[Federal Register Volume 80, Number 245 (Tuesday, December 22, 2015)]
[Notices]
[Pages 79636-79638]
[FR Doc No: 2015-32045]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-76664; File No. SR-BATS-2015-110]

Self-Regulatory Organizations; BATS Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change to Rule
13.3, Forwarding of Proxy and Other Issuer Materials; Proxy Voting

December 16, 2015.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on December 2, 2015, BATS Exchange, Inc. (the ``Exchange'' or
``BATS'') 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 this proposal as a ``non-controversial'' proposed rule
change pursuant to Section 19(b)(3)(A) of the Act \3\ and Rule 19b-
4(f)(6) thereunder,\4\ which renders it effective upon filing with the
Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange is proposing to amend paragraph (a) of Rule 13.3,
Forwarding or Proxy and other Issuer Materials; Proxy Voting, to
conform to the rules of EDGA Exchange, Inc. (``EDGA'') and EDGX
Exchange, Inc. (``EDGX'').\5\
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    \5\ See Securities Exchange Act Release Nos. 76329 (November 3,
2015), 80 FR 69259 (November 9, 2015); 76330 (November 3, 2015), 80
FR 69264 (November 9, 2015) (SR-EDGX-2015-51; SR-EDGA-2015-41).
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    The text of the proposed rule change is available at the Exchange's
Web site at www.batstrading.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

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 parts of such
statements.

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

1. Purpose
    In early 2014, the Exchange and its affiliate, BATS Y-Exchange,
Inc. (``BYX''), received approval to effect a merger (the ``Merger'')
of the Exchange's parent company, BATS Global Markets, Inc., with
Direct Edge Holdings LLC, the indirect parent of EDGX and EDGA
(together with BZX, BYX and EDGX, the ``BGM Affiliated Exchanges'').\6\
In the context of the Merger, the BGM Affiliated Exchanges are working
to align their rules, retaining only intended differences between the
BGM Affiliated Exchanges.
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    \6\ See Securities Exchange Act Release No. 71375 (January 23,
2014), 79 FR 4771 (January 29, 2014) (SR-BATS-2013-059; SR-BYX-2013-
039).
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    EDGA and EDGX recently filed proposed rule changes with the
Commission to restructure and amend their Rules 3.22. Proxy Voting, and
13.3, Forwarding of Proxy and Other Issuer Materials, to conform to BYX
and BZX Rule 13.3.\7\ In order to provide a consistent rule set across
each of the

BGM Affiliated Exchanges, the Exchange proposes to amend paragraph (a)
of Rule 13.3, Forwarding of Proxy and Other Issuer Materials; Proxy
Voting, to make two revisions to conform to the recently amended rules
of EDGA and EDGX.\8\
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    \7\ See supra note 3.
    \8\ The Exchange notes that BYX intends to file an identical
proposal with the Commission to amend paragraph (a) of Rule 13.3,
Forwarding of Proxy and Other Issuer Materials; Proxy Voting, to
conform to the rules of EDGA and EDGX.
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    In sum, paragraph (a) of Rule 13.3 requires Members to transmit
proxy materials and other communications to beneficial owners of
securities. The Exchange notes paragraph (a) of Rule 13.3 is
substantially similar to EDGA and EDGX Rules 13.3(a) which also
requires Members to transmit proxy materials to beneficial owners of
securities. Nonetheless, the Exchange proposes two revisions to make
the rule identical to the corresponding amended EDGA and EDGX Rules
13.3(a). These revisions to paragraph (a) of Rule 13.3 are: (i)
Pluralize the reference to ``proxy material'' in the first sentence;
and (ii) specify that the ``designated investment advisor'' is defined
in Interpretation and Policy .01 to this Rule 13.3. Otherwise, the
Exchange does not propose any additional changes to Rule 3.22. As
amended, Exchange Rule 13.3 would be identical to amended EDGA and EDGX
Rules 13.3. The Exchange believes that the changes described above will
help avoid confusion amongst Members of the Exchange that are also
members of EDGA, BYX, and EDGX by adopting identical rules across the
BGM Affiliated Exchanges with regard to proxy delivery.
2. Statutory Basis
    The Exchange believes that the proposed rule changes are consistent
with the requirements of the Act and the rules and regulations
thereunder that are applicable to a national securities exchange, and,
in particular, with the requirements of Section 6(b) of the Act.\9\
Specifically, the proposed changes are consistent with Section 6(b)(5)
of the Act,\10\ because they are designed to promote just and equitable
principles of trade, 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. None of these
changes alter the Exchange's current proxy delivery and voting
requirements. Rather, as mentioned above, the proposed rule changes,
combined with the planned filing for BYX, would allow the BGM
Affiliated Exchanges to provide an identical set of rules as it relates
to proxy delivery and voting. Consistent rules, in turn, will simplify
the regulatory requirements for Members of the Exchange that are also
participants on EDGA, BYZ and/or EDGX. The proposed rule change would
provide greater harmonization between rules of similar purpose on the
BGM Affiliated Exchanges, resulting in greater uniformity and less
burdensome and more efficient regulatory compliance and understanding
of Exchange Rules. As such, the proposed rule change would foster
cooperation and coordination with persons engaged in facilitating
transactions in securities and would remove impediments to and perfect
the mechanism of a free and open market and a national market system.
Similarly, the Exchange also believes that, by harmonizing the rules
across each BGM Affiliated Exchange, the proposal will enhance the
Exchange's ability to fairly and efficiently regulate its Members,
meaning that the proposed rule change would promote just and equitable
principles of trade in accordance with Section 6(b)(5) of the Act.\11\.
[sic] Finally, the Exchange believes that the non-substantive changes
discussed above will contribute to the protection of investors and the
public interest by helping to avoid confusion with respect to Exchange
Rules.
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    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(5).
    \11\ Id.
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. To the contrary, allowing the
Exchange to implement identical rules across each of the BGM Affiliated
Exchanges does not present any competitive issues, but rather is
designed to provide greater harmonization among Exchange, EDGX, BYX,
and EDGA rules of similar purpose. The proposed rule change should,
therefore, result in less burdensome and more efficient regulatory
compliance as well as a better understanding of Exchange Rules for
common members of the BGM Affiliated Exchanges.

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

    The Exchange has neither solicited nor received written comments on
the proposed rule change.

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

    Because the foregoing proposed rule change does not: (A)
Significantly affect the protection of investors or the public
interest; (B) impose any significant burden on competition; and (C)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \12\ and paragraph
(f)(6) of Rule 19b-4 thereunder.\13\
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    \12\ 15 U.S.C. 78s(b)(3)(A).
    \13\ 17 CFR 240.19b-4(f)(6). As required under Rule 19b-
4(f)(6)(iii), the Exchange provided the Commission with written
notice of its intent to file the proposed rule change, along with a
brief description and the 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.
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    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: (1)
Necessary or appropriate in the public interest; (2) for the protection
of investors; or (3) 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 email to<EMAIL_ADDRESS>Please include
File Number SR-BATS-2015-110 on the subject line.

