[Federal Register Volume 80, Number 125 (Tuesday, June 30, 2015)]
[Notices]
[Pages 37240-37241]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16014]


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DEPARTMENT OF DEFENSE

Office of the Secretary

[Docket ID: DoD-2015-HA-0066]


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 the Paperwork Reduction Act of 1995, the 
Office of the Assistant Secretary of Defense for Health Affairs 
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 
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 August 
31, 2015.

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: Department of Defense, Office of the Deputy Chief 
Management Officer, Directorate of Oversight and Compliance, Regulatory 
and Audit Matters Office, 9010 Defense Pentagon, Washington, DC 20301-
9010.
    Instructions: All submissions received must include the agency 
name, docket

[[Page 37241]]

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. Any 
associated form(s) for this collection may be located within this same 
electronic docket and downloaded for review/testing. Follow the 
instructions at http://www.regulations.gov for submitting comments. 
Please submit comments on any given form identified by docket number, 
form number, and title.

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 Naval Health 
Research Center, Deployment Health Research Department, ATTN: LCDR 
Rachel Lee, 140 Sylvester Rd., San Diego, CA 92106-3521 or call (619) 
553-8983.

SUPPLEMENTARY INFORMATION:
    Title; Associated Form; and OMB Number: ACAM2000[supreg] 
Myopericarditis Registry; OMB Control Number 0720-0054.
    Needs and Uses: The information collection requirement is necessary 
to address Food and Drug Administration requirements to establish 
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: Individuals or households; federal government.
    Annual Burden Hours: 10.
    Number of Respondents: 10.
    Responses per Respondent: 2.
    Average Burden per Response: 30 minutes.
    Frequency: Semi-annually.
    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.

    Dated: June 25, 2015.
Aaron Siegel,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 2015-16014 Filed 6-29-15; 8:45 am]
 BILLING CODE 5001-06-P