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Browse by Year / 2003 / December / Wednesday, December 10, 2003

[Federal Register: December 10, 2003 (Volume 68, Number 237)]
[Notices]               
[Page 68878-68879]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10de03-47]                         

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DEPARTMENT OF DEFENSE

Office of the Secretary

 
Proposed Collection; Comment Request

AGENCY: Office of the Assistant Secretary of Defense (Health Affairs), 
DoD.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: In compliance with Section 3506(c)(2)(A) of the Paperwork 
Reduction Act of 1995, the Office of the Assistant Secretary of Defense 
(Health Affairs) announces a proposed information collection and seeks 
public comment on the provisions thereof. Comments are invited on: (a) 
Whether the proposed collection of information is necessary for the 
proper performance of the functions of the agency, including whether 
the information shall have practical utility; (b) the accuracy of the 
agency's estimate of the burden of the proposed information collection; 
(c) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (d) ways to minimize the burden of the 
information collection on respondents, including the use of automated 
collection techniques or other forms of information technology.

DATES: Consideration will be given to all comments received by February 
9, 2004.

ADDRESSES: Written comments and recommendations on the continuing 
information collection should be sent to the Senior Investigator, DoD-
wise Surveillance for Potential Long-Term Adverse Events Associated 
with Smallpox Vaccination: Hospitalizations and Self-Reported Outcomes, 
Naval Health Research Center, DoD Center for Deployment Health 
Research, PO Box 85122, San Diego CA 92186-5122.

FOR FURTHER INFORMATION CONTACT: To request more information on this 
information collection, please write to the above address or contact 
Timothy S. Wells, Lt Col, USAF BSC, by calling (619) 553-7522 or e-mail at Wells@NHRC.NAVY.MIL.
    Title, Associated Form and OMB Number: Prospective Studies of U.S. 
Military Forces: DoD-wise Surveillance for Potential Long-Term Adverse 
Events Associated with smallpox Vaccination: Hospitalizations and Self-
Reported Outcomes.
    Needs and Uses: DoD-wide Surveillance for Potential Long-Term 
Adverse Events Associated with Smallpox Vaccination: Hospitalizations 
and Self-Reported Outcomes, a historical prospective study of U.S. 
military forces, responds to recent recommendations from Congress and 
the Institute of Medicine to systematically monitor and evaluate 
potential long-term health consequences of exposure to the smallpox 
vaccine ``Dryvax[reg]''.
    Affected Public: Individuals.
    Annual Burden Hours: 5000 participants x 45 minutes per 
questionnaire = 3750 hours.
    Number of Respondents: 5000 subjects comprised or current and 
former regular active duty and activated reservists.
    Responses per Respondent: 1.
    Average Burden per Response: 45 minutes.
    Frequency: Once time, cross-sectional.

SUPPLEMENTARY INFORMATION: 

[[Page 68879]]

Summary of Information Collection

    This cross-sectional postal survey is nested within an IRB-approved 
historical prospective epidemiologic study of DoD medical records 
designed to ascertain potential long-term deleterious effects of 
exposure to the smallpox vaccine. The postal survey will systematically 
collect self-reported demographic, health and exposure data from a 
randomly selected subset of the US military population. Half of those 
surveyed will have been immunized with the smallpox vaccine and half 
will not. Objective DoD healthcare utilization data will already have 
been collected for all survey subjects. The purpose of the survey will 
be to determine whether health problems exist among service members 
that are not visible to the DoD medical treatment system, and further, 
whether such problems may be related to exposure to the smallpox 
vaccine. Eligible respondents of this survey are individuals who were 
included in the historical prospective study and have verifiable 
mailing addresses.

    Dated: December 1, 2003.
Patricia L. Toppings,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 03-30549 Filed 12-9-03; 8:45 am]

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