[Federal Register: December 6, 2005 (Volume 70, Number 233)]
[Notices]               
[Page 72621-72622]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06de05-27]                         

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DEPARTMENT OF DEFENSE

Office of the Secretary

 
Submission for OMB Review; Comment Request

ACTION: Notice.

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    The Department of Defense has submitted to OMB for clearance, the 
following proposal for collection of information under the provisions 
of the Paperwork Reduction Act (44 U.S.C. Chapter 35).

DATES: Consideration will be given to all comments received by January 
5, 2006.
    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.

[[Page 72622]]

    Type of Request: New.
    Number of Respondents: 400.
    Responses per Respondent: 1.
    Annual Responses: 400.
    Average Burden per Response: 30 minutes.
    Annual Burden Hours: 200.
    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 condition of members of the Armed Forces 
upon their return from deployment * * *'' Based upon this 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 service our nation, now and in the future. The 
National Science and Technology Council (NSTC) Presidential Review 
Directive 5 (PRD-5), Planning for 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 
pericarditis 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.
    Frequency: On Occasion.
    Respondent's Obligation: Voluntary.
    OMB Desk Officer: Mr. John Kraemer.
    Written comments and recommendations on the proposed information 
collection should be sent to Mr. Kraemer at the Office of Management 
and Budget, Desk Office for DoD Health, Room 10102, New Executive 
Office Building, Washington, DC 20503.
    DOD Clearance Officer: Ms. Patricia Toppings.
    Written requests for copies of the information collection proposal 
should be sent to Ms. Toppings, WHS/ESD/Information Management 
Division, 1777 North Kent Street, RPN, Suite 11000, Arlington, VA 
22209-2133.

    Dated: November 29, 2005.
Patricia L. Toppings,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 05-23670 Filed 12-5-05; 8:45 am]

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