[Federal Register: October 25, 2005 (Volume 70, Number 205)]
[Notices]
[Page 61675-61677]
[DOCID:fr25oc05-97]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-52634; File No. SR-PCX-2005-111]

Self-Regulatory Organizations; Pacific Exchange, Inc.; Notice of
Filing and Order Granting Accelerated Approval to Proposed Rule Change
To Establish Certain Fees With Respect to Transactions Executed Through
the Intermarket Trading System

October 19, 2005.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on October 4, 2005, the Pacific Exchange, Inc. (``PCX'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'' or ``SEC'') the proposed rule change as described in
Items I and II below, which Items have been prepared by the PCX. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons, and is approving the
proposal on an accelerated basis.
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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 Exchange proposes to enter into arrangements with other
national securities exchanges to pass certain fees they have collected
from members for transactions executed on another exchange through the
Intermarket Trading System (``ITS''). This proposal does not require
changes to PCX rule text.

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

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

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

1. Purpose
    Section 31 of the Act \3\ requires each national securities
exchange to pay the Commission a fee based on the aggregate dollar
amount of certain sales of securities (``covered sales''). Rules 31 and
31T, adopted by the Commission in June 2004,\4\ established procedures
for the calculation and collection of Section 31 fees on such covered
sales. Rule 31 requires each national securities exchange that owes
Section 31 fees to submit a completed Form R31 to the Commission each
month, beginning with July 2004. Rule 31T required each exchange to
submit a completed Form R31 for each of the months September 2003 to
June 2004, inclusive. Each national securities exchange must report its
covered sales volume based on the data from a designated clearing
agency, when available. The designated clearing agency for covered
sales of equity securities is the National Securities Clearing
Corporation (``NSCC''). These covered sales are reported in Part I of
Form R31, and each exchange is required to ``provide in Part I only the
data supplied to it by a designated clearing agency.'' \5\ The data
supplied by NSCC for the period September 2003 through August 2004 did
not accurately reflect the aggregate dollar value of the covered sales
occurring on each exchange to permit reports to be made in accordance
with new Rules 31 and 31T. In particular, the data NSCC reported to
each national securities exchange included non-covered sales data for
sales originating on one exchange and executed on another exchange
through the ITS.\6\
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    \3\ 15 U.S.C. 78ee.
    \4\ See Securities Exchange Act Release No. 49928 (June 28,
2004), 69 FR 41060 (July 7, 2004) (``Adopting Release'').
    \5\ 17 CFR 240.31(b)(5).
    \6\ As a result of this and other inaccuracies in the data
reported by NSCC, the national securities exchanges were unable to
report accurate information on Form R31, unless they made
adjustments to the NSCC data based on data other than that provided
by NSCC. On October 6, 2004, the Commission's Division of Market
Regulation (``Division'') issued a ``no-action'' letter advising
exchanges for whom NSCC acts as a designated clearing agency under
Rule 31, that the Division staff would not recommend that the
Commission take enforcement action if a national securities exchange
adjusts the data provided by NSCC to accurately reflect covered
sales occurring on the national securities exchange. See letter from
Robert L.D. Colby, Deputy Director, Division, Commission to Ellen J.
Neely, Senior Vice President and General Counsel, Chicago Stock
Exchange, Inc. (``CHX''), dated October 6, 2004.
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    Section 31 requires that national securities exchanges pay a fee
based on the aggregate dollar amount of sales of securities transacted
on the exchange. Given the specific language of Section 31, the
Commission in the Adopting Release for Rules 31 and 31T advised that
the current methodology for treating sales of securities that occur
through ITS \7\ was no longer appropriate and that ``it would be
simpler and more transparent for each covered [self-regulatory
organization (``SRO'')] to report all covered sales that occur on its
market.'' The Commission further stated:

    \7\ In the Adopting Release, the Commission described the
current methodology: ``SRO A sends an ITS commitment to a member of
SRO B to sell a security, and the commitment is executed on SRO B.
Under existing arrangements, SRO A pays the Section 31 fee arising
from this trade and passes the fee to its member that initiated the
trade. * * * [T]he SROs devised this system because SRO B does not
have the ability to require members of SRO A to reimburse it for the
cost of its Section 31 fees.'' Adopting Release, 69 FR at 41067.
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    The Commission acknowledges that a covered SRO on which a
covered sale occurs as a result of an incoming ITS order may not be
able to collect funds to pay the Section 31 fee from one of its own
members. However, Section 31 does not address the manner or extent
to which covered SROs may seek to recover the amounts that they pay
pursuant to Section 31 from their members. Covered SROs may wish to
devise new arrangements for passing fees between themselves so that
the funds are collected from the covered SRO that originated the ITS
order.\8\
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    \8\ Id.

