Determination of Regulatory Review Period for Purposes of Patent Extension; ERTACZO, 25091-25092 [05-9462]
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Federal Register / Vol. 70, No. 91 / Thursday, May 12, 2005 / Notices
specific outcomes to be achieved;
performance targets which the project is
committed to achieving; critical
milestones, which must be achieved if
results are to be gained; and
organizational support; the level of
support including the priority this
project has for the agency.
Objectives and Need for Assistance 25
Points
carrying over the approved applications
up to a year for funding consideration
in a later competition of the same
program. These applications need not be
reviewed and scored again if the
program’s evaluation criteria have not
changed. However, they must then be
placed in rank order along with other
applications in later competition.
VI. Award Administration Information
Factors: The applicant documents that
the project addresses vital needs related
to the purposes stated and discussed
under this announcement.
Results or Benefits Expected 20 Points
Factor: The extent to which the
applicant adequately describes how the
project will assure long-term program
and management improvements that
will aid in removal from the ‘‘at risk
category.’’
Organizational Profiles 20 Points
Factors: The applicant fully describes,
for example in a resume, the experience
and skills of the proposed resources of
technical assistance showing specific
qualifications including how the CSBG
eligible entities will be monitored for a
specified period of time following the
corrective action to assure long-term
program and management
improvements that will aid the
organization from being in the ‘‘at-risk
category’’ again.
Budget and Budget Justification 5 Points
Factors: (a) The extent to which the
resources requested are reasonable and
adequate to accomplish the project. (0–
3 points)
(b) The extent to which total costs are
reasonable and consistent with
anticipated results. (0–2 points)
2. Review and Selection Process
No grant award will be made under
this announcement on the basis of an
incomplete application.
Since ACF will be using non-Federal
reviewers in the process, applicants
have the option of omitting from the
application copies (not the original)
specific salary rates or amounts for
individuals specified in the application
budget and Social Security Numbers, if
otherwise required for individuals. The
copies may include summary salary
information.
1. Award Notices
The successful applicants will be
notified through the issuance of a
Financial Assistance Award document
which sets forth the amount of funds
granted, the terms and conditions of the
grant, the effective date of the grant, the
budget period for which initial support
will be given, the non-Federal share to
be provided, and the total project period
for which support is contemplated. The
Financial Assistance Award will be
signed by the Grants Officer and
transmitted via postal mail.
Organizations whose applications will
not be funded will be notified in
writing.
2. Administrative and National Policy
Requirements
Grantees are subject to the
requirements in 45 CFR Part 74 (nongovernmental) or 45 CFR Part 92
(governmental) and 45 CFR Part 1050.
3. Reporting Requirements
VII. Agency Contacts
BILLING CODE 4184–01–P
Program Office Contact
Dr. Margaret Washnitzer, Department
of Health and Human Services (HHS),
Administration for Children and
Families (ACF), Office of Community
Services Operations Center, 1515
Wilson Blvd., Suite 100, Arlington, VA
22209. Phone: 800–281–9519. E-mail:
OCSGRANTS@acf.hhs.gov.
In cases where more applications are
approved for funding than ACF can
fund with the money available, the
Grants Officer shall fund applications in
their order of approval until funds run
out. In this case, ACF has the option of
Barbara Ziegler-Johnson, Department
of Health and Human Services (HHS),
Administration for Children and
Families (ACF), Office of Community
Services Operations Center, 1515
Wilson Blvd., Suite 100, Arlington, VA
Jkt 205001
VIII. Other Information
The FY 2006 President’s budget does
not include or propose funding for the
community Services Block Grant
Training and Technical Assistance
Program. Future funding is based on the
availability of Federal funds.
Direct Federal grants, subaward
funds, or contracts under the
Administration for Children and
Families programs shall not be used to
support inherently religious activities
such as religious instruction, worship,
or proselytization. Therefore,
organizations must take steps to
separate, in time or location, their
inherently religious activities from the
services funded under this program.
Regulations pertaining to the Charitable
Choice Provisions Applicable to
Programs Authorized under the
Community Services Block Grant Act
can be found at either 45 CFR Part 1050
or the HHS Web site at https://
www.os.dhhs.gov/fbci/waisgate21.pdf.
Notice: Beginning with FY 2006, the
Administration for Children and
Families (ACF) will no longer publish
grant announcements in the Federal
Register. Beginning October 1, 2005
applicants will be able to find a
synopsis of all ACF grant opportunities
and apply electronically for
opportunities via: https://
www.Grants.gov. Applicants will also be
able to find the complete text of all ACF
grant announcements on the ACF Web
site located at: https://www.acf.hhs.gov/
grants/.
Applicants will not be sent
acknowledgements of received
applications.
Dated: May 5, 2005.
Josephine B. Robinson,
Director, Office of Community Services.
[FR Doc. 05–9427 Filed 5–11–05; 8:45 am]
Grants Management Office Contact
19:04 May 11, 2005
22209. Phone: 800–281–9519. E-mail:
OCSGRANTS@acf.hhs.gov.
Grantees will be required to submit
program progress and financial reports
(SF–269) throughout the project period.
Program progress and financial reports
are due 30 days after the reporting
period. In addition, final programmatic
and financial reports are due 90 days
after the close of the project period.
Program Progress Reports: SemiAnnually.
Financial Reports: Semi-Annually.
