[Federal Register Volume 78, Number 62 (Monday, April 1, 2013)]
[Notices]
[Pages 19492-19495]
[FR Doc No: 2013-07445]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0286]

Draft Guidance for Industry on Formal Meetings Between FDA and
Biosimilar Biological Product Sponsors or Applicants; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Formal
Meetings Between the FDA and Biosimilar Biological Product Sponsors or
Applicants.'' This draft guidance provides recommendations to industry
on formal meetings between FDA and sponsors or applicants relating to
the development and review of biosimilar biological products regulated
by the Center for Drug Evaluation and Research (CDER) and the Center
for Biologics Evaluation and Research (CBER). The guidance assists
sponsors and applicants in generating and submitting a meeting request
and the associated meeting package to FDA for biosimilar biological
products.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by May 31, 2013. Submit either electronic or written comments
concerning the proposed collection of information by May 31, 2013.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002, or
Office of Communication, Outreach, and Development (HFM-40), Center for
Biologics Evaluation and Research (CBER), Food and Drug Administration,
1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Neel Patel, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 6483, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or
Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17),
Food and Drug Administration, 1401 Rockville Pike, Suite 200N,
Rockville, MD 20852-1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Formal Meetings Between the FDA and Biosimilar Biological
Product Sponsors or Applicants.'' This draft guidance provides
recommendations to industry on formal meetings between FDA and sponsors
or applicants relating to the development and review of biosimilar
biological products regulated by CDER and CBER. For the purposes of
this draft guidance, ``formal meeting'' includes any meeting that is
requested by a sponsor or applicant following the request procedures
provided in this draft guidance and includes meetings conducted in any
format (i.e., face-to-face meeting, teleconference, or
videoconference).
    The Biologics Price Competition and Innovation Act of 2009 amended
the Public Health Service (PHS) Act and other statutes to create an
abbreviated licensure pathway in section 351(k) of the PHS Act (42
U.S.C. 262(k)) for biological products shown to be biosimilar to, or
interchangeable with, an FDA-licensed biological product (see sections
7001 through 7003 of the Patient Protection and Affordable Care Act
(Pub. L. 111-148)). The Biosimilar User Fee Act of 2012 (BsUFA),
enacted as part of the Food and Drug Administration Safety and
Innovation Act (Pub. L. 112-144), amended the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) to authorize a new user fee program for
biosimilar biological products. FDA has committed to meeting certain
performance goals in connection with the new user fee program. The
performance goals, which are set forth in a letter from the Secretary
of Health and Human Services to the Chairman of the Committee on
Health, Education, Labor, and Pensions of the Senate and the Chairman
of the Committee on Energy and Commerce of the House of
Representatives,\1\ include meeting management goals for formal
meetings that occur between FDA and sponsors or applicants during the
development phase of a biosimilar biological product. This draft
guidance describes the Agency's current thinking on how it intends to
interpret and apply certain provisions of BsUFA, and also provides
information on specific performance goals for the management of
meetings associated with the development and review of biosimilar
biological products.
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    \1\ See http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM281991.pdf.
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    This draft guidance reflects a unified approach to all formal
meetings between sponsors or applicants and FDA for biosimilar
biological product development (BPD) programs. It is intended to assist
sponsors and applicants in generating and submitting a meeting request
and the associated meeting package to FDA for biosimilar biological
products. This draft guidance does not apply to new drug or abbreviated
new drug applications under section 505 of the FD&C Act or to biologics
license applications (BLAs) under section 351(a) of the PHS Act.
    FDA expects that review staff will participate in many meetings
with biosimilar biological product sponsors

or applicants who seek guidance relating to the development and review
of biosimilar biological products. Because these meetings often will
represent critical points in the regulatory process, it is important
that there are efficient, consistent procedures for the timely and
effective conduct of such meetings. The good meeting management
practices in this draft guidance are intended to provide consistent
procedures that will promote well-managed meetings and to ensure that
such meetings are scheduled within a reasonable time, conducted
efficiently, and documented appropriately. The following five meeting
types that occur between sponsors or applicants and FDA staff during
the biosimilar BPD phase are described in the draft guidance: (1)
Biosimilar Initial Advisory meeting; (2) BPD Type 1 meeting; (3) BPD
Type 2 meeting; (4) BPD Type 3 meeting; and (5) BPD Type 4 meeting.
    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 Agency's current thinking on formal
meetings between FDA and sponsors or applicants regarding biosimilar
biological products. It does not create or confer any rights for or on
any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501-
3520, Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a
60-day notice in the Federal Register concerning each proposed
collection of information, including each proposed extension of an
existing collection of information, before submitting the collection to
OMB for approval. To comply with this requirement, FDA is publishing
notice of the proposed collection of information set forth in this
document.
    With respect to the following collection of information, FDA
invites comments on: (1) Whether the proposed collection of information
is necessary for the proper performance of FDA's functions, including
whether the information will have practical utility; (2) the accuracy
of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
    The draft guidance on the procedures for formal meetings between
FDA and biosimilar biological product sponsors or applicants describes
procedures for requesting, scheduling, conducting, and documenting such
formal meetings.
    The draft guidance describes two types of collections of
information: (1) The submission of a meeting request containing certain
information and (2) the submission of an information package that
accompanies the meeting request. The draft guidance also refers to
previously approved collections of information found in FDA
regulations. The collections of information for 21 CFR 312.48 have been
approved under OMB control number 0910-0014.

A. Request for a Meeting

    Under the draft guidance, a sponsor or applicant interested in
meeting with CDER or CBER should submit a meeting request to the
sponsor's or applicant's application (e.g., investigational new drug
application, BLA) through the controlled document system. If there is
no application, the request should be submitted to either the
appropriate CDER division director with a copy sent to the division's
chief of project management staff or to the division director of the
appropriate product office within CBER. Before submitting any meeting
request by fax or email when there is no application, the sponsor or
applicant should contact the appropriate review division or the
Biosimilars Program staff, CDER, Office of New Drugs, to determine to
whom the request should be directed, how the request should be
submitted, and the appropriate format for the request, and to arrange
for confirmation of receipt of the request.
    FDA recommends that a request be submitted in this manner to
prevent the possibility of faxed or emailed requests being overlooked
because of the volume of emails received daily by FDA staff. Faxed or
emailed requests should be sent during official business hours (8 a.m.
to 4:30 p.m. EST/EDT) Monday through Friday (except Federal government
holidays). Processing and receipt may be delayed for requests where
confirmation of receipt has not been prearranged.
    Under the draft guidance, FDA requests that sponsors and applicants
include in meeting requests certain information about the proposed
meeting. This information includes:
    1. Product Name.
    2. Application Number (if applicable).
    3. Proposed Proper Name (or proper name if post-licensure).
    4. Structure (if applicable).
    5. Reference Product Name.
    6. Proposed Indication(s) or Context of Product Development.
    7. Meeting Type Being Requested (i.e., Biosimilar Initial Advisory
meeting, BPD Type 1, 2, 3, or 4 meeting). The rationale for requesting
the meeting type should be included.
    8. A Brief Statement of the Purpose of the Meeting. This statement
should include a brief background of the issues underlying the agenda.
It also can include a brief summary of completed or planned studies and
clinical trials or data that the sponsor or applicant intends to
discuss at the meeting, the general nature of the critical questions to
be asked, and where the meeting fits in overall development plans.
Although the statement need not provide detailed documentation of trial
designs or completed studies and clinical trials, it should provide
enough information to facilitate understanding of the issues, such as a
small table that summarizes major results.
    9. A List of the Specific Objectives/Outcomes the Requester Expects
from the Meeting.
    10. A Proposed Agenda, Including Estimated Times Needed for Each
Agenda Item.
    11. A List of Questions, Grouped by Discipline. For each question
there should be a brief explanation of the context and purpose of the
question.
    12. A List of Ill Individuals with Their Titles and Affiliations
Who Will Attend the Requested Meeting from the

Sponsor's or Applicant's Organization and Consultants.
    13. A List of FDA Staff, if Known, or Disciplines, Asked to
Participate in the Requested Meeting.
    14. Suggested Dates and Times (e.g., morning or afternoon) for the
Meeting Which are Within or Beyond the Appropriate Time Frame of the
Meeting Type Being Requested.
    15. The Proposed Format of the Meeting (i.e., face-to-face meeting,
teleconference, or videoconference).
    This information will be used by FDA to determine the utility of
the meeting, to identify FDA staff necessary to discuss proposed agenda
items, and to schedule the meeting.

