Determination of Regulatory Review Period for Purposes of Patent Extension; Fel-O-Vax® LvK/FIV Vaccine, 52847-52849 [E7-18266]
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52847
Notices
Federal Register
Vol. 72, No. 179
Monday, September 17, 2007
This section of the FEDERAL REGISTER
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DEPARTMENT OF AGRICULTURE
Submission for OMB Review;
Comment Request
jlentini on PROD1PC65 with NOTICES
September 11, 2007.
The Department of Agriculture has
submitted the following information
collection requirement(s) to OMB for
review and clearance under the
Paperwork Reduction Act of 1995,
Public Law 104–13. Comments
regarding (a) whether the collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information will have practical utility;
(b) the accuracy of the agency’s estimate
of burden including the validity of the
methodology and assumptions used; (c)
ways to enhance the quality, utility and
clarity of the information to be
collected; (d) ways to minimize the
burden of the collection of information
on those who are to respond, including
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other technological collection
techniques or other forms of information
technology should be addressed to: Desk
Officer for Agriculture, Office of
Information and Regulatory Affairs,
Office of Management and Budget
(OMB),
OIRA_Submission@OMB.EOP.GOV or
fax (202) 395–5806 and to Departmental
Clearance Office, USDA, OCIO, Mail
Stop 7602, Washington, DC 20250–
7602. Comments regarding these
information collections are best assured
of having their full effect if received
within 30 days of this notification.
Copies of the submission(s) may be
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sponsor a collection of information
unless the collection of information
displays a currently valid OMB control
number and the agency informs
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the collection of information that such
persons are not required to respond to
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the collection of information unless it
displays a currently valid OMB control
number.
Rural Utilities Service
Title: Weather Radio Transmitter
Grant Program.
OMB Control Number: 0572–0124.
Summary of Collection: The National
Weather Service operates an All
Hazards Early Warning System that
alerts people in areas covered by its
transmissions of approaching dangerous
weather and other emergencies. The
National Weather Service can typically
provide warnings of specific weather
dangers up to fifteen minutes prior to
the event. At present, this system covers
all major metropolitan areas and many
smaller cities and towns; however,
many rural areas lack National Oceanic
and Atmospheric Administration’s
Weather Radio and Alert System
(NOAA) Weather Radio coverage. The
Weather Radio Transmitter Grant
Program will provide grant funds, for
use in rural areas and communities of
50,000 or less inhabitants. The grant
funds will be processed on a first-come
basis until the appropriation is used in
its entirety.
Need and Use of the Information:
RUS will use the information from the
submissions to determine the following:
(1) That adequate coverage in the area
does not already exist and that the
proposed coverage will meet the needs
of the community; (2) that design
requirements are met; and (3) that the
funds needed to complete the project
are adequate based on the grant and the
matching portion from the applicant.
Description of Respondents: Not forprofit institutions; State, Local or Tribal
Government.
Number of Respondents: 113.
Frequency of Responses: Reporting:
On occasion.
Total Burden Hours: 678.
Rural Utility Service
Title: High Energy Cost Grants and
State Bulk Fuel Revolving Grant
Programs.
OMB Control Number: 0572–0136.
Summary of Collection: The Rural
Electrification Act of 1936 (RE Act) (7
U.S.C. 901 et seq.) was amended in
November 2000 to create new grant and
loan authority to assist rural
communities with extremely high
energy costs (Pub. L.106–472). This
amendment gives authorization to Rural
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Utilities Service (RUS) to provide
competitive grants for energy
generation, transmission, or distribution
facilities serving communities in which
the national average is at least 275% for
residential expenditure for home
energy. All applicants are required to
submit a project proposal containing the
elements in the prescribed format.
Need and Use of the Information:
USDA will collect information from
applicants to confirm that the eligibility
requirements and the proposals are
consistent with the purposes set forth in
the statute. Various forms and progress
reports are used to monitor compliance
with grant agreements, track
expenditures of Federal funds and
measure the success of the program.
Without collecting the listed
information, USDA will not be assured
that the projects and communities
served meet the statutory requirements
for eligibility or that the proposed
projects will deliver the intended
benefits.
