5452 Federal Register / Vol. 70, No. 21 / Wednesday, February 2, 2005 / Notices 

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

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N–0040]

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

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.

SUPPLEMENTARY INFORMATION:

I. Background

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:

(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