Prospective Transfer of Ownership and Exclusive Use of 510(K) Number K113336 for the CDC DENV-1-4 Real-Time RT-PCR ASSAY, 52346-52347 [2014-20859]

Download as PDF 52346 Federal Register / Vol. 79, No. 170 / Wednesday, September 3, 2014 / Notices provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel NIAID Clinical Trial Implementation Cooperative Agreement (U01). Date: September 12, 2014. Time: 1:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Room 3117, 6700B Rockledge Drive, Bethesda, MD 20817 (Telephone Conference Call). Contact Person: Raymond R. Schleef, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, National Institutes of Health/ NIAID, 6700B Rockledge Drive, MSC 7616, Bethesda, MD 20892–7616, 301–451–3679, schleefrr@niaid.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS). Dated: August 27, 2014. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2014–20858 Filed 9–2–14; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health mstockstill on DSK4VPTVN1PROD with NOTICES National Cancer Institute; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c) (4) and 552b(c) (6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which VerDate Mar<15>2010 17:40 Sep 02, 2014 Jkt 232001 would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Cancer Institute Special Emphasis Panel; Subcommittee F—Institutional Training and Education. Date: October 20–21, 2014. Time: 7:30 p.m. to 3:45 p.m. Agenda: To review and evaluate grant applications. Place: Gaithersburg Marriott Washingtonian Center 9751 Washingtonian Boulevard Gaithersburg, MD 20878. Contact Person: Timothy C. Meeker, MD, Ph.D. Scientific Review Officer Resources and Training Review Branch Division of Extramural Activities National Cancer Institute 9609 Medical Center Drive, Room 7W624 Bethesda, MD 20892–9750 240–276– 6464 meekert@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; Provocative Questions Group C. Date: October 22–23, 2014. Time: 5:00 p.m. to 12:00 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda North Marriott Hotel & Conference Center 5701 Marinelli Road Bethesda, MD 20852. Contact Person: Caron A Lyman, Ph.D. Chief, Scientific Review Officer Research Programs Review Branch Division Of Extramural Activities National Cancer Institute 9609 Medical Center Drive, Room 7W126 Bethesda, md 20892–9750 240–276– 6348 lymanc@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; Small Grants Program for Cancer Epidemiology (R03). Date: October 30, 2014. Time: 10:00 a.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute Shady Grove 9609 Medical Center Drive, Room 7E030 Rockville, MD 20850 (Telephone Conference Call). Contact Person: Adriana Stoica, Ph.D. Scientific Review Officer Resources and Training Review Branch Division of Extramural Activities National Cancer Institute, NIH 9609 Medical Center Drive, 7W234 Rockville, MD 20850 240–276–6368 stoicaa2@mail.nih.gov. Information is also available on the Institute’s/Center’s home page: https:// deainfo.nci.nih.gov/advisory/sep/sep.htm, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS). PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 Dated: August 27, 2014. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2014–20853 Filed 9–2–14; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Aging Special Emphasis Panel; MOST Study. Date: October 9, 2014. Time: 11:00 a.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute on Aging, Gateway Building, Suite 2C212, 7201 Wisconsin Avenue, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Isis S. Mikhail, MPH, DRPH, National Institute On Aging, Gateway Building, 7201 Wisconsin Avenue, Suite 2C212, Bethesda, MD 20892, 301–402–7702, MIKHAILI@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS). Dated: August 27, 2014. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2014–20854 Filed 9–2–14; 8:45 am] BILLING CODE 4140–01–P 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 RealTime RT–PCR ASSAY AGENCY: National Institutes of Health, HHS. E:\FR\FM\03SEN1.SGM 03SEN1 Federal Register / Vol. 79, No. 170 / Wednesday, September 3, 2014 / Notices ACTION: Freedom of Information Act, 5 U.S.C. 552. Notice. 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®) 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. SUMMARY: 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. DATES: 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: tarak@mail.nih.gov. 