[Federal Register Volume 77, Number 180 (Monday, September 17, 2012)]
[Notices]
[Pages 57168-57169]
[FR Doc No: 2012-22786]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-67826; File No. SR-OCC-2012-13]

Self-Regulatory Organizations; The Options Clearing Corporation;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change to
Correct an Administrative Oversight in SR-OCC-2012-10

September 11, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ notice is hereby given that on August 29, 2012, The
Options Clearing Corporation (``OCC'') filed with the Securities and
Exchange Commission (``Commission'') the proposed rule change described
in Items I, II and III below, which Items have been prepared primarily
by OCC. OCC filed the proposal pursuant to Section 19(b)(3)(A)(i) \2\
of the Act, and Rule 19b-4(f)(1) \3\ thereunder, so that the proposal
was effective upon filing with the Commission. 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\ 15 U.S.C. 78s(b)(3)(A)(i).
    \3\ 17 CFR 240.19b-4(f)(1).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The proposed rule change is to correct an administrative oversight
in rule filing SR-OCC-2012-10, a rule filing intended

to eliminate OCC's pledge program in its entirety.

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

    In its filing with the Commission, OCC 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. OCC 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

    The purpose of this proposed rule change is to correct an
administrative oversight in rule filing SR-OCC-2012-10, a rule filing
intended to eliminate OCC's pledge program in its entirety.
    In SR-OCC-2012-10, OCC proposed to eliminate its pledge program,
which was primarily contained within OCC Rule 614, ``Pledge Program.''
The Commission approved SR-OCC-2012-10 on August 22, 2012. OCC
subsequently learned that it inadvertently made an administrative
oversight in Item 1 of SR-OCC-2012-10 and did not include the entire
text of Rule 614 as ``material proposed to be deleted.''
    OCC now proposes to eliminate the remaining language of Rule 614,
which was intended to be deleted in SR-OCC-2012-10.
    The proposed changes to OCC's Rules are consistent with the
purposes and requirements of Section 17A of the Act \4\ because they
will allow OCC to remove a rarely used operational function and focus
its resources on core clearing operations. Moreover, OCC believes that
elimination of the Program will not materially affect clearing members
given its limited and infrequent use. The proposed rule change is not
inconsistent with any rules of OCC, including any proposed to be
amended.
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    \4\ 15 U.S.C. 78q-1.
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B. Self-Regulatory Organization's Statement on Burden on Competition

    OCC 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 were not and are not intended to be solicited with
respect to the proposed rule change and none have been received.

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

    The foregoing proposed rule change has become effective upon filing
pursuant to Section 19(b)(3)(A)(i) \5\ of the Act and Rule 19b-4(f)(1)
\6\ thereunder because it constitutes a stated policy, practice, or
interpretation with respect to the meaning, administration, or
enforcement of an existing rule. Notwithstanding the foregoing, OCC
will delay implementation of the rule change until it is deemed
certified under CFTC Regulation Sec.  40.6. At any time within 60 days
of the filing of the proposed rule change, the Commission summarily may
temporarily suspend such rule change if it appears to the Commission
that such action is necessary or appropriate in the public interest,
for the protection of investors, or otherwise in furtherance of the
purposes of the Act.
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    \5\ 15 U.S.C. 78s(b)(3)(A)(i).
    \6\ 17 CFR 240.19b-4(f)(1).
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-OCC-2012-13 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-OCC-2012-13. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filings also will be available
for inspection and copying at the principal office of OCC and on OCC's
Web site at http://www.optionsclearing.com/about/publications/bylaws.jsp. 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-OCC-
2012-13 and should be submitted on or before October 9, 2012.

    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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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-22786 Filed 9-14-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 45 (Friday, March 6, 2020)]
[Notices]
[Pages 13164-13165]
[FR Doc No: 2020-04604]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0179]

Training Program for Regulatory Project Managers; Information
Available to Industry

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) Center
for Drug Evaluation and Research (CDER) is announcing the continuation
of the Regulatory Project Management Site Tours and Regulatory
Interaction Program (the Site Tours Program). The purpose of this
document is to invite pharmaceutical companies interested in

participating in this program to contact CDER.