    The Commission further noted that any such arrangements devised by
the SROs would have to be established pursuant to Section 19(b) of the
Act and Rule 19b-4 thereunder.
    A subcommittee of the ITS Operating Committee \9\
(``Subcommittee'') has had discussions in order to devise new
arrangements for passing fees between the ITS participants that (1)
were collected from their members for the months of September 2003
through August 2004; and (2) are being collected from their members
beginning in September 2004 and continuing. This proposed rule change
is being submitted by the PCX with the understanding that the other
exchanges participating in the proposed arrangement devised by the
subcommittee will be submitting substantially similar rule change
proposals.\10\
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    \9\ The ITS participants are American Stock Exchange LLC, Boston
Stock Exchange, Chicago Board Options Exchange, CHX, National
Association of Securities Dealers (``NASD''), National Stock
Exchange, New York Stock Exchange (``NYSE''), PCX, and Philadelphia
Stock Exchange.
    \10\ NASD has determined not to participate in the arrangement
for passing fees between exchanges although they participated in
many of the conference calls regarding the proposed arrangement.

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    Pursuant to the new arrangement being proposed, each ITS
participant exchange determines whether it has received and executed
more in dollar value of covered sales than it has originated and sent
to each other ITS participant exchange. For example, for the historical
period, September 2003 through August 2004, SRO A sent ITS commitments
for covered sales whose dollar value was $150 million to SRO B for
execution. SRO A collected fees from its members to fund its Section 31
obligation for those covered sales executed on SRO B. SRO B, as the
executing market center, is obligated to pay the Section 31 fee to the
SEC. During the same period, SRO B sent ITS commitments for covered
sales whose dollar value was $210 million to SRO A. SRO B collected
fees from its members for those covered sales executed on SRO A. SRO A,
as the executing market center, is obligated to pay the Section 31 fee
to the SEC. Since SRO A executed a greater dollar value of covered
sales from SRO B than it sent to SRO B, the proposed arrangement
requires SRO A to determine the amount of the fees collected by SRO B
from its members based on the aggregate dollar value of covered sales
from SRO B and executed on SRO A through ITS commitments. When
invoicing SRO B, SRO A will deduct the amount of the fee it owes to SRO
B (i.e., the fee amount based on SRO A's $210 million in aggregate
covered sales less the fee amount based on SRO B's $150 million in
aggregate covered sales) and will invoice only for the difference of
$60 million.
    Once the fees have been invoiced and paid for the historical
period, the ITS participant exchanges plan to use the same arrangement
for the period beginning September 2004 and continuing. It is
anticipated that the invoicing process will occur twice yearly to
coincide with the March 15 and September 30 payment schedule for
Section 31 fees set forth in the Act.
    To implement this proposed arrangement, an ITS participant exchange
will require access to the aggregate dollar value of buy and sell
transactions occurring through ITS. Under the proposed arrangement for
fees collected for the months of September 2003 through August 2004, an
ITS participant exchange may choose to use data obtained from the
Inter-market Surveillance Information System (``ISIS'') or data that
provides comparable information that includes aggregate dollar value of
ITS transactions.\11\ The ISIS data is sorted by originating market
center (i.e., the sender of an ITS commitment) and receiving market
center (i.e., the market center that executes the ITS commitment).
Using this data, each ITS participant exchange can determine on a
monthly basis the dollar value of all executed commitments sent to and
received from another ITS participant exchange.
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    \11\ The NYSE has made available to the ITS participants
spreadsheets for each month in the period using the ISIS data.
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    At its meeting on February 23, 2005, the Subcommittee asked the
Securities Industry Automation Corporation (``SIAC'') to determine the
time and expense involved for SIAC to use the ITS database that it
maintains to provide reports of the aggregate dollar value of buy and
sell transactions occurring through ITS to the ITS participants. On
March 15, 2005, representatives of the Subcommittee authorized SIAC to
develop new reports. SIAC is in the process of developing these reports
and expects to complete testing by August 31, 2005. Once SIAC can
provide this data, it will no longer be necessary for ISIS data to be
used. The new reports provided by SIAC will be used by ITS participants
in connection with determining which ITS participant exchange will pay
the fee for transactions occurring through ITS and which ITS
participant exchange has collected the fee from its members.
    The PCX believes that the proposed arrangement is a fair and
efficient means for passing fees collected at one ITS participant
exchange based upon executions of covered sales occurring at another
ITS participant exchange. The PCX acknowledges that the legal duty to
report and pay the Section 31 fee remains with the ITS participant on
which the sale was in fact transacted.
2. Statutory Basis
    This proposal would establish a process for SROs to enter into
arrangements to pass fees they have collected from members for
transactions executed on another SRO through ITS. For these reasons,
the Exchange believes that the proposed rule change is consistent with
the Act and the rules and regulations thereunder that are applicable to
a national securities exchange and, in particular, the requirements of
Section 6(b) of the Act.\12\ Specifically, the Exchange believes the
proposed rule change is consistent with the requirements of Section
6(b)(5) of the Act,\13\ in that it is designed to promote just and
equitable principles of trade, to prevent fraudulent and manipulative
acts and practices, and, in general, to protect investors and the
public interest. In addition, the Exchange believes that the proposed
rule change is consistent with the provisions of Section 6(b)(4) of the
Act,\14\ which requires that the rules of an exchange provide for the
equitable allocation of reasonable dues, fees, and other charges among
its members and issuers and other persons using its facilities.
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    \12\ 15 U.S.C. 78f(b).
    \13\ 15 U.S.C. 78f(b)(5).
    \14\ 15 U.S.C. 78f(b)(4).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition 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 solicited or received with respect to the
proposed rule change.

