000]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2020-0072; Notice 1]

PT. Multistrada Arah Sarana Tbk, Receipt of Petition for Decision
of Inconsequential Noncompliance

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

ACTION: Receipt of petition.

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SUMMARY: PT. Multistrada Arah Sarana, Tbk (MASA) has determined that
certain Achilles, Corsa, Radar, and Milestar brand tires in various
sizes do not fully comply with Federal Motor Vehicle Safety Standard
(FMVSS) No. 139, New Pneumatic Radial Tires for Light Vehicles, and
Part 574, Tire Identification and Recordkeeping. MASA filed a
noncompliance report dated June 1, 2020, and subsequently petitioned
NHTSA on June 25, 2020, for a decision that the subject noncompliance
is inconsequential as it relates to motor vehicle safety. This notice
announces receipt of MASA's petition.

DATES: Send comments on or before March 29, 2021.

ADDRESSES: Interested persons are invited to submit written data,
views, and arguments on this petition. Comments must refer to the
docket and notice number cited in the title of this notice and
submitted by any of the following methods:
     Mail: Send comments by mail addressed to the U.S.
Department of Transportation, Docket Operations, M-30, West Building
Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC
20590.
     Hand Delivery: Deliver comments by hand to the U.S.
Department of Transportation, Docket Operations, M-30, West Building
Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC
20590. The Docket Section is open on weekdays from 10 a.m. to 5 p.m.
except for Federal holidays.
     Electronically: Submit comments electronically by logging
onto the Federal Docket Management System (FDMS) website at https://www.regulations.gov. Follow the online instructions for submitting
comments.
     Comments may also be faxed to<PHONE_NUMBER>.
    Comments must be written in the English language, and be no greater
than 15 pages in length, although there is no limit to the length of
necessary attachments to the comments. If comments are submitted in
hard copy form, please ensure that two copies are provided. If you wish
to receive confirmation that comments you have submitted by mail were
received, please enclose a stamped, self-addressed postcard with the
comments. Note that all comments received will be posted without change
to https://www.regulations.gov, including any personal information
provided.
    All comments and supporting materials received before the close of
business on the closing date indicated above will be filed in the
docket and will be considered. All comments and supporting materials
received after the closing date will also be filed and will be
considered to the fullest extent possible.
    When the petition is granted or denied, notice of the decision will
also be published in the Federal Register pursuant to the authority
indicated at the end of this notice.
    All comments, background documentation, and supporting materials
submitted to the docket may be viewed by anyone at the address and
times given above. The documents may also be viewed on the internet at
https://www.regulations.gov by following the online instructions for
accessing the docket. The docket ID number for this petition is shown
in the heading of this notice.
    DOT's complete Privacy Act Statement is available for review in a
Federal Register notice published on April 11, 2000 (65 FR 19477-78).

SUPPLEMENTARY INFORMATION:
    I. Overview: MASA has determined that certain Achilles, Corsa,
Radar, and Milestar brand tires in various sizes do not fully comply
with the requirements of paragraph S5.5.1 of FMVSS No. 139, New
Pneumatic Radial Tires for Light Vehicles (49 CFR 571.139) and S574.5
of Part 574, Tire Identification and Recordkeeping (49 CFR 574). MASA
filed a noncompliance report dated June 1, 2020, pursuant to 49 CFR
part 573, Defect and Noncompliance Responsibility and Reports, and
subsequently petitioned NHTSA on June 25, 2020, for an exemption from
the notification and remedy requirements of 49 U.S.C. Chapter 301 on
the basis that this noncompliance is inconsequential as it relates to
motor vehicle safety, pursuant to 49 U.S.C. 30118(d) and 30120(h) and
49 CFR part 556, Exemption for Inconsequential Defect or Noncompliance.
    This notice of receipt of MASA's petition is published under 49
U.S.C. 30118 and 30120 and does not represent any Agency decision or
other exercise of judgment concerning the merits of the petition.
    II. Tires Involved: Approximately 1,673,307 of the following
Achilles, Corsa, Radar, and Milestar brand tires in various sizes,
manufactured between January 3, 2016, and March 14, 2020, are
potentially involved:
     Achilles 868 All Seasons, ATR Sport 2, Desert Hawk H/T2,
122, ATR-K Sport, and Desert Hawk UHP.
     Radar Renegade H/T and Renegade A/T.
     Corsa All Terrain XL and Highway Terrain.
     Milestar MS932XP, Patagonia M/T, and Grantland.
    III. Noncompliance: MASA explains that the noncompliance is that
the optional code in tire identification numbers (TIN), on the subject
tires, exceeds the number of characters allowed and therefore does not
fully comply with Part 574.5(g)(3), as required by S5.5.1 of FMVSS No.
139. Specifically, MASA introduced a modified optional code sequence,
which utilized up to 6 characters in the tire identification number
third grouping, when the optional code should be no more than 4
characters.
    IV. Rule Requirements: Paragraph S5.5.1 of FMVSS No. 139 and part
574.5(g)(3) includes the requirements relevant to this petition. Each
tire must be labeled with the tire identification number required by 49
CFR part 574 on the intended outboard sidewall of the tire. For new
tires, the third group, consisting of no more than four symbols, may be
used at the option of the manufacturer or retreader as a

