82 FR 28052 - 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
Office of the Secretary Federal Register Volume 82, Issue 117 (June 20, 2017)
Office of the Secretary
Federal Register Volume 82, Issue 117 (June 20, 2017)
| Page Range | 28052-28052 | |
| FR Document | 2017-12840 |
[Federal Register Volume 82, Number 117 (Tuesday, June 20, 2017)] [Notices] [Page 28052] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-12840] ======================================================================= ----------------------------------------------------------------------- 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
![28052 Federal Register / Vol. 82, No. 117 / Tuesday, June 20, 2017 / Notices
Burden Statement: The respondent Evaluation of Non-United States FDA DEPARTMENT OF DEFENSE
burden for this collection is detailed Approved LDTs Demonstration Project,
below and includes the burden please see 79 FR 34726–34729. Department of the Navy
currently associated with OMB According to 32 CFR 199.4(g)(15)(i)(A),
Collection No. 3038–0079 in connection TRICARE may not cost-share medical Notice of Availability of Government-
with § 23.605 (Conflicts of Interest devices, including LDTs, that have not Owned Inventions; Available for
Policies and Procedures for Swap received FDA medical device 510(k) Licensing
Dealers and Major Swap Participants) clearance or premarket approval. AGENCY: Department of the Navy; DoD.
and the EBCS Rules. The purpose of this demonstration is
The Commission estimates the burden ACTION: Notice.
to improve the quality of health care
of this collection of information as
services for TRICARE beneficiaries. SUMMARY: The inventions listed below
follows:
Under this demonstration, the are assigned to the United States
Respondents/Affected Entities: Swap
Department of Defense reviews non- Government as represented by the
Dealers and Major Swap Participants.
Estimated Number of Respondents: FDA approved LDTs to determine if Secretary of the Navy and are available
102. they meet TRICARE’s requirements for for domestic and foreign licensing by
Estimated Average Burden Hours per safety and effectiveness, and allows the Department of the Navy.
Respondent: 2,352.9 hours. those that do to be covered as a benefit The following patents are available for
Estimated Total Annual Burden on under the demonstration. This licensing: U.S. Patent No. 9,180,933:
Respondents: 240,000 hours. demonstration also extends coverage for INTEGRATED STERN BULB AND
Frequency of Collection: Ongoing. prenatal and preconception cystic FLAP//U.S. Patent No. 9,228,805:
fibrosis (CF) carrier screening, when CORRUGATED BLAST FREQUENCY
Authority: 44 U.S.C. 3501 et seq.
provided in accordance with the CONTROL PANEL AND METHOD//U.S.
Dated: June 14, 2017. American College of Obstetricians and Patent No. 9,230,717: UNIVERSAL
Robert N. Sidman, Gynecologists guidelines. CABLE JACKET REMOVAL TOOL//U.S.
Deputy Secretary of the Commission. Patent No. 9,238,501: BILGE KEEL
The Department has determined that
[FR Doc. 2017–12790 Filed 6–19–17; 8:45 am] WITH POROUS LEADING EDGE//U.S.
continuation of the demonstration
BILLING CODE 6351–01–P Patent No. 9,306,360: TORSION
project for an additional three years is
ELIMINATING COMPRESSION DEVICE
necessary to provide the Secretary with
AND METHOD//U.S. Patent No.