III. 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-PCX-2005-111 on the subject line.

Paper Comments

     Send paper comments in triplicate to Jonathan G. Katz,
Secretary, Securities and Exchange Commission, Station Place, 100 F
Street, NE., Washington, DC 20549-9303.
    All submissions should refer to File Number SR-PCX-2005-111. 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
PCX. 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-PCX-
2005-111 and should be submitted on or before November 15, 2005.

IV. Commission's Findings and Order Granting Accelerated Approval of a
Proposed Rule Change

    After careful consideration, the Commission finds that the proposed
rule change is consistent with the Act and the rules and regulations
thereunder applicable to a national securities exchange.\15\ In
particular, the Commission believes that the proposal is consistent
with Section 6(b)(4) of the Act,\16\ which requires that the rules of
an exchange provide for the equitable allocation of reasonable dues,
fees, and other charges among its members and issuers and other persons
using its facilities. National securities exchanges obtain funds to pay
their Section 31 fees to the Commission by charging fees to broker-
dealers who generate the covered sales on which Section 31 fees are
based. An exchange can obtain most of these funds by imposing a fee on
one of its members whenever the member is on the sell side of a
transaction. However, when the exchange accepts an ITS commitment to
buy, the ultimate seller is a party on another market. The exchange
lacks the ability to pass a fee to that seller directly, because the
seller may not be a member of the exchange. Under the proposed
arrangement, which the Commission understands will be adopted by each
of the ITS participant exchanges,\17\ the exchange that routed the ITS
commitment away will continue to collect a fee from the broker-dealer
that placed the sell order. Then, with respect to each ITS participant
exchange, the exchange will determine whether it is a net sender or net
receiver of ITS trades and send fees to or accept fees from each other
exchange accordingly. The Commission believes this is an equitable
manner for the exchanges to obtain funds to pay their Section 31 fees
on covered sales resulting from ITS trades.
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    \15\ In approving this proposal, the Commission has considered
its impact on efficiency, competition, and capital formation. See 15
U.S.C. 78c(f).
    \16\ 15 U.S.C. 78f(b)(4).
    \17\ See letter from George W. Mann, Jr., Executive Vice
President and General Counsel, BSE, and Chairman, Subcommittee, to
Michael Gaw, Assistant Director, Division, Commission, dated
September 29, 2005.
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    Under Section 19(b)(2) of the Act,\18\ the Commission may not
approve any proposed rule change prior to the thirtieth day after the
date of publication of the notice of filing thereof, unless the
Commission finds good cause for so doing. The Commission hereby finds
good cause for approving the proposed rule change prior to the
thirtieth day after publishing notice of filing thereof in the Federal
Register. In this case, the Commission does not believe a comment
period is necessary because all of the parties affected by the proposed
fee--the other ITS participant exchanges--have already consented to and
will adopt the same fee arrangement.\19\
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    \18\ 15 U.S.C. 78s(b)(2).
    \19\ See supra note 17.
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    For the reasons set forth above, the Commission finds good cause to
accelerate approval of the proposed rule change pursuant to Section
19(b)(2) of the Act.\20\
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    \20\ Id.
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V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\21\ that the proposed rule change (SR-PCX-2005-111) is hereby
approved on an accelerated basis.
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    \21\ Id.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\22\
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    \22\ 17 CFR 200.30-3(a)(12).
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Jonathan G. Katz,
Secretary.
 [FR Doc. E5-5891 Filed 10-24-05; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 78, Number 49 (Wednesday, March 13, 2013)]
[Notices]
[Page 16030]
[FR Doc No: 2013-05482]

