Indiana; Amendment No. 7 to Notice of a Major Disaster Declaration, 67875 [E8-27164]
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Federal Register / Vol. 73, No. 222 / Monday, November 17, 2008 / Notices
have had an inadequate response to or
cannot be treated with surgery and/or
radiotherapy. Subsequent to this
approval, the Patent and Trademark
Office received a patent term restoration
application for SOMATULINE DEPOT
(U.S. Patent No. 5,595,760) from Society
De Conseils De Recherches Et
D’Applications Scientifiques, and the
Patent and Trademark Office requested
FDA’s assistance in determining this
patent’s eligibility for patent term
restoration. In a letter dated April 22,
2008, FDA advised the Patent and
Trademark Office that this human drug
product had undergone a regulatory
review period and that the approval of
SOMATULINE DEPOT represented the
first permitted commercial marketing or
use of the product. Shortly thereafter,
the Patent and Trademark Office
requested that FDA determine the
product’s regulatory review period.
FDA has determined that the
applicable regulatory review period for
SOMATULINE DEPOT is 3,629 days. Of
this time, 3,324 days occurred during
the testing phase of the regulatory
review period, while 305 days occurred
during the approval phase. These
periods of time were derived from the
following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
355) became effective: September 24,
1997. FDA has verified the applicant’s
claim that the date the investigational
new drug application became effective
was on September 24, 1997.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the act: October 30, 2006. FDA
has verified the applicant’s claim that
the new drug application (NDA) for
SOMATULINE DEPOT (NDA 22–074)
was initially submitted on October 30,
2006.
3. The date the application was
approved: August 30, 2007. FDA has
verified the applicant’s claim that NDA
22–074 was approved on August 30,
2007.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the U.S. Patent and
Trademark Office applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 5 years of patent
term extension.
Anyone with knowledge that any of
the dates as published are incorrect may
submit to the Division of Dockets
Management (see ADDRESSES) written or
electronic comments and ask for a
VerDate Aug<31>2005
18:18 Nov 14, 2008
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67875
redetermination by January 16, 2009.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
May 18, 2009. To meet its burden, the
petition must contain sufficient facts to
merit an FDA investigation. (See H.
Rept. 857, part 1, 98th Cong., 2d sess.,
pp. 41–42, 1984.) Petitions should be in
the format specified in 21 CFR 10.30.
Comments and petitions should be
submitted to the Division of Dockets
Management. Three copies of any
mailed information are to be submitted,
except that individuals may submit one
copy. Comments are to be identified
with the docket number found in
brackets in the heading of this
document. Comments and petitions may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
SUPPLEMENTARY INFORMATION:
Dated: October 20, 2008.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E8–27179 Filed 11–14–08; 8:45 am]
BILLING CODE 9111–23–P
BILLING CODE 4160–01–S
Federal Emergency Management
Agency
DEPARTMENT OF HOMELAND
SECURITY
[FEMA–1804–DR]
Federal Emergency Management
Agency
[FEMA–1795–DR]
Indiana; Amendment No. 7 to Notice of
a Major Disaster Declaration
Federal Emergency
Management Agency, DHS.
ACTION: Notice.
AGENCY:
SUMMARY: This notice amends the notice
of a major disaster declaration for the
State of Indiana (FEMA–1795–DR),
dated September 23, 2008, and related
determinations.
DATES: Effective Date: November 7,
2008.
FOR FURTHER INFORMATION CONTACT:
Peggy Miller, Disaster Assistance
Directorate, Federal Emergency
Management Agency, 500 C Street, SW.,
Washington, DC 20472, (202) 646–3886.
PO 00000
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The notice
of a major disaster declaration for the
State of Indiana is hereby amended to
include the following areas among those
areas determined to have been adversely
affected by the event declared a major
disaster by the President in his
declaration of September 23, 2008.
LaPorte County for Public Assistance
(already designated for Individual
Assistance).
Daviess County for Public Assistance.
(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.)
R. David Paulison,
Administrator, Federal Emergency
Management Agency.
[FR Doc. E8–27164 Filed 11–14–08; 8:45 am]
DEPARTMENT OF HOMELAND
SECURITY
Arkansas; Major Disaster and Related
Determinations
Federal Emergency
Management Agency, DHS.
ACTION: Notice.
AGENCY:
SUMMARY: This is a notice of the
Presidential declaration of a major
disaster for the State of Arkansas
(FEMA–1804–DR), dated October 22,
2008, and related determinations.
DATES: Effective Date: October 22, 2008.
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
October 22, 2008, the President declared
a major disaster under the authority of
the Robert T. Stafford Disaster Relief
and Emergency Assistance Act, 42
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]]>Agencies
[Federal Register Volume 73, Number 222 (Monday, November 17, 2008)]
[Notices]
[Page 67875]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-27164]
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DEPARTMENT OF HOMELAND SECURITY
Federal Emergency Management Agency
[FEMA-1795-DR]
Indiana; Amendment No. 7 to Notice of a Major Disaster
Declaration
AGENCY: Federal Emergency Management Agency, DHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Indiana (FEMA-1795-DR), dated September 23, 2008, and
related determinations.
DATES: Effective Date: November 7, 2008.
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: The notice of a major disaster declaration
for the State of Indiana is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of September 23, 2008.
LaPorte County for Public Assistance (already designated for
Individual Assistance).
Daviess County for Public Assistance.
(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.)
R. David Paulison,
Administrator, Federal Emergency Management Agency.
[FR Doc. E8-27164 Filed 11-14-08; 8:45 am]
BILLING CODE 9111-23-P
