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Federal Register / Vol. 74, No. 231 / Thursday, December 3, 2009 / Notices

FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
agency withdraws or suspends approval
of the drug’s NDA or ANDA for reasons
of safety or effectiveness, or if FDA
determines that the listed drug was
withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
Under § 314.161(a)(1) (21 CFR
314.161(a)(1)), the agency must
determine whether a listed drug was
withdrawn from sale for reasons of
safety or effectiveness before an ANDA
that refers to that listed drug may be
approved. FDA may not approve an
ANDA that does not refer to a listed
drug.
Schiff & Co. submitted a citizen
petition dated October 16, 2008 (Docket
No. FDA–2008–P–0560), under 21 CFR
10.30, requesting that the agency
determine whether MESANTOIN
(mephenytoin) Tablets, 100 mg, was
withdrawn from sale for reasons of
safety or effectiveness. MESANTOIN
(mephenytoin) Tablets, 100 mg, is the
subject of NDA 6–008, held by Novartis
and initially approved on October 23,
1946. MESANTOIN is indicated to
control grand mal, local, Jacksonian,
and psychomotor seizures in patients
who have been refractory to less toxic
anticonvulsants. In a letter dated
January 13, 2000, Novartis notified FDA
that MESANTOIN (mephenytoin)
Tablets, 100 mg, was being discontinued
and FDA moved the drug product to the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
FDA has reviewed its records and,
under § 314.161, has determined that
MESANTOIN (mephenytoin) Tablets,
100 mg, was not withdrawn from sale
for reasons of safety or effectiveness.
The petitioner identified no data or
other information suggesting that
MESANTOIN (mephenytoin) Tablets,
100 mg, was withdrawn for reasons of
safety or effectiveness. FDA has
independently evaluated relevant
literature and data for possible
postmarketing adverse events and has
found no information that would
indicate that this product was
withdrawn from sale for reasons of
safety or effectiveness. Accordingly, the
agency will continue to list
MESANTOIN (mephenytoin) Tablets,
100 mg, in the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ delineates, among other items,
drug products that have been
discontinued from marketing for reasons
other than safety or effectiveness.

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ANDAs that refer to MESANTOIN
(mephenytoin) Tablets, 100 mg, may be
approved by the agency if all other legal
and regulatory requirements for the
approval of ANDAs are met. If FDA
determines that labeling for this drug
product should be revised to meet
current standards, the agency will
advise ANDA applicants to submit such
labeling.
Dated: November 30, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–28872 Filed 12–2–09; 8:45 am]
BILLING CODE 4160–01–S

DEPARTMENT OF HOMELAND
SECURITY
[Docket No. DHS–2009–0138]

Homeland Security Advisory Council
AGENCY:

The Office of Policy, DHS.

ACTION: Notice of Cancellation of the
Homeland Security Advisory Council
Federal Advisory Committee Meeting.
SUMMARY: The meeting of the Homeland
Security Advisory Council, scheduled
for December 4, 2009 from 3 to 4 p.m.
EST is cancelled. Notice of this meeting
was published in the November 10,
2009 Federal Register (Volume 74,
Number 216) at DHS–2009–0138.
FOR FURTHER INFORMATION CONTACT:
Contact the HSAC staff at 202–447–3135
or [email protected].

The HSAC
provides independent advice to the
Secretary of the Department of
Homeland Security to aide in the
creation and implementation of critical
and actionable policies and capabilities
across the spectrum of homeland
security operations. The HSAC
periodically reports, as requested, to the
Secretary, on such matters. Notice of
cancellation of this meeting is given
under the Federal Advisory Committee
Act (FACA), Public Law 92–463, as
amended, 5 U.S.C. App.

SUPPLEMENTARY INFORMATION:

Dated: November 25, 2009.
Becca Sharp,
Executive Director, Homeland Security
Advisory Committee.
[FR Doc. E9–28861 Filed 12–2–09; 8:45 am]
BILLING CODE 9010–9M–P

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DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
Agency Information Collection
Activities: Application-Permit-Special
License Unlading-Lading-Overtime
Services
AGENCY: U.S. Customs and Border
Protection, Department of Homeland
Security.
ACTION: 30-Day notice and request for
comments; Extension of an existing
information collection: 1651–0005.
SUMMARY: U.S. Customs and Border
Protection (CBP) of the Department of
Homeland Security has submitted the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act: Application-PermitSpecial License Unlading-LadingOvertime Services (Form 3171). This is
a proposed extension of an information
collection that was previously
approved. CBP is proposing that this
information collection be extended with
no change to the burden hours. This
document is published to obtain
comments from the public and affected
agencies. This proposed information
collection was previously published in
the Federal Register (74 FR 50811) on
October 1, 2009, allowing for a 60-day
comment period. This notice allows for
an additional 30 days for public
comments. This process is conducted in
accordance with 5 CFR 1320.10.
DATES: Written comments should be
received on or before January 4, 2010.
ADDRESSES: Interested persons are
invited to submit written comments on
the proposed information collection to
the Office of Information and Regulatory
Affairs, Office of Management and
Budget. Comments should be addressed
to the OMB Desk Officer for Customs
and Border Protection, Department of
Homeland Security, and sent via
electronic mail to
[email protected] or faxed
to (202) 395–5806.
SUPPLEMENTARY INFORMATION: U.S.
Customs and Border Protection (CBP)
encourages the general public and
affected Federal agencies to submit
written comments and suggestions on
proposed and/or continuing information
collection requests pursuant to the
Paperwork Reduction Act (Pub. L. 104–
13). Your comments should address one
of the following four points:
(1) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the

