[Federal Register Volume 75, Number 227 (Friday, November 26, 2010)]
[Notices]
[Pages 72855-72857]
[FR Doc No: 2010-29721]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-63341; File No. SR-NASDAQ-2010-147]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Modify Two Aspects of the Rules and Operation of The NASDAQ Options
Market

November 18, 2010.
    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 10, 2010, The NASDAQ Stock Market

LLC (the ``Exchange'' or ``NASDAQ'') 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. The Exchange has designated the proposed rule change
as constituting a non-controversial rule change under Rule 19b-4(f)(6)
under the Act,\3\ which renders the proposal effective upon filing with
the Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange is filing this proposed rule change to modify two
aspects of the rules and operation of the NASDAQ Options Market
(``NOM''): (1) To eliminate the Closing Cross set forth in Chapter VI,
Section 9 of the rules; and (2) to increase the maximum order size from
9,999 to 999,999 contracts in Chapter VI, Section 1 of the rules. The
text of the proposed rule change is available at http://nasdaq.cchwallstreet.com/, at the Exchange's principal office, 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 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 Exchange has prepared summaries, set forth in
Sections A, B, and C below, of the most significant aspects of such
statements.

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

1. Purpose
    The NASDAQ Options Market (``NOM''), the options trading facility
of The NASDAQ Stock Market LLC, has been fully operational for just
over two years. After assessing NOM's performance, NASDAQ has
identified two minor changes to NOM's operation: (1) Eliminating the
Closing Cross set forth in Chapter VI, Section 9 of the rules; and (2)
increasing the maximum order size from 9,999 to 999,999 contracts in
Chapter VI, Section 1 of the rules. NASDAQ believes that neither of
these changes will have a material impact on the operation of NOM or of
NOM members.
1. Eliminating the NOM Closing Cross
    NASDAQ's proposal to transport the closing cross from NASDAQ's
equities market to NOM was intended to determine whether a standard
closing cross could aid price discovery and liquidity in a derivative
product. Although a few market participants experimented with the NOM
Closing Cross just after launch, the Closing Cross never attracted
meaningful liquidity. The Closing Cross has not been used by any market
participant in any options class for quite some time. Accordingly,
NASDAQ is proposing to eliminate that functionality from the technology
and from the rule book (Chapter VI, Section 9) governing NOM.
2. Increasing the Maximum Order Size
    NASDAQ members have requested the ability to enter orders into the
system of greater than 9,999 contracts. The existing limit on order
size was a technological constraint that can easily be modified.
Accordingly, NASDAQ proposes to modify the system and downstream
processes and data feeds to accept orders of up to 999,999 contracts.
Following this change, NOM will match the maximum order size currently
in place at other options exchanges.\4\
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    \4\ See. e.g., BATS Exchange Rule 21.1(e) (``The term ``Order
Size'' shall mean the number of contracts up to 999,999 associated
with the Order''); CBOE Regulatory Circular RG 10-43 (March 26,
2010) at https://www.cboe.org/publish/RegCir/RG10-043.pdf.
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    NASDAQ has safeguards in place to protect the market from
inadvertent entry of large orders. Each member that requests
connectivity through an order entry port is required to specify the
maximum order size for its individual port.\5\ NASDAQ sets the default
maximum order size at 2,500 contracts. Members are permitted to deviate
from the default maximum order size but NASDAQ members are required to
have processes and procedures in place to ensure the proper entry and
monitoring of orders entered into NASDAQ systems. Prior to implementing
this change, NASDAQ will issue an alert to members to ensure that they
have policies and procedures in place to employ the new functionality
in a prudent fashion.
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    \5\ See NASDAQ Options Port Request Form at http://www.nasdaqtrader.com/content/AdministrationSupport/AgreementsTrading/options_portrequest.pdf.
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2. Statutory Basis
    NASDAQ believes that the proposed rule change is consistent with
the provisions of Section 6 of the Act,\6\ in general, and with Section
6(b)(5) of the Act,\7\ in particular, in that the proposal is designed
to prevent fraudulent and manipulative acts and practices, to promote
just and equitable principles of trade, 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. The proposed rule changes
should enhance the NOM market as described above based on NASDAQ's
experience operating NOM for two years.
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    \6\ 15 U.S.C. 78f.
    \7\ 15 U.S.C. 78f(b)(5).
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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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act\8\ and Rule 19b-
4(f)(6) thereunder.\9\
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    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f)(6).
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    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. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or 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-NASDAQ-2010-147 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-NASDAQ-2010-147. 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,\10\ 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-NASDAQ-2010-147 and should be submitted on or before
December 17, 2010.
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    \10\ The text of the proposed rule change is available on
Exchange's Web site at http://nasdaq.cchwallstreet.com/, on the
Commission's Web site at http://www.sec.gov, at NASDAQ, and at the
Commission's Public Reference Room.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
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    \11\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-29721 Filed 11-24-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 189 (Thursday, September 29, 2011)]
[Rules and Regulations]
[Pages 60376-60378]
[FR Doc No: 2011-24688]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2011-0561; FRL-9469-1]

