[Federal Register Volume 79, Number 170 (Wednesday, September 3, 2014)]
[Notices]
[Pages 52346-52347]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-20859]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Transfer of Ownership and Exclusive Use of 510(K)
Number K113336 for the CDC DENV-1-4 Real-Time RT-PCR ASSAY
AGENCY: National Institutes of Health, HHS.
[[Page 52347]]
ACTION: Notice.
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SUMMARY: This is notice that the Centers for Disease Control and
Prevention, Department of Health and Human Services, is contemplating
the transfer of ownership and exclusive use of 510(k) Number K113336 to
American Type Culture Collection (ATCC), a District of Columbia non-
profit corporation. 510(k) Number K113336 allows marketing of the CDC
DENV-1-4 Real-Time RT-PCR Assay, an in vitro molecular diagnostic test
that consists of a panel of oligonucleotide primers and dual-labeled
hydrolysis (TaqMan[supreg]) probes for the qualitative detection of
dengue virus target sequences in serum and plasma using nucleic acid
isolation, amplification, and detection on the ABI 7500 Fast Dx Real-
Time PCR instrument. The contemplated transfer would occur in
conjunction with the grant of a non-exclusive patent license to ATCC to
practice the inventions embodied in patent applications under HHS Ref.
No E-148-2013/0, including U.S. Provisional Patent Application No. 61/
554,126, entitled ``Broad Detection of Dengue Virus Serotypes'', filed
November 1, 2011.
DATES: Only written comments and/or applications for a license to
practice the inventions embodied in HHS Ref. No E-148-2013/0 that
include a request for the transfer of 510(k) Number K113336 that are
received by the NIH Office of Technology Transfer on or before October
3, 2014 will be considered.
ADDRESSES: Any inquiries, comments, or other materials relating to the
contemplated 510(k) transfer should be directed to: Tara L. Kirby,
Ph.D., Unit Chief, CDC Unit, Office of Technology Transfer, National
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville,
MD 20852-3804; Telephone: (301) 435-4426; Facsimile: (301) 402-0220;
Email: [email protected]. Requests for copies of CDC's patent
applications related to ``Broad Detection of Dengue Virus Serotypes''
(HHS Ref. No. E-148-2013/0), which are available for non-exclusive
licensing, should also be directed as above.
SUPPLEMENTARY INFORMATION: Complete applications for a license to
practice the inventions embodied in HHS Ref. No E-148-2013/0 that
include a request for the transfer of 510(k) Number K113336 filed in
response to this notice will be treated as objections to the grant of
the contemplated transfer. Comments and objections submitted to this
notice will not be made available for public inspection and, to the
extent permitted by law, will not be released under the Freedom of
Information Act, 5 U.S.C. 552.
Dated: August 28, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-20859 Filed 9-2-14; 8:45 am]
BILLING CODE 4140-01-P