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Federal Register / Vol. 74, No. 231 / Thursday, December 3, 2009 / Notices

jlentini on DSKJ8SOYB1PROD with NOTICES

functions of the agency/component,
including whether the information will
have practical utility;
(2) Evaluate the accuracy of the
agencies/components estimate of the
burden of The proposed collection of
information, including the validity of
the methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
collections of information on those who
are to respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
techniques or other forms of
information.
Title: Application-Permit-Special
License Unlading-Lading-Overtime
Services.
OMB Number: 1651–0005.
Form Number: Form 3171.
Abstract: Form 3171 is used by
commercial carriers and importers as a
request for permission to unlade
imported merchandise, baggage, or
passengers, and for overtime services of
CBP officers in connection with lading
or unlading of merchandise, or the entry
or clearance of a vessel.
Current Actions: There are no changes
to the information collection. This
submission is being made to extend the
expiration date.
Type of Review: Extension (without
change).
Affected Public: Businesses.
Estimated Number of Respondents:
1,500.
Estimated Number of Annual
Responses per Respondent: 266.
Estimated Number of Total Annual
Responses: 399,000.
Estimated Time per Response: 8
minutes.
Estimated Total Annual Burden
Hours: 51,870.
If additional information is required
contact: Tracey Denning, U.S. Customs
and Border Protection, Office of
Regulations and Rulings, 799 9th Street,
NW., 7th Floor, Washington, DC 20229–
1177, at 202–325–0265.
Dated: November 27, 2009.
Tracey Denning,
Agency Clearance Officer, U.S. Customs and
Border Protection.
[FR Doc. E9–28854 Filed 12–2–09; 8:45 am]
BILLING CODE 9111–14–P

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DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
[Docket No. FR–5285–N–37]

Notice of Proposed Information
Collection: Comment Request;
Multifamily Default Status Report
AGENCY: Office of the Assistant
Secretary for Housing-Federal Housing
Commissioner, HUD.
ACTION: Notice.
SUMMARY: The proposed information
collection requirement described below
will be submitted to the Office of
Management and Budget (OMB) for
review, as required by the Paperwork
Reduction Act. The Department is
soliciting public comments on the
subject proposal.
DATES: Comments Due Date: February 1,
2010.
ADDRESSES: Interested persons are
invited to submit comments regarding
this proposal. Comments should refer to
the proposal by name and/or OMB
Control Number and should be sent to:
Lillian Deitzer, Departmental Reports
Management Officer, QDAM,
Department of Housing and Urban
Development, 451 7th Street, SW.,
Washington, DC 20410; e-mail
[email protected] or
telephone (202) 402–8048.
FOR FURTHER INFORMATION CONTACT:
Howard Mayfield, Deputy Director,
Office of Multifamily Asset
Management, Department of Housing
and Urban Development, 451 7th Street,
SW., Washington, DC 20410; telephone
(202) 402–2558 (this is not a toll free
number) for copies of the proposed
forms and other available information.
SUPPLEMENTARY INFORMATION: The
Department is submitting the proposed
information collection to OMB for
review, as required by the Paperwork
Reduction Act of 1995 (44 U.S.C.
Chapter 35, as amended).
This Notice is soliciting comments
from members of the public and affected
agencies concerning the proposed
collection of information to: (1) Evaluate
whether the proposed collection is
necessary for the proper performance of
the functions of the agency, including
whether the information will have
practical utility; (2) Evaluate the
accuracy of the agency’s estimate of the
burden of the proposed collection of
information; (3) Enhance the quality,
utility, and clarity of the information to
be collected; and (4) Minimize the
burden of the collection of information
on those who are to respond; including
the use of appropriate automated
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information technology, e.g., permitting
electronic submission of responses.
This Notice also lists the following
information:
Title of Proposal: Multifamily Default
Status Report.
OMB Control Number, if applicable:
2502–0041.
Description of the need for the
information and proposed use:
Mortgagees use this information
collection to notify HUD that a project
owner is more than 30 days past due on
a mortgage payment and to elect to
assign a mortgage to the Department
(per regulations at 24 CFR part 207.256).
To avoid an assignment of mortgage to
HUD, which costs the Government
millions of dollars each year, HUD and
the mortgagor may develop a plan for
reinstating the loan since HUD uses the
information as an early warning
mechanism. HUD Field Office and
Headquarters staff use the data to (a)
monitor mortgagee compliance with
HUD’s loan servicing procedures and
assignments; and (b) avoid mortgage
assignments in the future. This
information is submitted electronically
via the Internet.
Agency form numbers, if applicable:
HUD–92426.
Estimation of the total numbers of
hours needed to prepare the information
collection including number of
respondents, frequency of response, and
hours of response: The number of
burden hours is 1,256. The number of
respondents is 63, the number of
responses is 7,542, the frequency of
response is 120, and the burden hour
per response is 10 minutes.
Status of the proposed information
collection: Extension of a currently
approved collection.
Authority: The Paperwork Reduction Act
of 1995, 44 U.S.C., Chapter 35, as amended.
Dated: November 30, 2009.
Ronald Y. Spraker,
Acting General Deputy Assistant Secretary
for Housing—Federal Housing Commissioner.
[FR Doc. E9–28888 Filed 12–2–09; 8:45 am]
BILLING CODE 4210–67–P

DEPARTMENT OF THE INTERIOR
Office of the Secretary
National Environmental Policy Act
(NEPA) Implementing Procedures
Office of the Secretary, Interior.
Notice of proposed change to
the Departmental Manual; request for
comments.
AGENCY:
ACTION:

SUMMARY: The Department of the
Interior (Department) proposes to

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