[Federal Register Volume 88, Number 18 (Friday, January 27, 2023)]
[Notices]
[Page 5336]
[FR Doc No: 2023-01651]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL OP-OFA-054]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or https://www.epa.gov/nepa.

Weekly receipt of Environmental Impact Statements (EIS) Filed January
13, 2023 10 a.m. EST Through January 23, 2023 10 a.m. EST Pursuant to
40 CFR 1506.9.
    Notice: Section 309(a) of the Clean Air Act requires that EPA make
public its comments on EISs issued by other Federal agencies. EPA's
comment letters on EISs are available at: https://cdxapps.epa.gov/cdx-enepa-II/public/action/eis/search.

EIS No. 20230009, Draft, FERC, LA, CP2 LNG and CP Express Project,
Comment Period Ends: 03/13/2023, Contact: Office of External Affairs
866-208-3372.
EIS No. 20230011, Final, FERC, PA, Valley Connector Expansion Project,
Review Period Ends: 02/27/2023, Contact: Office of External Affairs
866-208-3372.
EIS No. 20230012, Draft, GSA, AZ, Expansion and Modernization of the
Raul Hector Castro Land Port of Entry and Proposed Commercial Land Port
of Entry in Douglas, Arizona, Comment Period Ends: 03/13/2023, Contact:
Osmahn Kadri<PHONE_NUMBER>.

    Dated: January 23, 2023.
Cindy S. Barger,
Director, NEPA Compliance Division, Office of Federal Activities.
[FR Doc. 2023-01651 Filed 1-26-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: March 16, 2009 (Volume 74, Number 49)]
[Notices]
[Page 11144-11146]
[DOCID:fr16mr09-104]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59546; File No. SR-CBOE-2009-016]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of Proposed
Rule Change To Modify the Hybrid Rule Pertaining to Orders Represented
in Open Outcry

March 10, 2009.
    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 March 6, 2009, the Chicago Board Options Exchange, Incorporated
(``Exchange'' or ``CBOE'') 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 Exchange. The Exchange filed the proposal as a ``non-
controversial'' proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \3\ and Rule 19b-4(f)(6) thereunder.\4\ 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.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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

    The Exchange proposes to make permanent the pilot program in Rule
6.45A(b) relating to the allocation of orders represented in open
outcry in equity option classes designated by the Exchange to be traded
on the CBOE Hybrid Trading System (``Hybrid''). The text of the
proposed rule change is available on the Exchange's Web site (http://
www.cboe.org/Legal), at the Exchange's Office of the Secretary and at
the Commission.

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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    In March 2005 the Commission approved revisions to CBOE Rule 6.45A
related to the introduction of Remote Market-Makers.\5\ Among other
things, Rule 6.45A(b), pertaining to the allocation of orders
represented in open outcry in equity options classes traded on Hybrid,
was amended to clarify that only in-crowd market participants would be
eligible to participate in open outcry trade allocations. In addition,
Rule 6.45A(b) was amended to limit the duration of paragraph (b) of
Rule 6.45A until September 14, 2005 to allow for an analysis of the
application of Section 11(a)(1) of the Securities Exchange Act of 1934
to trading conducted pursuant to paragraph 6.45A(b). The duration of
this paragraph was thereafter extended through March 31, 2009.\6\ The
Exchange now proposes to make paragraph (b) of Rule 6.45A permanent.
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 51366 (March 14,
2005), 70 FR 13217 (March 18, 2005) (SR-CBOE-2004-75).
    \6\ See Securities Exchange Act Release Nos. 52423 (September
14, 2005), 70 FR 55194 (September 20, 2005) (extension through
December 14, 2005), 52957 (December 15, 2005), 70 FR 76085 (December
22, 2005) (extension through March 14, 2006), 53524 (March 21,
2006), 71 FR 15235 (March 27, 2006) (SR-CBOE-2006-22) (extension
through July 14, 2006), 54164 (July 17, 2006), 71 FR 42143 (July 25,
2006) (SR-CBOE-2006-60) (extension through October 31, 2006), 54680
(November 1, 2006), 71 FR 65554 (November 8, 2006) (SR-CBOE-2006-86)
(extension through January 31, 2007), 55219 (February 1, 2007), 72
FR 6305 (February 9, 2007) (SR-CBOE-2007-10) (extension through
April 30, 2007), 55676 (April 27, 2007), 72 FR 25348 (May 4, 2007)
(SR-CBOE-2007-40) (extension through July 31, 2007), 56177 (August
1, 2007), 72 FR 44194 (August 7, 2007) (SR-CBOE-2007-89) (extension
through December 31, 2007), 57054 (December 27, 2007), 73 FR 899
(January 4, 2008) (SR-CBOE-2007-149) (extension through June 30,
2008) and 58048 (June 27, 2008) 73 FR 39355 (July 9, 2008) (SR-CBOE-
2008-65) (extension through December 31, 2008), 73 FR 79956
(December 30, 2008) (SR-CBOE-2008-126) (extension through March 31,
2009).
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    In connection with the elimination of subparagraph (iii) of Rule
6.45A(b) (elimination of the language providing that the effectiveness
of 6.45A(b) is temporary), the Exchange will issue a regulatory
circular providing members guidance on the application of Section
11(a)(1) to trading on the Hybrid System.\7\ The regulatory circular is
attached as Exhibit 5 to the 19b-4 filing. The circular describes
Section 11(a)(1) and certain of the exemptions to Section 11(a)(1) as
well as the application of the ``(G) Order'' exemption and the ``Effect
vs. Execute'' exemption (Rule 11a2-2(T)) to trading on the Hybrid
System.
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    \7\ In order to effect proprietary transactions on the floor of
the Exchange, in addition to complying with the requirements of CBOE
Rule 6.45A(b), members are also required to comply with the
requirements of Section 11(a)(1) of the Securities Exchange Act of
1934 (the ``Act''), 15 U.S.C. 78k(a)(1), or qualify for an
exemption. Section 11(a)(1) of the Act restricts any member of a
national securities exchange from effecting any transaction on such
exchange for (i) the member's own account, (ii) the account of a
person associated with the member, or (iii) an account over which
the member or a person associated with the member exercises
discretion, unless a specific exemption is available. The Exchange
has issued regulatory circulars to members informing them of the
applicability of these Section 11(a)(1) requirements each time the
duration of the Rule was extended. See CBOE Regulatory Circulars
RG05-103 (November 2, 2005), RG06-001 (January 3, 2006), RG06-34
(April 7, 2006), RG06-79 (July 31, 2006), RG06-115 (November 8,
2006), RG07-21 (February 8, 2007), RG07-53 (May 17, 2007), RG07-88
(August 15, 2007), RG08-08 (January 9, 2008) and RG08-83 (July 10,
2008).
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2. Statutory Basis
    Making the rule permanent will allow the Exchange to operate under
the existing allocation parameters for orders represented in open
outcry in Hybrid on an uninterrupted basis. Accordingly, CBOE believes
the proposed rule change is consistent with the Act \8\ and the rules
and regulations under the Act applicable to a national securities
exchange and, in particular, the requirements of Section 6(b) of the
Act.\9\ Specifically, the Exchange believes the proposed rule change is
consistent with the Section 6(b)(5) \10\ requirements that the rules of
an exchange be designed to promote just and equitable principles of
trade, to prevent fraudulent and manipulative acts and, in general, to
protect investors and the public interest.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78a et seq.
    \9\ 15 U.S.C. 78(f)(b).
    \10\ 15 U.S.C. 78(f)(b)(5).
---------------------------------------------------------------------------

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

    CBOE 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.

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

    The Exchange neither solicited nor received comments on the
proposal.

