UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

NATIONAL VEHICLE AND FUEL EMISSIONS LABORATORY

2565 PLYMOUTH ROAD

ANN ARBOR, MICHIGAN 48105-2498

OFFICE OF

AIR AND RADIATION

MEMORANDUM

SUBJECT:	Emissions Modeling Data Files for the Final Renewable Fuel
Standard Rule

FROM:	Margaret Zawacki

		Assessment and Standards Division, Office of Transportation and Air
Quality

		Marc Houyoux and Rich Mason

		Emissions Inventory and Analysis Group, Office of Air Quality Planning
and Standards

TO:		Docket EPA-HQ-OAR-2005-0161-DRAFT-3009

DATE:		January 13, 2010

The purpose of this memorandum is to transmit data files which were used
in the emissions modeling analyses for the final renewable fuel standard
rule.  The emissions modeling analyses are discussed in Section VI of
the preamble, Chapter 3 of the Regulatory Impact Analysis (RIA) and in
the Emissions Modeling Technical Support Document.  Following is a brief
description of the information contained on the enclosed DVDs.

County/SCC-level delimited summaries for criteria pollutants and (at
least) select hazardous air pollutants (benzene, acetaldehyde,
formaldehyde, acrolein, 1,3-butadiene, methanol, naphthalene) by
emissions modeling sector for the scenarios listed below.  Some
county-SCC summary files include emissions for all HAPs supported by the
multi-pollutant CMAQ model.  Onroad and nonroad mobile summaries are
included by month using average day emissions and separately with annual
totals.  For cases (1), (2), (3), and (5), point source inventories are

also provided in the format for the Sparse Matrix Operator Kernel
Emissions (SMOKE) modeling system.  The point "ORL" format of these
datasets can be found online at
http://www.smoke-model.org/version2.6/html/ch08s02s08.html#d0e43807.

1) 2005 base

2) 2022 AEO baseline

3) 2022 RFS1 baseline

4) 2022 RFS1 sensitivity with headspace profile speciation change
(8737B) - July 12-km EUS only

5) 2022 RFS2 control case

6) 2022 RFS2 sensitivity with missing cellulosic plants, nonroad
speciation & PFCs changes - Jan/April/July/Oct 12-km EUS only

Attachments


[Federal Register Volume 86, Number 173 (Friday, September 10, 2021)]
[Notices]
[Page 50713]
[FR Doc No: 2021-19530]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP21-1096-000.
    Applicants: El Paso Natural Gas Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Non-Conforming Agreement
Update (SoCal Sept-Oct 2021) to be effective 9/3/2021.
    Filed Date: 9/2/21.
    Accession Number: 20210902-5127.
    Comment Date: 5 p.m. ET 9/14/21.

    Docket Numbers: RP20-921-000.
    Applicants: Maritimes & Northeast Pipeline, L.L.C.
    Description: Refund Report: RP20-921 Refund Report to be effective
N/A.
    Filed Date: 9/2/21.
    Accession Number: 20210902-5092.
    Comment Date: 5 p.m. ET 9/14/21.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    Any person desiring to protest in any the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5:00 p.m. Eastern time on the specified
comment date.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: September 3, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-19530 Filed 9-9-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: March 26, 2007 (Volume 72, Number 57)]
[Notices]
[Page 14145-14149]
[DOCID:fr26mr07-97]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55491; File No. SR-CBOE-2006-95]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Order Granting Accelerated Approval
of Proposed Rule Change as Modified by Amendment Nos. 1 and 2 Thereto
To List for Trading Options on the Vanguard[supreg] Emerging Markets
Exchange Traded Fund

March 19, 2006.
    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 November 30, 2006, the Chicago Board Options Exchange, Incorporated
(``CBOE'' or ``Exchange'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule

change as described in Items I and II below, which Items have been
substantially prepared by the Exchange. The Exchange submitted
Amendment No. 1 to the proposed rule change on December 6, 2006. The
Exchange submitted Amendment No. 2 to the proposed rule change on
February 28, 2007. The Commission is publishing this notice and order
to solicit comments on the proposal, as amended, from interested
persons and to approve the proposed rule change, as modified by
Amendment Nos. 1 and 2, on an accelerated basis.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to list and trade options on the
Vanguard[supreg] Emerging Markets Exchange Traded Fund (``Fund
Options''). 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's Public Reference Room.

