[Federal Register Volume 85, Number 249 (Tuesday, December 29, 2020)]
[Notices]
[Page 85759]
[FR Doc No: 2020-28654]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-90739; File No. SR-NYSE-2020-90]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Designation of a Longer Period for Commission Action on a
Proposed Rule Change To Amend the Requirement Applicable to Special
Purpose Acquisition Companies Upon Consummation of a Business
Combination Concerning Compliance With the Round Lot Shareholder
Requirement

December 21, 2020.
    On October 27, 2020, New York Stock Exchange LLC (``Exchange'')
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
amend the requirement applicable to special purpose acquisition
companies upon consummation of a business combination concerning
compliance with the round lot shareholder requirement. The proposed
rule change was published for comment in the Federal Register on
November 16, 2020.\3\ The Commission has received no comment letters on
the proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 90382 (November 9,
2020), 85 FR 73121.
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    Section 19(b)(2) of the Act \4\ provides that within 45 days of the
publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding, or as to which the self-regulatory organization
consents, the Commission will either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day after publication of the notice for this proposed rule change
is December 31, 2020. The Commission is extending this 45-day time
period.
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    \4\ 15 U.S.C. 78s(b)(2).
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    The Commission finds it appropriate to designate a longer period
within which to take action on the proposed rule change so that it has
sufficient time to consider the proposed rule change. Accordingly, the
Commission, pursuant to Section 19(b)(2) of the Act,\5\ designates
February 14, 2021 as the date by which the Commission shall either
approve or disapprove, or institute proceedings to determine whether to
disapprove, the proposed rule change (File No. SR-NYSE-2020-90).
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    \5\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
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    \6\ 17 CFR 200.30-3(a)(31).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-28654 Filed 12-28-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: January 19, 2006 (Volume 71, Number 12)]
[Notices]
[Page 3144-3145]
[DOCID:fr19ja06-133]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53103; File No. SR-ISE-2006-01]

Self-Regulatory Organizations; International Securities Exchange,
Inc.; Notice of Filing of Proposed Rule Change To Amend Exchange Rule
Governing Directed Orders

January 11, 2006.
    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 January 5, 2006, the International Securities Exchange, Inc.
(``ISE'' or ``Exchange'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I, II, and III below, which Items have been prepared by the ISE.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The ISE is proposing to amend its ISE Rule 811 with respect to
identifying to a Directed Market Maker (``DMM'') the identity of the
firm entering a Directed Order.
    The text of the proposed rule change is below. Proposed new
language is in italics; proposed deletions are in [brackets].
* * * * *

Rule 811. Directed Orders

* * * * *
    (b) Exchange market makers may only receive and handle orders on an
agency basis if they are Directed Orders and only in the manner
prescribed in the Rule 811. A market maker can elect whether or not to
accept Directed Orders on a daily basis. If a market maker elects to be
a Directed Market Maker, it must accept Directed Orders from all
Electronic Access Members[. A Directed market maker] and cannot reject
a Directed Order. The identity of the Electronic Access Member that
entered the Directed Order will be made available to the Directed
Market Maker.
* * * * *

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 ISE included statements
concerning the purpose of and basis for the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The ISE has prepared summaries, set forth in Sections A,
B, and C below, of the most significant aspects of such statements.

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

1. Purpose
    The Exchange operates a Directed Order system in which Electronic
Access Members (``EAMs'') can send an order to a DMM for possible price
improvement.\3\ If a DMM accepts Directed Orders generally, that DMM
must accept all Directed Orders from all EAMs. Once such a DMM receives
a Directed Order, it either must enter the order into the Exchange's
``Price Improvement Mechanism'' (``PIM'') or must release the order
into the Exchange's limit order book, in which case there are certain
restrictions on the DMM interacting with the order.
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 52331 (August 24,
2005), 70 FR 51856 (August 31, 2005) (SR-ISE-2004-16).
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    The Boston Options Exchange (``BOX'') operates a system almost
identical to ISE's Directed Order system. Based on BOX's published
rules, the ISE believed that BOX's system had the same anonymity
feature as ISE's system. However, the Boston Stock Exchange, Inc.
(``BSE'') has filed a proposed rule change that acknowledges that BOX
provides its directed market makers with the identity of the order
entry firm and seeks to amend the BOX rules to be consistent with the
actual operation of the BOX system (the ``BOX Proposal'').\4\
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    \4\ See Securities Exchange Act Release No. 53015 (December 22,
2005), 70 FR 77207 (December 29, 2005) (SR-BSE-2005-52).
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    The ISE has significant concerns with the BOX Proposal and will be
filing a comment letter arguing against its approval. Notwithstanding
ISE's concerns with the BOX Proposal, the ISE believes it needs to
remain competitive in the market place if the Commission determines to
approve the BOX Proposal and allow exchanges to disclose the identity
of order-entry

firms in their order routing and execution systems. In this respect,
the ISE has modified its system to disclose the identity of order entry
firms to DMMs on a temporary basis.\5\ The purpose of this proposed
rule change is to specify in the ISE rules that Directed Orders are not
anonymous, which if approved by the Commission, will make the temporary
system change permanent.\6\
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    \5\ See Securities Exchange Act Release No. 53104 (January 11,
2006) (File No. SR-ISE-2006-02). This temporary system change was
effective upon filing pursuant to Rule 19b-4(f)(5) under the Act. 17
CFR 240.19b-4(f)(5).
    \6\ Currently, the ISE rules do not specify that Directed Orders
are sent to a DMM on an anonymous basis. The ISE also enforces
anonymity in certain other trading systems, such as its Facilitation
Mechanism. The Exchange plans to file a proposed rule change
eliminating the anonymity provisions in certain of these areas as
well.
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2. Statutory Basis
    The Exchange believes that the basis under the Act for this
proposed rule change is found in section 6(b)(5),\7\ in that the
proposed rule change is designed to promote just and equitable
principles of trade, to prevent fraudulent and manipulative acts, to
remove impediments to and perfect the mechanisms of a free and open
market and a national market system and, in general, to protect
investors and the public interest. In particular, the proposed rule
change will enable the Exchange to remain competitive in the market
place.
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    \7\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The proposed rule change does not impose any burden on competition
that is 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 has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the Exchange consents, the Commission shall:
    (a) By order approve such proposed rule change, or
    (b) Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File No. SR-ISE-2006-01 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, Station Place, 100 F
Street, NE., Washington, DC 20549-9303.
    All submissions should refer to File Number SR-ISE-2006-01. 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. Copies of such
filing also will be available for inspection and copying at the
principal office of the ISE.
    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-ISE-2006-01
and should be submitted on or before February 9, 2006.
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\8\
Nancy M. Morris,
Secretary.
[FR Doc. E6-521 Filed 1-18-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 87, Number 202 (Thursday, October 20, 2022)]
[Notices]
[Pages 63766-63767]
[FR Doc No: 2022-22769]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 6115-016]