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DEPARTMENT OF TRANSPORTATION

Intelligent Transportation Systems Program Advisory Committee;
Notice of Meeting

AGENCY: ITS Joint Program Office, Research and Innovative Technology
Administration, U.S. Department of Transportation.

ACTION: Notice.

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    The Intelligent Transportation Systems (ITS) Program Advisory
Committee (ITS PAC) will hold a meeting on March 27, 2013, from 8:00
a.m. to 4:00 p.m. (EST), and on March 28, 2013, from 8:00 a.m. to 4:00
p.m. (EST) in the Admiral II and III rooms of the Courtyard Marriott
Capitol Hill/Navy Yard Hotel, 140 L Street SE., Washington, DC 20003.
    The ITS PAC, established under Section 5305 of Public Law 109-59,
Safe, Accountable, Flexible, Efficient Transportation Equity Act: A
Legacy for Users, August 10, 2005, and re-established under Section
53003 of Public Law 112-141, Moving Ahead for Progress in the 21st
Century, July 6, 2012, was created to advise the Secretary of
Transportation on all matters relating to the study, development, and
implementation of intelligent transportation systems. Through its
sponsor, the ITS Joint Program Office (JPO), the ITS PAC makes
recommendations to the Secretary regarding ITS Program needs,
objectives, plans, approaches, content, and progress.
    The following is a summary of the meeting tentative agenda. March
27: (1) ITS JPO Activities Update, (2) Safety Pilot Program Update, and
(3) Shared Use Frequency Spectrum Issues Update. March 28: (1) NHTSA
Rule-making Process Overview, (2) Subcommittee Break-out Meetings, and
(3) Subcommittee Reports.
    The meeting will be open to the public, but limited space will be
available on a first-come, first-served basis. Members of the public
who wish to present oral statements at the meeting must request
approval from Mr. Stephen Glasscock, the Committee Designated Federal
Official, at<PHONE_NUMBER>, not later than March 20, 2013.
    Questions about the agenda or written comments may be submitted by
U.S. Mail to: U.S. Department of Transportation, Research and
Innovative Technology Administration, ITS Joint Program Office,
Attention: Stephen Glasscock, 1200 New Jersey Avenue SE, HOIT,
Washington, DC 20590 or faxed to<PHONE_NUMBER>. The ITS Joint Program
Office requests that written comments be submitted not later than March
20, 2013.
    Notice of this meeting is provided in accordance with the Federal
Advisory Committee Act and the General Services Administration
regulations (41 CFR part 102-3) covering management of Federal advisory
committees.

