[Federal Register Volume 76, Number 86 (Wednesday, May 4, 2011)]
[Notices]
[Pages 25389-25390]
[FR Doc No: 2011-10806]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64360; File No. SR-DTC-2011-05]

Self-Regulatory Organizations; The Depository Trust Company;
Notice of Filing of Proposed Rule Change To Amend Rules Relating to the
Memo Segregation Function

April 28, 2011.
    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 April 15, 2011, The Depository Trust Company (``DTC'') 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 primarily by DTC.\3\ The Commission is publishing this notice
to solicit comments on the proposed rule change from interested
persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ The text of the proposed rule change is attached as Exhibit
5 to DTC's filing, which is available at http://www.dtcc.com/downloads/legal/rule_filings/2010/dtc/2011-05.pdf.
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The purpose of this proposed rule change is to amend DTC's rules
relating to its Memo Segregation Service to no longer permit stock loan
or stock loan return-related turnaround deliveries for a security when
there is a deficit in the Memo Segregation account.

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

    In its filing with the Commission, DTC 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. DTC has prepared summaries, set forth in sections (A),
(B), and (C) below, of the most significant aspects of these
statements.\4\
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    \4\ The Commission has modified the text of the summaries
prepared by DTC.
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(A) Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    Rule 15c3-3 (``Customer Protection Rule''), which was implemented
by the Commission under the Act, requires, among other things, that
broker-dealers maintain possession or control of fully-paid or excess
margin securities they hold for the account of customers.\5\ DTC's Memo
Segregation Service (``MSEG'') is an optional service which offers a
mechanism for broker-dealer participants to protect fully-paid or
excess margin securities by allowing the participant to shield from
unintended delivery a designated quantity of securities that are in the
participant's DTC free account or that may be received during the daily
processing cycle. In this regard, the participant may set a ``counter''
for a specified minimum quantity of each security to be held in its
account as a threshold to any redelivery intraday. When the counter for
a security is greater than the inventory of the participant, MSEG will
prevent the delivery of any quantity of the affected security out of
the participant's account unless: (1) The delivery is a permitted
delivery (e.g., a free of value ACATS delivery or a ``turnaround'' as
described below) or (2) the participant provides DTC with new
instructions to reduce the MSEG counter.
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    \5\ 17 CFR 204.15c3-3.
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    The MSEG procedures currently support two optional ``turnaround''
MSEG indicators which enable participants to make deliveries for
certain transaction types (including, but not limited to, stock loans
and stock loan returns) from certain positions received intraday
regardless of any MSEG-related deficit. Recently, DTC was advised by
the Regulatory and Clearance Committee of the Securities Operations
Section of SIFMA that several broker-dealer participants had expressed
concern that their practices for turnaround of stock loans and stock
loan returns (i.e., MSEG overrides) may be deemed by FINRA to be
contrary to the Customer Protection Rule. DTC also communicated
directly with participants affected through their use of this
functionality, and they expressed similar concerns. In order to
accommodate its participants in this regard, DTC is therefore proposing
to revise its procedures so that MSEG would no longer permit stock loan
or stock loan return-related turnaround deliveries for a security when
there is an MSEG deficit in the account.
    In order to effect the proposed change described above, DTC will
amend its Settlement Service Guide (``Service Guide''), which is
incorporated into DTC's procedures, to make existing indicators that
allow for the turnaround of stock loans and stock loan returns more
restrictive. As a result, the

