THIS MEETING HAS BEEN CANCELLED

CLEAN AIR SUBCOMMITTEE

AGENDA

April 30, 2009

1:30 – 3:30 PM EST

Participation by Teleconference Only

866-299-3188

code:<PHONE_NUMBER>#

1:30 – 1:40 pm	Welcome

	-  Roll Call	Dr. Ken Demerjian,

	- Overview of Agenda	Subcommittee Chair

1:40 – 1:45 pm	BOSC DFO Remarks	Ms. Heather Drumm, ORD

1:45 – 2:00 pm	Materials Overview	Dr. Dan Costa, Clean Air National Program Director, ORD

2:00 – 2:30 pm	ORD Overview	Dr. Kevin Teichman, Deputy Assistant Administrator for Science, ORD

2:30 – 2:45 pm	Overview of Charge/	Dr. Ken Demerjian, Subcommittee

	Rating Program Performance	Chair & Mya Sjogren Accountability Team Leader, ORD

2:45 – 3:15 pm	Overview of ORD’s Clean Air 	Dr. Dan Costa, Clean Air

	Program	National Program Director, ORD

3:15 – 3:20 pm	Public Comment

3:20 – 3:30 pm	Preparation for Next Call and Face-to-Face 	Dr. Ken Demerjian,

	Meeting	Subcommittee Chair

	- Discuss Writing Assignments

	- Identify Additional Information Needs

3:30 pm	Adjourn

            A Federal Advisory Committee for the U.S. Environmental Protection Agency’s Office of Research and Development


[Federal Register Volume 76, Number 194 (Thursday, October 6, 2011)]
[Notices]
[Pages 62099-62100]
[FR Doc No: 2011-25789]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Form 4; OMB Control No. 3235-0287; SEC File No. 270-126.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget this request for extension of the previously approved
collection of information discussed below.
    Under the Exchange Act of 1934 (15 U.S.C. 78a et seq.) every person
who is directly or indirectly the beneficial owner of more than 10
percent of any class of any equity security (other than an exempted
security) which registered under Section 12 of the Exchange Act (15
U.S.C. 78l), or who is a director or any officer of the issuer of such
security (collectively ``insider''), must file a statement with the
Commission reporting their ownership. Form 4 is a statement to disclose
changes in an insider's ownership of securities. The information is
used for the purpose of disclosing the equity holdings of insiders of
reporting companies.

Approximately 225,000 insiders file Form 4 annually and it takes
approximately 0.5 hours to prepare for a total of 112,500 annual burden
hours.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    The public may view the background documentation for this
information collection at the following Web site, http://www.reginfo.gov. Comments should be directed to: (i) Desk Officer for
the Securities and Exchange Commission, Office of Information and
Regulatory Affairs, Office of Management and Budget, Room 10102, New
Executive Office Building, Washington, DC 20503, or by sending an e-
mail to<EMAIL_ADDRESS>and (ii) Thomas Bayer, Chief
Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 6432 General Green Way, Alexandria, VA 22312 or send an
e-mail to<EMAIL_ADDRESS>Comments must be submitted to OMB
within 30 days of this notice.

    Dated: October 3, 2011.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-25789 Filed 10-5-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: November 1, 2006 (Volume 71, Number 211)]
[Notices]
[Page 64323-64326]
[DOCID:fr01no06-130]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. IC-27540; File No. 812-13300]

AIG SunAmerica Life Assurance Company and Variable Annuity
Account Seven, Notice of Application

October 26, 2006.
AGENCY: Securities and Exchange Commission (``SEC'').

ACTION: Notice of an application for an order (the ``Order'') of
approval pursuant to section 26(c) of the Investment Company Act of
1940, as amended (the ``1940 Act'').

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    Applicants: AIG SunAmerica Life Assurance Company (``AIG
SunAmerica''), and Variable Annuity Account Seven (collectively, the
``Applicants'').
    Summary of the Application: The Applicants request an order
permitting the substitution of the Equity Income Fund (the ``Replaced
Portfolio'') with the Davis Venture Value Portfolio (the ``Replacement
Portfolio'') both of which are Portfolios of the SunAmerica Series
Trust (``SAST'') (the ``Substitution'').
    Filing Date: The application was filed on June 2, 2006, and an
amended and restated application was filed on October 19, 2006.
Applicants have agreed to file an amendment during the notice period,
the substance of which is reflected in this notice.
    Hearing or Notification of Hearing: An order granting the
application will be issued unless the SEC orders a hearing. Interested
persons may request a hearing on the application by writing to the
Secretary of the SEC and serving Applicants with a copy of the request,
personally or by mail. Hearing requests must be received by the SEC by
5:30 p.m. on November 16, 2006, and should be accompanied by proof of
service on Applicants in the form of an affidavit or, for lawyers, a
certificate of service. Hearing requests should state the nature of the
writer's interest, the reason for the request, and the issues
contested. Persons may request notification of a hearing by writing to
the Secretary of the SEC.

ADDRESSES: Secretary, Securities and Exchange Commission, 100 F Street,
NE., Washington, DC 20549-1090. Applicants: c/o Jorden Burt LLP, 1025
Thomas Jefferson Street, NW., East Lobby, Suite 400, Washington, DC
20007-5208, Attention: Joan E. Boros, Esq.

FOR FURTHER INFORMATION CONTACT: Jeffrey Foor, Esq., Senior Counsel, or
Zandra Y. Bailes, Esq., Branch Chief, Office of Insurance Products,
Division of Investment Management, at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application is available for a fee from the
Public Reference Branch of the SEC, 100 F Street, NE., Room 1580,
Washington, DC 20549<PHONE_NUMBER>).

Applicants' Representations

    1. AIG SunAmerica is a stock life insurance company originally
organized under the laws of the State of California in April 1965. AIG
SunAmerica, redomesticated under the laws of the State of Arizona on
January 1, 1996. AIG SunAmerica is a wholly-owned subsidiary of
SunAmerica Life Insurance Company, an Arizona corporation, which is, in
turn, wholly-owned by AIG Retirement Services, a Delaware corporation,
which is, in turn, wholly-owned by American International Group, Inc.
AIG SunAmerica is authorized to write annuities and life insurance in
the District of Columbia and all states except New York.
    2. Separate Account Seven (the ``Separate Account'') was
established by AIG SunAmerica on August 28, 1998, in accordance with
the laws of the State of Arizona. The Separate Account is registered as
a unit investment trust under the 1940 Act. The Separate Account is
used to fund the Contract and other annuity contracts issued by AIG
SunAmerica and is currently divided into a total of 42 subaccounts (the
``Sub-Accounts''). Each of the available Sub-Accounts invests in shares
of the available portfolios of the SAST. One of the Sub-Accounts
currently invests in the Replaced Portfolio.
    3. The Polaris Plus Contract (the ``Contract''), issued by AIG
SunAmerica through the Separate Account, is a flexible premium group
and individual deferred annuity contract that currently utilizes the
Replaced Portfolio as one of many underlying investments. AIG
SunAmerica discontinued offering the Contract as of the close of
business on February 28, 2002. Existing Contractowners (``Owners'') may
continue to allocate purchase payments to and transfer among the
available Sub-Accounts, including the Sub-Account that currently
invests in the Replaced Portfolio (the ``Equity Income Sub-Account'').
The allocation/transfer rights will continue until one week prior to
the date of the proposed Substitution requested by the application. The
Contract is the only contract investing in the Equity Income Sub-
Account, and no other sub-account of any other separate account invests
in the Replaced Portfolio. During the accumulation period, there are no
limits on the number of transfers Owners can make among the available
Sub-Accounts under the Contract and/or the Contract fixed accounts.
Transfers resulting from participation in the Dollar Cost Averaging or
Asset Rebalancing Programs do not count against the fifteen (15) free
transfers per contract year. All transfers in excess of fifteen (15)
transfer requests per contact year must be submitted by mail until the
next contract anniversary and may be subject to further restrictions.
    4. SAST was organized as a Massachusetts business trust on
September 11, 1992. SAST was established and serves to provide a
funding medium for the Sub-Accounts which constitute its sole
shareholders. SAST is registered as an open-end management investment
company under the 1940 Act (File No. 811-07238), and its offering of
its shares is registered under the Securities Act of 1933 (File No.
033-52742).
    5. The Replaced Portfolio, which offers a single class of shares,
constitutes a separate series available through SAST. The inception
date of the Replaced Portfolio was December 14, 1998, and it has been
offered in the Separate Account since the inception date of the
Contract on March 19, 1999.
    6. The Separate Account buys and sells shares of the Replaced
Portfolio at net asset value that is net of the advisory fee of 0.650%
based on average daily net assets, paid to the investment adviser, AIG
SunAmerica Asset Management (``AIG SAAMCo''), to manage the business
affairs of the Replaced Portfolio and to provide administrative
services pursuant to a written investment advisory agreement (the
``Advisory Agreement''). The Replaced Portfolio's other expenses were
1.25% for the fiscal year ended January 31, 2006. The Replaced
Portfolio's total annual operating expenses for this period were 1.90%,
subject to voluntary fee waivers and expense reimbursement by AIG
SAAMCo that provided for total annual net operating expenses of 1.35%.
FAF Advisors, Inc., formerly U.S. Bancorp Asset Management, Inc.
(``FAF'') serves as subadviser to the Replaced Portfolio. AIG SAAMCo is
affiliated with AIG SunAmerica, but FAF is not affiliated with AIG
SunAmerica.
    7. The Replaced Portfolio is a portfolio in which the Separate
Account invests under the Contract as one of the 42 Sub-Account
investment alternatives currently available. If the requested Order is
granted, the Substitution will result in the reduction of the available
investment alternatives by one. Shares of the Replacement Portfolio
will be offered at net asset value that is net of the current
Replacement Portfolio's advisory fee of 0.71% which is paid to AIG
SAAMCo to manage the business affairs of the Replacement Portfolio and
to provide administrative services