Pyrites Hydro, LLC; Notice Soliciting Scoping Comments

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: New Major License.
    b. Project No.: 6115-016.
    c. Date filed: August 31, 2021.
    d. Applicant: Pyrites Hydro, LLC (Pyrites Hydro).
    e. Name of Project: Pyrites Hydroelectric Project (Pyrites Project
or project).
    f. Location: The existing project is located on the Grass River
near the Town of Canton, St. Lawrence County, New York. The project
does not occupy any federal land.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Mr. Kevin M. Webb, Hydro Licensing Manager,
Pyrites Hydro, LLC, 670 N Commercial Street, Suite 204, Manchester, NH
03101,<PHONE_NUMBER>; [email protected]
    i. FERC Contact: Chris Millard at<PHONE_NUMBER>; or email at
[email protected].
    j. Deadline for filing scoping comments: November 12, 2022.
    The Commission strongly encourages electronic filing. Please file
scoping comments using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief
comments up to 6,000 characters, without prior registration, using the
eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You
must include your name and contact information at the end of your
comments. For assistance, please contact FERC Online Support at
[email protected],<PHONE_NUMBER> (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, please send a paper copy via
U.S. Postal Service to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC
20426. Submissions sent via any other carrier must be addressed to:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission,
12225 Wilkins Avenue, Rockville, Maryland 20852. All filings must
clearly identify the project name and docket number on the first page:
Pyrites Hydroelectric Project (P-6115-016).
    The Commission's Rules of Practice require all intervenors 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
intervenor 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. This application is not ready for environmental analysis at this
time.
    l. The project consists of: (1) a 170-foot-long and 12-foot-high
concrete Ambursen overflow spillway dam with 1.5-foot-high flashboards,
a 115-foot-long concrete auxiliary spillway, and a 208-foot-long non-
overflow intake dam, which includes a 50-foot-wide intake structure;
(2) a 6-foot-diameter, 700-foot-long steel penstock running from the
intake structure to an upper powerhouse and a 10-foot-diameter, 2,160-
foot-long penstock running from the intake structure to a lower
powerhouse; (3) a 21-foot by 31-foot upper powerhouse located 700 feet
downstream of the intake structure containing one 1.2-megawatt (MW)
turbine/generator unit operating under a rated head of 76 feet and a
50-foot by 53-foot lower powerhouse located 1,200 feet downstream of
the upper powerhouse tailrace containing two 3.5-MW turbine/generator
units operating under a rated head of 111 feet; (4) a 405-foot-long,
20-foot-wide tailrace; (5) a 50-foot by 97-foot, 115/4.16/2.3-kilovolt
(kV) switchyard and substation for use by both powerhouses; (6) a 470-
foot-long 2.3-kV transmission line connecting the upper powerhouse to
the switchyard; (7) a 1,150-foot-long 4.16-kV transmission line
connecting the lower powerhouse to the switchyard; and (8) appurtenant
facilities.
    The project is operated in a run-of-river mode, whereby outflow
from the project approximates inflow. The lower powerhouse is operated
in an automatic control mode using water level transducers to maintain
normal impoundment elevation at the flashboard crest (i.e., 484.8
feet).\1\ The

upper powerhouse is manually operated and serves as a backup to the
lower powerhouse when inflows exceed the hydraulic capacity of the
lower powerhouse (i.e., 860 cubic feet per second [cfs]).\2\ The
minimum and maximum hydraulic capacities of the project are 232 cfs and
1,090 cfs, respectively.
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    \1\ Elevation data are presented using the National Geodetic
Vertical Datum of 1929 (NGVD29).
    \2\ Pyrites Hydro estimates that the upper powerhouse operates
about 16% of the time on an annual basis.
---------------------------------------------------------------------------

    A continuous minimum flow of 45 cfs or inflow, whichever is less,
is passed into the bypassed reach. The minimum flow comprises 30 cfs at
the spillway and 15 cfs of leakage flow from the upper powerhouse.
Project operation ceases when inflow falls below the project's minimum
hydraulic capacity and all flow is passed via a minimum flow weir \3\
and/or over the project spillway. From 2010 to 2020, the project
generated an average of 27,865 megawatt-hours annually.
---------------------------------------------------------------------------

    \3\ The 8-foot-wide by 1.5-foot-deep minimum flow weir is
located at the north end of the spillway dam.
---------------------------------------------------------------------------

    m. In addition to publishing the full text of this notice in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this notice, as well
as other documents in the proceeding (e.g., scoping document) via the
internet through the Commission's Home Page (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 (P-
6115). For assistance, contact FERC at [email protected] or
call toll-free,<PHONE_NUMBER> or TYY,<PHONE_NUMBER>.
    n. You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    o. Scoping Process: Commission staff will prepare either an
environmental assessment (EA) or an environmental impact statement
(EIS) that describes and evaluates the probable effects, if any, of the
licensee's proposed action and alternatives. The EA or EIS will
consider environmental impacts and reasonable alternatives to the
proposed action. The Commission's scoping process will help determine
the required level of analysis and satisfy the National Environmental
Policy Act (NEPA) scoping requirements, irrespective of whether the
Commission prepares an EA or an EIS. At this time, we do not anticipate
holding on-site scoping meetings. Instead, we are soliciting written
comments and suggestions on the preliminary list of issues and
alternatives to be addressed in the NEPA document, as described in
scoping document 1 (SD1), issued October 13, 2022.
    Copies of SD1 outlining the subject areas to be addressed in the
NEPA document were distributed to the parties on the Commission's
mailing list and the applicant's distribution list. Copies of SD1 may
be viewed on the web 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. For assistance, call 1-866-
208-3676 or for TTY,<PHONE_NUMBER>.

    Dated: October 13, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-22769 Filed 10-19-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 129 (Tuesday, July 7, 2015)]
[Notices]
[Pages 38696-38699]
[FR Doc No: 2015-16561]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0169]

Chung Po Liu; Denial of Hearing; Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is denying Chung

Po Liu's (Liu) request for a hearing and is issuing an order under the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Liu for 5
years from importing articles of food or offering such articles for
importation into the United States. FDA bases this order on a finding
that Liu was convicted of a felony for conduct relating to the
importation of an article of food into the United States. In
determining the appropriateness and period of Liu's debarment, FDA has
considered the relevant factors listed in the FD&C Act. Liu has failed
to file with the Agency information and analysis sufficient to create a
basis for a hearing concerning this action.

DATES: This order is effective July 7, 2015.

ADDRESSES: Submit applications for termination of debarment to the
Division of Dockets Management Branch (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Julie Finegan, Office of Scientific
Integrity, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    On August 26, 2010, Chung Po Liu pleaded guilty to the felony crime
of entering honey, a food, into the commerce of the United States by
means of a false statement, in violation of 18 U.S.C. 542 and 2. Liu
admitted that he had caused his customs broker to declare Thailand to
be the country of origin of one honey shipment, although the majority
of the honey originated in China, and to declare the Philippines to be
the country of origin of a second honey shipment, although the honey
originated in China. Liu admitted that, in each instance, he had
documents in his possession establishing that the honey originated in
China, that the declaration of country of origin was false, and that he
was without reasonable cause to believe it was true. Liu also admitted
that the United States began requiring the deposit of estimated anti-
dumping duties of between 183 percent and 221 percent on all non-exempt
honey of Chinese origin beginning in 2001. Liu did not deposit
estimated anti-dumping duties for either of these two shipments of
imported honey. Liu also pleaded guilty to the misdemeanor crime of
introducing adulterated food into interstate commerce in violation of
sections 301(a), 303(a)(1), and 402(a)(2)(C)(i) of the FD&C Act (21
U.S.C. 331(a), 333(a)(1), and 342(a)(2)(C)(i)). Liu admitted that he
had introduced honey that contained the unsafe food additive
ciprofloxacin, an antibiotic, into interstate commerce. On December 20,
2010, the U.S. District Court for the Western District of Washington
entered a criminal judgment against Liu under his guilty plea.
    Section 306(b)(1)(C) of the FD&C Act (21 U.S.C. 335a(b)(1)(C))
authorizes FDA to debar a person from importing articles of food or
offering food for importation into the United States based on a
finding, under section 306(b)(3) of the FD&C Act, that the person was
convicted of a felony for conduct relating to the importation of food
into the United States. By letter dated April 25, 2011, in accordance
with section 306(i) of the FD&C Act and 21 CFR 10.50(c)(20) and
12.21(b), FDA, Office of Regulatory Affairs (ORA) notified Liu that the
Agency proposed to debar him for 5 years from importing any articles of
food or offering such articles for importation into the United States
and offered an opportunity to request a hearing on the proposed order
of debarment to resolve disputed issues of material fact. ORA advised
Liu that a request for a hearing may not rest upon mere allegations or
denials, but must present specific facts showing that there is a
genuine and substantial issue of fact that requires a hearing.
    In a letter dated May 24, 2011, Liu requested a hearing on his
proposed debarment. On June 11, 2011, Liu submitted materials in
support of his hearing request. In these materials, which were
submitted in accordance with 21 CFR 12.22, Liu acknowledges his felony
conviction. However, he urges FDA not to exercise its authority to
debar him based on that conviction. In the alternative, he argues that
any debarment should be limited to the 1-year period of supervised
release that the court ordered him to serve after his release from
custody after serving his sentence of incarceration of 1 year and 1
day.
    Under the authority delegated to him by the Commissioner of Food
and Drugs, the Director of the Office of Scientific Integrity (the
Director) has considered Liu's submission. FDA will grant a hearing
only if the material submitted shows that there is a genuine and
substantial issue of fact for resolution at the hearing. Hearings will
not be granted on issues of policy or law, on mere allegations,
denials, or general descriptions of positions and contentions, or on
data and information insufficient to justify the factual determination
urged (see 21 CFR 12.24(b)). Based on this review, the Director has
concluded that Liu has failed to raise a genuine and substantial issue
of fact for resolution at a hearing and that a hearing is not
justified. Accordingly, Liu's request for a hearing is denied, and FDA
is issuing this notice to explain the basis for this decision (see 21
CFR 12.24(a) and 12.28).

