[Federal Register: May 5, 2010 (Volume 75, Number 86)]
[Notices]
[Page 24690-24692]
[DOCID:fr05my10-77]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2010-0281; FRL-8821-1]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Plant-Incorporated Protectants; CBI Substantiation and
Adverse Effects Reporting; EPA ICR No. 1693.06, OMB Control No. 2070-
0142

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that EPA is planning to
submit a request to renew an existing approved Information Collection
Request (ICR) to the Office of Management and Budget (OMB). This ICR,
entitled: ``Plant-Incorporated Protectants; CBI Substantiation and
Adverse Effects Reporting'' and identified by EPA ICR No. 1693.06 and
OMB Control No. 2070-0142, is scheduled to expire on January 31, 2011.
Before submitting the ICR to OMB for review and approval, EPA is
soliciting comments on specific aspects of the proposed information
collection.

DATES: Comments must be received on or before July 6, 2010.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2010-0281, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2010-0281. EPA's policy is that all comments received will be included
in the 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 automatically captured and included as part
of the comment that is placed in the 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.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. 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, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Scott Drewes, Field and External
Affairs Division (7506P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-
mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. What Information Is EPA Particularly Interested in?

    Pursuant to section 3506(c)(2)(A) of PRA, EPA specifically solicits
comments and information to enable it to:
    1. Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility.
    2. Evaluate the accuracy of the Agency's estimates of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used.
    3. Enhance the quality, utility, and clarity of the information to
be collected.
    4. Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. In particular, EPA is requesting comments from
very small businesses (those that employ less than 25) on examples of
specific additional efforts that EPA could make to reduce the paperwork
burden for very small businesses affected by this collection.

II. What Should I Consider when I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible and provide specific
examples.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve the collection activity.
    7. Make sure to submit your comments by the deadline identified
under DATES.
    8. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.

III. What Information Collection Activity or ICR Does This Action Apply
to?

    Affected entities: Entities potentially affected by this ICR
include producers and importers of plant-incorporated protectants
(PIPs). The North American Industrial Classification System (NAICS)
codes for respondents under this ICR include: Pesticide and other
agricultural chemical manufacturing (NAICS code 325320), biological
products (except diagnostic) manufacturing (NAICS code 325414), farm
supplies wholesalers (NAICS code 422910), flower, nursery stock, and
florists's suppliers (NAICS code 422930), research and development in
the physical, engineering, and life sciences (NAICS code 541710), and
colleges, universities, and professional schools (NAICS code 611310).
    Title: Plant-Incorporated Protectants; CBI Substantiation and
Adverse Effects Reporting.
    ICR numbers: EPA ICR No. 1693.06, OMB Control No. 2070-0142.
    ICR status: This ICR is currently scheduled to expire on January
31, 2011. 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 OMB control number. The OMB control numbers for EPA's
regulations in title 40 of the Code of Federal Regulations (CFR), after
appearing in the Federal Register when approved, are listed in 40 CFR
part 9, are displayed either by publication in the Federal Register or
by other appropriate means, such as on the related collection
instrument or form, if applicable. The display of OMB control numbers
for certain EPA regulations is consolidated in 40 CFR part 9.
    Abstract: This ICR addresses the two information collection
requirements described in regulations pertaining to pesticidal
substances that are produced by plants (PIPs) and which are codified in
40 CFR part 174. A PIP is defined as ``the pesticidal substance that is
intended to be produced and used in a living plant and the genetic
material necessary for the production of such a substance.'' Many, but
not all, PIPs are exempt from registration requirements under the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
Registrants sometimes include in a submission to EPA for registration
of a PIP information that they claim to be CBI. CBI is protected by
FIFRA and generally cannot be released to the public. Under 40 CFR part
174, whenever a registrant claims that information submitted to EPA in
support of a registration application for PIPs contains CBI, the
registrant must substantiate such claims when they are made, rather
than provide it later upon request by EPA. In addition, manufacturers
of PIPs that are otherwise exempted from the requirements of
registration must report adverse effects of the PIP to the Agency. Such
reporting will allow the Agency to determine whether further action is
needed to prevent unreasonable adverse effects to the environment.
Submission of this information is mandatory.
    Burden statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 7
hours for an adverse effects report and 21.5 hours for substantiation
of a CBI claim, per response. Burden means the total time, effort, or
financial resources expended by persons to generate, maintain, retain,
or disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the