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

    Because the foregoing rule 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 if consistent with the protection of investors
and the public interest, the proposed rule change has become effective
pursuant to Section 19(b)(3)(A) of the Act \11\ and Rule 19b-4(f)(6)
thereunder.\12\
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires that a self-regulatory organization submit to the
Commission written notice of its intent to file the proposed rule
change, along with a brief description and text of the proposed rule
change, at least five business days prior to the date of filing of
the proposed rule change, or such shorter time as designated by the
Commission. The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    The Exchange has asked the Commission to waive the 30-day operative
delay to the extent necessary. The Commission believes that waiver of

the operative delay is consistent with the protection of investors and
the public interest because such waiver will enable CBOE Rule 6.45A(b)
to continue without interruption. The Commission notes that the rule
has been in effect on a pilot basis since March 14, 2005 \13\ and
therefore does not raise any novel or significant regulatory issues.
Therefore, the Commission designates the proposed rule change as
operative upon filing.\14\
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    \13\ See infra notes 5 and 6.
    \14\ For purposes only of waiving the operative date of this
proposal, the Commission has considered the 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 such proposed rule
change, the Commission may summarily abrogate 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.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-CBOE-2009-016 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CBOE-2009-016. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the CBOE. 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-CBOE-2009-016 and should be
submitted on or before April 6, 2009.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
---------------------------------------------------------------------------

    \15\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E9-5572 Filed 3-13-09; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register: January 19, 2007 (Volume 72, Number 12)]
[Notices]
[Page 2504]
[DOCID:fr19ja07-37]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. QF06-273-000]

City of Rocky Mount, NC; Notice of Filing of Self-Certification
of Qualifying Status of Cogeneration Facility

January 11, 2007.
    Take notice that on June 9, 2006, as completed on December 22,
2006, the City of Rocky Mount, NC filed a notice of self-certification
of qualifying status of a cogeneration facility, pursuant to 18 CFR
Sec.  292.207(a) of the Commission's Regulations.
    This qualifying cogeneration facility consists of a total of 2900
kW of packaged diesel engine generator sets operating on No. 2 fuel
oil. The packages are set on concrete pads. The units are self-
contained, including all necessary switchgear and controls. The
electricity is generated at 480 V, 3 phase, 60 Hz. The facility is
located at 6792 Corporate Parkway, Rocky Mount, North Carolina 27804.
    This qualifying facility interconnects with the City of Rocky
Mount's electric distribution system. The facility will provide standby
power and occasionally supplementary power to The Cheesecake Factory.
    A notice of self-certification does not institute a proceeding
regarding qualifying facility status; a notice of self-certification
provides notice that the entity making filing has determined the
Facility meets the applicable criteria to be a qualifying facility. Any
person seeking to challenge such qualifying facility status may do so
by filing a motion pursuant to 18 CFR 292.207(d)(iii).
    This filing is accessible online at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E7-660 Filed 1-18-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 195 (Tuesday, October 8, 2019)]
[Notices]
[Pages 53788-53791]
[FR Doc No: 2019-21881]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-87200; File No. SR-CboeEDGX-2019-012]

Self-Regulatory Organizations; Cboe EDGX Exchange, Inc.; Order
Granting Approval of a Proposed Rule Change, as Modified by Amendment
No. 1, To Introduce Retail Priority

October 2, 2019

I. Introduction

    On March 18, 2019, Cboe EDGX Exchange, Inc. (``Exchange'' or
``EDGX'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to introduce order book priority for equity orders
submitted on behalf of retail investors. The proposed rule change was
published for comment in the Federal Register on April 5, 2019.\3\ The
Commission received five comment letters from four commenters on the
proposed rule change.\4\ On May 16,

2019, the Commission extended the time period within which to approve,
disapprove the proposed rule change, or institute proceedings to
determine whether to approve or disapprove the proposed rule change to
July 4, 2019.\5\ On June 18, 2019, the Exchange filed Amendment No. 1
to the proposed rule change, which replaced and superseded the proposed
rule change as originally filed.\6\ On July 2, 2019, the Commission
published Amendment No. 1 for notice and comment and instituted
proceedings to under Section 19(b)(2)(B) of the Act \7\ to determine
whether to approve or disapprove the proposed rule change, as modified
by Amendment No. 1.\8\ On August 19, 2019 the Exchange submitted a
response to comments.\9\ This order approves the proposed rule change,
as modified by Amendment No. 1.

II. Description of the Proposed Rule Change, as Modified by Amendment
No. 1
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 85482 (April 2,
2019), 84 FR 13729 (``Notice'').
    \4\ See letters to Vanessa Countryman, Acting Secretary,
Commission, from Sean Paylor, Trader, AJO, L.P., dated April 25,
2019 and September 16, 2019 (``AJO Letter 1'' and ``AJO Letter 2'',
respectively); Joseph Saluzzi and Sal Arnuk, Partners, Themis
Trading LLC, dated May 8, 2019 (``Themis Letter''); T. Sean Bennett,
Principal Associate General Counsel, Nasdaq, dated May 9, 2019
(``Nasdaq Letter''); letter to Eduardo A. Aleman, Deputy Secretary,
Commission from Stephen John Berger, Global Heady of Government &
Regulatory Policy, Citadel Securities, dated April 26, 2019
(``Citadel Letter''). All comments received by the Commission on the
proposed rule change are available at: https://www.sec.gov/comments/sr-cboeedgx-2019-012/srcboeedgx2019012.htm.
    \5\ See Securities Exchange Act Release No. 85879, 84 FR 23591
(May 16, 2019).
    \6\ Amendment No. 1 modified the proposed rule change by: (1)
Adding a proposed definition of ``Retail Priority Order''; (2)
applying the proposed enhanced priority to ``Retail Priority
Orders'' instead of ``Retail Orders''; (3) imposing certain
requirements on Retail Member Organizations that enter ``Retail
Priority Orders''; (4) removing the proposed requirement that
``Retail Orders'' must be identified as such on the EDGX Book Feed;
and (5) requiring that all ``Retail Priority Orders'' be identified
as such on the EDGX Book Feed. To promote transparency of its
proposed amendment, when EDGX filed Amendment No. 1 with the
Commission, it also submitted Amendment No. 1 as a comment letter to
the file, which the Commission posted on its website and placed in
the public comment file for SR-CboeEDGX-2019-012 (available at
https://www.sec.gov/comments/sr-cboeedgx-2019-012/srcboeedgx2019012.htm).
    \7\ 15 U.S.C. 78s(b)(s)(B).
    \8\ See Securities Exchange Act Release No. 86280 (July 2,
2019), 84 FR 32808 (July 9, 2019) (``Notice of Amendment No. 1'').
Specifically, the Commission instituted proceedings to allow for
additional analysis of the proposed rule change's consistency with
Section 6(b)(5) of the Act, which requires, among other things, that
the rules of a national securities exchange be ``designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade,'' and ``to protect investors and the
public interest.'' See id. at 32815 (citing 15 U.S.C. 78f(b)(5)).
    \9\ See Letter to Vanessa Countryman, Secretary, Commission,
from Adrian Griffiths, Assistant General Counsel, EDGX, dated August
19, 2019 (``EDGX Response Letter'').
---------------------------------------------------------------------------

    EDGX proposes to introduce order book priority for Retail Priority
Orders. In addition, EDGX proposes to require that Retail Priority
Orders always be designated as such on the EDGX Book Feed.\10\
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    \10\ See EDGX Rule 13.8.
---------------------------------------------------------------------------

