03-30549. 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 [phone] or e-mail at [e-mail].

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®”.

Affected Public: Individuals.

Annual Burden Hours: 5000 participants × 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:

 

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.