pursuant to the Advisory Agreement. The Replacement Portfolio's other
expenses are 0.05%, and the Replacement Portfolio's total annual
operating expenses are 0.76% for Class 1 shares. The Replacement
Portfolio does not pay Rule 12b-1 fees for distribution activities.
Davis Selected Advisers, L.P. d/b/a Davis Advisers (``Davis'') serves
as the sub-adviser to the Replacement Portfolio. Davis is not
affiliated with AIG SunAmerica.
    8. The application covers a single portfolio in which the Separate
Account invests under the Contract. Applicants propose the Substitution
due to the Replaced Portfolio's declining assets and relatively high
total expenses. Applicants note that since the Replaced Portfolio's
inception on December 14, 1998, the Replaced Portfolio has accumulated
only $5.8 million in assets as of January 31, 2006. Applicants note
further that the Equity Income Sub-Account is the only sub-account that
invests in the Replaced Portfolio, that the Equity Income Sub-Account
is offered as an investment option in only one variable contract (the
Contract), and that the Contract is no longer offered to new contract
owners. Applicants also note that the Replaced Portfolio's total net
annual expenses of 1.35% exceed the median for its peer group by 0.43%.
The Replaced Portfolio's sub-adviser announced its intention to
terminate the voluntary expense reimbursement agreement within the
current fiscal period. As a result, the Replaced Portfolio's total net
annual expenses can be expected to increase significantly, further
limiting the Replaced Portfolio's ability to achieve competitive
performance. AIG SunAmerica undertook to review the various alternative
investment portfolios to determine which would be a suitable
replacement for the Replaced Portfolio. AIG SunAmerica determined that
the Replacement Portfolio is an appropriate and suitable replacement
for the Replaced Portfolio based on the following conclusions: (1) The
Replacement Portfolio has investment objectives, policies, and
restrictions substantially similar to those of the Replaced Portfolio;
(2) the Replaced Portfolio and the Replacement Portfolio take on
comparable levels of risk; (3) the Replacement Portfolio has
significantly lower total annual expense ratios than the Replaced
Portfolio prior to and after voluntary fee waivers and reimbursements
for the Replaced Portfolio; (4) the Replacement Portfolio has a
significantly greater number of outstanding shares than the Replaced
Portfolio; (5) the Replacement Portfolio has a significantly larger
asset base than the Replaced Portfolio. The Replacement Portfolio's
total assets at January 31, 2006, were approximately $2.4 billion,
while the Replaced Portfolio's assets at January 31, 2006 were
approximately $5.8 million. The larger asset base of the Replacement
Portfolio provides the potential for a future reduction in the total
annual expenses of all its share classes, in addition to providing
potential enhanced performance. Moreover, the larger asset base of the
Replacement Portfolio provides greater protection against adverse
effects on expenses and performance occasioned by large redemptions;
and (6) the Replacement Portfolio has a performance record
significantly superior to that of the Replaced Portfolio, and the
potential for enhanced future performance.
    9. The Applicants note that the Replaced Portfolio will process
redemption requests and the Replacement Portfolio will process purchase
orders at prices based on the current net asset values next computed
after receipt of the requests and orders in a manner consistent with
Rule 22c-1 under the 1940 Act. The Applicants will effect the proposed
Substitution by redeeming shares of the Replaced Portfolio in cash at
net asset value and then immediately contributing those assets to the
Replacement Portfolio to purchase their Class 1 shares. At all times,
before and after the Substitution, monies attributable to Owners that
have allocated assets to the Equity Income Sub-Account will remain
fully invested, and no change will result in the amount of any Owner's
Contract value, death benefit or investment in the Equity Income Sub-
Account so that the full net asset value of the redeemed shares will be
reflected in the Owners' accumulation values or annuity unit values
following the Substitution. In addition, AIG SunAmerica undertakes to
assume all transaction costs and expenses relating to the Substitution
so that the full net asset value of redeemed shares of the Replaced
Portfolio held by the Equity Income Sub-Account will be reflected in
the Owners' accumulation values or annuity unit values following the
Substitution.
    10. Owners will not incur any fees or charges as a result of the
Substitution, nor will the rights of Owners or obligations of AIG
SunAmerica under the Contract be altered in any way. The proposed
Substitution will not have any adverse tax consequences to Owners. The
proposed Substitution will not cause Contract fees and charges
currently being paid by existing Owners to be greater after the
proposed Substitution than before the proposed Substitution. The
proposed Substitution will not be treated as a transfer for the purpose
of transfer limits or assessing transfer charges.
    11. AIG SunAmerica will schedule the Substitution to occur after
issuance of the requested Order and any required state insurance
department approvals. Further, although the Substitution will result in
the replacement of the Replaced Portfolio as the investment of the
Equity Income Sub-Account under the Contract, AIG SunAmerica will not
exercise any right it may have under the Contract to collect transfer
fees or impose any additional restrictions on Owners who may wish to
make transfers from the Equity Income Sub-Account among the other
available Sub-Accounts for a period of at least thirty (30) days
following mailing of the Notice, as defined below, of the proposed
Substitution (the ``Free Transfer Period''). During the Free Transfer
Period, Owners may transfer all assets, as substituted, from the Equity
Income Sub-Account to other available Sub-Accounts without charge or
limitation and without those transfers being counted against any limit
on free transfers under the Contract, or any requirements for the
method of submitting transfer requests.
    12. Upon filing the application, AIG SunAmerica supplemented the
prospectus for the Contract to reflect the proposed Substitution.
Within five days after the Substitution, AIG SunAmerica will send to
its Owners written notice of the Substitution (``Notice'') identifying
the shares of the Replaced Portfolio that have been eliminated and the
shares of the Replacement Portfolio that have been substituted. AIG
SunAmerica will include in the mailing the applicable prospectus
supplement for the Contract describing the Substitution. AIG SunAmerica
will also mail a copy of the prospectus for the Replacement Portfolio
to Owners who have not already received a copy of that prospectus in
the ordinary course. The Notice will further advise Owners that during
the Free Transfer Period, Owners may transfer all assets, as
substituted, from the Equity Income Sub-Account to the other available
Sub-Accounts without limit or charge and without those transfers being
counted against any limit on free transfers under their Contracts, or
any requirements for the method of submitting transfer requests.

