Determination of Regulatory Review Period for Purposes of Patent Extension; ZILMAX, 30594-30595 [E7-10602]
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Federal Register / Vol. 72, No. 105 / Friday, June 1, 2007 / Notices
hsrobinson on PROD1PC76 with NOTICES
set of specific physical activity
recommendations. The Committee will
prepare a report to the Secretary of HHS
that documents the scientific
background and rationale for the
issuance of Physical Activity Guidelines
for Americans. The report will also
identify areas where further scientific
research is needed. HHS will use the
Final Report of the Committee to
develop Physical Activity Guidelines.
The intent is to develop physical
activity recommendations for all
Americans that will be tailored as
necessary for specific subgroups of the
population.
Public Participation at Meeting:
Members of the public are invited to
observe the Advisory Committee
meeting. Please note it is anticipated
that there will be no oral public
comments during the initial Physical
Activity Guidelines Advisory
Committee meeting, however, written
comments are welcome throughout the
Guidelines development process and
may be e-mailed to
PA.guidelines@hhs.gov. A summary of
the Advisory Committee meetings will
be made available shortly after each
meeting.
To observe the Committee meeting,
individuals must pre-register at the
Physical Activity Guidelines Web site at
https://www.health.gov/PAguidelines.
Registrations must be completed by June
22, 2007. Space for the meeting is
limited. Registrations will be accepted
until maximum room capacity is
reached. A waiting list will be
maintained should registrations exceed
room capacity. Individuals on the
waiting list will be contacted as
additional space for the meeting
becomes available.
Registrants for the Physical Activity
Advisory Committee meeting must
present valid government-issued photo
identification (i.e., driver’s license) and
should arrive 45 minutes prior to the
start of the meeting to pass through
security.
Registration questions may be
directed to Experient at
PAguidelines@experient-inc.com
(e-mail), (703) 525–8333 x3349 (phone)
or (703) 525–8557 (fax).
Dated: May 22, 2007.
Penelope Slade Royall,
RADM, USPHS, Deputy Assistant Secretary
for Health, Office of Disease Prevention and
Health Promotion.
[FR Doc. E7–10440 Filed 5–31–07; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
[Docket No. 2007E–0046]
[Docket No. 2006N–0197]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Registration of Food Facilities Under
the Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration is announcing that a
collection of information entitled
‘‘Registration of Food Facilities Under
the Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
In the
Federal Register of December 15, 2006
(71 FR 75555), the agency announced
that the proposed information collection
had been submitted to OMB for review
and clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0502. The
approval expires on May 31, 2010. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.fda.gov/
ohrms/dockets.
SUPPLEMENTARY INFORMATION:
Dated: May 29, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–10617 Filed 5–31–07; 8:45 am]
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Determination of Regulatory Review
Period for Purposes of Patent
Extension; ZILMAX
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
ZILMAX 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
which claims that animal 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–007), 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 animal drug
products, the testing phase begins on
the earlier date when either a major
environmental effects test was initiated
for the drug or when an exemption
under section 512(j) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 360b(j)) became effective and
runs until the approval phase begins.
The approval phase starts with the
initial submission of an application to
market the animal drug product and
E:\FR\FM\01JNN1.SGM
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hsrobinson on PROD1PC76 with NOTICES
Federal Register / Vol. 72, No. 105 / Friday, June 1, 2007 / Notices
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
an animal drug product will include all
of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(4)(B).
FDA recently approved for marketing
the animal drug product ZILMAX
(zilpaterol hydrochloride). ZILMAX is
indicated for increased rate of weight
gain, improved feed efficiency, and
increased carcass leanness in cattle fed
in confinement for slaughter during the
last 20 to 40 days on feed. Subsequent
to this approval, the Patent and
Trademark Office received a patent term
restoration application for ZILMAX
(U.S. Patent No. 4,900,735) from Intervet
International B.V., and the Patent and
Trademark Office requested FDA’s
assistance in determining this patent’s
eligibility for patent term restoration. In
a letter dated March 5, 2007, FDA
advised the Patent and Trademark
Office that this animal drug product had
undergone a regulatory review period
and that the approval of ZILMAX
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
ZILMAX is 4,720 days. Of this time,
4,674 days occurred during the testing
phase of the regulatory review period,
while 46 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 512(j) of the act involving this
animal drug product became effective:
September 9, 1993. FDA has verified the
applicant’s claim that the date the
investigational new animal drug
application (INAD) became effective
was on September 9, 1993.