procedures will no longer permit deliveries for stock loans (designated
in the Service Guide as Reason Code 10), stock loan returns (Reason
Code 20), The Options Clearing Corporation (``OCC'') stock loans
(reason code 260), OCC stock loan returns (reason code 270), American
Depository Receipt (``ADR'') stock loans (reason code 280), and ADR
stock loan returns (reason code 290) to be completed from turnaround
shares when an MSEG deficit exists.\6\
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    \6\ The proposed change will also eliminate references in the
Settlement Service Guide that MSEG-related functions are processed
through the Participant Terminal System (PTS), as participants may
currently use various platforms to communicate with DTC.
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    The proposed rule change is consistent with the requirements of the
Securities Exchange Act of 1934, as amended, (``Act'') and the rules
and regulations thereunder applicable to DTC because it modifies a
service of DTC so that it enables participants to better protect
customer fully-paid and excess margin securities which are held at DTC
and in general, protects investors and the public interest.
    In addition, the proposed rule change is consistent with the CPSS-
IOSCO Recommendations for securities settlement systems
(``Recommendations''). Recommendation 12, ``Protection of Customers'
Securities,'' states, in relevant part: ``Entities holding securities
in custody should employ accounting practices and safekeeping
procedures that fully protect customer's securities.'' Section 3.61 of
this Recommendation includes the statement that ``one way that a
customer can be protected in the event of a custodian's insolvency is
through segregation (identification) of customer securities on the
books of the custodian (and of all subcustodians, and ultimately, the
CSD [Central Securities Depository]).'' The term ``custodian'' in this
context would refer to the participant and not to DTC as we, DTC,
understand the Recommendations. DTC neither takes direct
responsibility, as the CSD, for the designation of assets as customer
assets nor is it required to do so by law or regulation. However, DTC
accommodates the needs of its participants to segregate (identify)
customer securities by identifying mechanisms such as MSEG. The MSEG
proposal is, accordingly, consistent with this Recommendation to the
extent it applies to DTC. The change will reduce the risk of unintended
delivery by broker-dealer participants of customer securities, which
might otherwise be deemed to be contrary to the Customer Protection
Rule.

(B) Self-Regulatory Organization's Statement on Burden on Competition

    DTC does not believe that the proposed rule change would impose any
burden on competition.

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

    Written comments relating to the proposed rule change have not been
solicited or received. DTC will notify the Commission of any written
comments received by DTC.

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

    Within forty-five 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 ninety 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 self-regulatory organization consents, the
Commission will:
    (A) By order approve or disapprove the 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 Number SR-DTC-2011-05 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 submission should refer to File Number SR-DTC-2011-05. 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 Web site viewing and
printing in the Commission's Public Reference Section, 100 F Street,
NE., Washington, DC 20549-1090, on official business days between the
hours of 10 a.m. and 3 p.m. Copies of such filings will also be
available for inspection and copying at the principal office of DTC and
on DTC's Web site at http://www.dtcc.com/downloads/legal/rule_filings/2011/dtc/2011-05.pdf. 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-DTC-2011-05 and should be submitted on or before May 25, 2011.

    For the Commission by the Division of Trading and Markets,
pursuant to delegated authority.\7\
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    \7\ 17 CFR 200.30-3(a)(12).
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Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-10806 Filed 5-3-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: January 3, 2007 (Volume 72, Number 1)]
[Proposed Rules]
[Page 67-68]
[DOCID:fr03ja07-20]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2004-TN-0004, EPA-R04-OAR-2005-TN-0009, EPA-R04-OAR-2006-
0532, 200607/17(b); FRL-8265-5]

Approval and Promulgation of Implementation Plans; Tennessee:
Approval of Revisions to the Knox County Portion of the Tennessee State
Implementation Plan

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve several revisions to the Tennessee
State Implementation Plan (SIP) submitted by the State of Tennessee,
through the Tennessee Department of Environment and Conservation, on
March 16, 2000, July 23, 2002, December 10, 2004, and January 31, 2006.
The revisions pertain to the Knox County portion of the Tennessee SIP
and include changes to Knox County Air Quality Regulations Section
16.0--Open Burning, Section 25.0--Permits, and Section 46.0--Regulation
of Volatile Organic Compounds. EPA is not taking any action at this
time on Section 13.0--Definitions (part of the December 10, 2004,
submittal) and Section 16.4.D., which was part of the January 31, 2006,
submittal but subsequently withdrawn by Knox County. The SIP revisions
described above are part of Knox County's strategy to attain and
maintain the national ambient air quality standards. This action is
being taken pursuant to the Clean Air Act. In the Final Rules Section
of this Federal Register, EPA is approving revisions to the Tennessee
SIP for these Tennessee SIP submittals as a direct final rule without
prior proposal because the Agency views these as a noncontroversial
submittals, and anticipates no adverse comments. A detailed rationale
for the approval is set forth in the direct final rule. If no
significant, material, and adverse comments are received in response to
this rule, no further activity is contemplated. If EPA receives adverse
comments, the direct final rule will be withdrawn and all public
comments received will be addressed in a subsequent final rule based on
this proposed rule. EPA will not institute a second comment period on
this document. Any parties interested in commenting on this document
should do so at this time.

