[Federal Register Volume 81, Number 65 (Tuesday, April 5, 2016)]
[Notices]
[Pages 19678-19680]
[FR Doc No: 2016-07688]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-77481; File No. SR-NASDAQ-2016-013]

Self-Regulatory Organizations; The Nasdaq Stock Market LLC;
Notice of Filing of Proposed Rule Change To Require Listed Companies to
Publicly Disclose Compensation or Other Payments by Third Parties to
Board of Director's Members or Nominees

March 30, 2016.
    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 March 15, 2016, The Nasdaq Stock Market LLC (``Exchange'') filed
with the Securities and Exchange Commission (``SEC'' or ``Commission'')
the proposed rule change as described in Items I, II, and III, below,
which Items have been prepared by the Exchange. The Commission is
publishing this notice to solicit comments on the proposed rule change
from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to require listed companies to publicly
disclose compensation or other payments by third parties to any nominee
for director or sitting director in connection with their candidacy for
or service on the companies' Board of Directors.
    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaq.cchwallstreet.com, at the principal office of
the Exchange, 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
    Nasdaq Rules require listed companies to make public disclosure in
several areas. For example, a listed company is required to publicly
disclose material information that would reasonably be expected to
affect the value of its securities or influence investors' decisions as
well as when non-independent directors serve on a committee that
generally requires only independent directors, such as for a controlled
company or under exceptional and limited circumstances.\3\ A listed
company is also required to file required periodic reports with the
Commission.\4\ A principal purpose of these disclosure requirements is
to protect investors and ensure these investors have necessary
information to make informed investment and voting decisions.
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    \3\ See Rules 5250(b)(1), 5615(c)(2), 5605(c)(2)(B),
5605(d)(2)(B) and 5605(e)(3).
    \4\ See Rule 5250(c).
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    In recent years, Nasdaq has observed one area where investors may
not have complete information. This is when third parties compensate
directors in connection with their candidacy for and/or service on
company Boards of Directors. This third-party compensation, which may
not be publicly disclosed, arises when a shareholder privately offers
to compensate nominee directors in connection with those nominees'
candidacy or service as directors. These arrangements vary but may
include compensating directors based on achieving benchmarks such as an
increase in share price over a fixed term.\5\
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    \5\ The Commission notes that various provisions of the federal
securities laws already require the disclosure of compensation
arrangements between third parties and directors or director
nominees. See, e.g., Items 401(a) and 402(a)(2) of Regulation S-K;
Item 5(b) of Schedule 14A; and Item 5.02(d) of Form 8-K.
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    Nasdaq believes these undisclosed compensation arrangements
potentially raise several concerns, including that they may lead to
conflicts of interest among directors and call into question the
directors' ability to satisfy their fiduciary duties. These
arrangements may also tend to promote a focus on short-term results at
the expense of long-term value creation. Nasdaq believes that enhancing
transparency around third-party board compensation would help address
these concerns and would benefit investors by making available
information potentially relevant to investment and voting decisions.
Nasdaq further believes that the proposed disclosure would not create
meaningful burdens on directors or those making these payments nor on
the companies required to make the disclosure.
    Accordingly, Nasdaq is proposing to adopt Rule 5250(c) to require
listed companies \6\ to publicly disclose on or through the companies'
Web site or proxy statement for the next annual meeting at which
directors are elected (or, if they do not file proxy statements, in
Form 10-K or Form 20-F),\7\ all agreements and arrangements between any
director or nominee and any person or entity (other than the company)
that provide for compensation or other payment in connection with that
person's candidacy or service as a director.\8\
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    \6\ Pursuant to Listing Rule 5615(a)(3), a foreign private
issuer may follow home country practice in lieu of the requirements
of the proposed rule.
    \7\ This disclosure method is consistent with the method under
Listing Rule 5605(d)(2)(B) for disclosure of the appointment of a
non-independent compensation committee member under exceptional and
limited circumstances. A Company that provides disclosure under
Commission rules--including the requirement in Item 5.02(d)(2) of
Form 8-K to provide ``a brief description of any arrangement or
understanding between the new director and any other persons, naming
such persons, pursuant to which such director was selected as a
director''--would not have to make separate disclosure under the
proposed rule if the disclosure identifies the material terms of the
agreement or arrangement and the Commission disclosure document
(i.e., Form 8-K) is posted on the company's Web site. However, such
an agreement or arrangement is subject to the continuous disclosure
requirements of the proposed rule on an annual basis.
    \8\ The proposal is intended to apply to agreements and
arrangements whether or not the right to nominate a director legally
belongs to the third party. See IM 5605-7 (Independent Director
Oversight of Director Nominations).
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    A listed company's obligation under the proposed rule to publicly
disclose such arrangements is continuous and will terminate at the
earlier of the resignation of the director subject to the arrangement
or one year following the termination of the arrangement. The proposed
rule is intended to be construed broadly and apply to both compensation
and other forms of payment such as health insurance premiums that are
made in connection with a person's candidacy or service as a director.
Further, at a minimum, the disclosure should identify the parties to
and the material terms of the agreement or arrangement. To allow listed
companies affected by the proposed rule a transition period, the rule
will be effective on June 30, 2016.\9\
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    \9\ The Commission notes that the proposed effective date of
June 30, 2016 is contingent on Commission approval of the rule
proposal under Section 19(b) of the Act by that date.
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    In recognition of circumstances that do not raise the concerns
noted above or where such disclosure may be duplicative, the proposed
rule would not apply to agreements and arrangements that existed before
the nominee's candidacy and have been otherwise publicly disclosed, for
example, pursuant to Items 402(a)(2) or 402(k) of Regulation S-K or in
a director's biographical summary included in periodic reports filed
with the Commission. An example of an agreement or arrangement falling
under this exception is a director or a nominee for director being
employed by a private equity fund where employees are expected to and
routinely serve on the boards of the fund's portfolio companies and
their remuneration is not materially affected by such service. If such
a director or a nominee's remuneration is materially increased in
connection with such person's candidacy or service as a director of the
company, only the difference between the new and the previous level of
compensation needs to be disclosed under the proposed rule.
    Additionally, the proposed rule would not apply to agreements and
arrangements that relate only to reimbursement of expenses incurred in
connection with candidacy as a director, whether or not such
reimbursement arrangement has been publicly disclosed. Finally,
Commission Rule 14a-12(c) subjects persons soliciting proxies in
opposition to companies' proxy solicitation to certain disclosure
requirements of Schedule 14A of the Act. The proposed rule relieves the
company from the initial disclosure requirements of the proposed rule
where an agreement or arrangement for a director or a nominee has been
disclosed under Item 5(b) of Schedule 14A of the Act. However, such an
agreement or arrangement is subject to the continuous disclosure
requirements of the proposed rule on an annual basis.
    Further, in recognition that a company, despite reasonable efforts,
may not be able to identify all such agreements and arrangements, the
proposed rule provides that a company shall not be deficient with the
proposed requirement if it has undertaken reasonable efforts to
identify all such agreements and arrangements, including by asking each
director or nominee in a

