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Federal Register / Vol. 71, No.

18 / Friday, January 27, 2006 / Notices 4593

August 31, 2004, FDA advised the 1984.) Petitions should be in the format This notice is issued under the
Patent and Trademark Office that this specified in 21 CFR 10.30. Federal Advisory Committee Act (5
human drug product had undergone a Comments and petitions should be U.S.C. app. 2) and 21 CFR part 14,
regulatory review period and that the submitted to the Division of Dockets relating to advisory committees.
approval of SPIRIVA HANDIHALER Management. Three copies of any Dated: January 17, 2006.
represented the first permitted mailed information are to be submitted,
Jason Brodsky,
commercial marketing or use of the except that individuals may submit one
copy. Comments are to be identified Acting Associate Commissioner for External
product. Thereafter, the Patent and
Relations.
Trademark Office requested that FDA with the docket number found in
brackets in the heading of this [FR Doc. E6–1003 Filed 1–26–06; 8:45 am]
determine the product’s regulatory
document. Comments and petitions may BILLING CODE 4160–01–S
review period.
FDA has determined that the be seen in the Division of Dockets
applicable regulatory review period for Management between 9 a.m. and 4 p.m.,
SPIRIVA HANDIHALER is 3,318 days. Monday through Friday. DEPARTMENT OF HEALTH AND
Of this time, 2,557 days occurred during HUMAN SERVICES
Dated: January 5, 2006.
the testing phase of the regulatory
Jane A. Axelrad, Food and Drug Administration
review period, while 761 days occurred
Associate Director for Policy, Center for Drug
during the approval phase. These Peripheral and Central Nervous
Evaluation and Research.
periods of time were derived from the System Drugs Advisory Committee;
[FR Doc. E6–1050 Filed 1–26–06; 8:45 am]
following dates: Notice of Meeting
1. The date an exemption under BILLING CODE 4160–01–S

section 505 of the Federal Food, Drug, AGENCY: Food and Drug Administration,
and Cosmetic Act (the act) (21 U.S.C. HHS.
355) became effective: January 1, 1995. DEPARTMENT OF HEALTH AND
ACTION: Notice.
The applicant claims February 2, 1995, HUMAN SERVICES
as the date the investigational new drug This notice announces a forthcoming
Food and Drug Administration meeting of a public advisory committee
application (IND) became effective.
However, FDA records indicate that the Oncologic Drugs Advisory Committee; of the Food and Drug Administration
IND effective date was January 1, 1995, Amendment of Notice (FDA). The meeting will be open to the
which was 30 days after FDA receipt of public.
the IND. AGENCY: Food and Drug Administration, Name of Committee: Peripheral and
2. The date the application was HHS. Central Nervous System Drugs Advisory
initially submitted with respect to the ACTION: Notice. Committee.
human drug product under section 505 General Function of the Committee:
of the act: December 31, 2001. FDA has The Food and Drug Administration To provide advice and
verified the applicant’s claim that the (FDA) is announcing an amendment to recommendations to the agency on
new drug application (NDA) for Spiriva the notice of meeting of the Oncologic FDA’s regulatory issues.
HandiHaler (NDA 21–395) was initially Drugs Advisory Committee. This Date and Time: The meeting will be
submitted on December 31, 2001. meeting was announced in the Federal held on March 7, 2006, from 8 a.m. to
3. The date the application was Register of January 6, 2006 (71 FR 943). 5 p.m.
approved: January 30, 2004. FDA has The amendment is being made to reflect Location: Holiday Inn Gaithersburg,
verified the applicant’s claim that NDA a change in the Date and Time portion The Ballrooms, Two Montgomery
21–395 was approved on January 30, of the document. The date of this Village Ave., Gaithersburg, MD.
2004. meeting is being changed. There are no Contact Person: Sohail Mosaddegh,
This determination of the regulatory other changes. Center for Drug Evaluation and Research
review period establishes the maximum FOR FURTHER INFORMATION CONTACT: (HFD–21), Food and Drug
potential length of a patent extension. Johanna Clifford, Center for Drug Administration, 5600 Fishers Lane (for
However, the U.S. Patent and Evaluation and Research (HFD–21), express delivery, 5630 Fishers Lane, rm.
Trademark Office applies several Food and Drug Administration, 5600 1093), Rockville, MD 20857, 301–827–
statutory limitations in its calculations Fishers Lane, Rockville, MD 20857, 301 7001, FAX: 301–827–6776, e-mail:
of the actual period for patent extension. 827–7001, FAX: 301–827–6776, e-mail: mosaddeghs@cder.fda.gov, or FDA
In its application for patent extension, cliffordj@cder.fda.gov, or the FDA Advisory Committee Information Line,
this applicant seeks 1,421 days of patent Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the
term extension. 1–800–741–8138 (301–443–0572 in the Washington, DC area), code
Anyone with knowledge that any of Washington DC area), code 3014512542. 3014512543. Please call the Information
the dates as published is incorrect may, Please call the information line for up- Line for up-to-date information on this
on or before March 28, 2006, submit to to-date information on this meeting. meeting.
the Division of Dockets Management SUPPLEMENTARY INFORMATION: In the Agenda: The committee will discuss
(see ADDRESSES) written comments and Federal Register of January 6, 2006, TYSABRI (natalizumab) biologic license
ask for a redetermination. Furthermore, FDA announced that a meeting of the application 125104/15; Biogen Idec Inc.,
any interested person may petition FDA, Oncologic Drugs Advisory Committee for an indication in patients with
on or before July 26, 2006, for a would be held on March 15, 2006, from relapsing forms of multiple sclerosis to
determination regarding whether the 8 a.m. to 5 p.m. On page 943, in the 2d reduce the frequency of clinical
applicant for extension acted with due column, the Date and Time portion of exacerbations. The committee will
rmajette on PROD1PC67 with NOTICES

diligence during the regulatory review the document is amended to read as discuss the risks (including progressive
period. To meet its burden, the petition follows: multifocal leukoencephalopathy)
must contain sufficient facts to merit an Date and Time: The meeting will be associated with TYSABRI (natalizumab)
FDA investigation. (See H. Rept. 857, held on March 13, 2006, from 8 a.m. to administration, its efficacy in the
part 1, 98th Cong., 2d sess., pp. 41–42, 5 p.m. treatment of multiple sclerosis relapses

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