Applicant's Legal Analysis

    1. Section 26(c) of the 1940 Act provides that ``[i]t shall be
unlawful for any depositor or trustee of a registered unit investment
trust holding the

security of a single issuer to substitute another security for such
security unless the [SEC] shall have approved such substitution.''
    2. Applicants represent that the proposed Substitution involves a
substitution of securities within the meaning of section 26(c) of the
1940 Act. The Applicants, therefore, request an order from the SEC
pursuant to section 26(c) approving the proposed Substitution.
    3. Applicants submit that the Substitution does not present the
type of costly forced redemption or other harms that section 26(c) was
intended to guard against and is consistent with the protection of
investors and the purposes fairly intended by the 1940 Act for the
following reasons: (i) The Substitution will continue to fulfill
Owners' objectives and risk expectations, because the Replacement
Portfolio has substantially similar objectives, policies, and
restrictions to the objectives, policies, and restrictions of the
Replaced Portfolio and comparable risk characteristics; (ii) after
mailing of the Notice informing an Owner of the Substitution, an Owner
may request that his or her assets in the Equity Income Sub-Account be
reallocated among the other available Sub-Accounts at any time during
the Free Transfer Period without any limit or charge and without those
transfers being counted against any limit on free transfers under the
Contract, or any requirements for the method of submitting transfer
requests. This right also will be granted to Owners, if any, who are
receiving variable payments based on the Replaced Portfolio. The Free
Transfer Period provides sufficient time for Owners to consider and
effect their reinvestment and withdrawal options; (iii) the
Substitution will be at net asset value of the respective shares
determined on the date of the Substitution in accordance with section
22 of the 1940 Act and Rule 22c-1 thereunder, without the imposition of
any transfer or similar charge; (iv) AIG SunAmerica has undertaken to
assume all expenses and transaction costs, including, but not limited
to, legal and accounting fees and any brokerage commissions, in
connection with the Substitution; (v) the Substitution will in no way
alter the contractual obligations of AIG SunAmerica or the rights and
privileges of Owners under the Contract; (vi) the Substitution will in
no way alter the tax treatment of Owners in connection with their
Contracts, and no tax liability will arise for Owners as a result of
the Substitution; (vii) the Substitution is expected to confer certain
future economic benefits on Owners by virtue of the greater asset base
or lower portfolio expenses; (viii) at the time of the Substitution,
the total annual expenses of the Replacement Portfolio's shares are
expected to be lower than the Replaced Portfolio; (ix) the Substitution
which will be effected in accordance with section 22 of the 1940 Act
and Rule 22c-1 thereunder by redeeming shares of the Replaced Portfolio
in cash to be conveyed immediately to the Replacement Portfolio to
purchase its respective shares; and (x) AIG SunAmerica represents that
at no time after date of the Substitution (the ``Substitution Date'')
will AIG SunAmerica increase Contract charges or total Separate Account
charges (net of any waiver or reimbursements) of the Sub-Account that
currently invests in the Replacement Portfolio (the ``Davis Sub-
Account''). If the total operating expenses for the Replacement
Portfolio (taking into account any expense waiver or reimbursement) for
any fiscal quarter following the Substitution Date, exceed on an
annualized basis the net expense ratio for the Replaced Portfolio for
the fiscal year ended January 31, 2006, AIG SunAmerica will reduce
(through reimbursement) the Separate Account expenses paid during that
quarter of the Davis Sub-Account to the extent necessary to offset the
amount by which the Replacement Portfolio's net expense ratio for such
period exceeds, on an annualized basis, 1.35%.
    4. AIG SunAmerica has determined that the Replacement Portfolio is
an appropriate replacement for the Replaced Portfolio. The Replacement
Portfolio has investment objectives, policies, and restrictions
substantially similar to the Replaced Portfolio with comparable levels
of risk. The Replacement Portfolio has a significantly lower total
expense ratio than the Replacement Portfolio. Also, the Replacement
Portfolio has a significantly larger asset base than the Replacement
Portfolio. In addition, the average annual total returns of the
Replacement Portfolio are clearly superior to those of the Replacement
Portfolio, other than with respect to the year to date performance.

Conclusion

    For the reasons set forth in the application, the Applicants state
that the proposed Substitution and the related transactions meet the
standards of section 26(c) of the 1940 Act and that the requested Order
should be granted.

    For the Commission, by the Division of Investment Management,
pursuant to delegated authority.
Nancy M. Morris,
Secretary.
 [FR Doc. E6-18349 Filed 10-31-06; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register: August 29, 2006 (Volume 71, Number 167)]
[Notices]
[Page 51237-51238]
[DOCID:fr29au06-87]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Filings and Information Services, Washington, DC
20549.

Extension:
    Rule 17g-1; SEC File No. 270-208; OMB Control No. 3235-0213.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520), the Securities and Exchange
Commission (the ``Commission'') has submitted to the Office of
Management and Budget (``OMB'') a request for extension of the
previously approved collection of information discussed below.
    Rule 17g-1 (17 CFR 270.17g-1) under the Investment Company Act of
1940 (the ``Act'') (15 U.S.C. 80a-17(g)) governs the fidelity bonding
of officers and employees of registered management investment companies
(``funds'') and their advisers. Rule 17g-1 requires, in part, the
following:

Independent Directors' Approval

    The form and amount of the fidelity bond must be approved by a
majority of the fund's independent directors at least once annually,
and the amount of any premium paid by the fund for any ``joint insured
bond,'' covering multiple funds or certain affiliates, must be approved
by a majority of the fund's independent directors.

Terms and Provisions of the Bond

    The amount of the bond may not be less than the minimum amounts of
coverage set forth in a schedule based on the fund's gross assets; the
bond must provide that it shall not be cancelled, terminated, or
modified except upon 60-days written notice to the affected party and
to the Commission; in the case of a joint insured bond, 60-days written
notice must also be given to each fund covered by the bond; a joint
insured bond must provide that the fidelity insurance company will
provide all funds covered by the bond with a copy of the agreement, a
copy of any claim on the bond, and notification of the terms of the
settlement of any claim prior to execution of that settlement; and a
fund that is insured by a joint bond must enter into an agreement with
all other parties insured by the joint bond regarding recovery under
the bond.

Filings With the Commission

    Upon the execution of a fidelity bond or any amendment thereto, a
fund must file with the Commission within 10 days a copy of the
executed bond or any amendment to the bond, the independent directors'
resolution approving the bond, and a statement as to the period for
which premiums have been paid on the bond. In the case of a joint
insured bond, a fund must also file (i) A statement showing the amount
the fund would have been required to maintain under the rule if it were
insured under a single insured bond and (ii) the agreement between the
fund and all other insured parties regarding recovery under the bond. A
fund must also notify the Commission in writing within five days of any
claim or settlement on a claim under the fidelity bond.

Notices to Directors

    A fund must notify by registered mail each member of its board of
directors of (i) Any cancellation, termination, or modification of the
fidelity bond at least 45 days prior to the effective date, and (ii)
the filing or settlement of any claim under the fidelity bond when
notification is filed with the Commission.
    Rule 17g-1's independent directors' annual review requirements,
fidelity bond content requirements, joint bond agreement requirement
and the required notices to directors are designed to ensure the safety
of fund assets against losses due to the conduct of persons who may
obtain access to those assets. These requirements also facilitate
oversight of a fund's fidelity bond. The rule's required filings with
the Commission are designed to assist the Commission in monitoring
funds' compliance with the fidelity bond requirements.
    The Commission staff estimates that approximately 4033 funds are
subject to the requirements of Rule 17g-1, and that on average a fund
spends approximately one hour per year complying with the rule's
paperwork requirements. The Commission staff therefore estimates the
total annual burden of the rule's paperwork requirements to be 4033
hours.
    These estimates of average burden hours are made solely for the
purposes of the Paperwork Reduction Act. These

estimates are not derived from a comprehensive or even a representative
survey or study of Commission rules. The collection of information
required by Rule 17g-1 is mandatory and will not be kept confidential.
An agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid control number.
    General comments regarding the above information should be directed
to the following persons: (i) Desk Officer for the Securities and
Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503 or e-mail to<EMAIL_ADDRESS>
and (ii) R. Corey Booth, Director/Chief Information Officer, Securities
and Exchange Commission, C/O Shirley Martinson, 6432 General Green Way,
Alexandria, Virginia 22312, or send an e-mail to<EMAIL_ADDRESS>
Comments must be submitted to OMB within 30 days of this notice.