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

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

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

1. Purpose
    The purpose of this rule change is to obtain approval to list for
trading on the Exchange options on the Vanguard[supreg] Emerging
Markets Exchange Traded Fund (``Fund'') on a pilot basis for six months
to commence on the date of approval and through six months after that
date. The Exchange currently has in place initial listing and
maintenance standards set forth in CBOE Rules 5.3.06 and 5.4.08,
respectively (``Listing Standards'') that are designed to allow the
Exchange to list funds structured as open-end investment companies,
such as the Fund, without having to file for Commission approval to
list for trading options on the fund.\3\ The request for approval is
based on the Exchange's determination that the Fund meets substantially
all of the Listing Standards requirements, and for the requirements
that are not met, sufficient mechanisms exist that would provide the
Exchange with adequate surveillance and regulatory information with
respect to the Fund.
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    \3\ CBOE Rules 5.3.06 and 5.4.08 set forth the initial listing
and maintenance standards for registered investment companies (or
series thereof) organized as open-end management investment
companies, unit investment trust or other similar entities traded on
a national securities exchange or through the facilities of a
national securities exchange (``Exchange Traded Funds''). See
Exchange Act Release, No. 34-40166 (July 2, 1998), 63 FR 37430 (July
10, 1998) (approval order for SR-CBOE-97-45, predating U.S.
Securities and Exchange Commission's (``Commission'') adoption of
Rule 19b-4(e) of the Securities Exchange Act of 1934 (``New Product
Release''). See Exchange Act Release No. 34-40761 (Dec. 8, 1998), 63
FR 70952 (Dec. 22, 1998)).
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    As provided in the Fund's most recent prospectus, dated November
10, 2006, the Fund is an open-end investment company that is designed
to hold a portfolio of securities that tracks the Morgan Stanley
Capital International, Inc. Emerging Markets Index (``MSCI Emerging
Markets Index'' or ``Index''), which includes approximately 850 common
stocks of companies located in 25 emerging markets around the world.\4\
The Fund employs a ``passive management''--or indexing--investment
approach by investing substantially all (normally about 95%) of its
assets in the common stocks that comprise the MSCI Emerging Markets
Index while employing a form of sampling to reduce risk.
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    \4\ As provided by Morgan Stanley Capital International, Inc.
(``MSCI''), which is the entity that created and currently maintains
the Index, the Index is a capitalization-weighted index whose
component securities are adjusted for available float and must meet
objective criteria for inclusion in the Index. The Index aims to
capture 85% of the publicly available total market capitalization in
each emerging market included in the Index. As of September 29,
2006, the Index was comprised of 852 constituents with the top five
constituents representing the following weights: 5.01%, 4.09%,
1.82%, 1.79%, and 1.76%. The Index is rebalanced quarterly,
calculated in U.S. Dollars on a real time basis, and disseminated
every 60 seconds during market trading hours.
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    As of January 31, 2007, the Fund was comprised of 862 securities
and the ten largest holdings in the fund made up 18.5% of the total
assets in the Fund.\5\ The security with the greatest individual weight
of 5.4% is OAO Gazprom ADRSamsung Electronics Co LTD GDR Registered, a
South KoreanRussian security. The security with the smallest weight is
Thanachart Capital Public Company Ltd., Metropolitan Bank & Trust Coa
Thai security, at less than 0.01%. As of January 31, 2007, the largest
markets covered in the Fund were South Korea (14.9%), Taiwan (12.3%),
Russia (9.9%), Brazil (10.7%) and South Africa (8.5%).
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    \5\ The ten largest holdings are: (1) OAO Gazprom ADR, (2)
Samsung Electronics Co., Ltd., (3) China Mobile (Hong Kong), Ltd.,
(4) America Movil SA de CV, (5) Lukoil Sponsored ADR; (6) Taiwan
Semiconductor Manufacturing Co., Ltd., (7) Petroleo Brasileiro SA
Pfd (8) Hon Hai Precision Industry Co., Ltd., (9) Cemex SA CPO, and
(10) Petroleo Brasileiro SA. See https://flagship.vanguard.com/VGApp/hnw/FundsSnapshot?FundId=0964&FundIntExt=INT
.

