[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