II. Arguments

    Liu raises two primary arguments in support of his hearing request.
Liu first contends generally that debarment is ``unwarranted in law and
without justification by the facts in the case.'' He also urges that
FDA should not debar him due to his advanced age and ill health, or,
alternatively, that FDA should debar him for a time period of less than
5 years, the debarment period proposed in the Notice of Opportunity for
Hearing.
    Liu notes that, under section 306(b), the decision whether to debar
him is committed to FDA's discretion, and that FDA is authorized to
debar him ``as a result of conviction of certain crimes'' (June 21
submission at 1). Indeed, section 306(b)(3) of the FD&C Act states that
a person is subject to debarment if the person has been convicted of a
felony for conduct relating to the importation into the United States
of any food. Liu does not dispute that he was convicted of a felony
crime in violation of 18 U.S.C. 542 and 2, or that his conviction was
based on conduct relating to the importation of honey, a food. In the
plea agreement Liu signed, which he does not now refute, he admitted
that: (1) He entered or introduced, or attempted to enter or introduce,
into the commerce of the United States, imported merchandise; (2) he
did so by means of any fraudulent or false invoice, declaration,
affidavit, letter, paper, or by means of any false statement, written
or verbal; and (3) he was without reasonable cause to believe the truth
of such statement or procured the making of any such false statement as
to any matter material thereto without reasonable cause to believe the
truth of such statement (Plea Agreement at 2). He further admitted that
this conduct related to the importation of honey, a food (see, for
example, Plea Agreement at 11-12, June 21 submission at 2-3).
Accordingly, Liu is subject to debarment under section 306(b)(3) on the
basis of that felony conviction.
    Since Liu's felony conviction for conduct relating to the
importation into the United States of honey establishes a predicate
from which FDA may choose to exercise its authority to debar him, Liu's
June 21 submission in support of his request for a hearing attempts to
raise factual issues concerning the

application of the factors in section 306(c)(3) that FDA is required to
consider in determining the appropriateness and the period of
debarment. These are the applicable criteria: (1) The nature and
seriousness of any offense involved; (2) the nature and extent of
management participation in any offense involved, whether corporate
policies and practices encouraged the offense, including whether
inadequate institutional controls contributed to the offense; (3) the
nature and extent of voluntary steps to mitigate the impact on the
public of any offense involved, including . . . full cooperation with
any investigations (including the extent of disclosure to appropriate
authorities of all wrongdoing) . . . and any other actions taken to
substantially limit potential or actual adverse effects on the public
health; (4) whether the extent to which changes in ownership,
management, or operations have corrected the causes of any offense
involved and provide reasonable assurances that the offense will not
occur in the future; and (5) prior convictions under the FD&C Act or
under other Acts involving matters within the jurisdiction of FDA.
    Significantly, the health and age of an individual subject to
debarment are not included as factors relevant to FDA's exercise of the
Agency's debarment authority. Although a defendant may sometimes argue
that poor health and advanced age should be considered in mitigation of
punishment, debarment under 21 U.S.C. 335a is not a punitive sanction.
Instead it is remedial in purpose. (See DiCola v. FDA, 77 F.3d 504, 507
(D.C. Cir. 1996) (permanent debarment of convicted individual is not
punishment, but instead is a remedy to protect the integrity of the
drug industry and public confidence in that industry); Bae v. Shalala,
44 F.3d 489, 493 (7th Cir. 1995) (purpose of statute establishing
debarment authority was to restore consumer confidence in generic drugs
by eradicating widespread corruption in generic drug approval
process).) In determining whether to debar Liu, as well as the length
of a term of debarment, FDA acts to protect the public health and not
to punish Liu. Because we are acting for this remedial, not punitive,
purpose, Liu's arguments concerning his health and age are not relevant
to this proceeding.
    I address each of the relevant factors in turn.

A. The Nature and Seriousness of the Offense

    Liu emphasizes that he was not convicted of the charge for which he
was originally indicted, conspiracy to violate 18 U.S.C. 545 by
conspiring to enter goods into the United States through false
statement, and to smuggle goods. He urges that conviction under the
original charge would have required proof that he acted ``knowingly and
intentionally'' (June 21 submission at 3). He devotes much of his
submission to his argument that he did not act ``knowingly and
intentionally.'' According to Liu's June 21 submission, Liu's
accomplices, Yong Xiang Yan, the owner of Changge Jixiang Bee Products,
Ltd. of Henan China, and Boa Zhong Zhang, a vice-president and part
owner of Changge, established a scheme to transship and import into the
United States Chinese honey, using Indigo Distribution Corp. in the
Philippines. He disclaims knowledge of the nature and extent of their
operations (June 21 submission at 4).
    However, these allegations are not relevant. Liu's conviction was
not for violating, or conspiring to violate, 18 U.S.C. 545. The offense
that must be considered is his felony violation of 18 U.S.C. 542 and 2,
which was based on Liu's causing the false declarations to be made even
though he was without reasonable cause to believe the truth of such
statements. Even in his June 21 submission, Liu expressly acknowledges
that he had documents in his possession indicating that, as described
in the Plea Agreement and as charged in the superseding information to
which he pleaded guilty, two shipments of honey he imported actually
originated in China (June 21 submission at 3). He leaves unchallenged
the factual basis for his conviction: That, without reasonable cause to
believe the truth of the statements, he caused his customs broker to
falsely state that the shipments originated in Thailand (December 20,
2006, shipment) and the Philippines (February 14, 2007, shipment).
Although he dismisses these as a ``few emails . . . among many hundreds
of documents relating to the importation of honey found in Mr. Liu's
house'' (June 21 submission at 3), he fully admits that these
communications were in his possession. Liu has raised no factual issue
for resolution at a hearing concerning whether he acted without
reasonable cause to believe the truth of the statements concerning
where the honey was produced.
    We further note that the statement of facts, which Liu admitted in
his plea agreement, provides additional information concerning his
actions which demonstrate the financial motive behind this offense. Had
Liu instructed his customs broker to declare the country of origin as
China, he and his companies would have been responsible for anti-
dumping duties in the amount of 221 percent of the value of the honey
(Plea Agreement at 11-12). Liu's misrepresentation was thus both
material and meaningful in the imports process, and it could not have
been lost on Liu how important the country of origin was in the context
of the anti-dumping duties for Chinese honey.
    Finally, I note that Liu's conviction did not rest on a single
false statement. Instead, he pleaded guilty to a superseding
information that included false statements with respect to two separate
entries of imported Chinese honey, 2 months apart. His conviction did
not rest on a single isolated incident, but on a repeated violation.
    Therefore, it is undisputed that Liu was responsible for multiple
material false statements that resulted in the avoidance of significant
duties for the importation of two shipments of honey with a total
declared value of $186,912. As such, I agree with ORA's evaluation of
this consideration and find that the nature and seriousness of Liu's
felony offense weighs strongly in favor of debarment.

