[Federal Register: October 18, 2010 (Volume 75, Number 200)]
[Rules and Regulations]
[Page 63710-63711]
[DOCID:fr18oc10-6]

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

DEPARTMENT OF TRANSPORTATION

14 CFR Part 97

[Docket No. 30748; Amdt. No. 3395]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This rule establishes, amends, suspends, or revokes Standard
Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums
and Obstacle Departure Procedures for operations at certain airports.
These regulatory actions are needed because of the adoption of new or
revised criteria, or because of changes occurring in the National
Airspace System, such as the commissioning of new navigational
facilities, adding new obstacles, or changing air traffic requirements.
These changes are designed to provide safe and efficient use of the
navigable airspace and to promote safe flight operations under
instrument flight rules at the affected airports.

DATES: This rule is effective October 18, 2010. The compliance date for
each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of October 18, 2010.

ADDRESSES: Availability of matter incorporated by reference in the
amendment is as follows:
    For Examination--
    1. FAA Rules Docket, FAA Headquarters Building, 800 Independence
Avenue, SW., Washington, DC 20591;
    2. The FAA Regional Office of the region in which the affected
airport is located;
    3. The National Flight Procedures Office, 6500 South MacArthur
Blvd., Oklahoma City, OK 73169; or
    4. The National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/code_of_
federal_regulations/ibr_locations.html.
    Availability--All SIAPs are available online free of charge. Visit
http://nfdc.faa.gov to register. Additionally, individual SIAP and
Takeoff Minimums and ODP copies may be obtained from:
    1. FAA Public Inquiry Center (APA-200), FAA Headquarters Building,
800 Independence Avenue, SW., Washington, DC 20591; or
    2. The FAA Regional Office of the region in which the affected
airport is located.

FOR FURTHER INFORMATION CONTACT: Harry J. Hodges, Flight Procedure
Standards Branch (AFS-420) Flight Technologies and Programs Division,
Flight Standards Service, Federal Aviation Administration, Mike
Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma
City, OK 73169 (Mail Address: P.O. Box 25082 Oklahoma City, OK 73125),
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends Title 14, Code of Federal
Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs.
The complete regulatory description of each SIAP is listed on the
appropriate FAA Form 8260, as modified by the National Flight Data
Center (FDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated
by reference in the amendment under 5 U.S.C. 552(a), 1 CFR part 51, and
Sec.  97.20 of Title 14 of the Code of Federal Regulations.
    The large number of SIAPs, their complex nature, and the need for a
special format make their verbatim publication in the Federal Register
expensive and impractical. Further, airmen do not use the regulatory
text of the SIAPs, but refer to their graphic depiction on charts
printed by publishers of aeronautical materials. Thus, the advantages
of incorporation by reference are realized and publication of the
complete description of each SIAP contained in FAA form documents is
unnecessary. This amendment provides the affected CFR sections and
specifies the types of SIAP and the corresponding effective dates. This
amendment also identifies the airport and its location, the procedure
and the amendment number.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP as amended in the transmittal. For safety and
timeliness of change considerations, this amendment incorporates only
specific changes contained for each SIAP as modified by FDC/P-NOTAMs.
    The SIAPs, as modified by FDC P-NOTAM, and contained in this
amendment are based on the criteria contained in the U.S. Standard for
Terminal Instrument Procedures

(TERPS). In developing these changes to SIAPs, the TERPS criteria were
applied only to specific conditions existing at the affected airports.
All SIAP amendments in this rule have been previously issued by the FAA
in a FDC NOTAM as an emergency action of immediate flight safety
relating directly to published aeronautical charts. The circumstances
which created the need for all these SIAP amendments requires making
them effective in less than 30 days.
    Because of the close and immediate relationship between these SIAPs
and safety in air commerce, I find that notice and public procedure
before adopting these SIAPs are impracticable and contrary to the
public interest and, where applicable, that good cause exists for
making these SIAPs effective in less than 30 days.

Conclusion

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 97

    Air Traffic Control, Airports, Incorporation by reference, and
Navigation (Air).

    Issued in Washington, DC, on October 1, 2010.
John M. Allen,
Director, Flight Standards Service.

Adoption of the Amendment

0
Accordingly, pursuant to the authority delegated to me, Title 14, Code
of Federal regulations, Part 97, 14 CFR part 97, is amended by amending
Standard Instrument Approach Procedures, effective at 0901 UTC on the
dates specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120,
44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows:

Sec. Sec.  97.23, 97.25, 97.27, 97.29, 97.31, 97.33, 97.35  [Amended]

    By amending: Sec.  97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or
TACAN; Sec.  97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; Sec.
97.27 NDB, NDB/DME; Sec.  97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV;
Sec.  97.31 RA DAR SIAPs; Sec.  97.33 RNAV SIAPs; and Sec.  97.35
COPTER SIAPs, Identified as follows:

