Notice of Three-Year Extension of Defense Health Agency Evaluation of Non-United States Food and Drug Administration Approved Laboratory Developed Tests Demonstration Project, 28052 [2017-12840]
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28052
Federal Register / Vol. 82, No. 117 / Tuesday, June 20, 2017 / Notices
Burden Statement: The respondent
burden for this collection is detailed
below and includes the burden
currently associated with OMB
Collection No. 3038–0079 in connection
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Policies and Procedures for Swap
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Estimated Average Burden Hours per
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Estimated Total Annual Burden on
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Frequency of Collection: Ongoing.
Authority: 44 U.S.C. 3501 et seq.
Dated: June 14, 2017.
Robert N. Sidman,
Deputy Secretary of the Commission.
[FR Doc. 2017–12790 Filed 6–19–17; 8:45 am]
BILLING CODE 6351–01–P
DEPARTMENT OF DEFENSE
Office of the Secretary
Notice of Three-Year Extension of
Defense Health Agency Evaluation of
Non-United States Food and Drug
Administration Approved Laboratory
Developed Tests Demonstration
Project
Department of Defense.
Notice of three-year extension of
Defense Health Agency Evaluation of
Non-United States Food and Drug
Administration Approved Laboratory
Developed Tests Demonstration Project.
AGENCY:
ACTION:
This notice is to advise
interested parties of a three-year
extension of a demonstration project
entitled Defense Health Agency (DHA)
Evaluation of Non-United States Food
and Drug Administration (FDA)
Approved Laboratory Developed Tests
(LDTs) Demonstration Project. The
original notice was published on June
18, 2014 (79 FR 34726–34729).
DATES: Effective July 19, 2017.
ADDRESSES: Defense Health Agency
(DHA), Attn: Clinical Support Division,
16401 East Centretech Parkway, Aurora,
CO 80011–9066.
FOR FURTHER INFORMATION CONTACT: Jim
Black, Clinical Support Division,
Defense Health Agency, Telephone
(303) 676–3487.
SUPPLEMENTARY INFORMATION: For
additional information on the DHA
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:01 Jun 19, 2017
Jkt 241001
Evaluation of Non-United States FDA
Approved LDTs Demonstration Project,
please see 79 FR 34726–34729.
According to 32 CFR 199.4(g)(15)(i)(A),
TRICARE may not cost-share medical
devices, including LDTs, that have not
received FDA medical device 510(k)
clearance or premarket approval.
The purpose of this demonstration is
to improve the quality of health care
services for TRICARE beneficiaries.
Under this demonstration, the
Department of Defense reviews nonFDA approved LDTs to determine if
they meet TRICARE’s requirements for
safety and effectiveness, and allows
those that do to be covered as a benefit
under the demonstration. This
demonstration also extends coverage for
prenatal and preconception cystic
fibrosis (CF) carrier screening, when
provided in accordance with the
American College of Obstetricians and
Gynecologists guidelines.
The Department has determined that
continuation of the demonstration
project for an additional three years is
necessary to provide the Secretary with
sufficient information to fully evaluate
the project while continuing to provide
TRICARE beneficiaries and their health
care providers with seamless access to
safe and effective, medically necessary
tests to support health care decisions
and treatment. During the next three
years, the DHA will continue to evaluate
the LDT examination and
recommendation process to assess
feasibility, resource requirements, and
the cost-effectiveness of establishing an
internal safety and efficacy review
process to permit TRICARE cost-sharing
for an ever-expanding pool of non-FDA
approved LDTs, including tests for
cancer risk, diagnosis and treatment,
blood and clotting disorders, a variety of
genetic diseases and syndromes, and
neurological conditions. The results of
the evaluation will provide an
assessment of the potential
improvement of the quality of health
care services for beneficiaries who
would not otherwise have access to
these safe and effective tests and to
support future regulatory revisions
which will enhance the flexibility of the
Military Health System in responding to
emerging technologies. The
demonstration project continues to be
authorized by 10 U.S.C. 1092.
Dated: June 15, 2017.
Aaron Siegel,
Alternate OSD Federal Register Liaison
Officer, Department of Defense.
[FR Doc. 2017–12840 Filed 6–19–17; 8:45 am]
Frm 00010
Fmt 4703
Department of the Navy
Notice of Availability of GovernmentOwned Inventions; Available for
Licensing
Department of the Navy; DoD.
Notice.
AGENCY:
ACTION:
The inventions listed below
are assigned to the United States
Government as represented by the
Secretary of the Navy and are available
for domestic and foreign licensing by
the Department of the Navy.
The following patents are available for
licensing: U.S. Patent No. 9,180,933:
INTEGRATED STERN BULB AND
FLAP//U.S. Patent No. 9,228,805:
CORRUGATED BLAST FREQUENCY
CONTROL PANEL AND METHOD//U.S.
Patent No. 9,230,717: UNIVERSAL
CABLE JACKET REMOVAL TOOL//U.S.
Patent No. 9,238,501: BILGE KEEL
WITH POROUS LEADING EDGE//U.S.
Patent No. 9,306,360: TORSION
ELIMINATING COMPRESSION DEVICE
AND METHOD//U.S. Patent No.