B. The Nature and Extent of Management Participation in the Offense

    Next, I consider whether Liu's response raised specific facts
showing that there is a genuine and substantial issue of fact that
requires a hearing concerning the nature and extent of management
participation in the offense, including whether corporate policies and
practices encouraged the offense, and whether inadequate institutional
controls contributed to the offense.
    In the Notice of Opportunity for a Hearing, ORA stated, ``As the
owner of the importing companies, you were responsible for the accuracy
of declarations made to United States customs officials. You were
without reasonable cause to believe the truth of these declarations
regarding the origins of the honey. Further, you directly profited from
the domestic sale of the imported honey.''
    Liu has not challenged these statements, and all of the
descriptions of Liu's actions in the June 21 submission show him to act
alone, as the individual responsible for importing these two shipments
of honey. I agree with ORA that, based upon these facts, the nature and
extent of Liu's management participation in the offense weighs in favor
of debarment.

C. The Nature and Extent of Voluntary Steps To Mitigate the Impact on
the Public

    Next, I consider whether Liu has raised specific facts showing that
there is a genuine and substantial issue of fact that requires a
hearing concerning the nature and extent of voluntary steps to mitigate
the impact of his offense on the public, including full cooperation
with any investigations (including the extent of disclosure to
appropriate authorities of all wrongdoing) and any other actions taken
to substantially limit potential or actual adverse effects on the
public health.
    In the Notice of Opportunity for a Hearing, ORA stated, ``You took
no steps to mitigate the impact on the public of your actions.'' Liu
has not challenged this statement. As such, I agree with ORA that the
nature and extent of Liu's voluntary steps to mitigate the impact to
the public weighs in favor of debarment.

D. The Impact of Changes in Ownership, Management, or Operations

    In the Notice of Opportunity for Hearing, ORA determined that this
factor was not applicable for consideration. Liu has not challenged
that determination.

E. Prior Convictions Under the FD&C Act or Related Acts

    In the Notice of Opportunity for Hearing, ORA acknowledged that the
Agency was unaware of any prior convictions involving matters within
the jurisdiction of FDA. The lack of previous violations of the FD&C
Act or related statutes by Liu weighs against debarment.

III. Findings and Order

    The Director of the Office of Scientific Integrity, under section
306(b)(3)(A) of the FD&C Act and under authority delegated to him,
finds that Liu has been convicted of a felony for conduct relating to
the importation of food into the United States. Accordingly, FDA may
debar Liu from importing articles of food or offering such articles for
import into the United States for a period of not more than 5 years.
    I have considered the arguments raised by Liu regarding the
relevant factors listed in section 306(c)(3) of the FD&C Act and have
determined that Liu has raised no genuine and substantial issues of
fact that require resolution at an evidentiary hearing. I have
considered the factors in section 306(c)(3) of the FD&C Act. The nature
and seriousness of Liu's offense, Liu's management participation in the
offense, and the lack of any voluntary steps to mitigate the impact of
the offense weigh in favor of debarring. Although Liu appears to have
no prior criminal convictions involving matters within the jurisdiction
of FDA, that consideration does not counterbalance to a sufficient
degree the remaining considerations to warrant decreasing the period of
debarment. Of particular note is the nature and seriousness of the
offense, in light of the volume of honey that was imported, the amount
of duties that were avoided, and the fact that false statements were
made with regard to two shipments of honey. I agree with ORA's proposed
period of debarment and find that a debarment of 5 years is
appropriate.
    As a result of the foregoing findings, Liu is debarred for a period
of 5 years from importing articles of food or offering such articles
for import into the United States, effective (see DATES). Under section
301(cc) of the FD&C Act, the importing or offering for import into the
United States of an article of food by, with the assistance of, or at
the direction of Liu is a prohibited act.
    Any application by Liu for termination of debarment under section
306(d) of the FD&C Act should be identified with Docket No. FDA-2011-N-
0169 and sent to the Division of Dockets Management Branch (see
ADDRESSES). All such submissions are to be filed in four copies. The
public availability of information in these submissions is governed by
21 CFR 10.20(j). Publicly available submissions may be seen in the
Division of Dockets Management Branch between 9 a.m. and 4 p.m., Monday
through Friday. Persons with access to the Internet may obtain
documents in the Docket at http://www.regulations.gov.

    Dated: June 25, 2015.
Nathan Doty,
Director, Office of Scientific Integrity.
[FR Doc. 2015-16561 Filed 7-6-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 188 (Thursday, September 29, 2022)]
[Notices]
[Pages 59072-59074]
[FR Doc No: 2022-21151]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP22-510-000]

Gulf South Pipeline Company, LLC; Notice of Application and
Establishing Intervention Deadline

    Take notice that on September 16, 2022, Gulf South Pipeline
Company, LLC (Gulf South), 9 Greenway Plaza, Suite 2800, Houston, TX
77046, filed an application under section 7(c) of the Natural Gas Act
(NGA), and Part 157 and 284 of the Commission's regulations requesting
authorization to modify the working gas and base gas capacities at its
Bistineau Gas Storage Facility (Bistineau Storage) located in Bienville
and Bossier Parishes, Louisiana.\1\
---------------------------------------------------------------------------

    \1\ Gulf South is not seeking abandonment authorization in this
application as Gulf South's proposal seeks only to reclassify the
capacity at Bistineau with no changes to firm services.
---------------------------------------------------------------------------

    Gulf South proposes to reduce the level of its interruptible
working gas capacity and increase its level of its base gas capacity
based on the results of a third-party engineering study. Gulf South
seeks authorization to (i) reclassify 13.54 billion cubic feet (Bcf) of
working gas capacity currently utilized for interruptible storage
services (ISS) as base gas capacity to establish a new base gas
capacity of 62.30 Bcf, and (ii) reclassify for use as base gas 13.54
Bcf of excess operational gas owned by Gulf South (Reclassification
Project or Project). Gulf South also requests Commission approval of
the accounting entries included as Exhibit Z-1 which reflect the
reclassification of this gas.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.
    Any questions regarding the proposed project should be directed to
J. Kyle Stephens, Vice President of Regulatory Affairs or to Juan
Eligio Jr., Manager of Regulatory Affairs, Gulf South Pipeline Company,
LLC, 9 Greenway Plaza, Houston, Texas 77046 or by phone at (713) 479-
8033, or by email at [email protected] or phone at (713)
479-3480 or by email at [email protected].
    Pursuant to Section 157.9 of the Commission's Rules of Practice and
Procedure,\2\ within 90 days of this Notice the Commission staff will
either: complete its environmental review and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or environmental
assessment (EA) for this proposal. The filing of an EA in the
Commission's public record for this proceeding or the issuance of a
Notice of Schedule for Environmental Review will serve to notify
federal and state agencies of the timing for the completion of all
necessary reviews, and the subsequent need to complete all federal
authorizations within 90 days of the date of issuance of the Commission
staff's FEIS or EA.
---------------------------------------------------------------------------

    \2\ 18 CFR (Code of Federal Regulations) 157.9.
---------------------------------------------------------------------------

Public Participation

    There are two ways to become involved in the Commission's review of
this project: you can file comments on the project, and you can file a
motion to intervene in the proceeding. There is no fee or cost for
filing comments or intervening. The deadline for filing a motion to
intervene is 5:00 p.m. Eastern Time on October 14, 2022.

