Renewal of Department of Defense Federal Advisory Committees, 34725-34726 [2014-14165]
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Federal Register / Vol. 79, No. 117 / Wednesday, June 18, 2014 / Notices
Organizations, State, Local or Tribal
Government.
Respondents: 2,000.
Annual responses: 2,000.
Frequency of Response: Once per
request.
Average minutes per response: 15.
Burden hours: 500.
An agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a currently valid
Office of Management and Budget
Control Number.
Dated: June 12, 2014.
Amy Borgstrom,
Associate Director of Policy.
[FR Doc. 2014–14225 Filed 6–17–14; 8:45 am]
BILLING CODE 6050–28–P
DEPARTMENT OF DEFENSE
Office of the Secretary
Renewal of Department of Defense
Federal Advisory Committees
DoD.
Renewal of Federal Advisory
Committee.
AGENCY:
ACTION:
The Department of Defense is
publishing this notice to announce that
it is renewing the charter for the
Missouri River (North Dakota) Task
Force (‘‘the Task Force’’).
FOR FURTHER INFORMATION CONTACT: Jim
Freeman, Advisory Committee
Management Officer for the Department
of Defense, 703–692–5952.
SUPPLEMENTARY INFORMATION: This
committee’s charter is being renewed
under the provisions of the Federal
Advisory Committee Act of 1972 (5
U.S.C. Appendix, as amended), the
Government in the Sunshine Act of
1976 (5 U.S.C. 552b) (‘‘the Sunshine
Act’’), and 41 CFR 102–3.50(d).
The Task Force is a nondiscretionary
Federal advisory committee that shall
provide independent advice and
recommendations to the Secretary of the
Army on plans and projects to reduce
siltation of the Missouri River in the
State of North Dakota and to meet the
objectives of the Pick-Sloan Program.
Specifically, the Task Force shall:
a. Prepare and approve, by a majority
of the members, a plan for the use of the
funds made available under the
Missouri River Act, to promote
conservation practices in the Missouri
River watershed, control and remove the
sediment from the Missouri River,
protect recreation on the Missouri River
from sedimentation, protect Indian and
non-Indian historical and cultural sites
emcdonald on DSK67QTVN1PROD with NOTICES
SUMMARY:
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16:35 Jun 17, 2014
Jkt 232001
along the Missouri River from erosion,
and control erosion along the Missouri
River;
b. Develop and recommend to the
Secretary of the Army for
implementation critical restoration
projects meeting the goals of the plan;
and
c. Determine if these projects
primarily benefit the Federal
Government.
The Task Force may, on an annual
basis, revise the plan and shall provide
the public with the opportunity to
review and comment on any proposed
revision.
The Task Force shall report to the
Secretary of the Army and the U.S.
Army Corps of Engineers.
The Secretary of the Army may act
upon the Task Force’s advice and
recommendations.
The Department of Defense (DoD),
through the Secretary of the Army, the
Assistant Secretary of the Army for Civil
Works, and the U.S. Army Corps of
Engineers, shall provide support, as
deemed necessary, for the performance
of the Task Force’s functions, and shall
ensure compliance with the
requirements of the FACA, the
Government in the Sunshine Act of
1976 (5 U.S.C. 552b, as amended) (‘‘the
Sunshine Act’’), governing Federal
statutes and regulations, and established
DoD policies and procedures.
Pursuant to Section 704 and 705 of
the Missouri River Protection and
Improvement Act of 2000 (‘‘the Missouri
River Act’’) (Title VII of Pub. L. 106–
541, the Water Resources Development
Act of 2000), the Task Force shall be
composed of not more than 20 members.