descriptive code for the purpose of identifying significant
characteristics of the tire.
    V. Summary of MASA's Petition: The following views and arguments
presented in this section, V. Summary of MASA's Petition, are the views
and arguments provided by MASA. They have not been evaluated by the
Agency and do not reflect the views of the Agency. MASA described the
subject noncompliance and stated their belief that the noncompliance is
inconsequential as it relates to motor vehicle safety.
    In support of its petition, MASA submitted the following reasoning:
    1. Operational Safety:
    a. MASA stated their belief that a TIN marking noncompliance does
not create any operational safety risk for the vehicle. The tires
comply with applicable FMVSS performance requirements and all other
applicable regulations. A summary of production tire compliance audit
testing will be provided to NHTSA separately from this filing.
    b. The incorrect TIN marking with additional characters in the
optional code has no bearing on tire performance.
    c. The subject tires are properly marked with all other markings
required under FVMSS No. 139, such as paragraph S5.5(c), maximum
permissible inflation pressure, and paragraph S5.5(d), maximum load
rating. The necessary information is available on the sidewall of the
tire to ensure proper application and usage.
    d. The subject tires contain the DOT symbol on both sidewalls,
thus, indicating conformance to applicable FMVSS.
    2. Identification and Traceability:
    a. All information required by 49 CFR 574.5 for the TIN (plant code
+size code+ option code+ date code) is present on the sidewall of the
tire.
    b. For identification and traceability purposes, the key
information of the plant code and manufacturing date is present on the
tire.
    c. The existence of extra characters in the optional code does not
inhibit the ability of a tire distributor, the tire dealer, or the
consumer to register the tires.
    d. ln the event that dealer/owner notifications are required, the
TIN, as molded on the subject tires, is sufficient to ensure proper
communication and identification of the tires.
    e. To date, there is no record of a distributor, dealer, consumer,
or other concerned party raising a question about tires with the
extraneous characters
    7. Summary: Based on the information presented, the tires molded
with extraneous TIN optional code characters do not present a risk for
motor vehicle safety. Additionally, identification and traceability of
the subject tires could be accomplished in the event of a need to
conduct a dealer/owner notification. Production records link plant
code, size code, and optional code with the manufacturing dates for all
concerned brands and tire sizes.
    MASA concluded by expressing the belief that the subject
noncompliance is inconsequential as it relates to motor vehicle safety,
and that its petition to be exempted from providing notification of the
noncompliance, as required by 49 U.S.C. 30118, and a remedy for the
noncompliance, as required by 49 U.S.C. 30120, should be granted.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners, purchasers, and dealers of a defect or noncompliance
and to remedy the defect or noncompliance. Therefore, any decision on
this petition only applies to the subject tires that MASA no longer
controlled at the time it determined that the noncompliance existed.
However, any decision on this petition does not relieve equipment
distributors and dealers of the prohibitions on the sale, offer for
sale, or introduction or delivery for introduction into interstate
commerce of the noncompliant tires under their control after MASA
notified them that the subject noncompliance existed.