Comments

    Any person wishing to comment on the project may do so. Comments
may include statements of support or objections to the project as a
whole or specific aspects of the project. The more specific your
comments, the more useful they will be. To ensure that your comments
are timely and properly

recorded, please submit your comments on or before October 14, 2022.
    There are three methods you can use to submit your comments to the
Commission. In all instances, please reference the Project docket
number CP22-510-000 in your submission.
    (1) You may file your comments electronically by using the eComment
feature, which is located on the Commission's website at www.ferc.gov
under the link to Documents and Filings. Using eComment is an easy
method for interested persons to submit brief, text-only comments on a
project;
    (2) You may file your comments electronically by using the eFiling
feature, which is located on the Commission's website (www.ferc.gov)
under the link to Documents and Filings. With eFiling, you can provide
comments in a variety of formats by attaching them as a file with your
submission. New eFiling users must first create an account by clicking
on ``eRegister.'' You will be asked to select the type of filing you
are making; first select ``General'' and then select ``Comment on a
Filing''; or
    (3) You can file a paper copy of your comments by mailing them to
the following address below. Your written comments must reference the
Project docket number (CP22-510-000).

Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street NE, Washington, DC 20426

    To mail via any other courier, use the following address:

Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission,
12225 Wilkins Avenue, Rockville, Maryland 20852

    The Commission encourages electronic filing of comments (options 1
and 2 above) and has eFiling staff available to assist you at (202)
502-8258 or [email protected]
    Persons who comment on the environmental review of this project
will be placed on the Commission's environmental mailing list, and will
receive notification when the environmental documents (EA or EIS) are
issued for this project and will be notified of meetings associated
with the Commission's environmental review process.
    The Commission considers all comments received about the project in
determining the appropriate action to be taken. However, the filing of
a comment alone will not serve to make the filer a party to the
proceeding. To become a party, you must intervene in the proceeding.
For instructions on how to intervene, see below.

Interventions

    Any person, which includes individuals, organizations, businesses,
municipalities, and other entities,\3\ has the option to file a motion
to intervene in this proceeding. Only intervenors have the right to
request rehearing of Commission orders issued in this proceeding and to
subsequently challenge the Commission's orders in the U.S. Circuit
Courts of Appeal.
---------------------------------------------------------------------------

    \3\ 18 CFR 385.102(d).
---------------------------------------------------------------------------

    To intervene, you must submit a motion to intervene to the
Commission in accordance with Rule 214 of the Commission's Rules of
Practice and Procedure \4\ and the regulations under the NGA \5\ by the
intervention deadline for the project, which is October 14, 2022. As
described further in Rule 214, your motion to intervene must state, to
the extent known, your position regarding the proceeding, as well as
the your interest in the proceeding. [For an individual, this could
include your status as a landowner, ratepayer, resident of an impacted
community, or recreationist. You do not need to have property directly
impacted by the project in order to intervene.] For more information
about motions to intervene, refer to the FERC website at https://www.ferc.gov/resources/guides/how-to/intervene.asp.
---------------------------------------------------------------------------

    \4\ 18 CFR 385.214.
    \5\ 18 CFR 157.10.
---------------------------------------------------------------------------

    There are two ways to submit your motion to intervene. In both
instances, please reference the Project docket number CP22-510-000 in
your submission.
    (1) You may file your motion to intervene by using the Commission's
eFiling feature, which is located on the Commission's website
(www.ferc.gov) under the link to Documents and Filings. New eFiling
users must first create an account by clicking on ``eRegister.'' You
will be asked to select the type of filing you are making; first select
``General'' and then select ``Intervention.'' The eFiling feature
includes a document-less intervention option; for more information,
visit https://www.ferc.gov/docs-filing/efiling/document-less-intervention.pdf.; or
    (2) You can file a paper copy of your motion to intervene, along
with three copies, by mailing the documents to the address below . Your
motion to intervene must reference the Project docket number CP22-510-
000.

Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street NE, Washington, DC 20426

    To mail via any other courier, use the following address:

Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission,
12225 Wilkins Avenue, Rockville, Maryland 20852

    The Commission encourages electronic filing of motions to intervene
(option 1 above) and has eFiling staff available to assist you at (202)
502-8258 or [email protected]
    Motions to intervene must be served on the applicant either by mail
or email at: 9 Greenway Plaza, Suite 2800, Houston, Texas 77046 or at
[email protected] and [email protected]. Any
subsequent submissions by an intervenor must be served on the applicant
and all other parties to the proceeding. Contact information for
parties can be downloaded from the service list at the eService link on
FERC Online. Service can be via email with a link to the document.
    All timely, unopposed \6\ motions to intervene are automatically
granted by operation of Rule 214(c)(1).\7\ Motions to intervene that
are filed after the intervention deadline are untimely, and may be
denied. Any late-filed motion to intervene must show good cause for
being late and must explain why the time limitation should be waived
and provide justification by reference to factors set forth in Rule
214(d) of the Commission's Rules and Regulations.\8\ A person obtaining
party status will be placed on the service list maintained by the
Secretary of the Commission and will receive copies (paper or
electronic) of all documents filed by the applicant and by all other
parties.
---------------------------------------------------------------------------

    \6\ The applicant has 15 days from the submittal of a motion to
intervene to file a written objection to the intervention.
    \7\ 18 CFR 385.214(c)(1).
    \8\ 18 CFR 385.214(b)(3) and (d).
---------------------------------------------------------------------------

Tracking the Proceeding

    Throughout the proceeding, additional information about the project
will be available from the Commission's Office of External Affairs, at
(866) 208-FERC, or on the FERC website at www.ferc.gov using the
``eLibrary'' link as described above. The eLibrary link also provides
access to the texts of all formal documents issued by the Commission,
such as orders, notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with

notification of these filings, document summaries, and direct links to
the documents. For more information and to register, go to
www.ferc.gov/docs-filing/esubscription.asp.
    Intervention Deadline: 5:00 p.m. Eastern Time on October 14, 2022.

    Dated: September 23, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-21151 Filed 9-28-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: February 8, 2010 (Volume 75, Number 25)]
[Notices]
[Page 6246-6248]
[DOCID:fr08fe10-102]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61451; File No. SR-NASDAQ-2010-012]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of a Proposed Rule Change
Describing the NASDAQ Ouch BBO Feed

February 1, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on January 22, 2010, The NASDAQ Stock Market LLC (``Nasdaq'' or the
``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 Nasdaq. Nasdaq has
designated the proposed rule change as constituting a rule change under
Rule 19b-4(f)(6) under the Act,\3\ which renders the proposal effective
upon filing with the Commission. 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\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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

    Nasdaq submits this proposal regarding the availability of the
NASDAQ Ouch BBO Feed, a data feed that represents Nasdaq's internal
view of the best bid and offer among all market centers other than
Nasdaq (the ``BBO''), which is provided at no cost.

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

    In its filing with the Commission, Nasdaq 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. Nasdaq 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
    Nasdaq submits this proposal regarding the availability of the
NASDAQ Ouch BBO Feed, a data feed that represents Nasdaq's internal
view of the best bid and offer among all market centers other than
Nasdaq. The NASDAQ Ouch BBO Feed is available to all NASDAQ members
equally at no charge, and offers all firms transparent, real-time data
concerning Nasdaq's internal view of the BBO. This data feed reflects
Nasdaq's view of the BBO, at any given time, based on orders executed
on Nasdaq and updated quote information from the SIPs. Nasdaq makes the
NASDAQ Ouch BBO Feed available to all market participants via
subscription through an established connection to Nasdaq through
extranets, direct connection, and Internet-based virtual private
networks.
    The NASDAQ Ouch BBO Feed contains the following data elements:
Symbol, bid price, and ask price.\4\ Unlike the Nasdaq TotalView feed,
the Ouch BBO feed does not contain information about individual orders,
either those residing within the Nasdaq system or those executed or
routed by Nasdaq. Unlike the SIP feeds containing the National Best Bid
and Offer (``NBBO''), the Ouch BBO Feed does not identify either the
market center quoting the BBO or the size of the BBO quotes. It merely
contains the symbol and bid and offer prices.
---------------------------------------------------------------------------

    \4\ Nasdaq also provides a time stamp and message type field for
reference.
---------------------------------------------------------------------------