    Issued in Washington, DC, on the 4th day of March 2013.
Kenneth M. Leonard,
Director, ITS Joint Program Office.
[FR Doc. 2013-05482 Filed 3-12-13; 8:45 am]
BILLING CODE 4910-HY-P


[Federal Register Volume 80, Number 87 (Wednesday, May 6, 2015)]
[Notices]
[Page 26030]
[FR Doc No: 2015-10617]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9927-34-Region 6]

Notice of Extension of Public Comment Period for the Preliminary
Designation of Certain Stormwater Discharges in the State of New Mexico
Under the National Pollutant Discharge Elimination System of the Clean
Water Act

AGENCY: Environmental Protection Agency.

ACTION: Notice and extension of public comment period.

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SUMMARY: The public comment period for the Environmental Protection
Agency Region 6 (EPA Region 6) Preliminary Designation of certain
stormwater discharges in Los Alamos County, New Mexico has been
extended until June 15, 2015.

DATES: The comment period for the notice published on March 17, 2015
(80 FR 13852) has been extended. Comments must be submitted in
electronic format or in writing to EPA on or before June 15, 2015.

ADDRESSES: Comments should be submitted to Ms. Evelyn Rosborough via
email<EMAIL_ADDRESS>or may be mailed to Ms. Evelyn
Rosborough, Environmental Protection Agency, Water Quality Protection
Division (6WQ-NP), 1445 Ross Ave., Suite 1200, Dallas, TX 75202.

FOR FURTHER INFORMATION CONTACT: Contact Ms. Evelyn Rosborough, (214)
665-7515 or at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Regional Administrator of EPA Region 6
published a Notice of Availability for the Preliminary Determination
that certain stormwater discharges in Los Alamos County, New Mexico
will be required to obtain National Pollutant Discharge Elimination
System (NPDES) permit coverage under the Clean Water Act in the Federal
Register on March 17, 2015 (80 FR 13852). In response to requests, the
EPA is extending the public comment period for the Preliminary
Designation until June 15, 2015. The comment period for the preliminary
designation was initially scheduled to close on April 16, 2015.
    The Preliminary Designation Document and supplementary information
are available on the EPA Region 6 Web page at http://www.epa.gov/region6/water/npdes/publicnotices/nm/nmdraft.htm and the extension of
the comment was posted on this Web page on April 15, 2015.

    Dated: April 24, 2015.
David W. Gray,
Acting Regional Administrator, Region 6.
[FR Doc. 2015-10617 Filed 5-5-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 21 (Thursday, January 31, 2019)]
[Notices]
[Pages 710-711]
[FR Doc No: 2019-00451]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM98-1-000]

Records Governing Off-the-Record Communications; Public Notice

    This constitutes notice, in accordance with 18 CFR 385.2201(b), of
the receipt of prohibited and exempt off-the-record communications.
    Order No. 607 (64 FR 51222, September 22, 1999) requires Commission
decisional employees, who make or receive a prohibited or exempt off-
the-record communication relevant to the merits of a contested
proceeding, to deliver to the Secretary of the Commission, a copy of
the communication, if written, or a summary of the substance of any
oral communication.
    Prohibited communications are included in a public, non-decisional
file associated with, but not a part of, the decisional record of the
proceeding. Unless the Commission determines that the prohibited
communication and any responses thereto should become a part of the
decisional record, the prohibited off-the-record communication will not
be considered by the Commission in reaching its decision. Parties to a
proceeding may seek the opportunity to respond to any facts or
contentions made in a prohibited off-the-record communication, and may
request that the Commission place the prohibited communication and
responses thereto in the decisional record. The Commission will grant
such a request only when it determines that fairness so requires. Any
person identified below as

having made a prohibited off-the-record communication shall serve the
document on all parties listed on the official service list for the
applicable proceeding in accordance with Rule 2010, 18 CFR 385.2010.
    Exempt off-the-record communications are included in the decisional
record of the proceeding, unless the communication was with a
cooperating agency as described by 40 CFR 1501.6, made under 18 CFR
385.2201(e)(1)(v).
    The following is a list of off-the-record communications recently
received by the Secretary of the Commission. The communications listed
are grouped by docket numbers in ascending order. These filings are
available for electronic review at the Commission in the Public
Reference Room or may be viewed on the Commission's website 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, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>.