Specifically, the Task Force
membership shall be composed of:
a. The Secretary of the Army or
designee, who shall serve as the Chair;
b. The Secretary of Agriculture or
designee;
c. The Secretary of Energy or
designee;
d. The Secretary of the Interior or
designee; and
e. The Trust, which is composed of 16
members to be appointed by the
Secretary of the Army, including:
i. Twelve members recommended by
the Governor of North Dakota that
represent, equally, the various interests
of the public and include
representatives of:
a. the North Dakota Department of
Health,
b. the North Dakota Department of
Parks and Recreation,
c. the North Dakota Department of
Game and Fish,
d. the North Dakota State Water
Commission,
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34725
e. the North Dakota Indian Affairs
Commission,
f. agricultural groups,
g. environmental or conservation
organizations,
h. the hydroelectric power industry,
i. recreations user groups,
j. local governments,
k. and other appropriate interests.
ii. Four members representing each of
the four Indian tribes in the State of
North Dakota. The members of the Trust
shall be appointed by the Secretary of
the Army as representative members to
the Task Force, pursuant to 41 CFR 102–
3.130(a). Those individuals who are
full-time or permanent part-time Federal
employees shall be appointed regular
government employee (RGE) members,
pursuant to 41 CFR 102–3.130(a).
All representative members of the
Trust shall be appointed for a two-year
term of service; and no member, unless
authorized by the Secretary of Defense
upon request of the Secretary of the
Army, may serve more than two
consecutive terms of service. In
addition, all Task Force members shall,
with the exception of reimbursement of
official Task Force-related travel and per
diem, serve without compensation.
The Department, when necessary and
consistent with the Task Force’s mission
and DoD policies and procedures, may
establish subcommittees, task forces, or
working groups to support the Task
Force. Establishment of subcommittees
will be based upon a written
determination, to include terms of
reference, by the Secretary of Defense,
the Deputy Secretary of Defense, or the
Secretary of the Army, as the Task
Force’s Sponsor.
Such subcommittees shall not work
independently of the chartered Task
Force and shall report all of their
recommendations and advice solely to
the Task Force for full and open
deliberation and discussion.
Subcommittees, task forces, or working
groups have no authority to make
decisions and recommendations,
verbally or in writing, on behalf of the
Task Force. No subcommittee or any of
its members can update or report,
verbally or in writing, on behalf of the
Task Force, directly to the DoD or any
Federal officers or employees.
The Secretary of Defense or the
Deputy Secretary of Defense may
approve the appointment of
subcommittee members for a two-year
term of service with annual renewals;
however, no member, unless authorized
by the Secretary of Defense, may serve
more than two consecutive terms of
service. These individuals may come
from the Task Force or may be new
nominees, as recommended by the
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34726
Federal Register / Vol. 79, No. 117 / Wednesday, June 18, 2014 / Notices
Secretary of the Army and based upon
the subject matters under consideration.
Subcommittee members, if not fulltime or permanent part-time Federal
employees, shall be appointed as
experts or consultants, pursuant to 5
U.S.C. 3109, to serve as special
government employee members. Those
individuals who are full-time or
permanent part-time Federal employees
will be appointed, pursuant to 41 CFR
102–3.130(a), to serve as RGE members.
With the exception of reimbursement
for official Task Force-related travel and
per diem, subcommittee members shall
serve without compensation.
All subcommittees operate under the
provisions of FACA, the Sunshine Act,
governing Federal statutes and
regulations, and established DoD
policies and procedures.
The Designated Federal Officer (DFO),
pursuant to DoD policy, shall be a fulltime or permanent part-time DoD
employee, and shall be appointed in
accordance with established DoD
policies and procedures.
In addition, the DFO is required to be
in attendance at all meetings of the Task
Force and any subcommittees, for the
entire duration of each and every
meeting; however, in the absence of the
DFO, a properly approved Alternate
DFO, duly appointed to the Task Force
according to established DoD policies
and procedures, shall attend the entire
duration of all meetings of the Task
Force or its subcommittees.
The DFO or the Alternate DFO, shall
call all meetings of the Task Force and
its subcommittees; prepare and approve
all meeting agendas; and adjourn any
meeting when the DFO, or the Alternate
DFO, determines adjournment to be in
the public interest or required by
governing regulations or DoD policies
and procedures.
Pursuant to 41 CFR 102–3.105(j) and
102–3.140, the public or interested
organizations may submit written
statements to Missouri River (North
Dakota) Task Force membership about
the Task Force’s mission and functions.
Written statements may be submitted at
any time or in response to the stated
agenda of planned meeting of Missouri
River (North Dakota) Task Force.
All written statements shall be
submitted to the DFO for the Missouri
River (North Dakota) Task Force, and
this individual will ensure that the
written statements are provided to the
membership for their consideration.
