Government-Owned Inventions; Availability for Licensing and Collaboration; Notification of Q&A Webinar, 13487 [2018-06306]
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Federal Register / Vol. 83, No. 61 / Thursday, March 29, 2018 / Notices
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TIME AND DATE:
Dated: March 27, 2018.
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Deputy General Counsel, Federal Retirement
Thrift Investment Board.
[FR Doc. 2018–06427 Filed 3–27–18; 11:15 am]
BILLING CODE 6760–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Government-Owned Inventions;
Availability for Licensing and
Collaboration; Notification of Q&A
Webinar
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
The invention named in this
notice is owned by agencies of the
United States Government and is
available for licensing in accordance
with the U.S. Federal Technology
Transfer Act of 1986. Related data for
510(k) submission is available as part of
the licensing package. The technology
and related data are being licensed to
achieve expeditious commercialization
of federally funded research and
development. A U.S. Provisional patent
application has been filed to extend
market coverage. CDC also seeks
collaboration partners with interest in
adapting the test for different
equipment, point-of-care, or more rapid
processing.
DATES: Individuals interested in this
technology opportunity are invited to
participate in a live question and
answer webinar on April 27, 2018 at 10
a.m. Eastern Daylight Time.
ADDRESSES: Licensing, related data for
510(k) submission, and other
information pertaining to the technology
listed below, may be obtained by
writing to Technology Transfer Office,
Centers for Disease Control and
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
19:09 Mar 28, 2018
Jkt 244001
Description of Technology
CDC Trioplex Real-time RT–PCR
(Reverse Transcription Polymerase
Chain Reaction) Assay for Detection of
Zika, Dengue, & Chikungunya Virus
Infections CDC ref. no.: I–009–17 NIH
ref. no.: E–081–2017 (See https://
www.ott.nih.gov/technology/e-0812017.)
CDC has developed the Trioplex realtime RT–PCR test to detect evidence of
Zika, dengue and chikungunya virus
infections, all of which are spread by
mosquito bites from the same Aedes
species and cause epidemics in more
than 100 countries. The real-time RT–
PCR assay is for qualitative detection
and differentiation of RNA (ribonucleic
acid) from dengue, chikungunya, and
Zika viruses in serum, whole blood, and
cerebral spinal fluid, and for the
qualitative detection of Zika virus RNA
in urine and amniotic fluid. This assay
protocol is designed to facilitate
simultaneous testing for the three
viruses using a single sample in the
same plate well (multiplex). A
singleplex reaction (measuring one
analyte at a time) is also an option for
chikungunya, and dengue testing if one
primer/probe set per well is preferred.
The test can be run in different
modalities and equipment available in
most laboratories. The test has been
designed to minimize the likelihood of
false positive results. Cross-reactivity for
any of the components is not expected.
The Food & Drug Administration (FDA)
issued emergency use authorization
(EUA) for the Trioplex assay on March
17, 2016. Additional information can be
found at: https://www.fda.gov/
downloads/MedicalDevices/Safety/
EmergencySituations/UCM491592.pdf.
Currently, there are no vaccines or
therapeutics commercially available for
Zika, dengue, or chikungunya virus
infections.
Competitive advantages:
• Currently, there is no multiplex assay
on the market that can detect Zika,
chikungunya and the four dengue
subtypes in one test; this test will also
help assess disease severity in dengue
secondary infections
• There is no FDA-approved
chikungunya PCR test on the market
and current Zika and dengue tests
must be run separately
• This was the first molecular test for
Zika to receive FDA’s EUA
PO 00000
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Fmt 4703
Sfmt 4703
13487
Question and Answer Webinar
Individuals interested in this
technology opportunity are invited to
participate in a live question and
answer webinar on April 27, 2018 at 10
a.m. Eastern Daylight Time. Individuals
must pre-register for the session by
sending an email to tto@cdc.gov by
Thursday, April 26, at 1 p.m. EDT.
After requesting the registration,
participants will receive a confirmation
of their registration along with access
information to enter prior to the
webinar. Persons interested in this
technology are strongly encouraged to
register for and participate in the
webinar.
A signed Confidential Disclosure
Agreement (available under Forms at
www.cdc.gov/tto) will be required to
receive copies of unpublished patent
applications and other information.
Inventors: Jorge Munoz-Jordan, Robert
Lanciotti, and Gilberto Santiago.
U.S. PCT (Patent Cooperation Treaty)
Application No. PCT/US2017/023021:
Filed March 17, 2017.
(CDC Ref. #: I–009–17; NIH Ref. #E–
081–2017—See https://www.ott.nih.gov/
technology/e-081-2017.)
Dated: March 26, 2018.
