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Proposed Collection; Comment Request

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DoD, Office of the Assistant Secretary of Defense for Health Affairs, TRICARE Management Activity.




In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Department of Defense, Office of the Assistant Secretary of Defense for Health Affairs, TRICARE Management Activity announces a proposed public 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 performances 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 through the use of automated collection techniques or other forms of information technology.


Consideration will be given to all comments received by May 3, 2005.


Written comments should be submitted to: Office of the Assistant Secretary of Defense for Health Affairs, TRICARE Management Activity, Skyline Five, Suite 810, 5111 Leesburg Pike, Falls Church, VA 22041-3206.

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To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to the above address or call Capt. Deborah McKay, Office of the Assistant Secretary of Defense for Health Affairs, TRICARE Management Activity at (703) 681-0064.

Title and OMB Number: A Case Control Study to Identify Risk Factors Associated with Myocarditis or Pericarditis Among Smallpox Primary Vaccinees in the U.S. Military; OMB Number 0720-TBD.

Needs and Uses: Section 743 of the Strom Thurmond National Defense Authorization Act for Fiscal Year 1999 authorized the Secretary of Defense to establish a center devoted to “* * * longitudinal study to evaluate data on the health conditions of members of the Armed Forces upon their return from deployment * * *” Based upon this Start Printed Page 10607legislation, the Assistant Secretary of Defense for Health Affairs established the DoD Center for Deployment Health Research on September 30, 1999 (OSD/HA Policy #99-028). The Department of Defense shares with the President and Congress a firm commitment to improve the health of our veterans, their families, and all who serve our nation, now and in the future. The National Science and Technology Council (NSTC) Presidential Review Directive 5 (PRD-5), Planning for the Health Preparedness for and Readjustment of the Military, Veterans, and their Families after Future Deployments is an interagency plan which provides a comprehensive set of recommendations designed to help ensure this obligation is met in a manner that takes into consideration the successes and failures of past deployments. A key recommendation in this plan and necessity if we are to meet this commitment is treatment, research, and surveillance efforts aimed at minimizing adverse health effects that may be experienced during and after deployment.

In its ongoing response to this legislation, DoD plans to conduct a postal survey of current and past U.S. service members who received the smallpox vaccine under the DoD Smallpox Vaccination Program, which began on December 13, 2002. Subsequent to initiation of this program, a small percentage of service members developed either myocarditis or pericarditis following a primary smallpox vaccination. (Refs: Halsell JS, et al., JAMA 2003;289:3283-9; Arness MK, et al., AJE 2004;160:642-51). In response to these cases, the DoD established additional policies and guidelines: (1) Policy for Smallpox Vaccination and Persons with Cardiac Conditions (OSD/HA, Policy 03-002), and (2) Establishment of Case Management Guidelines for Smallpox Vaccine Associated Myopericarditis (OSD/HA, June 9, 2003). The survey will obtain risk factor information from identified myocarditis or percarditis cases and a number of smallpox vaccinated but healthy controls. The objective of the study is to understand why a small percentage of smallpox-vaccinated service members develop myocarditis or pericarditis.

Affected Public: Individuals or households.

Annual Burden Hours: 200.

Number of Respondents: 400.

Responses per Respondent: 1.

Average Burden per Response: 30 minutes.

Frequency: On occasion.

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Summary of Collection

The survey to be implemented is comprised of 44 questions that ascertain the health status of the respondent in a temporal sequence with respect to his or her smallpox vaccination. The questions utilized are either from previously standardized instruments, or developed by a team of epidemiologists and clinicians, including cardiologists. Question categories include: Identification (3 questions), Smallpox Vaccination Education (5 questions), Weight and Height (4 questions), Family-Related and Other Risks (4 questions), Diet and Nutrition (2 questions), Exercise and Physical Fitness (12 questions), Tobacco Use: Smoking (7 questions), Occupational Exposures (1 question), Foreign Deployments (2 questions), Other Illnesses (2 questions), and Other Vaccinations (2 questions).

Data Collection Method

Addresses for potential cases will be obtained from the DoD National Vaccine Healthcare Center Network (NVHC). The NVHC will send a letter to each potential case informing them of this study. We expect to enroll approximately 80 myocarditis or pericarditis cases, and will also enroll approximately 320 non-cases. The DoD Center for Deployment Health will conduct all postcard and questionnaire mailings. All targeted subjects will receive up to three questionnaire mailings as prescribed in Dillman's Tailored Design Method. A postcard alerting the target subject to the arrival of each questionnaire will precede the questionnaire mailing. Each postcard will serve to confirm correct addresses. For those post cards returned as undeliverable, addresses will be sought from military and civilian address sources. New controls will be randomly selected to replace those individuals untraceable after exhaustive address search.

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Dated: February 28, 2005.

Patricia L. Toppings,

Alternate OSD Federal Register Liaison Officer, Department of Defense.

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[FR Doc. 05-4208 Filed 3-3-05; 8:45 am]