Paper Comments

     Send paper comments in triplicate to Brent J. Fields,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-BATS-2015-110. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet 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 10:00 a.m. and
3:00 p.m. Copies of such filing also will be available for inspection
and copying at the principal office of 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-BATS-2015-110, and should be
submitted on or before January 12, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
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    \14\ 17 CFR 200.30-3(a)(12).
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Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-32045 Filed 12-21-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 132 (Thursday, July 9, 2020)]
[Notices]
[Pages 41258-41259]
[FR Doc No: 2020-14747]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-495, OMB Control No. 3235-0553]

Proposed Collection; Comment Request

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

Extension:
    Rule 19b-7 and Form 19b-7

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.) (``PRA''), the Securities and Exchange
Commission (``SEC'' or ``Commission'') is soliciting comments on the
existing collection of information provided for in Rule 19b-7 (17 CFR
240.19b-7) and Form 19b-7--Filings with respect to proposed rule
changes submitted pursuant to Section 19b(7) under the Securities
Exchange Act of 1934 (15 U.S.C. 78a et seq.) (``Exchange Act''). The
Commission plans to submit this existing collection of information to
the Office of Management and Budget for extension and approval.
    The Exchange Act provides a framework for self-regulation under
which various entities involved in the securities business, including
national securities exchanges and national securities associations
(collectively, self-regulatory organizations or ``SROs''), have primary
responsibility for regulating their members or participants. The role
of the Commission in this framework is primarily one of oversight; the
Exchange Act charges the Commission with supervising the SROs and
assuring that each complies with and advances the policies of the
Exchange Act.
    The Exchange Act was amended by the Commodity Futures Modernization

Act of 2000 (``CFMA''). Prior to the CFMA, federal law did not allow
the trading of futures on individual stocks or on narrow-based stock
indexes (collectively, ``security futures products''). The CFMA removed
this restriction and provided that trading in security futures products
would be regulated jointly by the Commission and the Commodity Futures
Trading Commission (``CFTC'').
    The Exchange Act requires all SROs to submit to the SEC any
proposals to amend, add, or delete any of their rules. Certain entities
(Security Futures Product Exchanges) would be notice registered
national securities exchanges only because they trade security futures
products. Similarly, certain entities (Limited Purpose National
Securities Associations) would be limited purpose national securities
associations only because their members trade security futures
products. The Exchange Act, as amended by the CFMA, established a
procedure for Security Futures Product Exchanges and Limited Purpose
National Securities Associations to provide notice of proposed rule
changes relating to certain matters.\1\ Rule 19b-7 and Form 19b-7
implemented this procedure. Effective April 28, 2008, the SEC amended
Rule 19b-7 and Form 19b-7 to require that Form 19b-7 be submitted
electronically.\2\
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    \1\ These matters are higher margin levels, fraud or
manipulation, recordkeeping, reporting, listing standards, or
decimal pricing for security futures products; sales practices for
security futures products for persons who effect transactions in
security futures products; or rules effectuating the obligation of
Security Futures Product Exchanges and Limited Purpose National
Securities Associations to enforce the securities laws. See 15
U.S.C. 78s(b)(7)(A).
    \2\ See Securities Exchange Act Release No. 57526 (March 19,
2008), 73 FR 16179 (March 27, 2008).
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    The collection of information is designed to provide the Commission
with the information necessary to determine, as required by the
Exchange Act, whether the proposed rule change is consistent with the
Exchange Act and the rules thereunder. The information is used to
determine if the proposed rule change should remain in effect or
abrogated.
    The respondents to the collection of information are SROs. Three
respondents file an average total of approximately 2 responses per
year.\3\ Each response takes approximately 12.5 hours to complete and
each amendment takes approximately 3 hours to complete, which
correspond to an estimated annual response burden of 25 hours ((2 rule
change proposals x 12.5 hours) + (0 amendments \4\ x 3 hours)). The
average internal cost of compliance per response is $5,050 (11.5 legal
hours multiplied by an average hourly rate of $420 \5\ plus 1 hour of
paralegal work multiplied by an average hourly rate of $220 \6\). The
total resulting internal cost of compliance for a respondent is $10,100
per year (2 responses x $5,050 per response).
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    \3\ There are currently four Security Futures Product Exchanges
and one Limited Purpose National Securities Association, the
National Futures Authority. However, two Security Futures Product
Exchanges currently do not trade security futures products and, as a
result, have not been filing proposed rule changes. Therefore, there
are currently three respondents to Form 19b-7.
    \4\ SEC staff notes that even though no amendments were received
in the previous three years and that staff does not anticipate the
receipt of any amendments, calculation of amendments is a separate
step in the calculation of the PRA burden and it is possible that
amendments are filed in the future. Therefore, instead of removing
the calculation altogether, staff has shown the calculation as
anticipating zero amendments.
    \5\ The $420 per hour figure for an Attorney is from SIFMA's
Management & Professional Earnings in the Securities Industry 2013,
modified by Commission staff to account for inflation and an 1800-
hour work-year and then multiplied by 5.35 to account for bonuses,
firm size, employee benefits, and overhead.
    \6\ The $220 per hour figure for a Paralegal is from SIFMA's
Management & Professional Earnings in the Securities Industry 2013,
modified by Commission staff to account for inflation and an 1800-
hour work-year and then multiplied by 5.35 to account for bonuses,
firm size, employee benefits, and overhead.
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    In addition to filing its proposed rule changes and any amendments
thereto with the Commission, a respondent is also required to post each
of its proposals and any amendments thereto, on its website. This
process takes approximately 0.5 hours to complete per proposal and 0.5
hours per amendment. Thus, for approximately 2 responses and 0
amendments,\7\ the total annual reporting burden on a respondent to
post these on its website is 1 hour ((2 proposals per year x 0.5 hours
per filing) + (0 amendments x 0.5 hours)). Further, a respondent is
required to update its rulebook, which it maintains on its website, to
reflect the changes that it makes in each proposal and any amendment
thereto. Thus, for all filings that were not withdrawn by a respondent
(0 withdrawn filings in calendar years 2017-2019) or disapproved by the
Commission (0 disapproved filings in calendar years 2017-2019), a
respondent was required to update its online rulebook to reflect the
effectiveness of 2 filings on average, each of which takes
approximately 4 hours to complete per proposal. Thus, the total annual
reporting burden for updating an online rulebook is 8 hours ((2 filings
per year-0 withdrawn filings-0 disapproved filings) x 4 hours).
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    \7\ See supra note 4.
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    Compliance with Rule 19b-7 is mandatory. Information received in
response to Rule 19b-7 is not kept confidential; the information
collected is public information.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information
shall have practical utility; (b) the accuracy of the Commission's
estimates of the burden of the proposed collection of information; (c)
ways to enhance the quality, utility, and clarity of the information
collected; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted in
writing within 60 days of this publication.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    Please direct your written comments to: David Bottom, Director/
Chief Information Officer, Securities and Exchange Commission, c/o
Cynthia Roscoe, 100 F Street NE, Washington, DC 20549, or send an email
to<EMAIL_ADDRESS>
    Dated: July 2, 2020.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-14747 Filed 7-8-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 92 (Monday, May 13, 2019)]
[Notices]
[Pages 20951-20954]
[FR Doc No: 2019-09753]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2018-0004; Notice 1]

Daimler Trucks North America, LLC, Receipt of Petition for
Decision of Inconsequential Noncompliance

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

ACTION: Receipt of petition.

