AVA EUA Termination (PDF - 214KB)

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					                         Federal Register I Vol. 71, No. 21/Wednesday, February 1, 2006 I Notices                               5341

  B-. Federal Reserve Bank of San             FOR FURTHER INFORMATION CONTACT: Ms.          Dated: January 23, 2006.

Francisco (Tracy Basinger, Director,          Jocelyn Johnson, Office of Citizen          Michael w. Carleton,

Regional and Community Bank Group)            Services and Communications, at             ChiefInformation Officer.

101 Market Street, San Francisco,             telephone (202) 208-0043, or via e-mail     [FR Doc. E6-1217 Filed 1-31--06; 8:45 am]

California 94105-1579:                        to jocelyn.johnson@gsa.gov.                 BILLING CODE 6B2D-CX-S

  1. Western Alliance Bancorporation,
Las Vegas, Nevada; to merge with              ADDRESSES:   Submit comments regarding
Intermountain First Bancorp, Las Vegas,       this burden estimate or any other aspect
                                              of this collection of information,          DEPARTMENT OF HEALTH AND
Nevada, and thereby indirectly acquire
voting shares of Nevada First Bank, Las       including suggestions for reducing this     HUMAN SERVICES
Vegas, Nevada.                                burden to Ms. Jeanette Thornton, GSA
                                              Desk Officer, OMB, Room 10236, NEOB,        Food and Drug Administration
  Board of Governors of the Federal Reserve   Washington, DC 20503, and a copy to
System, January 27, 2006.                                                                 Termination, By Expiration, of
                                              the Regulatory Secretariat (VIR), General   Declaration of Emergency Justifying
Robert deV. Frierson,
                                              Services Administration, Room 4035,         Emergency Use Authorization of
Deputy Secretary ofthe Board.                 1800 F Street, NW., Washington, DC
[FR Doc. E6-1325 Filed 1-31--06; 8:45 am]                                                 Anthrax Vaccine Adsorbed
                                              20405. Please cite OMB Control No.
BILLING CODE 621CHll-S                        3090-0277, Market Research Collection       AGENCY:   Food and Drug Administration,

                                              for the Office of Citizen Services and      HHS.

                                              Communications, in all correspondence.      ACTION:   Notice.

