Determination of Regulatory Review Period for Purposes of Patent Extension; LEVEMIR, 7999-8000 [E7-3001]
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Federal Register / Vol. 72, No. 35 / Thursday, February 22, 2007 / Notices
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respondents
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Mentoring ToolKit Web-based Needs Assessment Questionannaire ...........
Mentoring ToolKit Web-based focus group ...................................................
Mentoring ToolKit Web-based Feedback questionnaire ...............................
Estimated Total Annual Burden
Hours: 397
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writing to the Administration for
Children and Families, Office of
Administration, Office of Information
Services, 370 L’Enfant Promenade, SW.,
Washington, DC 20447, Attn: ACF
Reports Clearance Officer. All requests
should be identified by the title of the
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Attn: Desk Officer for the
Administration for Children and
Families.
Dated: February 15, 2007.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 07–790 Filed 2–21–07; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006E–0252]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; LEVEMIR
AGENCY:
Food and Drug Administration,
HHS.
rwilkins on PROD1PC63 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
LEVEMIR and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of an
application to the Director of Patents
and Trademarks, Department of
VerDate Aug<31>2005
17:50 Feb 21, 2007
Jkt 211001
Number of
responses per
respondent
Average burden
hours per
response
1
1
1
.75
1
.25
442
40
100
Commerce, for the extension of a patent
that claims that human drug product.
ADDRESSES: Submit written comments
and petitions to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy (HFD–7), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–594–2041.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) and the Generic Animal Drug and
Patent Term Restoration Act (Public
Law 100–670) generally provide that a
patent may be extended for a period of
up to 5 years so long as the patented
item (human drug product, animal drug
product, medical device, food additive,
or color additive) was subject to
regulatory review by FDA before the
item was marketed. Under these acts, a
product’s regulatory review period
forms the basis for determining the
amount of extension an applicant may
receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the human drug
product becomes effective and runs
until the approval phase begins. The
approval phase starts with the initial
submission of an application to market
the human drug product and continues
until FDA grants permission to market
the product. Although only a portion of
a regulatory review period may count
toward the actual amount of extension
that the Director of Patents and
Trademarks may award (for example,
half the testing phase must be
subtracted, as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a human drug product will include all
of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA recently approved for marketing
the human drug product LEVEMIR
(insulin determir (rDNA origin)).
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
Total burden
hours
332
40
25
LEVEMIR is indicated for once or twicedaily subcutaneous administration in
the treatment of adult patients with
diabetes mellitus who require basal
(long acting) insulin for the control of
hyperglycemia. Subsequent to this
approval, the Patent and Trademark
Office received a patent term restoration
application for LEVEMIR (U.S. Patent
No. 5,750,497) from Novo Nordisk A/S,
and the Patent and Trademark Office
requested FDA’s assistance in
determining this patent’s eligibility for
patent term restoration. In a letter dated
July 24, 2006, FDA advised the Patent
and Trademark Office that this human
drug product had undergone a
regulatory review period and that the
approval of LEVEMIR represented the
first permitted commercial marketing or
use of the product. 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
LEVEMIR is 2,896 days. Of this time,
1,971 days occurred during the testing
phase of the regulatory review period,
while 925 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: July 14, 1997.
FDA has verified the applicant’s claim
that the date the investigational new
drug application became effective was
on July 14, 1997.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the act: December 5, 2002.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
LEVIMIR (NDA 21–536) was initially
submitted on December 5, 2002.
3. The date the application was
approved: June 16, 2005. FDA has
verified the applicant’s claim that NDA
21–536 was approved on June 16, 2005.
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,
E:\FR\FM\22FEN1.SGM
22FEN1
8000
Federal Register / Vol. 72, No. 35 / Thursday, February 22, 2007 / Notices
this applicant seeks 1,496 days 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
redetermination by April 23, 2007.
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
August 21, 2007. 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.
Dated: February 3, 2007.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E7–3001 Filed 2–21–07; 8:45 am]
BILLING CODE 4160–01–S
BILLING CODE 9110–10–P
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[FEMA–1680–DR]
Federal Emergency
Management Agency, DHS.
ACTION: Notice.
This is a notice of the
Presidential declaration of a major
disaster for the State of Florida (FEMA–
1680–DR), dated February 8, 2007, and
related determinations.
EFFECTIVE DATE: February 8, 2007.
FOR FURTHER INFORMATION CONTACT:
Magda Ruiz, Recovery Division, Federal
Emergency Management Agency,
Washington, DC 20472, (202) 646–2705.
SUPPLEMENTARY INFORMATION: Notice is
hereby given that, in a letter dated
February 8, 2007, the President declared
a major disaster under the authority of
the Robert T. Stafford Disaster Relief
and Emergency Assistance Act, 42
U.S.C. 5121–5206 (the Stafford Act), as
follows:
SUMMARY:
[FEMA–3271–EM]
Colorado; Amendment No. 3 to Notice
of an Emergency Declaration
Federal Emergency
Management Agency, DHS.
ACTION: Notice.
AGENCY:
SUMMARY: This notice amends the notice
of an emergency declaration for the
State of Colorado (FEMA–3271–EM),
dated January 7, 2007, and related
determinations.
February 12, 2007.
FOR FURTHER INFORMATION CONTACT:
rwilkins on PROD1PC63 with NOTICES
R. David Paulison,
Under Secretary for Federal Emergency
Management and Director of FEMA.
[FR Doc. E7–2948 Filed 2–21–07; 8:45 am]
AGENCY:
Federal Emergency Management
Agency
Magda Ruiz, Recovery Division, Federal
Emergency Management Agency,
Washington, DC 20472, (202) 646–2705.