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SUMMARY: Daimler Trucks North America, LLC (DTNA), has determined that
certain model year (MY) 2013-2018 Thomas Built Buses do not fully
comply with Federal Motor Vehicle Safety Standard (FMVSS) No. 222,
School Bus Passenger Seating and Crash Protection. DTNA filed a
noncompliance report dated November 27, 2017. DTNA in Collaboration
with SynTec Seating Solutions, LLC ``SynTec'' (the seating
manufacturer), subsequently petitioned NHTSA on December 15, 2017, and
later updated it on September 21, 2018, for a decision that the subject
noncompliance is inconsequential as it relates to motor vehicle safety.
This document announces receipt of DTNA's petition.

DATES: The closing date for comments on the petition is June 12, 2019.

ADDRESSES: Interested persons are invited to submit written data,
views, and arguments on this petition. Comments must refer to the
docket number cited in the title of this notice and submitted by any of
the following methods:
     Mail: Send comments by mail addressed to the U.S.
Department of Transportation, Docket Operations, M-30, West Building
Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC
20590.
     Hand Delivery: Deliver comments by hand to the U.S.
Department of Transportation, Docket Operations, M-30, West Building
Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC
20590. The Docket Section is open on weekdays from 10 a.m. to 5 p.m.
except for Federal Holidays.
     Electronically: Submit comments electronically by logging
onto the

Federal Docket Management System (FDMS) website at https://www.regulations.gov/. Follow the online instructions for submitting
comments.
     Comments may also be faxed to<PHONE_NUMBER>.
    Comments must be written in the English language, and be no greater
than 15 pages in length, although there is no limit to the length of
necessary attachments to the comments. If comments are submitted in
hard copy form, please ensure that two copies are provided. If you wish
to receive confirmation that comments you have submitted by mail were
received, please enclose a stamped, self-addressed postcard with the
comments. Note that all comments received will be posted without change
to https://www.regulations.gov, including any personal information
provided.
    All comments and supporting materials received before the close of
business on the closing date indicated above will be filed in the
docket and will be considered. All comments and supporting materials
received after the closing date will also be filed and will be
considered to the fullest extent possible.
    When the petition is granted or denied, notice of the decision will
also be published in the Federal Register pursuant to the authority
indicated at the end of this notice.
    All comments, background documentation, and supporting materials
submitted to the docket may be viewed by anyone at the address and
times given above. The documents may also be viewed on the internet at
https://www.regulations.gov by following the online instructions for
accessing the dockets. The docket ID number for this petition is shown
in the heading of this notice.
    DOT's complete Privacy Act Statement is available for review in a
Federal Register notice published on April 11, 2000, (65 FR 19477-78).

SUPPLEMENTARY INFORMATION:
    I. Overview: DTNA has determined that certain MY 2013-2018 Thomas
Built Buses do not fully comply with paragraph S<IP_ADDRESS> of FMVSS No.
222, School Bus Passenger Seating and Crash Protection (49 CFR
571.222). DTNA filed a noncompliance report dated November 27, 2017,
pursuant to 49 CFR part 573, Defect and Noncompliance Responsibility
and Reports. DTNA subsequently petitioned NHTSA on December 15, 2017,
and later amended it on September 21, 2018, for an exemption from the
notification and remedy requirements of 49 U.S.C. chapter 301 on the
basis that this noncompliance is inconsequential as it relates to motor
vehicle safety, pursuant to 49 U.S.C. 30118(d) and 30120(h) and 49 CFR
part 556, Exemption for Inconsequential Noncompliance or Defect.
    This notice of receipt, of DTNA's petition, is published under 49
U.S.C. 30118 and 30120 and does not represent any agency decision or
other exercise of judgment concerning the merits of the petition.
    II. Buses Involved: Affected are approximately 3,222 MY 2013-2018
versions of the following Thomas Built Buses, manufactured between
August 24, 2012, and May 1, 2017, specifically:

 Thomas Built Buses Saf-T-Liner C2
 Thomas Built Buses Saf-T-Liner EFX
 Thomas Built Buses Saf-T-Liner HDX
 Thomas Built Buses Minotour DRW

    III. Noncompliance: DTNA explains that the noncompliance is that
the subject buses are equipped with seats that have Type 2 (lap/
shoulder) seat belts, manufactured by SynTec Seating Solutions, LLC
(SynTec), that do not meet the head form force distribution impact
requirement as specified in paragraph S<IP_ADDRESS> of FMVSS No. 222.
Specifically, the Type 2 seat belts include a plastic bezel, where the
seat belt is routed through the seat, located within the head
protection zone.
    IV. Rule Requirements: Paragraph S<IP_ADDRESS> of FMVSS No. 222, titled
``Head form force distribution'' includes the requirements relevant to
this petition:

     When any contactable surface of the vehicle within the
zones specified in paragraph S<IP_ADDRESS> is impacted from any direction
at 6.7 m/s by the head form described in paragraph S6.6, the energy
necessary to deflect the impacted material shall be not less than
4.5 joules before the force level on the head form exceeds 667 N.
     When any contactable surface within such zones is
impacted by the head form from any direction at 1.5 m/s the contact
area on the head form surface shall be not less than 1,935 mm\2\.

    V. Summary of DTNA's Petition: DTNA described the subject
noncompliance and stated its belief that the noncompliance is
inconsequential as it relates to motor vehicle safety.
    DTNA provided the following background information:
    1. In January 2011, SynTec introduced the M2K lap/shoulder seat in
order to provide a number of additional safety features to passengers.
The company sold 2,272 M2K lap/shoulder seats to Thomas Built Buses
before discontinuing the product in 2012. SynTec then improved upon the
M2K lap/shoulder seat design with the S3C seat, which the Company
introduced in 2012. The back of these seats are substantially higher
than earlier school bus passenger seats and are equipped with lap/
shoulder seat belts. The seat also includes: Color coding and key
buckles to prevent improper buckling, a fixed buckle anchorage to
prevent side occupant incursion, flip up buckles in pockets to be out
of the way from debris, high shoulder anchorage, and contoured seat
cushion. The plastic ``bezel'' (the location from which the lap/
shoulder harness exits the seat back) was intentionally set high on the
seat fronts to provide protection to the maximum range of occupants.
Some M2K and S3C seats also are equipped with an integrated child seat.
    2. To ensure that the Affected Seats complied with all laws and
regulations, SynTec contracted with a third party, MGA Research
Corporation (``MGA''), to conduct certification testing under FMVSS No.
222. Specifically, MGA conducted tests on the M2K seat in June 2011,
and on the S3C seat in August 2012. The M2K and S3C complied with FMVSS
No. 222 requirements with respect to the back of the seat. Consistent
with the industry norm and MGA's past practice, MGA did not test
targets on the front of the seat. Based on its interactions and
conversations with MGA, SynTec understood that back seat-only testing
represents the industry norm. Front of the seat testing is not
conducted due to the low risk of harm from the front, and because the
small head impact zone makes it impossible to conduct the test per the
recommended test procedure. Indeed, as referenced above, the testing
was designed to ensure that the back of the seat was an energy absorber
and that various hazards were eliminated from the top. Nonetheless,
these early MGA tests results, specifically, the product's head injury
criterion (HIC) values and the strong contact area and impact velocity
scores on the back of the seat, highlighted the improved safety
benefits of SynTec's new seat design.
    In support of its petition, DTNA provided the following:
    1. The S<IP_ADDRESS> tests are outmoded for the front of the seat and
the equipment's HIC scores represent the most accurate accounting of
the seat's safety.
    2. As highlighted above, the original intent of the contact surface
test was to precipitate the elimination of metal grab bars and other
hostile objects above the passenger seats that could come into contact
with the occupant's head in the event of a crash. See 38 FR 4776 (Feb.
22, 1973) (Proposed Rule) (stating the goal of ``eliminating exposed
metal bars and similar designs and making the seat itself a significant
energy absorber.'') Likewise, the energy deflection analysis