    By making the NASDAQ Ouch BBO Feed data available, Nasdaq enhances
market transparency and fosters competition among orders and markets.
Member firms may use the NASDAQ Ouch BBO Feed to more accurately price
their orders based on Nasdaq's view of what the BBO is at any point in
time, which may not be reflected in the official NBBO due to latencies
inherent in the NBBO's dissemination. As a consequence, member firms
may more accurately price their orders on Nasdaq, thus avoiding price
adjustments by Nasdaq based on a quote that is no longer available.
Additionally, members can price orders more aggressively to narrow the
NBBO and provide better reference prices for investors.
    At this time, Nasdaq does not have plans to charge an additional
fee associated with the receipt of the NASDAQ Ouch BBO Feed. Should
Nasdaq determine to charge fees associated with the NASDAQ Ouch BBO
Feed, Nasdaq will submit a proposed rule change to the Commission in
order to implement those fees.
2. Statutory Basis
    Nasdaq believes that the proposed rule change is consistent with
the provisions of Section 6 of the Act,\5\ in general and with Sections
6(b)(5) of the Act,\6\ in particular in that it is designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, to foster cooperation and coordination
with persons engaged in regulating, clearing, settling, processing
information with respect to, and facilitating transactions in
securities, to remove impediments to and perfect the mechanism of a
free and open market and a national market system, and, in general, to
protect investors and the public interest. Nasdaq believes that this
proposal is in keeping with those principles by promoting increased
transparency through the dissemination of NASDAQ Ouch BBO Feed data and
by clarifying its availability.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f.
    \6\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

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

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 \7\ and Rule 19b-
4(f)(6) thereunder.\8\
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A).
    \8\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file 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.
Nasdaq has satisfied this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \9\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6) \10\ permits the Commission to
designate a shorter time if such action is consistent with the
protection of investors and the public interest. Nasdaq requests that
the Commission waive the 30-day operative delay because it would permit
Nasdaq to immediately provide the information regarding the NASDAQ Ouch
BBO Feed access requirements to market participants. The Commission
believes that waiving the 30-day operative delay \11\ is consistent
with the protection of investors and the public interest and designates
the proposal operative upon filing.
---------------------------------------------------------------------------

    \9\ 17 CFR 240.19b-4(f)(6).
    \10\ 17 CFR 240.19b-4(f)(6).
    \11\ 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 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-NASDAQ-2010-012 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-NASDAQ-2010-012. 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 such filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make publicly available. All
submissions should refer to File Number SR-NASDAQ-2010-012 and should
be submitted on or before March 1, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
---------------------------------------------------------------------------

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

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-2580 Filed 2-5-10; 8:45 am]
BILLING CODE 8011-01-P


Vickie S. Wilson EDVMS Meeting December 10 12 2003 Androgen Receptor Binding Assay Update Overview ° General introduction to binding assays ° NICEATM/ ICCVAM and Expert Panel ° Summary of work completed

Training and Protocol Refinement

Comparison of RPC and PV

Scatchard analyses

R1881 comparison

16 chemicals ° Future Direction HRE R R R DNA GENE A mRNA S SHBG mRNA Blood 2 3 4 6 7 8 Cytoplasm Nucleus HSP HSP tRNA mRNA Protein A LEG RT ' 98 tf r Target Cell 1 S c 9 Gonad S S S S SHBG S S S S S R S 3 10 5 aa Luciferase S Two basic types of receptor binding Two basic types of receptor binding experiments experiments ° Saturation Affinity of radioactive ligand for the receptor  Kd  Affinity of radioligand  Bmax  Binding sites ° Competition Affinity of unlabeled ligand in competition with high affinity radioligand  IC50, RBA  Ki   affinity of unlabeled ligand Basic Steps in Receptor Binding Assays Basic Steps in Receptor Binding Assays Receptor ( R) + [ 3H] Ligand ( Free) Receptor: Ligand Complex ( Bound)

k1 k2 Incubate R R 3H 3H R 3H 3H 3H 3H R 3H R 3H R Separate Bound from Free Measure Radioactivity Bound Analyze Results Radiolabeled ligand Test chemical R 3H Receptor [ T ]

[ T ]

1 [ T ]

[ T ]

2 [ T ]

[ T ]

7   1E 11 1E 10 1E 9 1E 8 1E 7 0 20 40 60 80 100 %

Bound Concentration, M Competitive Binding Curve Competitive Binding Curve Quality Data Quality Data 1E 12 1E 11 1E 10 1E 9 1E 8 1E 7 1E 6 1E 5 1E 4 1E 3 0.01 0 20 40 60 80 100 %

Bound Concentration, M Standard Unknown 1 1E 11 1E 10 1E 9 1E 8 1E 7 1E 6 1E 5 1E 4 1E 3 0.01 0 20 40 60 80 100 %

Bound Concentration, M Standard Unknown 2 Example Binding Curves:

Example Binding Curves:

Examine data carefully for problems Examine data carefully for problems 0.0 0.2 0.4 0.6 0.8 1.0 1.2 1.4 1.6 1.8 2.0 0.00 0.05 0.10 0.15 0.20 1/

Bound 1/ Free R1881 0 µ M 50 µ M 100 µ M 200 µ M Experimental Determination of Experimental Determination of Competitive Inhibition and Competitive Inhibition and K i 0 50 100 150 200 2 3 4 5 6 7 8 9 Slope X 100 [ Competitor] ( µ M)

Double reciprocal plot Double reciprocal plot Slope Slope replot replot EDC Expert Panel Report ° Acknowledged the lack of a standardized in vitro AR binding assay protocol ° Identified need for establishing comparative performance criteria ° Agreed on minimum procedural standards ° Acknowledged that RPC is " Gold Standard" for comparison purposes

Most frequently used  Particularly useful as a reference

Has several disadvantages ° Recommended as high priority the development of an assay using purified, recombinant full length AR ° Patent issues with hAR so an assay using an AR sequence from a species closely related to human may be necessary Overview ° General introduction to binding assays ° NICEATM/ ICCVAM and Expert Panel ° Summary of work completed

Training and Protocol Refinement

Comparison of RPC and PV

Scatchard analyses

R1881 comparison

16 chemicals ° Future Direction Comparison of RPC and PanVera Assays 2 Protocols Rat Ventral Prostate Cytosol ( RPC)  from EPA, RTD PanVera  from NCTR Design:

° 3 Technicians ° Each tech ran every chemical in both protocols ° 2 Duplicate tubes per run ( 3 runs in dup)

° Positives were repeated by all 3 techs ( 6 runs)

19 Chemicals over a range of potencies Identified by number only Test chemical concentrations as specified in each protocol 3.8 4.5 3.9 1 0.71 0.34 6.5 6.6 8.5 4.8 2.1 0.68  11  10  9  8  7  6  11  10  9  8  7  6 0 20 40 60 80 100 120 % r a d i o l a b e l l e d 1 8 8 1 b o u n d rAR STD rAR Mean PV STD PV Mean Comparison of RPC and PV binding assays for R1881.