----------------------------------------------------------------------------------------------------------------
                   Docket No.                        File date                Presenter or requester
----------------------------------------------------------------------------------------------------------------
Prohibited:
    1. CP18-46-000..............................      12-28-2018  Sheila McCarthy.
Exempt:
    1. P-2428-007, P-10254-026, P-10253-032.....        1-2-2018  FERC Staff.\1\
----------------------------------------------------------------------------------------------------------------

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    \1\ Communications Memorandum dated 1/2/2018 forwarding email
correspondence with Enel Green Power North America, Inc.

     Dated: January 8, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-00451 Filed 1-30-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 179 (Wednesday, September 16, 2015)]
[Notices]
[Pages 55632-55634]
[FR Doc No: 2015-23204]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-2102]

Syed Huda: Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The U.S. Food and Drug Administration (FDA or Agency) is
issuing an order under the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) permanently debarring Syed Huda from providing services in
any capacity to a person that has an approved or pending drug product
application. FDA bases this order on a finding that Mr. Huda was
convicted of two felonies under Federal law for conduct relating to the
regulation of a drug product. Mr. Huda was given notice of the proposed
permanent debarment and an opportunity to request a hearing within the
timeframe prescribed by regulation. Mr. Huda failed to respond. Mr.
Huda's failure to respond constitutes a waiver of his right to a
hearing concerning this action.

DATES: This order is effective September 16, 2015.

ADDRESSES: Submit applications for special termination of debarment to
the Division of Dockets Management (HFA-