Revisions to the California State Implementation Plan, Santa
Barbara Air Pollution Control District, Sacramento Municipal Air
Quality Management District and South Coast Air Quality Management
District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is taking direct final action to approve revisions to the
Santa Barbara Air Pollution Control District (SBAPCD), Sacramento
Municipal Air Quality Management District (SMAQMD) and South Coast Air
Quality Management District (SCAQMD) portions of the California State
Implementation Plan (SIP). These revisions concern volatile organic
compound (VOC) emissions from solvent cleaning machines and solvent
cleaning operations and oil and gas production wells. We are approving
local rules that regulate these emission sources under the Clean Air
Act as amended in 1990 (CAA or the Act).

DATES: This rule is effective on November 28, 2011 without further
notice, unless EPA receives adverse comments by October 31, 2011.
    If we receive such comments, we will publish a timely withdrawal in
the Federal Register to notify the public that this direct final rule
will not take effect.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2011-0561, by one of the following methods:
    1. Federal eRulemaking Portal: http://www.regulations.gov. Follow
the on-line instructions.
    2. E-mail<EMAIL_ADDRESS>    3. Mail or deliver: Andrew Steckel (Air-4), U.S. Environmental
Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA
94105-3901.
    Instructions: All comments will be included in the public docket
without change and may be made available online at http://www.regulations.gov, including any personal information provided,
unless the comment includes Confidential Business Information (CBI) or
other information whose disclosure is restricted by statute.
Information that you consider CBI or otherwise protected should be
clearly identified as such and should not be submitted through http://www.regulations.gov or e-mail. http://www.regulations.gov is an
``anonymous access'' system, and EPA will not know your identity or
contact information unless you provide it in the body of your comment.
If you send e-mail directly to EPA, your e-mail address will be
automatically captured and included as part of the public comment. 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: Generally, documents in the docket for this action are
available electronically at http://www.regulations.gov and in hard copy
at EPA Region IX, 75 Hawthorne Street, San Francisco, California. While
all documents in the docket are listed at http://www.regulations.gov,
some information may be publicly available only at the hard copy
location (e.g., copyrighted material, large maps), and some may not be
publicly available in either location (e.g., CBI). To inspect the hard
copy materials, please schedule an appointment during normal business
hours with the contact listed in the FOR FURTHER INFORMATION CONTACT
section.

FOR FURTHER INFORMATION CONTACT: Adrianne Borgia, EPA Region IX, (415)
972-3576<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us,''
and ``our'' refer to EPA.

Table of Contents

I. The State's Submittal
    A. What rules did the State submit?
    B. Are there other versions of these rules?
    C. What is the purpose of the submitted rules?
II. EPA's Evaluation and Action
    A. How is EPA evaluating the rules?
    B. Do the rules meet the evaluation criteria?

