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[Federal Register: March 15, 2011 (Volume 76, Number 50)]
[Notices]               
[Page 13990-13991]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15mr11-49]                         

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DEPARTMENT OF DEFENSE

Office of the Secretary

[Docket ID: DOD-2011-HA-0033]

 
Proposed Collection; Comment Request

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

ACTION: Notice.

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SUMMARY: In compliance with Section 3506(c)(2)(A) of the Paperwork 
Reduction Act of 1995, the Office of the Assistant Secretary of Defense 
for Health Affairs announces a proposed new 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 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 
through the use of automated collection techniques or other forms of 
information technology.

DATES: Consideration will be given to all comments received by May 16, 
2011.

ADDRESSES: You may submit comments, identified by docket number and 
title, by any of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: Federal Docket Management System Office, 1160 
Defense Pentagon, OSD Mailroom 3C843, Washington, DC 20301-1160.

    Instructions: All submissions received must include the agency 
name, docket number and title for this Federal Register document. The 
general policy for comments and other submissions from members of the 
public is to make these submissions available for public viewing on the 
Internet at http://www.regulations.gov as they are received without 
change, including any personal identifiers or contact information.

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 Naval Health 
Research Center, DoD Center for Deployment Health Research, Department 
164, ATTN: Tyler C. Smith, MS, PhD, 140 Sylvester Rd., San Diego, CA 
92106-3521, or call (619) 553-7593.
    Title; Associated Form; and OMB Number: ACAM2000[supreg] 
Myopericarditis Registry; OMB Control Number 0720-TBD.
    Needs and Uses: The Food and Drug Administration required the 
establishment of several Phase IV post-licensure studies to evaluate 
the long-term safety of ACAM2000[supreg] smallpox vaccine. Among the 
required post-licensure studies is the establishment of a 
myopericarditis registry. The ACAM2000[supreg] Myopericarditis Registry 
is designed to study the natural history of myopericarditis following 
receipt of the ACAM2000[supreg] vaccine, including evaluating factors 
that may influence disease prognosis, thus addressing the FDA post-
licensure requirement and ensuring the continued licensing of this 
vaccine.
    Affected Public: Civilians, former Active Duty or active Guard/
Reserve in the U.S. Military, who received the ACACM2000[supreg] 
smallpox vaccine while in the military and subsequently developed signs 
or symptoms of myopericarditis.
    Annual Burden Hours: 20.
    Number of Respondents: 20.
    Responses per Respondent: 2.
    Average Burden per Response: 30 minutes.
    Frequency: Semi-annually.

SUPPLEMENTARY INFORMATION: 

Summary of Information Collection

    Eligible respondents are civilians who are former Active Duty or 
active Guard/Reserve in the U.S. Military that received the 
ACACM2000[supreg] smallpox vaccine while in the military and 
subsequently developed signs or symptoms of myopericarditis. The 
information collected will illuminate the natural history of post-
vaccine myopericarditis and evaluate factors that may influence disease 
prognosis. Inclusion of civilians who were formerly in the military in 
addition to current military members is imperative in order to obtain 
information on those who may have separated from the military due to 
their medical condition. Conducting this Registry will ensure the 
continued licensure of this military relevant vaccine.

[[Page 13991]]

    Dated: March 8, 2011.
Morgan F. Park,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 2011-5910 Filed 3-14-11; 8:45 am]
BILLING CODE 5001-06-P
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