DATES: Written comments must be received on or before February 2, 2007.

ADDRESSES: Submit your comments, identified by Docket ID Nos. EPA-R04-
OAR-2004-TN-0004, EPA-R04-OAR-2005-TN-0009, and EPA-R04-OAR-2006-0532
by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for

submitting comments.
    2. E-mail<EMAIL_ADDRESS>or<EMAIL_ADDRESS>
    3. Fax:<PHONE_NUMBER>.
    4. Mail: ``EPA-R04-OAR-2004-TN-0004,'' ``EPA-R04-OAR-2005-TN-
0009,'' or ``EPA-R04-OAR-2006-0532,'' Regulatory Development Section,
Air Planning Branch, Air, Pesticides and Toxics Management Division,
U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street, SW.,
Atlanta, Georgia 30303-8960.
    5. Hand Delivery or Courier: Egide Louis or James Hou, Regulatory
Development Section, Air Planning Branch, Air, Pesticides and Toxics
Management Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street, SW., Atlanta, Georgia 30303-8960. Such deliveries are
only accepted during the Regional Office's official hours of business.
The Regional Office's official hours of business are Monday through
Friday, 8:30 to 4:30, excluding Federal holidays.
    Please see the direct final rule which is located in the Rules
section of this Federal Register for detailed instructions on how to
submit comments.

FOR FURTHER INFORMATION CONTACT: Egide Louis or James Hou, Regulatory
Development Section, Air Planning Branch, Air, Pesticides and Toxics
Management Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street, SW., Atlanta, Georgia 30303-8960. Dr. Louis can be
reached by telephone at<PHONE_NUMBER> or via electronic mail at
<EMAIL_ADDRESS>The telephone number for Mr. Hou is (404) 562-

8965. He can also be reached via electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: For additional information see the direct
final rule which is published in the Rules Section of this Federal
Register.

    Dated: December 20, 2006.
A. Stanley Meiburg,
Acting Regional Administrator, Region 4.
 [FR Doc. E6-22474 Filed 12-29-06; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register: May 26, 2010 (Volume 75, Number 101)]
[Notices]
[Page 29591-29592]
[DOCID:fr26my10-95]

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SECURITIES AND EXCHANGE COMMISSION

[Notice of Exempt; OMB Control No. 3235-0452; SEC File No. 270-396;
Preliminary Roll-Up Communication]

Submission for OMB Review; Comment Request

Upon Written Request; Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension: Notice of Exempt, OMB Control No. 3235-0452, SEC File No.
270-396, Preliminary Roll-Up Communication.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.) the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget this request for extension of the previously approved
collection of information discussed below.
    A Notice of Exempt Preliminary Roll-Up Communication (``Notice'')
(17 CFR 240.14a-104) provides information regarding ownership interests
and any potential conflicts of interest to be included in statements
submitted by or on behalf of a person pursuant Exchange Act Rule (17
CFR 240.14a-2(b)(4)) and Exchange Act Rule (17 CFR 240.14a-6(n)). The
Notice is filed on occasion and the information required is

mandatory. All information is provided to the public upon request. The
Notice takes approximately 0.25 hours per response and is filed by 4
respondents for a total of one annual burden hour.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    Written comments regarding the above information should be directed
to the following persons: (i) Desk Officer for the Securities and
Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503 or send an e-mail to: Shagufta_
<EMAIL_ADDRESS>and (ii) Charles Boucher, Director/CIO, Securities
and Exchange Commission, C/O Shirley Martinson, 6432 General Green Way,
Alexandria, VA 22312; or send an e-mail to<EMAIL_ADDRESS>
Comments must be submitted to OMB within 30 days of this notice.