The interassay CV for the PV assay is 13% versus 6% for the RPC assay. Hence the PV assay is 2 fold more variable, which will require more replicates. M003002 AR  11  10  9  8  7  6  5  4 0 50 100 150 2/ 8/ 01 ( 7 J)

2/ 8/ 01 ( 8 N)

2/ 8/ 01 ( 9 B)

2/ 12/ 01 ( 10 J)

2/ 12/ 01 ( 11 N)

2/ 12/ 01 ( 12 B)

Competitor Concentration ( M)

3 H

R1881 bound (%) M003002 Pan Vera  11  10  9  8  7  6  5  4  3 0 50 100 1/ 31/ 01 ( 1 N)

1/ 31/ 01 ( 2 B)

1/ 31/ 01 ( 3 J)

2/ 6/ 01 ( 4 J)

2/ 6/ 01 ( 5 N)

2/ 6/ 01 ( 6 B)

Competitor Competition ( M)

%

Bound Tritiated R

1881 Binding Binding Curves Curves Example of Example of Variability Variability between runs between runs 6 runs of same chemical in both protocols RPC PV PV Binding Assay for 3039 ( DEHP)

Comparison of RPC and PV for p, p' DDE Examples Illustrating Concerns with PV Assay 90 80 34 15 11 27 128 122 104 94 85 78 4.3E 10 4.3E 9 4.3E 8 4.3E 7 4.3E 6 4.3E 5 0 50 100 150 % r a d i o l a b e l l e d 1 8 8 1 b o u n d PV hAR STD High Interassay Variability Binding Greater than 100%

Comparison of RPC and PV for E2 1E 11 1E 10 1E 9 1E 8 1E 7 1E 6 1E 5 0.0001 0.001 0 20 40 60 80 100 120 140 % r a d i o l a b e l l e d 1 8 8 1 b o u n d PV hAR VP rAR 2003 U Shaped Curve 1E 10 1E 9 1E 8 1E 7 1E 6 1E 5 0.0001 0.001 0.01 0 10 20 30 40 50 60 70 80 90 100 110 % r a d i o l a b e l l e d 1 8 8 1 b o u n d PV hAR VP rAR 2003 Curve Shifted Analysis of Assay Comparison  High intra assay variability in PV ° 3.5% of duplicates rejected. Discrepancy of greater than 25%

 High inter assay CV in PV assay ° Twice the rejection rate of the RPC  Several PV assays with extraordinarily high CVs  Other Issues ° Some U Shaped binding curves in PV ° Binding greater than 100% in some PV assays  Different concentrations of unknowns used in RPC and PV assays complicates comparison of assays Scatchard Display 289 L 10/ 7/ 2002 0 2500 5000 7500 10000 12500 15000 0 2500 5000 7500 10000 12500 Specific Binding Bound/

Free WA 2 22 Saturation Studies Run 289 L 10/ 7/ 02 0 1 2 3 4 5 6 7 8 9 10 11 0 2500 5000 7500 10000 12500 15000 Equation 1 Best fit values BMAX KD Std. Error BMAX KD 95% Confidence Intervals BMAX KD 289L 13949 0.8800 376.3 0.04999 13142 to 14756 0.7728 to 0.9873 R1881 ( nM)

Specific Binding (

DPM) Run Kd, nM Bmax, fmol/ mg 288J 0.9418 65.29 289L 0.880 64.75 290J 0.9615 66.0 291L 0.8710 64.59 Mean 0.914 +/ 0.04 65.16 +/ 0.64 Saturation Binding Acceptable ° Two technicians ° Two Runs per technician ° Duplicates per run ° Runs on two different days Reference Chemical ( R1881) Comparison  2 Technicians each ran twice with duplicates   4 reps ( Subtask 3.2)

 Repeated   2 technicians; 6 runs each   12 reps ( Subtask 3.5)  Sixteen total replicates  Analysis was a nested ANOVA with a 5 x 2 x 8 x 2 design ( 5 concentrations of R1881; 2 techs; 8 replicates per tech; 2 duplicate observations per replicate) log( R1881)

 12  11  10  9  8  7  6 Percent Hot R1881 Bound 0 20 40 60 80 100 120 R303 R304 R305 R306 Data 5 Data 6 R318 R319 R320 R321 R322 R323 R332 R333 R334 R335 R337 R338 one site competition Sigma Plots's Ligand software R1881 Binding All runs converged and had R2 values greater than 99% 1 . 3 3 3 1 . 3 4 3 1 . 2 9 7 5 1 . 1 8 8 0 . 7 9 1 7 0 . 7 7 8 0 . 8 0 5 1 0 . 9 2 2 0 5 0 . 7 4 8 5 0 . 9 0 1 7 1 . 0 9 6 1 . 0 8 3 0 . 9 8 1 8 5 1 . 0 5 3 4 0 . 9 9 1 7 5 0 . 9 9 5 2 3 0 3 3 0 4 3 0 5 3 0 6 3 1 8 3 1 9 3 2 0 3 2 1 3 2 2 3 2 3 3 3 2 3 3 3 3 3 4 3 3 5 3 3 7 3 3 8 0.7 0.8 0.9 1 1.1 1.2 1.3 1.4 EC50s E 9 8 . 8 8 7 8 . 8 7 5 8 . 8 7 8 8 . 9 2 8 9 . 1 0 1 9 . 1 1 2 9 . 0 9 4 9 . 0 3 7 9 . 1 2 6 9 . 0 4 7 8 . 9 6 8 . 9 6 8 9 . 0 1 6 8 . 9 7 9 9 . 0 0 5 9 . 0 0 5 3 0 3 3 0 4 3 0 5 3 0 6 3 1 8 3 1 9 3 2 0 3 2 1 3 2 2 3 2 3 3 3 2 3 3 3 3 3 4 3 3 5 3 3 7 3 3 8 8.7 8.8 8.9 9 9.1 9.2 9.3  LogEC50s EC50 and log EC50 by Run EC50 and log EC50 by Run ° Shows clustering of results over time ° CV of reps ( 8) within batch = 4.6%

° CV between batches = 22.5%

° Note similarity of reps between 2 technicians 1 . 2 9 0 . 8 2 4 5 1 . 0 3 3 6 SOW 3.2 SOW 3.5 A SOW 3.5 B 0.7 0.8 0.9 1 1.1 1.2 1.3 1.4 EC50s E 9 8 . 8 9 2 9 . 0 8 6 8 . 9 9 SOW 3.2 SOW 3.5 A SOW 3.5 B 8 8.5 9  LogEC50s EC50 and log EC50  Mean and SE " Batch" Clustering of Results Over Time All Three groups differ significantly from each other CV between batches = 22.5% Summary and Conclusions R1881 R1881 Comparison ° Binding assay with R1881 was run 16 times in three " batches" by 2 technicians ° CV for duplicates   about 5%

° Interassay CV   about 22%

° Each run provided an excellent fit  R squared values greater than 99%

° In the worst case, the IC50 values varied by 2 fold ( 0.7 X10 9 to 1.3 X 10 9)

° Success 0.68 0.538 P 2 19 P2 22 0.5 0.55 0.6 0.65 0.7 0.75 4831 EC50 E 6 4 androstene 3,17 dione 1.28 1.047 P 2 19 P2 22 0.5 0.6 0.7 0.8 0.9 1 1.1 1.2 1.3 1.4 1.5 R1881 EC50 E 9 Task 3.3 AR Binding protocol comparison. Battelle concluded that there were only slight differences between the two protocols. However, we found that several of these were statistically significant. The " experiment" was unacceptable as designed, so such results should be ignored until the hypothesis is tested in a true side by side experiment.

p < 0.05 p < 0.012 2.5 2.21 P 2 19 P2 22 1.5 2 2.5 3 4833 EC50 E 9 5 alpha DHT 6.81 6.05 P 2 19 P2 22 5 5.5 6 6.5 7 7.5 4837 EC50 E 6 Corticosterone p < 0.053 p < 0.2 Results of 16 Chemicals Results of 16 Chemicals ° Original Report from Battelle classified ° 14 Chemicals as Binders ° 2 Chemicals as Non Binders ° EPA Review reclassification ° 10 Binders ° 4 Equivocal ° 2 Non binders ° Equivocal binders  need additional experiments to define Ki ° Chemicals were each run 2 3 times but better experimental design needed before detailed statistical analysis 4 tert Octylphenol Methoxychlor Vinclozolin Procymidone Linuron Cyproterone Acetate 17  Estradiol P, p' DDE Medroxyprogesterone Acetate Methyltrienolone Testosterone Progesterone Dexamethasone Spironolactone BINDERS Atrazine Di( 2 ethylhexyl) phthalate ( DEHP) EQUIVOCAL NON BINDERS Recombinant Androgen Receptor Expert Panel recommended as high priority the development of an assay using purified, recombinant full length AR  Patent issues with human AR  Species closely related to human Questions with truncated ( chimeric) AR Ongoing work at EPA, RTD  Chimpanzee cDNA library obtained  Screening for full length AR Future Direction ° Supplement binding data of 16 chemicals with additional runs and conduct statistical analysis ( intralaboratory)