was designed to ensure that the seat would depress and distribute the
force of impact in a manner that could not be achieved with exposed
metal surfaces on the seat.
    3. Although SynTec was noncompliant with these two tests, the
requirements are now outmoded with respect to the front of the affected
seats because the various hazards they are seeking to guard against no
longer exist. Indeed, the noncompliance did not occur because of a
hazard that the regulations were designed to protect against. Rather,
as explained below, the noncompliance resulted from a high-placed bezel
that actually makes the affected seats safer for more occupants. The
two tests were crafted for a school bus seat design that was
substantially different and less safe than the superior versions that
exist in the market today.
    4. Given that these tests are outmoded, the most accurate measure
of head safety for the front of the seat is the product's HIC value.
The HIC is the most widely accepted measure of head injury in use
today. Indeed, it is the standard measure of head injury throughout the
FMVSSs. See, e.g., FMVSS No. 201 and 208. Similarly, HIC is the metric
used by NHTSA's New Car Assessment Program. See 80 FR 78522, 78533
(2015) (noting that the HIC value ``is currently in use in FMVSS No.
208 and frontal NCAP tests.'') The HIC measure is particularly valuable
since it accounts for energy absorption and contact area by measuring
the deceleration of the head form over time.
    5. Over the past few years, both SynTec and NHTSA, internally and
at accredited external test agencies, have conducted HIC testing on the
front of the affected seats. During testing, the seats were positioned
at various angles, and impacts were performed on multiple locations of
the seat within the head protection zone ``hits'', including on the
portion of the plastic bezel that protrudes into the top 76 mm on the
front. These test results always produced a HIC value well below 1,000.
For instance, since March 2017 SynTec has conducted 253 ``hits'' on the
front of the seat. The average HIC value during these tests was 114.1,
with a low score of 51.7 and a high HIC value of 311.8. Even the
product's highest HIC value falls far short of the 1,000 maximum
requirement. These values illustrate the safety of SynTec's product and
the inconsequentiality of the noncompliance with the other FMVSS No.
222 test requirements.
    6. Simply stated, the tests which prompted DTNA and SynTec's 573
Reports, are searching for hazards on the front of the seat that do not
exist in the affected seats. See 38 FR 4776 (Feb. 22, 1973) (Proposed
Rule). As the product's HIC values show, the technical noncompliance of
the SynTec seats on these two tests is not relevant to the product's
safety. Accordingly, NHTSA should grant this petition for
inconsequentiality.
    7. The source of SynTec's noncompliance enhances the product's
safety. SynTec's seats are safer than regulators could have envisioned
in 1976. Indeed, the cause of the noncompliance, the location of the
plastic bezel, renders the seat safer than it would be with a bezel
that was not placed in the head protection zone. This higher
positioning combined with higher seat backs provides a belt for a
maximum range of occupants and keeps hard objects away from the most
vulnerable passengers. SynTec utilized automotive best practices and
BELFIT software from the Motor Industry Research Association to
determine the optimum geometric place for the belt position. SynTec's
objective was to provide maximum protection, taking into account the
wide range of occupant sizes riding on a school bus. Based on this
analysis, it placed the bezel at the higher portion of the seat. The
position also allowed for more adjustment by the d-ring, for better
torso restraint, and for a more comfortable fit (thereby encouraging
use).
    8. The higher shoulder harnesses also keep hard surfaces away from
small occupants who are most vulnerable. A typical occupant in the
vehicle would have a greater chance of coming into contact with a lower
bezel. In seats with lap/shoulder belts with a lower bezel, the bezel
would land in a smaller occupant's head area. Similarly, most designs
that include an integrated child seat, have a hard surface that sits
behind a smaller occupant's head. In contrast, the affected seat's
higher bezel location places the bezel outside of a smaller occupant's
head area. Likewise, for smaller occupants using integrated child
seats, the bezel also falls outside of the occupant head area.
Essentially, the higher bezel ensures better protection for the most
vulnerable riders. Rather than cause any safety issues, the
noncompliance, which occurred because of the location of the plastic
bezels, makes the affected seats safer.
    9. The noncompliance at issue relates to front-of-seat tests
designed to address features that are no longer present in school
buses, such as metal bars at the top of seat backs and low seat backs.
Therefore, DTNA believes the noncompliance is inconsequential as it
relates to school bus safety. Moreover, the location of the plastic
bezel on the lap/shoulder belts, which is the source of the
noncompliance, is actually a safety improvement, in that its high
position allows for maximum occupant ranges and fit, and protects the
smallest seat occupants. A typical occupant in the vehicle would have a
greater chance of coming into contact with a compliant lower bezel.
    10. Thus, the design represents an enhanced level of safety for
school bus occupants, especially younger passengers who are more
vulnerable in the event of a crash. Consistent with the enhanced safety
design of the lap/shoulder belt, DTNA is not aware of any complaints,
injuries or reports of safety concerns regarding this issue.
    11. NHTSA Precedents--DTNA notes that NHTSA has previously granted
petitions for decisions of inconsequential noncompliance for a wide
range of issues where a technical non-compliance exists, but does not
create a negative impact on safety. In the case detailed within this
petition, the lap/shoulder belt is an optional feature on the vast
majority of school buses. When added, lap/shoulder belts increase the
safety of the occupants as compared to a bus without passenger
seatbelts. Also, the high bezel increases the child protection
performance requirements by reducing the likelihood of an occupant
coming into contact with the hard surface. The following examples are
petitions for inconsequentiality that were granted by NHTSA and are
described within this petition to support DTNA's argument that, while
technically non-compliant, NHTSA has previously granted
inconsequentiality for cases where an additional level of safety above
the requirements of the standard is provided.
    12. See 70 FR 24464 (May 9, 2005), Docket No. NHTSA 2005-20545
(Grant of Petition for IC Corporation) for an example of a petition for
inconsequentiality that was granted by NHTSA. In this instance, school
buses were manufactured that were not compliant with FMVSS 217, but it
was deemed inconsequential because it did not compromise safety. ``. .
. The Agency agrees with IC that in this case the noncompliance does
not compromise safety in terms of emergency exit capability in
proportion to maximum occupant capacity, access to side emergency
doors, visibility of the exits, or the ability of bus occupants to exit
after an accident.''
    13. See also 63 FR 32694 (June 15, 1998), Docket No. NHTSA 98-3791
(Grant of Petition for New Flyer of America, Inc.) for another example
of a petition for inconsequentiality that was

