Proposed Collection; Comment Request, 71173-71174 [2012-28863]
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<![CDATA[
Federal Register / Vol. 77, No. 230 / Thursday, November 29, 2012 / Notices
71173
pmangrum on DSK3VPTVN1PROD with NOTICES
individuals via a verbal or written
exchange and is only collected to
facilitate beneficiary case resolution.
Authorized users may use the PII/PHI to
obtain and verify TRICARE eligibility,
treatment, payment, and other
healthcare operations information for a
specific individual. All data collected is
voluntarily given by the individual. At
any time during the case resolution
process, individuals may object to the
collection of PHI and PII via verbal or
written notice. Individuals are informed
that without PII/PHI the authorized user
of the system may not be able to assist
in case resolution, and that answers to
questions/concerns would be
generalities regarding the topic at hand.
Affected Public: Individuals or
households.
Annual Burden Hours: 63,500.
Number of Respondents: 254,000.
Responses per Respondent: 1.
Average Burden per Response: 15
minutes.
Frequency: Daily.
SUPPLEMENTARY INFORMATION:
workload and resolution, of which a
major component is educating
beneficiaries on their TRICARE benefits.
PHI and PII entered into the system is
received from individuals via a verbal or
written exchange and is only collected
to facilitate beneficiary case resolution.
Authorized users may use the PII/PHI to
obtain and verify TRICARE eligibility,
treatment, payment, and other
healthcare operations information for a
specific individual. All data collected is
voluntarily given by the individual. At
any time during the case resolution
process, individuals may object to the
collection of PHI and PII via verbal or
written notice. Individuals are informed
that without PII/PHI the authorized user
of the system may not be able to assist
in case resolution, and that answers to
questions/concerns would be
generalities regarding the topic at hand.
ADDRESSES:
Dated: November 26, 2012.
Aaron Siegel,
Alternate OSD Federal Register Liaison
Officer, Department of Defense.
Summary of Information Collection
The TRICARE Management Activity
Beneficiary Education and Support
Division designed the ART as a secure,
(Department of Defense Information
Assurance Certification and
Accreditation Process-certified with a
Privacy Impact Assessment on file with
the TMA Privacy and Civil Liberties
office) web-based system to track, refer,
reflect, and report workload associated
with resolution of beneficiary and/or
provider inquiries. The ART is also the
primary means by which MMSO staff
capture medical authorization
determinations and claims assistance
information for remotely located service
members, line of duty care, and for care
under the Transitional Care for Servicerelated Conditions benefit.
Users are comprised of MHS customer
service personnel, to include
Beneficiary Counseling and Assistance
Coordinators, Debt Collection
Assistance Officers, MMSO staff,
personnel, family support, recruiting
command, case managers, and others
who serve in a customer service support
role. Only individuals with a valid
need-to-know demonstrated by assigned
official Government duties are granted
access to the ART. These individuals
must satisfy all personnel security
criteria with special protection
measures or restricted distribution as
established by the data owner.
ART data reflects the customer service
mission within the MHS: it helps
customer service staff users prioritize
and manage their case workload; it
allows users to track beneficiary inquiry
[FR Doc. 2012–28861 Filed 11–28–12; 8:45 am]
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
VerDate Mar<15>2010
15:12 Nov 28, 2012
Jkt 229001
BILLING CODE 5001–06–P
DEPARTMENT OF DEFENSE
Office of the Secretary
[Docket ID DoD–HA–2012–0148]
Proposed Collection; Comment
Request
Office of the Assistant
Secretary of Defense for Health Affairs,
DoD.
ACTION: Notice.
AGENCY:
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.
PO 00000
Frm 00007
Fmt 4703
Sfmt 4703
You may submit comments,
identified by docket number and title,
by any of the following methods:
• Federal eRulemaking Portal: https://
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 https://
www.regulations.gov as they are
received without change, including any
personal identifiers or contact
information.
FOR FURTHER INFORMATION CONTACT:
E:\FR\FM\29NON1.SGM
29NON1
71174
Federal Register / Vol. 77, No. 230 / Thursday, November 29, 2012 / Notices
pmangrum on DSK3VPTVN1PROD with NOTICES
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
VerDate Mar<15>2010
15:12 Nov 28, 2012
Jkt 229001
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 builtin 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-themarket 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).
PO 00000
Frm 00008
Fmt 4703
Sfmt 4703
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]
BILLING CODE 5001–06–P
DEPARTMENT OF DEFENSE
Office of the Secretary
[Docket ID DoD–2012–HA–0145]
Proposed Collection; Comment
Request
Office of the Assistant
Secretary of Defense for Health Affairs,
DoD.
ACTION: Notice.
AGENCY:
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: https://
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 https://
www.regulations.gov as they are
received without change, including any
personal identifiers or contact
information.
E:\FR\FM\29NON1.SGM
29NON1
]]>Agencies
[Federal Register Volume 77, Number 230 (Thursday, November 29, 2012)]
[Notices]
[Pages 71173-71174]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-28863]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://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 https://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]
BILLING CODE 5001-06-P