manner designed to allow timely disclosure, and upon discovery of a
non-disclosed arrangement, promptly makes the required disclosure by
filing a Form 8-K or 6-K, where required by Commission rules, or by
issuing a press release.
    In cases where a company is considered deficient, the company must
provide a plan to regain compliance. Consistent with deficiencies from
most other rules that allow a company to submit a plan to regain
compliance,\10\ Nasdaq proposes to allow companies deficient under the
proposed rule 45 calendar days to submit a plan sufficient to satisfy
Nasdaq staff that the company has adopted processes and procedures
designed to identify and disclose relevant agreements and arrangements
in the future. If the company does not do so, it would be issued a
Staff Delisting Determination, which the company could appeal to a
Hearings Panel pursuant to Rule 5815.\11\
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    \10\ Pursuant to Rule 5810(c)(2)(A), a company is provided 45
days to submit a plan to regain compliance with Rules 5620(c)
(Quorum), 5630 (Review of Related Party Transactions), 5635
(Shareholder Approval), 5250(c)(3) (Auditor Registration), 5255(a)
(Direct Registration Program), 5610 (Code of Conduct), 5615(a)(4)(E)
(Quorum of Limited Partnerships), 5615(a)(4)(G) (Related Party
Transactions of Limited Partnerships), and 5640 (Voting Rights). A
company is generally provided 60 days to submit a plan to regain
compliance with the requirement to timely file periodic reports
contained in Rule 5250(c)(1).
    \11\ Separate from this proposed rule change, Nasdaq is
surveying interested parties as to whether Nasdaq should propose
additional requirements surrounding directors and candidates that
receive third party payments, including whether such directors
should be prohibited from being considered independent under Nasdaq
rules or prohibited from serving on the board altogether. Nasdaq has
made no decision about whether to propose additional rules. If
Nasdaq does determine to propose additional rules, any proposal
would be subject to a separate rule filing. Listing Rule 5605(a)(2)
excludes from the definition of Independent Director any
``individual having a relationship which, in the opinion of the
Company's board of directors, would interfere with the exercise of
independent judgment in carrying out the responsibilities of a
director.''
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2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\12\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\13\ in particular, in that it is designed 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. The proposal accomplishes these objectives by enhancing
transparency around third party compensation and payments made in
connection with board service. The Exchange believes such disclosure
has several benefits: It would provide information to investors to help
them make meaningful investing and voting decisions. It would also
address potential concerns that undisclosed third party compensation
arrangements may lead to conflicts of interest among directors and call
into question their ability to satisfy fiduciary duties.
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    \12\ 15 U.S.C. 78f(b).
    \13\ 15 U.S.C. 78f(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 not necessary or appropriate in
furtherance of the purposes of the Act, as amended. The proposed rule
to require listed companies to disclose third party compensation and
payments in connection with board service is intended to provide
meaningful information to investors and to address potential concerns
with undisclosed compensation schemes without creating unnecessary
burdens on directors or those making the payments.
    Further, the proposed rule change is intended to promote
transparency and protect investors and is not being adopted for
competitive purposes. To the extent a competitor marketplace believes
that the proposed rule change places them at a competitive
disadvantage, it may file with the Commission a proposed rule change to
adopt the same or similar rule.

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

    No written comments were either solicited or received.

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

    Within 45 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 Exchange consents, the Commission shall: (a) By order approve
or disapprove 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 email to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2016-013 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2016-013. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of 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-2016-013 and should
be submitted on or before April 26, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
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    \14\ 17 CFR 200.30-3(a)(12).
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Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-07688 Filed 4-4-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 43 (Friday, March 4, 2022)]
[Notices]
[Page 12439]
[FR Doc No: 2022-04553]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP21-20-000]

Algonquin Gas Transmission, LLC; Notice of Request for Extension
of Time

    Take notice that on February 18, 2022, Algonquin Gas Transmission,
LLC (Algonquin) requested that the Federal Energy Regulatory Commission
(Commission) grant an extension of time, until September 27, 2022, to
complete the construction of the Stony Point Anomaly MNR Crossing
Project (Project), as authorized after the 60-day deadline of
Algonquin's prior notice issued by the Commission on December 28, 2020.
By that process, Algonquin was initially required to complete and make
available for service in one year, by February 27, 2022.
    Algonquin states the Project has made substantial progress but
experienced extenuating circumstances delaying its completion.
Algonquin avers the delays have been a result of (i) complex dewatering
conditions at the work site that required enhanced measures, (ii)
slower than anticipated tunneling progress due to challenging substrate
conditions, and (iii) rainfall and flash flood conditions from Tropical
Storm Ida. Algonquin was able to complete the installation of the 26-
inch diameter pipeline by December 2021. However, Algonquin was unable
to complete the tie-in of these facilities because that would have
required an outage of the active pipeline during the winter heating
season.
    This notice establishes a 15-calendar day intervention and comment
period deadline. Any person wishing to comment on Algonquin's request
for an extension of time may do so. No reply comments or answers will
be considered. If you wish to obtain legal status by becoming a party
to the proceedings for this request, you should, on or before the
comment date stated below, file a motion to intervene in accordance
with the requirements of the Commission's Rules of Practice and
Procedure (18 CFR 385.214 or 385.211) and the Regulations under the
Natural Gas Act (18 CFR 157.10).
    As a matter of practice, the Commission itself generally acts on
requests for extensions of time to complete construction for Natural
Gas Act facilities when such requests are contested before order
issuance. For those extension requests that are contested,\1\ the
Commission will aim to issue an order acting on the request within 45
days.\2\ The Commission will address all arguments relating to whether
the applicant has demonstrated there is good cause to grant the
extension.\3\ The Commission will not consider arguments that re-
litigate the issuance of the certificate order, including whether the
Commission properly found the project to be in the public convenience
and necessity and whether the Commission's environmental analysis for
the certificate complied with the National Environmental Policy Act.\4\
At the time a pipeline requests an extension of time, orders on
certificates of public convenience and necessity are final and the
Commission will not re-litigate their issuance.\5\ The OEP Director, or
his or her designee, will act on all of those extension requests that
are uncontested.
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    \1\ Contested proceedings are those where an intervenor disputes
any material issue of the filing. 18 CFR 385.2201(c)(1) (2019).
    \2\ Algonquin Gas Transmission, LLC, 170 FERC ] 61,144, at P 40
(2020).
    \3\ Id. at P 40.
    \4\ Similarly, the Commission will not re-litigate the issuance
of an NGA section 3 authorization, including whether a proposed
project is not inconsistent with the public interest and whether the
Commission's environmental analysis for the permit order complied
with NEPA.
    \5\ Algonquin Gas Transmission, LLC, 170 FERC ] 61,144, at P 40
(2020).
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    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to Commission's Public Reference
Room, due to the proclamation declaring a National Emergency concerning
the Novel Coronavirus Disease (COVID-19), issued by the President on
March 13, 2020. For assistance, contact FERC at
[email protected] or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFile'' link at
http://www.ferc.gov. Persons unable to file electronically may mail
similar pleadings to the Federal Energy Regulatory Commission, 888
First Street NE, Washington, DC 20426. Hand delivered submissions in
docketed proceedings should be delivered to Health and Human Services,
12225 Wilkins Avenue, Rockville, Maryland 20852.
    Comment Date: 5:00 p.m. Eastern Time on March 11, 2022.

    Dated: February 24, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-04553 Filed 3-3-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: January 10, 2006 (Volume 71, Number 6)]
[Notices]
[Page 1580-1581]
[DOCID:fr10ja06-63]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53050; File No. SR-Amex-2005-114]

Self-Regulatory Organizations; American Stock Exchange LLC; Order
Granting Approval of a Proposed Rule Change and Amendment No. 1 Thereto
Relating to the Amex Initial Listing Standards

January 3, 2006.

I. Introduction

    On November 2, 2005, the American Stock Exchange LLC (``Amex'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to amend section 102(b) of the Amex Company Guide
(``Company Guide'') to require a minimum market price of $2 per share
for issuers seeking to qualify for initial listing pursuant to Initial
Listing Standard 3 (Section 101(c) of the Company Guide). On November
10, 2005, the Exchange filed Amendment No. 1 (``Amendment No. 1'') to
the proposed rule change to amend section 101 of the Company Guide to
include a reference to section 102(b) of the Company Guide in each of
the four initial Amex listings standards to clarify that section 102(b)
of the Company Guide applies to each standard.\3\ The proposed rule
change and Amendment No. 1 were published for comment in the Federal
Register on November 28, 2005.\4\ The Commission received no comments
on the proposal. This order approves the proposed rule change, as
amended.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Amendment No. 1 clarified the purpose section of the filing
and made proposed changes to section 101 of the Company Guide to
reference section 102(b) of the Company Guide in the listing
provisions.
    \4\ Securities Exchange Act Release No. 52804 (November 18,
2005), 70 FR 71342 (November 28, 2005) (SR-Amex-2005-114).
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II. Description

    In its filing, the Amex stated that an approval of an application
for the listing of securities on the Exchange is based on an
applicant's ability to satisfy a series of quantitative and qualitative
listing standards as evaluated by the Listing Qualifications
Department. The Amex represented that the quantitative standards
currently provide four alternative approaches for a company to satisfy
the Amex's initial listing standards.
    For applicants to meet Initial Listing Standards 1, 2, and 4
(Company Guide Section 101(a), (b), and (d), respectively), in addition
to specified minimum numerical standards, the Exchange requires a
minimum market price of $3 per share. The Amex noted that although
Listing Standard 3 currently requires an applicant to meet minimum
specified numerical standards, it does not require the applicant to
meet a minimum market price per share.
    The Exchange proposed to enhance its initial listing quantitative
standards to require applicants seeking to qualify under Initial
Listing Standard 3 pursuant to section 101(c) of the Company Guide to
have a minimum market price of $2 per share. In order to do so, the
Exchange proposed to amend section 102(b) to incorporate this
requirement. The Exchange also proposed to amend section 101 of the
Company Guide to include a reference to section 102(b) of the Company
Guide in each of the four initial listing standards to clarify that
section 102(b) of the Company Guide applies to each of the four listing
standards.\5\
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    \5\ See Amendment No. 1, supra note 3.
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    In addition, the Exchange proposed to delete the last sentence of
section 102(b) of the Company Guide. The Exchange noted that this
provision, which has been in place for many years, gives the Exchange
the discretion under certain circumstances to consider listing an issue
that qualified under Initial Listing Standards 1, 2, or 4 even if the
issue's share price is less than $3. The Exchange represented that this
provision was meant to cover the situation in which an applicant issuer
meets all of the initial listing standards but experiences a decline in
share price to below $3 per share just before listing. In light of the
current and proposed configuration of the initial listing standards,
the Exchange stated that it believes that this provision is no longer
necessary or appropriate.\6\
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    \6\ Id.
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III. Discussion