    C. EPA Recommendations To Further Improve the Rules
    D. Public Comment and Final Action
III. Statutory and Executive Order Reviews

I. The State's Submittal

A. What rules did the State submit?

    Table 1 lists the rules we are approving with the dates that they
were adopted by the local air agencies and submitted by the California
Air Resources Board (CARB).

                                            Table 1--Submitted Rules
----------------------------------------------------------------------------------------------------------------
          Local agency             Rule No.          Rule title                   Amended             Submitted
----------------------------------------------------------------------------------------------------------------
SBAPCD.........................          321  Solvent Cleaning         9/20/10.....................       4/5/11
                                               Machines and Solvent
                                               Cleaning.
SMAQMD.........................          466  Solvent Cleaning.......  10/28/10....................       4/5/11
SCAQMD.........................         1171  Solvent Cleaning         2/1/08......................       4/5/11
                                               Operations.
SCAQMD.........................       1148.1  Oil and Gas Production   Adopted 3/5/04..............      1/10/10
                                               Wells.
----------------------------------------------------------------------------------------------------------------

    On February 4, 2010 (1148.1) and May 6, 2011 (321, 466 and 1171),
EPA determined that the four submittals met the completeness criteria
in 40 CFR Part 51 Appendix V, which must be met before formal EPA
review.

B. Are there other versions of these rules?

    We approved an earlier version of SBAPCD Rule 321 into the SIP on
April 2, 1998 (64 FR 15922). We approved an earlier version of SMAQMD
Rule 466 into the SIP on May 5, 2010 (75 FR 24406). We approved an
earlier version of SCAQMD Rule 1171 into the SIP on July 1, 2005 (70 FR
38023). There are no previous versions of SCAMQD Rule 1148.1 in the
SIP.

C. What is the purpose of the submitted rules?

    VOCs help produce ground-level ozone and smog, which harm human
health and the environment. Section 110(a) of the CAA requires States
to submit regulations that control VOC emissions. SBAPCD Rule 321,
SMAQMD Rule 466, SCAQMD Rule 1171 and SCAQMD 1148.1 limit emissions of
VOC from solvent cleaning machines, the application of solvents, and
from oil and gas production wells. EPA's technical support documents
(TSDs) have more information about these rules.

II. EPA's Evaluation and Action

A. How is EPA evaluating the rules?

    Generally, SIP rules must be enforceable (see section 110(a) of the
Act), must require Reasonably Available Control Technology (RACT) for
each category of sources covered by a Control Techniques Guidelines
(CTG) document as well as each major source in nonattainment areas (see
sections 182(a)(2) and (b)(2)), and must not relax existing
requirements (see sections 110(l) and 193). SBAPCD regulates an
unclassifiable/attainable area for ozone, SMAQMD regulates an ozone
nonattainment area and SCAQMD regulates an ozone nonattainment area
(see 40 CFR part 81), so SMAQMD Rule 466 and SCAQMD Rule 1171 and Rule
1148.1 must fulfill RACT.
    Guidance and policy documents that we use to evaluate
enforceability and RACT requirements consistently include the
following:
    1. ``Issues Relating to VOC Regulation Cutpoints, Deficiencies, and
Deviations,'' EPA, May 25, 1988 (the Bluebook).
    2. ``Guidance Document for Correcting Common VOC & Other Rule
Deficiencies,'' EPA Region 9, August 21, 2001 (the Little Bluebook).
    3. CARB's Consumer Products Regulation, Title 17, California Code
of Regulations (CCR), Division 3, Chapter 1, Subchapter 8.5, Article 2,
Sections 94507-94517
    4. EPA's model VOC rule guidance titled, ``Model Volatile Organic
Compound Rules for Reasonably Available Control Technology'' (June
1992).

B. Do the rules meet the evaluation criteria?

    We believe these rules are consistent with the relevant policy and
guidance regarding enforceability, RACT and SIP relaxations. The TSDs
have more information on our evaluation.

C. EPA Recommendations to Further Improve the Rules

    The TSDs describe additional rule revisions that we recommend for
the next time the local agency modifies the rules.