Description of Respondents: Not-forprofit institutions; Business or other forprofit; and State, Local or Tribal
Government.
Number of Respondents: 55.
Frequency of Responses:
Recordkeeping: Reporting: On occasion.
Total Burden Hours: 1,228.
Charlene Parker,
Departmental Information Collection
Clearance Officer.
[FR Doc. E7–18201 Filed 9–14–07; 8:45 am]
BILLING CODE 3410–15–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2007–0121]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; Fel-O-Vax LvK/FIV
Vaccine
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
SUMMARY: We are advising the public
that the Animal and Plant Health
Inspection Service has determined the
regulatory review period for Fel-O-Vax
LvK/FIV Vaccine and is publishing this
notice of that determination as required
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52848
Federal Register / Vol. 72, No. 179 / Monday, September 17, 2007 / Notices
by law. We have made this
determination in response to the
submission of an application to the
Commissioner of Patents and
Trademarks, Department of Commerce,
for the extension of a patent that claims
that veterinary biologic.
DATES: We will consider all requests for
revision of the regulatory review period
determination that we receive on or
before October 17, 2007. We will
consider all due diligence petitions that
we receive on or before March 17, 2008.
ADDRESSES: You may submit revision
requests and due diligence petitions by
either of the following methods:
Federal eRulemaking Portal: Go to
https://www.regulations.gov, select
‘‘Animal and Plant Health Inspection
Service’’ from the agency drop-down
menu, then click ‘‘Submit.’’ In the
Docket ID column, select APHIS–2007–
0121 to submit or view public
comments and to view supporting and
related materials available
electronically. Information on using
Regulations.gov, including instructions
for accessing documents, submitting
comments, and viewing the docket after
the close of the comment period, is
available through the site’s ‘‘User Tips’’
link.
Postal Mail/Commercial Delivery:
Please send four copies of your request
or petition (an original and three copies)
to Docket No. APHIS–2007–0121,
Regulatory Analysis and Development,
PPD, APHIS, Station 3A–03.8, 4700
River Road Unit 118, Riverdale, MD
20737–1238. Please state that the
request or petition refers to Docket No.
APHIS–2007–0121.
Reading Room: You may read the
regulatory review period determination
and any revision requests or due
diligence petitions that we receive on
this determination in our reading room.
The reading room is located in room
1141 of the USDA South Building, 14th
Street and Independence Avenue, SW.,
Washington, DC. Normal reading room
hours are 8 a.m. to 4:30 p.m., Monday
through Friday, except holidays. To be
sure someone is there to help you,
please call (202) 690–2817 before
coming.
Other Information: Additional
information about APHIS and its
programs is available on the Internet at
https://www.aphis.usda.gov.
FOR FURTHER INFORMATION CONTACT: Dr.
Albert P. Morgan, Section Leader,
Operational Support Section, Center for
Veterinary Biologics, Policy Evaluation
and Licensing, VS, APHIS, 4700 River
Road Unit 148, Riverdale, MD 20737–
1231; phone (301) 734–8245; fax (301)
734–4314.
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17:00 Sep 14, 2007
Jkt 211001
For information concerning the
regulatory review period determination,
contact Dr. Patricia L. Foley, Center for
Veterinary Biologics, Policy Evaluation
and Licensing, VS, APHIS, 510 South
17th Street, Suite 104, Ames, IA 50010;
phone (515) 232–5785, fax (515) 232–
7120.
The
provisions of 35 U.S.C. 156, ‘‘Extension
of patent term,’’ provide, generally, that
a patent for a product may be extended
for a period of up to 5 years as long as
the patent claims a product that, among
other things, was subject to a regulatory
review period before its commercial
marketing or use. (The term ‘‘product’’
is defined in that section as ‘‘a drug
product’’ [which includes veterinary
biological products] or ‘‘any medical
device, food additive, or color additive
subject to regulation under the Federal
Food, Drug, and Cosmetic Act.’’) A
product’s regulatory review period
forms the basis for determining the
amount of extension an applicant may
receive.