A. Background

    EDGX operates based on price/display/time priority, similar to many
other equities and options exchanges.\11\ Under this framework, a
better priced order maintains priority over an order at a worse price.
At a particular price, the first Displayed \12\ order resting on the
EDGX Book \13\ at a particular price has priority over the next order
and so on based on the time of order entry. Non-Displayed \14\ orders
at that price are further categorized into a number of priority bands,
with orders within each priority band prioritized again based on the
time of order entry.
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    \11\ See EDGX Rule 11.9.
    \12\ ``Displayed'' is an instruction the User may attach to an
order stating that the order is to be displayed by the System on the
EDGX Book. See EDGX Rule 11.6(e)(1).
    \13\ ``EDGX Book'' means the System's electronic file of orders.
See EDGX Rule 1.5(d).
    \14\ ``Non-Displayed'' is an instruction the User may attach to
an order stating that the order is not to be displayed by the System
on the EDGX Book. See EDGX Rule 11.6(e)(2).
---------------------------------------------------------------------------

    Under EDGX rules, a ``Retail Order'' is defined as an agency or
riskless principal order that meets the criteria of FINRA Rule 5320.03
\15\ that originates from a natural person and is submitted to the
Exchange by a Retail Member Organization, provided that no change is
made to the terms of the order with respect to price or side of market
and the order does not originate from a trading algorithm or any other
computerized methodology.\16\ A ``Retail Member Organization''
(``RMO'') is a Member (or a division thereof) that has been approved by
the Exchange under EDGX Rule 11.21 to submit Retail Orders. EDGX Rule
11.21(b) describes the qualification and application process for
becoming a Retail Member Organization; generally, any member may
qualify as a Retail Member Organization if it conducts a retail
business or routes retail orders on behalf of another broker-dealer.
---------------------------------------------------------------------------

    \15\ FINRA Rule 5320.03 clarifies that an Retail Member
Organization may enter Retail Orders on a riskless principal basis,
provided that (i) the entry of such riskless principal orders meet
the requirements of FINRA Rule 5320.03, including that the Retail
Member Organization maintains supervisory systems to reconstruct, in
a time sequenced manner, all Retail Orders that are entered on a
riskless principal basis; and (ii) the Retail Member Organization
submits a report, contemporaneously with the execution of the
facilitated order, that identifies the trade as riskless principal.
    \16\ Retail Member Organizations will only be able to designate
their orders as Retail Orders on either an order-by-order basis
using FIX ports or by designating certain of their FIX ports at the
Exchange as ``Retail Order Ports.'' Unless otherwise instructed by
the Retail Member Organization, a Retail Order will be identified as
Retail when routed to an away Trading Center. See EDGX Rule
11.21(d).
---------------------------------------------------------------------------

B. Retail Order Priority

    The Exchange proposes to amend EDGX Rule 11.9 to introduce order
book priority benefits exclusively to Retail Orders that are entered on
behalf of retail investors that enter a limited number of equity orders
each trading day. Such orders are being defined by the Exchange as a
``Retail Priority Order.'' \17\ To qualify as a Retail Priority Order,
the order must be a Retail Order, as defined in EDGX Rule 11.21(a)(2),
that is entered on behalf of a person that does not place more than 390
equity orders per day on average during a calendar month for its own
beneficial account(s).\18\ All orders entered on behalf of a retail
customer would be counted to determine whether a customer's Retail
Orders could be identified as Retail Priority Orders. This would
therefore include both orders routed to other exchanges and orders that
are not entered as Retail Orders (e.g., because the price of such
orders is modified by a broker-dealer algorithm).\19\
---------------------------------------------------------------------------

    \17\ See proposed EDGX Rule 11.9, Interpretations and Policies
.01.
    \18\ Id. The Exchange states that 390 orders per day represents
one order entered each minute during regular trading hours--i.e.,
from 9:30 a.m. ET to 4:00 p.m. ET. See supra note 8, Notice of
Amendment No. 1 at 32809.
    \19\ The Exchange also addresses how to count parent/child
orders and cancel/replace orders when determining whether the 390
order per day threshold has been exceeded. As proposed, parent/child
orders would be counted as a single order--i.e., a ``parent'' order
that is broken into multiple ``child'' orders by a broker or dealer,
or by an algorithm housed at a broker or dealer or by an algorithm
licensed from a broker or dealer, but which is housed with the
customer, would count as one order even if the ``child'' orders are
routed across multiple exchanges. In addition, with one exception
for parent/child orders, any order that cancels and replaces an
existing order would count as a separate order. An order that
cancels and replaces any ``child'' order resulting from a ``parent''
order that is broken into multiple ``child'' orders, would not count
as a new order. See supra note 8 at 32809-10.
---------------------------------------------------------------------------

    Pursuant to the proposal, RMOs that enter Retail Priority Orders
would be required to have reasonable policies and procedures in place
to ensure that such orders are appropriately represented on

the Exchange.\20\ Such policies and procedures should provide for a
review of retail customers' activity on at least a quarterly basis.\21\
Retail Orders for any retail customer that had an average of more than
390 orders per day during any month of a calendar quarter would not be
eligible to be entered as Retail Priority Orders for the next calendar
quarter.\22\ RMOs would be required to conduct a quarterly review and
make any appropriate changes to the way in which they are representing
orders within five business days after the end of each calendar
quarter.\23\ While RMOs would only be required to review their accounts
on a quarterly basis, if during a quarter the Exchange identifies a
retail customer for which orders are being represented as Retail
Priority Orders but that has averaged more than 390 orders per day
during a month, the Exchange would notify the RMO, and the RMO would be
required to change the manner in which it is representing the retail
customer's orders within five business days.\24\ The Exchange notes
that the proposed provisions relating to the obligations of RMOs are
similar to the obligations applicable to the Priority Customer
designation in the options industry.\25\
---------------------------------------------------------------------------

    \20\ See proposed EDGX Rule 11.9, Interpretations and Policies
.02.
    \21\ Id.
    \22\ See proposed EDGX Rule 11.9, Interpretations and Policies
.02(a).
    \23\ Id.
    \24\ See proposed EDGX Rule 11.9, Interpretations and Policies
.02(b).
    \25\ See Notice of Amendment No. 1, supra note 8, at 32810.
---------------------------------------------------------------------------

    As described more fully in Amendment No. 1, that portion of a
Retail Order with a Displayed instruction would be given allocation
priority ahead of all other available interest on the EDGX Book.\26\
This would be true of both orders executed pursuant to the regular
priority bands described in EDGX Rule 11.9(a)(2)(A), and orders priced
at the midpoint of the NBBO pursuant to EDGX Rule 11.9(a)(2)(B) where
Retail Priority Orders subject to Display-Price Sliding would have
priority ahead of limit orders entered with such an instruction as well
as any other orders resting at the midpoint of the NBBO. In addition,
since Reserve Orders contain a Displayed instruction but include both
Displayed and Non-Displayed shares, the Reserve Quantity of Retail
Priority Orders would be given priority ahead of the Reserve Quantity
of other limit orders on the EDGX Book. Retail Priority Orders that are
not willing to be displayed, or are only willing to be displayed at a
less aggressive price than the execution price, would not receive any
special priority. This priority for Retail Orders would be in place
during all trading sessions and would be available to orders entered
for participation in the Exchange's opening process and the re-opening
process following a halt.\27\
---------------------------------------------------------------------------

    \26\ Id.
    \27\ Id.
---------------------------------------------------------------------------

C. Retail Order Attribution

    Currently, RMOs that submit Retail Orders to the Exchange have the
option of identifying Retail Orders as such on the EDGX Book Feed.\28\
In the instant proposal, EDGX is requiring that Retail Priority Orders
always be designated as such on the EDGX Book Feed.\29\ Retail Orders
that are not designated as Retail Priority Orders could continue to be
attributed or not, at the discretion of the RMO.
---------------------------------------------------------------------------

    \28\ See EDGX Rule 11.21(f).
    \29\ See proposed EDGX Rule 11.21(f).
---------------------------------------------------------------------------

III. Comment Summary

    The Commission received five comment letters from four commenters
on the proposed rule change.\30\ All four commenters express concerns
about the proposed rule change, as initially proposed. Following the
publication of Amendment No. 1, the one of the four commenters
submitted another comment letter that expresses continuing concerns
about the proposed rule change, as amended.
---------------------------------------------------------------------------