* * * Effective Upon Publication

--------------------------------------------------------------------------------------------------------------------------------------------------------
       AIRAC date              State              City               Airport         FDC No.      FDC date                     Subject
--------------------------------------------------------------------------------------------------------------------------------------------------------
18-Nov-10...............  CQ              SAIPAN ISLAND......  FRANCISCO C. ADA/        0/1358      9/29/10  ILS OR LOC/DME RWY 7, AMDT 5B.
                                                                SAIPAN INTL.
18-Nov-10...............  CQ              SAIPAN ISLAND......  FRANCISCO C. ADA/        0/1359      9/29/10  NDB/DME RWY 25, AMDT 2A
                                                                SAIPAN INTL.
18-Nov-10...............  CQ              SAIPAN ISLAND......  FRANCISCO C. ADA/        0/1360      9/29/10  NDB/DME RWY 7, AMDT 3A.
                                                                SAIPAN INTL.
18-Nov-10...............  OK              POTEAU.............  ROBERT S KERR.....       0/3020      9/29/10  RNAV (GPS) RWY 18, ORIG.
18-Nov-10...............  OK              POTEAU.............  ROBERT S KERR.....       0/3021      9/29/10  RNAV (GPS) RWY 36, ORIG.
18-Nov-10...............  AR              RUSSELLVILLE.......  RUSSELLVILLE RGNL.       0/3037      9/29/10  NDB A, AMDT 4B.
18-Nov-10...............  OH              JACKSON............  JAMES A RHODES....       0/3038      9/29/10  RNAV (GPS) RWY 19, AMDT 1A.
18-Nov-10...............  OH              JACKSON............  JAMES A RHODES....       0/3039      9/29/10  RNAV (GPS) RWY 1, AMDT 1A.
18-Nov-10...............  WI              EAU CLAIRE.........  CHIPPEWA VALLEY          0/3353      9/29/10  RNAV (GPS) RWY 22, ORIG.
                                                                RGNL.
18-Nov-10...............  TX              COLEMAN............  COLEMAN MUNI......       0/3457      9/29/10  GPS RWY 15, ORIG.
18-Nov-10...............  TX              CALDWELL...........  CALDWELL MUNI.....       0/3577      9/29/10  VOR/DME OR GPS A, AMDT 2B.
18-Nov-10...............  AR              MC GEHEE...........  MC GEHEE MUNI.....       0/3578      9/29/10  VOR/DME OR GPS A, AMDT 2A.
18-Nov-10...............  IA              MASON CITY.........  MASON CITY MUNI...       0/3700      9/29/10  VOR/DME RWY 18, AMDT 4B.
18-Nov-10...............  VA              WAKEFIELD..........  WAKEFIELD MUNI....       0/4187      9/29/10  NDB RWY 20, AMDT 4C.
18-Nov-10...............  NJ              ATLANTIC CITY......  ATLANTIC CITY INTL       0/4595      9/29/10  RADAR-1, AMDT 15.
18-Nov-10...............  MN              LITCHFIELD.........  LITCHFIELD MUNI...       0/6889      9/29/10  VOR/DME RWY 13, ORIG-A.
18-Nov-10...............  VA              NORFOLK............  NORFOLK INTL......       0/8197      9/29/10  RNAV (GPS) RWY 32, ORIG-A.
18-Nov-10...............  VA              NORFOLK............  NORFOLK INTL......       0/8198      9/29/10  VOR/DME RWY 5, AMDT 4C.
18-Nov-10...............  VA              NORFOLK............  NORFOLK INTL......       0/8199      9/29/10  ILS RWY 23, AMDT 6E.
18-Nov-10...............  VA              NORFOLK............  NORFOLK INTL......       0/8204      9/29/10  ILS OR LOC RWY 5, AMDT 24F.
18-Nov-10...............  VA              NORFOLK............  NORFOLK INTL......       0/8205      9/29/10  VOR RWY 23, AMDT 8C.
18-Nov-10...............  VA              NORFOLK............  NORFOLK INTL......       0/8206      9/29/10  RNAV (GPS) RWY 23, ORIG-B.
18-Nov-10...............  VA              NORFOLK............  NORFOLK INTL......       0/8207      9/29/10  RNAV (GPS) RWY 14, ORIG-A.
18-Nov-10...............  VA              NORFOLK............  NORFOLK INTL......       0/8208      9/29/10  VOR/DME RWY 32, AMDT 4D.
18-Nov-10...............  VA              NORFOLK............  NORFOLK INTL......       0/8212      9/29/10  VOR/DME RWY 14, AMDT 2D.
18-Nov-10...............  AL              TALLADEGA..........  TALLADEGA                0/8343      9/29/10  RNAV (GPS) RWY 3, ORIG.
                                                                MUNICIPAL.
18-Nov-10...............  CA              NAPA...............  NAPA COUNTY.......       0/8360      9/29/10  VOR RWY 6, AMDT 12A.
--------------------------------------------------------------------------------------------------------------------------------------------------------

[FR Doc. 2010-25834 Filed 10-15-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 208 (Monday, October 30, 2017)]
[Notices]
[Pages 50198-50201]
[FR Doc No: 2017-23478]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-81930; File No. SR-NASDAQ-2017-107]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Amend Nasdaq Closing Cross Rules

October 24, 2017.
    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 10, 2017, The NASDAQ Stock Market LLC (``Nasdaq'' 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
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\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

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

    The Exchange proposes to amend Rule 4702 (Order Types) and Rule
4754 [sic] (Nasdaq Closing Cross) to enhance the Nasdaq Closing Cross
by permitting members to submit LOC Orders until immediately prior to
3:55 p.m. ET subject to certain conditions, and to make other changes
related to Closing Cross/Extended Hours Orders [sic].
    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaq.cchwallstreet.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 aspects of such
statements.

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

1. Purpose
    On July 13, 2017, the Exchange filed a proposed rule change to
amend Rule 4702 (Order Types) and Rule 4754 (Nasdaq Closing Cross) to
enhance the Nasdaq Closing Cross by permitting members to submit Limit
On Close (``LOC'') Orders \3\ until immediately prior to 3:55 p.m. ET
subject to certain conditions.\4\ This proposed rule change was
approved by the Commission on September 8, 2017,\5\ and the Exchange
began to introduce this functionality pursuant to a symbol-by-symbol
rollout beginning on October 2, 2017.\6\ The purpose of the proposed
rule change is to amend the Nasdaq Closing Cross rules to: (1) Reject
all Market Maker Peg Orders flagged to participate in the Nasdaq
Closing Cross; and (2) account for the minimum increment for Tick Size
Pilot securities when re-pricing LOC Orders entered between 3:50 p.m.
ET and immediately prior to 3:55 p.m. ET.
---------------------------------------------------------------------------

    \3\ A ``Limit On Close Order'' or ``LOC Order'' is an Order Type
entered with a price that may be executed only in the Nasdaq Closing
Cross, and only if the price determined by the Nasdaq Closing Cross
is equal to or better than the price at which the LOC Order was
entered. See Rule 4702(b)(12).
    \4\ See Securities Exchange Act Release No. 81188 (July 21,
2017), 82 FR 35014 (July 27, 2017) (SR-NASDAQ-2017-061).
    \5\ See Securities Exchange Act Release No. 81556 (September 8,
2017), 82 FR 43264 (September 14, 2017) (SR-NASDAQ-2017-061)
(Approval Order).
    \6\ See Equity Trader Alert #2017-184.
---------------------------------------------------------------------------

    A ``Market Maker Peg Order'' is an Order Type designed to allow a
Market Maker to maintain a continuous two-sided quotation at a
displayed price that is compliant with the quotation requirements for
Market Makers set forth in Rule 4613(a)(2).\7\ Pursuant to SR-NASDAQ-
2017-061, a Market Maker Peg Order will not be permitted to operate as
a Closing Cross/Extend Hours Order.\8\ Instead, such orders will be
rejected. Market Maker Peg Orders would, however, remain permitted to
be flagged to participate solely in the Nasdaq Closing Cross if entered
with a time-in-force (``TIF'') that does not continue after the time of
the Nasdaq Closing Cross. After additional consideration, the Exchange
believes that all Market Maker Peg Orders flagged with an on-close
instruction should be rejected. The Exchange therefore proposes to
amend its rules to state that a Market Maker Peg Order may not be
flagged to solely participate in the Nasdaq Closing Cross. This will
supplement current language stating that such Market maker Peg Orders
may not operate as Closing Cross/Extended Hours Orders. With this
change, all Market Maker Peg Orders entered with an on-close
instruction will be rejected, regardless of whether the order is
entered with a TIF that continues after the Nasdaq Closing Cross. The
Exchange believes that this change will more closely align with member
expectations and the design of this order type, which is to assist
members with their quoting obligations. Market Maker Peg Orders that
are not entered with an on-close instruction will remain eligible to
participate in the Nasdaq Closing Cross if the order remains unexecuted
at the time of the Nasdaq Closing Cross.
---------------------------------------------------------------------------

