Termination, By Expiration, of Declaration of Emergency Justifying Emergency Use Authorization of Anthrax Vaccine Adsorbed, 5341-5342 [E6-1311]
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Federal Register / Vol. 71, No. 21 / Wednesday, February 1, 2006 / Notices
B. Federal Reserve Bank of San
Francisco (Tracy Basinger, Director,
Regional and Community Bank Group)
101 Market Street, San Francisco,
California 94105-1579:
1. Western Alliance Bancorporation,
Las Vegas, Nevada; to merge with
Intermountain First Bancorp, Las Vegas,
Nevada, and thereby indirectly acquire
voting shares of Nevada First Bank, Las
Vegas, Nevada.
Board of Governors of the Federal Reserve
System, January 27, 2006.
Robert deV. Frierson,
Deputy Secretary of the Board.
[FR Doc. E6–1325 Filed 1–31–06; 8:45 am]
BILLING CODE 6210–01–S
GENERAL SERVICES
ADMINISTRATION
A. Purpose
Office of Citizen Services and
Communications; Information
Collection; Market Research Collection
Office of Citizen Services and
Communications, General Services
Administration (GSA).
ACTION: Notice of request for comments
regarding a renewal to an existing OMB
clearance.
cchase on PROD1PC60 with NOTICES
AGENCY:
SUMMARY: Under the provisions of the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35), the General Services
Administration has submitted to the
Office of Management and Budget
(OMB) a request to review and approve
a renewal of a currently approved
information collection requirement
regarding Market Research for the Office
of Citizen Services and
Communications. A request for public
comments was published at 70 FR
69154, November 14, 2005. No
comments were received.
This information collection will be
used to determine the utility and ease of
use of GSA’s Web site, https://
www.gsa.gov. The respondents include
individuals and representatives from
businesses currently holding GSA
contracts.
Public comments are particularly
invited on: Whether this collection of
information is necessary and whether it
will have practical utility; whether our
estimate of the public burden of this
collection of information is accurate,
and based on valid assumptions and
methodology; ways to enhance the
quality, utility, and clarity of the
information to be collected.
DATES: Submit comments on or before:
March 3, 2006.
17:49 Jan 31, 2006
Submit comments regarding
this burden estimate or any other aspect
of this collection of information,
including suggestions for reducing this
burden to Ms. Jeanette Thornton, GSA
Desk Officer, OMB, Room 10236, NEOB,
Washington, DC 20503, and a copy to
the Regulatory Secretariat (VIR), General
Services Administration, Room 4035,
1800 F Street, NW., Washington, DC
20405. Please cite OMB Control No.
3090–0277, Market Research Collection
for the Office of Citizen Services and
Communications, in all correspondence.
Jkt 208001
Dated: January 23, 2006.
Michael W. Carleton,
Chief Information Officer.
[FR Doc. E6–1217 Filed 1–31–06; 8:45 am]
BILLING CODE 6820–CX–S
ADDRESSES:
SUPPLEMENTARY INFORMATION:
[OMB Control No. 3090–0277]
VerDate Aug<31>2005
Ms.
Jocelyn Johnson, Office of Citizen
Services and Communications, at
telephone (202) 208–0043, or via e-mail
to jocelyn.johnson@gsa.gov.
FOR FURTHER INFORMATION CONTACT:
5341
The General Services Administration
will be requesting the Office of
Management and Budget (OMB) to
review and approve information
collection 3090–0277 concerning
Market Research Collection for the
Office of Citizen Services and
Communications. The purpose of this
information collection is to inform GSA
on how to best provide service and
relevance to the American public via
GSA’s Web site https://www.gsa.gov. The
information collected from an online
survey, focus groups, and Web site
usability testing will be used to refine
the https://www.gsa.gov Web site. The
questions to be asked are non-invasive
and do not address or probe sensitive
issues. It is important for the GSA to
gain information from the many diffuse
groups it serves; therefore, the GSA will
be questioning individuals and
households, and businesses and other
for-profit groups.
B. Annual Reporting Burden
Respondents: 190.
Responses Per Respondent: 1.
Total Responses: 190.
