Determination of Regulatory Review Period for Purposes of Patent Extension; TYSABRI, 13604-13605 [E6-3781]
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13604
Federal Register / Vol. 71, No. 51 / Thursday, March 16, 2006 / Notices
those medical devices that are expected
to be in demand but in short supply in
an emergency/disaster. The data
collection system includes life-saving
and life-sustaining products (i.e.,
mechanically powered ventilators) as
well as products that would require
frequent changes resulting in rapidly
depleted supplies (i.e., face masks and
gloves).
In the Federal Register of November
4, 2005 (70 FR 67177), FDA published
a 60-day notice requesting public
comment on the information collection
provisions. No comments were received.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Annual Frequency per
Response
No. of Respondents
65
3
1There
Dated: March 10, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–3820 Filed 3–15–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005E–0238]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; TYSABRI
AGENCY:
Food and Drug Administration,
HHS.
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
TYSABRI 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 human biological
product.
Submit written or electronic
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.
ADDRESSES:
wwhite on PROD1PC61 with NOTICES
Hours per
Response
195
Total Hours
.5
98
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA based these estimates on past
experience with direct contact with the
medical device manufacturers. FDA
estimates that approximately 65
manufacturers would be contacted by
electronic mail three times per year to
get updated information at their
facilities. Further, it is estimated that
the manufacturers may require up to 30
minutes to check if information received
previously is still current and send
electronic mail back to FDA.
ACTION:
Total Annual
Responses
VerDate Aug<31>2005
15:48 Mar 15, 2006
Jkt 208001
FOR FURTHER INFORMATION CONTACT:
Claudia V. Grillo, Office of Regulatory
Policy (HFD–013), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 240–453–6681.
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
biological products, the testing phase
begins when the exemption to permit
the clinical investigations of the
biological 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 biological product
and continues until FDA grants
permission to market the biological
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 biological 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 biological product TYSABRI
(natalizumab). TYSABRI is indicated for
the treatment of patients, with relapsing
forms of multiple sclerosis, to reduce
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
the frequency of clinical exacerbations.
Subsequent to this approval, the Patent
and Trademark Office received a patent
term restoration application for
TYSABRI (U.S. Patent No. 5,840,299)
from Athena Neurosciences, Inc., 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 8, 2005, FDA advised the Patent
and Trademark Office that this human
biological product had undergone a
regulatory review period and that the
approval of TYSABRI 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
TYSABRI is 2,924 days. Of this time,
2,740 days occurred during the testing
phase of the regulatory review period,
while 184 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 (21 U.S.C. 355(i))
became effective: November 23, 1996.
FDA has verified the applicant’s claim
that the date the investigational new
drug application became effective was
on November 23, 1996.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
U.S.C. 262): May 24, 2004. FDA has
verified the applicant’s claim that the
product license application (BLA) for
TYSABRI (BLA 125104) was initially
submitted on May 24, 2004.
3. The date the application was
approved: November 23, 2004. FDA has
verified the applicant’s claim that BLA
125104 was approved on November 23,
2004.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the U.S. Patent and
E:\FR\FM\16MRN1.SGM
16MRN1
Federal Register / Vol. 71, No. 51 / Thursday, March 16, 2006 / Notices
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 1,189 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 May 15, 2006.
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
September 12, 2006. 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 13, 2006.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E6–3781 Filed 3–16–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Obstetrics and Gynecology Devices
Panel of the Medical Devices Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
wwhite on PROD1PC61 with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). At least one portion of the
meeting will be closed to the public.
Name of the Committee: Obstetrics
and Gynecology Devices Panel of the
Medical Devices Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
VerDate Aug<31>2005
15:48 Mar 15, 2006
Jkt 208001
Date and Time: The meeting will be
held on March 27, 2006, from 10 a.m.
to 5:45 p.m., and on March 28, 2006,
from 8 a.m. to 3 p.m.
Location: Gaithersburg Hilton, Salons
A, B, and C, 620 Perry Pkwy.,
Gaithersburg, MD.
Contact: Michael Bailey, Center for
Devices and Radiological Health (HFZ–
470), Food and Drug Administration,
9200 Corporate Blvd., Rockville, MD
20850, 301–594–1180, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), code
3014512524. Please call the Information
Line for up-to-date information on this
meeting.
Agenda: On March 27, 2006, the
committee will discuss, make
recommendations, and vote on a
premarket approval application for a
post-surgical adhesion prevention
device for use in patients undergoing
gynecological laparoscopic surgical
procedures. On March 28, 2006, the
committee will have a general topic
discussion of clinical trial design issues
for new devices intended to treat
symptomatic uterine fibroids.