DATES: Pharmaceutical companies may send proposed agendas to the Agency
by May 5, 2020.

FOR FURTHER INFORMATION CONTACT: Dan Brum, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 5480, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    An important part of CDER's commitment to make safe and effective
drugs available to all Americans is optimizing the efficiency and
quality of the drug review process. To support this goal, CDER has
initiated various training and development programs to promote high
performance in its regulatory project management staff. CDER seeks to
enhance review efficiency and review quality by providing the staff
with a better understanding of the pharmaceutical industry and its
operations. To this end, CDER is continuing its training program to
give regulatory project managers the opportunity to tour pharmaceutical
facilities. The goals are to provide the following: (1) Firsthand
exposure to industry's drug development processes and (2) a venue for
sharing information about project management procedures (but not drug-
specific information) with industry representatives.

II. The Site Tours Program

    In this program, which generally lasts a few days, small groups of
CDER regulatory project managers, often including a senior level
regulatory project manager, can observe operations of pharmaceutical
manufacturing and/or packaging facilities, pathology/toxicology
laboratories, and regulatory affairs operations. Neither this tour nor
any part of the program is intended as a mechanism to inspect, assess,
judge, or perform a regulatory function, but is meant rather to improve
mutual understanding and to provide an avenue for open dialogue. During
the Site Tours Program, regulatory project managers will also
participate in daily workshops with their industry counterparts,
focusing on selective regulatory issues important to both CDER staff
and industry. The primary objective of the daily workshops is to learn
about the team approach to drug development, including drug discovery,
nonclinical and clinical evaluation, postmarketing activities, and
regulatory submission operations. The overall benefit to regulatory
project managers will be exposure to project management, team
techniques, and processes employed by the pharmaceutical industry. By
participating in this program, the regulatory project manager will grow
professionally by gaining a better understanding of industry processes
and procedures.

III. Site Selection

    All travel expenses associated with the Site Tours Program will be
the responsibility of CDER; therefore, selection will be based on the
availability of funds and resources for each fiscal year. Selection
will also be based on firms having a favorable facility status as
determined by FDA's Office of Regulatory Affairs District Offices in
the firms' respective regions. Firms that want to learn more about this
training opportunity or that are interested in offering a site tour
should respond by sending a proposed agenda by email directly to Dan
Brum (see DATES and FOR FURTHER INFORMATION CONTACT).

    Dated: March 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-04604 Filed 3-5-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: April 12, 2006 (Volume 71, Number 70)]
[Notices]
[Page 18748-18749]
[DOCID:fr12ap06-63]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2006-0024; FRL-7765 -7]

Notice of Filing of Pesticide Petitions for Establishment of
Regulations for Residues of Difenoconazole in or on Various Commodities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of pesticide
petitions proposing the establishment of regulations for residues of
difenoconazole in or on various commodities.

DATES: Comments must be received on or before May 12, 2006.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-0024 and pesticide petition numbers (PPs)
9E5076, 0F6155, 6F4748, and 8F4953, by one of the following methods:
     http://www.regulations.gov. Follow the on-line

instructions for submitting comments.
     Mail: Public Information and Records Integrity Branch
(PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
     Hand Delivery: Public Information and Records Integrity
Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, Rm. 119, Crystal Mall 2, 1801
S. Bell St., Arlington, VA, Attention: Docket ID number EPA-HQ-OPP-
2006-0024. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
Docket Facility is<PHONE_NUMBER>. Such deliveries are only accepted
during the Docket's normal hours of operation, and special arrangements
should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006- 0024. EPA's policy is that all comments received will be included
in the public docket without change and may be made available on-line
at http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be captured automatically and included as part
of the comment that is placed in the public docket and made available
on the Internet. If you submit an electronic comment, EPA recommends
that you include your name and other contact information in the body of
your comment and with any disk or CD ROM you submit. If EPA cannot read
your comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket, visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.