SUPPLEMENTARY INFORMATION: The notice
of an emergency declaration for the
State of Colorado is hereby amended to
VerDate Aug<31>2005
Cheyenne, Huerfano, and Kiowa Counties
for emergency protective measures (Category
B), including snow removal, under the Public
Assistance program for any continuous 48hour period during or proximate to the
incident period.
(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 Program; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services
Program; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management
Assistance; 97.048, Individuals and
Households Housing; 97.049, Individuals and
Households Disaster Housing Operations;
97.050 Individuals and Households ProgramOther Needs, 97.036, Public Assistance
Grants; 97.039, Hazard Mitigation Grant
Program.)
Florida; Major Disaster and Related
Determinations
DEPARTMENT OF HOMELAND
SECURITY
EFFECTIVE DATE:
include the following areas among those
areas determined to have been adversely
affected by the catastrophe declared an
emergency by the President in his
declaration of January 7, 2007:
14:11 Feb 21, 2007
Jkt 211001
I have determined that the damage in
certain areas of the State of Florida resulting
from severe storms, tornadoes, and flooding
on December 25, 2006, is of sufficient
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
severity and magnitude to warrant a major
disaster declaration under the Robert T.
Stafford Disaster Relief and Emergency
Assistance Act, 42 U.S.C. 5121–5206 (the
Stafford Act). Therefore, I declare that such
a major disaster exists in the State of Florida.
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 Individual
Assistance in the designated areas, Hazard
Mitigation throughout the State, and any
other forms of assistance under the Stafford
Act you may deem appropriate. Consistent
with the requirement that Federal assistance
be supplemental, any Federal funds provided
under the Stafford Act for Hazard Mitigation
and Other Needs Assistance will be limited
to 75 percent of the total eligible costs. If
Public Assistance is later warranted, Federal
funds provided 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 time period prescribed for the
implementation of section 310(a),
Priority to Certain Applications for
Public Facility and Public Housing
Assistance, 42 U.S.C. 5153, shall be for
a period not to exceed six months after
the date of this declaration.
The Federal Emergency Management
Agency (FEMA) hereby gives notice that
pursuant to the authority vested in the
Director, under Executive Order 12148,
as amended, Jesse Munoz, of FEMA is
appointed to act as the Federal
Coordinating Officer for this declared
disaster.
I do hereby determine the following
areas of the State of Florida to have been
affected adversely by this declared
major disaster:
Volusia County for Individual Assistance.
All counties within the State of Florida 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 Program; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services
Program; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management
Assistance; 97.048, Individuals and
Households Housing; 97.049, Individuals and
Households Disaster Housing Operations;
97.050, Individuals and Households
Program-Other Needs; 97.036, Public
Assistance Grants; 97.039, Hazard Mitigation
Grant Program.)
R. David Paulison,
Under Secretary for Federal Emergency
Management and Director of FEMA.
[FR Doc. E7–2935 Filed 2–21–07; 8:45 am]
BILLING CODE 9110–10–P
E:\FR\FM\22FEN1.SGM
22FEN1
]]>Agencies
[Federal Register Volume 72, Number 35 (Thursday, February 22, 2007)]
[Notices]
[Pages 7999-8000]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-3001]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006E-0252]
Determination of Regulatory Review Period for Purposes of Patent
Extension; LEVEMIR
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for LEVEMIR and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of an application to the Director of Patents
and Trademarks, Department of Commerce, for the extension of a patent
that claims that human drug product.
ADDRESSES: Submit written comments and petitions to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to https://www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy (HFD-7), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-594-2041.
SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Public Law 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the human drug product becomes effective and runs
until the approval phase begins. The approval phase starts with the
initial submission of an application to market the human drug product
and continues until FDA grants permission to market the product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of Patents and
Trademarks may award (for example, half the testing phase must be
subtracted, as well as any time that may have occurred before the
patent was issued), FDA's determination of the length of a regulatory
review period for a human drug product will include all of the testing
phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA recently approved for marketing the human drug product LEVEMIR
(insulin determir (rDNA origin)). LEVEMIR is indicated for once or
twice-daily subcutaneous administration in the treatment of adult
patients with diabetes mellitus who require basal (long acting) insulin
for the control of hyperglycemia. Subsequent to this approval, the
Patent and Trademark Office received a patent term restoration
application for LEVEMIR (U.S. Patent No. 5,750,497) from Novo Nordisk
A/S, and the Patent and Trademark Office requested FDA's assistance in
determining this patent's eligibility for patent term restoration. In a
letter dated July 24, 2006, FDA advised the Patent and Trademark Office
that this human drug product had undergone a regulatory review period
and that the approval of LEVEMIR represented the first permitted
commercial marketing or use of the product. 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
LEVEMIR is 2,896 days. Of this time, 1,971 days occurred during the
testing phase of the regulatory review period, while 925 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: July
14, 1997. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on July 14,
1997.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the act: December 5,
2002. FDA has verified the applicant's claim that the new drug
application (NDA) for LEVIMIR (NDA 21-536) was initially submitted on
December 5, 2002.
3. The date the application was approved: June 16, 2005. FDA has
verified the applicant's claim that NDA 21-536 was approved on June 16,
2005.
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,
[[Page 8000]]
this applicant seeks 1,496 days 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 redetermination
by April 23, 2007. 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 August 21,
2007. 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.
Dated: February 3, 2007.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E7-3001 Filed 2-21-07; 8:45 am]
BILLING CODE 4160-01-S