    \7\ See Rule 4702(b)(7).
    \8\ A Closing Cross/Extended Hours Order is an order that is
flagged to participate in the Nasdaq Closing Cross and has a Time-
in-Force that continues after the time of the Nasdaq Closing Cross.
---------------------------------------------------------------------------

    Furthermore, when the Nasdaq Closing Cross changes are introduced,
the Exchange will re-price LOC Orders entered between 3:50 p.m. ET and
immediately prior to 3:55 p.m. ET to the less aggressive of the order's
limit price or the First Reference Price \9\ in order to prevent these
orders from having a significant impact on the price established by the
Nasdaq Closing Cross.\10\ In addition, Rule 4702 provides that if the
First Reference Price is not at a permissible minimum increment of
$0.01 or $0.0001, as applicable, the First Reference Price will be
rounded (i) to the nearest permitted minimum increment (with midpoint
prices being rounded up) if there is no imbalance, (ii) up if there is
a buy imbalance, or (iii) down if there is a sell imbalance. Although
the rule explicitly mentions the regular trading increments of $0.01 or
$0.0001, however, it does not account for the minimum increments
approved for securities selected for inclusion in the Tick Size Pilot
Program, which are subject to $0.05 minimum increments.\11\ The
Exchange therefore proposes to remove the explicit reference to these
specific minimum increments. With the proposed change, the rule will
state that if the First Reference Price is not at a permissible minimum
increment, the First Reference Price will be rounded (i) to the nearest
permitted minimum increment (with midpoint prices being rounded up) if
there is no imbalance, (ii) up if there is a buy imbalance, or (iii)
down if there is a sell imbalance. The Exchange believes that this
change will avoid potential member confusion with respect to the
application of this rule to securities selected for inclusion in the
Tick Size Pilot Program, and help ensure compliance with the Tick Size
Pilot Program.
---------------------------------------------------------------------------

    \9\ ``First Reference Price'' is the Current Reference Price in
the first Order Imbalance Indicator disseminated at or after 3:50
p.m. ET. See Rule 4754(a)(9).
    \10\ See Rule 4702(b)(12)(A).
    \11\ See Securities Exchange Act Release No. 74892 (May 6,
2015), 80 FR 27513 (May 13, 2015) (Order Approving the Tick Size
Pilot Program). See also Rule 4770 (Compliance with Regulation NMS
Plan to Implement a Tick Size Pilot).
---------------------------------------------------------------------------

Implementation
    The Exchange proposes to introduce the changes described in this
proposed rule change on October 10, 2017. The Exchange began the
rollout of functionality described in SR-NASDAQ-2017-061, as announced
to members via Equity Trader Alert, with three symbols, VSAT, TEAM, and
UNIT. The rollout of those changes will continue in the fourth quarter
of 2017 after the completion of additional industry testing of the
functionality.\12\ The Exchange believes that implementing the proposed
change to Market Maker Peg Order handling is important for the
operation of the three symbols to which the functionality proposed in
SR-NASDAQ-2017-061 currently applies. The changes to Market Maker Peg
Order handling proposed herein cannot be applied on a symbol-by-symbol
basis, but rather must be applied to all symbols simultaneously.
Accordingly, the Exchange is proposing to implement the

proposed changes applied to all symbols on October 10, 2017.
---------------------------------------------------------------------------

    \12\ The Exchange recently informed market participants that it
will pause the rollout of the remaining symbols for the enhancements
to the Nasdaq Closing Cross approved by the Commission on September
8, 2017, in an effort to provide further customer testing
opportunities. See Nasdaq Equity Trader Alert #2017-189. The
Exchange anticipates continuing the implementation in the near
future, with its completion in the fourth quarter consistent with
its proposal. The Exchange will release an Equity Trader Alert
announcing resumption of the rollout schedule.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\13\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\14\ in particular, in that it is 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.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78f(b).
    \14\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    When the Exchange filed to restrict Market Maker Peg Orders from
operating as Closing Cross/Extended Hours Orders, the Exchange
explained that Market Maker Peg Orders were designed to assist members
in meeting their quoting obligations and not as a means of submitting
interest flagged with an on-close instruction. Furthermore, the
Exchange explained that it did not believe that members want
functionality that allows Market Maker Peg Orders to be entered with a
flag designating an on-close instruction. The Exchange believes that
this is true both for Market Maker Peg Orders entered with a TIF that
continues after the time of the Nasdaq Closing Cross, and that
therefore operate as Closing Cross/Extended Hours Orders, and Market
Maker Peg Orders entered with a TIF that causes it to execute solely in
the Nasdaq Closing Cross. The Exchange is therefore proposing to reject
all Market Maker Peg Orders flagged to participate in the Nasdaq
Closing Cross, regardless of TIF. The Exchange believes that this
change will perfect the mechanism of a free and open market by
eliminating the possibility that members can inadvertently enter this
order type combination, while preserving the design of Market Maker Peg
Orders to aid members in meeting their quoting obligations.
    In addition, the Exchange believes that the current language in
Rule 4702 could be confusing to members and investors when applied to
securities that are selected for inclusion in the Tick Size Pilot
Program, as these securities are subject to a $0.05 minimum increment
instead of the $0.01 or $0.0001 minimum increments cited in the rule
today. The Exchange believes that removing the reference to these
specific increments will reduce confusion because permissible minimum
increments may be $0.01 or $0.0001 for most securities, and $0.05 for a
handful of securities selected for inclusion in the Tick Size Pilot
Program. The Exchange must round to a permissible minimum increment
whenever the First Reference Price is not in such a minimum increment.
The proposed rule change makes this clear and will therefore increase
transparency to the benefit of members and investors, and help ensure
compliance with the Tick Size Pilot Program.

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. With respect to Market Maker
Peg Orders flagged for the Nasdaq Closing Cross, the proposed change
eliminates an order type combination that is not consistent with the
purpose of aiding members in meeting their quoting obligations.
Furthermore, the proposed change related to minimum increments properly
reflects the increments applicable to securities traded on the
Exchange, including securities selected for inclusion in the Tick Size
Pilot Program. Neither of these proposed changes is designed to have
any significant competitive impact.

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

    No written comments were either solicited or received.

