Oncologic Drugs Advisory Committee; Amendment of Notice, 4593 [E6-1003]
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rmajette on PROD1PC67 with NOTICES
Federal Register / Vol. 71, No. 18 / Friday, January 27, 2006 / Notices
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 SPIRIVA HANDIHALER
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
SPIRIVA HANDIHALER is 3,318 days.
Of this time, 2,557 days occurred during
the testing phase of the regulatory
review period, while 761 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: January 1, 1995.
The applicant claims February 2, 1995,
as the date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was January 1, 1995,
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: December 31, 2001. FDA has
verified the applicant’s claim that the
new drug application (NDA) for Spiriva
HandiHaler (NDA 21–395) was initially
submitted on December 31, 2001.
3. The date the application was
approved: January 30, 2004. FDA has
verified the applicant’s claim that NDA
21–395 was approved on January 30,
2004.
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 1,421 days of patent
term extension.
Anyone with knowledge that any of
the dates as published is incorrect may,
on or before March 28, 2006, submit to
the Division of Dockets Management
(see ADDRESSES) written comments and
ask for a redetermination. Furthermore,
any interested person may petition FDA,
on or before July 26, 2006, for a
determination regarding whether the
applicant for extension acted with due
diligence during the regulatory review
period. 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,
VerDate Aug<31>2005
15:17 Jan 26, 2006
Jkt 208001
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: January 5, 2006.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E6–1050 Filed 1–26–06; 8:45 am]
BILLING CODE 4160–01–S
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: January 17, 2006.
Jason Brodsky,
Acting Associate Commissioner for External
Relations.
[FR Doc. E6–1003 Filed 1–26–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Peripheral and Central Nervous
System Drugs Advisory Committee;
Notice of Meeting
AGENCY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Oncologic Drugs Advisory Committee;
Amendment of Notice
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug Administration
(FDA) is announcing an amendment to
the notice of meeting of the Oncologic
Drugs Advisory Committee. This
meeting was announced in the Federal
Register of January 6, 2006 (71 FR 943).
The amendment is being made to reflect
a change in the Date and Time portion
of the document. The date of this
meeting is being changed. There are no
other changes.
FOR FURTHER INFORMATION CONTACT:
Johanna Clifford, Center for Drug
Evaluation and Research (HFD–21),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301
827–7001, FAX: 301–827–6776, e-mail:
cliffordj@cder.fda.gov, or the FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington DC area), code 3014512542.
Please call the information line for upto-date information on this meeting.
SUPPLEMENTARY INFORMATION: In the
Federal Register of January 6, 2006,
FDA announced that a meeting of the
Oncologic Drugs Advisory Committee
would be held on March 15, 2006, from
8 a.m. to 5 p.m. On page 943, in the 2d
column, the Date and Time portion of
the document is amended to read as
follows:
Date and Time: The meeting will be
held on March 13, 2006, from 8 a.m. to
5 p.m.
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
4593
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Peripheral and
Central Nervous System Drugs Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on March 7, 2006, from 8 a.m. to
5 p.m.
Location: Holiday Inn Gaithersburg,
The Ballrooms, Two Montgomery
Village Ave., Gaithersburg, MD.
Contact Person: Sohail Mosaddegh,
Center for Drug Evaluation and Research
(HFD–21), Food and Drug
Administration, 5600 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm.
1093), Rockville, MD 20857, 301–827–
7001, FAX: 301–827–6776, e-mail:
mosaddeghs@cder.fda.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512543. Please call the Information
Line for up-to-date information on this
meeting.
Agenda: The committee will discuss
TYSABRI (natalizumab) biologic license
application 125104/15; Biogen Idec Inc.,
for an indication in patients with
relapsing forms of multiple sclerosis to
reduce the frequency of clinical
exacerbations. The committee will
discuss the risks (including progressive
multifocal leukoencephalopathy)
associated with TYSABRI (natalizumab)
administration, its efficacy in the
treatment of multiple sclerosis relapses
E:\FR\FM\27JAN1.SGM
27JAN1
]]>Agencies
[Federal Register Volume 71, Number 18 (Friday, January 27, 2006)]
[Notices]
[Page 4593]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-1003]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Oncologic Drugs Advisory Committee; Amendment of Notice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing an amendment
to the notice of meeting of the Oncologic Drugs Advisory Committee.
This meeting was announced in the Federal Register of January 6, 2006
(71 FR 943). The amendment is being made to reflect a change in the
Date and Time portion of the document. The date of this meeting is
being changed. There are no other changes.
FOR FURTHER INFORMATION CONTACT: Johanna Clifford, Center for Drug
Evaluation and Research (HFD-21), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301 827-7001, FAX: 301-827-6776, e-
mail: cliffordj@cder.fda.gov, or the FDA Advisory Committee Information
Line, 1-800-741-8138 (301-443-0572 in the Washington DC area), code
3014512542. Please call the information line for up-to-date information
on this meeting.
SUPPLEMENTARY INFORMATION: In the Federal Register of January 6, 2006,
FDA announced that a meeting of the Oncologic Drugs Advisory Committee
would be held on March 15, 2006, from 8 a.m. to 5 p.m. On page 943, in
the 2d column, the Date and Time portion of the document is amended to
read as follows:
Date and Time: The meeting will be held on March 13, 2006, from 8
a.m. to 5 p.m.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.
Dated: January 17, 2006.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. E6-1003 Filed 1-26-06; 8:45 am]
BILLING CODE 4160-01-S