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    The Exchange believes that Vanguard's stated investment policies
prevent the Fund from being excessively weighted in any single security
or small group of securities and significantly reduces concerns that
trading in the Fund could become a surrogate for trading in
unregistered securities.
    Shares of the Fund (``Fund Shares'') are issued in exchange for an
``in kind'' deposit of a specified portfolio of securities, together
with a cash payment, in minimum size aggregation of 100,000 shares
(each, a ``Creation Unit''), as set forth in the Fund's prospectus.\6\
The Fund issues and sells Fund Shares in Creation Unit sizes through a
principal underwriter on a continuous basis at the net asset value per
share next determined after an order to purchase Fund Shares and the
appropriate securities are received. Following issuance, Fund Shares
are traded on an exchange like other equity securities, and equity-
trading rules apply. Likewise, redemption of Fund Shares is made in
Creation Unit size and ``in kind,'' with a portfolio of securities and
cash exchanged for Fund Shares that have been tendered for redemption.
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    \6\ See Exchange Act Release No. 34-44990, n. 16 (Oct. 25,
2001), 66 FR 56869 (Nov. 13, 2001) (approval order for SR-Amex-2001-
45, noting that local restrictions on transfers of securities to and
between certain kinds of investors exist in certain foreign markets
that preclude in-kind creation and redemptions of Exchange-Traded
Funds).
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    The Exchange notes that the maintenance Listing Standards set forth
in Rule 5.4.08 for open-end investment companies do not include
criteria based on either the number of shares or other units
outstanding or on their trading volume. As explained in SR-CBOE-97-
03,\7\ the absence of such criteria is justified on the ground that
since it should always be possible to create additional shares or other
interests in open-end investment companies at their net asset value by
making an in-kind deposit of the securities that comprise the
underlying index or portfolio, there is no limit on the available
supply of such shares or interests. This, in turn, should make it
highly unlikely that the market for listed, open-end investment company
shares could be capable of

manipulation, since whenever the market price for such shares departs
from net asset value, arbitrage will occur. Similarly, since the Fund
meets all of the requirements of the Listing Standards, except as
described below, the Exchange believes that the same analysis applies
to the Fund.
---------------------------------------------------------------------------

    \7\ See Securities Exchange Act Release No. 40166 (July 2,
1998), 63 FR 37430 (July 10, 1998).
---------------------------------------------------------------------------