The regulations in 9 CFR part 124,
‘‘Patent Term Restoration’’ (referred to
below as the regulations), set forth
procedures and requirements for the
Animal and Plant Health Inspection
Service’s (APHIS) review of applications
for the extension of the term of certain
patents for veterinary biological
products pursuant to 35 U.S.C. 156. As
identified in the regulations, the
responsibilities of APHIS include:
Assisting the Patent and Trademark
Office of the U.S. Department of
Commerce in determining eligibility for
patent term restoration;
Determining the length of a product’s
regulatory review period;
If petitioned, reviewing and ruling on
due diligence challenges to APHIS’
regulatory review period
determinations; and
Conducting hearings to review initial
APHIS findings on due diligence
challenges.
The regulations are designed to be
used in conjunction with regulations
issued by the Patent and Trademark
Office concerning patent term
extension, which may be found at 37
CFR 1.710 through 1.791.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For veterinary
biologics, the testing phase begins on
the date the authorization to prepare an
experimental veterinary biologic became
effective and runs until the approval
phase begins. The approval phase
begins on the date an application for a
license was initially submitted for
approval and ends on the date such
SUPPLEMENTARY INFORMATION:
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license was issued. Although only a
portion of a regulatory review period
may count toward the actual amount of
extension that the Commissioner of
Patents and Trademarks may award,
APHIS’ determination of the length of a
regulatory review period for a veterinary
biologic will include all of the testing
phase and approval phase as specified
in 35 U.S.C. 156(g)(5)(B).
APHIS recently licensed for
production and marketing the veterinary
biologic Fel-O-Vax LvK/FIV (Feline
Immunodeficiency-Leukemia Virus
Vaccine, Killed Virus) Vaccine.
Subsequent to this approval, the Patent
and Trademark Office received a patent
term restoration application for Fel-OVax LvK/FIV Vaccine (U.S. Patent No.
5,510,106) from the Regents of the
University of California, and the Patent
and Trademark Office requested APHIS’
assistance in determining this patent’s
eligibility for patent term restoration. In
a letter dated January 16, 2007, APHIS
advised the Patent and Trademark
Office that this veterinary biologic had
undergone a regulatory review period
and that the approval of Fel-O-Vax
LvK/FIV Vaccine represented the first
permitted commercial licensing or use
of the product. Subsequently, the Patent
and Trademark Office requested that
APHIS determine the product’s
regulatory review period.
APHIS has determined that the
applicable regulatory review period for
Fel-O-Vax LvK/FIV Vaccine is 1,348
days. Of this time, 0 days occurred
during the testing phase of the
regulatory review period, and 1,348
days occurred during the approval
phase. These periods were derived from
the following dates:
1. The date the application for a
license was initially submitted for
approval under the Virus-Serum-Toxin
Act: October 15, 1999. APHIS has
verified the applicant’s claim that the
application was initially submitted on
October 15, 1999.
2. The date the license was issued:
June 23, 2003. APHIS has verified the
applicant’s claim that the license for the
commercial marketing of the vaccine
was issued on June 23, 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 1,348 days of patent
term extension.
Section 124.22 of the regulations
provides that any interested person may
request a revision of the regulatory
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Federal Register / Vol. 72, No. 179 / Monday, September 17, 2007 / Notices
review period determination within 30
days of the date of this notice (see DATES
above). The request must specify the
following:
The identity of the product;
The identity of the applicant for
patent term restoration;
The docket number of this notice; and
The basis for the request for revision,
including any documentary evidence.
Further, under § 124.30 of the
regulations, any interested person may
file a petition with APHIS, no later than
180 days after the date of this notice (see
DATES above), alleging that a license
applicant did not act with due diligence
in seeking APHIS approval of the
product during the regulatory review
period. The filing, format, and content
of a petition must be as described in the
regulations in ‘‘Subpart D—Due
Diligence Petitions’’ (§§ 124.30 through
124.33).
Authority: 35 U.S.C. 156.
Done in Washington, DC, this 11th day of
September, 2007.
Kevin Shea,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. E7–18266 Filed 9–14–07; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Forest Service
Lincoln National Forest; New Mexico;
Perk-Grindstone III Hazardous Fuel
Reduction Project
Forest Service, USDA.
Notice of intent to prepare an
Environmental Impact Statement;
Correction.
