[Federal Register Volume 88, Number 179 (Monday, September 18, 2023)]
[Notices]
[Pages 63960-63963]
[FR Doc No: 2023-20139]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-1029]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Cosmetic Facility
Registration, Product Listing, and Labeling Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing that a proposed collection of information has been submitted
to the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by October 18, 2023.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0599. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Cosmetic Facility Registration, Product Listing, and Labeling
Requirements

OMB Control Number 0910-0599--Revision

    This information collection supports implementation of statutory
and regulatory provisions that govern cosmetics. On December 29, 2022,
the President signed into law the Consolidated Appropriations Act, 2023
(Pub. L. 117-328), which included the Modernization of Cosmetics
Registration Act of 2022 (MoCRA). MoCRA amended the Federal Food, Drug,
and Cosmetic Act (FD&C Act) by requiring, among other requirements,
manufacturers of cosmetic products to label products intended for use
only by licensed professionals to bear a label that the product must be
administered or used only by licensed professionals, in addition to
providing the same information on the label that is required of
cosmetic products intended for consumers. MoCRA also added the
requirement for cosmetic product labels to include contact information
through which the responsible person can receive adverse event reports.
Other requirements introduced by MoCRA include facility registration,
cosmetic product listing, and associated recordkeeping.

Cosmetic Labeling Requirements

    The FD&C Act and the Fair Packaging and Labeling Act (the FPLA)
require that cosmetic manufacturers, packers, and distributors disclose
information about themselves or their products on the labels or
labeling of their products. Sections 201, 301, 502, 601, 602, 603, 701,
and 704 of the FD&C Act (21 U.S.C. 321, 331, 352, 361, 362, 363, 371,
and 374) and sections 4 and 5 of the FPLA (15 U.S.C. 1453 and 1454)
provide authority to FDA to regulate the labeling of cosmetic products.
Failure to comply with the requirements for cosmetic labeling may
render a cosmetic adulterated under section 601 of the FD&C Act or
misbranded under section 602 of the FD&C Act.
    FDA's cosmetic labeling regulations are codified in part 701 (21
CFR part 701). Section 701.3 (21 CFR 701.3) requires the label of a
cosmetic product to bear a declaration of the ingredients in descending
order of predominance. Section 701.11 (21 CFR 701.11) requires the
principal display panel of a cosmetic product to bear a statement of
the identity of the product. Section 701.12 (21 CFR 701.12) requires
the label of a cosmetic product to specify the name and place of
business of the manufacturer, packer, or distributor. Section 701.13
(21 CFR 701.13) requires the label of a cosmetic product to declare the
net quantity of contents of the product.
    MoCRA amended the FD&C Act by requiring, among other requirements,
manufacturers of cosmetic products to label products intended for use
only by licensed professionals to bear a label that the product must be
administered or used only by licensed professionals, in addition to
providing the same information on the label that is required of
cosmetic products intended for consumers. MoCRA also added the
requirement for cosmetic product labels to include contact information
(domestic address, phone number, or electronic contact information that
may include a website) through which the responsible person can receive
adverse event reports.

Facility Registration and Cosmetic Product Listing Program

    MoCRA amended the FD&C Act by requiring, among other requirements,
operators and owners of facilities manufacturing or processing cosmetic
products to register with FDA and renew such registrations biennially.
Facilities will also need to notify FDA of any changes to information
that was required as part of registration. FDA may suspend registration
if we determine that a cosmetic product manufactured or processed by a
registered facility has a reasonable probability of causing serious
adverse health consequences or death. Upon notice that FDA intends to
suspend registration, the responsible person for the facility may
submit a corrective action plan for addressing the reasons for possible
suspension of the facility registration. MoCRA also added the
requirement for responsible persons to submit a product listing for
each of their cosmetic products to FDA.
    As we update our infrastructure to include a mechanism to accept
submissions for registrations and product listings consistent with the
provisions in MoCRA, we have discontinued use of Forms FDA 2511, 2512,
and 2512a, previously used for voluntary registration activities and
have stopped accepting new submissions to the Voluntary Cosmetic
Registration Program (VCRP).
    Description of Respondents: Respondents to this collection of
information include cosmetic manufacturers and processors. Respondents
are from the private sector (for-profit businesses).
    In the Federal Register of May 1, 2023 (88 FR 26564), we published
a 60-day notice requesting public comment on the proposed collection of
information. Several comments were received, however those not
pertaining to the PRA topics solicited in the notice are not addressed.
Comments pertaining to the necessity and practical utility of the
information being collected included concerns with protecting privacy
and