existing ways to comply with any previously applicable instructions and
requirements which have subsequently changed; train personnel to be
able to respond to a collection of information; search data sources;
complete and review the collection of information; and transmit or
otherwise disclose the information.
    The ICR provides a detailed explanation of this estimate, which is
only briefly summarized here:
    Estimated total number of potential respondents: 18.
    Frequency of response: On occasion.
    Estimated total average number of responses for each respondent:
One for each registration application, experimental use permit, or
reporting of adverse effects.
    Estimated total annual burden hours: 389 hours.
    Estimated total annual costs: $26,875.00. This includes an annual
cost of $26,721 for CBI substantiations and $154 for adverse effects
reporting.

IV. Are There Changes in the Estimates From the Last Approval?

    There is an increase of 86 hours in the total estimated respondent
burden compared with that identified in the ICR currently approved by
OMB. This increase reflects an increase in the number of PIP
applications during the last 2 years. EPA expects that this higher
level of activity will continue. This change is an adjustment.

V. What Is the Next Step in the Process for This ICR?

    EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. EPA will issue another
Federal Register notice pursuant to 5 CFR 1320.5(a)(1)(iv) to announce
the submission of the ICR to OMB and the opportunity to submit
additional comments to OMB. If you have any questions about this ICR or
the approval process, please contact the person listed under FOR
FURTHER INFORMATION CONTACT.

List of Subjects

    Environmental protection, Reporting and recordkeeping requirements.

    Dated: April 27, 2010.
Stephen A. Owens,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2010-10413 Filed 5-4-10; 8:45 am]
BILLING CODE 6560-50-S


                 EPA/HQ Summary  -  Communications with Genco

Attendees

Genco Participant: Ashley Swanson EPA/HQ Participant: Drew Lausch

Dates:  December 16, 2016; January 5, 2017; January 6, 2017

Location:  E-mail Exchanges

Summary

EPA HQ posed a question to a representative from Genco, a third party logistics provider and reverse distributor of pharmaceuticals, regarding prescription drugs (Rx) and the "aging" process that occurs when otherwise potentially creditable pharmaceuticals are held based on the manufacturer's current return policy. As an example, EPA noted its experience that a manufacturer does not take back indated (non-expired) items even though the drug meets all the creditable criteria  -  except that it has not yet expired  -  adding that pharmaceuticals may sometimes be held for many months or even longer during the "aging" process.

EPA stated its understanding that "aging" would only occur in the case of Rx drugs and not with other items such as over-the-counter medications (OTCs) and dietary supplements but requested clarification.  EPA also asked about the rationale for "aging" pharmaceuticals; in other words, why certain pharmaceuticals that would otherwise be creditable cannot be returned for credit until the expiration date is met.

Genco indicated that EPA's understanding is mostly correct but added that its understanding is that indates, while largely Rx, can also include OTCs and dietary supplements  -  adding that this is dependent upon the requirements of the owner of the product.  Genco stated that the rationale for indating is that the owner of the product does not believe the product can be dispensed but it is still not eligible for manufacturer credit.  Genco further stated that product eligibility for credit is dictated by agreements between the manufacturer and owner of the product and that one of the terms of eligibility is frequently that the product must be expired or within a certain window of the expiration date.