B. Information Package

    FDA requests that a sponsor or applicant submit a meeting package
to the appropriate review division with the meeting request. FDA
recommends that information packages generally include:
    1. Product Name and Application Number (if applicable).
    2. Proposed Proper Name (or proper name if postlicensure).
    3. Structure (if applicable).
    4. Reference Product Name.
    5. Proposed Indication(s) or Context of Product Development.
    6. Dosage Form, Route of Administration, Dosing Regimen (frequency
and duration), and Presentation(s).
    7. A List of Sponsor or Applicant Attendees, Affiliations, and
Titles.
    8. A Background Section that Includes the Following:
    a. A brief history of the development program.
    b. The status of product development (e.g., chemistry,
manufacturing, and controls; nonclinical; and clinical, including any
development outside the United States, as applicable).
    9. A Brief Statement Summarizing the Purpose of the Meeting.
    10. A Proposed Agenda.
    11. A List of Questions for Discussion Grouped by Discipline and
with a Brief Summary for Each Question to Explain the Need or Context
for the Question.
    12. Data to Support Discussion Organized by Discipline and
Question. The level of detail of the data should be appropriate to the
meeting type requested and the product development stage.
    The purpose of the information package is to provide FDA staff the
opportunity to adequately prepare for the meeting, including the review
of relevant data concerning the product.
    Description of Respondents: A sponsor or applicant for a biosimilar
biological product who requests a formal meeting with FDA regarding the
development and review of a biosimilar biological product.
    Burden Estimate: Provided below is an estimate of the annual
reporting burden for the submission of meeting requests and information
packages under the draft guidance.
    The estimated number of respondents submitting meeting requests and
information packages is based on the current workload and development
expectations for biosimilar biological products. The burden hour
estimate includes any time that may be needed by sponsors or applicants
for rescheduling and canceling meetings, for premeetings and other
communications with FDA about the meetings, and for resolution of
disputes about meeting minutes.
    Based on the current workload and development expectations, FDA
estimates that approximately 15 sponsors and applicants (respondents)
may request approximately a total of 30 formal meetings, and submit
approximately 30 information packages, with CDER annually, and
approximately 1 respondent may request approximately 2 formal meetings,
and submit approximately 2 information packages, with CBER annually.
    For a meeting request, the hours per response, which is the
estimated number of hours that a respondent would spend preparing the
information to be submitted with a meeting request in accordance with
the draft guidance, is estimated to be approximately 15 hours. Based on
FDA's experience, we expect it will take respondents this amount of
time to gather and copy brief statements about the product and a
description of the purpose and details of the meeting.
    For an information package, the hours per response, which is the
estimated number of hours that a respondent would spend preparing the
information package in accordance with the draft guidance, is estimated
to be approximately 30 hours. Based on FDA's experience, we expect it
will take respondents this amount of time to gather and copy brief
statements about the product, a description of the details for the
anticipated meeting, and data and information that generally would
already have been compiled for submission to FDA. In total, we expect
sponsors to spend 480 hours preparing meeting requests and 960 hours
preparing information packages each year.

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
 Draft guidance for industry on                                                       Average
 formal meetings between FDA and     Number of       Number of     Total annual     burden per
  biosimilar biological product     respondents    responses per     responses       response       Total hours
     sponsors or  applicants                        respondent                        (hours)
----------------------------------------------------------------------------------------------------------------
Meeting Requests:
    CDER........................              15               2              30              15             450
    CBER........................               1               2               2              15              30
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             480
Information Packages:
    CDER........................              15               2              30              30             900
    CBER........................               1               2               2              30              60
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             960
                                 -------------------------------------------------------------------------------
        Total...................  ..............  ..............  ..............  ..............           1,440
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or http://www.regulations.gov.

    Dated: March 27, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-07445 Filed 3-29-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 75, Number 214 (Friday, November 5, 2010)]
[Notices]
[Pages 68387-68389]
[FR Doc No: 2010-27944]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-63219; File No. SR-Phlx-2010-152]

Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Establish
a Revenue Sharing Program With Correlix, Inc. and Free Trial Period for
New Users

November 1, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on October 26, 2010, NASDAQ OMX PHLX LLC (``Phlx'' or ``Exchange'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared by the Exchange. The Exchange has designated the
proposed rule change as effecting a change described under Rule 19b-
4(f)(6) under the Act,\3\ which renders the proposal effective upon
filing with the Commission.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 17 CFR 240.19b-4(f)(6).
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    The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.

I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange is filing with the Securities and Exchange Commission
(``Commission'') a proposed rule change to establish a revenue sharing
program with Correlix, Inc. and a free trial period for new users. The
text of the proposed rule change is available at http://www.nasdaqtrader.com/micro.aspx?id=PHLXRulefilings, at the Exchange's
principal office, on the Commission's Web site at http://www.sec.gov,
and at the Commission's Public Reference Room. The Exchange will
implement the proposed rule change immediately.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
Sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange is filing a proposed rule change to establish a
revenue sharing program with Correlix. The Exchange has entered into an
agreement with Correlix to provide to users of the Exchange real-time
analytical tools to measure the latency of orders to and from its
systems. Under the agreement, the Exchange will receive 30% of the
total monthly subscription fees received by Correlix from parties who
have contracted directly with Correlix to use their RaceTeam latency
measurement service for the Exchange's systems. The Exchange will not
bill or contract with any Correlix RaceTeam customer directly.
    Pricing for the Correlix RaceTeam product for the Exchange varies
depending on the number of unique MPIDs and ports selected by the
customer for monitoring by Correlix. For the Exchange, the fee will be
an initial $1,000 monthly base fee for the first unique MPID monitored.
For each additional unique MIPD sought to be monitored, an additional
monthly charge of $1,000 will be assessed. The monthly price for each
unique MPID includes the monitoring of up to 25 Exchange port
connections associated with that particular MPID. Customers that wish
to exceed 25 ports per-MPID for monitoring can purchase additional 25
port blocks for an additional fee of $1000 per month per MPID.
    Under the program, Correlix will see an individualized unique
Exchange-generated identifier that will allow Correlix RaceTeam to
determine round trip order time \4\, from the time the order reaches
the Exchange extranet, through the Exchange matching engine, and back
out of the Exchange extranet. The RaceTeam product offering does not
measure latency outside of the Exchange extranet. The unique identifier
serves as a technological information barrier so that the RaceTeam data
collector will only be able to view data for Correlix RaceTeam
subscriber firms related to latency. Correlix will not see subscriber's
individual order detail such as security, price or size. Individual