ADMINISTRATION                                                                            SUMMARY:   The Food and Drug
                                              A. Purpose                                  Administration (FDA) is issuing this
[OMB Control No. 3090-0277]                                                               notice, under the Federal Food, Drug,
                                                 The General Services Administration      and Cosmetic Act (the act), of the
Office of Citizen Services and                will be requesting the Office of            termination, by expiration, of the
Communications; Information                   Management and Budget (OMB) to              declaration of emergency justifying
Collection; Market Research Collection        review and approve information              emergency use authorization of Anthrax
AGENCY: Office of Citizen Services and        collection 3090-0277 concerning             Vaccine Adsorbed (AVA) that was
Communications, General Services              Market Research Collection for the          issued by the former Secretary of Health
Administration (GSA).                         Office of Citizen Services and              and Human Services Secretary Tommy
                                              Communications. The purpose of this         G. Thompson (the former HHS
ACTION: Notice ofrequest for comments
                                              information collection is to inform GSA     Secretary) on January 14, 2005. The
regarding a renewal to an existing OMB                                                    declaration of emergency terminated by
clearance.                                    on how to best provide service and
                                              relevance to the American public via        expiration on January 14, 2006, which is
SUMMARY: Under the provisions of the          GSA's Web site http://www.gsa.gov. The      the end of the I-year period that began
Paperwork Reduction Act of 1995 (44           information collected from an online        on the date that the declaration was
U.S.c. Chapter 35), the General Services      survey, focus groups, and Web site          made. Under the act, advance notice of
Administration has submitted to the           usability testing will be used to refine    the termination of the declaration was
Office of Management and Budget               the http://www.gsa.govWeb site. The         provided to the Department of Defense.
(OMB) a request to review and approve         questions to be asked are non-invasive      DATES: The Notice is effective as of
a renewal of a currently approved             and do not address or probe sensitive       February 1, 2006.
information collection requirement            issues. It is important for the GSA to      FOR FURTHER INFORMATION CONTACT:
regarding Market Research for the Office      gain information from the many diffuse      Boris Lushniak, Office of
of Citizen Services and                       groups it serves; therefore, the GSA will   Counterterrorism Policy and Planning
Communications. A request for public          be questioning individuals and              (HF-29), Food and Drug
comments was published at 70 FR               households, and businesses and other        Administration, 5600 Fishers Lane,
69154, November 14, 2005. No                  for-profit groups.                          Rockville, MD 20857, 301-827-4067.
comments were received.                                                                   SUPPLEMENTARY INFORMATION:
   This information collection will be        B. Annual Reporting Burden
used to determine the utility and ease of                                                 I. Background
                                                Respondents: 190.
use of GSA's Web site, http://                                                               On December 10, 2004, the Deputy
www.gsa.gov. The respondents include            Responses Per Respondent: 1.              Secretary of Defense determined, under
individuals and representatives from            Total Responses: 190.                     section 564(b)(1)(B) of the act (21 U.S.C.
businesses currently holding GSA                Hours Per Response: 72.6 minutes.         360bbb-3(b)(1)(B)), that there was a
contracts.                                                                                significant potential for a military
  Public comments are particularly              Total Burden Hours: 230.                  emergency involving a heightened risk
invited on: Whether this collection of          Obtaining Co pies ofProposals:            to U.S. military forces of attack with
information is necessary and whether it       Requesters may obtain a copy of the         anthrax. On the basis of such
will have practical utility; whether our      information collection documents from       determination and under section
estimate of the public burden of this         the General Services Administration,        564(b)(1) of the act, the former HHS
collection of information is accurate,        Regulatory Secretariat (VIR), 1800 F        Secretary declared an emergency
and based on valid assumptions and            Street, NW., Room 4035, Washington,         justifying the authorization of the
methodology; ways to enhance the              DC 20405, telephone (202) 208-7312.         emergency use of Anthrax Vaccine
quality, utility, and clarity of the          Please cite OMB Control No. 3090-0277,      Adsorbed. A notice of the determination
information to be collected.                  Market Research Collection for the          of the Deputy Secretary of Defense and
DATES: Submit comments on or before:          Office of Citizen Services and              the declaration of the former HHS
March 3, 2006.                                Communications, in all correspondence.      Secretary was published in the Federal
5342                  Federal Register/Vol. 71, No. 21/Wednesday, February 1, 2006/Notices