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

Otto G. Matheke III,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2021-04000 Filed 2-25-21; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 84, Number 91 (Friday, May 10, 2019)]
[Notices]
[Pages 20634-20636]
[FR Doc No: 2019-09691]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-2165]

Oncology Pharmaceuticals: Reproductive Toxicity Testing and
Labeling Recommendations; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Oncology
Pharmaceuticals: Reproductive Toxicity Testing and Labeling
Recommendations.'' The purpose of this guidance is to assist sponsors
in evaluating reproductive toxicity (mainly related to embryo-fetal
development (EFD)) for anticancer pharmaceuticals and to provide
recommendations to applicants for pharmaceutical labeling on duration
of contraception following cessation of therapy to minimize potential
risk to a developing embryo or fetus. The guidance also clarifies FDA's
current thinking on when nonclinical studies for reproductive
toxicology assessment may not be needed (e.g., for pharmaceuticals
intended for use in postmenopausal women only). The intended outcome of
this guidance is to facilitate the development of oncology
pharmaceuticals while avoiding unnecessary use of animals, in
accordance with the 3R (reduce, refine, replace) principles, and to
provide a consistent approach to labeling recommendations for the
duration of contraception after completion of therapy. This guidance
finalizes the guidance of the same name issued September 29, 2017.

DATES: The announcement of the guidance is published in the Federal
Register on May 10, 2019.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are

solely responsible for ensuring that your comment does not include any
confidential information that you or a third party may not wish to be
posted, such as medical information, your or anyone else's Social
Security number, or confidential business information, such as a
manufacturing process. Please note that if you include your name,
contact information, or other information that identifies you in the
body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-D-2165 for ``Oncology Pharmaceuticals: Reproductive Toxicity
Testing and Labeling Recommendations.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations .gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: John Leighton, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2204, Silver Spring, MD 20993-0002, 301-
796-7550; or Haleh Saber, Center for Drug Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2117,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Oncology Pharmaceuticals: Reproductive Toxicity Testing and
Labeling Recommendations.'' This guidance represents FDA's current
approach to assessing potential risk to a developing embryo or fetus
associated with the use of anticancer pharmaceuticals in male and
female patients. The term oncology pharmaceutical in this guidance
refers to small molecules, biotechnology-derived products, and related
compounds such as conjugated products. This guidance describes: (1) How
to evaluate EFD toxicity for various types of pharmaceuticals, such as
for genotoxic, biological, conjugated, and combination products; (2)
whether reproductive toxicity assessment is warranted for specific
patient populations, such as pharmaceuticals being developed for use in
male patients only or in postmenopausal women only; and (3)
recommendations for the duration of contraception after completion of
therapy to minimize risk to a developing embryo or fetus.
    Although, current regulatory guidances exist regarding the need to
assess the EFD toxicity potential of pharmaceuticals and the overall
design of the studies, this guidance provides additional
recommendations for evaluation of EFD toxicity for specific types of
pharmaceuticals and for specific populations, which are not covered
under other guidances. This guidance also expands on the weight of
evidence approaches that could be utilized to substitute for dedicated
EFD toxicology studies and hence facilitate the development of oncology
pharmaceuticals while avoiding unnecessary use of animals, in
accordance with the 3R principles. Moreover, this guidance provides
labeling recommendations on the duration of contraception after
completion of therapy, not previously addressed in other guidance
documents. This guidance finalizes the guidance of the same name issued
on September 29, 2017 (82 FR 45593).
    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 ``Oncology Pharmaceuticals: Reproductive
Toxicity Testing and Labeling Recommendations.'' It does not establish
any rights for any person and is not binding on FDA or the public. You
can use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations. This guidance is not subject to
Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information that 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 parts 312 and 314 have
been approved under OMB control numbers 0910-0014 and 0910-0001,
respectively. The collections of

information in 21 CFR 201.56 and 201.57 and the final rule ``Content
and Format of Labeling for Human Prescription Drug and Biological
Products; Requirements for Pregnancy and Lactation Labeling'' have been
approved under OMB control numbers 0910-0572 and 0910-0624.