    \30\ See supra note 4.
---------------------------------------------------------------------------

    Two commenters expressed concerns about the Exchange's initial
definition of ``Retail Order,'' both noting that the definition does
not adequately distinguish retail investors' orders from active
professional traders' orders, potentially resulting in the granting of
queue priority to professional traders.\31\ One commenter stated that
this would impair market quality, undermine the intended benefits for
bona fide retail investors, adversely affect institutional investor
fill rates, and impair the provision of displayed liquidity.\32\ This
commenter also suggested that active professional orders could more
easily implement spread capture models by simply trading back-and-forth
at the top of the queue.\33\ This commenter further suggested that the
Exchange should amend the definition of ``Retail Order'' and noted that
the options markets use a definition of ``professional customer'' to
distinguish them from retail customers.\34\ The other commenter
expressed concern that the Exchange has not addressed issues with
enforcing the Retail Order definition, by, among other things, failing
to adequately consider investor protection issues raised by the
proposed rule change.\35\ This commenter stated that the Exchange does
not provide any detail on how it would protect investors from the
misuse of retail priority and believes that the Exchange must provide
more detail on how it will protect investors.\36\
---------------------------------------------------------------------------

    \31\ See Citadel Letter, supra note 4, at 1-2; Nasdaq Letter,
supra note 4, at 1.
    \32\ See Citadel Letter, supra note 4, at 1-2.
    \33\ See Citadel Letter, supra note 4, at 2.
    \34\ See Citadel Letter, supra note 4, at 2.
    \35\ See Nasdaq Letter, supra note 4, at 1.
    \36\ See Nasdaq Letter, supra note 4, at 2.
---------------------------------------------------------------------------

    One commenter stated that the initial rule proposal is ``the
quintessential example of customer discrimination.'' \37\ This
commenter noted that the initial rule proposal is purportedly designed
with ordinary investors in mind, but the Retail Order designation can
only be utilized by a minority of ordinary investors, noting that
pension funds and institutional managers trading on behalf of
``ordinary investors'' would not receive the benefit of order
priority.\38\ This commenter maintained that the proposed order type
discriminates against a significant portion of ordinary investors as
initially proposed and even as amended.\39\
---------------------------------------------------------------------------

    \37\ See AJO Letter 1, supra note 4, at 2-3.
    \38\ See AJO Letter 1, supra note 4, at 1; see also AJO Letter
2, supra note 4, at 2.
    \39\ See AJO Letter 1, supra note 4, at 4; see also AJO Letter
2, supra note 4, at 2, 4.
---------------------------------------------------------------------------

    Three commenters expressed concerns relating to the requirement, as
set forth in the initial proposal, that Retail Orders will be
designated as such on the EDGX Book Feed.\40\ Two of these commenters
stated that only those market participants who purchase the appropriate
EDGX proprietary data feeds will have access to this information, and
identifying Retail Orders will allow these market participants to
identify institutional orders.\41\ One commenter suggested that this
places these market participants at an ``informational advantage over
others.'' \42\ Another commenter stated that such order information
leakage will result in increased adverse selection for institutional
investors and also believes that the unique data will make the relevant
EDGX data feed more valuable and likely encourages consumers of those
data feeds to continue purchasing these data feeds.\43\ One commenter
noted that institutional investors have no ability to opt out, unlike
Retail Member Organizations that could

choose to submit orders that would qualify as Retail Orders if so
designated, but are submitted without applying such designation.\44\
---------------------------------------------------------------------------

    \40\ See Nasdaq Letter, supra note 4, at 2-3; AJO Letter 1,
supra note 4 at 2; Themis Letter, supra note 4 at 2.
    \41\ See AJO Letter 1, supra note 4, at 2; Themis Letter, supra
note 4, at 1-2.
    \42\ See AJO Letter 1, supra note 4, at 2.
    \43\ See Themis Letter, supra note 4, at 2.
    \44\ See AJO Letter 1, supra note 4, at 3.
---------------------------------------------------------------------------

    In its response letter, EDGX states that the proposal, as modified
by Amendment No. 1, limits retail priority to only a subset of Retail
Orders (i.e., Retail Priority Orders) and therefore renders the
information leakage question ``moot'' because the RMO would retain the
choice of whether or not to attribute the order.\45\ EDGX also notes
that because only a subset of Retail Orders would be required to be
attributed on the EDGX Book Feed, market participants would not be able
to infer that any non-attributable order is an institutional order.\46\
---------------------------------------------------------------------------

    \45\ See EDGX Response Letter, supra note 9 at 2. One commenter
maintained that there is still ``information leakage'' which will
permit institutional orders to be identified after the Exchange
amended the original proposal to remove the requirement that all
retail orders be attributed. See AJO Letter 2, supra note 4, at 2.
    \46\ Id.
---------------------------------------------------------------------------

    EDGX responds to the concern raised by a commenter regarding the
possible abuse of retail order priority by noting that the Exchange has
limited retail priority to orders entered on behalf of investors that
enter only a limited number of equity order each trading day, and
asserting that the Exchange has an effective regulatory program to
address member compliance with the retail priority order
requirements.\47\ EDGX also states that its Regulatory Division intends
to implement enhancements to its current regulatory program designed to
oversee RMO compliance with the retail priority rules to ensure that
orders entered with a priority attribute are appropriately marked.\48\
---------------------------------------------------------------------------

    \47\ See EDGX Response Letter, supra note 9 at 3.
    \48\ Id.
---------------------------------------------------------------------------

IV. Discussion and Commission Findings

    After careful review, the Commission finds that the proposed rule
change, as modified by Amendment No.1, is consistent with the
requirements of the Act and the rules and regulations thereunder
applicable to a national securities exchange.\49\ In particular, the
Commission finds that the proposed rule change, as modified by
Amendment No. 1, is consistent with Section 6(b)(5) of the Act,\50\
which requires, among other things, that the Exchange's rules be
designed to prevent fraudulent and manipulative acts and practices, 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, and that the rules are not designed to permit unfair
discrimination between customers, issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \49\ In approving this proposed rule change the Commission notes
that it has considered the proposed rule's impact on efficiency,
competition, and capital formation. See 15 U.S.C. 78c(f).
    \50\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Commission believes that the Exchange's proposal represents a
reasonable effort to enhance the ability of bona fide retail trading
interest to compete for executions with orders entered by other market
participants that may be better equipped to optimize their place in the
intermarket queue.\51\ Under the proposal, bona fide retail orders will
be in a position to compete for executions as long as they are
qualified as such and attributed as such, which should lead to
increased or more immediate execution opportunities on the Exchange for
resting Retail Priority Orders. Furthermore, in order to qualify as a
Retail Priority Order, the Exchange is requiring RMOs that enter Retail
Priority Orders to have reasonable policies and procedures in place to
ensure that such order are appropriately represented on the
Exchange.\52\ RMOs also must conduct a quarterly review of retail
customers' activity and make any appropriate changes to the way in
which the RMO is representing orders within five business days after
the end of each calendar quarter. In addition, if the Exchange
identifies a retail customer whose orders are being represented by an
RMO that exceed 390 order per day during a month, the Exchange will
notify the RMO and the RMO will be required to change the manner in
which it is representing the retail customer's orders within five
business days. The Commission also notes that the Exchange's Regulatory
Division intends to implement enhancements to its current regulatory
program designed to oversee RMO compliance with the retail priority
rules to ensure that orders entered with a priority attribute are
appropriate marked.\53\
---------------------------------------------------------------------------