° Work on recombinant system is being conducted but lags behind ° desirable but 2 3 years for development and standardization ° no commercial or non commercial source available ° Move forward with RPC assay ° standard data set ° comparative performance criteria ° interlaboratory study


language to the language used to discuss conditions that trigger the
disclosure requirement; (4) add the phrase ``an applicable index'' to
proposed Supplementary Material .06(b)(ii)(B) of Rule G-30 to ensure
that the proposed guidance contemplates an appropriate

spread relied upon for tax-exempt municipal securities; and (5) extend
the implementation period of the proposed rule change from no later
than one year to no later than 18 months.
    According to the MSRB, it has proposed the revisions included in
Amendment No. 1 in response to specific commenter suggestions and
commenters' general preference for the MSRB and FINRA to adopt
harmonized mark-up disclosure rules and prevailing market price
guidance. The Commission notes that the addition of the terms ``off-
setting'' and ``an applicable index'' to the proposed rule change is
solely a clarification amendment for the avoidance of doubt and that
the amendment does not alter the substance of the rule. Furthermore,
extension of the implementation period of the proposal from no later
than one year to no later than 18 months is appropriate and responsive
to the operational and implementation concerns raised by commenters.
The Commission also notes that after consideration of the comments the
MSRB received on its proposal to require a security-specific hyperlink
to EMMA and the execution time of the transaction, the MSRB amended its
proposal in a manner that is identical to the Amendment No. 1 that
FINRA has filed.\262\ Based on the foregoing, the Commission finds that
the proposed rule change, as modified by Amendment No. 1, is consistent
with Section 15B(b)(2)(C) of the Act, which requires, among other
things, that the MSRB's rules be designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, to foster cooperation and coordination with
persons engaged in regulating, clearing, settling, processing
information with respect to, and facilitating transactions in municipal
securities and municipal financial products, to remove impediments to
and perfect the mechanism of a free and open market in municipal
securities and municipal financial products, and, in general, to
protect investors, municipal entities, obligated persons, and the
public interest, and not be designed to impose any burden on
competition not necessary or appropriate in furtherance of the purposes
of the Act.\263\
---------------------------------------------------------------------------

    \262\ See FINRA Amendment No. 1, supra note 11.
    \263\ 15 U.S.C. 78o-4(b)(2)(C).
---------------------------------------------------------------------------

    The Commission notes that it today has approved the FINRA Proposal,
as modified by FINRA Amendment No. 1, and believes that in the
interests of promoting efficiency in the implementation of both
proposals, it is appropriate to approve the proposed rule change, as
modified by Amendment No. 1, concurrently. Accordingly, the Commission
finds good cause, pursuant to Section 19(b)(2) of the Exchange
Act,\264\ to approve the proposed rule change, as modified by Amendment
No. 1, on an accelerated basis.
---------------------------------------------------------------------------

    \264\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

VII. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\265\ that the proposed rule change (SR-MSRB-2016-12), as modified
by Amendment No. 1, is approved on an accelerated basis.
---------------------------------------------------------------------------

    \265\ 15 U.S.C. 78s(b)(2).

    For the Commission, pursuant to delegated authority.\266\
---------------------------------------------------------------------------

    \266\ 17 CFR 200.30-3(a)(12).
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Brent J. Fields,
Secretary.
[FR Doc. 2016-28197 Filed 11-22-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 64 (Friday, April 3, 2015)]
[Notices]
[Pages 18239-18240]
[FR Doc No: 2015-07632]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0566]

Residual Solvents in Animal Drug Products; Questions and Answers;
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry #211 entitled ``Residual
Solvents in Animal Drug Products; Questions and Answers.'' The
questions and answers guidance addresses the United States Pharmacopeia
(USP) General Chapter <467> Residual Solvents that applies to both
human and veterinary drugs and to compendial and non-compendial drug
products. This document answers questions regarding the Center for
Veterinary Medicine's (CVM) implementation of USP <467> Residual
Solvents.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of the guidance to
the Communications Staff (HFV-12), Center for Veterinary Medicine, Food
and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send
one self-addressed adhesive label to assist that office in processing
your request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Heather Longstaff, Center for
Veterinary Medicine (HFV-145), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of December 3, 2010 (75 FR 75482), FDA
published the notice of availability for a draft guidance entitled
``Residual Solvents in Animal Drug Products; Questions and Answers''
giving interested persons until February

1, 2011, to comment on the draft guidance. FDA received one comment on
the draft guidance and that comment was considered as the guidance was
finalized. Two of the questions and answers were revised, in addition
to a few editorial changes made to improve clarity. The guidance
announced in this notice finalizes the draft guidance dated December 2,
2010.
    On July 1, 2008, the USP implemented a requirement for the control
of residual solvents in drug products marketed in the United States.
Once implemented, the requirement, USP General Chapter <467> Residual
Solvents, became a statutory requirement under section 501(b) of the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 351(b)).
This document answers questions regarding CVM's implementation of USP
<467> Residual Solvents.

II. Significance of Guidance

    This level 1 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 ``Residual Solvents in Animal Drug
Products; Questions and Answers.'' 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.

III. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in 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 21 CFR part 514 have been approved under
OMB control number 0910-0032; the collections of information in section
512(n)(1) of the FD&C Act (21 U.S.C. 360k) have been approved under OMB
control number 0910-0669.

IV. Comments

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

V. Electronic Access

    Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.

    Dated: March 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07632 Filed 4-2-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 192 (Tuesday, October 4, 2016)]
[Notices]
[Page 68493]
[FR Doc No: 2016-23908]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-78968; File No. SR-NYSEMKT-2016-63]

Self-Regulatory Organizations; NYSE MKT LLC; Notice of
Designation of Longer Period for Commission Action on a Proposed Rule
Change Amending the Co-Location Services Offered by the Exchange To Add
Certain Access and Connectivity Fees

September 28, 2016.
    On August 16, 2016, NYSE MKT LLC (the ``Exchange'' or ``NYSE MKT'')
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 (1)
to provide additional information regarding access to various trading
and execution services; connectivity to market data feeds and testing
and certification feeds; connectivity to third party systems; and
connectivity to DTCC provided to Users using data center local area
networks; and (2) to establish fees relating to a User's access to
various trading and execution services; connectivity to market data
feeds and testing and certification feeds; connectivity to DTCC; and
other services. The proposed rule change was published for comment in
the Federal Register on August 26, 2016.\3\ The Commission received no
comments in response to the proposed rule change.\4\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 34-78629 (August 22,
2016), 81 FR 58992.
    \4\ The Commission notes that it did receive one comment letter
on a related filing, NYSE-2016-45, which is equally relevant to this
filing.
    In response to the comment letter, the NYSE submitted a
response.
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \5\ provides that, within 45 days of
the publication of the notice of the filing of a proposed rule change,
or within such longer period up to 90 days as the Commission may
designate if it finds such longer period to be appropriate and
publishes its reasons for so finding or as to which the self-regulatory
organization consents, the Commission shall approve the proposed rule
change, disapprove the proposed rule change, or institute proceedings
to determine whether the proposed rule change should be disapproved.
The Commission is extending this 45-day time period.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission finds that it is appropriate to designate a longer
period within which to take action on the proposed rule change so that
it has sufficient time to consider the proposed rule change.
Accordingly, the Commission, pursuant to Section 19(b)(2) of the
Act,\6\ designates November 24, 2016, as the date by which the
Commission should approve, disapprove, or institute proceedings to
determine whether to disapprove the proposed rule change (File No. SR-
NYSEMKT-2016-63).
---------------------------------------------------------------------------

    \6\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
---------------------------------------------------------------------------

    \7\ 17 CFR 200.30-3(a)(57).
---------------------------------------------------------------------------

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-23908 Filed 10-3-16; 8:45 am]
 BILLING CODE 8011-01-P