RaceTeam subscribers' logins will restrict access to only their own
latency data. Correlix will see no specific information regarding the
trading activity of non-subscribers. The Exchange believes that the
above arrangement will provide users of its systems greater
transparency into the processing of their trading activity and allow
them to make more efficient trading decisions.
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    \4\ The product measures latency of orders whether the orders
are rejected, executed, or partially executed.
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    In addition, the Exchange seeks Commission approval to establish a
flexible 60-day free trial so parties will be eligible for one free 60-
day trial period of Correlix services whenever they initially elect to
sign-up for the service, now or in the future. The Exchange is
proposing the flexible trial to ensure that all Correlix users have an
equal opportunity to take advantage of an initial free trial period.
NASDAQ also notes that the introduction of more flexibility in
determining when to participate in the free trial period will allow
Correlix users to introduce the product into their own technology
infrastructure at a time of their own choosing and in coordination with
other scheduled technology initiatives.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6 of the Act,\5\ in general, and with
Section 6(b)(5) of the Act,\6\ in particular, in that the proposal is
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in regulating, clearing,
settling, processing information with respect to, and facilitating
transactions in securities, to remove impediments to and perfect the
mechanism of a free and open market and a national market system, and,
in general, to protect investors and the public interest. In
particular, the filing makes transparent uniform fees imposed for
latency measurement services.
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    \5\ 15 U.S.C. 78f.
    \6\ 15 U.S.C. 78f(b)(5).
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    In addition, the Exchange believes that the proposed rule change is
consistent with the provisions of Section 6 of the Act,\7\ in general,
and with Section 6(b)(4) of the Act,\8\ in particular, in that it
provides for the equitable allocation of reasonable dues, fees and
other charges among members and issuers and other persons using any
facility or system which the Exchange operates or controls. In
particular, the Exchange notes that the use of Correlix latency
measurement services is entirely voluntary and made available on a non-
discriminatory basis.
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    \7\ 15 U.S.C. 78f.
    \8\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act, as amended.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    Written comments were neither solicited nor received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The proposed rule change is effective upon filing pursuant to
Section 19(b)(3)(A) of the Act and paragraph (f)(6) of Rule 19b-4
thereunder, in that the proposed rule change: (i) Does not
significantly affect the protection of investors or the public
interest; (ii) does not impose any significant burden on competition;
and (iii) does not become operative for 30 days after the date of the
filing, or such shorter time as the Commission may designate if
consistent with the protection of investors and the public interest;
provided the self-regulatory organization has given the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission.
    The Exchange has requested that the Commission waive the 30-day
operative delay. The Commission believes that waiving the 30-day
operative delay is consistent with the protection of investors and the
public interest. The Commission notes that the Correlix service and its
fee sharing model have been previously approved by the Commission for
other markets.\9\ Waiver of the 30-day operative delay will ensure that
the free period is made available to all interested parties without
delay. Accordingly, the Commission designates the proposed rule change
operative upon filing with the Commission.\10\
---------------------------------------------------------------------------

    \9\ See Exchange Act Release Nos. 62605 (July 30, 2010)
(Approval of Correlix fee sharing for NASDAQ Exchange), 62928
(September 17, 2010) (Approval of Correlix fee sharing for EDGEA
Exchange), and 62929 (September 17, 2010) (Approval of Correlix fee
sharing for EDGEX Exchange).
    \10\ For the purposes only of waiving the 30-day operative
delay, the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78(c)(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. 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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-Phlx-2010-152 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

    All submissions should refer to File Number SR-Phlx-2010-152. This
file number should be included on the subject line if e-mail 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 Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change 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 Web site
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
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-Phlx-2010-152, and should be
submitted on or before November 26, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
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    \11\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-27944 Filed 11-4-10; 8:45 am]
BILLING CODE 8011-01-P


Commandant
United States Coast Guard
2703 Martin Luther King Jr. Ave SE
Washington, DC 20593-7516
Staff Symbol: CG-MER
Phone:<PHONE_NUMBER>
Fax:<PHONE_NUMBER>

		16450
		DATE
From:	J. B. Loring, CAPT
	COMDT (CG-MER)

To: 	Distribution
SUBJ:
MER POLICY LETTER 01-16: ALTERNATIVE PLANNING CRITERIA GUIDELINES FOR VESSEL RESPONSE PLANS
REF:
 Title 33, Code of Federal Regulations (C.F.R.) § 155.1065
 Title 33, C.F.R. § 155.5067
 U. S. Coast Guard Marine Environmental Response and Preparedness Manual, COMDTINST M16000.14A
 Guidelines for the U. S. Coast Guard Oil Spill Removal Organization Classification Program

   1. PURPOSE.  This policy letter provides the maritime industry with guidance on developing and submitting an Alternative Planning Criteria (APC) request in accordance with References (a) and (b).  It is also intended to provide both industry and Coast Guard personnel with the appropriate information and tools to facilitate the consistent development and review of APC requests.  Within the limits of the regulations and these guidelines, and in consultation with Coast Guard Headquarters, District offices may require additional measures specific to their respective areas of responsibility as a condition to positively endorse an APC request.

BACKGROUND.  Pursuant to 33 C.F.R. §§ 155.1035(i) and 155.5035(i), vessel owners and operators are required to prepare Vessel Response Plans (VRP) with Geographic Specific Appendices (GSAs) for any Captain of the Port zone where their vessels intend to transit or operate.  VRPs cover an extensive list of planning requirements, which are the foundation for responding effectively to a marine casualty that requires an oil spill and/or salvage and marine firefighting (SMFF) response.  However, because several areas under United States jurisdiction do not currently have sufficient private sector response resources to meet the national planning criteria (NPC) prescribed under 33 C.F.R. Part 155, Subparts D  -  J and related appendices, the Coast Guard would consider an APC in accordance with reference (a). APCs should be clearly identified in the GSA section of the VRP and clearly listed on the VRP's approval letter.  References (a) and (b) list basic requirements for vessel owners and operators to follow if they believe the NPC contained in 33 C.F.R. Part 155 are inappropriate for a vessel intending to operate in a particular geographic area.  In such cases, vessel owners and operators may submit an APC that identifies any NPC criteria that its vessel does not meet and may propose alternatives for consideration by the Coast Guard.  APCs are not "required," they are voluntary alternatives to the NPC.  This policy letter further clarifies the regulatory requirements and provides additional policy and guidance on Coast Guard expectations for APC requests.

   2. DISCLAIMER.  The information provided within this document and its enclosures is not a substitute for applicable legal requirements, nor is it itself a rule.  It is not intended to nor does it impose legally binding requirements on any party.  It represents the Coast Guard's current guidance on the submission and content of an APC and may assist industry, mariners, the general public, and the Coast Guard, as well as other federal and state regulators, in applying the regulatory requirements associated with an APC.  You can use an alternative approach for complying with these requirements if the approach satisfies the requirements of the applicable statutes and regulations.  If you want to discuss an alternative approach (you are not required to do so), you may contact Commandant (CG-MER).

   4. ACTION.

         a.       District Commanders and Captains of the Port (COTPs) shall direct their staffs to use this guidance when evaluating APC requests for original endorsements, and renewals.

         b.       Vessel owners and operators and authorized APC administrators should use this policy letter when developing and submitting APC requests.

   5. DIRECTIVES AFFECTED.  The following policy documents are hereby cancelled:

         a.       CG-543 Policy Letter 09-02: Industry Guidelines for Requesting Alternate Planning Criteria Approval, One Time Waivers and Interim Operating Authorization, dated 12 August 2009.

         b.       Sector Anchorage Marine Safety Information Bulletin 03-14: Nontank Vessel Alternative Planning Criteria Requirements for Western Alaska, dated 28 April 2014.

   6. ENVIRONMENTAL ASPECT AND IMPACT CONSIDERATIONS.  The general policies contained within this policy letter have been thoroughly reviewed by the originating office in conjunction with the Office of Environmental Management, and are categorically excluded (CE) under current Department of Homeland Security (DHS) CE L5 from further environmental analysis, in accordance with Appendix A, Table 1 of the DHS Instruction Manual # 023-01-001-01, Revision 01, Implementation of the National Environmental Policy Act (NEPA). Since this policy letter implements, without substantive change, the applicable Commandant Instruction or other federal agency regulations, procedures, manuals, and other guidance documents, DHS categorical exclusion L5 is appropriate. This directive will not have any of the following: significant cumulative impacts on the human environment; substantial controversy or substantial change to existing environmental conditions; or inconsistencies with any Federal, State, or local laws or administrative determinations relating to the environment. All future specific actions resulting from the general policies in this Letter must be individually evaluated for compliance with the NEPA, DHS and Coast Guard NEPA policy, and compliance with all other environmental mandates.