    \51\ Under existing EDGX Rules, to qualify as a RMO, Members
must submit to the Exchange, among other things, an attestation that
substantially all orders submitted as Retail Orders will qualify as
such, and must have written policies and procedures that are
reasonably designed to ensure that the Member will only designate
orders as Retail Order if all the requirements of a Retail Order are
met. In addition, if the Member represents Retail Orders from
another broker-dealer customer, that Member's supervisory procedures
must be reasonably designed to assure that the orders it receives
from such broker dealer customer that it designates as Retail Orders
meet the definition of a Retail Order. Such Members also must (i)
obtain an annual written representation from each broker-dealer
customer that sends it orders to be designated as Retail Orders that
entry of such orders as Retail Orders will be in compliance with the
requirements specified by the Exchange, and (ii) monitor whether its
broker-dealer customer's Retail Order flow continues to meet the
applicable requirements. See generally EDGX Rule 11.21(b).
    \52\ See proposed EDGX Rule 11.9, Interpretations and Policies
.02.
    \53\ Id.
---------------------------------------------------------------------------

    For the foregoing reasons, the Commission finds that the proposed
rule change, as modified by Amendment No. 1, is consistent with Section
6(b)(5) of the Act \54\ and the rules and regulations thereunder
applicable to a national securities exchange.
---------------------------------------------------------------------------

    \54\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\55\ that the proposed rule change, as modified by Amendment No. 1
(SR-CboeEDGX-2019-012) be, and hereby is, approved.
---------------------------------------------------------------------------

    \55\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\56\
---------------------------------------------------------------------------

    \56\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-21881 Filed 10-7-19; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: June 4, 2008 (Volume 73, Number 108)]
[Notices]
[Page 31856]
[DOCID:fr04jn08-48]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM07-16-000]

Filing Via the Internet; Notice of Discontinuation of Text
Version of Commission Issuances

May 28, 2008.
    Pursuant to Commission Order No. 703, issued November 15, 2007,\1\
and effective December 24, 2007, the Commission will discontinue
creating Text files (.TXT file extension) for new Commission
issuances.\2\ The Commission proposed in this proceeding to eliminate
the Text versions of issuances and received no comments.
---------------------------------------------------------------------------

    \1\ Filing Via the Internet, Order No. 703, 72 FR 65,659
(November 23, 2007), FERC Stats. & Regs. ] 61,171] 31,259 (2007)
(Order No. 703).
    \2\ The Text versions of previous Commission issuances will
remain available through the eLibrary system.
---------------------------------------------------------------------------

    The Commission will continue to make issuances available in the
native format--primarily Microsoft Word for issuances--and will
continue to create a PDF (Portable Document Format) version.\3\
---------------------------------------------------------------------------

    \3\ The PDF version is created from the native file on a `best
efforts' basis for Commission issuances and submittals to the
agency.
---------------------------------------------------------------------------

    The Commission began creating Text versions of its issuances nearly
20 years ago when the public accessed documents through either paper
copies or an electronic bulletin board using a dial-up connection. Text
files made agency issuances accessible to the public in an open format
without the need to purchase proprietary software. With today's
Internet access and the availability of viewers for various file
formats, the utility of the Text version is greatly diminished. In
addition, other agencies generally do not create Text versions of
issuances.
    This implementation action is effective immediately.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-12365 Filed 6-3-08; 8:45 am]

BILLING CODE 6717-01-P


Inputs to the Solvent Extraction for Vegetable Oil Production Residual Risk HEM Modeling in Support of the Risk and Technology Review, September 2017
Contains the Modeling Inputs used to support the Risk and Technology Review and includes the following files:

VOP_HEM_Source_ID_Xwalk.xlsx (converted from Microsoft Access Format)
VOP_Actual_Acute_HEM_Inputs_EmisLoc_Grp1_20170726.xlsx
VOP_Actual_Acute_HEM_Inputs_VOP_FacList_Grp1_20170726.xlsx
VOP_Actual_Acute_HEM_Inputs_VOP_HAPEmis_Grp1_20170726.xlsx
VOP_Allowable_HEM_Inputs_VOP_Allow_EmisLoc_Grp1_20170726.xlsx
VOP_Allowable_HEM_Inputs_VOP_Allow_FacList_Grp1_20170726.xlsx
VOP_Allowable_HEM_Inputs_VOP_Allow_HAPEmis_Grp1_20170726.xlsx
VOP_Whole_Facility_VOP_whole_emisloc_new_facid_20190204.xlsx
VOP_Whole_Facility_VOP_whole_FacList_Grp1_20170726.xlsx
VOP_Whole_Facility_VOP_whole_hapemis_new_facid.xlsx


The specific level in the 1 5 range is dependent on the level at which the sample will be spiked. If the sample will be spiked at 2 times the background concentration of mercury, the regulatory compliance limit would need to be greater than 2 times the background concentration in order for the sample to be spiked at the regulatory compliance limit rather than at 2 times the background concentration.

If two analytical batches of 20 or fewer samples are run in the same day, must there be a total of 6 bubbler blanks, 2 OPRs, and 2 QCSs ?

No, there must be 3 bubbler blanks, 2 OPRs ( one at the beginning and one at the end) and a QCS associated with each batch, as required by Section 9.1.7 of the Method.

What frequency is required for the OPR ?

The OPR must be run at the beginning and end of each batch of 20 or fewer samples. If there is only one sample in the batch, an OPR must be run before and after the sample. See Section 9.5.1 of Method 1631. The purpose of requiring an OPR before and after the batch is to assure that the analytical system remains in calibration during the period that samples are run. The OPR at the end of one batch of samples can serve as the OPR at the beginning of the following batch of samples, so long as the 12 hour shift for the batch ( Method 1613B, Section 9.1.7) is not exceeded.

Laboratories are not always in contact with sampling teams. Why should we have to communicate that sampling precision is inadequate, as stated in Section 9.7 of the Method?

Section 9.7 of the method states that the laboratory may be required to analyze field duplicates if needed for specific program requirements. It also states that, when these are analyzed, the relative percent difference ( RPD) between field duplicates should be < 20% and that the laboratory should notify the sampling team if the RPD exceeds 20%. The words " should" in Section 9.7 convey that the action is recommended and is not required. The reason for the suggestion to communicate inadequate sampling precision to the sampling team was to alert the team that samples were not being collected precisely. This would allow the team to study its collection activities and attempt to determine why duplicate samples either were not collected correctly or resulted in different levels of mercury. Guidance  EPA Method 1631, March 2001 Guidance  Method 1631 5 15 Miscellaneous Questions How much should I be concerned about contamination from the bromine monochloride ( BrCl) and other reagents ?

Method 1631 requires analysis of at least one reagent blank ( with monthly verification in triplicate) for each new batch of reagents. The degree of concern is based on the level of mercury to be measured and on the amount of reagent required for complete oxidation. The amount of reagent used depends on the matrix being analyzed ( for example, samples that are high in organic material may require additional BrCl). The way in which you can make sure that any reagent used in the analysis will not contaminate a sample is to test that reagent using the reagent blank procedure in Section 9.4.2 of Method 1631. We suggest that laboratories test the reagents daily. If a method blank is run with each batch, the method blank can serve this purpose ( see the subsection on the method blank under the question " Is the bubbler blank the same as a laboratory ( method) blank?")

How safe is bromine monochloride ? It seems dangerous to us.

BrCl is dangerous, as are the hot acid vat and the acids suggested for use in labware cleaning in Method 1631. Precautions for handling these materials are given in Section 5.0 and Section 7.0 and are further noted in various sections throughout the Method. Laboratory personnel should be trained in safe handling of these reagents and materials. See Section 5.0 ( Safety) in Method 1631.

How do I know when enough BrCl has been added to an opaque sample ?

Method 1631 requires the addition of 0.5 mL BrCl solution to clear samples and 1.0 mL BrCl solution to brown or turbid samples. There are matrices, particularly those with high organic content, that may require additional BrCl, elevated temperatures, or photo oxidation. Method 1631 requires addition of BrCl ( or complete oxidation) until a yellow color persists or until starch iodide paper indicates the presence of residual BrCl oxidizer ( see Section 11.1.1 of Method 1631).