    After careful consideration, the Commission finds that the proposed
rule change, as amended, is consistent with section 6(b) of the Act,\7\
in general, and furthers the objectives of section 6(b)(5) of the
Act,\8\ in particular, in that it 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, and is not designed to
permit unfair discrimination between customers, issuers, brokers, or
dealers.\9\
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    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
    \9\ In approving this proposal, the Commission has considered
the proposed rule's impact on efficiency, competition, and capital
formation. 15 U.S.C. 78c(f).
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    The Commission believes that the proposed rule change will allow
for the evaluation of an issuer's initial listing eligibility against
more comprehensive criteria and strengthen the listing standards of the
Amex. The Commission notes that the three other listing standards
(i.e., Listing Standards 1, 2, and 4) of the Amex already contain a $3
market price requirement.\10\ The adoption of a $2 minimum market price
for listing under section 101(c) of the Company Guide will help to
ensure that all companies initially listing on Amex under section 101
must meet a minimum price requirement. The Commission notes that under
section 101 of the Company Guide, the fact that an applicant may meet
the Amex's numerical standards does not necessarily mean its
application will be approved, and section 101 of the Company Guide sets
forth other factors the Exchange may consider for listing, including
the nature of the applicant's business and the reputation of
management, among others. The Commission expects Amex to continue

to review companies for listing under all the relevant factors. The new
standard being adopted, as well as the elimination of the discretionary
provision in section 102(b) of the Company Guide, will nevertheless
ensure that a minimum price must be met at the outset to be considered
for initial listing under section 101 of the Company Guide.\11\
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    \10\ See Sections 101 and 102 of the Company Guide.
    \11\ The Commission believes the adoption of the $2 minimum
market price standard under section 101(c) of the Company Guide is a
good, first step in strengthening Amex's listing standards and
continues to encourage the Exchange to consider adopting a minimum
market price continued listing standard.
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    Finally, the Commission notes that the rule proposal does not
discriminate among different issuers because the new minimum price
standard for listing under section 101(c) of the Company Guide will
apply equally to all potential issuers for listing. Based on the above,
the Commission believes that the proposal will help investors and the
public interest by ensuring that securities that are listed on the
Exchange, pursuant to Initial Listing Standard 3 of section 101(c) of
the Company Guide, are traded initially at least with a $2 minimum
market share requirement and must meet a minimum price listing standard
at all times.

IV. Conclusion

    It Is Therefore Ordered, pursuant to section 19(b)(2) of the
Act,\12\ that the proposed rule change (SR-Amex-2005-114), as amended,
is approved.
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    \12\ 15 U.S.C. 78f(b).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\13\
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    \13\ 17 CFR 200.30-3(a)(12).
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Nancy M. Morris,
Secretary.
 [FR Doc. E6-82 Filed 1-9-06; 8:45 am]

BILLING CODE 8010-01-P


APPENDIX B ( 1 4)

TSCA Guidelines with Annotations as Appropriate RECEIVED OPPT NCIC 2003 MAR11 5: 00PM OPPT 2003 0010 0006 Environmental Protection Agency § 799.9135 ( ix) Manufacturer ( source), lot number and purity of test substance. ( x) Identification and composition of any vehicles ( e. g., diluents. suspending agents, and emulsifiers) or other materials , if used in administering the test substance. ( xi) A list of references cited in the body of the report. References to any published literature used in developing the test protocol, performing the testing making and interpreting observations and compiling and evaluating the results. ( g) References. For additional background information on this test guideline the following references should be consulted. These references are available for inspection at the TSCA Nonconfidential Information Center, Rm. NE   B607, Environmental Protection Agency, 401 M St., NW., Washington, DC, 12 noon to 4 p. m., Monday through Friday, except legal holidays. ( 1) Chanter, DO. and Heywood, R. The L~ 0 test: some considerations of prectston. Toxicology Letters 10: 303 307 ( 1982). ( 2) Finney, D. G. Chapter 3 Estimation of the median effective dose, Chapter 4 Maximum likelihood estimation. Probit Analysis. 3rd Ed. ( Cambridge, London. ( 1971). ( 3) Finney, D. J. The Median Lethal Dose and Its Estimation, Archives of Toxicology 56: 215 218 ( 1985). ( 4) Organization for Economic Cooperation and Development. OECD Guidelines for the Testing of Chemicals. Final Draft OECD Guideline 425: Acute Oral Toxicity: Up and Down Procedure to be adopted in the Tenth Addendum to the OECD Guidelines for the Testing of Chemicals. ( 5) Organization for Economic Cooperation and Development. OECD Guidelines for Testing of Chemicals. Guideline 403: Acute Inhalation Toxicity. Adopted: May 12, 1981. ( 6) Organization for Economic Cooperation and Development. OECD Guidelines for Testing of Chemicals. Guideline 420: Acute Oral Toxicity Fixed Dose Method. Adopted: July 17. 1992. ( 7) Organization for Economic Cooperation and Development. OECD Guidelines for Testing of Chemicals, Guideline 423: Acute Oral Toxicity Acute Toxic Class Method, Adopted: March 22, 1996. ( 8) U. S. EPA. Interim Policy for Particle Size and Limit Concentration Issues in Inhalation Toxicity Studies. 211: 94. Health Effects Division, Office of Pesticide Programs.

( 65 FR 18T16. Dec. 15. 2000) § 799.9135 TSCA acute inhalation toxicity with histopathology.

( a) Scope. This section is intended to meet the testing requirements under section 4 of the Toxic Substances Control Act ( TSCA). In the assessment and evaluation of the potential human health effects of chemical substances, it is appropriate to test for acute inhalation toxic effects. The goals of this test are to characterize the exposureresponse relationship for sensitive endpoints following acute exposure and to characterize toxicologic response following acute high exposures. The latter is of particular concern in relation to spills and other accidental releases This testing is designed to determine the gross pathology and histopathology resulting from acute inhalation exposure to a substance. Because toxic effects on the respiratory tract are of particular concern following inhalation exposure, several indicators of respiratory toxicity consisting of histopathology on fixed tissue and evaluation of cellular and biochemical parameters in bronchoalveolar lavage fluid should be employed. The respiratory histopathology consists of specialized techniques to preserve tissues of the respiratory tract in order to allow detailed microscopic examination to identify adverse effects of chemical substances on this organ system. The bronchoalveolar lavage is designed to be a rapid screening test to provide an early indicator of pulmonary toxicity by examining biochemical and cytologic endpoints of material from the lungs of animals exposed to potentially toxic chemical substances. These acute tests are designed to assess the relationship, if any, between the animals exposure to the test substance and to demonstrate relationship between the animals' exposure and the incidence and severity of observed abnormalities including gross or histopathologic lesions, body weight changes, effects on mortality, and any other toxic effects. These acute tests are not intended to provide a complete evaluation of the toxicologic effects of a substance, and additional functional and morphological evaluations may be necessary to assess completely the p0 tential effects produced by a chemical 319 § 799.9135 40 CFR Ch. I ( 7   1   02 Edition)