granted. In this case, non-school buses were manufactured that were not
compliant with FMVSS 217, but were granted inconsequentiality because
the buses had additional safety features that were not required in the
standard. The following quote is from NHTSA's notice granting the
petition: ``Thus, the buses have the minimum number of emergency exits
required by FMVSS No. 217. However, these exits were not distributed
properly. Instead of a second emergency exit on the right side, these
buses have an additional roof exit. This additional roof exit would
provide for much need emergency exit openings should the bus occupants
need to evacuate due to a rollover incident. While this additional roof
exit is not required by the standard, it does provide for an additional
level of safety in the above situation. In consideration of the
foregoing, NHTSA has decided that the applicant has met its burden of
persuasion that the noncompliance it described above is inconsequential
to motor vehicle safety.'' Id.
    DTNA expressed the belief that the subject noncompliance is
inconsequential as it relates to motor vehicle safety, and that its
petition to be exempted from providing notification of the
noncompliance, as required by 49 U.S.C. 30118, and a remedy for the
noncompliance, as required by 49 U.S.C. 30120, should be granted.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners, purchasers, and dealers of a defect or noncompliance
and to remedy the defect or noncompliance. Therefore, any decision on
this petition only applies to the subject vehicles that DTNA no longer
controlled at the time it determined that the noncompliance existed.
However, any decision on this petition does not relieve vehicle
distributors and dealers of the prohibitions on the sale, offer for
sale, or introduction or delivery for introduction into interstate
commerce of the noncompliant vehicles under their control after DTNA
notified them that the subject noncompliance existed.

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

Otto G. Matheke III,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2019-09753 Filed 5-10-19; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 81, Number 34 (Monday, February 22, 2016)]
[Notices]
[Pages 8812-8813]
[FR Doc No: 2016-03523]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-77140; File No. SR-NYSEArca-2016-27]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change Amending Rule 7.35P
To Provide for Price Collar Thresholds for Trading Halt Auctions

February 16, 2016.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act''),\2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that on February 4, 2016, NYSE Arca, Inc. (the ``Exchange'' or
``NYSE Arca'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Rule 7.35P to provide for price
collar thresholds for Trading Halt Auctions. The proposed rule change
is available on the Exchange's Web site at www.nyse.com, at the
principal office of the Exchange, and at the Commission's Public
Reference Room.

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 self-regulatory organization
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 those 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 parts 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 proposes to amend Rule 7.35P to provide for price
collar thresholds for Trading Halt Auctions on Pillar. As previously
described, the Exchange is in the process of implementing Pillar, its
new trading platform.\4\ The Exchange anticipates beginning migrating
symbols to Pillar on February 22, 2016. As symbols migrate to Pillar,
specified current rules not designated with ``P'' will no longer be
applicable, and rules with a ``P'' designation will govern the
applicable conduct. With respect to auctions, on Pillar, current Rules
1.1(s) and 7.35 will no longer govern trading; Rule 7.35P will govern
all aspects of auctions on Pillar.\5\
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release Nos. 74951 (May 13,
2015), 80 FR 28721 (May 19, 2015) (Notice) and 75494 (July 20,
2015), 80 FR 44170 (July 24, 2015) (Order) (SR-NYSEArca-2015-38)
(``Pillar I Filing''); 75497 (July 21, 2015), 80 FR 45022 (July 28,
2015) (Notice) and 76267 (Oct. 26, 2015), 80 FR 66951 (Oct. 30,
2015) (Order) (SR-NYSEArca-2015-56)(``Pillar II Filing''); 75467
(July 16, 2015), 80 FR 43515 (July 22, 2015) (Notice) and 76198
(Oct. 20, 2015), 80 FR 65274 (Oct. 26, 2015) (Order) (SR-NYSEArca-
2015-58) (``Pillar III Filing''); and 76085 (Oct. 6, 2015), 80 FR
61513 (Oct. 13, 2015) (Notice) and 76869 (Jan. 11, 2016), 81 FR 2276
(Jan. 15, 2016) (Order) (SR-NYSEArca-2015-86) (``Pillar Auction
Filing'').
    \5\ See Pillar Auction Filing.
---------------------------------------------------------------------------

    The Exchange recently amended Rule 1.1(s) to provide for price
collar thresholds for Trading Halt Auctions on a temporary basis.\6\
However, Rule 1.1(s)(B) will not be applicable to trading on Pillar.
Accordingly, the Exchange proposes to amend Rule 7.35P to adopt price
collar thresholds for Trading Halt Auctions on the same terms and
conditions as approved in Rule 1.1(s)(B). As proposed, Rule
7.35P(a)(10) would be amended to add reference to Trading Halt Auctions
by providing that ``Auction Collar'' would mean the price collar
thresholds for the Indicative Match Price for the Core Open Auction,
Trading Halt Auction, or Closing Auction.
---------------------------------------------------------------------------

    \6\ See Securities Exchange Act Release No. 76994 (Jan. 28,
2016) (SR-NYSEArca-2015-121) (Approval Order) (``Trading Halt
Auction Collar Filing''). Rule 1.1(s)(B) will be in effect until
July 28, 2016.
---------------------------------------------------------------------------

    The Exchange would further amend Rule 7.35P(a)(10)(A) to add the
specified percentages for price collar thresholds for Trading Halt
Auctions. Consistent with Rule 1.1(s)(B), the price collar thresholds
for Trading Halt Auctions would be 10% for securities with a
consolidated last sale price of $25.00 or less, 5% for securities with
a consolidated last sale price greater than $25.00 but less than or
equal to $50.00, and 3% for securities with a consolidated last sale
price greater than $50.00. The Exchange proposes a non-substantive
difference from Rule 1.1(s) to refer to the ``Auction Reference Price''
in Rule 7.35P instead of the last consolidated sale price. Rule 7.35P
defines the term ``Auction Reference Price'' for the Trading Halt
Auction to be the last consolidated round-lot price of that trading
day, and if none, the prior trading day's Official Closing Price.
Because the Rule 7.35P Auction Reference Price for Trading Halt
Auctions is based on the same reference price for Trading Halt Auctions
as specified in Rule 1.1(s)(B), the Exchange proposes in Rule 7.35P to
reference the term ``Auction Reference Price'' rather than refer to the
last consolidated sale price.
    Finally, as with Rule 1.1(s), the Exchange proposes that the price
collar thresholds for Trading Halt Auctions would be in effect
temporarily. Because the Rule 1.1(s)(B) Trading Halt Auction collars
will be in effect until July 28, 2016, the Exchange proposes that the
price collar thresholds specified in Rule 7.35P(a)(10)(A) applicable to
Trading Halt Auctions would similarly be in effect until July 28, 2016.
    As the Exchange noted in the Trading Halt Auction Collar Filing,
the Exchange is continuing its analysis to identify what changes, if
any, would be appropriate for how the Exchange conducts its Trading
Halt Auctions and, based on this analysis, will file a separate rule
proposal to either make the price collar thresholds for Trading Halt
Auctions permanent or propose other or additional changes to the re-
opening auction process.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Securities Exchange Act of 1934 (the ``Act''),\7\ in general, and
furthers the objectives of Section 6(b)(5),\8\ in particular, because
it 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 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.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange recently amended Rule 1.1(s) to provide price collar
thresholds for Trading Halt Auctions on a temporary basis. However, the
Exchange will be migrating symbols to its Pillar trading platform and
Rule 1.1(s) will no longer govern auctions on the Exchange once a
symbol trades on Pillar. The Exchange therefore believes that it would
remove impediments to and perfect the mechanism of a free and open
market and a national market system to provide that the rule that
governs auctions on the Exchange on Pillar be amended to reflect
recently approved changes to Rule 1.1(s)(B). The Exchange further
believes the proposed price collar thresholds for Trading Halt
Auctions, which would be based on the numerical guidelines set forth in
Rule 7.10(c)(1) and Rule 1.1(s)(B), would also remove impediments to
and perfect the mechanism of a fair and orderly market and protect
investors and the public interest because they would reduce the
potential for a Trading Halt Auction to be a clearly erroneous
execution on Pillar.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposed change is not
designed to address any competitive issue but rather to provide for a
price protection mechanism to prevent Trading Halt Auctions from
occurring at prices that could be a clearly erroneous execution.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    Because the proposed rule change does not (i) significantly affect
the protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate, it has become effective pursuant to Section
19(b)(3)(A) of the Act \9\ and Rule 19b-4(f)(6) thereunder.\10\
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f)(6). As required under Rule 19b-
4(f)(6)(iii), the Exchange provided the Commission with written
notice of its intent to file the proposed rule change, along with a
brief description and the 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.
---------------------------------------------------------------------------