Sandra Cashman,
Executive Secretary, Centers for Disease
Control and Prevention.
[FR Doc. 2018–06306 Filed 3–28–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers CMS–10148]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995 (the
PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information (including each proposed
extension or reinstatement of an existing
collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
SUMMARY:
E:\FR\FM\29MRN1.SGM
29MRN1
]]>Agencies
[Federal Register Volume 83, Number 61 (Thursday, March 29, 2018)]
[Notices]
[Page 13487]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06306]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Government-Owned Inventions; Availability for Licensing and
Collaboration; Notification of Q&A Webinar
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The invention named in this notice is owned by agencies of the
United States Government and is available for licensing in accordance
with the U.S. Federal Technology Transfer Act of 1986. Related data for
510(k) submission is available as part of the licensing package. The
technology and related data are being licensed to achieve expeditious
commercialization of federally funded research and development. A U.S.
Provisional patent application has been filed to extend market
coverage. CDC also seeks collaboration partners with interest in
adapting the test for different equipment, point-of-care, or more rapid
processing.
DATES: Individuals interested in this technology opportunity are
invited to participate in a live question and answer webinar on April
27, 2018 at 10 a.m. Eastern Daylight Time.
ADDRESSES: Licensing, related data for 510(k) submission, and other
information pertaining to the technology listed below, may be obtained
by writing to Technology Transfer Office, Centers for Disease Control
and Prevention, 1600 Clifton Road NE, Mailstop D-42, Atlanta, GA 30329;
Telephone (404)639-1330; or email [email protected].
SUPPLEMENTARY INFORMATION:
Description of Technology
CDC Trioplex Real-time RT-PCR (Reverse Transcription Polymerase
Chain Reaction) Assay for Detection of Zika, Dengue, & Chikungunya
Virus Infections CDC ref. no.: I-009-17 NIH ref. no.: E-081-2017 (See
https://www.ott.nih.gov/technology/e-081-2017.)
CDC has developed the Trioplex real-time RT-PCR test to detect
evidence of Zika, dengue and chikungunya virus infections, all of which
are spread by mosquito bites from the same Aedes species and cause
epidemics in more than 100 countries. The real-time RT-PCR assay is for
qualitative detection and differentiation of RNA (ribonucleic acid)
from dengue, chikungunya, and Zika viruses in serum, whole blood, and
cerebral spinal fluid, and for the qualitative detection of Zika virus
RNA in urine and amniotic fluid. This assay protocol is designed to
facilitate simultaneous testing for the three viruses using a single
sample in the same plate well (multiplex). A singleplex reaction
(measuring one analyte at a time) is also an option for chikungunya,
and dengue testing if one primer/probe set per well is preferred. The
test can be run in different modalities and equipment available in most
laboratories. The test has been designed to minimize the likelihood of
false positive results. Cross-reactivity for any of the components is
not expected. The Food & Drug Administration (FDA) issued emergency use
authorization (EUA) for the Trioplex assay on March 17, 2016.
Additional information can be found at: https://www.fda.gov/downloads/MedicalDevices/Safety/EmergencySituations/UCM491592.pdf.
Currently, there are no vaccines or therapeutics commercially
available for Zika, dengue, or chikungunya virus infections.
Competitive advantages:
Currently, there is no multiplex assay on the market that can
detect Zika, chikungunya and the four dengue subtypes in one test; this
test will also help assess disease severity in dengue secondary
infections
There is no FDA-approved chikungunya PCR test on the market
and current Zika and dengue tests must be run separately
This was the first molecular test for Zika to receive FDA's
EUA
Question and Answer Webinar
Individuals interested in this technology opportunity are invited
to participate in a live question and answer webinar on April 27, 2018
at 10 a.m. Eastern Daylight Time. Individuals must pre-register for the
session by sending an email to [email protected] by Thursday, April 26, at 1
p.m. EDT.
After requesting the registration, participants will receive a
confirmation of their registration along with access information to
enter prior to the webinar. Persons interested in this technology are
strongly encouraged to register for and participate in the webinar.
A signed Confidential Disclosure Agreement (available under Forms
at www.cdc.gov/tto) will be required to receive copies of unpublished
patent applications and other information.
Inventors: Jorge Munoz-Jordan, Robert Lanciotti, and Gilberto
Santiago.
U.S. PCT (Patent Cooperation Treaty) Application No. PCT/US2017/
023021: Filed March 17, 2017.
(CDC Ref. #: I-009-17; NIH Ref. #E-081-2017--See https://www.ott.nih.gov/technology/e-081-2017.)
Dated: March 26, 2018.
Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2018-06306 Filed 3-28-18; 8:45 am]
BILLING CODE 4163-18-P