substance. Additional tests may include longer term exposures, or more in depth evaluation of specific organ systems as indicated by signs of toxicity following acute exposure. ( b) Source. This a new section developed by the United States Environmental Protection Agency. ( c) Definitions. The following definitions apply to this section. Aerodynamic diameter ( d~~.) refers to the size of particles. It is the diameter of a sphere of unit density that behaves aerodynamically ( has the same settling velocity in air) as the particle of the test substance. It is used to compare particles of different size, shape, and density, and to predict where in the respiratory tract such particles may be primarily deposited. Exposure response is the relationship between the exposure concentration and the measured toxic response, whether expressed as a group mean ± standard deviation) in the case of a continuous variable or as incidence in the case of a quantal variable. This definiton should not preclude the exploration of other dose metrics in establishing this relationship. Geometric standard deviation ( GSD) is a dimensionless number equal to the ratio between the mass median aerodynamic diameter ( MMAD) and either 84% or 16% of the diameter size distribution ( e. g., MMAD = 2 pm; 84% = 4 pm: GSD = 4/ 2 = 2.0.) The MMAD, together with the GSD, describe the particle size distribution of an aerosol. Use of the GSD may not be valid for non lognormally distributed aerosols. ( If the size distribution deviates from the lognormal, it shall be noted). Inhalability is the ratio of the number concentration of particles of a certain aerodynamic diameter, d,~, that are inspired through the nose or mouth to the number concentration of the same d:,,, present in the inspired volume of ambient air. In humans. inhalability can exceed 15 pm d~, whereas inhalability dramatically decreases for particles above 4 pm d,~ in small laboratory animals. Lower respiratory tract consists of those structures of the respiratory tract below the larynx. Mass geometric mean aerodynamic diameter or the mass median aerodynamic diameter ( MMAD) is the calculated aerodynamic diameter that divides the particles of an aerosol ( a gaseous suspension of fine liquid or solid particles) in half, based on the weight of the particles By weight, 50% of the particles will be larger than the MMAD and 50% of the particles will be smaller than the MMAD. Particle regional deposition is the fraction of inhaled particles that deposits in the specific region of the respiratory tract. The major mechanisms of particle deposition in the respiratory tract include impaction, sedimentation, diffusion interception, and electrostatic precipitation, The deposition mechanism that is dominant for a given region depends on the respiratory tract architecture and ventilation rate of the species and the aerosol particle size and distribution. The respiratory tract in both humans and various experimental mammals can be divided into three regions on the basis of structure, size, and function: ( 1) The extrathoracic region or upper respiratory tract that includes the nose, mouth, nasopharynx, oropharynx, laryngopharynx, and larynx. ( 2) The tracheobronchial region that includes the trachea, bronchi, and bronchioles ( including the terminal bronchioles). ( 3) The alveolar region that includes the respiratory bronchioles ( if present in the species), alveolar ducts, alveolar sacs, and alveoli. Respiratory effects are any adverse effects on the structure or functions of the respiratory system related to exposure to a chemical substance. Target organ is any organ found to be a target of toxicity in the 4 hour ( hr) high concentration group as a result of: ( 1) The initial histopathologic examination ( respiratory tract, liver, kidney gross lesions); or ( 2) The retrospective histopathologic examination of archived organs triggered by their identification as targets of toxicity in a 90 day' study. Toxic effects are any adverse changes ( a change that is statistically and biologically significant) in the structure or function of an experimental animal as a result of exposure to a chemical substance.

320 Environmental Protection Agency § 799.9135 Upper respiratory tract consists of those structures of the respiratory tract above and including the larynx. ( d) Principle of the test method. The test substance shall be administered to several groups of experimental animals one concentration level and duration being used per group. Bronchoalveolar lavage shall be used to evaluate early effects on the respiratory system by examining changes in the content of the lavage fluid of the lung. At 24 hrs following exposure, the animals shall be sacrificed and necropsied, and tissue samples from the respiratory tract and other major organs will be prepared for microscopic examination. The exposure levels at which significant toxic effects on the respiratory organ system are produced are compared to those levels that produce other toxic effects. As triggered by the results of the 4 hr test, additional exposure periods of 1 hr and 8 hrs will be required to determine the effect of exposure time on the toxicity observed. A 1 hr exposure study can be elected as an option to provide data suitable for risk assessment for very short duration exposures as may occur from chemical releases. In the absence of adequate toxicological data for 1 hr exposure, the Agency will extrapolate to shorter term exposures from the 4 hr data on the basis of concentration alone. This is a conservative method of extrapolation, consistent with general Agency methods for deriving criteria for short term exposure from longerterm studies ( a concentration x time extrapolation would result in higher concentration for a shorter duration). ( e) Test procedures   ( 1) Animal selection   ( i) Species. In general, the laboratory rat and mouse should be used. Under some circumstances, other species such as the hamster or guinea pig, may be more appropriate, and if these or other species are used, justification should be provided. ( ii) Strain. If rats and mice are used, the use of the F344 rat and the B6C3F1 mouse is preferred to facilitate comparison with existing data. ( iii) Age. Young adults shall be used. The weight variation of animals used in a test should not exceed ` 61' 20% of the mean weight for each species. ( iv) Sex. Equal numbers of animals of each sex shall be used for each concentration level. The females shall be nulliparous and nonpregnant. ( v) Health status. Body weight and feed consumption are not sufficient indicators of the health status of animals prior to initiating an inhalation toxicity study. Prior to initiating the study, animals shall be monitored for known viral and bacterial respiratory pathogens determined by conventional microbiological assays ( e. g., serology). The animals shall be free from pathogens at the start of exposure. ( 2) Number of animals. At least five males and five females shall be used in each concentration/ duration and control group. Animals shall be randomly assigned to treatment and control groups. ( 3) Control groups. The control group shall be a sham treated group. Except for treatment with the test substance, animals in the control group shall be handled in a manner identical to the test group animals. Where a vehicle is used to help generate an appropriate concentration of the substance in the atmosphere, a vehicle control group shall be used. If the 4 and 8 hr exposure studies are conducted concurrently a concurrent 8 hr sham exposed control group may serve as the control group for both the 4 hr and the 8 hr exposure studies, provided there is adequate historical control data showing no changes in histopathology or bronchoalveolar lavage of controls exposed for 4 and 8 hrs. Similarly, if the optional 1 hr exposure study is conducted concurrently with the 4 and/ or 8 hr study, the concurrent control group for those studies may also be used for the 1 hr study, provided adequate historical control data show no changes in histopathology or bronchoalveolar lavage between controls exposed for these time periods. ( 4) Concentration level and concentration selection. For the 4 hr study, at least three concentrations shall be used in addition to the control group. Ideally, the data generated from the test should be sufficient to produce an exposure response curve. The concentrations can either be linearly or logarithmically spaced depending on 321 § 799.9135 40 CFR Ch. I ( 7   1   02 Edition)