Method 1631 uses calibration factors and the relative standard deviation of calibration factors for establishing calibration linearity. Nearly all other metals methods use linear regression. Why is Method 1631 different ?

The calibration factor approach is the simplest form of weighted regression that we have been able to devise. It assumes that a straight line through the origin is most representative for most instruments and analytical systems. We have studied various approaches to calibration over the past several years and have worked with statisticians to resolve the proper means of establishing calibration. Nearly all statisticians and knowledgeable analytical chemists now agree that, for nearly all analytical systems and instruments, a weighted regression is the proper form. Recently, the International Union of Pure and Applied Chemistry ( IUPAC) came to the same conclusion ( see Pure and Applied Chemistry 70, 993 1014 ( 1998)).

For Method 1631, laboratories in our inter laboratory method validation study had little difficulty using the calibration factor approach or in meeting the relative standard deviation ( RSD) criterion of 15 percent in the calibration factor approach. Therefore, the 15 percent criterion was retained in Method 1631.

Regarding the regression used in nearly all metals methods, this regression is unweighted; i. e., it assumes that the standard deviation is the same at all concentrations. An unweighted regression is incorrect for Guidance  EPA Method 1631, March 2001 Guidance  Method 1631 5 16 nearly all instruments and analytical systems. Weighting should be inversely proportional to concentration for nearly all analytical systems and instruments as we and IUPAC have learned ( pH would be an exception). Therefore, we have required use of the simplest form of weighted regression in Method 1631.

Can we use the slope, intercept, and correlation coefficient method of calibrating and calculating results, provided that we demonstrate equivalency ?

As stated above, we have found that a weighted regression is most appropriate for analytical chemistry measurements, and that the calibration factor approach is the simplest form of weighted regression. Therefore, only a weighted regression would be considered equivalent to the CF approach. The slope, intercept, and correlation coefficient method traditionally used for metals measurements, and that uses an unweighted regression, may not be used.

Recently, EPA allowed use of a " linear calibration" for automated calculations in metals methods. This " linear calibration" can be used for automated calculations provided that the linear calibration is weighted.

Why doesn't EPA make every effort to communicate its expectations on linear regression to manufacturers of instruments ?

The calibration factor and weighted linear regression approach to calibration have been in existence for more than 25 years and have been used in automated GC/ MS data systems since that time. Therefore, instrument manufacturers have known about this approach for some time. EPA proposed Method 1631 in May of 1998 and published the final rule in June of 1999. The calibration factor approach was included in the proposal, giving instrument manufacturers more than a year to implement the calibration factor/ weighted regression approach.

EPA reviewed a study performed by Tekran, Inc., one of the manufacturers of instruments for determination of mercury using EPA Method 1631, that used both the calibration factor/ weighted regression ( CF/ WR) and unweighted regression approaches. The calibration included a data point at the Method 1631 MDL ( 0.2 ng/ L). The RSD for the CF/ WR approach was 7.8 percent. The coefficient of determination ( r2) for the unweighted approach was 1.000, indicating no error in calibration. The reason for the indication of zero error is that the low calibration points are, essentially, unweighted. Therefore, the unweighted regression is equivalent to a single point calibration at the highest calibration point. We do not believe that this form of calibration is consistent with the best science.

Why doesn't EPA require dilution when the concentration in a sample is greater than 90 percent of the linear dynamic range ( LDR), as with some other EPA metals methods ?

The LDR for Method 1631 is to 100 ng/ L. You may dilute the sample when 90 percent of the LDR is exceeded, if desired. The reason that we did not require dilution of the sample when this level is exceeded is that all of the laboratories in EPA's interlaboratory validation study of Method 1631 were able to demonstrate linearity to 100 ng/ L. Guidance  EPA Method 1631, March 2001 Guidance  Method 1631 5 17 The highest ambient criterion for mercury is 12 ng/ L. Why is calibration performed to 100 ng/ L ?

The range of Method 1631 was established by the technology used. In initial tests it was found that the linear range extended to 100 ng/ L. This range was verified in the interlaboratory validation study. If you chose to use a lesser range, you may dilute samples into the region of the ambient criterion. However, you must calibrate to 100 ng/ L and demonstrate linearity to this level.

Must our laboratory discard the secondary standard on the expiration date even if it is still within the control limits of Method 1631 ?

Yes. The secondary standard ( typically 1.00 F g/ mL Hg) must be discarded ( Section 7.8 of the Method) . The reason is that there is error associated with testing the standard. If the results of testing show that the standard is barely within the high or low control limit, the results of sample analyses could be inaccurate. To preclude generation of waste containing mercury, the amount of the secondary standard prepared should be consistent with the amount that will be required during the life of the standard. Section 14.1 of Method 1631 states: " Standards should be prepared in volumes consistent with laboratory use to minimize the disposal of excess volumes of expired standards."

Sections 7.9 and 7.10 state that the working standards " should" be replaced monthly. Does the word " should" imply that it is the laboratory's discretion ?

Yes. As defined in the Glossary at the end of Method 1631, " should" means that a given action, activity, or procedure is suggested, but not required. However, if it is later shown that a working standard held for more than one month was inaccurate, the intended objective of ensuring reliable measurements of mercury by Method 1631 would not have been met. It is the laboratory's responsibility to assure that measurements made are reliable.

How expensive is it to set up Method 1631 ?

Depending on how many analyses are to be performed and whether new or used materials will be used for construction, costs can range from thousands to hundreds of thousands of dollars. The Clean Spaces Guidance can assist you in cost minimization. This document describes how costs to establish a trace metals laboratory at the University of California Santa Cruz were minimized to a few thousand dollars. For a complete, new, clean room for mercury analyses, we estimate the cost at approximately $ 150,000 and the costs for equipment and instrumentation at $ 50,000. If one or only a few samples are to be analyzed, the most cost effective means is to contract through a laboratory routinely determining mercury at the levels required.

What criteria should I use in selecting a laboratory ?

As with other analyses, selection should be based on the experience of the laboratory in making the particular measurement, the knowledge and skill of laboratory personnel with the particular technology, the quality assurance/ quality control applied to the analysis, the documented history of performance of the laboratory in making the measurements, and to a lesser extent, the fee charge by the laboratory. For determination of mercury using Method 1631, particularly for making measurements at or near 1 ng/ L, a documented history of freedom from contamination and recovery of OPRs and MS/ MSDs within the QC acceptance criteria of Method 1631 provides an indication that the analyses are being performed reliably. Guidance  EPA Method 1631, March 2001 Guidance  Method 1631 5 18 EPA believes that the laboratories that participated in the interlaboratory validation of Method 1631 are all capable of performing mercury determinations reliably. However, the user should review the performance of these and other laboratories in the context of the objectives of any study.

What data can and cannot be reported for regulatory compliance purposes, and is it the laboratory or discharger's responsibility to make the determination ?

In general, only sample results that are associated with QC data that meet the QC requirements in Method 1631 may be reported or used for permitting or regulatory compliance purposes. See Sections <IP_ADDRESS>, <IP_ADDRESS>, <IP_ADDRESS>, and 13.2 of Method 1631.

If the data are to be used for permitting or regulatory compliance under a permit, all data are the responsibility of the discharger/ permittee. It is the laboratory's responsibility to make sure that all QC acceptance criteria are met. An exception would be if a matrix interference could not be overcome and precluded the MS/ MSD recovery and precision criteria from being met. See the chapter on Matrix Interferences in this guidance for the action to be taken when a matrix interference is encountered.