confidential commercial information. One comment expressed concern for
the disclosure of a person's residential address while another
suggested that a contract manufacturer would not be able to comply with
the facility registration provisions without disclosing the brands it
is manufacturing.
    Comments pertaining to the accuracy of our burden estimates
questioned whether FDA assumes manufactures will need to change their
label due to new labeling requirements, whether our listing figures
reflect only products in the U.S. market or the number of products each
manufacturer makes, and another comment suggested that submissions for
registration and product listing will take more time than FDA estimated
based on its experience with VCRP.
    Comments regarding ways to enhance the quality, utility, and
clarity of the information to be collected suggested that registration
under MoCRA should mirror FDA's Food Facility Registration program,
including aligning the biennial registration schedule between the
programs. Finally, comments regarding ways to minimize the burden of
the collection of information on respondents requested that FDA extend
the deadline for manufacturers to comply with the newly mandated
labeling, registration, and product listing requirements. Other
comments sought more information about the electronic system and forms
for registration and product listing including whether there is a fee.
    While we have increased burden estimates we attribute to product
listing reporting activities in response to these public comments, we
intend to refrain from making further modifications to our burden
estimates until we have more experience with implementation of the new
mandatory requirements. Privacy and trade-secret, commercial
confidential information is governed by the Privacy Act of 1974 and
part 20 of our regulations (21 CFR part 20). The registration and
listing requirements set forth in section 605 of the FD&C Act (21
U.S.C. 364(c)) require that FDA begin receiving registration and
listing information no later than December 29, 2023. We have therefore
made no other modifications to the proposed collections of information.
    At the same time, on our own initiative we have taken the following
actions:
     We have developed Form FDA 5066 entitled ``Registration of
Cosmetic Product Facility,'' and Form FDA 5067 entitled ``Cosmetic
Product Listing,'' to be used for registrations and product listings,
respectively. These forms will be available in paper format or via an
electronic system for submission. Draft screenshots of the paper forms
and electronic system for submission are available for viewing at
https://www.fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products.
     We developed Agency guidance to further assist industry
with cosmetic registration and product listing requirements. In the
Federal Register of August 8, 2023 (88 FR 53490), we announced the
availability of a draft guidance for industry entitled ``Registration
and Listing of Cosmetic Product Facilities and Products'' (available at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-registration-and-listing-cosmetic-product-facilities-and-products). The draft guidance, when finalized,
is intended to provide instruction and further assist industry in
preparing and submitting registrations and product listings required by
MoCRA. The draft guidance discusses, among other things, who must
register and list, when, and what must be submitted.
     Also in the Federal Register of August 8, 2023 (88 FR
53499), we announced a pilot, including instruction on participation,
intended to gather input to inform evaluation of the new electronic
cosmetic registration and listing submission portal.
     We have added information collection elements to account
for mandatory adverse event recordkeeping requirements under new
section 605 of the FD&C Act added by MoCRA, and we are revising OMB
control number 0910-0291 to include corresponding adverse event
reporting. We are currently modifying our MedWatch forms, approved in
0910-0291, to receive mandated adverse event reporting elements
associated with cosmetic products as introduced by MoCRA.
    We estimate the burden of this collection of information as
follows:

                                               Table 1--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Number of                        Average
    Legal authority; information collection activity         Number of      disclosures    Total annual     burden per      Total hours    Total capital
                                                            respondents   per respondent    disclosures     disclosure                       costs \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   701.3; ingredients in order of predominance......           1,518              21          31,878               1          31,878  ..............
Sec.   701.11; statement of identity....................           1,518              24          36,432               1          36,432  ..............
Sec.   701.12; name and place of business...............           1,518              24          36,432               1          36,432  ..............
Sec.   701.13; net quantity of contents.................           1,518              24          36,432               1          36,432  ..............
Sec. 609(a) of the FD&C Act (MoCRA); contact information           1,518              24          36,432               1          36,432     $91,080,000
 to send adverse event reports..........................
Sec. 609(c) of the FD&C Act (MoCRA); professional use                100              12           1,200               1           1,200       3,000,000
 only...................................................
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............         178,806      94,080,000
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\1\ There are no operating and maintenance costs associated with this collection of information.
\2\ One-time burden for capital costs.