    The Exchange has reviewed the Fund and determined that it satisfies
the Listing Standards, except for the requirement set forth in CBOE
Rule 5.3.06(A), which requires the Fund to meet the following
condition: ``any non-U.S. component securities of the index or
portfolio on which the Units are based that are not subject to
comprehensive surveillance agreements do not in the aggregate represent
more than 50% of the weight of the index or portfolio.'' The Exchange
currently has in place comprehensive surveillance sharing agreements
(``CSSA'') with foreign exchanges that cover 48.10% of the securities
in the Fund. One of the foreign exchanges on which component securities
of the Fund are traded and with which the Exchange does not have a CSSA
is the Bolsa Mexicana de Valores (``Bolsa''). The percentage of the
weight of the Fund represented by these securities is 6.60%.
    The Exchange notes that the Commission recently approved the
listing and trading of options on the iShares MSCI Emerging Markets
Index Fund on a on a pilot basis \8\ and permitted the Exchange to rely
on the memorandum of understanding executed by the Commission and the
CNBV, dated as of October 18, 1990 (``MOU'') for purposes of satisfying
its surveillance and regulatory responsibilities for the component
securities in the Fund that trade on the Bolsa until the Exchange is
able to secure a surveillance agreement with the Bolsa.\9\
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    \8\ See Exchange Act Release No. 34-53621 (April 10, 2006), 71
FR 79568 (April 14, 2006) (approving 60 day pilot listing and
trading, until June 9, 2006); see also Exchange Act Release No. 34-
53960 (June 1, 2006), 71 FR 33322 (June 8, 2006) (continuation of
pilot program for additional 90 days, until September 7, 2006); see
also Exchange Act Release No. 34-54347 (Aug. 22, 2006), 71 FR 51242
(Aug. 29, 2006) (continuation of pilot program for additional 90
days, until December 7, 2006); see also Exchange Act Release No. 34-
54876 (Dec. 5, 2006), 71 FR 74968 (Dec. 13, 2006) (continuation of
pilot program for additional six months, until June 7, 2007).
    \9\ The CNBV is the successor to the Comision Nacional y de
Valores of Mexico, which was merged with the Mexican Banking
Commission in April 1995 to form the CNBV. See Exchange Act Release
No. 36415, at n.23 (Oct. 25, 1995), 60 FR 55620 (Nov. 1, 1995)
(approval order for SR-CBOE-95-045). The Bolsa falls within the
regulatory oversight of CNBV.
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    Specifically, in connection with the listing and trading of options
on the iShares MSCI Emerging Markets Index Fund, the Exchange contacted
the Bolsa with a request to enter into a CSSA. In response, the Bolsa
expressed a willingness to enter into a surveillance sharing agreement
but indicated that it was unable to provide certain information that is
required as part of a CSSA. As a result of being unable to secure a
CSSA with the Bolsa, the Exchange requested permission to rely for a
pilot period on the MOU and the Exchange agreed to use its best efforts
that during this period to obtain a CSSA with the Bolsa, which would
reflect the following: (1) Express language addressing market trading
activity, clearing activity, and customer identify; (2) the Bolsa's
reasonable ability to obtain access to and produce requested
information; and (3) based on the CSSA and other information provided
by the Bolsa, the absence of existing rules, law or practices that
would impede the Exchange from obtaining foreign information relating
to market activity, clearing activity, or customer identity, or in the
event such rules, laws, or practices exist, they would not materially
impede the production of customer or other information.
    On other occasions, the Commission has been willing to allow an
exchange to rely on a memorandum of understanding entered into between
regulators in the event that the exchanges themselves cannot enter into
a CSSA. For example, the Exchange previously attempted to enter into a
CSSA with the Bolsa around the time the Exchange sought approval to
list for trading options on the CBOE Mexico 30 Index in 1995, which was
comprised of stocks trading on the Bolsa.\10\ Since the Bolsa was
unable to provide a CSSA, the Commission allowed the Exchange to rely
on the MOU between the SEC and CNBV.
---------------------------------------------------------------------------

    \10\ See Exchange Act Release No. 36415 (Oct. 25, 1995), 60 FR
55620 (Nov. 1, 1995) (approval order for SR-CBOE-95-045).
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    The Commission noted in the Approval Order regarding the CBOE
Mexico 30 Index that, in cases where it would be impossible to secure a
CSSA, the Commission has relied in the past on surveillance sharing
agreements between the relevant regulators. The Commission further
noted in the Approval Order that, pursuant to the terms of the MOU, it
was the Commission's understanding that both the Commission and the
CNBV could acquire information from and provide information to the
other, similar to that which would be required in a CSSA between
exchanges. Therefore, should CBOE need information on Mexican trading
in the component securities of the CBOE Mexico 30 Index, the Commission
could request such information from the CNBV under the MOU.
    The practice of relying on surveillance agreements between
regulators when a foreign exchange was unable or unwilling to provide a
CSSA was affirmed by the Commission in the Commission's New Product
Release.\11\ In the New Product Release, the Commission noted that if
securing an information sharing agreement is not possible, an exchange
should contact the Commission prior to listing a new derivative
securities product. The Commission also noted that the Commission might
determine instead that it is appropriate to rely on a memorandum of
understanding between the Commission and the foreign regulator.
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    \11\ See n. 4, supra.
---------------------------------------------------------------------------

