[Federal Register Volume 76, Number 250 (Thursday, December 29, 2011)]
[Notices]
[Page 81918]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-33476]


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DEPARTMENT OF DEFENSE

Office of the Secretary

[Docket ID DOD-2011-HA-0033]


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 
30, 2012.
    Title, Form, and OMB Number: ACAM2000[reg] Myopericarditis 
Registry; OMB Control Number 0720-TBD.
    Type of Request: New.
    Number of Respondents: 20.
    Responses per Respondent: 2.
    Annual Responses: 40.
    Average Burden per Response: 30 minutes.
    Annual Burden Hours: 20 hours.
    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[reg] smallpox vaccine. Among the 
required post licensure studies is the establishment of a 
myopericarditis registry. The ACAM2000[reg] Myopericarditis Registry is 
designed to study the natural history of myopericarditis following 
receipt of the ACAM2000[reg] 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: Individuals or households.
    Frequency: Semi-annually.
    Respondent's Obligation: Voluntary.
    OMB Desk Officer: Ms. 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 Officer for DoD, Room 10236, New Executive Office 
Building, Washington, DC 20503.
    You may also submit comments, identified by docket number and 
title, by the following method:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
    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.
    DoD Clearance Officer: Ms. Patricia Toppings.
    Written requests for copies of the information collection proposal 
should be sent to Ms. Toppings at WHS/ESD/Information Management 
Division, 4800 Mark Center Drive, 2nd Floor, East Tower, Suite 02G09, 
Alexandria, VA 22350-3100.

    Dated: December 23, 2011.
Aaron Siegel,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 2011-33476 Filed 12-28-11; 8:45 am]
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