30-Day FRN

Federal Register / Vol. 74, No. 163 / Tuesday, August 25, 2009 / Notices
Register of August 11, 2009 (74 FR
40207). The amendment is being made
to reflect a change in the Agenda
portion of the document. There are no
other changes.
FOR FURTHER INFORMATION CONTACT:
Kalyani Bhatt, Center for Drug
Evaluation and Research (HFD–21),
Food and Drug Administration, 5600
Fishers Lane, (for express delivery, 5630
Fishers Lane, rm. 1093), Rockville, MD
20857, 301–827–7001, FAX: 301–827–
6776, e-mail:
Kalyani.Bhatt@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington DC area), codes 3014512529
or 3014512535. Please call the
Information Line for up-to-date
information on this meeting.
SUPPLEMENTARY INFORMATION: In the
Federal Register of August 11, 2009,
FDA announced that a meeting of the
Anesthetic and Life Support Drugs
Advisory Committee and the Drug
Safety and Risk Management Advisory
Committee would be held on September
23, 2009, from 8 a.m. to 4:30 p.m. On
page 40207, in the second column, the
Agenda portion of the document is
changed to read as follows:
Agenda: The committees will discuss
new drug application (NDA) 21–217,
EXALGO (hydromorphone HC1),
Neuromed Pharmaceuticals, Inc., a
modified-release hydromorphone drug
product indicated for the treatment of
moderate-to-severe pain in opioidtolerant patients.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to the advisory committees.
Dated: August 19, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–20377 Filed 8–24–09; 8:45 am]
BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]

Oncologic Drugs Advisory Committee;
Notice of Meeting
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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.

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Name of Committee: Oncologic 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 October 6, 2009, from 8 a.m. to 4 p.m.
Location: Hilton Washington DC North/
Gaithersburg, The Ballrooms, 620 Perry
Pkwy., Gaithersburg, MD. The hotel phone
number is 301–977–8900.
Contact Person: Nicole Vesely, Center for
Drug Evaluation and Research (HFD–21),
Food and Drug Administration, 5600 Fishers
Lane (for express delivery, 5630 Fishers
Lane, rm. 1093), Rockville, MD 20857, 301–
827–6793, FAX: 301–827–6776, e-mail:
nicole.vesely@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–741–
8138 (301–443–0572 in the Washington, DC
area), code 3014512542. Please call the
Information Line for up-to-date information
on this meeting. 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 and call the
appropriate advisory committee hot line/
phone line to learn about possible
modifications before coming to the meeting.
Agenda: The committee will discuss new
drug application (NDA) 021–825, proposed
trade name FERRIPROX (deferiprone) filmcoated tablets and oral solution,
manufactured by ApoPharma Inc. The
proposed indications (uses) for this product
is as an iron chelating agent, which is a drug
that binds with iron in the body and helps
to make elimination of iron easier, reducing
iron build-up. There are two specific
proposed indications (uses) of FERRIPROX:
(1) the treatment of iron overload, or buildup in patients with transfusion-dependent
thalassemia, an inherited blood disorder that
necessitates frequent transfusion of normal
blood which can lead to iron build-up due
to the iron content in the blood a patient
receives; and (2) for the treatment of iron
overload in patients with other transfusiondependent anemias (other blood disorders
that require frequent transfusions) for which
the use of other iron chelating agents has
been considered inappropriate.
FDA intends to make background material
available to the public no later than 2
business days before the meeting. If FDA is
unable to post the background material on its
Web site prior to the meeting, the background
material will be made publicly available at
the location of the advisory committee
meeting, and the background material will be
posted on FDA’s Web site after the meeting.
Background material is available at http://
www.fda.gov/AdvisoryCommittees/Calendar/
default.htm. Scroll down to the appropriate
advisory committee link.
Procedure: Interested persons may present
data, information, or views, orally or in
writing, on issues pending before the
committee. Written submissions may be
made to the contact person on or before
September 21, 2009. Oral presentations from
the public will be scheduled between
approximately 1 p.m. and 2 p.m. Those

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desiring to make 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 September 11,
2009. 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 September 14, 2009.
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 Nicole
Vesely 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/AboutAdvisory
Committees/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: August 19, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–20378 Filed 8–24–09; 8:45 am]
BILLING CODE 4160–01–S

DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
Agency Information Collection
Activities: Crew Member’s Declaration
AGENCY: U.S. Customs and Border
Protection, Department of Homeland
Security.
ACTION: 30–Day notice and request for
comments; Revision of an existing
information collection: 1651–0021.
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: Crew Member’s
Declaration. This is a proposed
extension and revision of an
information collection that was