Background information, including the
agenda and questions for the committee,
will be available to the public, 1
business day before the meeting, on the
Internet at https://www.fda.gov/cdrh/
panelmtg.html.
Procedure: On March 27, 2006, from
10 a.m. to 5:45 p.m., and on March 28,
2006, from 9 a.m. to 3 p.m., the meeting
is open to the public. Interested persons
may present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person by March 20, 2006. Oral
presentations from the public will be
scheduled on March 27, 2006, between
approximately 10:10 a.m. and 10:40 a.m.
and between approximately 4:15 p.m.
and 4:45 p.m., and on March 28, 2006,
between approximately 10:15 a.m. and
11:15 a.m. Time allotted for each
presentation may be limited. Those
desiring to make formal oral
presentations should notify the contact
person before March 20, 2006, and
submit a brief statement of the general
nature of the evidence or arguments
they wish to present, the names and
addresses of proposed participants, and
an indication of the approximate time
requested to make their presentation.
Closed Committee Deliberations: On
March 28, 2006, from 8 a.m. to 9 a.m.,
the meeting will be closed to permit
discussion and review of trade secret
and/or confidential information (5
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
13605
U.S.C. 552b(c)(4)) regarding pending
and future device issues.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact AnnMarie
Williams, Conference Management
Staff, at 240–276–0450, ext. 113, at least
7 days in advance of the meeting.
FDA regrets that it was unable to
publish this notice 15 days prior to the
Obstetrics and Gynecology Devices
Panel of the Medical Devices Advisory
Committee meeting. Because the agency
believes there is some urgency to bring
these issues to public discussion and
qualified members of the Obstetrics and
Gynecology Devices Panel of the
Medical Devices Advisory Committee
were available at this time, the
Commissioner of Food and Drugs
concluded that it was in the public
interest to hold this meeting even if
there was not sufficient time for the
customary 15-day public notice.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app.2).
Dated: March 7, 2006.
Jason Brodsky,
Acting Associate Commissioner for External
Relations.
[FR Doc. E6–3786 Filed 3–15–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0103]
Guidance for Industry on Using a
Centralized IRB Process in Multicenter
Clinical Trials; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Using a Centralized IRB
Process in Multicenter Clinical Trials.’’
The guidance is intended to assist
sponsors, institutions, institutional
review boards (IRBs), and clinical
investigators involved in multicenter
clinical research in meeting the
requirements of FDA regulations by
E:\FR\FM\16MRN1.SGM
16MRN1
]]>Agencies
[Federal Register Volume 71, Number 51 (Thursday, March 16, 2006)]
[Notices]
[Pages 13604-13605]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-3781]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005E-0238]
Determination of Regulatory Review Period for Purposes of Patent
Extension; TYSABRI
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for TYSABRI 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 human biological product.
ADDRESSES: Submit written or electronic 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: Claudia V. Grillo, Office of
Regulatory Policy (HFD-013), Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 240-453-6681.
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 biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological 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 biological
product and continues until FDA grants permission to market the
biological 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 biological 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 biological product
TYSABRI (natalizumab). TYSABRI is indicated for the treatment of
patients, with relapsing forms of multiple sclerosis, to reduce the
frequency of clinical exacerbations. Subsequent to this approval, the
Patent and Trademark Office received a patent term restoration
application for TYSABRI (U.S. Patent No. 5,840,299) from Athena
Neurosciences, Inc., 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 8, 2005, FDA advised the
Patent and Trademark Office that this human biological product had
undergone a regulatory review period and that the approval of TYSABRI
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
TYSABRI is 2,924 days. Of this time, 2,740 days occurred during the
testing phase of the regulatory review period, while 184 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 (21 U.S.C. 355(i)) became effective: November
23, 1996. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on November
23, 1996.
2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): May 24, 2004. FDA has verified the
applicant's claim that the product license application (BLA) for
TYSABRI (BLA 125104) was initially submitted on May 24, 2004.
3. The date the application was approved: November 23, 2004. FDA
has verified the applicant's claim that BLA 125104 was approved on
November 23, 2004.
This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and
[[Page 13605]]
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 1,189 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 May 15, 2006. 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 September 12,
2006. 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 13, 2006.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E6-3781 Filed 3-16-06; 8:45 am]
BILLING CODE 4160-01-S