D. Public Comment and Final Action

    As authorized in section 110(k)(3) of the Act, EPA is fully
approving the submitted rules because we believe they fulfill all
relevant requirements. We do not think anyone will object to this
approval, so we are finalizing it without proposing it in advance.
However, in the Proposed Rules section of this Federal Register, we are
simultaneously proposing approval of the same submitted rules. If we
receive adverse comments by October 31, 2011, we will publish a timely
withdrawal in the Federal Register to notify the public that the direct
final approval will not take effect and we will address the comments in
a subsequent final action based on the proposal. If we do not receive
timely adverse comments, the direct final approval will be effective
without further notice on November 28, 2011. This will incorporate
these rules into the federally enforceable SIP.
    Please note that if EPA receives adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, EPA may adopt as final those provisions
of the rule that are not the subject of an adverse comment.

III. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve State
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves State law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by State law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);

     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address disproportionate human health or environmental effects with
practical, appropriate, and legally permissible methods under Executive
Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the State, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rules,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Parties with objections to this direct final rule are encouraged to
file a comment in response to the parallel notice of proposed
rulemaking for this action published in the Proposed Rules section of
today's Federal Register, rather than file an immediate petition for
judicial review of this direct final rule, so that EPA can withdraw
this direct final rule and address the comment in the proposed
rulemaking. This action may not be challenged later in proceedings to
enforce its requirements (see section 307(b)(2)).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Reporting and recordkeeping requirements, Volatile organic
compounds.

    Dated: September 7, 2011.
Jared Blumenfeld,
Regional Administrator, Region IX.
    Part 52, Chapter I, Title 40 of the Code of Federal Regulations is
amended as follows:

PART 52 [AMENDED]

0
1. The authority citation for Part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart F--California

0
2. Section 52.220, is amended by adding paragraphs (378)(i)(A)(3), and
(c)(388)(i)(A)(5), (C), (D) and to read as follows:

Sec.  52.220  Identification of plan.

* * * * *
    (c) * * *
    (378) * * *
    (i) * * *
    (A) * * *
    (3) Rule 1148.1, ``Oil and Gas Production Wells,'' adopted on March
5, 2004.
* * * * *
    (388) * * *
    (i) * * *
    (A) * * *
    (5) Rule 1171, ``Solvent Cleaning Operations,'' amended February 1,
2008.
* * * * *
    (C) Santa Barbara County Air Pollution Control District.
    (1) Rule 321, ``Solvent Cleaning Machines and Solvent Cleaning,''
revised September 20, 2010.
    (D) Sacramento Metropolitan Air Quality Management District.
    (1) Rule 466, ``Solvent Cleaning,'' amended October 28, 2010.
* * * * *
[FR Doc. 2011-24688 Filed 9-28-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: January 28, 2009 (Volume 74, Number 17)]
[Notices]
[Page 4950]
[DOCID:fr28ja09-29]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13299-000]

Alaska Village Electric Cooperative; Notice of Preliminary Permit
Application Accepted for Filing and Soliciting Comments, Motions To
Intervene, and Competing Applications

January 21, 2009.
    On October 9, 2008, and supplemented on January 15, 2009, Alaska
Village Electric Cooperative filed an application, pursuant to section
4(f) of the Federal Power Act, proposing to study the feasibility of
the Shungnak River Hydroelectric Project located on the Shungnak River
in the Northwest Arctic Borough, Alaska.
    The proposed Shungnak River Hydroelectric Project would consist of:
(1) A proposed 200-foot-high, 400-foot-long earth filled gravity dam;
(2) a proposed 2.2 square mile reservoir with a storage capacity of
42,000 acre-feet; (3) a proposed 2,000-foot-long, 10-foot diameter
steel or concrete penstock; (4) a proposed powerhouse containing four
1.25-megawatt generators; (5) a proposed 12.7-mile-long, 7,200/12,400-
volt transmission line; and (6) appurtenant facilities. The Shungnak
River Hydroelectric Project is estimated to have an annual generation
of 35.04-gigawatt-hours, which would be sold to the community of
Shungnak or mining operations in the vicinity of the project.
    Applicant Contact: Mr. Daniel Hertrich, Polarconsult Alaska, Inc.,
1503 W 33rd Ave, 310, Anchorage, Alaska 99503, phone: (907)
258-2420.
    FERC Contact: Kelly T. Houff<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Comments, motions to intervene, notices of intent, and competing
applications may be filed electronically via the Internet. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. If unable to be filed electronically,
documents may be paper-filed. To paper-file, an original and eight
copies should be mailed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426. For
more information on how to submit these types of filings please go to
the Commission's Web site located at http://www.ferc.gov/filing-
comments.asp. More information about this project can be viewed or
printed on the ``eLibrary'' link of Commission's Web site at http://
www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number (P-
13299) in the docket number field to access the document. For
assistance, call toll-free 1-866-208-3372.