Approved But Unfunded Applications
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004E–0316]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; ERTACZO
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
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12MYN1
25092
Federal Register / Vol. 70, No. 91 / Thursday, May 12, 2005 / Notices
ERTACZO 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.
FOR FURTHER INFORMATION CONTACT:
Claudia Grillo, Office of Regulatory
Policy (HFD–013), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 240–453–6699.
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 drug 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 drug 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 ERTACZO
(sertaconazole nitrate). ERTACZO is
indicated for the topical treatment of
athlete’s foot (interdigital tinea pedis)
caused by certain fungus (Trichophyton
rubrum, T. mentagrophytes, and
Epidermophyton floccosum). ERTACZO
VerDate jul<14>2003
19:04 May 11, 2005
Jkt 205001
is for people 12 years of age and older
who have a normal immune system.
Subsequent to this approval, the Patent
and Trademark Office received a patent
term restoration application for
ERTACZO (U.S. Patent No. 5,135,943)
from Ferrer Internacional, S.A., and the
Patent and Trademark Office requested
FDA’s assistance in determining this
patent’s eligibility for patent term
restoration. In a letter dated August 31,
2004, FDA advised the Patent and
Trademark Office that this human drug
product had undergone a regulatory
review period and that the approval of
ERTACZO 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
ERTACZO is 2,718 days. Of this time,
1,914 days occurred during the testing
phase of the regulatory review period,
while 804 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505 of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
355) became effective: July 3, 1996. The
applicant claims June 11, 1996, as the
date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was July 3, 1996,
which was 30 days after FDA receipt of
the IND.
2. The date the application was
initially submitted with respect to the
human drug product under section 505
of the act: September 28, 2001. FDA has
verified the applicant’s claim that the
new drug application (NDA) for
ERTACZO (NDA 21–385) was initially
submitted on September 28, 2001.
3. The date the application was
approved: December 10, 2003. FDA has
verified the applicant’s claim that NDA
21–385 was approved on December 10,
2003.
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 1,776 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
comments and ask for a redetermination
by July 11, 2005. Furthermore, any
PO 00000
Frm 00079
Fmt 4703
Sfmt 4703
interested person may petition FDA for
a determination regarding whether the
applicant for extension acted with due
diligence during the regulatory review
period by November 8, 2005. 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: March 29, 2005.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. 05–9462 Filed 5–11–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; Evaluation of
National Cancer Institute’s Central
Institutional Review Board To Improve
Cancer Clinical Trials System
Summary: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Cancer Institute (NCI), the National
Institutes of Health has submitted to the
Office of Management and Budget
(OMB) a request to review and approve
the information collection listed below.
This proposed information collection
was previously published in the Federal
Register on July 19, 2004 on page 43003
and allowed 60 days for public
comment. No public comments were
received. The purpose of this notice is
to allow an additional 30 days for public
comment. The National Institutes of
Health may not conduct or sponsor, and
the respondent is not required to
respond to, an information collection
that has been extended, revised, or
implemented on or after October 1,
1995, unless it displays a currently valid
OMB control number.
Proposed Collection: Title: Evaluation
of National Cancer Institute’s Central
Institutional Review Board to Improve
Cancer Clinical Trials System. Type of
E:\FR\FM\12MYN1.SGM
12MYN1
]]>Agencies
[Federal Register Volume 70, Number 91 (Thursday, May 12, 2005)]
[Notices]
[Pages 25091-25092]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-9462]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004E-0316]
Determination of Regulatory Review Period for Purposes of Patent
Extension; ERTACZO
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for
[[Page 25092]]
ERTACZO 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.
FOR FURTHER INFORMATION CONTACT: Claudia Grillo, Office of Regulatory
Policy (HFD-013), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 240-453-6699.
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 drug 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 drug 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 ERTACZO
(sertaconazole nitrate). ERTACZO is indicated for the topical treatment
of athlete's foot (interdigital tinea pedis) caused by certain fungus
(Trichophyton rubrum, T. mentagrophytes, and Epidermophyton floccosum).
ERTACZO is for people 12 years of age and older who have a normal
immune system. Subsequent to this approval, the Patent and Trademark
Office received a patent term restoration application for ERTACZO (U.S.
Patent No. 5,135,943) from Ferrer Internacional, S.A., and the Patent
and Trademark Office requested FDA's assistance in determining this
patent's eligibility for patent term restoration. In a letter dated
August 31, 2004, FDA advised the Patent and Trademark Office that this
human drug product had undergone a regulatory review period and that
the approval of ERTACZO 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
ERTACZO is 2,718 days. Of this time, 1,914 days occurred during the
testing phase of the regulatory review period, while 804 days occurred
during the approval phase. These periods of time were derived from the
following dates:
1. The date an exemption under section 505 of the Federal Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 355) became effective: July
3, 1996. The applicant claims June 11, 1996, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was July 3, 1996,
which was 30 days after FDA receipt of the IND.
2. The date the application was initially submitted with respect to
the human drug product under section 505 of the act: September 28,
2001. FDA has verified the applicant's claim that the new drug
application (NDA) for ERTACZO (NDA 21-385) was initially submitted on
September 28, 2001.
3. The date the application was approved: December 10, 2003. FDA
has verified the applicant's claim that NDA 21-385 was approved on
December 10, 2003.
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 1,776 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 comments and ask for a redetermination by July 11,
2005. 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 November 8, 2005.
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: March 29, 2005.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 05-9462 Filed 5-11-05; 8:45 am]
BILLING CODE 4160-01-S