    The estimated annual third-party disclosure burden for labeling is
based on data available to the Agency, our knowledge of and experience
with cosmetics, and informal communications with industry. The hour
burden is the additional or incremental time that establishments need
to design and print labeling that includes the following required
elements: a declaration of ingredients in decreasing order of
predominance, a statement of the identity of the product, a
specification of the name and place of business of the establishment,
and a

declaration of the net quantity of contents. These requirements
increase the time establishments needed to design labels because they
increase the number of label elements that establishments must consider
when designing labels. These requirements do not generate any recurring
burden per label because establishments must already print and affix
labels to cosmetic products as part of normal business practices.
Regarding the new statutory labeling requirements for products intended
for professional use only and contact information for manufacturers to
receive reports of adverse events, we estimate that there will be a
capital cost of $94,080,000 associated with relabeling. This is the
cost of designing a revised label and incorporating it into the
manufacturing process. We believe that this will be a one-time cost.

                                 Table 2--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    No. of
 Legal authority; information       No. of       responses per   Total annual    Average burden     Total hours
      collection activity         respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Sec. 607(a)(1) of the FD&C               3,400               1           3,400  0.5 (30 minutes)           1,700
 Act; initial registrations.
Sec. 607(a)(2) and (5) of the            1,700               1           1,700  0.25 (15                     425
 FD&C Act; biennial                                                              minutes).
 registration renewals.
Sec. 607(a)(4) of the FD&C                 100               1             100  0.25 (15                      25
 Act; registration updates.                                                      minutes).
Sec. 607(f) of the FD&C Act;                 5               1               5  10..............              50
 post-hearing corrective
 action plan.
Sec. 607(c)(1) and (2) of the            3,400              10          34,000  1...............          34,000
 FD&C Act; cosmetic product
 listing.
Sec. 607(c)(3) of the FD&C               3,400              10          34,000  0.25 (15                   8,500
 Act; product listing                                                            minutes).
 abbreviated renewals.
Sec. 607(c)(5) of the FD&C                 200               1             200  0.25 (15                      50
 Act; product listing updates.                                                   minutes).
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................          44,750
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    We base our estimate of reporting burden hours on information from
the VCRP, because it provided the best available data to FDA in terms
of the number of respondents and responses. We believe that the VCRP
reflected less than half of cosmetic manufacturers and processors
because it was a voluntary system. We initially doubled our estimate
for the number of respondents registering and used this number to
estimate other activities related to facility registration and cosmetic
product listing. We have since further increased the number of product
listings per respondent, which also increases the number of responses
(products). Based on a review of the information collection since our
last request for OMB approval, we have increased our estimate to
account for an anticipated increase in respondents and responses
resulting from new statutory requirements.
    MoCRA amended the FD&C Act by adding section 605 to require, among
other requirements, responsible persons to submit reports of serious
adverse events to FDA no later than 15 business days after receiving
the report, including any new medical information received within 1
year of the initial report. The responsible person shall receive
adverse event reports through the domestic address, domestic telephone
number, or electronic contact information included on the label.
Further, FDA may request a complete list of ingredients in specific
fragrances or flavors in a cosmetic product if FDA has reasonable
grounds to believe that an ingredient or combination of ingredients has
caused a serious adverse event. We are revising the scope of OMB
control number 0910-0291 to include this reporting activity as we
modify corresponding electronic and paper-based forms.

                                                   Table 3--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Legal authority; information collection        Number of       Number of records     Total annual          Average burden  per
                 activity                      recordkeepers     per recordkeeper         records               recordkeeping             Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 605(e) of the FD&C Act; adverse                    1,000                   1               1,000   0.5 (30 minutes)............                500
 events records.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating costs associated with the collection of information.

    MoCRA also amended the FD&C Act by adding recordkeeping
requirements. Responsible persons are required to maintain records
related to each report of an adverse event for a period of 6 years (or
3 years for a small business that does not manufacture or process
certain cosmetic products) and authorizes FDA to have access to such
records during an inspection. We base our estimate of recordkeeping
burden hours on estimates found in the information collection approved
under OMB control number 0910-0291 (FDA's Adverse Event and Product
Experience Reporting Program). The collection currently estimates 1,793
paper reports and 1,398 Safety Reporting Portal submissions, for CFSAN
which includes food, infant formula, and cosmetic products, equaling
3,191. We estimate that cosmetic products account for around a third of
the reports (estimating 1,000) with each report corresponding to a
separate recordkeeping. We estimate that maintaining the record will
take 30 minutes. However, once the

documents pertaining to an adverse event report have been assembled and
filed in accordance with MoCRA, we expect the records retention burden
to be minimal, as we believe most responsible persons would normally
keep this kind of record for at least several years after creating the
document, as a matter of usual and customary business practice.