AGENCY:
ACTION:
On September 22, 2006, the
Federal Register published a Notice of
Intent (NOI) to prepare an
Environmental Impact Statement (EIS)
for the Perk-Grindstone III Hazardous
Fuel Reduction Project on the Lincoln
National Forest, Smokey Bear Ranger
District (71 FR 55419–55421). That
document estimated that the Draft
Environmental Impact Statement would
be available February 2007, and would
require a single forest plan amendment,
correction of both the estimated date
and the number of forest plan
amendments is necessary.
Correction: In the Federal Register of
September 22, 2006, in FR Doc. 71–184,
on page 55419, in the first column,
correct the DATES caption, second
sentence to read:
The draft EIS is expected to be
available for public review in January
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SUMMARY:
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17:00 Sep 14, 2007
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2008 and the final EIS is expected to be
published in June 2008.
In the Federal Register of September
22, 2006, in FR Doc. 71–184, on page
55419, in the third column, additional
information must be added to the
Proposed Action caption, first and
second paragraph to read:
Proposed forest management work
includes noncommercial thinning,
commercial thinning involving removal
of logs and slash by ground-based
skidding or helicopter, ground-based
machine work and hand work to pile
thinning slash, and slash-pile burning or
broadcast burning to dispose of or
reduce woody fuels. On existing roads
used to support these treatments,
maintenance work including forestry
best management practices would be
performed. Up to 14 miles of road may
be constructed or reconstructed, these
road will be developed to facilitate
proper ground-based skidding and
access log-landing areas. Upon
completion of logging and other
mechanized treatments, temporary
roads would be rehabilitated and closed.
The remaining roads, needed for long
term access would be closed by
installing gates or other barriers at road
entrances to eliminate motor vehicle use
on the road (Forest Plan, p. 47). Closed
roads may be reopened when needed for
subsequent fuel reduction or other
management activities, and then closed
following completion of that activity
(Forest Plan, p. 37). Closed roads may be
used as trails for hiking, mountain
biking and horseback-riding. The
proposed forest management treatments
and roadwork integrated various detail
design-features to conserve cultural or
historical sites, air quality, soil, water
quality, wildlife, native plants and trees,
scenery, and recreation.
To achieve desired conditions for the
area, the proposed action involves some
removal of commercial-size trees from
areas of protected habitat of the Mexican
spotted owl, a threatened species. Under
the current forest plan as amended,
these treatments to reduce fuels near
urban areas are anticipated; nonetheless,
they are a departure from the forestwide
standards and guidelines adopted to
implement the recovery plan for this
species. Additionally, the proposed
action will remove canopy cover within
Northern goshawk post-fledging areas.
Northern goshawk is a Regional Forester
sensitive species. These areas may not
meet forest plan standards and
guidelines for canopy cover. Forest plan
standards and guidelines also restrict
operation of wheeled of tracked logging
equipment to slopes of less than 40%.
Operation of logging equipment on
slopes in excess of 40% is anticipated
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52849
under one or more alternatives.
Vegetative removal and road
construction is likely to be clearly
evident, for approximately 10 years,
within the project area. The forest plan
standards and guidelines for the Visual
Quality Objective (VQO) within the
project area specify that the area should
be managed with a VQO of Retention.
Under a Retention VQO, forest
management activities may be visible
but not clearly evident to the average
viewer. Disturbances must appear to be
from natural causes. Therefore, to
ensure project consistency with the
forest plan, the plan would be amended
at the same time as and in conjunction
with the approval of an action
alternative, should one be selected, that
involve similar departure form current
standards and guidelines to conserve
Mexican spotted owl, Northern
goshawk, visual quality and limitations
on activities on slopes over 40%. The
plan amendments would be limited to
apply only to the Perk-Grindstone III
hazardous fuel reduction project area
and its approved activities (36 CFR
219.8(e)).
FOR FURTHER INFORMATION CONTACT:
Buck Sanchez, District Ranger, Smokey
Bear Ranger District, Lincoln National
Forest, 901 Mechem, Ruidoso, NM
88345, telephone (505) 257–4095.
Dated: September 10, 2007.
S.E. ‘‘Lou’’ Woltering,
Forest Supervisor.
