[Federal Register Volume 76, Number 30 (Monday, February 14, 2011)]
[Notices]
[Pages 8349-8350]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-3208]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF DEFENSE

Office of the Secretary

[Docket ID DoD-2011-OS-0016]


Proposed Collection; Comment Request

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

ACTION: Notice.

-----------------------------------------------------------------------

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

[[Page 8350]]

(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 April 
15, 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, 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 Defense Health 
Information Management System (DHIMS), Attn: COL DaCosta Barrow, 5109 
Leesburg Pike, Skyline 6, Suite 100, Falls Church, VA 22041, or call 
DHIMS at 703-998-6900.
    Title; Associated Form; and OMB Number: Enterprise Blood Management 
System (EBMS); OMB Control Number 0720-TBD.
    Needs and Uses: EBMS is a commercial-off-the-shelf (COTS) automated 
information system (AIS) software application that provides the 
Military Health System (MHS) with a comprehensive enterprise wide Blood 
Donor Management System (DBMS) and Blood Transfusion Management System 
(BTMS) with capabilities to manage blood donors (both in-house and at 
mobile collection sites), including Theater and VA; manage blood 
products both fresh and frozen throughout the collection, processing, 
testing, storing, and shipping procedures; interface with testing 
instrumentation for enterprise (Global) results management; shipping 
blood with in-transit visibility and shipping data transmit and 
receive; automate, enterprise-wide ``lookback'' for donors, patients, 
and products; automated, blood order issue, and transfusion records; 
manage enterprise inventory (Global). It has built-in safeguards to 
limit access and visibility of personal or sensitive information in 
accordance with the Privacy Act of 1974. The application will account 
for everyone that donates blood and receives blood transfusions in the 
MHS--Active Duty, Reserves, National Guard, government civilian, 
contractors and volunteers assigned or borrowed--this also includes 
non-appropriated fund employees and foreign nationals.
    Affected Public: Contractors, civilians, and foreign nationals 
donating to the Military Health Systems.
    Annual Burden Hours: 766.
    Number of Respondents: 4,600.
    Responses per Respondent: 1.
    Average Burden per Response: 10 minutes.
    Frequency: On occasion.

SUPPLEMENTARY INFORMATION:

Summary of Information Collection

    In order to attain standardization, ensure a safe blood product, 
and comply with Federal law, all Military blood facilities are licensed 
and/or registered by the Food and Drug Administration (FDA) and must 
operate according to Title 21, Code of Federal Regulations, Part 211, 
Current Good Manufacturing Practices for Finished Pharmaceuticals, Part 
610 series, Biologics, and Part 820 series, Medical Devices.
    EBMS is a commercial-off-the-shelf (COTS) FDA 510K cleared Medical 
Device automated information system (AIS) software application that 
provides the Military Health System (MHS) with a comprehensive 
enterprise wide Blood Donor Management System (DBMS) and Blood 
Transfusion Management System (BTMS) with capabilities to manage blood 
donors (both in-house and at mobile collection sites), including 
Theater and VA; manage blood products both fresh and frozen throughout 
the collection, processing, testing, storing, and shipping procedures; 
interface with testing instrumentation for enterprise (Global) results 
management; shipping blood with in-transit visibility and shipping data 
transmit and receive; automate, enterprise-wide ``lookback'' for 
donors, patients, and products; automated, blood order issue, and 
transfusion records; manage enterprise inventory (Global). It has 
built-in safeguards to limit access and visibility of personal or 
sensitive information in accordance with the Privacy Act of 1974. The 
application will account for everyone that donates blood and receives 
blood transfusions in the MHS--Active Duty, Reserves, National Guard, 
government civilian, contractors and volunteers assigned or borrowed--
this also includes non-appropriated fund employees and foreign 
nationals.
    EBMS is a n-tier enterprise solution. The solution will use COTS 
products, installed at a Central Server location. EBMS which is 
delineated in several DoD issuances, including DoD Directive 6000.12, 
DoD Instruction 6480.4, and AR10-64, has applicability at the 
headquarters level allowing Armed Services Blood Program (ASBP) and 
Service Blood Program Office (SBPO) to use this product to conduct its 
own day-to-day blood inventory management. This comprehensive tool 
provides the capability to manage inventory, monitor adverse trends, 
review lookback case, manage donor deferrals and develop standard 
operation procedure. Deciding to implement EBMS within MHS, provides an 
enterprise solution for transfusion and donor processing that can be 
applied to enterprise-wide blood inventory, and traceability through 
out patient and donor life.
    The information in EBMS is personal or sensitive; therefore, it 
contains built-in safeguards to limit access and visibility of this 
information. EBMS uses role-based security so a user sees only the 
information for which permission has been granted. It uses state-of-
the-market 128-bit encryption security for our transactions. It is 
DITSCAP certified having been subjected to and passed thorough security 
testing and evaluation by independent parties. It meets safeguards 
specified by the Privacy Act of 1974 in that it maintains a published 
DoD Privacy Impact Assessment and System of Record covering Active Duty 
Military, Reserve, National Guard, and government civilian employees, 
to include non-appropriated fund employees and foreign nationals, DoD 
contractors, and volunteers. EBMS is hosted in a secure facility 
managed by the Defense Information Systems Agency.

Morgan F. Park,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 2011-3208 Filed 2-11-11; 8:45 am]
BILLING CODE 5001-06-P