    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \11\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6)(iii) \12\ permits the
Commission to designate a shorter time if such action is consistent
with the protection of investors and the public interest. The Exchange
has asked the Commission to waive the 30-day operative delay so that
the proposal may become operative immediately upon filing. The Exchange
stated that it anticipates beginning the migration of symbols to Pillar
on February 22, 2016 and therefore there would be symbols trading on
the Exchange that will no longer be governed by Rule 7.35 or 1.1(s) in
less than 30 days. The Exchange stated that waiver of the operative
delay would allow the Exchange to immediately implement the approved
changes to Rule 1.1(s)(B) on its Pillar trading platform without delay.
The Commission believes the waiver of the operative delay is consistent
with the protection of investors and the public interest. Therefore,
the Commission hereby waives the operative delay and designates the
proposal operative upon filing.\13\
---------------------------------------------------------------------------

    \11\ 17 CFR 240.19b-4(f)(6).
    \12\ 17 CFR 240.19b-4(f)(6)(iii).
    \13\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(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 change 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 email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2016-27 on the subject line.

Paper Comments

     Send paper comments in triplicate to Brent J. Fields,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSEArca-2016-27. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet 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
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal office of 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-NYSEArca-2016-27, and should
be submitted on or before March 14, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Brent J. Fields,
Secretary.
[FR Doc. 2016-03523 Filed 2-19-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 82 (Thursday, April 28, 2016)]
[Rules and Regulations]
[Pages 25326-25328]
[FR Doc No: 2016-09784]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2011-N-0143]
RIN 0910-AG64

Foreign Supplier Verification Programs for Importers of Food for
Humans and Animals; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending a final
rule published in the Federal Register of November 27, 2015. That final
rule established requirements for importers to verify that food they
import into the United States is produced consistent with the hazard
analysis and risk-based preventive controls and standards for produce
safety provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act), is not adulterated, and is not misbranded with respect to food
allergen labeling. The final rule published with some editorial and
inadvertent errors. This document corrects those errors.

DATES: Effective April 28, 2016.

FOR FURTHER INFORMATION CONTACT: Brian Pendleton, Office of Policy,
Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring,
MD 20993-0002,<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Federal Register of November 27, 2015
(80 FR 74226), FDA published the final rule ``Foreign Supplier
Verification Programs for Importers of Food for Humans and Animals''
with some editorial and inadvertent errors. We are taking this action
to correct inadvertent errors in the preamble to the final rule

and to improve the accuracy of the provisions added to the Code of
Federal Regulations.
    1. On page 74271, in the second paragraph of section III.E.5, in
the discussion of allowing importers to obtain certain information
needed to meet their FSVP requirements from other entities as described
in certain sections of the document, the reference to ``sections
III.E.5, III.F.4, and III.G.4'' is corrected to read ``sections
III.A.7, III.F.4, and III.G.4''.
    2. On page 74332, in the third column, in the second ``bullet''
point in Response 334, ``For the importation of food from a supplier
that is subject to the preventive controls regulations for human food
or animal food or the produce safety regulation, 6 months after the
foreign supplier of the food is required to comply with the relevant
regulations;'' is corrected to read ``For the importation of food from
a supplier that is subject to the preventive controls regulation for
human food, the preventive controls or CGMP requirements in the
preventive controls regulation for animal food, or the produce safety
regulation, 6 months after the foreign supplier of the food is required
to comply with the relevant regulations;''.

List of Subjects in 21 CFR Part 1

    Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling,
Reporting and recordkeeping requirements.

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
1. The authority citation for 21 CFR part 1 continues to read as
follows:

    Authority:  15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C.
1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 343, 350c,
350d, 350j, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371,
374, 381, 382, 384a, 384b, 384d, 387, 387a, 387c, 393; 42 U.S.C.
216, 241, 243, 262, 264, 271.

0
2. Amend Sec.  1.500 by revising the definitions of ``Environmental
pathogen'', ``Harvesting'', and ``Manufacturing/processing'' to read as
follows:

Sec.  1.500  What definitions apply to this subpart?

* * * * *
    Environmental pathogen means a pathogen capable of surviving and
persisting within the manufacturing, processing, packing, or holding
environment such that food may be contaminated and may result in
foodborne illness if that food is consumed without treatment to
significantly minimize the environmental pathogen. Examples of
environmental pathogens for the purposes of this part include Listeria
monocytogenes and Salmonella spp. but do not include the spores of
pathogenic sporeforming bacteria.
* * * * *
    Harvesting applies to applies to farms and farm mixed-type
facilities and means activities that are traditionally performed on
farms for the purpose of removing raw agricultural commodities from the
place they were grown or raised and preparing them for use as food.
Harvesting is limited to activities performed on raw agricultural
commodities, or on processed foods created by drying/dehydrating a raw
agricultural commodity without additional manufacturing/processing, on
a farm. Harvesting does not include activities that transform a raw
agricultural commodity into a processed food as defined in section
201(gg) of the Federal Food, Drug, and Cosmetic Act. Examples of
harvesting include cutting (or otherwise separating) the edible portion
of the raw agricultural commodity from the crop plant and removing or
trimming part of the raw agricultural commodity (e.g., foliage, husks,
roots, or stems). Examples of harvesting also include cooling, field
coring, filtering, gathering, hulling, shelling, sifting, threshing,
trimming of outer leaves of, and washing raw agricultural commodities
grown on a farm.
* * * * *
    Manufacturing/processing means making food from one or more
ingredients, or synthesizing, preparing, treating, modifying, or
manipulating food, including food crops or ingredients. Examples of
manufacturing/processing activities include: Baking, boiling, bottling,
canning, cooking, cooling, cutting, distilling, drying/dehydrating raw
agricultural commodities to create a distinct commodity (such as
drying/dehydrating grapes to produce raisins), evaporating,
eviscerating, extracting juice, extruding (of animal food),
formulating, freezing, grinding, homogenizing, irradiating, labeling,
milling, mixing, packaging (including modified atmosphere packaging),
pasteurizing, peeling, pelleting (of animal food), rendering, treating
to manipulate ripening, trimming, washing, or waxing. For farms and
farm mixed-type facilities, manufacturing/processing does not include
activities that are part of harvesting, packing, or holding.
* * * * *

0
3. Revise the section heading of Sec.  1.501 to read as follows:

Sec.  1.501  To what foods do the requirements in this subpart apply?