    Dated: August 20, 2006.
Nancy M. Morris,
Secretary.
[FR Doc. E6-14298 Filed 8-28-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 76, Number 31 (Tuesday, February 15, 2011)]
[Rules and Regulations]
[Pages 8618-8620]
[FR Doc No: 2011-2823]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-1038; Directorate Identifier 2009-NM-250-AD;
Amendment 39-16601; AD 2011-04-01]
RIN 2120-AA64

Airworthiness Directives; Fokker Services B.V. Model F.28 Mark
0070 and 0100 Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above. This AD results from mandatory continuing
airworthiness information (MCAI) originated by an aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as:

    During a normal walkaround check on a F28 Mark 0100 aeroplane, a
large crack was discovered in the lower portion of the right (RH)
MLG [main landing gear] piston. The affected MLG unit had
accumulated 7909 flight cycles (FC) at the time of detection. * * *
    This condition, if not detected and corrected, could lead to MLG
failure, possibly resulting in loss of control of the aeroplane
during the landing roll-out.

We are issuing this AD to require actions to correct the unsafe
condition on these products.

DATES: This AD becomes effective March 22, 2011.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of March 22,
2011.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC.

FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone 425-
227-1137; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on October 21, 2010 (75
FR 64963). That NPRM proposed to correct an unsafe condition for the
specified products. The MCAI states:

    During a normal walkaround check on a F28 Mark 0100 aeroplane, a
large crack was discovered in the lower portion of the right (RH)
MLG [main landing gear] piston. The affected MLG unit had
accumulated 7909 flight cycles (FC) at the time of detection. The
piston has been sent to Goodrich, the landing gear manufacturer, for
detailed investigation.
    This condition, if not detected and corrected, could lead to MLG
failure, possibly resulting in loss of control of the aeroplane
during the landing roll-out.
    For the reasons described above, this AD requires a one-time
detailed visual inspection of the MLG pistons, the replacement of
any MLG pistons on which cracks are detected, and the reporting of
all findings to the aeroplane TC [type certificate] holder. The
inspection results, in combination with the findings of the crack/
metallurgical investigation of the cracked piston by Goodrich, will
be used to determine the necessity of additional and/or more
detailed inspections, or any other corrective action. This AD is
considered an interim measure, and further action is likely to
follow.

You may obtain further information by examining the MCAI in the AD
docket.

Comments

    We gave the public the opportunity to participate in developing
this AD. We considered the comment received.

Request To Update Reference to MCAI

    The European Aviation Safety Agency (EASA) requested that we update
the NPRM to refer to EASA AD 2009-0221R1, dated June 30, 2010. This
EASA AD corrects a typographical error, which was the source of a
difference between the FAA NPRM and the EASA AD.
    We agree with the EASA's request to update this final rule to refer
to the latest EASA AD. We have also revised Note 1 of the final rule to
state that there are no differences between the EASA AD and the FAA AD.

Conclusion

    We reviewed the available data, including the comment received, and
determined that air safety and the

public interest require adopting the AD with the changes described
previously. We determined that these changes will not increase the
economic burden on any operator or increase the scope of the AD.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have required different actions in this AD from those
in the MCAI in order to follow our FAA policies. Any such differences
are highlighted in a Note within the AD.

Costs of Compliance

    We estimate that this AD will affect 6 products of U.S. registry.
We also estimate that it will take about 3 work-hours per product to
comply with the basic requirements of this AD. The average labor rate
is $85 per work-hour. Based on these figures, we estimate the cost of
this AD to the U.S. operators to be $1,530 or $255 per product.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains the NPRM, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Operations office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2011-04-01 Fokker Services, B.V.: Amendment 39-16601. Docket No.
FAA-2010-1038; Directorate Identifier 20009-NM-250-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective March
22, 2011.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Fokker Services B.V. Model F.28 Mark 0070
and 0100 airplanes, certificated in any category, equipped with
Goodrich (formerly Menasco, Colt Industries) main landing gear (MLG)
units having part number (P/N) 41050-7, 41050-8, 41050-9, 41050-10,
41050-11, 41050-12, 41050-13, 41050-14, 41050-15, 41050-16, 41060-1,
41060-2, 41060-3, 41060-4, 41060-5, or 41060-6.

Subject

    (d) Air Transport Association (ATA) of America Code 32: Landing
gear.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:

    During a normal walkaround check on a F28 Mark 0100 aeroplane, a
large crack was discovered in the lower portion of the right (RH)
MLG piston. The affected MLG unit had accumulated 7909 flight cycles
(FC) at the time of detection. The piston has been sent to Goodrich,
the landing gear manufacturer, for detailed investigation.
    This condition, if not detected and corrected, could lead to MLG
failure, possibly resulting in loss of control of the aeroplane
during the landing roll-out.
    For the reasons described above, this AD requires a one-time
detailed visual inspection of the MLG pistons, the replacement of
any MLG pistons on which cracks are detected, and the reporting of
all findings to the aeroplane TC [type certificate] holder. The
inspection results, in combination with the findings of the crack/
metallurgical investigation of the cracked piston by Goodrich, will
be used to determine the necessity of additional and/or more
detailed inspections, or any other corrective action. This AD is
considered an interim measure, and further action is likely to
follow.

Compliance

    (f) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Inspection

    (g) Within 30 days after the effective day of this AD, do a
detailed visual inspection for cracks of the MLG pistons, in
accordance with the Accomplishment Instructions of Fokker Service
Bulletin SBF100-32-158, dated October 2, 2009.
    (h) If any cracked MLG piston is found during the inspection
required by paragraph (g) of this AD, before further flight replace
the affected piston with a serviceable part, in accordance with the
Accomplishment Instructions of Fokker Service Bulletin SBF100-32-
158, dated October 2, 2009.
    (i) At the applicable time specified in paragraph (i)(1) or
(i)(2) of this AD, report the inspection results (including no
findings) to Fokker Services B.V. by using the Questionnaire
provided in Fokker Service Bulletin SBF100-32-158, dated October 2,
2009.
    (1) If the inspection was done on or after the effective date of
this AD: Submit the report within 30 days after the inspection.
    (2) If the inspection was done before the effective date of this
AD: Submit the report within 30 days after the effective date of
this AD.

FAA AD Differences

    Note 1:  This AD differs from the MCAI and/or service
information as follows: No differences.

Other FAA AD Provisions

    (j) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. Send information to ATTN: Tom Rodriguez, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone 425-
227-1137; fax<PHONE_NUMBER>. Before using any approved AMOC, notify
your appropriate principal inspector, or lacking a principal
inspector, the manager of the local flight standards district
office/certificate holding district office. The AMOC approval letter
must specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: A federal agency may not conduct or
sponsor, and a person is not required to respond to, nor shall a
person be subject to a penalty for failure to comply with a
collection of information subject to the requirements of the
Paperwork Reduction Act unless that collection of information
displays a current valid OMB Control Number. The OMB Control Number
for this information collection is 2120-0056. Public reporting for
this collection of information is estimated to be approximately 5
minutes per response, including the time for reviewing instructions,
completing and reviewing the collection of information. All
responses to this collection of information are mandatory. Comments
concerning the accuracy of this burden and suggestions for reducing
the burden should be directed to the FAA at: 800 Independence Ave.,
SW., Washington, DC 20591, Attn: Information Collection Clearance
Officer, AES-200.

