[Federal Register Volume 77, Number 230 (Thursday, November 29, 2012)]
[Notices]
[Pages 71173-71174]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-28863]


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DEPARTMENT OF DEFENSE

Office of the Secretary

[Docket ID DoD-HA-2012-0148]


Proposed Collection; Comment Request

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

ACTION: Notice.

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    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 the proposed extension of a 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 January 
28, 2013.

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, 4800 Mark 
Center Drive, East Tower, 2nd floor, Suite 02G09, Alexandria VA 22350-
3100.
    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 Program Manager, 
Defense Health Information Management System (DHIMS), ATTN: COL Aaron 
J. Silver, 5109 Leesburg Pike, Skyline 6, Suite 703, Falls Church, VA 
22041, or call DHIMS, at (703) 681-7122.
    Title; Associated Form; and OMB Number: Enterprise Blood Management 
System (EBMS); OMB Control Number 0720-TBD.
    Needs And Uses: EBMS is a family of related automated information 
systems (AIS) comprised of two separate and distinct commercial-off-
the-shelf (COTS) software applications that provides the Military 
Health System (MHS) with a comprehensive enterprise wide Blood Donor 
Management System (BDMS) and a Blood Management Blood Bank and 
Transfusion Service (BMBB/TS).
     The Blood Donor Management System (BDMS) employs two 
separate COTS software applications, Mediware Corporation's LifeTrak 
DonorTM and LifeTrak Lab & DistributionTM. BDMS 
is a technology modernization effort intended to enhance the DoD's 
Blood Program capabilities for Donor Centers through the seamless 
integration of blood products inventory management, transport, 
availability, and most importantly, blood and blood products 
traceability from collection to disposition within the electronic 
health record (EHR).
     The Blood Management Blood Bank Transfusion Service (BMBB/
TS) employs two separate COTS software applications, Mediware 
Corporation's

[[Page 71174]]

HCLLTM (Transfusion) and KnowledgeTrakTM 
(Learning Management). BMBB/TS is an effort intended to enhance the 
DoD's Blood Program capabilities for a seamless integration of blood 
banking and transfusion activities, products inventory management, 
transport, availability, and most importantly traceability from 
transfusion to disposition or destruction within the electronic health 
record (EHR).
    EBMS 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 a blood transfusion 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, civilian 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.
    The EBMS Mediware Corporation developed COTS are FDA 510K cleared 
Medical Devices that provides the Military Health System (MHS) with a 
comprehensive enterprise wide Blood Donor Management System (BDMS) and 
Blood Management Blood Banking and Transfusion Service (BMBB/TS) with 
capabilities to manage blood donors (both in-house and at mobile 
collection sites), 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), 
including Theater and VA. 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 
donate blood and receive blood transfusion 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 an n-tier enterprise solution. The solution will use COTS 
products, installed at a Central Server location. EBMS has 
applicability at the headquarters level allowing Armed Services Blood 
Program (ASBP) which is delineated in several regulations, including 
DoDD 6000.12, DoDI 6480.4, and AR10-64 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 cases, 
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 throughout 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 DoD 
Information Assurance Certification and Accreditation Process (DIACAP) 
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 Department of 
Defense (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 MHS Cyber-Infrastructure Services (MCIS).

    Dated: November 26, 2012.
Aaron Siegel,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 2012-28863 Filed 11-28-12; 8:45 am]
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