the anticipated steepness of the concentration response curve. A rationale for concentration selection should be provided to indicate that the selected concentrations will maximally support detection of concentration response relationship The high concentration should be clearly toxic or a limit concentration but should not result in an incidence of fatalities that would preclude a meaningful evaluation of the data. The lowest concentration should define a no observed adverse effects level ( NOAEL). ( i) Limit concentration. For aerosols and particles, the high concentrations need not be greater than 2 mg/ L, or concentrations that cannot maintain a particle size distribution having an MMAD between 1 and 4 pm ( i. e., a particle size that permits inhalability and deposition throughout the respiratory tract). For fibers, the bivariate distribution of length and diameter must ensure inhalability. For gases and vapors the concentrations need not be greater than 50,000 ppm or 50% of the lower explosive limit, whichever is lower. If a test at an aerosol or particulate exposure of 2 mg/ L ( actual concentration of respirable substance) for 4 hrs or, where this is not feasible, the maximum attainable concentration. using the procedures described for this study, produces no observable toxic effects then a full study using three concentrations will not be necessary. Similarly, if a test at a gas or vapor exposure of 50,000 ppm or 50% of the lower explosive limit, whichever is lower, produces no observable toxic effects, then a full study using three concentrations will not be necessary. ( ii) 8 hr study and optional 1 hr study. If the 8 hr study is triggered, three concentrations shall be tested. These concentrations should allow for the determination of an effect level and a NOAEL. If the option to perform a 1 hr study is elected, three concentrations shall be selected and tested in a similar manner. ( 5) Inhalation exposure. Animals can be exposed to the substance by either a nose only procedure or in a whole body exposure chamber. ( i) Inhalation chambers. The animals shall be tested in inhalation equipment designed to sustain a dynamic airflow for nose only exposures of at least 300 mI/ minute/ animal or an airflow for whole body exposures of at least 12 to 15 air changes per hr and ensure an adequate oxygen content of at least 19% and an evenly distributed exposure atmosphere. Where a whole body chamber is used, its design shall minimize crowding by providing individual caging As a general rule, to ensure stability of a chamber atmosphere, the total " volume" of the test animals should not exceed 5% of the volume of the test chamber. ( ii) Environmental conditions. The temperature at which the test is performed shall be maintained at 22 ° C( ± 2 ° C). Ideally, the relative humidity should be maintained between 40% and 60%, but in certain instances ( e. g., tests using water as a vehicle), this may not be practical. ( iii) Exposure periodicity. For acute testing, the exposure design shall enable 4 hrs of exposure to the target concentrations, as defined by an average of ± 5% for gases and vapors and ± 15% for particles and aerosols. If triggered by the results of the 4 hr exposure additional testing shall be conducted in a comparable manner using an 8 hr exposure period. ( 6) Physical measurements. Measurements or monitoring shall be made of the following: ( i) Chemical purity of the test material shall be analyzed. ( ii) The rate of airflow shall be monitored continuously, but shall be recorded at least every 30 minutes. ( iii) The actual concentrations of the test substance shall be measured in the breathing zone. During the exposure period, the actual concentrations of the test substance shall be held as constant as practical, monitored continuously or intermittently depending on the method of analysis, and recorded at least at the beginning, at an intermediate time, and at the end of the exposure period. Well established and published monitoring methods should be used where available. If no standard methods are available, then accuracy and precision information must be supplied ( iv) During the development of the generating system, appropriate particle size analysis shall be performed to 322 Environmental Protection Agency § 799.9135 establish the stability of the aerosol. During exposure, analysis should be conducted as often as necessary to determine the consistency of particle size distribution. The particle size distribution shall have an MMAD between 1 and 4 pm. The particle size of hygroscopic materials shall be small enough when dry to assure that the size of the particle at saturation will still have an MMAD between 1 and 4 pm. Characterization for fibers shall include the bivariate distribution of length and diameter this distribution must ensure inhalability. ( v) If the test substance is present in a mixture, the mass and composition of the entire mixture, as well as the principal compound, shall be measured. ( vi) Temperature and humidity shall be monitored continuously, but shall be recorded at least every 30 minutes. ( 7) Food and water during exposure period Food shall be withheld during exposure Water may also be withheld in certain cases. ( 8) Observation period. The bronchoalveolar lavage and respiratory pathology shall be conducted 24 hrs following exposure to allow expression of signs of toxicity. There is concern that some latency time will be required to allow migration of cells and macromolecules into the lungs following exposure, and that some pathology may require macromolecular synthesis or degradation before cell damage develops. ( 9) Gross pathology. ( i) All animals shall be subjected to a full gross necropsy which includes examination of orifices and the cranial, thoracic, and abdominal cavities and their contents. ( ii) At least the lungs, liver, kidneys, adrenals, brain, and gonads shall be weighed wet, as soon as possible after dissection to avoid drying. ( iii) The following organs and tissues, or representative samples thereof, shall be preserved in a suitable medium for possible future histopathological examination All gross lesions; brain including sections of medulla/ pons; cerebellar cortex and cerebral cortex; pituitary; thyroid/ parathyroid; thymus; heart; sternum with bone marrow; salivary glands; liver: spleen: kidneys; adrenals; pancreas; gonads; accessory genital organs ( epididymis, prostrate, and, if present, seminal vesicles); aorta; skin; gall bladder ( if present): esophagus; stomach; duodenum; jejunum; ileum; cecum; colon; rectum; urinary bladder; representative lymph nodes; thigh musculature; peripheral nerve; spinal cord at three levels cervical, midthoracic, and lumbar; and eyes. Respiratory tract tissues shall also be preserved in a suitable medium. ( 10) Histopathology. The following histopathology shall be performed: ( i) Full histopathology shall be performed on the respiratory tract, liver and kidney of all animals in the control and high concentration groups. The histopathology of the respiratory tract is described under paragraph ( e)( 11) of this section. ( ii) All gross lesions which differ from controls in frequency, distribution type, or severity in all concentration groups. ( iii) Target organs in all animals, as indicated by the observations in the high concentration group in this study. Histopathologic examination of target organs in animals at all concentration levels ( rather than only to the extent necessary to define the NOAEL) can support the application of exposure response analyses such as the benchmark concentration approach. ( iv) Archived organs identified as targets of toxicity from results of the 90 day study ( if a 90 day study is required for this substance) should be elevated in high concentration animals of the 4 hr acute study to determine if they are also targets of acute toxicity. ( 11) Respiratory tract histopatho logy. ( i) Representative sections of the respiratory tract shall be examined histologically These shall include the trachea major conducting airways, alveolar region, terminal and respiratory bronchioles ( if present), alveolar ducts and sacs, and interstitial tissues. ( ii) Care shall be taken that the method used to kill the animal does not result in damage to the tissues of the upper or lower respiratory tract. The lungs shall be infused with a fixative while in an inflated state of fixed pressure. ( iii) The upper respiratory tract shall be examined for histopathologic lesions This examination shall use a minimum of four sections located as 323 § 799.9135 40 CFR Ch. I ( 7   1   02 Edition)

specified under paragraphs ( e)( ll.)( iii)( A) through ( e)( 11)( iii)( D) of this section. An evaluation of the nasal vestibule shall be conducted. The method described by the reference under paragraph ( h)( 11) of this section should be given consideration. The use of additional sections shall be left to the discretion of the study pathologist, but consideration should be given to additional sections as recommended in the reference under paragraph ( h)( 8) of this section to ensure adequate evaluation of the entire upper respiratory tract, particularly the nasopharyngeal meatus. The following transverse sections shall be examined: ( A) Immediately posterior to the upper incisor teeth. ( B) At the incisor papilla. ( C) At the second palatal ridge. ( D) At the level of the first upper molar teeth. ( iv) The laryngeal mucosa shall be examined for histopathologic changes. Sections of the larynx to be examined include the epithelium covering the base of the epiglottis, the ventral pouch, and the medial surfaces of the vocal processes of the arytenoid cartilages ( 12) Bronchoalveolar lavage. ( i) Animals can be exposed to the substance by either a nose only procedure or in a whole body exposure chamber. ( ii) Care should be taken that the method used to kill the animal results in minimum changes in the fluid of the lungs of the test animals. ( iii) At the appropriate time, the test animals shall be killed and the heartlung including trachea removed in bloc. Alternatively, lungs can be lavaged in situ. If the study will not be compromised, one lobe of the lungs may be used for lung lavage while the other is fixed for histologic evaluation. The lungs should be lavaged using physiological saline. The lavages shall consist of two washes, each of which consists of approximately 80% ( e. g.. 5 ml in rats and 1 ml in mice) of the total lung volume. Additional washes merely tend to reduce the concentrations of the material collected. The lung lavage fluid shall be stored on ice at 5 ° Cuntil assayed. ( iv) The following parameters shall be determined in the lavage fluid as indicators of cellular damage in the lungs: total protein, cell count, and percent leukocytes. In addition, a phagocytosis assay shall be performed to determine macrophage activity. Assay methods described in the references under paragraphs ( h)( 1) and ( h)( 3) of this section may be used. ( 13) Combined protocol. The tests described may be combined with any other toxicity study. as long as none of the requirements of either are violated by the combination. ( f) Triggered testing. If no adverse effects are seen in the 4 hr study as compared with controls, no further testing is necessary. If the 4 hr study shows positive effects in histopathology or the bronchoalveolar lavage, an 8 hr study shall be conducted. Only those tissues showing positive results in the 4 hr study must be pursued in the follow up 8 hr study. Similarly, if the option to perform a 1 hr study is exercised only those tissues showing positive results in the 4 hr study shall be pursued. ( g) Data reporting and evaluation. The final test report shall include the following information: ( 1) Description of equipment and test methods. A description of the general design of the experiment and any equipment used shall be provided. ( 1) Description of exposure apparatus, including design, type, dimensions, source of air, system for generating particles, aerosols, gasses, and vapors, method of conditioning air, treatment of exhaust air, and the method of housing animals in a test chamber. ( ii) Description of the equipment for measuring temperature, humidity, and particulate aerosol concentration and size. ( iii) Exposure data shall be tabulated and presented with mean values and measure of variability ( e. g., standard deviation) and should include: ( A) Chemical purity of the test material ( B) Airflow rates through the inhalation equipment. ( C) Temperature and humidity of air. ( D) Nominal concentration ( total amount of test substance fed into the inhalation equipment divided by the volume of air).

