[Federal Register Volume 70, Number 42 (Friday, March 4, 2005)]
[Notices]
[Pages 10606-10607]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-4208]


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DEPARTMENT OF DEFENSE

Office of the Secretary


Proposed Collection; Comment Request

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

ACTION: Notice.

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SUMMARY: 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.

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

ADDRESSES: 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.

FOR FURTHER INFORMATION CONTACT: 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

[[Page 10607]]

legislation, 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.

SUPPLEMENTARY INFORMATION:

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.

    Dated: February 28, 2005.
Patricia L. Toppings,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 05-4208 Filed 3-3-05; 8:45 am]
BILLING CODE 5001-06-M