     Docket: All documents in the docket are listed in the
regulations.gov index. Although listed in the index, some information
is not publicly available, e.g., CBI or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
at http://www.regulations.gov or in hard copy at the Public Information

and Records Integrity Branch (PIRIB) (7502C), Office of Pesticide
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall
2, 1801 S. Bell St., Arlington, VA. The Docket Facility is
open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Docket Facility is (703) 305-
5805.

FOR FURTHER INFORMATION CONTACT: John Bazuin, Registration Division
(7505C), Office of Pesticide Programs, U. S. Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; 703-
305-7381; e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American

Industrial Classification System (NAICS) codes have been provided to
assist you and others in determining whether this action might apply to
certain entities. If you have any questions regarding the applicability
of this action to a particular entity, consult the person listed under
FOR FURTHER INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

     1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
     2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. What Action is the Agency Taking?

    EPA is printing a summary of each pesticide petition received under
section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, proposing the establishment or amendment of regulations in
40 CFR part 180 for residues of pesticide chemicals in or on various
food commodities. EPA has determined that these pesticide petitions
contain data or information regarding the elements set forth in FFDCA
section 408(d)(2); however, EPA has not fully evaluated the sufficiency
of the submitted data at this time or whether the data support granting
of these pesticide petitions. Additional data may be needed before EPA
rules on these pesticide petitions.
    Pursuant to 40 CFR 180.7(f), a summary of each petition included in
this notice, prepared by the petitioner along with a description of the
analytical method available for the detection and measurement of the
pesticide chemical residues is available on EPA's Electronic Docket at
http://www.regulations.gov. To locate this information on the home page

of EPA's Electronic Docket, select ``Quick Search'' and type the OPP
docket ID number. Once the search has located the docket, clicking on
the ``Docket ID'' will bring up a list of all documents in the docket
for the pesticide including the petitions summary.

New Tolerances

    1. PP 9E5076. Syngenta Crop Protection, Inc., P.O. Box 18300,
Greensboro, NC 27419, proposes to establish import tolerances for
residues of the fungicide difenoconazole in or on food or feed
commodities Grapes at 0.1 parts per million (ppm); and Pome fruit at
0.1 ppm.
    2. PP 0F6155. Corn, sweet, forage at 0.01 ppm; Corn, sweet, kernel
plus cob with husks removed at 0.01 ppm; and Corn, sweet, stover at
0.01 ppm;
    3. PP 6F4748. Barley, forage at 0.05 ppm; Barley, hay at 0.05 ppm;
and Barley, straw at 0.05 ppm;
    4. PP 8F4953. Cotton, gin byproducts at 0.05 ppm; and Cotton,
undelinted seed at 0.05 ppm.
    For the above food commodities, Syngenta Crop Protection, Inc., has
submitted a practical analytical method (AG-575B) for detecting and
measuring levels of difenoconazole in or on food with a limit of
quantitation (LOQ) that allows monitoring of food with residues at or
above the levels set in the proposed tolerances. EPA has validated this
method and copies have been provided to the U. S. Food and Drug
Administration (FDA) for insertion into pesticide analytical manual
(PAM) II. For livestock commodities, a practical analytical method (AG-
544A) for detecting and measuring levels of difenoconazole in or on
cattle tissues and milk, and poultry tissues and eggs with an LOQ that
allows monitoring of food with residues at or above the levels set in
the proposed tolerances. EPA has validated this method and copies have
been provided to FDA for insertion into PAM II. Tolerances in meat,
milk, poultry or eggs were established for enforcement purposes.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.

    Dated: March 27, 2006.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

[FR Doc. E6-5391 Filed 4-11-06; 8:45 am]

BILLING CODE 6560-50-S