324 Environmental Protection Agency § 799.9135 ( E) Actual concentration in test breathing zone. ( F) Particle size distribution ( e. g., MMAD with GSD) and the bivariate distribution of fiber length and diameter where appropriate. ( 2) Results   ( i) General group animal data. The following information shall be arranged by test group exposure level. ( A) Number of animals exposed. ( B) Number of animals dying. ( C) Number of animals showing overt signs of toxicity. ( D) Pre and post exposure body weight change in animals, and weight change during the observation period. ( ii) Counts and incidence of gross alterations observed at necropsy in the test and control groups. Data shall be tabulated to show: ( A) The number of animals used in each group and the number of animals in which any gross lesions were found. ( B) The number of animals affected by each different type of lesion, and the locations and frequency of each type of lesion. ( iii) Counts and incidence of general histologic alterations in the test group. Data shall be tabulated to show: ( A) The number of animals used in each group and the number of animals in which any histopathologic lesions were found. ( B) The number of animals affected by each different type of lesion, and the locations, frequency, and average grade of each type of lesion. ( iv) Counts and incidence of respiratory histopathologic alterations by the test group. Data shall be tabulated to show: ( A) The number of animals used in each group and the number of animals in which any histopathologic lesions were found. ( B) The number of animals affected by each different type of lesion, and the locations, frequency. and average grade of each type of lesion. ( v) Results of the bronchoalveolar lavage study. Data shall be tabulated to show: ( A) The ` amount of administered lavage fluid and recovered lavage fluid for each test animal. ( B) The magnitude of change of biochemical and cytologic indices in lavage fluids at each test concentration for each animal. ( C) Results shall be quantified as amount of constituent/ mL of lavage fluid. This assumes that the amount of lavage fluid recovered is a representative sample of the total lavage fluid. ( 3) Evaluation of data. The findings from this acute study should be evaluated in the context of preceding and/ or concurrent toxicity studies and any correlated functional findings. The evaluation shall include the relationship between the concentrations of the test substance and the presence or absence incidence, and severity of any effects. The evaluation should include appropriate statistical analyses, for example parametric tests for continuous data and non parametric tests for the remainder. Choice of analyses should consider tests appropriate to the experimental design, including repeated measures. The report must include concentration response curves for the bronchoalveolar lavage and tables reporting observations at each concentration level for necropsy findings and gross, general, and respiratory system histopathology. ( h) Reference. For additional background information on this test guideline the following references should be consulted. These references are available for inspection at the TSCA Nonconfidential Information Center, Rm. NE   B607, Environmental Protection Agency, 401 M St., SW., Washington, DC, 12 noon to 4 p. m.. Monday through Friday, except legal holidays. ( 1) Burleson, G. R., Fuller, L. B.: e nache, MG., and Graham, J. A. Poly ( I): poly ( C) enhanced alveolar peritoneal macrophage phagocytosis: Quantification by a new method utilizing fluorescent beads. Proceedings of the Society of Experimental Biology and Medicine. 184: 468   476 ( 1987). ( 2) Gardner, D. E., Crapo, J. D., and McClellan, R. O. ( Eds.) Toxicology of the Lung. ( Raven Press, New York, 1993) pp. i   xii, 1 30. ( 3) Gilmour, G. I., and Selgrade, M. K. A comparison of the pulmonary defenses against streptococcal infection in rats and mice following 03 exposure: Differences in disease susceptibility and neutrophil recruitment. Toxicology 325 § 799.9305 40 CFR Ch. I ( 7   1   02 Edition)

and Applied Pharmacology. 123: 211   218 ( 1993). ( 4) Henderson, R. F., Benson, J. M., Hahn. F. F., Hobbs, C. H., Jones, R. K., Mauderly, J. L., McClellan, R. O.. and Pickrell, J. A. New approaches for the evaluation of pulmonary toxicity: Bronchoalveolar lavage fluid analysis. Fundamental and Applied Toxicology. 5: 451   458 ( 1985). ( 5) Henderson, R. F. Use of bronchoalveolar lavage to detect lung damage. Environmental Health Perspectives 56: 115   129 ( 1984). ( 6) Henderson, R. F., Rebar, A. H., Pickrell, J. A., and Newton, G. J. Early damage indicators in the lung. III. Biochemical and cytological response of the lung to inhaled metal salts. Toxicology and Applied Pharmacology. 50: 123   136 ( 1979). ( 7) McClellan, R. O. and Henderson. R. F. ( Eds.) Second edition. Concepts in Inhalation Toxicology. ( Taylor and Francis. Washington, DC, 1995) pp. i   xxiv, 1   24, 441   470. ( 8) Mery, S., Gross, E. A., Joyner, D. R., Godo, M., and Morgan, K. T. Nasal Diagrams: A Tool for Recording the Distribution of Nasal Lesions in Rats and Mice. Toxicologic Pathology. 22: 353   372 ( 1994). ( 9) Phalen, R. F. ( Ed) Methods in Inhalation Toxicology. ( CRC Press, Boca Raton, FL, 1997) pp. i   xii, 1   12. ( 10) Renne. R. A., Gideon, KM., Miller R. A., Mellick, P. W., and Grumbein, S. L. Histologic methods and interspecies variations in the laryngeal histology of F344./ N rats and B6C3F1 mice. Toxicology and Pathology. 20: 44   51 ( 1992). ( 11) Young, J. T. Histopathologic examination of the rat nasal cavity. Fundamental and Applied Toxicology. 1: 309   312 ( 1981).

§ 799.9305 TSCA Repeated dose 28   day oral toxicity study in rodents.

( a) Scope   ( 1) Applicability. This section is intended to meet testing requirements of the Toxic Substances Control Act ( TSCA) ( 15 U. S. C. 2601). ( 2) Source. The source material used in developing this TSCA test guideline is the Office of Prevention, Pesticides and Toxic Substances ( OPPTS) harmonized test guideline 870.3050 ( July 2000. final guidelines). This source is available at the address in paragraph ( h) of this section. ( b) Purpose. ( 1) In the assessment and evaluation of the toxic characteristics of a' chemical, the determination of oral toxicity using repeated doses may be carried out after initial information on toxicity has been obtained by acute testing. This study provides information on the possible health hazards likely to arise from repeated exposure over a relatively limited period of time. The method comprises the basic repeated dose toxicity study that may be used for chemicals on which a 90   day study is not warranted ( e. g., when the production volume does not exceed certain limits) or as a preliminary to a long term study. The duration of exposure should normally be 28 days although a 14 day study may be appropriate in certain circumstances; justification for use of a 14   day exposure period should be provided. ( 2) This section places emphasis on neurological effects as a specific endpoint and the need for careful clinical observations of the animals, so as to obtain as much information as possible is stressed. The method should identify chemicals with neurotoxic potential which may warrant further indepth investigation of this aspect. In addition, the method may give an indication of immunological effects and reproductive organ toxicity. ( c) Definitions. The definitions in section 3 of TSCA and in 40 CFR Part 792   Good Laboratory Practice Standards apply to this section. The following definitions also apply to this section. Dosage is a general term comprising of dose, its frequency and the duration of dosing. Dose is the amount of test substance administered. Dose is expressed as weight ( g, mg) or as weight of test substance per unit weight of test animal ( e. g., mg/ kg), or as constant dietary concentrations ( parts per million ( ppm)). No observed effects level ( NOEL) is the maximum dose used in a study which produces no adverse effects. The NOEL is usually expressed in terms of the weight of a test substance given daily per unit weight of test animals ( milligrams per kilograms per day).

326


[Federal Register Volume 76, Number 218 (Thursday, November 10, 2011)]
[Rules and Regulations]
[Pages 70051-70053]
[FR Doc No: 2011-29122]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2011-0496; Airspace Docket No. 11-AWP-6]

Establishment of Class D and Amendment of Class E Airspace; Los
Angeles, CA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action establishes Class D airspace at Los Angeles
International Airport, Los Angeles, CA. Controlled airspace is
necessary to contain potential missed approaches at Los Angeles
International Airport. This action enhances the safety and management
of aircraft operations at the airport. This action also edits Class E
airspace by adding the geographic coordinates and the airport name to
the airspace designation.

DATES: Effective date, 0901 UTC, December 15, 2011. The Director of the
Federal Register approves this

incorporation by reference action under 1 CFR part 51, subject to the
annual revision of FAA Order 7400.9 and publication of conforming
amendments.