Contact information for the Missouri
River (North Dakota) Task Force DFO
can be obtained from the GSA’s FACA
Database—https://
www.facadatabase.gov/. The DFO,
pursuant to 41 CFR 102–3.150, will
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16:35 Jun 17, 2014
Jkt 232001
announce planned meetings of the
Missouri River (North Dakota) Task
Force. The DFO, at that time, may
provide additional guidance on the
submission of written statements that
are in response to the stated agenda for
the planned meeting in question.
Dated: June 12, 2014.
Aaron Siegel,
Alternate OSD Federal Register Liaison
Officer, Department of Defense.
[FR Doc. 2014–14165 Filed 6–17–14; 8:45 am]
BILLING CODE 5001–06–P
DEPARTMENT OF DEFENSE
Office of the Secretary
Defense Health Agency Evaluation of
Non-United States Food and Drug
Administration; Approved Laboratory
Developed Tests Demonstration
Project
Department of Defense.
Notice of Demonstration.
order to be able to evaluate the
feasibility of establishing a cost-effective
and efficient way to review an expanded
pool of non-FDA approved LDTs
prioritized based on their potential high
utilization and clinical utility within the
TRICARE population. This new
demonstration project will also extend
coverage for prenatal and preconception
cystic fibrosis carrier screening, when
provided in accordance with the
American College of Obstetricians and
Gynecologists guidelines in order to
allow DoD to establish whether there is
a benefit to offering such testing to
TRICARE beneficiaries.
DATES: This demonstration will be
effective July 18, 2014. This
demonstration will remain in effect for
three years.
ADDRESSES: Defense Health Agency,
Attn: Clinical Support Division, 7700
Arlington Blvd., Falls Church, VA
22040.
AGENCY:
FOR FURTHER INFORMATION CONTACT:
ACTION:
Black, Clinical Support Division,
Defense Health Agency, Telephone
(703) 681–0068.
SUPPLEMENTARY INFORMATION:
This notice is to advise
interested parties of a Military Health
System (MHS) demonstration project
under the authority of Title 10, United
States Code, Section 1092, entitled
Defense Health Agency (DHA)
Evaluation of Non-United States Food
and Drug Administration (FDA)
Approved Laboratory Developed Tests
(LDTs) Demonstration Project. The
demonstration project is intended to
further evaluate whether it is feasible for
the Department of Defense (DoD) to
review LDTs not yet examined by the
FDA to determine if they meet
TRICARE’s requirements for safety and
effectiveness according to the hierarchy
of reliable evidence (32 CFR
199.4(g)(15)(i)(C) and 32 CFR 199.2(b)),
or TRICARE’s rare disease policy (32
CFR 199.4(g)(15)(ii)) in the case of LDTs
used in the diagnosis or medical
management of a rare disease (32 CFR
199.2(b)), and allow those that do to be
covered as a benefit under the TRICARE
Program. The demonstration project will
evaluate feasible alternatives to support
modifications to 32 CFR
199.4(g)(15)(i)(A) to allow coverage for
non-FDA approved LDTs that otherwise
meet the TRICARE requirements for
safety and effectiveness. The
Department currently has an ongoing
demonstration project to test this same
provision for LDTs with a Center for
Medicare and Medicaid Services (CMS)
national or local coverage determination
that were submitted by laboratories for
consideration for coverage under
TRICARE. However, this new
demonstration is being conducted in
SUMMARY:
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Jim
A. Background
1. LDTs
According to 32 CFR
199.4(g)(15)(i)(A), TRICARE may not
cost-share medical devices including
LDTs if the tests are non-FDA cleared or
approved; that is, they have not received
FDA medical device 510(k) clearance or
premarket approval. For purposes of
this demonstration, LDTs that are not
FDA cleared or approved will
hereinafter be referred to as non-FDA
approved for brevity purposes. Under
the current regulation cited above, LDTs
that have been identified as non-FDA
approved are summarily denied.
An LDT is an in vitro diagnostic (IVD)
that is designed, manufactured, and
used within a single laboratory. In the
past, these tests were relatively simple
tests used within a single laboratory,
usually at a local large hospital or
academic medical center, to diagnose
rare diseases or for other uses to meet
the needs of a local patient population.
