5450 Federal Register / Vol. 70, No. 21 / Wednesday, February 2, 2005 / Notices 

program staff and grants officials in 

assessing the adequacy of applicant’s 

proposals to accomplish project 

objectives and determine whether the 

business aspects of grants applications 

reflect program needs and grants 

policies. Federal agencies will not be 

required to collect all of the information 

included in the proposed data set. The 

agency will identify the data that must 

be provided by applicants through 

instructions that will accompany the 

application forms. 

Frequency: Recording, Reporting, and 

on Occasion; 

Affected Public: Federal, State, local, 

or tribal governments, business or other 

for profit, not for profit institutions; 

Annual Number of Respondents:

459,425; 

Total Annual Responses: 459,425; 

Average Burden Per Response: 40 

hours; 

Total Annual Hours: 19,037,350; 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access the HHS Web 

site address at http://www.hhs.gov/

oirm/infocollect/pending/ or e-mail your 

request, including your address, phone 

number, OMB number, and OS 

document identifier, to 

naomi.cook@hhs.gov, or call the Reports 

Clearance Office on (202) 690–6162. 

Written comments and 

recommendations for the proposed 

information collections must be mailed 

directly to the Desk Officer at the 

address below: OMB Desk Officer: John 

Kraemer, OMB Human Resources and 

Housing Branch, Attention: (OMB#OS–

4040–0001), New Executive Office 

Building, Room 10235, Washington DC 

20201.

Dated: January 26, 2005. 

Robert E. Polson, 

Office of the Secretary, Paperwork Reduction 

Act Reports Clearance Officer.

[FR Doc. 05–1962 Filed 2–1–05; 8:45 am] 

BILLING CODE 4168–17–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

[Document Identifier: OS–0990–New] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request

AGENCY: Office of the Secretary.

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Office of the Secretary (OS), Department 

of Health and Human Services, is 

publishing the following summary of 

proposed collections for public 

comment. Interested persons are invited 

to send comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

Type of Information Collection 

Request: New Collection, Regular; 

Title of Information Collection: Office 

for Human Research Protections, 

Fellowship Program; 

Form/OMB No.: OS–0990–New; 

Use: The Office for Human Research 

Protections (OHRP) developed the 

Fellowship Program to provide 

individuals who are interested in 

learning about OHRP’s regulatory 

processes and programs with an 

opportunity to expand their knowledge 

and experience regarding the 

complexities of the ethical and 

regulatory issues relating to human 

subject protections in biomedical and 

behavioral research. 

Frequency: Reporting, 

Affected Public: Business or other forprofit; 

Annual Number of Respondents: 25; 

Total Annual Responses: 25; 

Average Burden Per Response: 1 hour; 

Total Annual Hours: 50; 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access the HHS Web 

site address at http://www.hhs.gov/

oirm/infocollect/pending/ or e-mail your 

request, including your address, phone 

number, OMB number, and OS 

document identifier, to 

naomi.cook@hhs.gov, or call the Reports 

Clearance Office on (202) 690–6162. 

Written comments and 

recommendations for the proposed 

information collections must be mailed 

within 60 days of this notice directly to 

the OS Paperwork Clearance Officer 

designated at the following address: 

Department of Health and Human 

Services, Office of the Secretary, 

Assistant Secretary for Budget, 

Technology, and Finance, Office of 

Information and Resource Management, 

Attention: Naomi Cook (0990–New), 

Room 531–H, 200 Independence 

Avenue, SW., Washington DC 20201.

Dated: January 21, 2005. 

Robert E. Polson, 

Office of the Secretary, Paperwork Reduction 

Act Reports Clearance Officer.

[FR Doc. 05–1963 Filed 2–1–05; 8:45 am] 

BILLING CODE 4168–17–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Determination and Declaration 

Regarding Emergency Use of Anthrax 

Vaccine Adsorbed for Prevention of 

Inhalation Anthrax

AGENCY: Office of the Secretary (OS), 

HHS.

ACTION: Notice.

SUMMARY: The Secretary of the 

Department of Health and Human 

Services is issuing this notice pursuant 

to section 564(b)(4) of the Federal Food, 

Drug, and Cosmetic Act to justify the 

emergency use of Anthrax Vaccine 

Adsorbed (AVA) for prevention of 

inhalation anthrax. The Secretary 

provides notice of the determination of 

the Department of Defense that there is 

a significant potential for a military 

emergency involving a heightened risk 

to United States military forces of attack 

with anthrax. The determination of the 

Department of Defense was effective as 

of December 10, 2004. The Secretary 

also provides notice that, on the basis of 

such determination, he has declared an 

emergency justifying the authorization 

of the emergency use of AVA.

DATES: This Notice and the referenced 

declaration are effective as of January 

14, 2005.

FOR FURTHER INFORMATION CONTACT:

Stewart Simonson, Assistant Secretary 

for Public Health Emergency 

Preparedness, (202) 205–2882.

SUPPLEMENTARY INFORMATION: 

I. Background 

AVA was first licensed by the 

National Institutes of Health in 

November 1970. Upon the delegation of 

vaccine regulation to FDA in 1972, FDA 

undertook a comprehensive review of 

the safety, effectiveness, and labeling of 

all vaccines. See 21 CFR 601.25. Under 

this review, independent advisory 

panels evaluated the safety and 

effectiveness data of vaccines to assure 

that they met appropriate standards. 

The advisory panel that reviewed AVA 

concluded that it is safe, effective, and 

not misbranded, and FDA issued a 

proposal to adopt the panel’s 

recommendation (the Bacterial Vaccines