* * * * *

0
4. Revise the section heading and the paragraph headings in paragraphs
(a) and (b) of Sec.  1.511 to read as follows:

Sec.  1.511  What FSVP must I have if I am importing a food subject to
certain requirements in the dietary supplement current good
manufacturing practice regulation?

    (a) Importers subject to certain requirements in the dietary
supplement current good manufacturing practice regulation. * * *
    (b) Importers whose customer is subject to certain requirements in
the dietary supplement current good manufacturing practice regulation.
* * *
* * * * *

0
5. In Sec.  1.512, revise the first sentence of paragraphs (b)(3)(ii)
introductory text and (c)(1)(i) and revise paragraphs (b)(3)(iii) and
(iv) to read as follows:

Sec.  1.512  What FSVP may I have if I am a very small importer or I am
importing certain food from certain small foreign suppliers?

* * * * *
    (b) * * *
    (3) * * *
    (ii) If your foreign supplier is a qualified facility as defined by
Sec.  117.3 or Sec.  507.3 of this chapter and you choose to comply
with the requirements in this section, you must obtain written
assurance, before importing the food and at least every 2 years
thereafter, that the foreign supplier is producing the food in
compliance with applicable FDA food safety regulations (or, when
applicable, relevant laws and regulations of a country whose food
safety system FDA has officially recognized as comparable or determined
to be equivalent to that of the United States). * * *
* * * * *
    (iii) If your foreign supplier is a farm that grows produce and is
not a covered farm under part 112 of this chapter in accordance with
Sec.  112.4(a) of this chapter, or in accordance with Sec. Sec.
112.4(b) and 112.5 of this chapter, and you choose to comply with the
requirements in this section, you must obtain written assurance, before
importing the produce and at least every 2 years thereafter, that the
farm acknowledges that its food is subject to section 402 of the
Federal Food, Drug, and Cosmetic Act (or, when applicable, that its
food is subject to relevant laws

and regulations of a country whose food safety system FDA has
officially recognized as comparable or determined to be equivalent to
that of the United States).
    (iv) If your foreign supplier is a shell egg producer that is not
subject to the requirements of part 118 of this chapter because it has
fewer than 3,000 laying hens and you choose to comply with the
requirements in this section, you must obtain written assurance, before
importing the shell eggs and at least every 2 years thereafter, that
the shell egg producer acknowledges that its food is subject to section
402 of the Federal Food, Drug, and Cosmetic Act (or, when applicable,
that its food is subject to relevant laws and regulations of a country
whose food safety system FDA has officially recognized as comparable or
determined to be equivalent to that of the United States).
* * * * *
    (c) * * *
    (1) * * *
    (i) Except as specified in paragraph (c)(1)(iii) of this section,
in approving your foreign suppliers, you must evaluate the applicable
FDA food safety regulations and information relevant to the foreign
supplier's compliance with those regulations, including whether the
foreign supplier is the subject of an FDA warning letter, import alert,
or other FDA compliance action related to food safety, and document the
evaluation. * * *
* * * * *

    Dated: April 21, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-09784 Filed 4-27-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 102 (Friday, May 28, 2021)]
[Proposed Rules]
[Pages 28740-28742]
[FR Doc No: 2021-11149]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 70

[EPA-R04-OAR-2020-0461; FRL-10024-40-Region 4]

Air Plan and Operating Permit Program Approval; Kentucky; Public,
Affected State, and EPA Review

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve changes to the Kentucky State Implementation Plan (SIP) and the
Kentucky Title V Operating Permit Program (Title V) submitted by the
Commonwealth of Kentucky, through the Energy and Environment Cabinet
(Cabinet) on August 12, 2020, and March 29, 2021. These revisions
address the public notice rule provisions for the New Source Review
(NSR), Federally Enforceable State Operating Permits (FESOP) and Title
V programs of the Clean Air Act (CAA or Act) by providing for
electronic notice (``e-notice'') and removing the mandatory requirement
to provide public notice of a draft air permit in a newspaper. EPA is
proposing to approve these changes as they are consistent with the
Clean Air Act (CAA or Act) and implementing federal regulations.

DATES: Comments must be received on or before June 28, 2021.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2020-0461 at www.regulations.gov. Follow the online instructions
for submitting comments. Once submitted, comments cannot be edited or
removed from Regulations.gov. EPA may publish any comment received to
its public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, the full EPA public comment
policy, information about CBI or multimedia submissions, and general
guidance on making effective comments, please visit www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Sarah LaRocca, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air and
Radiation Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street SW, Atlanta, Georgia 30303-8960. The telephone number is
(404) 562-8994. Ms. LaRocca can also be reached via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On October 5, 2016, EPA finalized revised public notice provisions
for the NSR, Title V, and Outer Continental Shelf permitting programs
of the CAA. See 81 FR 71613 (October 18, 2016). These rule revisions
removed the mandatory requirement to provide public notice of
permitting actions through publication in a newspaper and allow for
internet e-notice as an option for permitting authorities implementing
their own EPA-approved SIP rules and Title V rules, such as Kentucky's
EPA-approved permitting programs. Permitting authorities are not
required to adopt e-notice. Nothing in the revised rules prevents a
permitting authority with an EPA-approved permitting program from
continuing to use newspaper notification and/or from supplementing e-
notice with newspaper notification and/or additional means of
notification. For the noticing of draft permits issued by permitting
authorities with EPA-approved programs, the rule requires the
permitting authority to use ``a consistent noticing method'' for all
permit notices under the specific permitting program. When e-notice is
provided, EPA's rule requires electronic access (e-access) to the draft
permit for the duration of the public comment period.
    EPA anticipates that e-notice, which is already being practiced by
many permitting authorities, will enable permitting authorities to
communicate permitting and other affected actions to the public more
quickly and efficiently and will provide cost savings over newspaper
publication. EPA further anticipates that e-access will expand access
to permit-related documents. A full description of the e-notice and e-
access provisions are contained in EPA's October 18, 2016 rulemaking
notice. See 81 FR 71613.
    EPA is proposing to approve changes to 401 Kentucky Administrative
Regulations (KAR) 52:100, Public, affected state, and U.S. EPA review,
of the Kentucky SIP and Title V program, submitted by the Commonwealth
on August 12, 2020, and March 29, 2021. The August 12, 2020, and March
29, 2021, SIP and Title V program revisions seek to establish a revised
method of publication of public notices for public hearings and public
comment periods, establish a revised method of notification of the
opportunity to be placed on a mailing list of permit actions, change
how documents related to permit proceedings will be available for
public inspection, and make minor changes to 401 KAR 52:100 that do not
alter the meaning of the regulation. The SIP revision updates the
current SIP-approved version of 401 KAR 52:100 (Version 1) to Version
2. The Title V revision updates the approved version of 401 KAR 52:100
originally approved in the Kentucky Title V program in the same
manner.\1\
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    \1\ EPA fully approved Kentucky's title V permitting program in
2001. See 66 FR 54955 (October 31, 2001).
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II. EPA's Analysis of Kentucky's Submittals