    Given the Exchange's current inability to enter into a CSSA with
the Bolsa, the Exchange requests permission to rely on a pilot basis on
the MOU entered into between the Commission and the CNBV for purposes
of satisfying its surveillance and regulatory responsibilities for the
component securities in the Fund that trade on the Bolsa until the
Exchange is able to secure a CSSA with the Bolsa. The Exchange believes
this request is reasonable because the Commission has already
acknowledged that the MOU permits both the Commission and the CNBV to
acquire information from and provide information to the other, which is
similar to that which would be required in a surveillance sharing
agreement between exchanges.
    Additionally, if the Commission approves the listing of the Fund on
a pilot basis, during this period, the Exchange represents that it will
continue its efforts to obtain a CSSA with the Bolsa. The Exchange also
represents that it will regularly update the Commission on the status
of its discussions with the Bolsa. The Commission's approval of this
request would otherwise render the Fund compliant with all of the
Listing Standards.\12\
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    \12\ The Exchange notes that the component securities of the
Fund change periodically. Therefore, the Exchange may in fact have
in place CSSAs that would otherwise cover the percent weighting
requirements set forth in the Listing Standards for securities not
trading on the Bolsa. In this event, the Fund would satisfy all of
the Listing Standards and reliance on an approval order for the Fund
would be unnecessary.

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2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Act \13\ and the rules and regulations under the Act applicable to
a national securities exchange and, in particular, the requirements of
Section 6(b) of the Act.\14\ Specifically, the Exchange believes the
proposed rule change is consistent with the Section 6(b)(5) \15\
requirements that the rules of an exchange be designed to promote just
and equitable principles of trade, to prevent fraudulent and
manipulative acts and, in general, to protect investors and the public
interest.
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    \13\ 15 U.S.C. 78a et seq.
    \14\ 15 U.S.C. 78(f)(b).
    \15\ 15 U.S.C. 78(f)(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

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

    No written comments were solicited or received with respect to the
proposed rule change.

III. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change, as amended, 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-2006-95 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-CBOE-2006-95. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal offices 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-2006-95 and should be submitted on or before April
16, 2007.

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

    The Commission finds that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder applicable to a national securities exchange.\16\ In
particular, the Commission finds that the proposed rule change is
consistent with Section 6(b)(5) of the Act,\17\ which requires that an
exchange have rules designed, among other things, to promote just and
equitable principles of trade, 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.
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    \16\ In approving this rule change, the Commission notes that it
has considered the proposed rule's impact on efficiency,
competition, and capital formation. See 15 U.S.C. 78c(f).
    \17\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The listing of the Fund Options does not satisfy CBOE Rule
5.3.06(A), which requires that: ``any non-U.S. component securities of
the index or portfolio on which the Units are based that are not
subject to comprehensive surveillance agreements do not in the
aggregate represent more than 50% of the weight of the index or
portfolio.'' Although the Commission has been willing to allow an
exchange to rely on a memorandum of understanding entered into between
regulators where the listing SRO finds it impossible to enter into an
information sharing agreement, it is not clear that that CBOE has
exhausted all avenues of discussion with foreign markets, including
Bolsa, in order to obtain such an agreement. Indeed, with regard to
Bolsa, conditions may have changed in the time period since CBOE last
raised the issue with Bolsa in 1995 such that Bolsa now would be able
to entering a comprehensive surveillance agreement with CBOE.
    Consequently, the Commission has determined to approve CBOE's
listing and trading of Fund Options for a six-month pilot period during
which time CBOE may rely on the MOU with respect to Fund components
trading on Bolsa. During this period, the Exchange has agreed to use
its best efforts to obtain a comprehensive surveillance agreement with
Bolsa, which shall reflect the following: (1) Express language
addressing market trading activity, clearing activity, and customer
identify; (2) the Bolsa's reasonable ability to obtain access to and
produce requested information; and (3) based on the CSSA and other
information provided by the Bolsa, the absence of existing rules, law
or practices that would impede the Exchange from obtaining foreign
information relating to market activity, clearing activity, or customer
identity, or in the event such rules, laws, or practices exist, they
would not materially impede the production of customer or other
information.
    The Exchange also represents that it will regularly update the
Commission on the status of its negotiations with Bolsa. In approving
the proposed rule change, the Commission notes that CBOE currently has
in place surveillance agreements with foreign exchanges that cover
48.10% of the securities in the Fund and that the Index upon which the
Fund is based appears to be a broad-based index.
    The Exchange has requested accelerated approval of the proposed
rule change. The Commission finds good cause, consistent with Section
19(b)(2) of the Act,\18\ for approving this proposed rule change before
the thirtieth day after the publication of notice thereof in the
Federal Register. The Exchange has agreed to use its best efforts to
obtain a comprehensive surveillance agreement with the Bolsa during a
six-month pilot period in which the Exchange will rely on the MOU.
---------------------------------------------------------------------------