   7. DEFINITIONS.  A list of commonly used terms and their definitions as used in this policy letter are provided below.

         a.        APC Administrator.  An entity or third party organization governing the administration of an APC construct that may have developed in some areas and is distinct from other various parties also involved in vessel response planning initiatives.  Vessel owners and operators (VO/Os) may utilize a third party organization to manage the additional requirements associated with an APC.  However, all required contracts or other approved means must be between the VO/O and the response resource provider.  Third parties may contract on behalf of a VO/O if they are an authorized agent or have power of attorney for the VO/O.

       VO/Os retain full responsibility for obtaining required response resource capabilities to respond to potential worst case discharges from their vessel operations.

         b.        Strategic Plan.  A strategic plan is a formal statement of long-term NPC compliance goals, reasons they are attainable and plans for reaching them.  Strategic plans are generally written for 3-to-5 year periods and are annually reviewed by the APC holder as part of the VRP annual review requirement.

       A strategic plan shall include:

          1) Discussion of long-term goals and milestones to manage solutions (e.g., gap closures).
          2) Analysis of previous year's achievements related to operations and long-term goals to reach compliance with the NPC.
          3) Anticipated targets and challenges for coming calendar year(s).

         c.        In Region.  This term relates to the maximum distance (usually expressed in hours) from a staging or on-scene location that a response resource (i.e., vessel, equipment, and/or personnel) can normally operate in order for the resource to respond within the required mobilization timeframes.

       For APCs, in region determinations for the following resource types are as follows:

                     1)               Dedicated vessels:  Located at or near the location that it supports and able to meet the mobilization planning standards (i.e., en route to the scene and on-scene arrival).
                     2)               Vessels of Opportunity (VOO):  Located within the associated region and able to meet a specified timeframe for on-scene arrival.
                     3)               Dedicated equipment and personnel:  Located to meet the mobilization planning timeframes.

         d.        National Planning Criteria (NPC).  NPC are the minimum requirements for oil spill and SMFF response preparedness as discussed in the various subsections of Title 33, C.F.R. Part 155.  In order to address the NPC related to resources, VO/Os are generally required to contract for and/or identify (i.e., list) resources in their VRPs.

       NPC are not performance standards; the NPC are planning standards that establish minimum preparedness capabilities, which VO/Os are required by law to maintain when operating on the navigable waters of the U.S.   Planning standards are a methodology for creating response goals that attempt to generally account for complexities that may or may not exist during an actual response (e.g., the 5 knot vessel planning standard accounts for possible speed restrictions, other vessel traffic, weather delays, navigation challenges, etc.).  APC requests must reference specific NPC when identifying gaps.

         e.        Remote.  A staging site is considered remote if it lacks infrastructure, responders, and/or supplies required for a COTP City or Alternate Classification City as defined in reference (d).

       For initial response operations, an on-scene location is considered remote if one or more of the following conditions exist:

                     1)               The potential spill is outside of the planning standard response timeframe.
                     2)               Operations require establishing overnight accommodations on-scene (i.e., on-shore camps and/or accommodation vessels/barges).
                     3)               Long-term operations require routine sustainment transits of greater than 6 hours (e.g., waste stream management for shoreline cleanup).
                     4)               Availability of aircraft suitable for aerial oil spill tracking is limited to nonexistent.
                     5)               Availability of support infrastructure, services and personnel are limited to nonexistent due to seasonal maritime activities.

         f.        Response Resources.  Response resource categories include:  shore-based management, on-water oil recovery (AMPD, MMPD, WCD), aerial tracking, sustainment of initial responders, salvage and marine firefighting services, shoreline protection, and shoreline cleanup.

   8. FORMS/REPORTS.  Vessel owners and operators and authorized APC administrators should submit APC requests and renewals in accordance with Enclosures (1) and (2).  Enclosure 3 will be used by Coast Guard personnel to document reviews of submitted APC requests.

   9. DISCUSSION.  The intent of an APC is to identify and address resource and capability gaps until private industry response resources are sufficiently built up to meet the NPC.  APCs are an alternative to the NPC contained in the Coast Guard's VRP regulations.  The VRP regulations are promulgated under the authority contained in the Federal Water Pollution Control Act, Section 311(j).  This statutory authority and its corresponding regulations are specific to response resources and do not directly cover prevention measures.  The Coast Guard understands some APCs incorporate prevention measures, such as vessel monitoring, to mitigate gaps between the available response resources and those required by the NPC.  Prevention measures are an important mitigation strategy to address identified gaps between required response resources and the NPC.  However, it must be noted that the ultimate goal is to ensure full compliance with the NPC, which is primarily focused on actual response equipment and capability.  As such, the Coast Guard considers APC-associated prevention measures to be a temporary alternative, but not a replacement, for the NPC.  In certain regions where APCs may be part of a long-term solution, the Coast Guard views the placement of additional response resources and equipment to be a positive incremental step to increasing overall response readiness.

An APC should provide the Qualified Individual (QI), Spill Management Team (SMT), response resource providers and COTP with a clear understanding of response resource capabilities and limitations for areas that may be impacted as a result of a marine casualty requiring an oil spill and/or SMFF response.  The Coast Guard intends to coordinate with interested parties in each applicable area of responsibility through Coast Guard Sectors, Area Committees, and District Response Advisory Teams to ensure submitted APC requests best address oil spill and SMFF response and capability gaps while progressing toward overall response preparedness.  Therefore, COTP recommendations will hold significant influence during the APC review process and in the final decision to accept a submitted APC request.  Even in areas in which the NPC are inappropriate, vessel owners and operators must address all gaps and meet the NPC to the maximum extent practicable.

   10. APC POLICY AND PROCEDURES.

 a. Applicability.
       	This policy letter applies to any vessel owner and operator, required to have a VRP in accordance with 33 C.F.R. Part 155, Subpart D or Subpart J.  This policy letter also applies to any applicant who submits an APC for acceptance on behalf of a vessel owner and operator.

 b. Scope.

    1)           Vessel Fleets.
          An APC may cover a single vessel or a fleet of vessels.  The request must clearly state the size of the fleet, vessel type(s), and corresponding VRP control number(s).

    2)           Geographic Areas.
          APCs should only cover the geographic area where a documented gap in the NPC exists.  In certain circumstances, this may include a particular segment of a COTP Zone.  In other circumstances, it may warrant an APC with region or nation-wide applicability.  APC requests must include specific details regarding the geographic scope of the request.  Districts and COTPs should thoroughly review each request to ensure the scope of each APC is the minimum necessary to mitigate the specific gap(s) in the NPC.

    3) Tank and Nontank Vessels.
          	Based on different NPC requirements, tank vessel and nontank vessel APCs must be submitted separately, or if in the same request package, clearly separated into separate appendices, and in accordance with Enclosures (1) and (2).

 c. Submission Process.
       Vessel owners and operators or APC administrators should use the guidance found in Enclosures (1) and (2) when developing an APC request.  Per references (a) and (b), applicants shall submit an APC request to the cognizant COTP no less than 90-days before a vessel intends to operate under the proposed APC.  Note, however, that complexity and the need for coordination with various Coast Guard offices may require review timelines to exceed 90-days.  Commandant (CG-MER) is the final decision authority for all APC requests.  Depending on the geographic scope, an APC request would be submitted as follows:

          1)           Local APCs.
          Requests for a local APC, which includes a single COTP zone or any portion therein, shall be submitted to the cognizant COTP.  The COTP will review and forward endorsements, via the respective District and Area offices, to Commandant (CG-MER) for final determination.

          2)           Regional APCs.
          Requests for a regional APC, which includes multiple COTP zones, shall be submitted to the applicable District office(s) with jurisdiction.  The District office will review and consult with relevant COTPs and forward endorsements, via the respective Area office to Commandant (CG-MER) for final determination.