Related Information

    (k) For related information, refer to MCAI European Aviation
Safety Agency Airworthiness Directive 2009-0221R1, dated June 30,
2010; and Fokker Service Bulletin SBF100-32-158, dated October 2,
2009.

Material Incorporated by Reference

    (l) You must use Fokker Service Bulletin SBF100-32-158, dated
October 2, 2009, to do the actions required by this AD, unless the
AD specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Fokker Services B.V., Technical Services Dept., P.O. Box 231, 2150
AE Nieuw-Vennep, the Netherlands; telephone +31 (0)252-627-350; fax
+31 (0)252-627-211; e-mail
<EMAIL_ADDRESS>Internet http://www.myfokkerfleet.com.
    (3) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.
    (4) You may also review copies of the service information that
is incorporated by reference at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

    Issued in Renton, Washington, on January 31, 2011.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2011-2823 Filed 2-14-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 108 (Monday, June 6, 2016)]
[Notices]
[Pages 36310-36312]
[FR Doc No: 2016-13224]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0797]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Human Tissue Intended for Transplantation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
requirements relating to FDA regulations for human tissue intended for
transplantation.

DATES: Submit either electronic or written comments on the collection
of information by August 5, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to

the docket unchanged. Because your comment will be made public, you are
solely responsible for ensuring that your comment does not include any
confidential information that you or a third party may not wish to be
posted, such as medical information, your or anyone else's Social
Security number, or confidential business information, such as a
manufacturing process. Please note that if you include your name,
contact information, or other information that identifies you in the
body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2013-N-0797 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Human Tissue Intended for
Transplantation.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at http://www.regulations.gov or at the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Human Tissue Intended for Transplantation--21 CFR Part 1270 (OMB
Control Number 0910-0302)--Extension

    Under section 361 of the Public Health Services Act (42 U.S.C.
264), FDA issued regulations under part 1270 (21 CFR part 1270) to
prevent the transmission of human immunodeficiency virus, hepatitis B,
and hepatitis C, through the use of human tissue for transplantation.
The regulations provide for inspection by FDA of persons and tissue
establishments engaged in the recovery, screening, testing, processing,
storage, or distribution of human tissue. These facilities are required
to meet provisions intended to ensure appropriate screening and testing
of human tissue donors and to ensure that records are kept documenting
that the appropriate screening and testing have been completed.
    Section 1270.31(a) through (d) requires written procedures to be
prepared and followed for the following steps: (1) All significant
steps in the infectious disease testing process under Sec.  1270.21;
(2) all significant steps for obtaining, reviewing, and assessing the
relevant medical records of the donor as prescribed in Sec.  1270.21;
(3) designating and identifying quarantined tissue; and (4) for
prevention of infectious disease contamination or cross-contamination
by tissue during processing. Sections 1270.31(a) and (b) also requires
recording and justification of any deviation from the written
procedures. Section 1270.33(a) requires records to be maintained
concurrently with the performance of each significant step required in
the performance of infectious disease screening and testing of human
tissue donors. Section 1270.33(f) requires records to be retained
regarding the determination of the suitability of the donors and of the
records required under Sec.  1270.21. Section 1270.33(h) requires all
records to be retained for at least 10 years beyond the date of
transplantation if

known, distribution, disposition, or expiration of the tissue,
whichever is the latest. Section 1270.35(a) through (d) requires
specific records to be maintained to document the following: (1) The
results and interpretation of all required infectious disease tests;
(2) information on the identity and relevant medical records of the
donor; (3) the receipt and/or distribution of human tissue, and (4) the
destruction or other disposition of human tissue.
    Respondents to this collection of information are manufacturers of
human tissue intended for transplantation. Based on information from
the Center for Biologics Evaluation and Research's (CBER's) database
system, FDA estimates that there are approximately 383 tissue
establishments of which 262 are conventional tissue banks and 121 are
eye tissue banks. Based on information provided by industry, there are
an estimated total of 2,141,960 conventional tissue products and
130,987 eye tissue products distributed per year with an average of 25
percent of the tissue discarded due to unsuitability for transplant. In
addition, there are an estimated 29,799 deceased donors of conventional
tissue and 70,027 deceased donors of eye tissue each year.
    Accredited members of the American Association of Tissue Banks
(AATB) and Eye Bank Association of America (EBAA) adhere to standards
of those organizations that are comparable to the recordkeeping
requirements in part 1270. Based on information provided by CBER's
database system, 90 percent of the conventional tissue banks are
members of AATB (262 x 90% = 236), and 95 percent of eye tissue banks
are members of EBAA (121 x 95% = 115). Therefore, recordkeeping by
these 351 establishments (236 + 115 = 351) is excluded from the burden
estimates as usual and customary business activities (5 CFR
1320.3(b)(2)). The recordkeeping burden, thus, is estimated for the
remaining 32 establishments, which is 8.36 percent of all
establishments (383 - 351 = 32, or 32/383 = 8.36%).
    FDA assumes that all current tissue establishments have developed
written procedures in compliance with part 1270. Therefore, their
information collection burden is for the general review and update of
written procedures estimated to take an annual average of 24 hours, and
for the recording and justifying of any deviations from the written
procedures under Sec.  1270.31(a) and (b), estimated to take an annual
average of 1 hour. The information collection burden for maintaining
records concurrently with the performance of each significant screening
and testing step and for retaining records for 10 years under Sec.
1270.33(a), (f), and (h) include documenting the results and
interpretation of all required infectious disease tests and results and
the identity and relevant medical records of the donor required under
Sec.  1270.35(a) and (b). Therefore, the burden under these provisions
is calculated together in table 1 of this document. The recordkeeping
estimates for the number of total annual records and hours per record
are based on information provided by industry and FDA experience.
    FDA estimates the burden of this information collection as follows:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
         21 CFR Section              Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
1270.31(a), (b), (c), and (d)                 32               1              32              24             768
 \2\............................
1270.31(a) and 1270.31(b) \3\...              32               2              64               1              64
1270.33(a), (f), and (h), and                 32        6,198.84         198,363             1.0         198,363
 1270.35(a) and (b).............
1270.35(c)......................              32       11,876.12         380,036             1.0         380,036
1270.35(d)......................              32        1,454.50          47,504             1.0          47,504
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         626,735
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Review and update of standard operating procedures (SOPs).
\3\ Documentation of deviations from SOPs.

    Dated: May 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-13224 Filed 6-3-16; 8:45 am]
 BILLING CODE 4164-01-P


Dermal Sensitization Testing of Dermal Sensitization Testing of Chromium Chromium Timothy F. McMahon, Ph. D.

Timothy F. McMahon, Ph. D.

U. S. EPA U. S. EPA Office of Pesticide Programs Office of Pesticide Programs May 2, 2006 May 2, 2006 2 Outline of Presentation Outline of Presentation  Allergic Contact Dermatitis ( ACD)

  Regulatory framework   Science background  SAP Review  Nethercott et al. study 3 DERMAL SENSITIZATION DERMAL SENSITIZATION CURRENT CURRENT APPROACHES APPROACHES USEPA, § 40 CFR 798.4100:

 " Information derived from tests for skin sensitization serves to identify the possible hazard to a population repeatedly exposed to a test substance." 4 DERMAL SENSITIZATION DERMAL SENSITIZATION CURRENT CURRENT APPROACHES APPROACHES Treated Articles ( § 40 CFR 152.25)

A registered pesticide is incorporated into an article to protect the integrity of the article or substance itself

Treated articles such as treated wood do not bear pesticide labels or other information to inform the public about potential hazards, including dermal sensitization 5 Allergic Contact Dermatitis ( ACD)

Allergic Contact Dermatitis ( ACD)

Contact Hypersensitivity

Contact Allergy 6 Allergic Contact Dermatitis ( ACD)

Allergic Contact Dermatitis ( ACD)

Delayed Contact Hypersensitivity:

   A delayed, immunologically mediated inflammatory skin disease consisting of various degrees of erythema,

edema, and vesiculation.  ( Marzulli and Maibach, 1996)