In addition, a laboratory cannot be responsible for activities over which it has no control. If a discharger collects samples and a field blank, and the field blank is contaminated, it is the discharger's responsibility. If, however, a reagent or laboratory blank is contaminated and the associated field blank is contaminated, it is possible that the laboratory contaminated the field blank. In this case, the contaminated field blank would be the laboratory's responsibility. Regardless of whose responsibility it is, the result for a sample associated with a contaminated field blank generally may not be reported or otherwise used for permitting or regulatory compliance purposes ( see Section <IP_ADDRESS> of Method 1631), unless the contamination has no negative effect on the objective of the monitoring program. For example, sample results that are associated with contaminated field blanks, but also are still below the regulatory compliance threshold, may be used to demonstrate permit compliance. Additional guidance concerning the possible use of data associated with certain types of QC failures is provided in Guidance on the Documentation and Evaluation of Trace Metals Data Collected for Clean Water Act Compliance Monitoring, which is referenced in Chapter 6 of this document.

Are reporting requirements in Section 12.4 of Method 1631 the laboratory's responsibility or the discharger's ?

For permitting or regulatory compliance purposes, the reporting requirements are the responsibility of the discharger/ permittee. However, the discharger/ permittee can only report results as reliable as those produced by the laboratory. In addition, the laboratory is closest to the analysis and, therefore, most familiar with the data being reported to the discharger/ permittee. To the extent possible, the laboratory should provide data to the discharger/ permittee that will satisfy the requirements in Section 12.4 and the permit.

Can laboratories report results below the ML for field samples ?

Yes. There is nothing in Method 1631 that precludes laboratories from reporting results in ways different from those specified in Section 12.4, provided that the results are also reported as specified in Section 12.4. Section 12.4 requires that laboratories report results below the ML as < 0.5 ng/ L or as required by the regulatory authority or in the permit. However, if a regulatory/ control authority or the permit requires reporting of results without censoring at the ML or MDL ( i. e., at as low a level as possible), the result must be reported without censoring. Guidance  EPA Method 1631, March 2001 Guidance  Method 1631 6 1 Chapter 6: Sources of Information This section provides sources of information related to the final guidelines establishing test procedures for measurement of mercury in water. Specifically, this section provides a listing of documents pertaining to the regulatory background and data gathering for EPA Method 1631.

Regulatory Background Act Clean Water Act ( CWA)  Public Law 92 500, et. seq.; 33 U. S. C. 1251 et. seq.

Analytical methods under CWA Sections 301, 304, and 501 History: see Federal Register, February 7, 1991 ( 56 FR 5090) Support for effluent guidelines: see Federal Register, October 18, 1995 ( 60 FR 53988). Proposal of Method 1631: See Federal Register, May 26, 1998 ( 64 FR 28867). Promulgation of Method 1631, Revision B: See Federal Register, June 8, 1999 ( 64 FR 30417)

Data Gathering for EPA Method 1631 Proposal See Federal Register, May 26, 1998 ( 64 FR 28867) See the administrative record in the Water Docket ( Docket W 98 15) for reports supporting the proposal of Method 1631.

Notice of data availability ( NODA) See Federal Register, March 5, 1999 ( 64 FR 10596)

Data received from commenters See the administrative record in the Water Docket ( Docket W 98 15) for the final rule Final rule See Federal Register, June 8, 1999 ( 64 FR 30417) See the administrative record in the Water Docket ( Docket W 98 15) for reports supporting the promulgation of Method 1631, Revision B.

Documents Supporting EPA Method 1631 ° Bloom, Nicolas, Draft Total Mercury in Aqueous Media, Frontier Geosciences, Inc., September 7, 1994. ° Method 1669: Sampling Ambient Water for Trace Metals at EPA Water Quality Criteria Levels, EPA 821 R 96 011, July 1996 ° Sampling Ambient and Effluent Waters for Trace Metals, EPA 821 V 97 001, 1997 ° Results of the EPA Method 1631 Interlaboratory Validation Study, Available from the EPA Sample Control Center Guidance  EPA Method 1631, March 2001 Guidance  Method 1631 6 2 ° Guidance on Establishing Trace Metal Clean Rooms in Existing Facilities (" Clean Spaces Guidance"), EPA 821 B 96 001, April 1995 ° Trace Metal Cleanroom, RTI/ 6302/ 04 02 F, Research Triangle Institute, October 1995. ° An Analytical Survey of Nine POTWs from the Great Lakes Basin, Draft Report, US EPA Office of Science and Technology, Analytical Methods Staff, December 15, 1994 ° Evaluating Field Techniques for Collecting Effluent Samples for Trace Metals Analysis, EPA 821 R 98 008, June 1998 ° Guidance on the Documentation and Evaluation of Trace Metals Data Collected for Clean Water Act Compliance Monitoring, EPA 821B 96 004, July 1996 See also the references at the end of EPA Method 1631 Documents on Compliance Monitoring and Methods Guidance on Evaluation, Resolution, and Documentation of Analytical Problems Associated with Compliance Monitoring, EPA 821 B 93 00, June 1993.

Source for Documents The documents listed in this guidance may be viewed at or obtained from the Water Docket ( see the address below). Nearly all documents are also available from the EPA Sample Control Center:

EPA Sample Control Center EPA Water Docket DynCorp I& ET Waterside Mall 6101 Stevenson Avenue 401 M Street, Southwest Alexandria, VA 22304 3540 Washington, DC Tel: ( 703) 461 2100 Tel: ( 202) 260 3027 Fax: ( 703) 461 8056 E mail: SCC@ DynCorp. com Guidance  EPA Method 1631, March 2001 Guidance  Method 1631 7 1 Chapter 7: Where to Get Additional Help This section lists reference locations and EPA contacts that may provide additional information related to the final guidelines establishing test procedures for measurement of mercury using EPA Method 1631.

EPA contact for questions specifically related to Method 1631 Maria Gomez Taylor Engineering and Analysis Division ( 4303) U. S. EPA Ariel Rios Building 1200 Pennsylvania Avenue, N. W. Washington, DC 20460 Tel: ( 202) 260 1639 Fax: ( 202) 260 7185 E Mail: gomez taylor. maria@ epa. gov Water Docket The administrative record ( public comments, EPA responses, and all supporting documents for Method 1631, including those listed below) are available for review at the Water Docket. For access to docket materials, phone the Water Docket between 9: 00 a. m. and 3: 30 p. m. for an appointment. The address below is for the physical location of the Water Docket and is not a mailing address. For the EPA mailing address, see the address for the EPA contact above.

EPA Water Docket Waterside Mall 401 M Street, Southwest Washington, DC Tel: ( 202) 260 3027 Websites EPA's home page on the World Wide Web: http:// www. epa. gov EPA's Office of Science and Technology's analytical methods and water documents pages on the World Wide Web: http:// www. epa. gov/ OST/ Methods ( water methods) http:// www. epa. gov/ ost/ guide ( water documents) Guidance  EPA Method 1631, March 2001 1 This Standard Operating Procedure is based on a procedure provided by Frontier Geosciences, Inc. Guidance  Method 1631 A 1 APPENDIX A Standard Operating Procedure for Collection of Ambient Water and Wastewater Samples for Determination of Mercury Using EPA Method 1631 1 Note: This procedure should be viewed as containing the minimum steps necessary for reliable sampling. Some of the additional measures in the Sampling Guidance ( EPA Method 1669) may be necessary to preclude contamination at some sampling sites. EPA Methods 1631 and 1669 are referenced throughout this SOP. Advice on training, equipment, and sampling technique is also available from laboratories analyzing samples using EPA Method 1631.