    Dated: September 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-20139 Filed 9-15-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: November 24, 2009 (Volume 74, Number 225)]
[Notices]
[Page 61395-61397]
[DOCID:fr24no09-88]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61024; File No. SR-CBOE-2009-025]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing of Proposed Rule Change, as Modified by
Amendment No. 1, Related to the Simple Auction Liaison (SAL)

November 18, 2009.
    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 May 4, 2009, the Chicago Board Options Exchange, Incorporated
(``Exchange'' or ``CBOE'') 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
Exchange. On November 13, 2009, the Exchange filed Amendment No. 1 to
the proposal, which replaced the original filing in its entirety. The
Commission is publishing this notice to solicit comments on the
proposed rule change, as amended, 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 Rule 6.13A, Simple Auction Liaison
(SAL), to revise the Designated Primary Market-Maker (``DPM'')/Lead
Market-Maker (``LMM'') participation entitlement formula that is
applicable to SAL executions in Hybrid 3.0 classes. The text of the
proposed rule change is available on the Exchange's Web site (http://
www.cboe.org/Legal), at the Office of the Secretary, CBOE and at the
Commission.

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 those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

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

1. Purpose
    The purpose of Amendment No. 1, which replaces the original filing
in its entirety, is to modify the proposed rule change so that the
revised DPM/LMM participation entitlement formula applicable to SAL
executions in selected Hybrid 3.0 classes will operate on a 1-year
pilot basis.
    SAL is a feature within CBOE's Hybrid System that auctions
marketable orders for price improvement over the national best bid or
offer (``NBBO''). For Hybrid 3.0 Classes, the Exchange determines, on a
class-by-class basis, which electronic matching algorithm from Rule
6.45B, Priority and Allocation of Trades in Index Options and Options
on ETFs on the CBOE Hybrid System, shall apply to SAL executions (e.g.,
pro-rata, price-time, UMA priority with public customer, participation
entitlement and/or market turner priority overlays). Additionally, the
Exchange may establish, on a class-by-class basis, a DPM/LMM
participation entitlement that is applicable only to SAL executions.
Pursuant to Rules 8.15B and 8.87, the participation entitlement
generally is 50% when there is one other Market-Maker also quoting at
the best bid/offer on the Exchange, 40% when there are two Market-
Makers also quoting at the best bid/offer on the Exchange, and 30% when
there are three or more Market-Makers also quoting at the best bid/
offer on the Exchange. In addition, the participation entitlement must
be in compliance with Rule 6.45B(a)(i)(2). In relevant part, Rule
6.45B(a)(i)(2) provides that the DPM or LMM may not be allocated a
total quantity greater than the quantity that it is quoting (including
orders not part of quotes) at that price. In addition, if pro-rata
priority is in effect and the DPM or LMM's allocation of an order
pursuant to its participation entitlement is greater than its
percentage share of quotes/orders at the best price at the time that
the participation entitlement is granted (the ``pro-rata share''), the
DPM or LMM shall not receive any further allocation of that order. The
rule also provides that the participation entitlement shall not be in
effect unless public customer priority is in effect in a priority
sequence ahead of the participation entitlement and then the
participation entitlement shall only apply to any remaining balance.\3\
In addition, responses to SAL auctions are capped to the size of the
Agency Order for allocation purposes pursuant to Rule 6.13A.
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    \3\ Rule 6.45B(a)(i)(2) also provides that, to be entitled to
their participation entitlement, the DPM/LMM's order and/or quote
must be at the best price on the Exchange. For purposes of SAL
executions, the Exchange interprets this to mean that the DPM/LMM
must be at the best price at both the start and the conclusion of
the SAL auction.
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    Thus, for example, assume an incoming agency order to buy 250
contracts is received and at the conclusion of the SAL auction the LMM
is offered at the best price for 200 contracts, 1 customer is offered
at the best price for 50 contracts and 4 other Maker-Makers are offered
at the best price for 140 contracts each. In this