The FDA has exercised enforcement
discretion in that the agency has
generally not enforced applicable
provisions under the Federal Food,
Drug, and Cosmetic Act (FFDCA) and its
regulations with respect to LDTs.
The 1976 Medical Device
Amendments modified the FFDCA to
provide for a comprehensive system for
the regulation of medical devices. The
term ‘‘device’’ is defined broadly in 21
U.S.C. 321(h) to include: ‘‘an
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]]>Agencies
[Federal Register Volume 79, Number 117 (Wednesday, June 18, 2014)]
[Notices]
[Pages 34725-34726]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-14165]
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DEPARTMENT OF DEFENSE
Office of the Secretary
Renewal of Department of Defense Federal Advisory Committees
AGENCY: DoD.
ACTION: Renewal of Federal Advisory Committee.
-----------------------------------------------------------------------
SUMMARY: The Department of Defense is publishing this notice to
announce that it is renewing the charter for the Missouri River (North
Dakota) Task Force (``the Task Force'').
FOR FURTHER INFORMATION CONTACT: Jim Freeman, Advisory Committee
Management Officer for the Department of Defense, 703-692-5952.
SUPPLEMENTARY INFORMATION: This committee's charter is being renewed
under the provisions of the Federal Advisory Committee Act of 1972 (5
U.S.C. Appendix, as amended), the Government in the Sunshine Act of
1976 (5 U.S.C. 552b) (``the Sunshine Act''), and 41 CFR 102-3.50(d).
The Task Force is a nondiscretionary Federal advisory committee
that shall provide independent advice and recommendations to the
Secretary of the Army on plans and projects to reduce siltation of the
Missouri River in the State of North Dakota and to meet the objectives
of the Pick-Sloan Program. Specifically, the Task Force shall:
a. Prepare and approve, by a majority of the members, a plan for
the use of the funds made available under the Missouri River Act, to
promote conservation practices in the Missouri River watershed, control
and remove the sediment from the Missouri River, protect recreation on
the Missouri River from sedimentation, protect Indian and non-Indian
historical and cultural sites along the Missouri River from erosion,
and control erosion along the Missouri River;
b. Develop and recommend to the Secretary of the Army for
implementation critical restoration projects meeting the goals of the
plan; and
c. Determine if these projects primarily benefit the Federal
Government.
The Task Force may, on an annual basis, revise the plan and shall
provide the public with the opportunity to review and comment on any
proposed revision.
The Task Force shall report to the Secretary of the Army and the
U.S. Army Corps of Engineers.
The Secretary of the Army may act upon the Task Force's advice and
recommendations.
The Department of Defense (DoD), through the Secretary of the Army,
the Assistant Secretary of the Army for Civil Works, and the U.S. Army
Corps of Engineers, shall provide support, as deemed necessary, for the
performance of the Task Force's functions, and shall ensure compliance
with the requirements of the FACA, the Government in the Sunshine Act
of 1976 (5 U.S.C. 552b, as amended) (``the Sunshine Act''), governing
Federal statutes and regulations, and established DoD policies and
procedures.
Pursuant to Section 704 and 705 of the Missouri River Protection
and Improvement Act of 2000 (``the Missouri River Act'') (Title VII of
Pub. L. 106-541, the Water Resources Development Act of 2000), the Task
Force shall be composed of not more than 20 members. Specifically, the
Task Force membership shall be composed of:
a. The Secretary of the Army or designee, who shall serve as the
Chair;
b. The Secretary of Agriculture or designee;
c. The Secretary of Energy or designee;
d. The Secretary of the Interior or designee; and
e. The Trust, which is composed of 16 members to be appointed by
the Secretary of the Army, including:
i. Twelve members recommended by the Governor of North Dakota that
represent, equally, the various interests of the public and include
representatives of:
a. the North Dakota Department of Health,
b. the North Dakota Department of Parks and Recreation,
c. the North Dakota Department of Game and Fish,
d. the North Dakota State Water Commission,
e. the North Dakota Indian Affairs Commission,
f. agricultural groups,
g. environmental or conservation organizations,
h. the hydroelectric power industry,
i. recreations user groups,
j. local governments,
k. and other appropriate interests.
ii. Four members representing each of the four Indian tribes in the
State of North Dakota. The members of the Trust shall be appointed by
the Secretary of the Army as representative members to the Task Force,
pursuant to 41 CFR 102-3.130(a). Those individuals who are full-time or
permanent part-time Federal employees shall be appointed regular
government employee (RGE) members, pursuant to 41 CFR 102-3.130(a).