Hours Per Response: 72.6 minutes.
Total Burden Hours: 230.
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the General Services Administration,
Regulatory Secretariat (VIR), 1800 F
Street, NW., Room 4035, Washington,
DC 20405, telephone (202) 208–7312.
Please cite OMB Control No. 3090–0277,
Market Research Collection for the
Office of Citizen Services and
Communications, in all correspondence.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Termination, By Expiration, of
Declaration of Emergency Justifying
Emergency Use Authorization of
Anthrax Vaccine Adsorbed
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is issuing this
notice, under the Federal Food, Drug,
and Cosmetic Act (the act), of the
termination, by expiration, of the
declaration of emergency justifying
emergency use authorization of Anthrax
Vaccine Adsorbed (AVA) that was
issued by the former Secretary of Health
and Human Services Secretary Tommy
G. Thompson (the former HHS
Secretary) on January 14, 2005. The
declaration of emergency terminated by
expiration on January 14, 2006, which is
the end of the 1-year period that began
on the date that the declaration was
made. Under the act, advance notice of
the termination of the declaration was
provided to the Department of Defense.
DATES: The Notice is effective as of
February 1, 2006.
FOR FURTHER INFORMATION CONTACT:
Boris Lushniak, Office of
Counterterrorism Policy and Planning
(HF–29), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4067.
SUPPLEMENTARY INFORMATION:
I. Background
On December 10, 2004, the Deputy
Secretary of Defense determined, under
section 564(b)(1)(B) of the act (21 U.S.C.
360bbb–3(b)(1)(B)), that there was a
significant potential for a military
emergency involving a heightened risk
to U.S. military forces of attack with
anthrax. On the basis of such
determination and under section
564(b)(1) of the act, the former HHS
Secretary declared an emergency
justifying the authorization of the
emergency use of Anthrax Vaccine
Adsorbed. A notice of the determination
of the Deputy Secretary of Defense and
the declaration of the former HHS
Secretary was published in the Federal
E:\FR\FM\01FEN1.SGM
01FEN1
5342
Federal Register / Vol. 71, No. 21 / Wednesday, February 1, 2006 / Notices
Register of February 2, 2005 (70 FR
5452).
II. Advance Notice of Termination
Under section 564(b)(3) of the act, the
FDA Commissioner provided advance
notice of the termination of the former
HHS Secretary’s declaration of
emergency to the Department of
Defense.
The January 2006 letter notifying the
Department of Defense of the
termination of the declaration of
emergency follows:
William Winkenwerder, Jr., M.D.,
Assistant Secretary of Defense for Health
Affairs,
The Pentagon,
Washington, D.C. 20301–1200
Dear Dr. Winkenwerder:
This letter is to provide advance notice of
the termination of the above-referenced
declaration of emergency that was issued by
Secretary of Health and Human Services
Tommy G. Thompson on January 14, 2005,
pursuant to section 564(b)(1) of the Federal
Food, Drug, and Cosmetic Act (the Act), 21
U.S.C. § 360bbb–3.
In accordance with section 564(b)(2)(A)(ii)
of the Act, the declaration of emergency will
terminate by expiration on January 14, 2006,
which is the end of the one year period that
began on the date that the declaration was
made. This advance notice of termination
will be published in the Federal Register,
pursuant to section 564(b)(4) of the Act.
Sincerely,
Andrew C. von Eschenbach, M.D.
Acting Commissioner of Food and Drugs
Dated: January 25, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–1311 Filed 1–31–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004E–0445]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; HUMIRA
AGENCY:
Food and Drug Administration,
HHS.
cchase on PROD1PC60 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
HUMIRA 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
VerDate Aug<31>2005
19:42 Jan 31, 2006
Jkt 208001
Commerce, for the extension of a patent
which claims that human biological
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:
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 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 HUMIRA
(adalimumab). HUMIRA is indicated for
reducing signs and symptoms, including
major clinical response, inhibiting the
progression of structural damage and
improving physical function in adult
patients with moderately to severely
active rheumatoid arthritis. Subsequent
to this approval, the Patent and
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Sfmt 4703
Trademark Office received a patent term
restoration application for HUMIRA
(U.S. Patent No. 6,090,382) from Abbott
Biotechnology Ltd., and the Patent and
Trademark Office requested FDA’s
assistance in determining this patent’s
eligibility for patent term restoration. In
a letter dated April 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
HUMIRA 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
HUMIRA is 1,722 days. Of this time,
1,443 days occurred during the testing
phase of the regulatory review period,
while 279 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: April 16, 1998. FDA
has verified the applicant’s claim that
the date the investigational new drug
application became effective was on
April 16, 1998.