Kimberly D. Bose,
Secretary.
 [FR Doc. E9-1761 Filed 1-27-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: October 5, 2009 (Volume 74, Number 191)]
[Notices]
[Page 51161-51163]
[DOCID:fr05oc09-57]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0247]

Food and Drug Administration Transparency Task Force; Public
Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a second
public meeting to discuss issues related to transparency at the agency.
The purpose of this public meeting is to receive detailed and in-depth
comments on three specific issues related to

transparency at FDA. The topics to be covered are early communication
about emerging safety issues concerning FDA-regulated products,
disclosure of information about product applications that are abandoned
(which means that no work is being done or will be undertaken to have
the application approved) or withdrawn by the applicant before
approval, and communication of agency decisions about pending product
applications.

DATES: The public meeting will be held on November 3, 2009, from 9 a.m.
to 3 p.m. Persons interested in attending and/or participating in the
meeting must register by 5 p.m. on October 27, 2009. Submit electronic
or written comments by November 6, 2009.

ADDRESSES: The public meeting will be held at the National
Transportation Safety Board Conference Center, 429 L'Enfant Plaza, SW.,
Washington, DC 20594. Submit electronic comments to http://
www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. All comments should be identified with
the docket number found in brackets at the heading of this document.
Submit electronic registration by e-mail to
<EMAIL_ADDRESS>    For Registration to Attend and/or to Participate in the Meeting: If
you wish to attend the public meeting, you must register by e-mail (see
ADDRESSES) by close of business on October 27, 2009. When registering,
you must provide the following information: (1) Your name, (2) title,
(3) company or organization (if applicable), (4) mailing address, (5)
telephone number, and (6) e-mail address.
    At the time of registration, if you wish to participate in one of
the three planned discussion groups, you must indicate which discussion
group(s), in rank order (see section III. Issues for Discussion).
Please also submit a brief statement that describes your experience
with the discussion topic and/or the general nature of what you would
like to present about the discussion topic. The Transparency Task Force
(``Task Force'') is seeking participants interested in engaging in an
in-depth discussion about the considerations and principles the agency
should consider with respect to communicating to the public about each
of the issues outlined below (see section III. Issues for Discussion).
    Each discussion group will include 4 to 6 people. Only one
participant from an organization or company will be assigned to a
discussion group. FDA will attempt to have a range of stakeholders
participate in each discussion group. Participants will be contacted
prior to the meeting with the approximate time the discussion group is
scheduled to begin. Others in attendance at the public meeting will
have an opportunity to listen to the discussion and comment on the
issues discussed during the public comment period that will occur after
each discussion group.
    There is no fee to register for the public meeting and registration
will be on a first-come, first-served basis. Early registration is
recommended because seating is limited. Registration on the day of the
public meeting will be permitted on a space-available basis beginning
at 7:30 a.m.
    If you need special accommodations due to a disability, please
contact Afia Asamoah (see FOR FURTHER INFORMATION CONTACT) by October
27, 2009.