    The SIP and Title V program revisions contain changes to 401 KAR
52:100, Public, affected state, and U.S. EPA review, which establishes
the procedures used by the Cabinet to provide for the review of
federally-enforceable permits by the public, affected states, and EPA.
Specifically, 401 KAR 52:100 applies to permit actions established in
401 KAR 52.020, Title V Permits and 401 KAR 52.030, Federally-
enforceable permits for non-major sources.\2\ In addition, the public

participation provisions of Kentucky's major source NSR permitting
programs at 401 KAR 51:017, Prevention of significant deterioration of
air quality (PSD), and 401 KAR 52:052, Review of new sources in or
impacting upon nonattainment areas (addressing nonattainment new source
review (NNSR)) cross reference 52 KAR 52:100. Specifically, Kentucky's
PSD rules at 401 KAR 51:017, Section 5, Exclusions from Increment
Consumption; Section 10, Air Quality Models; Section 14, Sources
Impacting Class I Areas; Section 15, Public Participation; and Section
20, Plant-wide Applicability Limit Provisions, cite to 401 KAR 52:100
and to 40 CFR 51.166(q). Kentucky's NNSR rules at 401 KAR 51:052,
Section 7(5)(f), Source Obligation; Section 10(3), Federal land manager
notification; Section 10(4), Public participation; and Section 11,
Plant-wide Applicability Limit Provisions, cite to 401 KAR 52:100 and
to 40 CFR 52.21(4) (to the extent that 401 KAR 52:100 procedures do not
apply).
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    \2\ 401 KAR 52:030 establishes requirements for sources that
accept emission limitations to avoid major source NSR requirements
under Title I of the Act or Operating Permit Program requirements
under Title V of the Act. Sources subject to these types of permits
restricting potential to emit (PTE), both for construction
permitting of new or modified sources and operating permitting for
existing major sources, are commonly referred to as synthetic minor
sources. Kentucky prefers to distinguish between the Title V and
Title I requirements that a source is attempting to avoid. Hence,
they use the term ``conditional major'' for sources whose emissions
are limited below the threshold for Title V, and ``synthetic minor''
for sources whose emissions are below the threshold for Title I. See
``Cabinet Provisions and Procedures for Issuing Federally-
Enforceable Permits for Nonmajor Sources,'' which is incorporated by
reference in Section 26 of 401 KAR 52:030. SIP-approved operating
permit programs that restrict PTE primarily to avoid major source
operating permitting under title V are commonly referred to as FESOP
programs. The FESOP program is a voluntary mechanism for states to
create federally enforceable restrictions on PTE to avoid major
source permitting requirements, such as the title V operating permit
program, and there are no specific CAA provisions or federal
regulations regarding the issuance of synthetic minor or conditional
major operating permits.
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    In this proposed action, EPA is proposing to approve the following
changes to 401 KAR 52:100. In Section 2, ``Public Comment Period,''
Section 3, ``Public Hearing,'' and Section 4, ``Public Notice,'' the
Cabinet is replacing the public notice method for the aforementioned
permit programs from newspaper publication to website notification at
http://eec.ky.gov. This method of notification is consistent with the
public availability of information requirements for permits under 40
CFR 51.161, 51.166(q), 51.165(i), and 70.7 and the criteria for FESOP
programs (see 54 FR 27274 (June 28, 1989)) (hereinafter FESOP
Guidance). Additionally, this regulation allows the Cabinet to provide
further notice in newspapers, newsletters, and press releases under
Section 4(2).
    Section 7, ``Mailing List,'' is updated to require the Cabinet to
notify persons of the opportunity to be on a mailing list to receive
notification of permit actions via the Cabinet's website, rather than
notification through hard copy publications.
    Section 8, ``Public Inspection of Documents,'' is also updated to
require the Cabinet to post draft permits on the Cabinet's website for
the duration of the public comment period. The revision to Section 8
deletes the requirement that the permit application, draft permit, and
supporting material information be available for public inspection in
local public libraries and county clerk offices, but retains the
requirement that, during the public comment period, all non-
confidential information contained in the permit application, draft
permit, and supporting materials be made available at the main office
of the Division of Air Quality and the Division for Air Quality
Regional office having jurisdiction over the source. As described
above, posting draft permits on a designated website is required for
consistency under the federal rules when e-notice is provided.
    In addition, the submission contains minor textual changes to
provide clarity and greater consistency. These textual revisions
include: updating references to the Cabinet, Division for Air Quality,
and regional offices; language changes for clarity and consistency such
as changing ``specified'' to ``established'' and adding ``public''
before references to notice and hearings; clarifying that confidential
information refers to confidential business information (CBI) under 40
CFR part 2 and 400 KAR 1:060 in Section 5(11)(b); and clarifying that
the Cabinet will issue a revised permit upon receipt of EPA objection
under Section 10(9)(c)(2). It does not change substantive elements of
the content of such notifications or time periods associated with
notifications. EPA is proposing to approve these revisions because the
revisions are consistent with the SIP revision requirements of CAA
section 110, the Title V program revision requirements of 40 CFR 70.4,
and EPA's permitting requirements for public participation.

III. Incorporation by Reference

    In this document, EPA is proposing to include in a final EPA rule
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, EPA is proposing to incorporate by
reference 401 KAR 52:100, Public, affected state, and U.S. EPA review,
Version 2, state effective June 2, 2020, into the Kentucky SIP, as well
as the State's federally approve title V program. The proposed
incorporation includes minor textual changes and establishes a revised
means of publication for public notices for public hearing, public
comment periods, and the opportunity to join mailing lists, and a
revised means to inspect documents related to permit proceedings. EPA
has made, and will continue to make, these materials generally
available through www.regulations.gov and at the EPA Region 4 office
(please contact the person identified in the FOR FURTHER INFORMATION
CONTACT section of this preamble for more information).

IV. Proposed Action

    EPA is proposing to approve the changes to 401 KAR 52:100, Public,
affected state, and U.S. EPA review, of the Kentucky SIP and Title V
program, as submitted on August 12, 2020, and March 29, 2021, for the
reasons stated above.

V. Statutory and Executive Order Reviews

    In reviewing SIP and Title V submissions, EPA's role is to approve
such submissions, provided that they meet the criteria under the CAA,
and EPA's implementing regulations. This action merely proposes to
approve state law as meeting Federal requirements and does not impose
additional requirements beyond those imposed by state law. For that
reason, this proposed action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1955 (Pub. L. 104-4);
     Does not have Federalism implications as specified in the
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
national Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898

(59 FR 7629, February 16, 1994). The SIP is not approved to apply on
any Indian reservation land or any other area where EPA or an Indian
tribe has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the SIP-related rules do not have tribal implications
as specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
nor will it impose substantial direct costs on tribal governments or
preempt tribal law.
    Furthermore, the proposed rules regarding Title V Operating Permit
programs do not have tribal implications because they are not approved
to apply to any source of air pollution over which an Indian Tribe has
jurisdiction, nor will these proposed rules impose substantial direct
costs on tribal governments or preempt tribal law.

List of Subjects

40 CFR Part 52

    Environmental protection, Administrative practice and procedure,
Air pollution control, Incorporation by reference, Intergovernmental
relations, Reporting and recordkeeping requirements.

40 CFR Part 70

    Environmental protection, Administrative practice and procedure,
Air pollution control, Incorporation by reference, Intergovernmental
relations, Operating Permits, Reporting and recordkeeping requirements.

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

    Dated: May 20, 2021.
John Blevins,
Acting Regional Administrator, Region 4.
[FR Doc. 2021-11149 Filed 5-27-21; 8:45 am]
BILLING CODE 6560-50-P