          3)           National APCs.
          Requests for a national APC, which includes more than one Coast Guard District, should be submitted to Commandant (CG-MER).  After initial review, Commandant (CG-MER) will consult with respective Areas, Districts, and COTPs.  Based on cumulative comments and recommendations, Commandant (CG-MER) will make a final determination for the APC request.

 d.        APC Evaluations.
       The Coast Guard will use the criteria outlined in Enclosures (1) and (2) to evaluate APC requests.

 e. APC Conditions of Acceptance.

          1)           Plan Validity  -  Accepted vs. Approved.
          After the Coast Guard receives an APC request, the Coast Guard will respond to let the submitter know that the APC has been "accepted" if applicable criteria have been met.  When a vessel owner or operator submits a VRP containing the previously "accepted" APC, Coast Guard can then "approve" the APC.

          The Coast Guard will not accept APC requests for areas in which the NPC contained in References (a) and (b) can be met.  APC requests  - must clearly document and articulate the specific NPC that cannot be attained and the prevention and/or response measures to adequately mitigate this gap(s).  APC requests must also identify progressive measures to increase response capabilities in the geographic area to eventually reduce or eliminate the gap(s).  Once accepted, APCs remain subject to Coast Guard verification of ongoing compliance throughout the period of validity, including documented progress towards the goals identified in the approved APC.

          2)           Equipment Verifications.
          Verification of equipment may be necessary to evaluate an APC request.  COTPs can verify equipment locations, condition, type, and operability prior to forwarding an APC request up the review chain.  This can also include ensuring the personnel identified to operate the equipment are fully trained to do so for each applicable operating environment through the use of records, certifications, and/or operational exercises.  This verification may be part of the Preparedness Assessment Visit (PAV) program managed by the National Strike Force Coordination Center (NSFCC) or, depending on the unique nature of APCs, may be a separate verification all together.  COTPs should coordinate with the NSFCC and District Response Advisory Team (DRAT) to ensure a comprehensive review of APC gaps, while minimizing burden on industry.

          3)           Inspections and Exercises.
          APC acceptance is contingent upon the APC Administrator and/or VO/O's ability to respond to an incident and function as described in the APC request.  If deemed necessary, COTPs can conduct tests, inspections, and operational exercises to verify an APC's ability to sustain readiness and availability of both equipment and personnel.  This includes, but is not limited to, response resources, vessel tracking and monitoring systems, vessel communications, and incident reporting procedures.  COTPs should coordinate any on-scene inspections and/or exercises with applicable APC Administrators and/or VO/Os.  It is recommended reference (d) be consulted in establishing criteria for these measures.  For APCs in regions where seasonality prohibits operational exercises for a large portion of the year, acceptance of the APC may be delayed until the COTP can conduct such tests or is otherwise satisfied regarding equipment and personnel readiness.

          4)           Response Resource Inventory.
          As a condition of APC acceptance, all applicable response resource equipment identified in the APC must be entered into the Response Resource Inventory maintained by the NSFCC.

          5)           Period of Acceptance.
          Generally, an APC will be valid for up to five years from the date of acceptance.  The Coast Guard may consider shorter periods of acceptance on a case by case basis.  Period of acceptance may be determined by, but not be limited to, (1) expected changes to available response resources in the designated area; (2) specific requests from the APC applicant for a shorter acceptance period; and (3) inability to achieve prescribed milestones mentioned in the strategic plan and show measurable progress towards reducing identified gaps (APC renewals).

 f.        Enforcement.
       Tank vessels and nontank vessels required to meet 33 C.F.R. Part 155 Subparts D and J, respectively, are required to have approved Coast Guard VRPs when operating in the navigable waters of the United States.  COTPs should ensure vessels that  operate or make port calls within their zone are in compliance with the tank and nontank VRP requirements, including any approved APC, in accordance with 33 C.F.R. §§ 155.1025 and 155.5021.  COTPs can verify whether a vessel has an approved VRP by reviewing Advance Notice of Arrivals and/or automated identification system (AIS) data and comparing it with the VRP status available through VRP Express.  Failure for a tank or nontank vessel to obtain a valid GSA before operating in or transiting a specific COTP zone when transiting to or from a port or place subject to the jurisdiction of the United States is a violation of 33 C.F.R. §§ 155.1030 and 155.5030.  If the COTP determines a tank or nontank vessel is operating without an approved VRP and/or APC within the COTP's zone, the COTP should take appropriate enforcement action in accordance with the Notice of Violation User's Guide, COMDTINST M5582.1A, and Civil Penalty Procedures and Administration, COMDTINST 16200.3A. NOVs will typically be issued to tank and nontank vessels for failure to comply with the requirements of 33 C.F.R. §§ 155.1025 and 155.5021, respectively.

       10. QUESTIONS.  All CG-MER Policy Letters, as well as other guidance documents, are posted to the CG-MER portal page.  Questions or comments regarding this policy can be directed to the Office of Marine Environmental Response Policy (MER) via<EMAIL_ADDRESS>

                                       #

 Enclosure	(1) Requirements for Nontank Vessel APC Requests
       (2) Requirements for Tank Vessel APC Requests
       (3) APC Request Checklists

 Distribution: 	COMDT (CG-CVC)
            NSFCC
            LANTAREA (LANT-3/LANT-5)
            PACAREA (PAC-3/PAC-5)
            Districts (dp and dr)
            Sectors and Marine Safety Units
		Industry Stakeholders


[Federal Register: July 24, 2007 (Volume 72, Number 141)]
[
Notices]
[Page 40337-40338]
[DOCID:fr24jy07-132]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2007-0059]

Concrete and Masonry Construction; Extension of the Office of
Management and Budget's (OMB) Approval of Information Collection
(Paperwork) Requirements

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Request for public comment.

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SUMMARY: OSHA solicits comments concerning its proposal to extend OMB
approval of the Information Collection requirements contained in the
Standard on Concrete and Masonry Construction (29 CFR part 1926,
subpart Q). This Subpart protects employees who construct, erect,
brace, maintain, remove, or perform similar tasks on concrete or
masonry structures.

DATES: Comments must be submitted (postmarked, sent, or received) by
September 24, 2007.

ADDRESSES:
    Electronically: You may submit comments and attachments
electronically at http://www.regulations.gov, which is the Federal

eRulemaking Portal. Follow the instructions online for submitting
comments.
    Facsimile: If your comments, including attachments, are not longer
than 10 pages, you may fax them to the OSHA Docket Office at (202) 693-
1648.
    Mail, hand delivery, express mail, messenger, or courier service:
When using this method, you must submit three copies of your comments
and attachments to the OSHA Docket Office, Docket No. OSHA-2007-0059,
U.S. Department of Labor, Occupational Safety and Health
Administration, Room N-2625, 200 Constitution Avenue, NW., Washington,
DC 20210. Deliveries (hand, express mail, messenger, and courier
service) are accepted during the Department of Labor's and Docket
Office's normal business hours, 8:15 a.m. to 4:45 p.m., e.t.
    Instructions: All submissions must include the Agency name and OSHA
docket number for the ICR (OSHA-2007-0059). All comments, including any
personal information you provide, are placed in the public docket
without change, and may be made available online at http://
www.regulations.gov.
 For further information on submitting comments see

the ``Public Participation'' heading in the section of this notice
titled SUPPLEMENTARY INFORMATION.
    Docket: To read or download comments or other material in the
docket, go to http://www.regulations.gov or the OSHA Docket Office at

the address above. All documents in the docket (including this Federal
Register notice) are listed in the http://www.regulations.gov index;

however, some information (e.g., copyrighted material) is not publicly
available to read or download through the Web site. All submissions,
including copyrighted material, are available for inspection and
copying at the OSHA Docket Office. You may also contact Stewart
Burkhammer at the address below to obtain a copy of the ICR.

FOR FURTHER INFORMATION CONTACT: Stewart Burkhammer, Directorate of
Construction, OSHA, U.S. Department of Labor, Room N-3468, 200
Constitution Avenue, NW., Washington, DC 20210; telephone (202) 693-
2020.