9,307,156: LONGWAVE INFRARED
IMAGING OF A HIGH TEMPERATURE
HIGH INTENSITY LIGHT SOURCE//
U.S. Patent No. 9,340,284: CARGO
SUSPENSION FRAME FOR
AIRCRAFT//U.S. Patent No. 9,365,262:
WIGGLE HULL DESIGN HAVING A
CONCAVE AND CONVEX PLANING
HULL//U.S. Patent No. 9,376,171:
MOORING CLEAT WITH OPEN
DESIGN FOR NON THREAD ENTRY//
U.S. Patent No. 9,376,175: WATER
VESSEL WITH INTEGRATED
BUOYANCY BULB AND STERN
RAMP//U.S. Patent No. 9,381,979:
PORTABLE LIGHTWEIGHT
APPARATUS AND METHOD FOR
TRANSFERRING HEAVY LOADS//U.S.
Patent No. 9,417,155: CALCAREOUS
DEPOSIT WIPE TEST APPARATUS
AND METHOD//U.S. Patent No.
9,421,618: CLAMPING DEVICE FOR
SECURING CABLES TO SUBMERGED
FERROUS HULL SURFACE.//
ADDRESSES: Requests for copies of the
patents cited should be directed to
Office of Counsel, Naval Surface
Warfare Center Carderock Division,
9500 MacArthur Blvd., West Bethesda,
MD 20817–5700.
FOR FURTHER INFORMATION CONTACT: Dr.
Joseph Teter, Director, Technology
Transfer Office, Naval Surface Warfare
Center Carderock Division, Code 0120,
9500 MacArthur Blvd., West Bethesda,
MD 20817–5700, telephone 301–227–
4299.
SUMMARY:
Authority: 35 U.S.C. 207, 37 CFR part 404.
BILLING CODE 5001–06–P
PO 00000
DEPARTMENT OF DEFENSE
Sfmt 4703
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20JNN1
]]>Agencies
[Federal Register Volume 82, Number 117 (Tuesday, June 20, 2017)]
[Notices]
[Page 28052]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12840]
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DEPARTMENT OF DEFENSE
Office of the Secretary
Notice of Three-Year Extension of Defense Health Agency
Evaluation of Non-United States Food and Drug Administration Approved
Laboratory Developed Tests Demonstration Project
AGENCY: Department of Defense.
ACTION: Notice of three-year extension of Defense Health Agency
Evaluation of Non-United States Food and Drug Administration Approved
Laboratory Developed Tests Demonstration Project.
-----------------------------------------------------------------------
SUMMARY: This notice is to advise interested parties of a three-year
extension of a demonstration project entitled Defense Health Agency
(DHA) Evaluation of Non-United States Food and Drug Administration
(FDA) Approved Laboratory Developed Tests (LDTs) Demonstration Project.
The original notice was published on June 18, 2014 (79 FR 34726-34729).
DATES: Effective July 19, 2017.
ADDRESSES: Defense Health Agency (DHA), Attn: Clinical Support
Division, 16401 East Centretech Parkway, Aurora, CO 80011-9066.
FOR FURTHER INFORMATION CONTACT: Jim Black, Clinical Support Division,
Defense Health Agency, Telephone (303) 676-3487.
SUPPLEMENTARY INFORMATION: For additional information on the DHA
Evaluation of Non-United States FDA Approved LDTs Demonstration
Project, please see 79 FR 34726-34729. According to 32 CFR
199.4(g)(15)(i)(A), TRICARE may not cost-share medical devices,
including LDTs, that have not received FDA medical device 510(k)
clearance or premarket approval.
The purpose of this demonstration is to improve the quality of
health care services for TRICARE beneficiaries. Under this
demonstration, the Department of Defense reviews non-FDA approved LDTs
to determine if they meet TRICARE's requirements for safety and
effectiveness, and allows those that do to be covered as a benefit
under the demonstration. This demonstration also extends coverage for
prenatal and preconception cystic fibrosis (CF) carrier screening, when
provided in accordance with the American College of Obstetricians and
Gynecologists guidelines.
The Department has determined that continuation of the
demonstration project for an additional three years is necessary to
provide the Secretary with sufficient information to fully evaluate the
project while continuing to provide TRICARE beneficiaries and their
health care providers with seamless access to safe and effective,
medically necessary tests to support health care decisions and
treatment. During the next three years, the DHA will continue to
evaluate the LDT examination and recommendation process to assess
feasibility, resource requirements, and the cost-effectiveness of
establishing an internal safety and efficacy review process to permit
TRICARE cost-sharing for an ever-expanding pool of non-FDA approved
LDTs, including tests for cancer risk, diagnosis and treatment, blood
and clotting disorders, a variety of genetic diseases and syndromes,
and neurological conditions. The results of the evaluation will provide
an assessment of the potential improvement of the quality of health
care services for beneficiaries who would not otherwise have access to
these safe and effective tests and to support future regulatory
revisions which will enhance the flexibility of the Military Health
System in responding to emerging technologies. The demonstration
project continues to be authorized by 10 U.S.C. 1092.
Dated: June 15, 2017.
Aaron Siegel,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 2017-12840 Filed 6-19-17; 8:45 am]
BILLING CODE 5001-06-P