All representative members of the Trust shall be appointed for a
two-year term of service; and no member, unless authorized by the
Secretary of Defense upon request of the Secretary of the Army, may
serve more than two consecutive terms of service. In addition, all Task
Force members shall, with the exception of reimbursement of official
Task Force-related travel and per diem, serve without compensation.
The Department, when necessary and consistent with the Task Force's
mission and DoD policies and procedures, may establish subcommittees,
task forces, or working groups to support the Task Force. Establishment
of subcommittees will be based upon a written determination, to include
terms of reference, by the Secretary of Defense, the Deputy Secretary
of Defense, or the Secretary of the Army, as the Task Force's Sponsor.
Such subcommittees shall not work independently of the chartered
Task Force and shall report all of their recommendations and advice
solely to the Task Force for full and open deliberation and discussion.
Subcommittees, task forces, or working groups have no authority to make
decisions and recommendations, verbally or in writing, on behalf of the
Task Force. No subcommittee or any of its members can update or report,
verbally or in writing, on behalf of the Task Force, directly to the
DoD or any Federal officers or employees.
The Secretary of Defense or the Deputy Secretary of Defense may
approve the appointment of subcommittee members for a two-year term of
service with annual renewals; however, no member, unless authorized by
the Secretary of Defense, may serve more than two consecutive terms of
service. These individuals may come from the Task Force or may be new
nominees, as recommended by the
[[Page 34726]]
Secretary of the Army and based upon the subject matters under
consideration.
Subcommittee members, if not full-time or permanent part-time
Federal employees, shall be appointed as experts or consultants,
pursuant to 5 U.S.C. 3109, to serve as special government employee
members. Those individuals who are full-time or permanent part-time
Federal employees will be appointed, pursuant to 41 CFR 102-3.130(a),
to serve as RGE members.
With the exception of reimbursement for official Task Force-related
travel and per diem, subcommittee members shall serve without
compensation.
All subcommittees operate under the provisions of FACA, the
Sunshine Act, governing Federal statutes and regulations, and
established DoD policies and procedures.
The Designated Federal Officer (DFO), pursuant to DoD policy, shall
be a full-time or permanent part-time DoD employee, and shall be
appointed in accordance with established DoD policies and procedures.
In addition, the DFO is required to be in attendance at all
meetings of the Task Force and any subcommittees, for the entire
duration of each and every meeting; however, in the absence of the DFO,
a properly approved Alternate DFO, duly appointed to the Task Force
according to established DoD policies and procedures, shall attend the
entire duration of all meetings of the Task Force or its subcommittees.
The DFO or the Alternate DFO, shall call all meetings of the Task
Force and its subcommittees; prepare and approve all meeting agendas;
and adjourn any meeting when the DFO, or the Alternate DFO, determines
adjournment to be in the public interest or required by governing
regulations or DoD policies and procedures.
Pursuant to 41 CFR 102-3.105(j) and 102-3.140, the public or
interested organizations may submit written statements to Missouri
River (North Dakota) Task Force membership about the Task Force's
mission and functions. Written statements may be submitted at any time
or in response to the stated agenda of planned meeting of Missouri
River (North Dakota) Task Force.
All written statements shall be submitted to the DFO for the
Missouri River (North Dakota) Task Force, and this individual will
ensure that the written statements are provided to the membership for
their consideration. Contact information for the Missouri River (North
Dakota) Task Force DFO can be obtained from the GSA's FACA Database--
https://www.facadatabase.gov/. The DFO, pursuant to 41 CFR 102-3.150,
will announce planned meetings of the Missouri River (North Dakota)
Task Force. The DFO, at that time, may provide additional guidance on
the submission of written statements that are in response to the stated
agenda for the planned meeting in question.
Dated: June 12, 2014.
Aaron Siegel,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 2014-14165 Filed 6-17-14; 8:45 am]
BILLING CODE 5001-06-P