   Stimulation by chemical allergen ( in an inherently susceptible individual) of an immune response of the quality and vigor required to permit the provocation of an elicitation reaction upon subsequent encounter with the same chemical.  ( Kimber, 2004) 7 Allergic Contact Dermatitis ( ACD)

Allergic Contact Dermatitis ( ACD)

Characterized by two phases:

Induction:

 Exposure of sufficient magnitude and/ or duration to activate specific immune mechanisms resulting in the acquisition of sensitization

Elicitation/ challenge :

 Responses induced in sensitized individuals upon exposure to the allergen by a relevant route 8 Dermal Irritation vs. ACD Dermal Irritation vs. ACD ACD ACD

Edema

Erythema

Reaction time: 24   72 hrs

No response on 1st exposure

Requires immune memory Irritation Irritation

Erythema

Edema

Reaction time:

immediate

Response on 1st exposure

No immune memory 9 INDUCTION ELICITATION LOW MOLECULAR WT ALLERGEN MIGRATION TO LOCAL LYMPH NODE IL 1  , IL 6, IL 12 IL 1  , TNF

 , GM CSF T CELL LYMPHOCYTE PROLIFERATION ICAM 1 LANGERHANS CELL ( LC) " PRIMED" LYMPHOCYTES SPECIFIC INFLAMMATORY RESPONSE CYTOKINES,

COSTIMULATORY, ADHESION MOLECULES INCREASE CELLULAR INFLUX EDEMA AND ERYTHEMA Contact Hypersensitivity*

Reprinted with permission from Sailstad, 2003 10 Background Summary Background Summary ACD

Generally recognized as a threshold phenomenon

Thresholds largely determined by the potency of the allergen

Induction/ elicitation thresholds vary among individuals ( Kimber et al., 2003)

Dose response relationships observed for both induction and elicitation ( Scott et al., 2002) 11 Background Summary Cont.

Background Summary Cont.

ACD

Induction may occur after a single exposure to a sufficiently large area of skin, or as a consequence of repeated skin exposures

Some data suggest sensitizing potential may increase with repeated exposures ( Griem et. al., 2003) 12 Independent Science Reviews Independent Science Reviews   May, 2004, scientific issues pertaining to Agency s interest in developing the foundation of a scientifically sound approach to quantitative assessment of dermal sensitization risks for pesticide chemicals presented to FIFRA Scientific Advisory Panel ( SAP)

  Included chemicals incorporated in other materials ( i. e., treated articles)

  Included hexavalent chromium as a case study 13 Hexavalent Hexavalent Chromium Chromium

One of the most common and potent contact sensitizers

Exposures occur in occupational and non occupational settings

Chromium induced ACD evaluated by Nethercott et. al. ( 1994) 14 Hexavalent Hexavalent Chromuim Chromuim

Both animal ( LLNA) and human ( patch test)

data are available on dermal sensitization of hexavalent chromium

SAP cited limitations of LLNA for risk assessment, and deficiencies in other human studies

SAP identified Nethercott et al. study as the critical study 15 Human Testing of Chromium for Dermal Sensitization:

Nethercott et. al. 16 Nethercott Nethercott Human Testing Human Testing

113 possible volunteers selected from examination of 6000 patient files

Ultimately, 102 took part in the study ( 78 men, 24 women)

All study participants believed to be chromium + 6 sensitive based on previous patch tests performed by their physicians 17 Nethercott Nethercott Human Testing Human Testing

Persons taking immunosuppresive or steroidal medications excluded

Written consent provided to participate in study

Medical/ occupational history questionnaire filled out

Information on allergic and atopic dermatitis available for all 102 subjects 18 Nethercott Nethercott et. al et. al.

Concentrations selected based on best estimate of a range from review of open literature where:

Highest dose provided 100% response

Lowest dose elicited < 10% response

Concentrations from 0.018 4.4 µ g/ cm 2 chosen 19 Nethercott Nethercott et. al et. al. Cont.

. Cont.

Three rounds of testing using TRUE test patches

In all rounds, patches applied to the upper sides of the back 7 cm apart

Patches remained in place 48 hours 20 Nethercott Nethercott et. al et. al. cont.

. cont.

Round one:

Patch test with 4.4 ug of Cr+ 6/ cm2

102 subjects to verify sensitization

Those responding positively moved on to round two  54 subjects ( 39 men, 15 women) 21 Nethercott Nethercott et. al. Cont.

et. al. Cont.

Round Two:

Patch test with 0.018 and 0.088 µ g Cr+ 6/ cm2

Those showing positive responses to either 0.018 or both 0.018 and 0.088 Cr+ 6/ cm2 were not tested in round three Round Three:

49 nonresponding subjects ( breakdown by sex not reported)

Tested with Cr+ 6 concentrations of 0.18 and 0.88 µ g/ cm2 22 Nethercott Nethercott et. al. cont.

et. al. cont.

Round one response: 54 positive responses to 4.4 µ g Cr + 6 / cm 2

Round two response: 4/ 54 positive at 0.088 but not 0.018 µ g Cr + 6 / cm 2 . 1/ 54 positive at both 0.088 and 0.018 µ g Cr + 6 / cm 2 . 49 nonresponders

Round three response: 1 positive at both 0.88 and 0.18 µ g Cr + 6 / cm 2 . 22 positive at 0.88 but not 0.18 µ g Cr + 6 / cm 2 . Remainder negative at both concentrations 23 Nethercott Nethercott et. al. cont.

et. al. cont.

Cumulative response showed a 2%

response at the lowest concentration of 0.018 µ g Cr + 6 / cm 2

The 10% MET was calculated as 0.089 µ g Cr + 6 / cm 2 24 Nethercott Nethercott et al. Cumulative Response et al. Cumulative Response 25 Nethercott Nethercott et. al. Cont.

et. al. Cont.

SAP identified Nethercott et al. as best available, based on animal and human data

Panel identified the critical dose as 0.089 µ g/ cm 2

This was considered a conservative level 26 Strengths/ Weaknesses of Strengths/ Weaknesses of Nethercott Nethercott

Strengths:

 Both males and females represented in study  Large pop. of sensitized individuals  Good experimental design w/ several rounds of testing to establish dose response relationship for elicitation  TRUE test patches used; sensitive for metals testing 27

Weaknesses:

 MET value may be conservative based on possibility of misreading irritant vs. allergic reactions Strengths/ Weaknesses of Strengths/ Weaknesses of Nethercott Nethercott 28 Nethercott Nethercott et. al. cont.

et. al. cont.

Agency used SAP recommendation for selection of 10% MET but did not use UF < 1 in deriving the total UF

The Agency has concluded that the Nethercott study contains information sufficient for assessing human risk from potential dermal exposure to chromium 29 Scientific Considerations Scientific Considerations

EPA has identified a study performed with subjects who had documented sensitivity to chromium ( Nethercott, et al., 1994)

The study was conducted to identify a level of exposure to chromium below which dermal exposure did not appear to elicit an ACD response 30 Scientific Considerations Scientific Considerations

The Agency has concluded that the Nethercott study contains information sufficient for assessing human risk resulting from potential dermal exposure to hexavalent chromium

Please comment on whether the Nethercott study is sufficiently sound, from a scientific perspective, to be used to estimate a safe level of dermal exposure to hexavalent chromium


[Federal Register Volume 84, Number 162 (Wednesday, August 21, 2019)]
[Notices]
[Pages 43645-43648]
[FR Doc No: 2019-17995]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2019-0004-N-13]

Proposed Agency Information Collection Activities; Comment
Request

AGENCY: Federal Railroad Administration (FRA), U.S. Department of
Transportation (DOT).

ACTION: Notice of information collection; request for comment.

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

SUMMARY: Under the Paperwork Reduction Act of 1995 (PRA) and its
implementing regulations, FRA seeks approval of the Information
Collection Requests (ICRs) abstracted below. Before submitting these
ICRs to the Office of Management and Budget (OMB) for approval, FRA is
soliciting public

comment on specific aspects of the activities identified below.

DATES: Interested persons are invited to submit comments on or before
October 21, 2019.