SUPPLEMENTARY INFORMATION:

I. Background

    The Department of Labor, as part of its continuing effort to reduce
paperwork and respondent (i.e., employer) burden, conducts a
preclearance consultation program to provide the public with an
opportunity to comment on proposed and continuing information
collection requirements in accordance with the Paperwork Reduction Act
of 1995 (44 U.S.C. 3506(c)(2)(A)). This program ensures that
information is in the desired format, reporting burden (time and costs)
is minimal, collection instruments are clearly understood, and OSHA's
estimate of the information collection burden is accurate. The
Occupational Safety and Health Act of 1970 (the OSH Act) (29 U.S.C. 651
et seq.) authorizes information collection by employers as necessary or
appropriate for enforcement of the OSH Act or for developing
information regarding the causes and prevention of occupational
injuries, illnesses, and accidents (29 U.S.C. 657). The OSH Act also
requires that OSHA obtain such information with minimum burden upon
employers, especially those operating small businesses, and to reduce
to the maximum extent feasible unnecessary duplication of efforts in
obtaining information (29 U.S.C. 657). The information collection
requirements, and their rationale, contained in 29 CFR part 1926,
subpart Q Concrete and Masonry Construction are listed below.
    Paragraph (c)(2) of Sec.  1926.701 requires that signs and barriers
be erected to limit employee access to the post-tensioning area during
tensioning operations. Paragraphs (a)(2), (j)(1), and (j)(2) warn
equipment operators not to activate their equipment if another employee
enters the area to perform a task (e.g., cleaning, inspecting,
maintenance, repairing), thereby preventing serious injury or death.
    Paragraph (a)(2) of Sec.  1926.703 requires employers to make
available, at the jobsite, drawings or plans for: The jack layout,
formwork (including shoring equipment), working decks, and scaffolds,
as well as any revisions to these documents. Paragraph (a) of Sec.
1926.705 requires employers engaged in lift-slab operations to have
specific designs and plans detailing the lift-slab operation. Drawings,
plans and/or designs are developed and kept available at the jobsite as
a usual and customary business practice to be used by the various
contractors during construction; therefore, OSHA assumes there are no
burden hours or costs associated with preparing drawings, plans, or
designs and having them at the jobsite.
    Section 1926.705(b) requires that jacks used for lifting operations
be marked to indicate their rated capacity. Manufacturers of jacks rate
the equipment as a usual and customary practice; therefore, OSHA
assumes there are no burden hours or costs to employers for these
marking requirements.

II. Special Issues for Comment

    OSHA has a particular interest in comments on the following issues:
     Whether the proposed information collection requirements
are necessary for the proper performance of the Agency's functions,
including whether the information is useful;
     The accuracy of OSHA's estimate of the burden (time and
costs) of the

information collection requirements, including the validity of the
methodology and assumptions used;
     The quality, utility, and clarity of the information
collected; and
     Ways to minimize the burden on employers who must comply;
for example, by using automated or other technological information
collection and transmission techniques.

III. Proposed Actions

    OSHA is requesting that OMB extend its approval of the information
collection requirements contained in the Standard on Concrete and
Masonry Construction (29 CFR part 1926, subpart Q). The Agency is
requesting to increase its current burden hour estimate associated with
this Standard from 22,400 hours to 37,488 hours for a total increase of
15,088 hours. The increase results from increasing the number of
construction sites. The Agency will summarize the comments submitted in
response to this notice and will include this summary in the request to
OMB.
    Type of Review: Extension of a currently approved collection.
    Title: Concrete and Masonry Construction (29 CFR 1926, Subpart Q).
    OMB Number: 1218-0095.
    Affected Public: Business or other for-profit.
    Number of Respondents: 468,600.
    Frequency: On occasion.
    Average Time per Response: Five minutes (.08 hour) to post or place
warning signs, locks, or tags.
    Estimated Total Burden Hours: 37,488.
    Estimated Cost (Operation and Maintenance): $0.

IV. Public Participation--Submission of Comments on This Notice and
Internet Access to Comments and Submissions

    You may submit comments in response to this document as follows:
(1) Electronically at http://www.regulations.gov, which is the Federal

eRulemaking Portal; (2) by facsimile (FAX); or (3) by hard copy. All
comments, attachments, and other material must identify the Agency name
and the OSHA docket number for the ICR (Docket No. OSHA-2007-0059). You
may supplement electronic submissions by uploading document files
electronically. If you wish to mail additional materials in reference
to an electronic or facsimile submission, you must submit them to the
OSHA Docket Office (see the section of this notice titled ADDRESSES).
The additional materials must clearly identify your electronic comments
by your name, date, and the docket number so the Agency can attach them
to your comments.
    Because of security procedures, the use of regular mail may cause a
significant delay in the receipt of comments. For information about
security procedures concerning the delivery of materials by hand,
express delivery, messenger, or courier service, please contact the
OSHA Docket Office at<PHONE_NUMBER> (TTY<PHONE_NUMBER>).
    Comments and submissions are posted without change at http://
www.regulations.gov.
 Therefore, OSHA cautions commenters about

submitting personal information such as social security numbers and
date of birth. Although all submissions are listed in the http://
www.regulations.gov
 index, some information (e.g., copyrighted

material) is not publicly available to read or download through this
Web site.
    All submissions, including copyrighted material, are available for
inspection and copying at the OSHA Docket Office. Information on using
the http://www.regulations.gov Web site to submit comments and access

the docket is available at the Web site's ``User Tips'' link. Contact
the OSHA Docket Office for information about materials not available
through the Web site, and for assistance in using the Internet to
locate docket submissions.

V. Authority and Signature

    Edwin G. Foulke, Jr., Assistant Secretary of Labor for Occupational
Safety and Health, directed the preparation of this notice. The
authority for this notice is the Paperwork Reduction Act of 1995 (44
U.S.C. 3506 et seq.) and Secretary of Labor's Order No. 5-2002 (67 FR
65008).

    Signed at Washington, DC, on July 17, 2007.
Edwin G. Foulke, Jr.,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. E7-14256 Filed 7-23-07; 8:45 am]

BILLING CODE 4510-26-P


[Federal Register Volume 86, Number 217 (Monday, November 15, 2021)]
[Rules and Regulations]
[Pages 62925-62928]
[FR Doc No: 2021-24794]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2020-0481; FRL-8918-01-OCSPP]

Methylorubrum populi Strain NLS0089; Exemption From the
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of Methylorubrum populi strain NLS0089 in
or on all food commodities when used in accordance with label
directions and good agricultural practices. NewLeaf Symbiotics
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic
Act (FFDCA), requesting an exemption from the requirement of a
tolerance. This regulation eliminates the need to establish a maximum
permissible level for residues of Methylorubrum populi strain NLS0089
under FFDCA when used in accordance with this exemption.

DATES: This regulation is effective November 15, 2021. Objections and
requests for hearings must be received on or before January 14, 2022
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2020-0481, is available at
https://www.regulations.gov or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) in the Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Public Reading Room are closed to visitors
with limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Charles Smith, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Office of the Federal

Register's e-CFR site at https://ecfr.federalregister.gov/current/title-40.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2020-0481 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
January 14, 2022. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b), although EPA
strongly encourages those interested in submitting objections or a
hearing request to submit objections and hearing requests
electronically. See Order Urging Electronic Service and Filing (April
10, 2020), https://www.epa.gov/sites/production/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf.
At this time, because of the COVID-19 pandemic, the judges and staff of
the Office of Administrative Law Judges are working remotely and not
able to accept filings or correspondence by courier, personal delivery,
or commercial delivery, and the ability to receive filings or
correspondence by U.S. Mail is similarly limited. When submitting
documents to the U.S. EPA Office of Administrative Law Judges (OALJ), a
person should utilize the OALJ e-filing system at https://yosemite.epa.gov/OA/EAB/EAB-ALJ_upload.nsf.
    Although EPA's regulations require submission via U.S. Mail or hand
delivery, EPA intends to treat submissions filed via electronic means
as properly filed submissions during this time that the Agency
continues to maximize telework due to the pandemic; therefore, EPA
believes the preference for submission via electronic means will not be
prejudicial. If it is impossible for a person to submit documents
electronically or receive service electronically, e.g., the person does
not have any access to a computer, the person shall so advise OALJ by
contacting the Hearing Clerk at<PHONE_NUMBER>. If a person is without
access to a computer and must file documents by U.S. Mail, the person
shall notify the Hearing Clerk every time it files a document in such a
manner. The address for mailing documents is U.S. Environmental
Protection Agency, Office of Administrative Law Judges, Mail Code
1900R, 1200 Pennsylvania Ave. NW, Washington, DC 20460.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2020-0481, by one of
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Background