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Federal Register / Vol. 74, No. 163 / Tuesday, August 25, 2009 / Notices

previously approved. CBP is proposing
that this information collection be
extended with a 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 30103) on June 24, 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 September 24,
2009.
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
oira_submission@omb.eop.gov 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
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: Crew Member’s Declaration.
OMB Number: 1651–0021.
Form Number: Form 5129.
Abstract: The Form 5129 is used to
accept and record importations of
merchandise by crewmembers, and to
enforce agricultural quarantines,
currency reporting laws, and revenue

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collection laws. CBP is proposing to
increase the burden hours for this
collection of information as a result of
increasing the estimated time to fill out
Form 5129 from 3 minutes to 10
minutes.
Current Actions: This submission is
being made to extend the expiration
date with a change to the burden hours.
Type of Review: Revision and
Extension.
Affected Public: Businesses.
Estimated Number of Respondents:
6,000,000.
Estimated Time per Respondent: 10
minutes.
Estimated Total Annual Burden
Hours: 996,000.
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: August 12, 2009.
Tracey Denning,
Agency Clearance Officer, Customs and
Border Protection.
[FR Doc. E9–20425 Filed 8–24–09; 8:45 am]
BILLING CODE 9111–14–P

DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Internal Agency Docket No. FEMA–1854–
DR; Docket ID FEMA–2008–0018]

Iowa; Major Disaster and Related
Determinations
AGENCY: Federal Emergency
Management Agency, DHS.
ACTION: Notice.
SUMMARY: This is a notice of the
Presidential declaration of a major
disaster for the State of Iowa (FEMA–
1854–DR), dated August 13, 2009, and
related determinations.
DATES: Effective Date: August 13, 2009.
FOR FURTHER INFORMATION CONTACT:
Peggy Miller, Disaster Assistance
Directorate, Federal Emergency
Management Agency, 500 C Street, SW.,
Washington, DC 20472, (202) 646–3886.
SUPPLEMENTARY INFORMATION: Notice is
hereby given that, in a letter dated
August 13, 2009, the President issued a
major disaster declaration under the
authority of the Robert T. Stafford
Disaster Relief and Emergency
Assistance Act, 42 U.S.C. 5121 et seq.
(the ‘‘Stafford Act’’), as follows:

I have determined that the damage in
certain areas of the State of Iowa resulting

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from a severe storm on July 10, 2009, is of
sufficient severity and magnitude to warrant
a major disaster declaration under the Robert
T. Stafford Disaster Relief and Emergency
Assistance Act, 42 U.S.C. 5121 et seq. (the
‘‘Stafford Act’’). Therefore, I declare that such
a major disaster exists in the State of Iowa.
In order to provide Federal assistance, you
are hereby authorized to allocate from funds
available for these purposes such amounts as
you find necessary for Federal disaster
assistance and administrative expenses.
You are authorized to provide Public
Assistance in the designated areas, Hazard
Mitigation throughout the State, and any
other forms of assistance under the Stafford
Act that you deem appropriate. Consistent
with the requirement that Federal assistance
is supplemental, any Federal funds provided
under the Stafford Act for Public Assistance
and Hazard Mitigation will be limited to 75
percent of the total eligible costs. If Other
Needs Assistance under Section 408 of the
Stafford Act is later requested and warranted,
Federal funding under that program will also
be limited to 75 percent of the total eligible
costs.
Further, you are authorized to make
changes to this declaration to the extent
allowable under the Stafford Act.

The Federal Emergency Management
Agency (FEMA) hereby gives notice that
pursuant to the authority vested in the
Administrator, under Executive Order
12148, as amended, Michael L. Parker of
FEMA is appointed to act as the Federal
Coordinating Officer for this major
disaster.
The following area of the State of
Iowa has been designated as adversely
affected by this major disaster:
Black Hawk County for Public Assistance.
All counties within the State of Iowa are
eligible to apply for assistance under the
Hazard Mitigation Grant Program.
The following Catalog of Federal Domestic
Assistance Numbers (CFDA) are to be used
for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora
Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034,
Disaster Unemployment Assistance (DUA);
97.046, Fire Management Assistance Grant;
97.048, Disaster Housing Assistance to
Individuals and Households in Presidentially
Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance—
Disaster Housing Operations for Individuals
and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals
and Households—Other Needs; 97.036,
Disaster Grants—Public Assistance
(Presidentially Declared Disasters); 97.039,
Hazard Mitigation Grant.
W. Craig Fugate,
Administrator, Federal Emergency
Management Agency.
[FR Doc. E9–20420 Filed 8–24–09; 8:45 am]
BILLING CODE 9111–23–P

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