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

    Because the foregoing 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 \15\ and Rule 19b-
4(f)(6) thereunder.\16\
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78s(b)(3)(A).
    \16\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
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. The Commission has waived this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \17\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6)(iii) \18\ 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. The
Commission notes that waiver of the operative delay would allow the
Exchange to implement the proposed change to Market Maker Peg Orders
for all symbols without delay, including the three symbols to which the
functionalities described in SR-NASDAQ-2017-061 currently apply.
Moreover, the proposed change relating to minimum increments is
designed to avoid confusion and help ensure compliance with the Tick
Size Pilot Program. The Commission believes that waiving the 30-day
operative delay is consistent with the protection of investors and the
public interest. Accordingly, the Commission hereby waives the 30-day
operative delay and designates the proposed rule change operative upon
filing.\19\
---------------------------------------------------------------------------

    \17\ 17 CFR 240.19b-4(f)(6).
    \18\ 17 CFR 240.19b-4(f)(6)(iii).
    \19\ For 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.
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 protected]. Please include
File Number SR-NASDAQ-2017-107 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2017-107. 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 the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change. Persons submitting
comments are cautioned that we do not redact or edit personal
identifying information from comment submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-NASDAQ-2017-107 and should
be submitted on or before November 20, 2017.
---------------------------------------------------------------------------

    \20\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\20\
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-23478 Filed 10-27-17; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 51 (Thursday, March 15, 2012)]
[Rules and Regulations]
[Page 15263]
[FR Doc No: 2012-6313]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2012-0129]

Security Zone; Portland Rose Festival on Willamette River;
Portland, OR

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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

SUMMARY: The Coast Guard will enforce the Portland Rose Festival
Security Zone in 33 CFR 165.1312 from 11 a.m. on June 6, 2012 until 11
a.m. on June 11, 2012. This action is necessary to ensure the security
of maritime traffic, including the public vessels present on the
Willamette River during the Portland Rose festival. During the
enforcement period, no person or vessel may enter or remain in the
security zone without permission of the Captain of the Port, Columbia
River, Oregon.

DATES: The regulations in 33 CFR 165.1312 will be enforced from 11 a.m.
on June 6, 2012 until 11 a.m. on June 11, 2012.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call or email ENS Ian McPhillips, Waterways Management Division, MSU
Portland, Oregon, Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the security
zone for the Portland Rose Festival detailed in 33 CFR 165.1312 for all
vessels operating in the Columbia River Captain of the Port Zone from
11 a.m. on June 6, 2012 until 11 a.m. on June 11, 2012.
    Under the provisions of 33 CFR 165.1312 and 33 CFR part 165,
subpart D, no person or vessel may enter or remain in the security zone
without permission of the Captain of the Port, Columbia River. Persons
or vessels wishing to enter the security zone may request permission to
do so from the on scene Captain of the Port representative via VHF
Channel 16 or 13. The Coast Guard may be assisted by other Federal,
State, or local enforcement agencies in enforcing this regulation.
    This notice is issued under authority of 33 CFR 165.1312 and 5
U.S.C. 552(a). In addition to this notice in the Federal Register, the
Coast Guard will provide the maritime community with notification of
this enforcement period via the Local Notice to Mariners.

    Dated: February 24, 2012.
B.C. Jones,
Captain, U.S. Coast Guard, Captain of the Port, Columbia River.
[FR Doc. 2012-6313 Filed 3-14-12; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 84, Number 89 (Wednesday, May 8, 2019)]
[Notices]
[Pages 20143-20145]
[FR Doc No: 2019-09380]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-2245]

Classification and Requirements for Laser Illuminated Projectors
(Laser Notice No. 57); Guidance for Industry and Food and Drug
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Classification and
Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No.
57).'' This guidance describes FDA's policy with respect to certain
LIPs that comply with International Electrotechnical Commission (IEC)
standards during laser product classification under the Electronic
Product Radiation Control provisions of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) that apply to electronic products.

DATES: The announcement of the guidance is published in the Federal
Register on May 8, 2019.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management

Staff, FDA will post your comment, as well as any attachments, except
for information submitted, marked and identified, as confidential, if
submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2014-D-2245 for ``Classification and Requirements for Laser
Illuminated Projectors (LIPs) (Laser Notice No. 57); Guidance for
Industry and Food and Drug Administration Staff.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Classification and Requirements for Laser Illuminated Projectors
(LIPs) (Laser Notice No. 57)'' to the Office of Policy, Guidance and
Policy Development, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Patrick Hintz, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4228, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    This guidance describes FDA's policy with respect to certain LIPs
that comply with IEC standards during laser product classification
under the Electronic Product Radiation Control provisions of the FD&C
Act (Pub. L. 90-602, amended by Pub. L. 103-80) that apply to
electronic products. For purposes of this guidance, the term ``laser
illuminated projector'' refers to a type of demonstration laser product
regulated under 21 CFR 1040.10(b)(13) that is designed to project a
display image without the use of raster-scanned collimated laser beams.
LIPs may be used in locations such as indoor or outdoor cinema
theaters, laser shows, presentations at conventions, image/data
projectors in office settings, or homes. Under 21 CFR 1040.10(c), FDA
recognizes four major hazard classes (I to IV) of lasers, including
three subclasses (IIa, IIIa, and IIIb). Under this classification
procedure higher laser classes correspond to more powerful lasers and a
higher potential to pose serious danger if used improperly.
    As demonstration laser products, LIPs and applications for LIPs
cannot exceed class IIIa emission limits as specified in 21 CFR
1040.11(c) (which is comparable to IEC 60825-1 Ed. 3.0 Class 3R) unless
granted a variance by FDA under 21 CFR 1010.4. Some LIPs and
applications for LIPs will exceed the class IIIa limits and therefore
require a variance to exceed those emission limits.
    This guidance document describes FDA's intent to clarify the
application of certain aspects of the performance standard requirements
in 21 CFR 1040.11(c) for LIPs. Because the radiant emission levels
produced by LIPs can be scientifically characterized by an alternative
IEC standard, IEC 62471-5:Ed. 1.0, FDA does not intend to enforce the
requirements under 21 CFR 1040.10(c)(1) and 21 CFR 1040.11(c) when LIP
manufacturers conform to these standards under the situations outlined
in sections III and IV of this guidance.
    FDA considered comments received on the draft guidance that
appeared in the Federal Register of October 2, 2017 (82 FR 45861). FDA
revised the guidance as appropriate in response to the comments. This
guidance supersedes ``Immediately in Effect Guidance Document:
Classification and Requirements for Laser Illuminated Projectors
(LIPs); Guidance for Industry and Food and Drug Administration Staff,''
issued February 18, 2015.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on classification and requirements for LIPs
(Laser Notice No. 57). It does not establish any rights for any person
and is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations. This guidance is not subject to Executive Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance document is also available at https://www.regulations.gov.
Persons unable to download an electronic copy of ``Classification and
Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No.
57)'' may send an email request to<EMAIL_ADDRESS>to receive
an electronic copy of the document. Please use the document number
1400056 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520). The collections

of information in the following FDA regulations and forms have been
approved by OMB as listed in the following table:

------------------------------------------------------------------------
                                                            OMB control
      21 CFR part and form                Topic                 No.
------------------------------------------------------------------------
1002, 1010, 1040, and form FDA   Reporting and                 0910-0025
 3632.                            Recordkeeping for
                                  Electronic Products--
                                  General Requirements.
------------------------------------------------------------------------

    Dated: May 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-09380 Filed 5-7-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: September 15, 2009 (Volume 74, Number 177)]
[Notices]
[Page 47237-47238]
[DOCID:fr15se09-65]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13467-000]

Notice of Preliminary Permit Application Accepted for Filing and
Soliciting Comments, Motions To Intervene, and Competing Applications

September 4, 2009.
    On May 19, 2009, Hydrodynamics, Inc. filed an application for a
preliminary permit, pursuant to section 4(f) of the Federal Power Act,
proposing to study the feasibility of the Bear Creek Hydroelectric
Project, which would be located on Bear Creek, in Park County, Montana.
The sole purpose of a preliminary permit, if issued, is to grant the
permit holder priority to file a license application during the permit
term. A preliminary permit does not authorize the permit holder to
perform any land disturbing activities or

otherwise enter upon lands or waters owned by others without the
owners' express permission.
    The proposed project would consist of the following: (1) A new 8-
foot-high, 100-foot-long concrete diversion dam; (2) a new 7-foot-wide,
30-foot-long intake extending from the right side of the dam; (3) a new
36-inch-diameter, 2.3-mile-long steel penstock; (4) a new powerhouse
containing one generating unit with an installed capacity of 1.5
megawatts; (5) a new tailrace discharging flows into Bear Creek; (6) a
new substation; (7) a new 69-kilovolt, 1,500-foot-long transmission
line; and (8) appurtenant facilities. The proposed project would have
an average annual generation of 7.0 gigawatt-hours.
    Applicant Contact: Ben Singer, Project Manager, Hydrodynamics,
Inc., P.O. Box 1136, Bozeman, MT 59771; phone:<PHONE_NUMBER>.
    FERC Contact: Dianne Rodman,<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Comments, motions to intervene, notices of intent, and competing
applications may be filed electronically via the Internet. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
(http://www.ferc.gov/docs-filing/ferconline.asp) under the ``eFiling''
link. For a simpler method of submitting text only comments, click on
``Quick Comment.'' For assistance, please contact FERC Online Support
at<EMAIL_ADDRESS>call toll-free at<PHONE_NUMBER>; or,
for TTY, contact<PHONE_NUMBER>. Although the Commission strongly
encourages electronic filing, documents may also be paper-filed. To
paper-file, mail an original and eight copies to: Kimberly D. Bose,
Secretary, Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-13467) in the docket number field to access
the document. For assistance, contact FERC Online Support.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-22092 Filed 9-14-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 183 (Thursday, September 20, 2012)]
[Notices]
[Pages 58400-58401]
[FR Doc No: 2012-23185]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Anti-Infective Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Anti-Infective Drugs Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on November 29, 2012, from
8 a.m. to 5 p.m.
    Location: DoubleTree by Hilton Hotel Washington DC-Silver Spring,
The Ballroom, 8727 Colesville Rd., Silver Spring, MD 20910. The hotel's
phone number is<PHONE_NUMBER>.
    Contact Person: Diane Goyette, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, Rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX: 301-847-
8533, email<EMAIL_ADDRESS>or FDA Advisory Committee Information
Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC area). A
notice in the Federal Register about last minute modifications that
impact a previously announced advisory committee meeting cannot always
be published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
    Agenda: The committee will discuss new drug application (NDA)
22407, VIBATIV (telavancin hydrochloride) sterile powder for injection,
submitted by Theravance, Inc., for the requested

indication of nosocomial pneumonia (pneumonia contracted by
hospitalized patients), including ventilator-associated pneumonia,
caused by susceptible isolates of the following Gram-positive bacteria:
Staphylococcus aureus (including methicillin-susceptible and -resistant
isolates) or Streptococcus pneumoniae (penicillin susceptible strains).
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
November 13, 2012. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Those individuals interested in
making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before November 2, 2012. Time allotted
for each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by November 5, 2012.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Diane Goyette at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: September 13, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-23185 Filed 9-19-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 79, Number 164 (Monday, August 25, 2014)]
[Rules and Regulations]
[Pages 50549-50551]
[FR Doc No: 2014-20022]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 862

[Docket No. FDA-2014-N-1112]

Medical Devices; Clinical Chemistry and Clinical Toxicology
Devices; Classification of Hemoglobin A1c Test System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

SUMMARY: The Food and Drug Administration (FDA) is classifying
hemoglobin A1c test system into class II (special controls). The
special controls that will apply to this device are identified in this
order and will be part of the codified language for the hemoglobin A1c
test system classification. The Agency is classifying the device into
class II (special controls) in order to provide a reasonable assurance
of safety and effectiveness of the device.

DATES: This order is effective September 24, 2014. The classification
was applicable May 23, 2013.

FOR FURTHER INFORMATION CONTACT: Meshaun Payne, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5650, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were
not in commercial distribution before May 28, 1976 (the date of
enactment of the Medical Device Amendments of 1976), generally referred
to as postamendments devices, are classified automatically by statute
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval, unless and until the
device is classified or reclassified into class I or II, or FDA issues
an order finding the device to be substantially equivalent, in
accordance with section 513(i) of the FD&C Act, to a predicate device
that does not require premarket approval. The Agency determines whether
new devices are substantially equivalent to predicate devices by means
of premarket notification procedures in section 510(k) of the FD&C Act
(21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act, as amended by section 607 of the
Food and Drug Administration Safety and Innovation Act (Public Law 112-
144), provides two procedures by which a person may request FDA to
classify a device under the criteria set forth in section 513(a)(1).
Under the first procedure, the person submits a premarket notification
under section 510(k) of the FD&C Act for a device that has not
previously been classified and, within 30 days of receiving an order
classifying the device into class III under section 513(f)(1) of the
FD&C Act, the person requests a classification under section 513(f)(2).
Under the second procedure, rather than first submitting a premarket
notification under section 510(k) of the FD&C Act and then a request
for classification under the first procedure, the person determines
that there is no legally marketed device upon which to base a
determination of substantial equivalence and requests a classification
under section 513(f)(2) of the FD&C Act. If the person submits a
request to classify the device under this second procedure, FDA may
decline to undertake the classification request if FDA identifies a
legally marketed device that could provide a reasonable basis for