sufficient information to fully evaluate
DEPARTMENT OF DEFENSE 9,307,156: LONGWAVE INFRARED
the project while continuing to provide
IMAGING OF A HIGH TEMPERATURE
TRICARE beneficiaries and their health HIGH INTENSITY LIGHT SOURCE//
Office of the Secretary
care providers with seamless access to U.S. Patent No. 9,340,284: CARGO
Notice of Three-Year Extension of safe and effective, medically necessary SUSPENSION FRAME FOR
Defense Health Agency Evaluation of tests to support health care decisions AIRCRAFT//U.S. Patent No. 9,365,262:
Non-United States Food and Drug and treatment. During the next three WIGGLE HULL DESIGN HAVING A
Administration Approved Laboratory years, the DHA will continue to evaluate CONCAVE AND CONVEX PLANING
Developed Tests Demonstration the LDT examination and HULL//U.S. Patent No. 9,376,171:
Project recommendation process to assess MOORING CLEAT WITH OPEN
feasibility, resource requirements, and DESIGN FOR NON THREAD ENTRY//
AGENCY: Department of Defense. the cost-effectiveness of establishing an U.S. Patent No. 9,376,175: WATER
ACTION:Notice of three-year extension of internal safety and efficacy review VESSEL WITH INTEGRATED
Defense Health Agency Evaluation of process to permit TRICARE cost-sharing BUOYANCY BULB AND STERN
Non-United States Food and Drug for an ever-expanding pool of non-FDA RAMP//U.S. Patent No. 9,381,979:
Administration Approved Laboratory approved LDTs, including tests for PORTABLE LIGHTWEIGHT
Developed Tests Demonstration Project. cancer risk, diagnosis and treatment, APPARATUS AND METHOD FOR
blood and clotting disorders, a variety of TRANSFERRING HEAVY LOADS//U.S.
SUMMARY: This notice is to advise
genetic diseases and syndromes, and Patent No. 9,417,155: CALCAREOUS
interested parties of a three-year
neurological conditions. The results of DEPOSIT WIPE TEST APPARATUS
extension of a demonstration project
the evaluation will provide an AND METHOD//U.S. Patent No.
entitled Defense Health Agency (DHA)
assessment of the potential 9,421,618: CLAMPING DEVICE FOR
Evaluation of Non-United States Food
improvement of the quality of health SECURING CABLES TO SUBMERGED
and Drug Administration (FDA)
care services for beneficiaries who FERROUS HULL SURFACE.//
Approved Laboratory Developed Tests
(LDTs) Demonstration Project. The would not otherwise have access to
ADDRESSES: Requests for copies of the
original notice was published on June these safe and effective tests and to
patents cited should be directed to
18, 2014 (79 FR 34726–34729). support future regulatory revisions
Office of Counsel, Naval Surface
which will enhance the flexibility of the Warfare Center Carderock Division,
DATES: Effective July 19, 2017.
Military Health System in responding to 9500 MacArthur Blvd., West Bethesda,
ADDRESSES: Defense Health Agency emerging technologies. The
(DHA), Attn: Clinical Support Division, MD 20817–5700.
demonstration project continues to be
16401 East Centretech Parkway, Aurora, FOR FURTHER INFORMATION CONTACT: Dr.
sradovich on DSK3GMQ082PROD with NOTICES
authorized by 10 U.S.C. 1092.
CO 80011–9066. Joseph Teter, Director, Technology
Dated: June 15, 2017. Transfer Office, Naval Surface Warfare
FOR FURTHER INFORMATION CONTACT: Jim
Black, Clinical Support Division, Aaron Siegel, Center Carderock Division, Code 0120,
Defense Health Agency, Telephone Alternate OSD Federal Register Liaison 9500 MacArthur Blvd., West Bethesda,
(303) 676–3487. Officer, Department of Defense. MD 20817–5700, telephone 301–227–
SUPPLEMENTARY INFORMATION: For [FR Doc. 2017–12840 Filed 6–19–17; 8:45 am] 4299.
additional information on the DHA BILLING CODE 5001–06–P Authority: 35 U.S.C. 207, 37 CFR part 404.
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Document Created: 2017-06-20 02:21:24
Document Modified: 2017-06-20 02:21:24
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| 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. | |
| Dates | Effective July 19, 2017. | |
| Contact | Jim Black, Clinical Support Division, Defense Health Agency, Telephone (303) 676-3487. | |
| FR Citation | 82 FR 28052 |
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