[Federal Register: March 4, 2005 (Volume 70, Number 42)]
[Notices]
[Page 10606-10607]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04mr05-37]
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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