review of substantial equivalence with the device or if FDA determines
that the device submitted is not of ``low-moderate risk'' or that
general controls would be inadequate to control the risks and special
controls to mitigate the risks cannot be developed.
    In response to a request to classify a device under either
procedure provided by section 513(f)(2) of the FD&C Act, FDA will
classify the device by written order within 120 days. This
classification will be the initial classification of the device.
    In accordance with section 513(f)(1) of the FD&C Act, FDA issued an
order on March 14, 2013, classifying the COBAS INTEGRA 800 Tina-quant
HbA1cDx Gen.2 assay into class III, because it was not substantially
equivalent to a device that was introduced or delivered for
introduction into interstate commerce for commercial distribution
before May 28, 1976, or a device which was subsequently reclassified
into class I or class II. On March 29, 2013, Roche Diagnostics
Corporation submitted a request for classification of the COBAS INTEGRA
800 Tina-quant HbA1cDx Gen.2 assay under section 513(f)(2) of the FD&C
Act. The manufacturer recommended that the device be classified into
class II.
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed
the request in order to classify the device under the criteria for
classification set forth in section 513(a)(1). FDA classifies devices
into class II if general controls by themselves are insufficient to
provide reasonable assurance of safety and effectiveness, but there is
sufficient information to establish special controls to provide
reasonable assurance of the safety and effectiveness of the device for
its intended use. After review of the information submitted in the de
novo request, FDA determined that the device can be classified into
class II with the establishment of special controls. FDA believes these
special controls, in addition to general controls, will provide
reasonable assurance of the safety and effectiveness of the device.
    Therefore, on May 23, 2013, FDA issued an order to the requestor
classifying the device into class II. FDA is codifying the
classification of the device by adding Sec.  862.1373.
    Following the effective date of this final classification
administrative order, any firm submitting a premarket notification
(510(k)) for a hemoglobin A1c test system will need to comply with the
special controls named in the final administrative order.
    The device is assigned the generic name hemoglobin A1c test system,
and it is identified as a device used to measure the percentage
concentration of hemoglobin A1c in blood. Measurement of hemoglobin A1c
is used as an aid in the diagnosis of diabetes mellitus and as an aid
in the identification of patients at risk for developing diabetes
mellitus.
    FDA has identified the following risks to health associated with
this type of device and the measures required to mitigate these risks
in table 1:

                               Table 1--Identified Risks and Required Mitigations
----------------------------------------------------------------------------------------------------------------
                    Identified risks                                       Required mitigations
----------------------------------------------------------------------------------------------------------------
False negative result due to inadequate device           Special controls (1) and (2).
 performance.
False positive result due to inadequate device           Special controls (1) and (2).
 performance.
Use of the test for patients with hemoglobin variants    Special control (3).
 that may interfere with the test system, and lead to
 incorrect results.
----------------------------------------------------------------------------------------------------------------

    FDA believes that the following special controls, in addition to
the general controls, address these risks to health and provide
reasonable assurance of safety and effectiveness:
    1. The device must have initial and annual standardization
verification by a certifying glycohemoglobin standardization
organization deemed acceptable by FDA.
    2. The premarket notification submission must include performance
testing to evaluate precision, accuracy, linearity and interference,
including the following:
     Performance testing of device precision must, at a
minimum, use blood samples with concentrations near 5.0 percent, 6.5
percent, 8.0 percent and 12 percent hemoglobin A1c. This testing must
evaluate precision over a minimum of 20 days using at least three lots
of the device and three instruments, as applicable.
     Performance testing of device accuracy must include a
minimum of 120 blood samples that span the measuring interval of the
device and compare results of the new device to results of a
standardized test method. Results must demonstrate little or no bias
versus the standardized method.
     Total error of the new device must be evaluated using
single measurements by the new device compared to results of the
standardized test method, and this evaluation must demonstrate a total
error less than or equal to 6 percent.
     Performance testing must demonstrate that there is little
to no interference from common hemoglobin variants, including
Hemoglobin C, Hemoglobin D, Hemoglobin E, Hemoglobin A2, and Hemoglobin
S.
    3. When assay interference from Hemoglobin F or interference with
other hemoglobin variants with low frequency in the population is
observed, a warning statement must be placed in a black box and must
appear in all labeling material for these devices describing the
interference and any affected populations.
    Hemoglobin A1c test system devices are prescription devices
restricted to patient use only upon the authorization of a practitioner
licensed by law to administer or use the device. (See section 520(e) of
the FD&C Act (21 U.S.C. 360j(e)) and 21 CFR 801.109 (Prescription
devices).). Prescription-use restrictions are a type of general control
as defined in section 513(a)(1)(A)(i) of the FD&C Act.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) if FDA determines that premarket notification is not necessary
to provide reasonable assurance of the safety and effectiveness of the
device. For this type of device, FDA has determined that premarket
notification is necessary to provide reasonable assurance of the safety
and effectiveness of the device. Therefore, this device type is not
exempt from premarket notification requirements. Persons who intend to
market this type of device must submit to FDA a premarket notification,
prior to marketing the device, which contains information about the
hemoglobin A1c test system they intend to market.

II. Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment

nor an environmental impact statement is required.

III. Paperwork Reduction Act of 1995

    This final administrative order establishes special controls that
refer to previously approved collections of information found in other
FDA regulations. These collections of information are subject to review
by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of
information in part 807, subpart E, regarding premarket notification
submissions have been approved under OMB control number 0910-0120; the
collections of information in 21 CFR part 820 have been approved under
OMB control number 0910-0073; and the collections of information in 21
CFR parts 801 and 809 regarding labeling have been approved under OMB
control number 0910-0485.

List of Subjects in 21 CFR Part 862

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
862 is amended as follows:

PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

0
1. The authority citation for 21 CFR part 862 continues to read as
follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Add Sec.  862.1373 to subpart B to read as follows:

Sec.  862.1373  Hemoglobin A1c test system.

    (a) Identification. A hemoglobin A1c test system is a device used
to measure the percentage concentration of hemoglobin A1c in blood.
Measurement of hemoglobin A1c is used as an aid in the diagnosis of
diabetes mellitus and as an aid in the identification of patients at
risk for developing diabetes mellitus.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The device must have initial and annual standardization
verification by a certifying glycohemoglobin standardization
organization deemed acceptable by FDA.
    (2) The premarket notification submission must include performance
testing to evaluate precision, accuracy, linearity, and interference,
including the following:
    (i) Performance testing of device precision must, at a minimum, use
blood samples with concentrations near 5.0 percent, 6.5 percent, 8.0
percent, and 12 percent hemoglobin A1c. This testing must evaluate
precision over a minimum of 20 days using at least three lots of the
device and three instruments, as applicable.
    (ii) Performance testing of device accuracy must include a minimum
of 120 blood samples that span the measuring interval of the device and
compare results of the new device to results of a standardized test
method. Results must demonstrate little or no bias versus the
standardized method.
    (iii) Total error of the new device must be evaluated using single
measurements by the new device compared to results of the standardized
test method, and this evaluation must demonstrate a total error less
than or equal to 6 percent.
    (iv) Performance testing must demonstrate that there is little to
no interference from common hemoglobin variants, including Hemoglobin
C, Hemoglobin D, Hemoglobin E, Hemoglobin A2, and Hemoglobin S.
    (3) When assay interference from Hemoglobin F or interference with
other hemoglobin variants with low frequency in the population is
observed, a warning statement must be placed in a black box and must
appear in all labeling material for these devices describing the
interference and any affected populations.