ADDRESSES: Submit written comments on the ICRs activities by mail to
either: Ms. Hodan Wells, Information Collection Clearance Officer,
Office of Railroad Safety, Regulatory Analysis Division, Federal
Railroad Administration, 1200 New Jersey Avenue SE, Washington, DC
20590; or Ms. Kim Toone, Information Collection Clearance Officer,
Office of Information Technology, Federal Railroad Administration, 1200
New Jersey Avenue SE, Washington, DC 20590. Commenters requesting FRA
to acknowledge receipt of their respective comments must include a
self-addressed stamped postcard stating, ``Comments on OMB Control
Number 2130-XXXX,'' (the relevant OMB control number for each ICR is
listed below) and should also include the title of the ICR.
Alternatively, comments may be faxed to<PHONE_NUMBER> or<PHONE_NUMBER>,
or emailed to Ms. Wells at<EMAIL_ADDRESS>or Ms. Toone at
<EMAIL_ADDRESS>Please refer to the assigned OMB control number in
any correspondence submitted. FRA will summarize comments received in
response to this notice in a subsequent notice and include them in its
information collection submission to OMB for approval.

FOR FURTHER INFORMATION CONTACT: Ms. Hodan Wells, Information
Collection Clearance Officer, Office of Railroad Safety, Regulatory
Analysis Division, Federal Railroad Administration, 1200 New Jersey
Avenue SE, Washington, DC 20590 (telephone:<PHONE_NUMBER>) or Ms. Kim
Toone, Information Collection Clearance Officer, Office of Information
Technology, Federal Railroad Administration, 1200 New Jersey Avenue SE,
Washington, DC 20590 (telephone:<PHONE_NUMBER>).

SUPPLEMENTARY INFORMATION: The PRA, 44 U.S.C. 3501-3520, and its
implementing regulations, 5 CFR part 1320, require Federal agencies to
provide 60-days' notice to the public to allow comment on information
collection activities before seeking OMB approval of the activities.
See 44 U.S.C. 3506, 3507; 5 CFR 1320.8 through 1320.12. Specifically,
FRA invites interested parties to comment on the following ICRs
regarding: (1) Whether the information collection activities are
necessary for FRA to properly execute its functions, including whether
the activities will have practical utility; (2) the accuracy of FRA's
estimates of the burden of the information collection activities,
including the validity of the methodology and assumptions used to
determine the estimates; (3) ways for FRA to enhance the quality,
utility, and clarity of the information being collected; and (4) ways
for FRA to minimize the burden of information collection activities on
the public, including the use of automated collection techniques or
other forms of information technology. See 44 U.S.C. 3506(c)(2)(A); 5
CFR 1320.8(d)(1).
    FRA believes that soliciting public comment may reduce the
administrative and paperwork burdens associated with the collection of
information that Federal regulations mandate. In summary, FRA reasons
that comments received will advance three objectives: (1) Reduce
reporting burdens; (2) organize information collection requirements in
a ``user-friendly'' format to improve the use of such information; and
(3) accurately assess the resources expended to retrieve and produce
information requested. See 44 U.S.C. 3501.
    The summaries below describe the ICRs that FRA will submit for OMB
clearance as the PRA requires:
    Title: Filing of Dedicated Cars.
    OMB Control Number: 2130-0502.
    Abstract: Title 49 CFR part 215 contains freight car safety
standards, including conditions for freight cars in dedicated service.
``Dedicated service'' means the exclusive assignment of railroad cars
to the transportation of freight between specified points under the
conditions listed in 49 CFR 215.5(d), including stenciling, or
otherwise displaying, in clear legible letters on each side of the car
body, the words ''Dedicated Service.'' The railroad must notify FRA in
writing that the cars are to be operated in dedicated service.
    Type of Request: Extension without change of a currently approved
collection.
    Affected Public: Businesses.
    Form(s): N/A.
    Respondent Universe: 746 railroads.
    Frequency of Submission: On occasion/monthly.
    Reporting Burden:
---------------------------------------------------------------------------

    \1\ Throughout the tables in this document, the dollar
equivalent cost is derived from the Surface Transportation Board's
Full Year Wage A&B data series using the appropriate employee group
hourly wage rate that includes 75-percent overhead charges.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Average time per     Total annual     Total cost
          CFR section            Respondent universe (railroads)       Total annual responses             responses        burden hours   equivalent \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
215.5(d)(6)--Dedicated          746 railroads...................  4 notifications.................  1 hour..............               4            $304
 Service--Notification to FRA.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Total Estimated Annual Responses: 4.
    Total Estimated Annual Burden: 4 hours.
    Total Estimated Annual Burden Hour Dollar Cost Equivalent: $304.

    Title: Rear End Marking Devices.
    OMB Control Number: 2130-0523.
    Abstract: Title 49 CFR part 221 contains requirements for rear end
marking devices. Railroads must give FRA a detailed description of the
type of marking devices used for any locomotive operating singly or for
cars or locomotives operating at the end of a train (trailing end) to
ensure they meet minimum standards for visibility and display.
Specifically, part 221 requires railroads to furnish a certification
that each device has been tested in accordance with current
``Guidelines for Testing of Rear End Marking Devices.'' Additionally,
part 221 requires railroads to furnish detailed test records, which
include the names of testing organizations, description of tests,
number of samples tested, and the test results, to demonstrate
compliance with the performance standard.
    Type of Request: Extension with change (revised estimates) of a
currently approved collection.
    Affected Public: Businesses (railroads).
    Form(s): N/A.
    Respondent Universe: 746 railroads + 24 manufacturers.
    Frequency of Submission: On occasion.
    Reporting Burden:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Average time per     Total annual     Total cost
          CFR section                  Respondent universe             Total annual responses             responses        burden hours     equivalent
--------------------------------------------------------------------------------------------------------------------------------------------------------
221.14 and Appendix A--Marking  746 railroads + 24 manufacturers  2 requests/submissions..........  1 hour..............               2            $152
 Devices, and Procedures for
 Approval of Rear End Marking.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Total Estimated Annual Responses: 2.
    Total Estimated Annual Burden: 2 hours.
    Total Estimated Annual Burden Hour Dollar Cost Equivalent: $152.