FOR FURTHER INFORMATION CONTACT: Afia Asamoah, Office of the
Commissioner, Food and Drug Administration, Bldg. 1, rm. 2220, 10903
New Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX:
301-847-3531<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On January 21, 2009, President Obama's first full day in office,
the President issued a memorandum to the heads of executive departments
and agencies on transparency and openness in government. The memorandum
expressed the Administration's commitment to achieve ``an unprecedented
level of openness in Government'' and instructed executive departments
and agencies to solicit public input to identify information of
greatest use to the public. Executive departments and agencies were
also charged with harnessing new technologies to make information about
agency operations and decisions available online and readily available
to the public.
    In response to the Administration's commitment to promote
transparency in government, FDA formed an internal Task Force to
consider how to make FDA and its processes more transparent to the
public. The Task Force is soliciting input from the public to develop
recommendations for making useful and understandable information about
FDA activities and decisionmaking more readily available to the public
in a timely manner and in a user-friendly format, while appropriately
protecting confidential information. To solicit public input on
improving agency transparency, the Task Force established a public
docket, launched an online blog, and held a public meeting in June. At
the first public meeting, the Task Force posed six questions about ways
in which the agency should provide information to the public about what
FDA is doing, the bases for the agency's decisions, and the processes
used to make agency decisions.\1\
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    \1\ See 74 FR 26712, June 3, 2009.
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    Based on the comments received to date, the Task Force is holding a
second public meeting to solicit in-depth and detailed comments on
three specific issues related to transparency at the agency.

II. Second Public Meeting

    The objective of the second public meeting on transparency is for
the Task Force to receive public input and hear different points of
view about the agency's communications about, and public disclosures of
information about, the following issues:
    (1) Emerging safety issues concerning FDA-regulated products,
    (2) Product applications that are abandoned (no work is being done
or will be undertaken to have the application approved) or withdrawn by
the applicant before approval, and
    (3) Agency decisions about pending product applications.
    The Task Force is interested in focused, detailed comments about
the considerations and principles the agency should assess regarding
its communications to the public about the topics outlined in the
previous paragraphs.
    The second public meeting will be conducted as a series of three
moderated discussion groups covering these three topics. The specific
topic for each discussion will be presented in the form of a case
study. Only one discussion group will be held at a time. Following each
moderated discussion, Task Force members may ask questions of the
participants in each discussion group. Others in attendance at the
public meeting then will have an opportunity to comment on the issues
discussed during the public comment period that will occur after each
discussion group.
    At least 7 days in advance of the meeting, the initial scenarios of
the case studies for each of the three topics will be made available on
the Internet. The initial scenarios will be placed on file in the
public docket (docket number found in brackets in the heading of this
document), which is available at http://www.regulations.gov. The
initial scenarios will also be available on

FDA's Web site at http://www.fda.gov/transparency along with the agenda
for this meeting. The complete case studies will be available in the
same locations after the public meeting.

III. Issues for Discussion

    The discussion of the three issues described in the following
section of this document should not be limited by current statutes or
regulations, as the proposals the Task Force develops may include
recommendations for changes to current law.

A. Emerging Safety Issues Concerning FDA-Regulated Products

    When FDA receives safety information associated with a marketed
FDA-regulated product, e.g., medical device, drug, biologic, dietary
supplement, cosmetic, or food (including ingredients and food
additives), FDA evaluates the information in deciding whether and what
actions to take, such as regulatory action regarding the product. FDA
will continue to receive, gather, and evaluate additional information
to further inform its decisions.
    During this process, while still evaluating the situation, FDA may
communicate with the public based on the agency's current analysis of
the available information about the situation. For example, the agency
may issue an early communication about its ongoing safety review of a
drug, device, or biologic, or may issue an early communication advising
consumers not to eat a certain type of food that may be linked to a
foodborne illness or to stop using a certain dietary supplement that
may be associated with adverse events.
    The Task Force is interested in discussing the principles the
agency should use when deciding whether to issue an early communication
about a potential problem with an FDA-regulated product. For example,
when is it appropriate, or not appropriate for the agency to advise the
public about a possible, but unconfirmed foodborne illness outbreak or
to issue an early communication about an emerging safety issue with a
medical product, dietary supplement, or cosmetic? If appropriate, how
should this information be conveyed to the public so that it is useful
and does not cause unfounded or unnecessary concern about the product?
And what mechanisms (e.g., Internet, mass media, cell phones, direct
outreach to health professional and patient organizations) should FDA
use to effectively reach the target audiences in a timely manner?