III. Electronic Access

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

    Dated: May 7, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-09691 Filed 5-9-19; 8:45 am]
BILLING CODE 4164-01-P


Coastal Development

Enforceable Policies for Coastal Development:

Policy CD-1	In accordance with the prioritization requirement set forth
in 11 AAC 112.200(b),

	A.  “Water-dependent” uses are economically and physically
dependent upon a coastal location and are given a higher priority than
those land and water uses and activities that are not water-dependent.
Water dependent uses in the Skagway coastal district include:

boat harbors;

freight, fuel or other docks;

marine-based tourism facilities;

boat repair, haul outs, marine ways and accessory attached house;

shipwrights;

facilities that service the transportation of good and services between
the marine transportation system and the road system;

fish hatcheries, mariculture activities and fish processing; and

facilities to provide public access to coastal waters.

B.   “Water-related” uses in the Skagway coastal district include:

commercial activities such as hotels, restaurants and other similar uses
that provide views and access to the waterfront.  Commercial uses that
promote physical or visual use of shorelines by the public will be given
preference over other commercial uses in developing shoreline locations.

residential development.

C.	Accessory developments to residential use shall not be located along
the coastline unless no practicable inland alternative exists, and shall
not be permitted over the water unless water-dependent, such as piers
and floats for recreational or personal use.  Joint or community use of
private piers or floats shall be used over proliferation of piers and
floats for individual lots, where practicable.  Mooring buoys shall be
used where practicable.

D.  Facilities for water-dependent recreation, such as fishing,
swimming, and boating, and water-related recreation such as picnicking,
hiking and walking shall be located near the shoreline, while
non-water-related recreation facilities shall be located inland where
practicable.

Policy CD-2	Placement of fill in coastal waters for residential
development is prohibited unless there is no practicable upland
alternative.

Natural Hazards

Designation of Natural Hazard Areas:  The SCMP is designating the
following areas as natural hazard areas in accordance with 11 AAC
112.210(a) and 11 AAC 14.250(b).  These areas are mapped on Figures 3.3,
3.4 and 3.5.  Policy NH-1 applies within these designated areas.

Skagway River, 100-year floodplain (Chapter 3.0, Section 3.4.2; and
Skagway River AMSA plan, Chapter 5.0, Section 5.4.4).

Taiya River, 100-year floodplain (Chapter 3.0, Section 3.4.3).

Areas in Taiya Inlet subject to underwater landslides and
locally-generated tsunami (Chapter 3.0, Section 3.4.5).

Enforceable Policy for Natural Hazards:

Policy NH-1	Development in the Skagway River and Taiya River designated
natural hazard areas must be designed and constructed to withstand a
100-year flood.

Coastal Access

Enforceable Policies for Coastal Access:

Policy CA-1	New development sited along coastal waters shall provide
physical access to shorelines, unless such access would significantly
interfere with operations or present a hazard to life or property.

Recreation

Designation of Recreation Use Areas:  The SCMP is designating the
following areas as recreation use areas in accordance with 11 AAC
14.250(c).  These areas are mapped on Figure 3.12.  Policies R-1 through
R-4 apply in these designated areas.

Skagway Trail System and 50-foot wide corridor on each side of trail
(excluding trails on federal lands, within a KLGO park unit, or outside
of the Skagway coastal zone boundary)

Dewey Lakes Recreation Area (excluding the small area outside of the
Skagway coastal zone boundary)

Townsite Coastal Recreation and View Areas

Yakutania Point AMSA

Pullen Creek Shoreline Park AMSA

City “View” Lot (Lot 30 on Dyea Road)

Seven Pastures ballfields

Taiya River Watershed – West Creek, Nourse River (excluding federal
lands, lands within the KLGO Chilkoot Trail Unit, or lands outside of
the Skagway coastal zone boundary)

Upper Skagway River  (excluding federal lands, lands within the KLGO
White Pass Trail Unit, and lands outside of the Skagway coastal zone
boundary)

Enforceable Policies for Recreation:

Policy R-1	Proposed uses or activities in the designated Recreation Use
Areas, as depicted on Figure 3.12, shall not prevent, significantly
impede or cause significant adverse impacts to the recreation uses;
recreation resources; and the physical (including scenic), biological or
cultural features upon which public recreation in these areas depend.
(See Chapter 3, Section 3.10, for information about the recreation uses,
resources and features that must be considered for each Recreation Use
Area).