Register of February 2. 2005 (70 FR          Commerce. for the extension of a patent     Trademark Office received a patent term
5452).                                       which claims that human biological          restoration application for HUMIRA
                                             product.                                    (US. Patent No. 6.090,382) from Abbott
II. Advance Notice of Termination
                                             ADDRESSES: Submit written comments          Biotechnology Ltd., and the Patent and
   Under section 564(b)(3) of the act. the   and petitions to the Division of Dockets    Trademark Office requested FDA's
FDA Commissioner provided advance            Management (HFA-305), Food and Drug         assistance in determining this patent's
notice of the termination of the former      Administration, 5630 Fishers Lane, rm.      eligibility for patent term restoration. In
HHS Secretary's declaration of               1061, Rockville, MD 20852. Submit           a letter dated April 8, 2005, FDA
emergency to the Department of               electronic comments to http://              advised the Patent and Trademark
Defense.                                     www.fda.gov/docketslecomments.              Office that this human biological
   The January 2006 letter notifying the     FOR FURTHER INFORMATION CONTACT:
                                                                                         product had undergone a regulatory
Department of Defense ofthe                    Claudia V. Grillo, Office of Regulatory   review period and that the approval of
termination of the declaration of              Policy (HFD-013). Food and Drug           HUMIRA represented the first permitted
emergency follows:                             Administration. 5600 Fishers Lane,        commercial marketing or use of the
William Winkenwerder, Jr., M.D.,
              Rockville, MD 20857. 240-453-6681.        product. Shortly thereafter. the Patent
Assistant Secretary of Defense for Health
                                                                                         and Trademark Office requested that
                                      Price Competition and Patent Term         FDA determine the product's regulatory
                                               Restoration Act of 1984 (Public Law 98­   review period.
The Pentagon,
                                                                              FDA has determined that the
Washington, D.C. 20301-1200
                   417) and the Generic Animal Drug and
                                               Patent Term Restoration Act (Public       applicable regulatory review period for
Dear Dr. Winkenwerder:
                                                                  HUMIRA is 1.722 days. Of this time,
   This letter is to provide advance notice of Law 100-670) generally provide that a
the termination ofthe above-referenced         patent may be extended for a period of    1,443 days occurred during the testing
declaration of emergency that was issued by    up to 5 years so long as the patented     phase of the regulatory review period,
Secretary of Health and Human Services         item (human drug product, animal drug     while 279 days occurred during the
Tommy G. Thompson on January 14, 2005,         product, medical device, food additive,   approval phase. These periods of time
pursuant to section 564(b)(1) of the Federal   or color additive) was subject to         were derived from the following dates:
Food. Drug, and Cosmetic Act (the Act). 21                                                  1. The date an exemption under
U.S.C. § 360bbb-3.                             regulatory review by FDA before the
                                               item was marketed. Under these acts. a    section 505(i) of the Federal Food, Drug,
   In accordance with section 564(b)(2)(A)(ii)                                           and Cosmetic Act (21 U.S.c. 355(i))
of the Act, the declaration of emergency will  product's regulatory review period
terminate by expiration on January 14, 2006,   forms the basis for determining the       became effective: April 16, 1998. FDA
which is the end of the one year period that   amount of extension an applicant may      has verified the applicant's claim that
began on the date that the declaration was     receive.                                  the date the investigational new drug
made. This advance notice of termination          A regulatory review period consists of application became effective was on
will be published in the Federal Register.     two periods of time: A testing phase and April 16, 1998.
pursuant to section 564(b)(4) ofthe Act.       an approval phase. For human                 2. The date the application was
Sincerely,                                     biological products, the testing phase    initially submitted with respect to the
Andrew C. von Eschenbach, M.D.
                begins when the exemption to permit       human biological product under section
Acting Commissioner of Food and Drugs
         the clinical investigations of the        351 of the Public Health Service Act (42
   Dated: January 25, 2006.                    biological becomes effective and runs     U.s.C. 262): March 28. 2002. FDA has
Jeffrey Shuren.                                until the approval phase begins. The      verified the applicant's claim that the
                                               approval phase starts with the initial    product license application (BLA) for
Assistant Commissioner for Policy.
                                               submission of an application to market    HUMIRA (BLA 125057) was initially
[FRDoc. E6-1311 Filed 1-31--06; 8:45 am]                                                 submitted on March 28, 2002.
                                               the human biological product and
BILLING CODE 416()-{)1-S
                                               continues until FDA grants permission        3. The date the application was
                                               to market the biological product.         approved: December 31, 2002. FDA has
                                               Although only a portion of a regulatory   verified the applicant's claim that BLA
                                               review period may count toward the        125057 was approved on December 31.
                                               actual amount of extension that the       2002.
Food and Drug Administration                   Director of Patents and Trademarks may      This determination of the regulatory
                                               award (for example, half the testing      review period establishes the maximum
[Docket No. 2004E-04451
                                               phase must be subtracted as well as any potential length of a patent extension.
                                               time that may have occurred before the    However, the U,S. Patent and
Determination of Regulatory Review
Period for Purposes of Patent                  patent was issued). FDA's determination Trademark Office applies several
                                               of the length of a regulatory review      statutory limitations in its calculations
Extension; HUMIRA
                                               period for a human biological product     of the actual period for patent extension.
AGENCY: Food and Drug Administration.
 will include all of the testing phase and         In its application for patent extension,
                                          approval phase as specified in 35 U.S.C. this applicant seeks 326 days of patent
ACTION: Notice.
                               156(g)(1)(B).                             term extension.
                                                  FDA recently approved for marketing      Anyone with knowledge that any of
SUMMARY: The Food and Drug                     the human biological product HUMIRA       the dates as published are incorrect may
Administration (FDA) has determined            (adalimumab). HUMIRA is indicated for submit to the Division of Dockets
the regulatory review period for               reducing signs and symptoms, including Management (see ADDRESSES) written or
HUMIRA and is publishing this notice           major clinical response, inhibiting the   electronic comments and ask for a
of that determination as required by           progression of structural damage and      redetermination by April 3, 2006.
law. FDA has made the determination            improving physical function in adult      Furthermore. any interested person may
because of the submission of an                patients with moderately to severely      petition FDA for a determination
application to the Director of Patents         active rheumatoid arthritis. Subsequent   regarding whether the applicant for
and Trademarks. Department of                  to this approval, the Patent and          extension acted with due diligence

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