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Federal Register / Vol. 70, No.

148 / Wednesday, August 3, 2005 / Notices 44657

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1


No. of Annual Frequency Total Annual Hours per
Section of the Act Respondents per Response Responses Response Total Hours

801 3,406 1,089 3,709,134 .14 519,279


1There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: July 27, 2005. Temporary Marketing Permit office in processing your request or
Jeffrey Shuren, Applications’’. include a fax number to which the
Assistant Commissioner for Policy. 3. On page 43159, in the third Authorization may be sent. See the
[FR Doc. 05–15371 Filed 8–2–05; 8:45 am] column, in the SUMMARY section of the SUPPLEMENTARY INFORMATION section for
BILLING CODE 4160–01–S document, beginning in the fourth line, electronic access to the Authorization.
‘‘State Petitions for Exemption From FOR FURTHER INFORMATION CONTACT:
Preemption’’ is corrected to read Boris D. Lushniak, Office of
DEPARTMENT OF HEALTH AND ‘‘Temporary Marketing Permit Counterterrorism Policy and Planning
HUMAN SERVICES Applications’’. (HF–29), Food and Drug
Dated: July 27, 2005. Administration, 5600 Fishers Lane,
Food and Drug Administration Rockville, MD 20857, 301–827–4067.
Jeffrey Shuren,
[Docket No. 2004N–0564] Assistant Commissioner for Policy. SUPPLEMENTARY INFORMATION:
[FR Doc. 05–15369 Filed 8–2–05; 8:45 am] I. Background
Agency Information Collection
BILLING CODE 4160–01–S Section 564 of the Federal Food, Drug,
Activities; Announcement of Office of
Management and Budget Approval; and Cosmetic Act (the act) (21 U.S.C.
Temporary Marketing Permit 360bbb–3), as amended by the Project
DEPARTMENT OF HEALTH AND BioShield Act of 2004 (Public Law 108–
Applications; Correction HUMAN SERVICES 276), allows the FDA Commissioner, by
AGENCY: Food and Drug Administration, delegation from the Secretary of Health
HHS. Food and Drug Administration
and Human Services (the Secretary), to
ACTION: Notice; correction. [Docket No. 2005N–0299] authorize the use of an unapproved
medical product or an unapproved use
SUMMARY: The Food and Drug Authorization of Emergency Use of of an approved medical product during
Administration is correcting a notice Anthrax Vaccine Adsorbed for a declared emergency involving a
that appeared in the Federal Register of Prevention of Inhalation Anthrax by heightened risk of attack on the public
July 26, 2005 (70 FR 43159). The Individuals at Heightened Risk of or U.S. military forces. As a result of an
document announced Office of Exposure Due to Attack With Anthrax; October 27, 2004, order by the U.S.
Management Budget approval for State Extension; Availability District Court for the District of
petitions for exemption from Columbia, the use of AVA by DoD for
preemption. The document was AGENCY: Food and Drug Administration,
the prevention of inhalation anthrax is
published with an incorrect title and an HHS.
deemed an unapproved use of an
incorrect docket number. This ACTION: Notice. approved product for purposes of
document corrects those errors. section 564(a)(2) of the act.
SUMMARY: The Food and Drug
FOR FURTHER INFORMATION CONTACT: On December 10, 2004, under section
Peggy Robbins, Office of Management Administration (FDA) is announcing an
564(b)(1)(B) of the act, the Deputy
Programs (HFA–250), Food and Drug extension of the Emergency Use
Secretary of Defense determined that
Administration, 5600 Fishers Lane, Authorization (EUA) (the Authorization)
there is a significant potential for a
Rockville, MD 20857, 301–827–1223. for Anthrax Vaccine Adsorbed (AVA),
military emergency involving a
issued on January 27, 2005, for
SUPPLEMENTARY INFORMATION: In FR Doc. heightened risk to U.S. military forces of
prevention of inhalation anthrax for
05–14697, appearing on page 43159 in attack with anthrax. On December 22,
individuals between 18 and 65 years of
the Federal Register of Tuesday, July 2004, DoD requested an EUA for AVA
age who are deemed by the Department
26, 2005, the following corrections are for protection against inhalation
of Defense (DoD) to be at heightened
made: anthrax. DoD asked for a 6-month
risk of exposure due to attack with
1. On page 43159, in the third authorization and indicated that, if
anthrax. The FDA Commissioner is
column, in the heading of the necessary, it might ask for an extension
extending the term of this Authorization
document, ‘‘[Docket No. 2004N–0565]’’ of the duration of the EUA.
on the request of DoD. Under section 564(b) of the act, and
is corrected to read ‘‘[Docket No.
2004N–0564]’’. DATES: The extension of the on the basis of the Deputy Secretary of
2. On page 43159, in the third Authorization was effective as of July Defense’s determination of a significant
column, in the heading of the 22, 2005. potential for a military emergency, on
document, ‘‘Agency Information ADDRESSES: Submit written requests for January 14, 2005, the Secretary of
Collection Activities; Announcement of single copies of the extension of the Health and Human Services, Tommy G.
Office of Management and Budget Authorization to the Office of Thompson, declared an emergency
Approval; State Petitions for Exemption Counterterrorism Policy and Planning justifying the authorization of the
From Preemption’’ is corrected to read (HF–29), Food and Drug emergency use of AVA. Notice of the
‘‘Agency Information Collection Administration, 5600 Fishers Lane, determination of the Deputy Secretary
Activities; Announcement of Office of Rockville, MD 20857. Send one self- of Defense and the declaration of the
Management and Budget Approval; addressed adhesive label to assist that Secretary of Health and Human Services

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