1.0 Scope and Application 1.1 This standard operating procedure ( SOP) gives details for collection of grab samples of ambient water and wastewater for the determination of low level mercury. Adherence to this SOP can be expected to minimize contamination from the sample bottle and external sources. 1.2 This SOP is for collection of a grab sample directly into the sample bottle ( e. g., effluents, rapidly flowing streams/ rivers) ( Method 1669, Section 8.2.5). If transfer containers ( e. g., dippers) or other equipment ( sampling pumps, etc.) are required to obtain samples, including composite samples, refer to EPA Method 1669 for detailed guidance.

2.0 Sample bottle requirements 2.1 Sample bottles may be either fluoropolymer that has been cleaned, tested, and double bagged in a Class 100 clean bench ( Method 1631, Section <IP_ADDRESS> and Method 1669, Section 6.3), or borosilicate glass with fluoropolymer lined lids obtained from a supplier that certifies cleanliness for metals sampling ( e. g., I Chem, Series 200 or equivalent). If sample bottles are from a bottle lot, a statistically relevant number of bottles in the lot should be tested to demonstrate freedom from contamination at levels that could compromise results ( Method 1613B, Section <IP_ADDRESS>). Untested sample bottles must not be used as they may be the source of possible contamination ( Method 1613B, Section <IP_ADDRESS>). 2.2 Sample bottles may also be obtained in kit form from the laboratory. A kit would consist of double bagged sample bottles, reagent water for the field blank( s), gloves, and ice. Blue Ice may be obtained from the laboratory or locally; wet ice should be obtained locally. 3.0 Sample collection 3.1 Collection of samples is performed using the " clean hands dirty hands" technique ( Method 1669, Section 2.4). Bottles are sealed tightly and re bagged using the opposite series of steps as were used to open them. Samples are either preserved immediately upon collection, or bottles are shipped to the analytical laboratory via overnight courier for preservation and analysis. 3.2 Ideally, at least two persons each wearing fresh cleanroom gloves ( Method 1631, Section 4.3.6 and Method 1669, Section <IP_ADDRESS>) are required on a sampling crew. Cleanroom gloves should be worn at all times when handling samples or sampling equipment. 3.3 One person ( designated " dirty hands") removes a bagged bottle from the box or cooler, and opens the outer bag, avoiding touching the inside surface of that bag. 3.4 The other person ( designated " clean hands") reaches in, opens the inner bag, and removes the sample bottle. " Clean hands" should not touch anything but the outside surface of the sample bottle and cap, and the water being sampled. If anything other than the sample bottle, cap, or water is touched, " clean hands" must change gloves. Guidance  EPA Method 1631, March 2001 Guidance  Method 1631 A 2 3.5 " Clean hands" opens the sample bottle and holds the bottle in one hand and the cap in the other. If it is necessary to set the cap down, it should be placed in the inner bag from which the sample bottle was removed.

Note: The person collecting the sample should be wary of disturbing the flow upstream of the sampling point. The insertion of the bottle into a flowing stream, or standing in the flow downstream of the sampling point, creates eddies ( disturbances in the upstream flow) that can resuspend solids near the sampling point. Entry of such re suspended solids into the sample may produce a non representative sample and could increase the mercury concentration.

3.6 Rinse the sample bottle and inside surface of the cap three times with sample water, and fill the bottle to the top with sample ( Method 1669, Section <IP_ADDRESS>). Replace the cap and tighten securely.

Note: If the person collecting the sample cannot directly reach the water to be sampled, a poletype sampler may be attached to the sample bottle to extend the reach for sample collection. The pole and bottle clamp should be made of plastic and/ or stainless steel and the mouth of the bottle should be held facing upstream of the pole. The use of a transfer vessel should be avoided.

3.7 Re bag the bottle in the opposite order that it was removed. 3.8 Cleanroom gloves should be changed between samples and whenever anything not known to be trace metal clean is touched.

4.0 Collection of field blanks 4.1 EPA Method 1631 requires collection of a field blank with every 10 samples from a given site ( Method 1631, Section <IP_ADDRESS>). A sample bottle for the field blank should be requested from the laboratory when the sampling kit is requested ( Section 2.2 of this SOP). A separate sample bottle as well as a bottle filled with reagent water are used to collect the field blank. 4.2 To collect the field blank, open an empty sample bottle using the " clean hands dirty hands" techniques described above. Also open the bottle containing the reagent water. 4.3 Pour the reagent water into the empty sample bottle. This is now the field blank. 4.4 Re bag the field blank in the opposite order that it was removed.

5.0 Preservation, packing, refrigeration, and shipment of samples 5.1 Following collection, samples must either be preserved ( Method 1631, Section 8.5) or may be shipped unpreserved if they are ( 1) collected in glass or fluoropolymer bottles, ( 2) filled to the top with no head space, ( 3) capped tightly, and ( 4) maintained at 0   4 E C from the time of collection until preservation. The samples must be acid preserved within 48 h after sampling ( Method 1631, Section 8.5.1). 5.2 Pack sample bottles upright to prevent the area around the bottle cap from becoming wet. Wrap glass sample bottles with bubble type packing to prevent breakage during shipment. 5.3 Blue Ice or wet ice may be used to refrigerate sample bottles. The Blue Ice must be frozen prior to sampling. If the sample in a glass sample bottle is cooled to 0 E C prior to shipment and packed in frozen blue ice, the sample may freeze and rupture the bottle. Wet ice avoids this problem but increases the potential for mercury contamination because the sample bottle may become immersed in water from the melting ice. Packaging the wet ice in multiple plastic bags will preclude water from melted ice from reaching the sample bottle.


[Federal Register Volume 83, Number 28 (Friday, February 9, 2018)]
[Notices]
[Pages 5781-5783]
[FR Doc No: 2018-02592]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2016-E-1851; FDA-2016-E-1878; FDA-2016-E-1879; FDA-
2016-E-1880; and FDA-2016-E-1882]

Determination of Regulatory Review Period for Purposes of Patent
Extension; ENTRESTO

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for ENTRESTO and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of applications to the Director
of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by April
10, 2018. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by August 8, 2018.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 10, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 10, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

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 Nos.
FDA-2016-E-1851; FDA-2016-E-1878; FDA-2016-E-1879; FDA-2016-E-1880; and
FDA-2016-E-1882 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; ENTRESTO.'' Received comments, those
filed in a timely manner (see ADDRESSES), 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 Sec.  10.20 (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.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product ENTRESTO
(sacubitril and valsartan). ENTRESTO is indicated to reduce the risk of
cardiovascular death and hospitalization for heart failure in patients
with chronic heart failure (New York Heart Association Class II-IV) and
reduced ejection fraction. Subsequent to this approval, the USPTO
received patent term restoration applications for ENTRESTO (U.S. Patent
Nos. 7,468,390; 8,101,659; 8,404,744; 8,796,331; and 8,877,938) from
Novartis Pharmaceuticals Corporation, and the USPTO requested FDA's
assistance in determining the patents' eligibility for patent term
restoration. In a letter dated August 25, 2016, FDA advised the USPTO
that this human drug product had undergone a regulatory review period
and that the approval of ENTRESTO represented the first permitted
commercial marketing or use of the product. Thereafter, the USPTO
requested that FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
ENTRESTO is 3,148 days. Of this time, 2,945 days occurred during the
testing phase of the regulatory review period, while 203 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
November 25, 2006. Novartis Pharmaceuticals Corporation claims that
April 8, 2007, is the date the investigational new drug application
(IND) became effective. However, FDA records indicate that the IND
effective date was November 25,

2006, which was 30 days after FDA receipt of an earlier IND.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: December
17, 2014. FDA has verified the applicant's claim that the new drug
application (NDA) for ENTRESTO (NDA 207620) was initially submitted on
December 17, 2014.
    3. The date the application was approved: July 7, 2015. FDA has
verified the applicant's claim that NDA 207620 was approved on July 7,
2015.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 1,296 days, 732 days, 519 days, 270 days or 225
days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: February 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02592 Filed 2-8-18; 8:45 am]
BILLING CODE 4164-01-P