    Title: System Safety Program.
    OMB Control Number: 2130-0599.
    Abstract: FRA uses the collection of information to ensure that
commuter and intercity passenger railroads establish and implement
System Safety Programs (SSPs) to improve the safety of their operations
and to ensure compliance with the rule. Each railroad will use its SSP/
SSP Plan to proactively identify and mitigate or eliminate hazards and
the resulting risk on its system at an early stage to reduce the number
of railroad accidents, incidents, and associated injuries, fatalities,
and property damage. A railroad has the flexibility to tailor an SSP to
its specific operations. An SSP will be implemented when FRA approves a
railroad's submitted SSP Plan. Under this information collection, FRA
will audit a railroad's compliance with its SSP Plan. FRA will use the
information to ensure and enforce compliance with this new regulation.
    Type of Request: Extension with change (revised estimates) of a
currently approved collection.
    Affected Public: Businesses (railroads).
    Form(s): N/A.
    Respondent Universe: 33 railroads.
    Frequency of Submission: On occasion/monthly.
    Reporting Burden:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Total annual
      CFR section/subject              Respondent universe             Total annual responses         Average time per     Total annual     dollar cost
                                                                                response         burden hours     equivalent
--------------------------------------------------------------------------------------------------------------------------------------------------------
270.103--System Safety Program  33 railroads....................  9 plans.........................  40 hours............             360         $32,976
 Plan (SSP Plan)--
 Comprehensive written SSP
 Plan that meets all of this
 section's requirements.
    --Records of system safety  33 railroads....................  495 records.....................  15 seconds..........               2             152
     training for employees/
     contractors/others.
    --(q)(1) Performance of     33 railroads....................  33 analyses results.............  20 hours............             660          50,160
     risk-based hazard
     analyses and furnishing
     of RR results of risk-
     based hazard analyses
     upon request of FRA/
     participating part 212
     States.
    --(q)(2) Identification     33 railroads....................  33 mitigation methods             10 hours............             330          25,080
     and implementation of                                         descriptions.
     risk mitigation methods
     and furnishing of
     descriptions of RR's
     specific risk mitigation
     methods that address
     hazards upon request of
     FRA/participating part
     212 States.
    --(r)(1) Performance of     33 railroads....................  33 results of technology          10 hours............             330          25,080
     technology analysis and                                       analysis.
     furnishing of results of
     railroad's technology
     analysis upon request of
     FRA/participating part
     212 States.
270.107(a)--Consultation        33 railroads....................  11 consults (w/labor union        1 hour..............              11             836
 requirements--RR consultation                                     reps.).
 with its directly affected
 employees on SSP Plan.
    --(a)(3)(ii) RR             33 railroads....................  11 notices......................  30 minutes..........               6             456
     notification to directly
     affected employees of
     preliminary meeting at
     least 60 days before
     being held.
    --(b) RR consultation       33 railroads....................  11 statements...................  1 hour..............              11             836
     statements that includes
     service list with name &
     contact information for
     labor organization
     chairpersons & non-union
     employees who
     participated in process.
    --Copies of consultations   33 railroads....................  11 copies.......................  1 minute............             .18              14
     statements by RR to
     service list individuals.
270.201(b)--SSP Plan found      33 railroads....................  4 amended plans.................  30 hours............             120           9,120
 deficient by FRA and
 requiring amendment.
    --Review of amended SSP     33 railroads....................  1 further amended plan..........  20 hours............              20           1,520
     Plan found deficient and
     requiring further
     amendment.
    --Reopened review of        33 railroads....................  1 amended plan..................  30 hours............              30           2,280
     initial SSP Plan approval
     for cause stated.
270.203--Retention of SSP       33 railroads....................  15 copies.......................  10 minutes..........               3             228
 Plans--Retained copies of SSP
 Plans.
270.303--Annual internal SSP    33 railroads....................  16 evaluations/reports..........  2 hours.............              32           2,432
 assessments/reports conducted
 by RRs.
    --Certification of results  33 railroads....................  33 certification statements.....  2 hours.............              66           7,590
     of RR internal assessment
     by chief safety official.
270.305--External safety        33 railroads....................  6 plans.........................  12 hours............              72           8,280
 audit--RR submission of
 improvement plans in response
 to results of FRA audit.
    --Improvement plans found   33 railroads....................  2 amended plans.................  10 hours............              20           1,520
     deficient by FRA and
     requiring amendment.
    --RR status report to FRA   33 railroads....................  2 reports.......................  4 hours.............               8             608
     of implementation of
     improvements set forth in
     the improvement plan.
Appendix B--Additional          33 railroads....................  4 documents.....................  15 minutes..........               1              76
 documents provided to FRA
 upon request.

Appendix C--Written requests    33 railroads....................  7 written requests..............  15 minutes..........               2             152
 by RRs to file required
 submissions electronically.
                               -------------------------------------------------------------------------------------------------------------------------
    Totals....................  33 railroads....................  738 replies/responses...........  N/A.................           2,084         169,396
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Total Estimated Annual Responses: 738.
    Total Estimated Annual Burden: 2,084 hours.
    Total Estimated Annual Burden Hour Dollar Cost Equivalent:
$169,396.
    Under 44 U.S.C. 3507(a) and 5 CFR 1320.5(b) and 1320.8(b)(3)(vi),
FRA informs all interested parties that it may not conduct or sponsor,
and a respondent is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.

    Authority: 44 U.S.C. 3501-3520.

Brett A. Jortland,
Acting Chief Counsel.
[FR Doc. 2019-17995 Filed 8-20-19; 8:45 am]
 BILLING CODE 4910-06-P


[Federal Register Volume 81, Number 52 (Thursday, March 17, 2016)]
[Notices]
[Pages 14448-14449]
[FR Doc No: 2016-05959]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]

Endocrinologic and Metabolic Drugs Advisory Committee; 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: Endocrinologic and Metabolic Drugs Advisory
Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on May 25, 2016, from 8
a.m. to 5 p.m.
    Location: FDA White Oak Campus, Building 31 Conference Center, the
Great Room (Rm. 1503), 10903 New Hampshire Ave., Silver Spring, MD
20993-0002. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    Contact Person: LaToya Bonner, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, Rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX: 301-847-
8533<EMAIL_ADDRESS>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: The committee will discuss the safety and efficacy of new
drug application (NDA) 208583 for insulin degludec and liraglutide
injection, submitted by Novo Nordisk Inc., for the proposed indication:
Adjunct to diet and exercise to improve glycemic control in the
treatment of adults with type 2 diabetes mellitus.
    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 meeting
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 May
10, 2016. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 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 May 2, 2016. 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 May 3, 2016.
    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 LaToya Bonner 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: March 11, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-05959 Filed 3-16-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: July 29, 2010 (Volume 75, Number 145)]
[Notices]
[Page 44787-44788]
[DOCID:fr29jy10-40]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

 [Docket No. ER10-1810-000]

E.I. du Pont de Nemours and Company; Supplemental Notice That
Initial Market-Based Rate Filing Includes Request for Blanket Section
204 Authorization

July 22, 2010.
    This is a supplemental notice in the above-referenced proceeding of
E. I. du Pont de Nemours and Company's application for market-based
rate authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214). Anyone filing a motion to intervene or protest must serve a
copy of that document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is August 11, 2010.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a

document is added to a subscribed dockets(s). For assistance with any
FERC Online service, please e-mail<EMAIL_ADDRESS>or call
(866) 208-3676 (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2010-18597 Filed 7-28-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 12 (Wednesday, January 20, 2016)]
[Notices]
[Page 3218]
[FR Doc No: 2016-00902]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-76891; File No. SR-BATS-2015-102]

Self-Regulatory Organizations; BATS Exchange, Inc.; Notice of
Designation of Longer Period for Commission Action on a Proposed Rule
Change To Adopt Rule 11.27 Regarding the Data Collection Requirements
of the Tick Size Pilot Program

January 13, 2016.
    On November 13, 2015, BATS Exchange, Inc. (the ``Exchange'' or
``BATS'') 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 adopt Exchange Rule 11.27 to implement the data
collection requirements set forth in the Regulation NMS Plan to
Implement a Tick Size Pilot Program.\3\ The proposed rule change was
published for comment in the Federal Register on December 1, 2015.\4\
The Commission has received one comment letter on the proposal.\5\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 74892 (May 6, 2015),
80 FR 27513 (May 13, 2015) (order approving the Tick Size Pilot)
(``Approval Order'').
    \4\ See Securities Exchange Act Release No. 76524 (November 25,
2015), 80 FR 75141.
    \5\ See Letter from Mary Lou Von Kaenel, Managing Director,
Financial Information Forum, to Robert W. Errett, Deputy Secretary,
Commission, dated December 22, 2015.
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \6\ provides that, within 45 days of
the publication of the notice of the filing of a proposed rule change,
or within such longer period up to 90 days as the Commission may
designate if it finds such longer period to be appropriate and
publishes its reasons for so finding or as to which the self-regulatory
organization consents, the Commission shall either approve the proposed
rule change, disapprove the proposed rule change, or institute
proceedings to determine whether the proposed rule change should be
disapproved. The 45th day for this filing is January 15, 2016.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission is extending this 45-day time period. The Commission
finds that it is appropriate to designate a longer period within which
to take action on the proposed rule change so that it has sufficient
time to consider the proposal.
    Accordingly, pursuant to section 19(b)(2) of the Act,\7\ the
Commission designates February 29, 2016, as the date by which the
Commission should either approve or disapprove or institute proceedings
to determine whether to disapprove the proposed rule change (File No.
SR-BATS-2015-102).
---------------------------------------------------------------------------

    \7\ Id.
    \8\ 17 CFR 200.30-3(a)(31).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
Robert W. Errett.
 Deputy Secretary.
[FR Doc. 2016-00902 Filed 1-19-16; 8:45 am]
 BILLING CODE 8011-01-P