Policy R-2	Developments within recreation areas intended to provide a
recreational experience must be designed, constructed and operated in a
manner that would not present a hazard to life or property.

Policy R-3	Commercial tours are prohibited in the following recreation
areas, mapped on Figure 3.12.  Commercial tours include any group larger
than one person that is being guided for any form of compensation.

A.  Trails maintained by the City, excluding trails on federal lands,
outside of the Skagway coastal zone boundary, or within KLGO park units

B.  Dewey Lakes Recreation Area

C.  Yakutania Point AMSA

D.  City-owned land in the Pullen Creek Shoreline Park AMSA

E.  West Creek Road or off-road into the West Creek Valley, excluding
areas on federal lands.

Policy R-4	To the extent practicable, utilities shall be installed
underground in the designated recreation use areas for which enjoying
scenic views is listed as a recreational use in Table 3.1-A (Chapter 3,
Section 3.10).

Fisheries Enhancement

Designation of Sites Suitable for Commercial Fishing/Seafood Processing
(including Fisheries Enhancement Sites):  The SCMP is designating three
areas as areas suitable for location or development of fisheries
enhancement sites, in accordance with 11 AAC 14.250(f).  They are mapped
on Figure 3.10.  Policy F-1 applies in these designated areas.

Pullen Creek Shoreline Park AMSA, and upstream existing hatchery site on
Pullen Creek  (See AMSA Plan, Chapter 5.0, Section 5.2.)

Burro Creek Hatchery

Head of Nahku (Long) Bay

Enforceable Policy for Fisheries and Fishery Enhancement:

Policy F-1	Facilities accessory to fisheries enhancement and aquaculture
shall not be located on the coastline unless the accessory development
is dependent upon that waterfront location to fulfill its role in
supporting the fishery enhancement or aquaculture activity.  Fisheries
enhancement includes a range of techniques used with the purpose of
producing and releasing fish to augment natural fish stocks, such as a
fish hatchery operation.

Subsistence

Designation of Subsistence Use Areas:  The SCMP is designating the areas
mapped on Figure 3.8A and Figure 3.8B as Subsistence Use Areas in
accordance with 11 AAC 112.210(a) and 11 AAC 14.250(g).  The SCMP is
adopting no additional enforceable policies related to subsistence use.

History, Prehistory, Archaeology and Cultural Resources

Designation of Areas Important to History, Prehistory, Archaeology and
Cultural Resources:  The SCMP is designating two areas important to the
study, understanding or illustration of national, state, or local
history or prehistory, in accordance with 11 AAC 112.320 and 11 AAC
14.250(i).  The areas are mapped on Figure 3.7.  Policy H-1 will apply
in these designated areas.

Skagway and White Pass National Historic Landmark, excluding areas
outside of the Skagway coastal zone boundary

Chilkoot Trail and Dyea National Historic Landmark, excluding areas
outside of the Skagway coastal zone boundary and areas on federal land

Enforceable Policy for History, Prehistory, Archaeology and Cultural
Resources:

Policy H-1	Uses and activities in designated areas identified in Figure
3.7 shall comply with the following:

A.  Known artifacts of significant historic, prehistoric, or
archaeological importance shall not be disturbed during project
development unless the Skagway Coastal District approves the action.

B.	If previously undiscovered artifacts or areas of historic,
prehistoric, or archaeological importance are encountered during
development, an artifact agreement will be developed between the
landowner, the Skagway Traditional Council, appropriate state or federal
agencies, and a curation facility if artifacts are disturbed by the
project.

Activities occurring on federal or state land are excluded from this
policy, since they fall under the authority of federal and state
agencies.

 For purposes of this policy, trails maintained by the City include the
Dewey Lake trail system, Yakutania Point trail system, the Lost Lake
Trail and the West Creek Trail from the slide toward the back of the
valley.