FOR FURTHER INFORMATION CONTACT: Eldon Taylor, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue SW., Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On June 17, 2011, the FAA published in the Federal Register a
notice of proposed rulemaking to amend controlled airspace at Los
Angeles, CA (76 FR 35369). Interested parties were invited to
participate in this rulemaking effort by submitting written comments on
the proposal to the FAA. The FAA received four comments.
    One commenter had concerns about losing their hang gliding training
area. While there is no change to existing hang gliding operations, a
Letter of Agreement between Los Angeles Air Traffic Control Tower and
hang gliding operators will be initiated once the rule is adopted.
    Two commenters are opposed in general to the establishment of Class
D airspace adjacent to Los Angeles Class B airspace. As proposed, the
Class D design area is intended to minimize the airspace reclassified,
yet contain potential operations at Los Angeles International Airport,
and is of sufficient size to allow for safe and efficient handling of
these operations.
    One commenter had several concerns and suggestions; one suggestion
was to pursue non-rulemaking alternatives. Two concerns were that
published missed approach procedures are not used because they conflict
with other aircraft and operations; and alternate missed approach
procedures are ``ad-hoc'' procedures. Firstly, the FAA considered non-
rulemaking solutions but found they did not provide the equivalent
level of safety as would Class D airspace. Secondly, both standard and
alternate missed approach procedures are used as appropriate to ensure
the safety of arriving and departing aircraft. Alternate missed
approach instructions may be required in addition to published missed
approach procedures to ensure that during unplanned missed approaches
or unusual traffic situations, aircraft remain safely separated.
    The commenter was also concerned that the proposal does not address
all Los Angeles International Airport Class B airspace containment
issues. The Los Angeles Class B airspace area is currently under review
to specifically address aircraft containment issues. The Class D
proposal has been designed to address specific safety concerns
involving large turbojet aircraft operations in Class E airspace
adjacent to Los Angles International Airport. Currently, non-
participating aircraft may fly in close proximity to arriving and
departing Instrument Flight Rules (IFR) aircraft in this Class E
airspace. The establishment of the Los Angeles International Airport
Class D airspace area may be incorporated into the future Los Angeles
Class B airspace design proposal.
    Another concern was frequency congestion. The FAA found that pilot,
controller workload and frequency congestion are not impacted by this
proposal as all alternate missed approach instructions currently
require this communication. Also of concern was that the FAA pursues a
full review, including a redesign of the Los Angeles Class B airspace.
The FAA agrees that a redesign of the Los Angeles Class B airspace area
may provide a unified airspace utilization solution in the Los Angeles
Basin. This redesign will be pursued in accordance with Joint Order
(JO) 7400.2H, Procedures for Handling Airspace Matters, as part of the
ongoing Los Angeles Basin airspace review.
    This action also amends Class E airspace to include the airport
name and geographic coordinates in the airspace designation. With the
exception of editorial changes, this rule is the same as that proposed
in the NPRM.
    Class D and Class E airspace designations are published in
paragraphs 5000 and 6005, respectively, of FAA Order 7400.9V dated
August 9, 2011, and effective September 15, 2011, which is incorporated
by reference in 14 CFR 71.1. The Class D and Class E airspace
designations listed in this document will be published subsequently in
that Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
Part 71 by establishing Class D airspace at Los Angeles International
Airport, Los Angeles, CA, for containment of potential missed
approaches at Los Angeles International Airport. This action is based
on the results of a study conducted by the Los Angeles VFR Task Force,
and the Los Angeles Class B Workgroup. This action further enhances the
safety and management of aircraft operations at the airport. This
action also amends Class E airspace extending upward from 700 feet
above the surface by adding ``Los Angeles International Airport, CA''
and ``lat. 33[deg]56'33'' N., long. 118[deg]24'26'' W.'' to the
airspace designation.
    The FAA has determined this regulation only involves an established
body of technical regulations for which frequent and routine amendments
are necessary to keep them operationally current. Therefore, this
regulation: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act. The FAA's authority to
issue rules regarding aviation safety is found in Title 49 of the U.S.
Code. Subtitle 1, Section 106 discusses the authority of the FAA
Administrator. Subtitle VII, Aviation Programs, describes in more
detail the scope of the agency's authority. This rulemaking is
promulgated under the authority described in Subtitle VII, Part A,
Subpart I, Section 40103. Under that section, the FAA is charged with
prescribing regulations to assign the use of airspace necessary to
ensure the safety of aircraft and the efficient use of airspace. This
regulation is within the scope of that authority as it establishes
additional controlled airspace at Los Angeles International Airport,
Los Angeles, CA.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority:  49 U.S.C. 106(g), 40103, 40113, 40120; E. O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of the Federal
Aviation Administration Order 7400.9V, Airspace Designations and
Reporting Points, dated August 9, 2011, and effective

September 15, 2011 is amended as follows:

Paragraph 5000 Class D airspace.

* * * * *

AWP CA D Los Angeles, CA [New]

Los Angeles International Airport, CA
    (Lat. 33[deg]56'33'' N., long. 118[deg]24'26'' W.)
Santa Monica Municipal Airport, CA
    (Lat. 34[deg]00'57'' N., long. 118[deg]27'05'' W.)

    That airspace extending upward from the surface to and including
2,700 feet MSL bounded by a line beginning at lat. 33[deg]57'42''
N., long. 118[deg]27'23'' W.; to lat. 33[deg]58'18'' N., long.
118[deg]26'24'' W.; then via the 2.7-mile radius of the Santa Monica
Municipal Airport counterclockwise to lat. 34[deg]00'00'' N., long.
118[deg]24'02'' W.; to lat. 34[deg]00'00'' N., long. 118[deg]22'58''
W.; to lat. 33[deg]57'42'' N., long. 118[deg]22'10'' W., thence to
the point of beginning. That airspace extending upward from the
surface to and including 2,500 feet MSL bounded by a line beginning
at lat. 33[deg]55'50'' N., long. 118[deg]22'06'' W.; to lat.
33[deg]54'16'' N., long. 118[deg]24'17'' W.; to lat. 33[deg]52'47''
N., long. 118[deg]26'22'' W.; to lat. 33[deg]55'51'' N., long.
118[deg]26'05'' W., thence to the point of beginning. This Class D
airspace area is effective during the specific dates and times
established in advance by a Notice to Airmen. The effective date and
time will thereafter be continuously published in the Airport/
Facility Directory.

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface of the earth.

* * * * *

AWP CA E5 Los Angeles, CA [Amended]

Los Angeles International Airport, CA
    (Lat. 33[deg]56'33'' N., long. 118[deg]24'26''W.)

    That airspace extending upward from 700 feet above the surface
bounded by a line beginning at lat. 34[deg]05'00'' N., long.
118[deg]33'03'' W.; to lat. 34[deg]05'00'' N., long. 118[deg]15'03''
W.; to lat. 34[deg]00'00'' N., long. 118[deg]15'03'' W.; to lat.
34[deg]00'00'' N., long. 118[deg]07'03'' W.; to lat. 33[deg]56'00''
N., long. 118[deg]07'03'' W.; to lat. 33[deg]56'00'' N., long.
117[deg]53'03'' W.; to lat. 33[deg]46'00'' N., long. 117[deg]45'03''
W.; to lat. 33[deg]39'00'' N., long. 117[deg]30'03'' W.; to lat.
33[deg]30'00'' N., long. 117[deg]30'03'' W.; to lat. 33[deg]30'00''
N., long. 117[deg]45'03'' W.; to lat. 33[deg]42'00'' N., long.
118[deg]09'03'' W.; to lat. 33[deg]42'00'' N., long. 118[deg]26'03''
W.; to lat. 33[deg]48'00'' N., long. 118[deg]26'03'' W.; to lat.
33[deg]53'00'' N., long. 118[deg]33'03'' W., thence to the point of
beginning. That airspace extending upward from 1,200 feet above the
surface bounded by a line beginning at lat. 34[deg]00'00'' N., long.
119[deg]05'03'' W.; to lat. 34[deg]00'00'' N., long. 118[deg]33'03''
W.; to lat. 34[deg]05'00'' N., long. 118[deg]33'03'' W.; to lat.
34[deg]05'00'' N., long. 117[deg]59'03'' W.; to lat. 33[deg]56'00''
N., long. 117[deg]59'03'' W.; to lat. 33[deg]56'00'' N., long.
117[deg]53'03'' W.; to lat. 33[deg]46'00'' N., long. 117[deg]45'03''
W.; to lat. 33[deg]39'00'' N., long. 117[deg]30'03'' W.; to lat.
33[deg]30'00'' N., long. 117[deg]30'03'' W.; to lat. 33[deg]30'00''
N., long. 118[deg]34'03'' W.; to lat. 33[deg]28'30'' N., long.
118[deg]34'03'' W.; to lat. 33[deg]28'30'' N., long. 119[deg]07'03''
W.; to lat. 33[deg]52'03'' N., long. 119[deg]07'02'' W., thence to
the point of beginning.

    Issued in Seattle, Washington, on November 2, 2011.
Robert Henry,
Acting Manager, Operations Support Group, Western Service Center
[FR Doc. 2011-29122 Filed 11-9-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 98 (Tuesday, May 21, 2013)]
[Notices]
[Pages 29810-29811]
[FR Doc No: 2013-12064]

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 DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2013-0061; Notice 1]

Receipt of Petition for Decision That Nonconforming 2003 BMW K
1200 GT Motorcycles Are Eligible for Importation

AGENCY: National Highway Traffic Safety Administration, DOT.