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): March 28, 2002. FDA has
verified the applicant’s claim that the
product license application (BLA) for
HUMIRA (BLA 125057) was initially
submitted on March 28, 2002.
3. The date the application was
approved: December 31, 2002. FDA has
verified the applicant’s claim that BLA
125057 was approved on December 31,
2002.
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 326 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 April 3, 2006.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
E:\FR\FM\01FEN1.SGM
01FEN1
]]>Agencies
[Federal Register Volume 71, Number 21 (Wednesday, February 1, 2006)]
[Notices]
[Pages 5341-5342]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-1311]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Termination, By Expiration, of Declaration of Emergency
Justifying Emergency Use Authorization of Anthrax Vaccine Adsorbed
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is issuing this notice,
under the Federal Food, Drug, and Cosmetic Act (the act), of the
termination, by expiration, of the declaration of emergency justifying
emergency use authorization of Anthrax Vaccine Adsorbed (AVA) that was
issued by the former Secretary of Health and Human Services Secretary
Tommy G. Thompson (the former HHS Secretary) on January 14, 2005. The
declaration of emergency terminated by expiration on January 14, 2006,
which is the end of the 1-year period that began on the date that the
declaration was made. Under the act, advance notice of the termination
of the declaration was provided to the Department of Defense.
DATES: The Notice is effective as of February 1, 2006.
FOR FURTHER INFORMATION CONTACT: Boris Lushniak, Office of
Counterterrorism Policy and Planning (HF-29), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4067.
SUPPLEMENTARY INFORMATION:
I. Background
On December 10, 2004, the Deputy Secretary of Defense determined,
under section 564(b)(1)(B) of the act (21 U.S.C. 360bbb-3(b)(1)(B)),
that there was a significant potential for a military emergency
involving a heightened risk to U.S. military forces of attack with
anthrax. On the basis of such determination and under section 564(b)(1)
of the act, the former HHS Secretary declared an emergency justifying
the authorization of the emergency use of Anthrax Vaccine Adsorbed. A
notice of the determination of the Deputy Secretary of Defense and the
declaration of the former HHS Secretary was published in the Federal
[[Page 5342]]
Register of February 2, 2005 (70 FR 5452).
II. Advance Notice of Termination
Under section 564(b)(3) of the act, the FDA Commissioner provided
advance notice of the termination of the former HHS Secretary's
declaration of emergency to the Department of Defense.
The January 2006 letter notifying the Department of Defense of the
termination of the declaration of emergency follows:
William Winkenwerder, Jr., M.D.,
Assistant Secretary of Defense for Health Affairs,
The Pentagon,
Washington, D.C. 20301-1200
Dear Dr. Winkenwerder:
This letter is to provide advance notice of the termination of
the above-referenced declaration of emergency that was issued by
Secretary of Health and Human Services Tommy G. Thompson on January
14, 2005, pursuant to section 564(b)(1) of the Federal Food, Drug,
and Cosmetic Act (the Act), 21 U.S.C. Sec. 360bbb-3.
In accordance with section 564(b)(2)(A)(ii) of the Act, the
declaration of emergency will terminate by expiration on January 14,
2006, which is the end of the one year period that began on the date
that the declaration was made. This advance notice of termination
will be published in the Federal Register, pursuant to section
564(b)(4) of the Act.
Sincerely,
Andrew C. von Eschenbach, M.D.
Acting Commissioner of Food and Drugs
Dated: January 25, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-1311 Filed 1-31-06; 8:45 am]
BILLING CODE 4160-01-S