    Dated: May 19, 2010.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-12554 Filed 5-25-10; 8:45 am]
BILLING CODE 8010-01-P


[Federal Register Volume 81, Number 117 (Friday, June 17, 2016)]
[Notices]
[Pages 39652-39653]
[FR Doc No: 2016-14356]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-E-0677]

Determination of Regulatory Review Period for Purposes of Patent
Extension; ZILVER PTX DRUG ELUTING PERIPHERAL STENT

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for ZILVER PTX DRUG ELUTING PERIPHERAL STENT
and is publishing this notice of that determination as required by law.
FDA has made the determination because of the submission of an
application by Cook Medical Technologies, LLC, to the Director of the
U.S. Patent and Trademark Office (USPTO), Department of Commerce, for
the extension of a patent which claims that medical device.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by August
16, 2016. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by December 14, 2016.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2013-E-0677 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; ZILVER PTX DRUG ELUTING PERIPHERAL
STENT.'' Received comments will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
http://www.regulations.gov or at the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in

accordance with 21 CFR 10.20 and other applicable disclosure law. For
more information about FDA's posting of comments to public dockets, see
80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

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

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
permission to market the device is granted. Although only a portion of
a regulatory review period may count toward the actual amount of
extension that the Director of USPTO may award (half the testing phase
must be subtracted as well as any time that may have occurred before
the patent was issued), FDA's determination of the length of a
regulatory review period for a medical device will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(3)(B).
    FDA has approved for marketing the medical device ZILVER PTX DRUG
ELUTING PERIPHERAL STENT. ZILVER PTX DRUG ELUTING PERIPHERAL STENT is
indicated for improving luminal diameter for the treatment of de novo
or restenotic symptomatic lesions in native vascular disease of the
above-the-knee femoropopliteal arteries having reference vessel
diameters from 4 millimeters (mm) to 9 mm and total lesion lengths up
to 140 mm per limb and 280 mm per patient. Subsequent to this approval,
the USPTO received a patent term restoration application for ZILVER PTX
DRUG ELUTING PERIPHERAL STENT (U.S. Patent No. 6,299,604) from Cook
Medical Technologies, LLC, and the USPTO requested FDA's assistance in
determining this patent's eligibility for patent term restoration. In a
letter dated March 25, 2014, FDA advised the USPTO that this medical
device had undergone a regulatory review period and that the approval
of ZILVER PTX DRUG ELUTING PERIPHERAL STENT represented the first
permitted commercial marketing or use of the product. Thereafter, the
USPTO requested that FDA determine the product's regulatory review
period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
ZILVER PTX DRUG ELUTING PERIPHERAL STENT is 3,075 days. Of this time,
2,180 days occurred during the testing phase of the regulatory review
period, while 895 days occurred during the approval phase. These
periods of time were derived from the following dates:
    1. The date an exemption under section 520(g) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(g)) involving
this device became effective: June 16, 2004. FDA has verified the
applicant's claim that the date the investigational device exemption
(IDE) required under section 520(g) of the FD&C Act for human tests to
begin became effective was June 16, 2004.
    2. The date an application was initially submitted with respect to
the device under section 515 of the FD&C Act (21 U.S.C. 360e): June 4,
2010. FDA has verified the applicant's claim that the premarket
approval application (PMA) for ZILVER PTX DRUG ELUTING PERIPHERAL STENT
(PMA P100022) was initially submitted June 4, 2010.
    3. The date the application was approved: November 14, 2012. FDA
has verified the applicant's claim that PMA P100022 was approved on
November 14, 2012.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 1,826 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and ask for
a redetermination (see DATES). Furthermore, any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must be timely (see DATES) and contain
sufficient facts to merit an FDA investigation. (See H. Rept. 857, part
1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the
format specified in 21 CFR 10.30.
    Submit petitions electronically to http://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: June 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-14356 Filed 6-16-16; 8:45 am]
 BILLING CODE 4164-01-P