[FR Doc. 07–4582 Filed 9–14–07; 8:45 am]
BILLING CODE 3410–11–M
DEPARTMENT OF AGRICULTURE
Forest Service
Lake Tahoe Basin Federal Advisory
Committee
Forest Service, USDA.
ACTION: Notice of meeting.
AGENCY:
SUMMARY: The Lake Tahoe Basin Federal
Advisory Committee will hold a
meeting on October 9, 2007 at the Sierra
Nevada College, 999 Tahoe Boulevard,
Incline Village, NV 89451. This
Committee, established by the Secretary
of Agriculture on December 15, 1998 (64
FR 2876), is chartered to provide advice
to the Secretary on implementing the
terms of the Federal Interagency
Partnership on the Lake Tahoe Region
and other matters raised by the
Secretary.
The meeting will be held
October 9, 2007, beginning at 1 p.m. and
ending at 4 p.m.
DATES:
E:\FR\FM\17SEN1.SGM
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]]>Agencies
[Federal Register Volume 72, Number 179 (Monday, September 17, 2007)]
[Notices]
[Pages 52847-52849]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-18266]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2007-0121]
Determination of Regulatory Review Period for Purposes of Patent
Extension; Fel-O-Vax[supreg] LvK/FIV Vaccine
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: We are advising the public that the Animal and Plant Health
Inspection Service has determined the regulatory review period for Fel-
O-Vax[supreg] LvK/FIV Vaccine and is publishing this notice of that
determination as required
[[Page 52848]]
by law. We have made this determination in response to the submission
of an application to the Commissioner of Patents and Trademarks,
Department of Commerce, for the extension of a patent that claims that
veterinary biologic.
DATES: We will consider all requests for revision of the regulatory
review period determination that we receive on or before October 17,
2007. We will consider all due diligence petitions that we receive on
or before March 17, 2008.
ADDRESSES: You may submit revision requests and due diligence petitions
by either of the following methods:
Federal eRulemaking Portal: Go to https://www.regulations.gov,
select ``Animal and Plant Health Inspection Service'' from the agency
drop-down menu, then click ``Submit.'' In the Docket ID column, select
APHIS-2007-0121 to submit or view public comments and to view
supporting and related materials available electronically. Information
on using Regulations.gov, including instructions for accessing
documents, submitting comments, and viewing the docket after the close
of the comment period, is available through the site's ``User Tips''
link.
Postal Mail/Commercial Delivery: Please send four copies of your
request or petition (an original and three copies) to Docket No. APHIS-
2007-0121, Regulatory Analysis and Development, PPD, APHIS, Station 3A-
03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state
that the request or petition refers to Docket No. APHIS-2007-0121.
Reading Room: You may read the regulatory review period
determination and any revision requests or due diligence petitions that
we receive on this determination in our reading room. The reading room
is located in room 1141 of the USDA South Building, 14th Street and
Independence Avenue, SW., Washington, DC. Normal reading room hours are
8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure
someone is there to help you, please call (202) 690-2817 before coming.
Other Information: Additional information about APHIS and its
programs is available on the Internet at https://www.aphis.usda.gov.
FOR FURTHER INFORMATION CONTACT: Dr. Albert P. Morgan, Section Leader,
Operational Support Section, Center for Veterinary Biologics, Policy
Evaluation and Licensing, VS, APHIS, 4700 River Road Unit 148,
Riverdale, MD 20737-1231; phone (301) 734-8245; fax (301) 734-4314.
For information concerning the regulatory review period
determination, contact Dr. Patricia L. Foley, Center for Veterinary
Biologics, Policy Evaluation and Licensing, VS, APHIS, 510 South 17th
Street, Suite 104, Ames, IA 50010; phone (515) 232-5785, fax (515) 232-
7120.
SUPPLEMENTARY INFORMATION: The provisions of 35 U.S.C. 156, ``Extension
of patent term,'' provide, generally, that a patent for a product may
be extended for a period of up to 5 years as long as the patent claims
a product that, among other things, was subject to a regulatory review
period before its commercial marketing or use. (The term ``product'' is
defined in that section as ``a drug product'' [which includes
veterinary biological products] or ``any medical device, food additive,
or color additive subject to regulation under the Federal Food, Drug,
and Cosmetic Act.'') A product's regulatory review period forms the
basis for determining the amount of extension an applicant may receive.