    In the Federal Register of March 22, 2021 (86 FR 15162) (FRL-10021-
44), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide tolerance exemption
petition (PP 0F8823) by NewLeaf Symbiotics, 1005 North Warson Rd., Ste.
102, St. Louis, MO 63132. The petition requested that 40 CFR part 180
be amended by establishing an exemption from the requirement of a
tolerance for residues of the fungicide Methylorubrum populi strain
NLS0089 in or on all food commodities. That notice referenced a summary
of the petition prepared by the petitioner NewLeaf Symbiotics and
available in the docket via https://www.regulations.gov. No comments
were received on the notice of filing.

III. Final Rule

A. EPA's Safety Determination

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement of a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings but does not include
occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
FFDCA section 408(b)(2)(C), which require EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance or tolerance exemption and
to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue. . . .'' Additionally, FFDCA section 408(b)(2)(D)
requires that EPA consider ``available information concerning the
cumulative effects of [a particular pesticide's] . . . residues and
other substances that have a common mechanism of toxicity.''
    EPA evaluated the available toxicological and exposure data on
Methylorubrum populi strain NLS0089 and considered their validity,
completeness, and reliability, as well as the relationship of this
information to human risk. A full explanation of the data upon which
EPA relied and its risk assessment based on those data can be found
within the document entitled ``Revised Human Health Risk Assessment of
Methylorubrum populi strain NLS0089, a New Active Ingredient, in TS601,
a new End-Use Product Proposed for Registration, and an Associated
Petition Requesting a Tolerance Exemption'' (Methylorubrum populi
strain NLS0089 Human Health Assessment). This document, as well as
other relevant information, is available in the docket for this action
as described under ADDRESSES.
    The available data demonstrated that, with regard to humans,
Methylorubrum populi strain NLS0089 is not anticipated to be toxic,
pathogenic, or infective via any reasonably foreseeable route of
exposure.
    In an acute pulmonary toxicity/pathogenicity study, four test
animals (one male rat and three female rats) treated with Methylorubrum
populi strain NLS0089 died on days 2 or 3. Three of four of these test
animals

exhibited irregular respiration before death, and, upon necropsy, were
found to have red mottled lungs and/or fluid-filled intestines.
Further, several of the surviving test animals treated with
Methylorubrum populi strain NLS0089 exhibited abnormal clinical signs
through day 4 (e.g., irregular respiration or pale color) and/or had
abnormal gross findings upon necropsy up to day 23 (e.g., red mottled
lungs and/or enlarged lymph nodes). Body weight and body weight gain
were not adversely affected by treatment, and no abnormal clinical
signs, mortalities, or gross necropsy findings were seen in the control
animals (not treated or treated with inactivated Methylorubrum populi
strain NLS0089). The abnormal clinical observations, mortalities, and
abnormal necropsy findings are likely consistent with and attributed to
factors such as anesthesia administration and test substance
administration, which was higher than the recommended maximum hazard
dose, via the intratracheal route. As a result, these findings are
likely attributed to a combination of anesthesia effects and
overdosing, which are not indicative of toxicity or relevant to
pesticide exposure concerns when used according to label directions and
good agricultural practices. Overall, this study established that
Methylorubrum populi strain NLS0089 is not pathogenic or infective when
administered intratracheally at a single dose of 2.93 x 10\9\ colony-
forming units (CFU) per test animal and demonstrated a pattern of
clearance of Methylorubrum populi strain NLS0089 from the blood, cecum
contents, and organs of the test animals.
    In an acute injection toxicity/pathogenicity study, numerous test
animals treated with Methylorubrum populi strain NLS0089 and one test
animal treated with inactivated Methylorubrum populi strain NLS0089 had
enlarged spleens upon necropsy up to day 22. There were no adverse
effects of mortality, clinical signs, body weight, or body weight gain
in any of the test groups. The abnormal necropsy findings likely
reflect a physiological response to a blood-borne antigen rather than a
toxic effect on the spleen due to the spleen's function of filtering
blood of infectious agents. The assay was testing an artificial
infection and most likely indicated lymphocytes producing antibodies
reacting to the infection, which were filtered by the spleen causing an
enlargement. It should be noted that signs of infection, i.e., the
spread of the microbial pest control agents (MPCA) across the blood/
brain barrier or to other organs not involved with an immune response,
were not noted, and there were no other signs of toxin production
during exposure. Overall, this study established that Methylorubrum
populi strain NLS0089 is not pathogenic or infective when administered
intravenously at a single dose of 1.21 x 10\7\ CFU per test animal and
demonstrated a pattern of clearance of Methylorubrum populi strain
NLS0089 from the blood, cecum contents, and organs of the test animals.
    There may be some dietary and non-occupational exposures to
residues of Methylorubrum populi strain NLS0089 when used in accordance
with label directions and good agricultural practices, which exposures
are only slightly more than environmental background levels for a short
period of time after application. However, there is not a concern due
to the lack of potential for adverse effects. Because there are no
threshold levels of concern with the toxicity, pathogenicity, or
infectivity of Methylorubrum populi strain NLS0089, EPA determined that
no additional margin of safety is necessary to protect infants and
children as part of the qualitative assessment conducted. Based upon
its evaluation in the Methylorubrum populi strain NLS0089 Human Health
Assessment, which concludes that there are no risks of concern from
aggregate exposure to Methylorubrum populi strain NLS0089, EPA
concludes that there is a reasonable certainty that no harm will result
to the U.S. population, including infants and children, from aggregate
exposure to residues of Methylorubrum populi strain NLS0089.

B. Analytical Enforcement Methodology

    An analytical method is not required for Methylorubrum populi
strain NLS0089 because EPA is establishing an exemption from the
requirement of a tolerance without any numerical limitation.

C. Conclusion

    Therefore, an exemption from the requirement of a tolerance is
established for residues of Methylorubrum populi strain NLS0089 in or
on all food commodities when used in accordance with label directions
and good agricultural practices.

IV. Statutory and Executive Order Reviews

    This action establishes a tolerance exemption under FFDCA section
408(d) in response to a petition submitted to EPA. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001), or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act, 44 U.S.C. 3501 et seq., nor does it require any special
considerations under Executive Order 12898, entitled ``Federal Actions
to Address Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance
exemption in this action, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (5 U.S.C. 601
et seq.) do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes. As a result, this
action does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, EPA has determined that this
action will not have a substantial direct effect on States or Tribal
Governments, on the relationship between the National Government and
the States or Tribal Governments, or on the distribution of power and
responsibilities among the various levels of government or between the
Federal Government and Indian Tribes. Thus, EPA has determined that
Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 10,
1999), and Executive Order 13175, entitled ``Consultation and
Coordination with Indian Tribal Governments'' (65 FR 67249, November 9,
2000), do not apply to this action. In addition, this action does not
impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act (2 U.S.C.
1501 et seq.).
    This action does not involve any technical standards that would
require EPA's consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (15 U.S.C. 272 note).

V. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: October 26, 2021.
Edward Messina,
Director, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Add Sec.  180.1385 to subpart D to read as follows:

Sec.  180.1385  Methylorubrum populi strain NLS0089; exemption from the
requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for
residues of Methylorubrum populi strain NLS0089 in or on all food
commodities when used in accordance with label directions and good
agricultural practices.

