Delegation of Authority, 5452 [05-1896]
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Federal Register / Vol. 70, No. 21 / Wednesday, February 2, 2005 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
SUPPLEMENTARY INFORMATION:
Administration for Children and
Families
Food and Drug Administration
Delegation of Authority
Authorization of Emergency Use of
Anthrax Vaccine Adsorbed for
Prevention of Inhalation Anthrax by
Individuals at Heightened Risk of
Exposure Due to Attack With Anthrax;
Availability
Section 564 of the act (21 U.S.C.
360bbb–3), as amended by the Project
BioShield Act of 2004 (Public Law 108–
276), allows FDA to strengthen the
public health protections against
biological, chemical, nuclear, and
radiological agents. Among other things,
section 564 of the act allows FDA to
authorize the use of an unapproved
medical product or an unapproved use
of an approved medical product during
a declared emergency involving a
heightened risk of attack on the public
or U.S. military forces. With this EUA
authority, FDA can help assure that
medical countermeasures may be used
in an emergency to diagnose, treat, or
prevent serious or life-threatening
diseases or conditions caused by such
agents, when there are no adequate,
approved, and available alternatives to
protect the American people and the
U.S. military.
Section 564(b)(1) of the act provides
that, before an EUA may be issued, the
Secretary must declare an emergency
based on one of the following grounds:
[Docket No. 2005N–0040]
Notice is hereby given that, under the
authority vested in me by the Secretary,
Department of Health and Human
Services, I have redelegated to the
Commissioner, Administration on
Children, Youth and Families, with the
authority to further redelegate to the
Director, Family Youth Services Bureau,
the authority to approve/disapprove
cooperative research or demonstration
projects under Section 1110 of the
Social Security Act, and as amended
hereafter, when such projects pertain to
the abstinence education activities
referenced in Public Law 108–447 at
Title II, Division F.
This delegation excludes the authority
to submit reports to Congress. Further,
this delegation shall be exercised under
the Department’s existing delegation
and policy on regulations and under
financial and administrative
requirements applicable to all
Administration for Children and
Families authorities. In addition, where
all or part of any research or
demonstration project is wholly
financed with Federal funds made
available under section 1110 of the
Social Security Act, without any State,
local, or other non-Federal financial
participation, that project must be
approved by the Secretary of Health and
Human Services.
I have ratified any actions taken by
the Commissioner, Administration on
Children, Youth and Families, or any
other Administration on Children,
Youth and Families officials, which, in
effect, involved the exercise of this
authority prior to the effective date of
this delegation. This delegation was
effective on the date of signature.
Dated: January 21, 2005.
Wade F. Horn,
Assistant Secretary for Children and Families.
[FR Doc. 05–1896 Filed 2–1–05; 8:45 am]
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AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
issuance of an Emergency Use
Authorization (EUA) (the Authorization)
for Anthrax Vaccine Adsorbed (AVA)
for prevention of inhalation anthrax for
individuals between 18 and 65 years of
age who are deemed by the Department
of Defense (DoD) to be at heightened
risk of exposure due to attack with
anthrax. FDA is issuing this
Authorization under the Federal Food,
Drug, and Cosmetic Act (the act), as
requested by DoD. The Authorization
contains, among other things,
conditions on the emergency use of
AVA. The Authorization follows the
determination by DoD that there is 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, Secretary of Health and
Human Services Tommy G. Thompson
(the Secretary) declared an emergency
justifying the authorization of the
emergency use of AVA. The
Authorization, which includes an
explanation of the reasons for its
issuance, is reprinted in this Notice.
DATES: The Authorization is effective as
of January 27, 2005.
ADDRESSES: Submit written requests for
single copies of the Emergency Use
Authorization to the Office of
Counterterrorism Policy and Planning
(HF–29), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857. Send one selfaddressed adhesive label to assist that
office in processing your request or
include a fax number to which the
Authorization may be sent. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the Authorization.
FOR FURTHER INFORMATION CONTACT:
Margaret O’K. Glavin, Office of
Counterterrorism Policy and Planning
(HF–29), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4067.
PO 00000
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I. Background
(1) a determination by the Secretary of
Homeland Security that there is a domestic
emergency, or a significant potential for a
domestic emergency, involving a heightened
risk of attack with a specified biological,
chemical, radiological, or nuclear agent or
agents;
(2) a determination by the Secretary of
Defense that there is a military emergency, or
a significant potential for a military
emergency, involving a heightened risk to
United States military forces of attack with a
specified biological, chemical, radiological,
or nuclear agent or agents; or
(3) a determination by the Secretary of a
public health emergency under section 319 of
the Public Health Service Act (PHS Act) that
affects, or has a significant potential to affect,
national security, and that involves a
specified biological, chemical, radiological,
or nuclear agent or agents, or a specified
disease or condition that may be attributable
to such agent or agents.
Once the Secretary has declared an
emergency justifying an authorization
under section 564 of the act, FDA may
authorize the emergency use of a drug,
device, or biological product if the
agency concludes, based on the
information and data available to the
agency, that the statutory criteria of
section 564(c) of the act are satisfied.
Under section 564(h)(1) of the act FDA
is required to publish in the Federal
Register notice of each authorization,
and each termination or revocation of an
authorization, and an explanation of the
reasons for the action. The explanation
may include a summary of data
submitted to FDA in an application
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02FEN1
]]>Agencies
[Federal Register Volume 70, Number 21 (Wednesday, February 2, 2005)]
[Notices]
[Page 5452]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-1896]
[[Page 5452]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Delegation of Authority
Notice is hereby given that, under the authority vested in me by
the Secretary, Department of Health and Human Services, I have
redelegated to the Commissioner, Administration on Children, Youth and
Families, with the authority to further redelegate to the Director,
Family Youth Services Bureau, the authority to approve/disapprove
cooperative research or demonstration projects under Section 1110 of
the Social Security Act, and as amended hereafter, when such projects
pertain to the abstinence education activities referenced in Public Law
108-447 at Title II, Division F.
This delegation excludes the authority to submit reports to
Congress. Further, this delegation shall be exercised under the
Department's existing delegation and policy on regulations and under
financial and administrative requirements applicable to all
Administration for Children and Families authorities. In addition,
where all or part of any research or demonstration project is wholly
financed with Federal funds made available under section 1110 of the
Social Security Act, without any State, local, or other non-Federal
financial participation, that project must be approved by the Secretary
of Health and Human Services.
I have ratified any actions taken by the Commissioner,
Administration on Children, Youth and Families, or any other
Administration on Children, Youth and Families officials, which, in
effect, involved the exercise of this authority prior to the effective
date of this delegation. This delegation was effective on the date of
signature.
Dated: January 21, 2005.
Wade F. Horn,
Assistant Secretary for Children and Families.
[FR Doc. 05-1896 Filed 2-1-05; 8:45 am]
BILLING CODE 4184-01-M
