[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]
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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.
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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
[[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]
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