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. ADDRESSES: 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 mstockstill on DSK4VPTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: VerDate Mar<15>2010 17:40 Sep 02, 2014 Jkt 232001 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 DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG–2014–0801] Commercial Fishing Safety Advisory Committee Coast Guard, Department of Homeland Security. ACTION: Notice of Federal Advisory Committee Meeting. AGENCY: The Commercial Fishing Safety Advisory Committee will meet in Providence, Rhode Island to discuss various issues relating to safety in the commercial fishing industry. This meeting will be open to the public. DATES: The Committee will meet on Tuesday, September 23 and Wednesday, September 24, 2014, from 8 a.m. to 5:30 p.m. The meeting may close early if all business is finished. All submitted written materials, comments, and requests to make an oral presentation at the meeting should reach Jack Kemerer, Alternate Designated Federal Officer for the Commercial Fishing Safety Advisory Committee, no later than September 16, 2014. For contact information, please see the FOR FURTHER INFORMATION CONTACT section below. Any written material submitted by the public both before and after the meeting will be distributed to the Commercial Fishing Safety Advisory Committee and become part of the public record. ADDRESSES: The Committee will meet at Rhode Island Department of Environmental Management Headquarters located at 235 Promenade Street, Providence, Rhode Island, Room 300. For information on facilities or services for individuals with disabilities or to request special assistance at the meeting, contact the person listed in the SUMMARY: FOR FURTHER INFORMATION CONTACT section, as soon as possible. To facilitate public participation, we are inviting public comment on the issues to be considered by the Committee as listed in the ‘‘Agenda’’ section below. Written comments must be submitted no later than September PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 52347 16, 2014 if you want Committee members to be able to review it before the meeting, and must be identified by docket number USCG–2014–0801, and submitted by one of the following methods: • Federal Electronic Rulemaking Portal: https://www.regulations.gov (preferred method to avoid delays in processing). • Mail: Docket Management Facility (M–30), United States Department of Transportation, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue SE., Washington, DC 20590– 0001. • Facsimile: (202) 493–2251. • Hand Delivery: Same as mail address above, between 9 a.m. and 5 p.m., Monday through Friday, except Federal Holidays. The telephone number is 202–366–9329. Instructions: All submissions received must include the words ‘‘Department of Homeland Security’’ and docket number for this action. Comments received will be posted without alteration at www.regulations.gov, including any personal information provided. You may review a Privacy Act notice regarding our public dockets in the January 17, 2008 issue of the Federal Register (73 FR 3316). Docket: For access to the docket to read documents or comments related to this notice, go to https://www.regulations.gov, enter the docket number in the ‘‘SEARCH’’ box, press Enter and then click on the item you wish to view. Public oral comment periods will be held during the meeting after each presentation and at the end of each day. Speakers are requested to limit their comments to 3 minutes. Please note that the public oral comment periods may end before the prescribed ending time following the last call for comments. Contact Jack Kemerer as indicated below to register as a speaker. FOR FURTHER INFORMATION CONTACT: Jack Kemerer, Alternate Designated Federal Officer of Commercial Fishing Safety Advisory Committee, Commandant (CG–CVC–3), United States Coast Guard Headquarters, 2703 Martin Luther King Junior Avenue SE., Mail Stop 7501, Washington, DC 20593–7501; telephone 202–372–1249, facsimile 202–372–8376, electronic mail: jack.a.kemerer@ uscg.mil. If you have any questions on viewing or submitting material to the docket, call Cheryl Collins, Program Manager, Docket Operations, telephone 202–493–0402 or 1–800–647–5527. SUPPLEMENTARY INFORMATION: Notice of this meeting is given under the Federal Advisory Committee Act, Title 5 United States Code Appendix. E:\FR\FM\03SEN1.SGM 03SEN1

Agencies

[Federal Register Volume 79, Number 170 (Wednesday, September 3, 2014)]
[Notices]
[Pages 52346-52347]
From the Federal Register Online via the Government Printing 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.

-----------------------------------------------------------------------

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: tarak@mail.nih.gov. 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
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