[FR Doc. 2021-24794 Filed 11-12-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 61 (Wednesday, March 30, 2016)]
[Notices]
[Pages 17763-17764]
[FR Doc No: 2016-07143]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2014-0056; Notice 2]

Chrysler Group LLC, Grant of Petition for Decision of
Inconsequential Noncompliance

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

ACTION: Grant of petition.

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

SUMMARY: Chrysler Group LLC (Chrysler) \1\ has determined that certain
model year (MY) 2013 and 2014 Fiat brand, 500e model, passenger cars do
not fully comply with paragraph S5.4.1 of Federal Motor Vehicle Safety
Standard (FMVSS) No. 101, Controls and Displays. Chrysler has filed an
appropriate report dated April 1, 2014, pursuant to 49 CFR part 573,
Defect and Noncompliance Responsibility and Reports. Chrysler then
petitioned NHTSA under 49 CFR part 556 requesting a decision that the
subject noncompliance is inconsequential to motor vehicle safety.
---------------------------------------------------------------------------

    \1\ Chrysler is a wholly owned subsidiary of the automaker Fiat
S.p.A.

ADDRESSES: For further information on this decision contact John
Finneran, Office of Vehicle Safety Compliance, National Highway Traffic
Safety Administration (NHTSA), telephone<PHONE_NUMBER>, facsimile
---------------------------------------------------------------------------
(202) 366-5930.

SUPPLEMENTARY INFORMATION:

I. Chrysler's Petition

    Pursuant to 49 U.S.C. 30118(d) and 30120(h) and the rule
implementing those provisions at 49 CFR part 556), Chrysler has
petitioned for an exemption from the notification and remedy
requirements of 49 U.S.C. Chapter 301 on the basis that this
noncompliance is inconsequential to motor vehicle safety.
    Notice of receipt of Chrysler's petition was published, with a 30-
Day public comment period, on June 19, 2014 in the Federal Register (79
FR 35227). No comments were received. To view the petition and all
supporting documents log onto the Federal Docket Management System
(FDMS) Web site at: http://www.regulations.gov/. Then follow the online
search instructions to locate docket number ``NHTSA-2014-0056.''

II. Vehicles Involved

    Affected are approximately 3,447 MY 2013 and 2014 Fiat brand, 500e
model, passenger cars manufactured between March 21, 2013 and February
11, 2014 at Chrysler's Toluca Assembly Plant.

III. Noncompliance

    Chrysler explains that the noncompliance is that the low tire
pressure indicator telltale installed on the subject vehicles is orange
in color rather than yellow as required by paragraph S5.4.1 of FMVSS
No. 101.

IV. Rule Text

    Paragraph S5.4 of FMVSS No. 101 requires in pertinent part:

S5.4 Color
S5.4.1 The light of each telltale listed in Table 1 must be of the
color specified for that telltale in column 6 of that table.

V. Summary of Chrysler's Analyses

    Chrysler stated that in the FMVSS No. 138 Final Rule (Federal
Register Volume 70, Number 67 (April 8, 2005)) NHTSA indicated that the
intent of a TPMS warning telltale is to notify the operator of safety
consequences that do not constitute an emergency requiring immediate
service. While the affected vehicles may display an orange TPMS
telltale, Chrysler's position is the operator notification conveys the
appropriate message to the operator when there is either significant
tire under-inflation or a TPMS malfunction.
    Chrysler's reasoning in support of the position is as follows:
     For the subject vehicles, if the TPMS telltale is
illuminated and the operator does not understand its meaning, the TPMS
telltale graphic is shown and described in the Introduction, Instrument
Cluster Descriptions, and Starting and Operating sections of the
vehicle owner's manual. An operator can easily refer to the owner's
manual and determine the TPMS telltale relates to significant tire
under-inflation or a TPMS malfunction. The owner's manual

does not reference the color of the TPMS telltale, but rather that it
``illuminates'' in the event of low tire pressure and/or TPMS fault.
     In the event there is significant under-inflation of
tires, the TPMS telltale is illuminated and the instrument cluster
Electronic Vehicle Information Center (EVIC) will display a highlighted
graphic of the locations including the pressure values of the affected
tires.
     In the event there is a TPMS fault, the telltale will
flash on and off for 75 seconds and then maintain a continuous
illumination. The system fault will sound a chime and also display a
``Service TPM System'' message in the EVIC for approximately 3 seconds.
This message contains the same symbol as the telltale. If the ignition
switch is cycled, this sequence will repeat, providing the system fault
still exists. If the system fault no longer exists, the TPMS telltale
will no longer flash, and the ``Service TPM System'' message will no
longer display.
    In addition to the TPMS telltale alerting the operator of a
significant loss of tire pressure, or a TPMS malfunction as required,
the EVIC messages and owner's manual provide more than the minimum
level of information required aiding the operator's association of the
illuminated telltale with an appropriate response.
    Chrysler also made reference to a previous petition for
inconsequential noncompliance that addressed labeling issues that NHTSA
granted.
    Chrysler has additionally informed NHTSA that it has corrected the
noncompliance so that all future production vehicles will comply with
FMVSS No. 101.
    In summation, Chrysler believes that the described noncompliance of
the subject vehicles is inconsequential to motor vehicle safety, and
that its petition, to exempt Chrysler from providing recall
notification of noncompliance as required by 49 U.S.C. 30118 and
remedying the recall noncompliance as required by 49 U.S.C. 30120
should be granted.

NHTSA'S Decision

    NHTSA'S Analysis: Chrysler explained that if the TPMS telltale is
illuminated and the operator does not understand its meaning, the
operator can easily refer to the owner's manual and determine that the
TPMS telltale relates to significant tire under-inflation or a TPMS
malfunction. Chrysler also stated that the owner's manual does not
reference the color of the TPMS telltale, but rather that it
``illuminates'' in the event of low tire pressure and/or TPMS fault.
    NHTSA understands that many vehicle operators are not familiar with
the standard TPMS telltale used in vehicles today. The agency
anticipates that regardless of TPMS telltale color, yellow or orange,
vehicle operators familiar with the telltale symbol will not be
confused by the telltale color, and those not familiar with the
telltale symbol will still have to reference the owner's manual to
determine the meaning when illumination occurs.
    Chrysler explained that in the event there is a significant low
inflation pressure condition, the TPMS telltale will illuminate as
required, and the instrument cluster Electronic Vehicle Information
Center (EVIC) will display a highlighted graphic depicting locations
and pressure values of affected tires.
    The agency is in agreement with Chrysler that the information
provided by the EVIC is in addition to the telltale required by the
TPMS safety standard (FMVSS No. 138). The EVIC information and warnings
will aid the vehicle operator in the recognition of low tire inflation
pressure and TPMS system malfunctions.
    For the reasons stated above, the agency concludes that in the case
of the subject vehicles, the low tire pressure indicator telltales
installed on the subject vehicles being orange in color rather than
yellow poses little if any risk to motor vehicle safety.
    NHTSA'S Decision: In consideration of the foregoing, NHTSA finds
that Chrysler has met its burden of persuasion that the subject FMVSS
No. 101 noncompliance in the subject vehicles is inconsequential to
motor vehicle safety. Accordingly, Chrysler's petition is hereby
granted and Chrysler is exempted from the obligation of providing
notification of, and a free remedy for, that noncompliance under 49
U.S.C. 30118 and 30120.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners, purchasers, and dealers of a defect or noncompliance
and to remedy the defect or noncompliance. Therefore, any decision on
this petition only applies to the subject vehicles that Chrysler no
longer controlled at the time it determined that the noncompliance
existed. However, the granting of this petition does not relieve
Chrysler distributors and dealers of the prohibitions on the sale,
offer for sale, or introduction or delivery for introduction into
interstate commerce of the noncompliant vehicles under their control
after Chrysler 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.

Jeffrey M. Giuseppe,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2016-07143 Filed 3-29-16; 8:45 am]
 BILLING CODE 4910-59-P