    Dated: August 19, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-20022 Filed 8-22-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: August 20, 2009 (Volume 74, Number 160)]
[Notices]
[Page 42062-42063]
[DOCID:fr20au09-22]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 637-064]

Public Utility District No. 1 Chelan County (PUD); Notice of
Application To Amend License and Soliciting Comments, Motions To
Intervene, and Protests

August 13, 2009.
    Take notice that the following application has been filed with the
Commission and is available for public inspection:
    a. Application Type: Amendment to License.
    b. Project No. 637-064.
    c. Date Filed: June 15, 2009.
    d. Applicant: Public Utility District No. 1 Chelan County (PUD).
    e. Name of Project: Lake Chelan Hydroelectric Project.
    f. Location: The project is located on the Chelan River in Chelan
County near the City of Chelan, Washington.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. Sec.  Sec.
791(a)-825(r).
    h. Applicant Contact: Michele Smith, Licensing and Compliance
Manager at P.O. Box 1231, Wenatchee, Washington. Phone:<PHONE_NUMBER>.
    i. FERC Contact: Any questions on this notice should be addressed
to Brian Romanek at<PHONE_NUMBER> or by e-mail:
<EMAIL_ADDRESS>

    Deadline for filing comments and/or motions: September 14, 2009.
    j. Deadline for filing motions to intervene and protests, comments,
and recommendations are due 30 days from the issuance date of this
notice. All documents (original and eight copies) should be filed with:
Secretary, Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.
    The Commission's Rules of Practice require all interveners filing
documents with the Commission to serve a copy of that document on each
person on the official service list for the project. Further, if an
intervener files comments or documents with the Commission relating to
the merits of an issue that may affect the responsibilities of a
particular resource agency, they must also serve a copy of the document
on that resource agency.
    k. Description of the Application: The PUD, licensee for the Lake
Chelan Hydroelectric Project, has filed a request for Commission
approval to amend the Chelan Riverwalk Park boundary and project
boundary by removing 0.26 acre of land. The land is located in the City
of Chelan (city) and is owned by the city. This proposal would be
consistent with the city's master plan and would accommodate the city's
planning effort to develop within the city and to redesign and improve
the entrance to the park.
    l. Location of the Application: This filing is available for review
at the Commission or may be viewed on the Commission's Web site at
http://www.ferc.gov, using the ``eLibrary'' link. Enter the docket
number excluding the last three digits in the docket number field to
access the document. You may also register online at http://
www.ferc.gov/docs-filing/esubscription.asp to be notified via e-mail of
new filings and issuances related to this or other pending projects.
For assistance, contact FERC Online Support at
<EMAIL_ADDRESS>or toll-free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>. A copy is also available for inspection and
reproduction at the address in item (h) above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene--Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Responsive Documents: Any filings must
bear in all capital letters the title ``COMMENTS'', ``PROTEST'', or
``MOTION TO INTERVENE'', as applicable, and the Project Number of the
particular application to which the filing refers. All documents
(original and eight copies) should be filed with: Secretary, Federal
Energy Regulatory Commission, 888 First Street, NE., Washington DC
20426. A copy of any motion to intervene must also be served upon each
representative of the Applicant specified in the particular
application.
    p. Agency Comments--Federal, State, and local agencies are invited
to file comments on the application. A copy of the application may be
obtained by agencies directly from the Applicant. If an agency does not
file comments within the time specified for filing comments, it will be
presumed to have no comments. One copy of an agency's comments must
also be sent to the Applicant's representatives.
    q. Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper. See, 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's Web site at http://www.ferc.gov
under the ``e-Filing'' link.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-19924 Filed 8-19-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 1 (Tuesday, January 3, 2012)]
[Notices]
[Pages 97-98]
[FR Doc No: 2011-33636]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC12-3-000]

Commission Information Collection Activities, Proposed Collection
(FERC-598); Comment Request; Extension

AGENCY: Federal Energy Regulatory Commission.

ACTION: Notice of Proposed Information Collection and Request for
Comments.

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

SUMMARY: In compliance with the requirements of Section 3506(c)(2)(a)
of the Paperwork Reduction Act of 1995 (Pub. L. 104-13), the Federal
Energy Regulatory Commission (FERC or Commission) is soliciting public
comment on the specific aspects of the information collection described
below.

DATES: Comments in consideration of the collection of information are
due March 5, 2012.

ADDRESSES: Comments may be filed either electronically (eFiled) or in
paper format, and should refer to Docket No. IC12-3-000. Documents must
be prepared in an acceptable filing format and in compliance with
Commission submission guidelines at: http://www.ferc.gov/help/submission-guide.asp. eFiling instructions are available at: http://www.ferc.gov/docs-filing/efiling.asp. First time users must follow
eRegister instructions at: http://www.ferc.gov/docs-filing/eregistration.asp, to establish a user name and password before
eFiling. The Commission will send an automatic acknowledgement to the
sender's email address upon receipt of eFiled comments. Commenters
making an eFiling should not make a paper filing. Commenters that are
not able to file electronically must send an original of their comments
to: Federal Energy Regulatory Commission, Secretary of the Commission,
888 First Street NE., Washington, DC 20426.
    Users interested in receiving automatic notification of activity in
this docket may do so through eSubscription at: http://www.ferc.gov/docs-filing/esubscription.asp. All comments and FERC issuances may be
viewed, printed or downloaded remotely through FERC's eLibrary at:
http://www.ferc.gov/docs-filing/elibrary.asp, by searching on Docket
No. IC12-3-000. For user assistance, contact FERC Online Support by
email at<EMAIL_ADDRESS>or by phone at:<PHONE_NUMBER>
(toll-free), or<PHONE_NUMBER> for TTY.

FOR FURTHER INFORMATION CONTACT: Ellen Brown may be reached by email at
<EMAIL_ADDRESS>telephone at<PHONE_NUMBER>, or by fax at (202)
273-0873.