ACTION: Notice of receipt.

-----------------------------------------------------------------------

SUMMARY: This document announces receipt by the National Highway
Traffic Safety Administration (NHTSA) of a petition for a decision that
2003 BMW K 1200 GT Motorcycles that were not originally manufactured to
comply with all applicable Federal Motor Vehicle Safety Standards
(FMVSS) are eligible for importation into the United States because (1)
they are substantially similar to vehicles that were originally
manufactured for sale in the United States and that were certified by
their manufacturer as complying with the safety standards, and (2) they
are capable of being readily altered to conform to the standards.

DATES: The closing date for comments on the petition is June 20, 2013.

ADDRESSES: Comments should refer to the docket and notice numbers above
and be submitted by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility: U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., between 9 a.m. and 5 p.m. ET,
Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    Instructions: Comments must be written in the English language, and
be no greater than 15 pages in length, although there is no limit to
the length of necessary attachments to the comments. If comments are
submitted in hard copy form, please ensure that two copies are
provided. If you wish to receive confirmation that your comments were
received, please enclose a stamped, self-addressed postcard with the
comments. Note that all comments received will be posted without change
to http://www.regulations.gov, including any personal information
provided. Please see the Privacy Act heading below.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    How to Read Comments submitted to the Docket: You may read the
comments received by Docket Management at the address and times given
above. You may also view the documents from the Internet at http://www.regulations.gov. Follow the online instructions for accessing the
dockets. The docket ID number and title of this notice are shown at the
heading of this document notice. Please note that even after the
comment closing date, we will continue to file relevant information in
the Docket as it becomes available. Further, some people may submit
late comments. Accordingly, we recommend that you periodically search
the Docket for new material.

FOR FURTHER INFORMATION CONTACT: Coleman Sachs, Office of Vehicle
Safety Compliance, NHTSA<PHONE_NUMBER>).

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 30141(a)(1)(A), a motor vehicle that was not
originally manufactured to conform to all applicable FMVSS shall be
refused admission into the United States unless NHTSA has decided that
the motor vehicle is substantially similar to a motor vehicle
originally manufactured for sale in the United States, certified under
49 U.S.C. 30115, and of the same model year as the model of the motor
vehicle to be compared, and is capable of being readily altered to
conform to all applicable FMVSS.
    Petitions for eligibility decisions may be submitted by either
manufacturers or importers who have registered with NHTSA pursuant to
49 CFR part 592. As specified in 49 CFR 593.7, NHTSA publishes notice
in the Federal Register of each petition that it receives, and affords
interested persons an opportunity to comment on the petition. At the
close of the comment period, NHTSA decides, on the basis of the
petition and any comments that it has received, whether the vehicle is
eligible for importation. The agency then publishes this decision in
the Federal Register.
    Wallace Environmental Testing Laboratories, Inc (``WETL''), of
Houston, Texas (Registered Importer R-09-005) has petitioned NHTSA to
decide whether non-U.S. certified 2003 BMW K 1200 GT motorcycles are
eligible for importation into the United States. The vehicles that WETL
believes are substantially similar are 2003 BMW K 1200 GT motorcycles
that were manufactured for sale in the United States and certified by
their manufacturer as conforming to all applicable FMVSS.
    The petitioner claims that it carefully compared non-U.S. certified
2003 BMW K 1200 GT motorcycles to their U.S. certified counterparts,
and found the vehicles to be substantially similar with respect to
compliance with most FMVSS.
    WETL submitted information with its petition intended to
demonstrate that non-U.S. certified 2003 BMW K 1200 GT motorcycles, as
originally manufactured, conform to many FMVSS in the same manner as
their U.S. certified counterparts, or are capable of being readily
altered to conform to those standards. Specifically, the petitioner
claims that non-U.S. certified 2003 BMW K 1200 GT motorcycles are
identical to their U.S. certified counterparts with respect to
compliance with Standard Nos. 106 Brake Hoses, 116 Brake Fluid, 119 New
Pneumatic Tires for Vehicles other than Passenger Cars, 122 Motorcycle
Brake Systems, 205 Glazing Materials.
    The petitioner further contends that the vehicles are capable of
being readily altered to meet the following standards, in the manner
indicated below:
    Standard No. 108 Lamps, Reflective Devices and Associated
Equipment: installation of the following U.S.-certified components:
front amber reflectors, rear red reflectors, and front running lights.
    Standard No. 111 Rearview Mirrors: installation of U.S.-model
mirrors.
    Standard No. 120 Tire Selection and Rims for Vehicles other than
Passenger Cars: installation of a tire information placard and
inspection of each vehicle to assure compliance with rim marking
requirements.
    Standard No. 123 Motorcycle Controls and Displays: installation of
a U.S.-model speedometer/odometer unit.
    WETL further states that labels will be affixed to conform to the
requirements of 49 CFR part 567: Certification.
    All comments received before the close of business on the closing
date indicated above will be considered, and will be available for
examination in the docket at the above addresses both before and after
that date. To the extent possible, comments filed after the closing
date will also be considered.

Notice of final action on the petition will be published in the Federal
Register pursuant to the authority indicated below.

    Authority:  49 U.S.C. 30141(a)(1)(A) and (b)(1); 49 CFR 593.8;
delegations of authority at 49 CFR 1.95 and 501.8.

    Issued On: May 14, 2013.
Claude H. Harris,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2013-12064 Filed 5-20-13; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 78, Number 20 (Wednesday, January 30, 2013)]
[Notices]
[Pages 6332-6333]
[FR Doc No: 2013-01944]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No: FDA-2013-N-0001]

Science Board to the Food and Drug Administration; Notice of
Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Science Board to the Food and Drug
Administration (Science Board).
    General Function of the Committee: The Science Board provides
advice primarily to the Commissioner of Food and Drugs and other
appropriate officials on specific complex scientific and technical
issues important to the FDA and its mission, including emerging issues
within the scientific community. Additionally, the Science Board
provides advice to the Agency on keeping pace with technical and
scientific developments including in regulatory science; and input into
the Agency's research agenda; and on upgrading its scientific and
research facilities and training opportunities. It will also provide,
where requested, expert review of Agency-sponsored intramural and
extramural scientific research programs.
    Date and Time: The meeting will be held on Wednesday, February 27,
2013, from approximately 8:30 a.m. to 5:15 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building
31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD
20993. For those unable to attend in person, the meeting will also be
webcast. The link for the webcast is available at https://collaboration.fda.gov/scienceboard/. Information regarding special
accommodations due to a disability, visitor parking, and transportation
may be accessed at: http://www.fda.gov/AdvisoryCommittees/default.htm;
under the heading ``Resources for You,'' click on ``Public Meetings at
the FDA White

Oak Campus.'' Please note that visitors to the White Oak Campus must
enter through Building 1.
    Contact Person: Martha Monser, Office of the Chief Scientist, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 4286,
Silver Spring, MD 20993,<PHONE_NUMBER>, or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area). A notice in the Federal Register about last minute modifications
that impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice. Therefore,
you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
    Agenda: On February 27, 2013, the Science Board will be provided
with updates and/or draft reports from the Center for Devices and
Radiological Health Research Review subcommittee and the Global Health
subcommittee. A progress update will be presented regarding the
recently established Center for Biologics Evaluation and Review Post-
Marketing Safety Review subcommittee. An update on the plan to
establish a new subcommittee to evaluate the Agency's continuing work
to address the challenges identified in Science Board's 2007 ``Science
and Mission at Risk'' Report will be presented. Plans will also be
presented and a proposed charge reviewed for a second subcommittee to
assess similar issues with respect to information technology including
evaluation of scientific data utilization, data liberation and
innovation. Overviews of genomics activities at the Centers for Food
Safety and Applied Nutrition and Veterinary Medicine will be presented,
along with plans for an Agency-wide working group to address cross-
cutting genomics activities. Finally, recipients of the FY2012
Scientific Achievement awards (selected by the Science Board) will
provide overviews of the activities for which the awards were given.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
Wednesday, February 20, 2013. Oral presentations from the public will
be scheduled between approximately 4:30 p.m. and 5 p.m. Those
individuals interested in making formal oral presentations should
notify the contact person and submit a brief statement of the general
nature of the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before
Tuesday, February 12, 2013. Time allotted for each presentation may be
limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person will
notify interested persons regarding their request to speak by
Wednesday, February 13, 2013.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Martha Monser at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: January 24, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-01944 Filed 1-29-13; 8:45 am]
BILLING CODE 4160-01-P