    \18\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\19\ that the

proposed rule change (SR-CBOE-2006-95), as modified by Amendment Nos. 1
and 2, be, and it hereby is approved on an accelerated basis for a six-
month pilot period ending on September 19, 2007.
---------------------------------------------------------------------------

    \19\ Id.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\20\
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    \20\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-5423 Filed 3-23-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 85, Number 151 (Wednesday, August 5, 2020)]
[Notices]
[Pages 47389-47390]
[FR Doc No: 2020-17041]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0424]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Postmarketing Safety
Information Sharing by Constituent Part Applicants for Combination
Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) 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 September 4, 2020.

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 0910-0834. Also include the FDA docket number found in
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
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.

Postmarketing Information Sharing Among Constituent Part Applicants for
Combination Products--21 CFR 4.103

OMB Control Number 0910-0834--Extension

    This information collection request applies to ``constituent part
applicants'' as defined under 21 CFR 4.101 (i.e., any person holding an
application under which a constituent part (drug, device, or biological
product) of a combination product received marketing authorization if
the other constituent part(s) received marketing authorization under an
application held by a different person). Under this collection,
constituent part applicants must share safety information they receive
related to certain events with the other constituent part applicant(s)
and maintain associated records.\1\
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    \1\ The Postmarketing Safety Reporting (PMSR) information
collections for drugs, biological products, and devices found in
Sec. Sec.  314.80, 314.81, 600.80, 600.81, 606.170, 606.171, 803.50,
803.53, 803.56, 806.10, and 806.20 (21 CFR 314.80, 314.81, 600.80,
600.81, 606.170, 606.171, 803.50, 803.53, 803.56, 806.10, and
806.20) have already been approved and are in effect or their
extension is being sought separately as required, including with
respect to burden for combination products (reflected in the
authorization for OMB control number 0910-0834, but, therefore, not
addressed in this extension request). The pertinent PMSR information
collection provisions for Sec.  314.80(c) and (e), as well as for
Sec.  314.81(b) are approved under OMB control numbers 0910-0001,
0910-0230, and 0910-0291. The information collection provisions for
Sec. Sec.  600.80 and 600.81 are approved under OMB control number
0910-0308. Those for Sec.  606.170 are approved under OMB control
number 0910-0116. Those for Sec.  606.171 are approved under OMB
control number 0910-0458. The information collection provisions for
Sec. Sec.  803.50, 803.53, and 803.56 are approved under OMB control
numbers 0910-0291 and 0910-0437. The information collection
provisions for Sec. Sec.  806.10 and 806.20 are approved under OMB
control number 0910-0359.
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    In the Federal Register of April 30, 2020 (85 FR 23971), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                        Table 1--Estimated Annual Third-Party Disclosure and Recordkeeping Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Number of
                                               Number of     disclosures/    Total annual
         21 CFR section; activity            respondents/     records per    disclosures/   Average burden per  disclosure/recordkeeping    Total hours
                                             recordkeepers    respondent/       records
                                                             recordkeeper
--------------------------------------------------------------------------------------------------------------------------------------------------------
4.103, Sharing information with other                   33              18             594  0.35 (21 minutes)...........................             208
 constituent part applicants.
4.103(b) and 4.105(a)(2), Records of                    33              18             594  0.1 (6 minutes).............................              59
 information shared by constituent part
 applicants.
                                           -------------------------------------------------------------------------------------------------------------
    Total.................................  ..............  ..............  ..............  ............................................             267
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate. We note in this regard that FDA extended the compliance date
for 21 CFR part 4, subpart B, until July 2020 for most combination
products, and until January 2021 for the remainder, in response to
stakeholder feedback, to ensure that Combination Product Applicants
have sufficient time to update reporting and recordkeeping systems and
procedures.\2\ Consequently, entities subject to this rule have not yet
had to comply with this information request.
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    \2\ See Compliance Policy for Combination Product Postmarketing
Safety Reporting (April 2019) (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/compliance-policy-combination-product-postmarketing-safety-reporting).

    Dated: July 30, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-17041 Filed 8-4-20; 8:45 am]
BILLING CODE 4164-01-P