SUPPLEMENTARY INFORMATION: The Commission uses the information
collected under the requirements of FERC-598, ``Self Certification for
Entities Seeking Exempt Wholesale Generator or Foreign Utility Company
Status'' (OMB Control No. 1902-0166), to implement the statutory
provisions of Title XII, subchapter F of the Energy Policy Act of 2005
(EPAct 2005).\1\
---------------------------------------------------------------------------

    \1\ Energy Policy Act of 2005, Public Law 109-58, 119 Stat. 594
(2005) (codified at 42 U.S.C. 16451, et seq.)
---------------------------------------------------------------------------

    EPAct 2005 repealed the Public Utility Holding Company Act (PUHCA)
of 1935 in its entirety, including section 32. This repeal enabled the
Commission to exempt wholesale generators from PUHCA 1935 on a case-by-
case basis. The Commission amended its regulations (in Order No. 667
\2\) to add procedures for self-certification by entities seeking
exempt wholesale generator (EWG) and foreign utility company (FUCO)
status. Moreover, Order No. 667 implemented the repeal of PUHCA 1935
and the supplementary enactment of PUHCA 2005. This self-certification
is similar to the process available to entities that seek qualifying
facility status.
---------------------------------------------------------------------------

    \2\ Repeal of the Public Utility Holding Company Act of 1935 and
Enactment of the Public Utility Holding Company Act of 2005, 70 FR.
75,592 (2005), FERC Statutes and Regulations ] 31,197 (2005) Order
on reh'g, 71 FR 28,446 (2006), FERC Statutes and Regulations ]
31,213 (2006), order on reh'g, 71 FR 42,750 (2006), FERC Statutes
and Regulations ] 31,224 (2006), order on reh'g, FERC ] 61,133
(2007).
---------------------------------------------------------------------------

    An EWG is a ``person engaged directly, or indirectly through one or
more affiliates * * *, and exclusively in the business of owning or
operating, or both owning and operating, all or part of one or more
eligible facilities and selling electric energy at wholesale.'' \3\ A
FUCO is a company that ``owns or operates facilities that are not
located in any state and that are used for the generation,
transmission, or distribution of electric energy for sale or the
distribution at retail of natural or manufactured gas for heat, light,
or power, if such company: (1) Derives no part of its income, directly
or indirectly, from the generation, transmission, or distribution of
electric energy for sale or the distribution at retail of natural or
manufactured gas for heat, light, or power, within the United States;
and (2) neither the company nor any of its subsidiary companies is a
public-utility company operating in the United States.'' \4\
---------------------------------------------------------------------------

    \3\ 18 CFR 366.1.
    \4\ 18 CFR 366.1.
---------------------------------------------------------------------------

    An exempt EWG or FUCO or its representative may file with the
Commission a notice of self certification demonstrating that it
satisfies the definition of exempt wholesale generator or foreign
utility company. In the case of EWGs, the person filing a notice of
self certification must also file a copy of the notice of self
certification with the state regulatory authority of the state in which
the facility is located and that person must also represent to the
Commission in its submission that it has filed a copy of the notice
with the appropriate state regulatory authority.\5\
---------------------------------------------------------------------------

    \5\ 18 CFR 366.7.
---------------------------------------------------------------------------

    A submission of the information is necessary for the Commission to
carry out its responsibilities under EPAct 2005.\6\ The Commission
implements its responsibilities through the Code of Federal Regulations
(CFR) Title 18 Part 366. These filing requirements are mandatory.
---------------------------------------------------------------------------

    \6\ 42 U.S.C. 16451 et seq.
---------------------------------------------------------------------------

    Action: The Commission is requesting a three-year extension of the
current expiration date with no changes to the existing collection. The
information filed with the Commission is mandatory.

    Burden Statement: The Commission estimates the Public Reporting
Burden for this collection as:

----------------------------------------------------------------------------------------------------------------
                                                                  Number of      Average burden    Total annual
              Number of respondents annually (1)                responses per      hours per       burden hours
                                                                respondent (2)    response (3)     (1)*(2)*(3)
----------------------------------------------------------------------------------------------------------------
102..........................................................               1                6              612
----------------------------------------------------------------------------------------------------------------

    The total annual cost of filing FERC-598 is: 612 hours/2080 \7\
hours x $142,372 \8\ per year = $41,890. The annual cost of filing
FERC-598 per respondent is $411. This cost estimate for respondents
includes salary and employee benefits and is based on the cost for
professional and clerical support within the Commission.
---------------------------------------------------------------------------

    \7\ Number of hours an employee works per year.
    \8\ Average annual salary per employee.
---------------------------------------------------------------------------

    The reporting burden includes the total time, effort, or financial
resources expended to generate, maintain, retain, disclose, or provide
the information including: (1) Reviewing instructions; (2) developing,
acquiring, installing, using technology and systems for the purposes of
collecting, validating, verifying, processing, maintaining, disclosing
and providing information; (3) adjusting the existing ways to comply
with any previously applicable filing instructions and requirements;
(4) training personnel to respond to a collection of information; (5)
searching data sources; (6) completing and reviewing the collection of
information; and (7) transmitting, or otherwise disclosing the
information.
    Comments are invited on: (1) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (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 those who are
to respond, including through the use of automated collection
techniques or other forms of information technology.

    Dated: December 23, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-33636 Filed 12-30-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 244 (Thursday, December 20, 2018)]
[Notices]
[Page 65392]
[FR Doc No: 2018-27775]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

Sunshine Act Meetings; Unified Carrier Registration Plan Board of
Directors

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of Unified Carrier Registration Plan Board of Directors
and Subcommittee Meetings.

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

TIME AND DATE: The meetings will occur on the following schedule and
will take place in the Eastern (Standard) Time Zone:

Monday, January 28, 2019

9:00 a.m.-9:50 a.m. Procedures Subcommittee
9:50 a.m.-10:45 a.m. Audit Subcommittee
11:00 a.m.-12:00 Noon Finance Subcommittee
1:30 p.m.-3:00 p.m. Registration System Subcommittee
3:15 p.m.-4:15 p.m. Industry Advisory Subcommittee
4:15 p.m.-5:00 p.m. Dispute Resolution Subcommittee

Tuesday, January 29, 2019

    The Unified Carrier Registration Plan Board of Directors meeting
will be held from 8:30 a.m. until noon.

PLACE: These meetings will be open to the public at the Embassy Suites,
Tampa Downtown Convention Center, 513 South Florida Ave., Tampa, FL
33602, and via conference call. Those not attending the meetings in
person may call toll-free; 1-866-210-1669, passcode 5253902#, to listen
and participate in the meetings.

STATUS: Open to the public.

MATTERS TO BE CONSIDERED: The Unified Carrier Registration Plan Board
of Directors will continue its work in developing and implementing the
Unified Carrier Registration Plan and Agreement and to that end, may
consider matters properly before the Board. An agenda for these
meetings will be available no later than 5:00 p.m. Eastern Standard
Time, January 18, 2019 at: https://ucrplan.org.

FOR FURTHER INFORMATION CONTACT: Mr. Avelino Gutierrez, Chair, Unified
Carrier Registration Board of Directors at<PHONE_NUMBER>.

    Issued on: December 11, 2018.
Larry W. Minor,
 Associate Administrator, Office of Policy, Federal Motor Carrier
Safety Administration.
[FR Doc. 2018-27775 Filed 12-18-18; 4:15 pm]
 BILLING CODE 4910-EX-P