[Federal Register Volume 77, Number 136 (Monday, July 16, 2012)]
[Notices]
[Pages 41847-41849]
[FR Doc No: 2012-17198]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-67380; File No. SR-EDGA-2012-29]

Self-Regulatory Organizations; EDGA Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Relating to
Amendments to the EDGA Exchange, Inc. Fee Schedule

July 10, 2012.
    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 June 29, 2012, EDGA Exchange, Inc. (the ``Exchange'' or
``EDGA'') 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 self-regulatory
organization. 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 Exchange proposes to amend its fees and rebates applicable to
Members \3\ of the Exchange pursuant to EDGA Rule 15.1(a) and (c). All
of the changes described herein are applicable to EDGA Members. The
text of the proposed rule change is available on the Exchange's
Internet Web site at http://www.directedge.com, at the Exchange's
principal office, and at the Public Reference Room of the Commission.
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    \3\ A Member is any registered broker or dealer, or any person
associated with a registered broker or dealer, that has been
admitted to membership in the Exchange.
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II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of these statements may be examined at
the places specified in Item IV below. The self-regulatory organization
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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    Flag DM is yielded where non-displayed orders add or remove
liquidity using the Mid-Point Discretionary order type.\4\ In order to
provide additional transparency to Members and for the reasons
discussed below, Flag DM is proposed to be bifurcated into two flags:
Flag DM (adds liquidity in the discretionary range) and Flag DT
(removes liquidity in the discretionary range). The Exchange proposes
to continue to charge a fee of $0.0005 per share for Flags DM and
DT.\5\
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    \4\ See Securities Exchange Act Release No. 67226 (June 20,
2012), 77 FR 38113 (June 26, 2012) (SR-EDGA-2012-22).
    \5\ See SR-EDGA-2012-24 (June 19, 2012) (describing the
Exchange's proposal to amend its fee schedule pursuant to Rule
15.1(a) and (c) regarding Flag DM).
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    In addition, the Exchange proposes to delete Footnote 18 that is
appended to Flag DM in the fee schedule because the proposed Flags DM
and DT will count towards volume tiers as the Exchange can now
differentiate between non-displayed liquidity that adds liquidity in
the discretionary range from non-displayed liquidity that removes
liquidity in the discretionary range.\6\
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    \6\ See SR-EDGA-2012-24 (June 19, 2012) (where the Exchange
excluded the volume generated from Flag DM from counting towards the
volume tiers because a Member could potentially receive Flag DM if
the Member either added or removed liquidity using the Midpoint
Discretionary Order).
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    The Exchange also proposes to amend Flag K to only apply to
Members' orders routed to NASDAQ OMX PSX (``PSX'') using the ROUC or
ROUE routing strategy as defined in Rule 11.9(b)(3). The Exchange
proposes to reduce the rate from $0.0025 per share to $0.0005 per
share, which represents a pass-through of the Exchange's rate for
routing orders to PSX, in response to the proposed pricing changes in
PSX's pending filing with the Commission.\7\ Accordingly, where
Members' orders are routed to the BATS BZX Exchange (``BATS BZX'')
using the ROBA routing strategy (EDGA + BATS), the Exchange proposes to
apply Flag X, which is yielded when Members route orders through EDGA
and the Exchange assesses a charge of $0.0029 per share.
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    \7\ See PSX's Equity Trader Alert 2012-28 at http://www.nasdaqtrader.com/TraderNews.aspx?id=ETA2012-28 (discussing PSX's
pending fee changes effective July 2, 2012).
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    Similarly, the Exchange also proposes to amend the rate for Flag
RS, which is yielded when Members route orders to PSX that add
liquidity. The Exchange proposes to amend the pricing for Flag RS from
a rebate of $0.0024 per share to a charge of $0.0005 per share in
response to PSX's pending filing, which represents a pass-through of
the Exchange's rate for routing orders to PSX.
    The Exchange proposes to implement these amendments to its fee
schedule on July 1, 2012.
2. Statutory Basis
    The Exchange believes that the proposed rule changes are consistent
with the objectives of Section 6 of the Act,\8\ in general, and
furthers the objectives of Section 6(b)(4),\9\ in particular, as it is
designed to provide for the equitable allocation of reasonable dues,
fees and other charges among its Members and other persons using its
facilities.
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    \8\ 15 U.S.C. 78f.
    \9\ 15 U.S.C. 78f(b)(4).
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    The Exchange believes that the proposed technical amendment to
bifurcate Flag DM into Flags DM and DT promotes market transparency and
improves investor protection by adding additional transparency to its
fee schedule by more precisely delineating for Members whether they are
``adders of liquidity'' or ``removers of liquidity'' for purposes of
Members' non-displayed orders using the Mid-Point Discretionary order
type. In addition, the Exchange believes that counting Flags DM and DT
towards volume tiers is reasonable and equitable as the Exchange can
now differentiate between non-displayed liquidity that adds liquidity
in the discretionary range from non-displayed liquidity that removes
liquidity in the discretionary range, as explained above. Including
Flags DM and DT in volume tiers allows their associated volume to be
tracked by the Exchange in the appropriate tier(s), which may incent
Members to increase use of the volume tiers in the fee