scenario, the customer would be allocated 50 contracts, the LMM would
be allocated 60 contracts (30% x 200 remaining contracts), and the 4
other Market-Makers would be allocated the remaining 140 contract
balance on a pro-rata basis with each receiving 35 contracts.
    In order to offer additional incentives for DPMs or LMMs to support
and participate in SAL auctions in Hybrid 3.0 classes (which currently
only includes options on the Standard and Poor's 500 Index, SPX), and
thus offer additional opportunities for price improvement, we are
proposing to modify the DPM/LMM entitlement when the pro-rata algorithm
is in effect for SAL in selected Hybrid 3.0 classes as part of a pilot
program that will operate on a 1-year basis. For such pro-rata classes,
after all public customer orders in the book at the best bid/offer and
the DPM/LMM participation entitlement have been satisfied, the DPM/LMM
shall be eligible to participate in any remaining balance on a pro-rata
basis (regardless of whether its participation entitlement is greater
than its pro-rata share).
    Using the example above, the customer would be allocated 50
contracts, the LMM would be allocated 60 contracts (30% x 200 remaining
balance), and the LMM and 4 other Market-Makers would be allocated the
remaining 140 contract balance on a pro-rata basis with each receiving
28 contracts (140 remaining balance/(MM1's 140 contract offer + MM2's
140 contract offer + MM3's 140 contract offer + MM4's 140 contract
offer + LMM's 140 decremented contract offer) x applicable pro-rata
share). Thus, the LMM would receive a total of 88 contracts under the
revised algorithm.
    As part of the pilot program, on a quarterly basis the Exchange
will evaluate the number of SAL executions in each pilot class where
the DPM/LMM participation entitlement was applied and the allocation
was greater than what it would have been under the pre-pilot allocation
algorithm, i.e., the allocation was greater than (i) the DPM/LMM's pro-
rata share as calculated prior to the pilot and (ii) the DPM/LMM's
participation entitlement share as calculated prior to the pilot. The
Exchange will reduce the DPM/LMM participation entitlement for the
class if the number of SAL executions that exceeded the benchmark is
more than 1% of the total number of SAL executions in the class
evaluated during the quarter. This evaluation will be based on a random
sampling of three days for each month in each quarter. The
``benchmark'' will be 60% where there is one Market-Maker also quoting
at the best bid/offer on the Exchange; 40% where there are two Market-
Makers also quoting at the best bid/offer on the Exchange; and 40%
where there are three or more Market-Makers also quoting at the best
bid/offer on the Exchange. The benchmark percentages, which in some
instances are greater than CBOE's DPM/LMM participation entitlement
percentages contained in Rules 8.15B and 8.87 (see discussion above),
are based on the market-maker participation entitlement percentages
that are available on other options exchanges.\4\
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    \4\ See, e.g., International Securities Exchange Rule
7.13.01(b)(provides a 60% participation right if there is only one
other Professional Order or market maker quotation at the best
price) and NYSE Arca, Inc. Rule 6.76A(a)(1)(A)(i)(provides a 40%
participation right regardless of the number of other market
participants at the best price).
---------------------------------------------------------------------------

    During the pilot, the Exchange will submit a quarterly report
containing certain data related to this evaluation to the Commission
and any such data submitted will be provided on a confidential basis.
The report will be submitted within 10 business days of the conclusion
of each quarter. The report will provide data on the total number of
SAL executions evaluated during the period. It will also provide data
on SAL executions where a DPM/LMM participation entitlement was applied
and the allocation was greater than it would have been under the pre-
pilot allocation algorithm, including information on the number of
Market-Makers also quoting at the NBBO and on the actual allocation
percentage the DPM/LMM received per execution as compared to the
benchmark. For purposes of the report, the ``actual allocation
percentage'' will be calculated by adding the participation entitlement
contracts plus the pro-rata share contracts, and dividing the sum by
the number of contracts executed on SAL less public customer orders
that were satisfied.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
Section 6(b) of the Act \5\ in general and furthers the objectives of
Section 6(b)(5) of the Act \6\ in particular in that it is designed to
foster cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general, to protect investors and the public interest.
In particular, the Exchange believes that the proposed change would
provide additional incentives for DPMs or LMMs to support and
participate in SAL auctions in Hybrid 3.0 classes, which would result
in additional opportunities to provide orders executions at improved
prices.
---------------------------------------------------------------------------

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

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

    CBOE does not believe that the proposed rule change will impose any
burden on competition 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. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-CBOE-2009-025 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-CBOE-2009-025. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of 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-CBOE-2009-025 and should be
submitted on or before December 15, 2009.

    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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Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-28100 Filed 11-23-09; 8:45 am]

BILLING CODE 8011-01-P