2. The date the application was
initially submitted with respect to the
animal drug product under section
512(b) of the act: June 26, 2006. FDA
has verified the applicant’s claim that
the new animal drug application
(NADA) for ZILMAX (NADA 141–258)
was initially submitted on June 26,
2006.
3. The date the application was
approved: August 10, 2006. FDA has
verified the applicant’s claim that
VerDate Aug<31>2005
18:10 May 31, 2007
Jkt 211001
NADA 141–258 was approved on
August 10, 2006.
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 is incorrect may
submit to the Division of Dockets
Management (see ADDRESSES) written or
electronic comments and ask for a
redetermination by July 31, 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
November 28, 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: May 7, 2007.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E7–10602 Filed 5–31–07; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007E–0011]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; LANTUS
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
LANTUS and is publishing this notice
of that determination as required by
law. FDA has made the determination
PO 00000
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30595
because of the submission of an
application to the Director of Patents
and Trademarks, Department of
Commerce, for the extension of a patent
which 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–007), 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 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 approved for marketing the
human drug product LANTUS (insulin
glargine [rDNA origin]). LANTUS is
indicated for once-daily subcutaneous
administration for the treatment of adult
and pediatric patients with type 1
diabetes mellitus or adult patients with
type 2 diabetes mellitus who require
basal (long-acting) insulin for the
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]]>Agencies
[Federal Register Volume 72, Number 105 (Friday, June 1, 2007)]
[Notices]
[Pages 30594-30595]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-10602]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007E-0046]
Determination of Regulatory Review Period for Purposes of Patent
Extension; ZILMAX
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for ZILMAX 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
which claims that animal 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-007), 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 animal drug products, the
testing phase begins on the earlier date when either a major
environmental effects test was initiated for the drug or when an
exemption under section 512(j) of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 360b(j)) became effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the animal drug product and
[[Page 30595]]
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 an animal drug product will include all of the testing phase
and approval phase as specified in 35 U.S.C. 156(g)(4)(B).
FDA recently approved for marketing the animal drug product ZILMAX
(zilpaterol hydrochloride). ZILMAX is indicated for increased rate of
weight gain, improved feed efficiency, and increased carcass leanness
in cattle fed in confinement for slaughter during the last 20 to 40
days on feed. Subsequent to this approval, the Patent and Trademark
Office received a patent term restoration application for ZILMAX (U.S.
Patent No. 4,900,735) from Intervet International B.V., and the Patent
and Trademark Office requested FDA's assistance in determining this
patent's eligibility for patent term restoration. In a letter dated
March 5, 2007, FDA advised the Patent and Trademark Office that this
animal drug product had undergone a regulatory review period and that
the approval of ZILMAX 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
ZILMAX is 4,720 days. Of this time, 4,674 days occurred during the
testing phase of the regulatory review period, while 46 days occurred
during the approval phase. These periods of time were derived from the
following dates:
1. The date an exemption under section 512(j) of the act involving
this animal drug product became effective: September 9, 1993. FDA has
verified the applicant's claim that the date the investigational new
animal drug application (INAD) became effective was on September 9,
1993.
2. The date the application was initially submitted with respect to
the animal drug product under section 512(b) of the act: June 26, 2006.
FDA has verified the applicant's claim that the new animal drug
application (NADA) for ZILMAX (NADA 141-258) was initially submitted on
June 26, 2006.
3. The date the application was approved: August 10, 2006. FDA has
verified the applicant's claim that NADA 141-258 was approved on August
10, 2006.
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 is
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) written or electronic comments and ask for a redetermination
by July 31, 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 November 28,
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: May 7, 2007.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E7-10602 Filed 5-31-07; 8:45 am]
BILLING CODE 4160-01-S