schedule. Such volume will increase potential revenue to the Exchange,
and would allow the Exchange to spread its administrative and
infrastructure costs over a greater number of shares, leading to lower
per share costs. These lower per share costs would allow the Exchange
to pass on the savings to Members in the form of higher rebates/lower
costs. The increased liquidity also benefits all investors by deepening
EDGA's liquidity pool, offering additional flexibility for all
investors to enjoy cost savings, supporting the quality of price
discovery, promoting market transparency and improving investor
protection. The Exchange also believes that proposed change is non-
discriminatory because it applies uniformly to all Members.
    The rates and rebates associated with routing orders to PSX on the
Exchange's fee schedule are pass-through rates. Currently, PSX charges
the Exchange $0.0025 per share for Members' orders that are routed to
PSX using the ROUC or ROUE routing strategy and the Exchange charges
its Members $0.0025 per share as a pass-through. Therefore, the
Exchange believes that the proposed reduction from $0.0025 per share to
$0.0005 per share is equitable and reasonable because PSX is reducing
the rate it charges the Exchange for routing to PSX to $0.0005.
Currently, PSX provides the Exchange a rebate of $0.0024 per share for
Members' orders that are routed to PSX and add liquidity and the
Exchange rebates Members $0.0024 per share as a pass-through (Flag RS).
Therefore, the Exchange believes that the proposed reduction from a
rebate of $0.0024 per share to a charge of $0.0005 per share is
equitable and reasonable because PSX is increasing the rate it charges
the Exchange for routing to PSX to $0.0005 per share. In addition, the
Exchange also believes that the proposed pass-through of this rate is
non-discriminatory because it applies uniformly to all Members.
    The Exchange believes that increasing the charge assessed for
Members' orders that are routed to BATS BZX using the ROBA routing
strategy (EDGA + BATS) from $0.0025 per share to $0.0029 per share
(yielding Flag X) is equitable and reasonable because the Exchange is
removing the $0.0004 per share incentive it previously associated with
this routing strategy and replacing it with a straight pass-through of
the charge BATS BZX assesses the Exchange for removing liquidity from
the BZX Exchange order book.\10\ Accordingly, the Exchange will assess
a charge of $0.0029 per share for Members' orders that route to BATS
BZX using the ROBA routing strategy as well as other routed orders that
yield Flag X. In addition, the Exchange also believes that the proposed
pass-through of this rate is non-discriminatory because it applies
uniformly to all Members.
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    \10\ See BATS BZX fee schedule at http://batstrading.com/FeeSchedule/.
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    The Exchange also notes that it operates in a highly-competitive
market in which market participants can readily direct order flow to
competing venues if they deem fee levels at a particular venue to be
excessive. The proposed rule change reflects a competitive pricing
structure designed to incent market participants to direct their order
flow to the Exchange. The Exchange believes that the proposed rates are
equitable and non-discriminatory in that they apply uniformly to all
Members. The Exchange believes the fees and credits remain competitive
with those charged by other venues and therefore continue to be
reasonable and equitably allocated to Members.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3) of the Act \11\ and Rule 19b-4(f)(2) \12\ thereunder. At any
time within 60 days of the filing of such 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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    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(2).
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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-EDGA-2012-29 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-EDGA-2012-29. 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
a.m. and 3 p.m. Copies of the 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 available publicly. All
submissions should refer to File Number SR-EDGA-2012-29 and should be
submitted on or before August 6, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
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    \13\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-17198 Filed 7-13-12; 8:45 am]
BILLING CODE 8011-01-P