305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kenny Shade (ELEM-4144) Division of
Enforcement, Office of Enforcement and Import Operations, Office of
Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr.,
Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(a)(2)(B) of the FD&C Act (21 U.S.C. 335a(a)(2)(B))
requires debarment of an individual if FDA finds that the individual
has been convicted of a felony under Federal law for conduct relating
to the regulation of any drug product under the FD&C Act.
    On May 16, 2014, the U.S. District Court for the Eastern District
of Virginia entered judgment against Mr. Huda for one count of
importation contrary to law, in violation of 18 U.S.C. 545 and 2, one
count of introducing misbranded drugs into interstate commerce, in
violation of 21 U.S.C. 331(a), 333(a)(2), and 18 U.S.C. 2, one count of
unlicensed wholesale distribution of prescription drugs, in violation
of 21 U.S.C. 331(t), 333(b)(1)(D), 353(e)(2)(A), and 18 U.S.C. 2, and
one count of wire fraud, in violation of 18 U.S.C. 1343.
    FDA's finding that debarment is appropriate is based on the felony
convictions referenced herein. The factual basis for this conviction is
as follows: Mr. Huda was a cofounder and co-owner of Gallant Pharma
International Inc. (Gallant Pharma), between August 2009 and August
2013. Gallant was a company dedicated to the illegal importation and
sale of misbranded and non-FDA approved chemotherapy drugs and
injectable cosmetic drugs and devices in the United States.
    As cofounder and co-owner of Gallant Pharma, Mr. Huda was primarily
responsible for the United States based portion of the conspiracy,
including: (1) Identifying a drop shipper willing to accept illegal
importations of behalf of Gallant Pharma, (2) locating space for
Gallant Pharma to store misbranded and non-FDA approved drugs and
devices, (3) establishing relationships with customers in the
Washington, DC metropolitan area, (4) interviewing and hiring sales
representatives in other parts of the United States, and (5)
establishing merchant accounts with credit card processors, for receipt
of illegal proceeds via wire transfer into Canadian bank accounts.
Gallant Pharma was not licensed as a prescription drug wholesaler by
the Commonwealth of Virginia. Some of the drugs and devices that Mr.
Huda acquired were not approved by the FDA for use on patients in the
United States. Mr. Huda admitted that the drugs sold by Gallant Pharma
were prescription only; and were misbranded in that, among other
things, they did not bear adequate directions for use and were not
subject to an exemption from that requirement; and they were
accompanied by non-FDA approved packaging and inserts. The drugs
Gallant Pharma sold also lacked the FDA-required pedigree, which
protects patient health by tracking each sale, purchase, or trade of a
drug from the time of manufacturing to delivery to the patient.
    Immediately after establishing Gallant Pharma's presence in the
Eastern District of Virginia, on or about September 25, 2009, Mr. Huda
received a cease and desist letter from a law firm on behalf of
Medicis, the exclusive authorized marketer of RESTYLANE and PERLANE in
the United States and Canada. The letter informed Gallant Pharma that
its marketing of these drugs violated the FD&C Act and could subject
Gallant Pharma to substantial criminal and civil penalties. The letter
included Gallant Pharma's marketing materials, which falsely claimed
that Gallant Pharma had been ``strictly working with the current FDA
rules and regulations for almost 10 years.''
    Mr. Huda personally solicited orders on behalf of Gallant Pharma,
and on or about October 19, 2010, he sold 10 vials of misbranded
TAXOTERE to a physician in Oceanside, CA, in exchange for $2450,
thereby causing misbranded drugs to travel in interstate commerce from
the Eastern District of Virginia. Mr. Huda was aware of several
occasions in which physicians complained after receiving drugs with
packaging and inserts written in language other than English, and he
authorized a price reduction upon receiving such complaints.
    Between August 2009 and August 2013, Gallant Pharma received
illegal proceeds of at least $12,400,000 from the sale of misbranded
and non-FDA approved drugs and devices in the United States. Mr. Huda
admitted that he was an organizer or leader of this criminal activity
and that his actions were in all respects knowing, voluntary, and
intentional, and did not occur by accident, mistake, or for another
innocent reason.
    As a result of his conviction, on May 20, 2015, FDA sent Mr. Huda a
notice by certified mail proposing to permanently debar him from
providing services in any capacity to a person that has an approved or
pending drug product application. The proposal was based on the
finding, under section 306(a)(2)(B) of the FD&C Act, that Mr. Huda was
convicted of felonies under Federal law for conduct related to the
regulation of a drug product. The proposal also offered Mr. Huda an
opportunity to request a hearing, providing him 30 days from the date
of receipt of the letter in which to file the request, and advised him
that failure to request a hearing constituted a waiver of the
opportunity for a hearing and of any contentions concerning this
action. The proposal was received on May 26, 2015. Mr. Huda failed to
respond within the timeframe prescribed by regulation and has,
therefore, waived his opportunity for a hearing and has waived any
contentions concerning his debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Director, Office of Enforcement and Import
Operations, Office of Regulatory Affairs, under section 306(a)(2)(B) of
the FD&C Act, under authority delegated to him (Staff Manual Guide
1410.35), finds that Syed Huda has been convicted of felonies under
Federal law for conduct relating to the regulation of a drug product.
    As a result of the foregoing finding, Syed Huda is permanently
debarred from providing services in any capacity to a person with an
approved or pending drug product application under sections 505, 512,
or 802 of the FD&C Act (21 U.S.C. 355, 360b, or 382), or under section
351 of the Public Health Service Act (42 U.S.C. 262), effective (see
DATES)(see section 201(dd), 306(c)(1)(B), and 306(c)(2)(A)(ii) of the
FD&C Act (21 U.S.C. 321(dd), 335a(c)(1)(B), and 335a(c)(2)(A)(ii)). Any
person with an approved or pending drug product application who
knowingly employs or retains as a consultant or contractor, or
otherwise uses the services of Syed Huda, in any capacity during his
debarment, will be subject to civil money penalties (section 307(a)(6)
of the FD&C Act (21 U.S.C. 335b(a)(6))). If Mr. Huda provides services
in any capacity to a person with an approved or pending drug product
application during his period of debarment he will be subject to civil
money penalties (section 307(a)(7) of the FD&C Act. In addition, FDA
will not accept or review any abbreviated new drug applications from
Syed Huda during his period of debarment (section 306(c)(1)(B) of the
FD&C Act.
    Any application by Mr. Huda for special termination of debarment
under section 306(d)(4) of the FD&C Act should be identified with
Docket No.

FDA-2014-N-2102 and sent to the Division of Dockets Management (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.
    Publicly available submissions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: September 10, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-23204 Filed 9-15-15; 8:45 am]
 BILLING CODE 4164-01-P