B. Product Applications That Are Abandoned (Which Means That No Work is
Being Done or Will Be Undertaken to Have the Application Approved) or
Withdrawn By the Applicant Before Approval

    The Task Force is interested in discussing the principles and
considerations the agency should apply to disclosure of data contained
in product applications that are abandoned during the approval process
or withdrawn before approval by the applicant. The Task Force would
also like to receive comments on whether the considerations governing
treatment of these data should depend on the reason the product
application was abandoned or withdrawn.

C. Communicating Agency Decisions About Pending Product Applications

    The Task Force is interested in discussing what information about
pending product applications should be disclosed. Should the agency
inform the public when:
     A marketing application seeking approval of a drug or
biologic is submitted to the agency for review?
     A marketing application seeking approval or clearance of a
medical device is submitted to the agency for review?
    When the agency does not approve a marketing application for a drug
or biologic, it issues a letter that informs the applicant of FDA's
determination not to approve the application in its current form,
identifying all apparent deficiencies in the application. Should the
agency disclose to the public a determination not to approve a
marketing application for a drug or biologic? What, if any, information
should the agency disclose about the determination not to approve the
application? What, if any, information contained in the response letter
should the agency disclose? What principles should the agency apply in
making these determinations?
    When the agency does not approve a premarket application (PMA) for
a medical device, it may issue a ``not approvable'' letter that informs
the applicant of FDA's determination not to approve the application in
its current form. When the agency does not clear a device submitted
through the 510(k) process, a ``not substantially equivalent'' (NSE)
letter is issued to the applicant. Should the agency disclose to the
public a determination not to approve or clear a marketing application
for a medical device? What, if any, information should the agency
disclose about the determination not to approve or clear the
application? What, if any, information contained in the not approvable
letter or the NSE letter should the agency disclose? What principles
should the agency apply in making these determinations?

IV. Request for Comments

    Regardless of attendance at the public meeting, interested persons
may submit written or electronic comments (see ADDRESSES). Submit a
single copy of electronic comments to http://www.regulations.gov or two
paper copies of any mailed comments, except that individuals may submit
one paper copy. Comments are to be identified with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday.

V. Transcripts

    Please be advised that as soon as a transcript is available, it
will be accessible at http://www.regulations.gov. It may be viewed at
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to Division of Freedom of Information (HFI-35), Office
of Management Programs, Food and Drug Administration, 5600 Fishers
Lane, rm. 6-30, Rockville, MD 20857.

    Dated: September 29, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-23916 Filed 10-2-09; 8:45 am]

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[Federal Register: June 21, 2010 (Volume 75, Number 118)]
[Notices]
[Page 35124-35125]
[DOCID:fr21jn10-163]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

Sunshine Act Meetings; Unified Carrier Registration Plan Board of
Directors

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

TIME AND DATE: July 8, 2010, 12 noon to 3 p.m., Eastern Daylight Time.

PLACE: This meeting will take place telephonically. Any interested
person may call Mr. Avelino Gutierrez at<PHONE_NUMBER> to receive the
toll free number and pass code needed to participate in this meeting by
telephone.

STATUS: Open to the public.

MATTERS TO BE CONSIDERED: The Unified Carrier Registration Plan Board
of Directors (the Board) will continue its work in developing and
implementing the Unified Carrier Registration Plan and Agreement and to
that end, may consider matters properly before the Board.

FOR FURTHER INFORMATION CONTACT: Mr. Avelino Gutierrez, Chair, Unified
Carrier Registration Board of Directors at<PHONE_NUMBER>.

    Issued on: June 16, 2010.
Larry W. Minor,
Associate Administrator for Policy and Program Development.
[FR Doc. 2010-15078 Filed 6-17-10; 4:15 pm]
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