The regulations in 9 CFR part 124, ``Patent Term Restoration''
(referred to below as the regulations), set forth procedures and
requirements for the Animal and Plant Health Inspection Service's
(APHIS) review of applications for the extension of the term of certain
patents for veterinary biological products pursuant to 35 U.S.C. 156.
As identified in the regulations, the responsibilities of APHIS
include:
Assisting the Patent and Trademark Office of the U.S. Department of
Commerce in determining eligibility for patent term restoration;
Determining the length of a product's regulatory review period;
If petitioned, reviewing and ruling on due diligence challenges to
APHIS' regulatory review period determinations; and
Conducting hearings to review initial APHIS findings on due
diligence challenges.
The regulations are designed to be used in conjunction with
regulations issued by the Patent and Trademark Office concerning patent
term extension, which may be found at 37 CFR 1.710 through 1.791.
A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For veterinary biologics, the
testing phase begins on the date the authorization to prepare an
experimental veterinary biologic became effective and runs until the
approval phase begins. The approval phase begins on the date an
application for a license was initially submitted for approval and ends
on the date such license was issued. Although only a portion of a
regulatory review period may count toward the actual amount of
extension that the Commissioner of Patents and Trademarks may award,
APHIS' determination of the length of a regulatory review period for a
veterinary biologic will include all of the testing phase and approval
phase as specified in 35 U.S.C. 156(g)(5)(B).
APHIS recently licensed for production and marketing the veterinary
biologic Fel-O-Vax[supreg] LvK/FIV (Feline Immunodeficiency-Leukemia
Virus Vaccine, Killed Virus) Vaccine. Subsequent to this approval, the
Patent and Trademark Office received a patent term restoration
application for Fel-O-Vax[supreg] LvK/FIV Vaccine (U.S. Patent No.
5,510,106) from the Regents of the University of California, and the
Patent and Trademark Office requested APHIS' assistance in determining
this patent's eligibility for patent term restoration. In a letter
dated January 16, 2007, APHIS advised the Patent and Trademark Office
that this veterinary biologic had undergone a regulatory review period
and that the approval of Fel-O-Vax[supreg] LvK/FIV Vaccine represented
the first permitted commercial licensing or use of the product.
Subsequently, the Patent and Trademark Office requested that APHIS
determine the product's regulatory review period.
APHIS has determined that the applicable regulatory review period
for Fel-O-Vax[supreg] LvK/FIV Vaccine is 1,348 days. Of this time, 0
days occurred during the testing phase of the regulatory review period,
and 1,348 days occurred during the approval phase. These periods were
derived from the following dates:
1. The date the application for a license was initially submitted
for approval under the Virus-Serum-Toxin Act: October 15, 1999. APHIS
has verified the applicant's claim that the application was initially
submitted on October 15, 1999.
2. The date the license was issued: June 23, 2003. APHIS has
verified the applicant's claim that the license for the commercial
marketing of the vaccine was issued on June 23, 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 1,348 days of
patent term extension.
Section 124.22 of the regulations provides that any interested
person may request a revision of the regulatory
[[Page 52849]]
review period determination within 30 days of the date of this notice
(see DATES above). The request must specify the following:
The identity of the product;
The identity of the applicant for patent term restoration;
The docket number of this notice; and
The basis for the request for revision, including any documentary
evidence.
Further, under Sec. 124.30 of the regulations, any interested
person may file a petition with APHIS, no later than 180 days after the
date of this notice (see DATES above), alleging that a license
applicant did not act with due diligence in seeking APHIS approval of
the product during the regulatory review period. The filing, format,
and content of a petition must be as described in the regulations in
``Subpart D--Due Diligence Petitions'' (Sec. Sec. 124.30 through
124.33).
Authority: 35 U.S.C. 156.
Done in Washington, DC, this 11th day of September, 2007.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E7-18266 Filed 9-14-07; 8:45 am]
BILLING CODE 3410-34-P
