Prospective Grant of Exclusive License: Use of Quaking-Induced Conversion (QUIC) for Detection of Prions, 61375 [2013-24141]

Download as PDF Federal Register / Vol. 78, No. 192 / Thursday, October 3, 2013 / Notices protection, or easement acquisition; development and implementation of a data recovery plan to retrieve and analyze the site’s resourcesimplementation of innovative, alternative mitigation measures- or a combination of these measures. Practicable Means to Avoid or Minimize Potential Environmental Harm From the Selected Alternative Air quality permit standards will be met, as will all federal, state, and local requirements to protect the environment and public health. Conclusion Based upon review and careful consideration, the NIH has decided to implement the Selected Alternative for a long-range physical Master Plan for NIH Animal Center located in Dickerson, Maryland. The decision accounts for potential growth at NIHAC personnel, and consequent construction of space over the planning period. The decision was based upon review and careful consideration of the impacts identified in the Final EIS and public comments received throughout the NEPA process. tkelley on DSK3SPTVN1PROD with NOTICES BILLING CODE 4140–01–P VerDate Mar<15>2010 18:29 Oct 02, 2013 Jkt 232001 Prospective Grant of Exclusive License: Use of Quaking-Induced Conversion (QUIC) for Detection of Prions National Institutes of Health, HHS. Pollution Prevention [FR Doc. 2013–24205 Filed 10–2–13; 8:45 am] National Institutes of Health AGENCY: All practicable means to avoid or minimize adverse environmental effects from the Selected Action have been identified and incorporated into the action. The proposed Master Plan construction will be subject to the existing NIHAC pollution prevention, waste management, and safety, security, and emergency response procedures as well as existing environmental permits. Best management practices, spill prevention and control, and stormwater management plans will be followed to appropriately address the construction and operation of the new Master Plan and comply with applicable regulatory and NIH requirements. No additional mitigation measures have been identified. Dated: September 27, 2013. Daniel G. Wheeland, Director, Office of Research Facilities Development and Operations, National Institutes of Health. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACTION: Notice. This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in U.S. provisional Application 60/961,364 filed July 20, 2007 [E–109–2007/0–US–01], PCT/ US2008/070656, filed July 21, 2008; [E– 109–2007/1–PCT–01], EPC application No 08796382.3 filed July 21, 2008 [E– 109–2007/1–EP–03], US Application No. 12/177,012, filed July 21, 2008 and issued as US patent 8,216,788 on July 10, 2012 [E–109–2007/1–US–02], and US Application No. 13/489,321, filed June 5, 2012 [E–109–2007/1–US–04]; Each entitled ‘‘Detection of Infectious Prion Protein by Seeded Conversion of Recombinant Prion Protein’’ By Byron Caughey et al. to Prionics AG having a place of business at Wagistrasse 27a CH–8952 Schlieren-Zurich, Switzerland. The patent rights in this invention have been assigned to the United States of America. DATES: Only written comments and/or application for a license that are received by the NIH Office of Technology Transfer on or before November 4, 2013 will be considered. ADDRESSES: Requests for a copy of the patent application, inquiries, comments and other materials relating to the contemplated license should be directed to: Tedd Fenn, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; Email: Tedd.Fenn@mail.nih.gov; Telephone: 301–435–5031; Facsimile: 301–402– 0220. SUMMARY: SUPPLEMENTARY INFORMATION: The prospective worldwide exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license may be granted unless, within thirty (30) days from the date of this published Notice, NIH receives written evidence and argument that establishes that the grant of the license would not be PO 00000 Frm 00055 Fmt 4703 Sfmt 9990 61375 consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404. The invention relates to methods and compositions for the detection of infectious proteins or prions and diagnosis of prion related diseases. Prion diseases are neurodegenerative diseases of great public concern because humans may be infected from hoofed animals used as food, food products such as milk, or blood products. Currently available tests for diseasecausing prions are either incapable of detecting low concentrations of prions and must be used post-mortem or are incapable of detecting low concentrations of prions economically or accurately. This technology enables rapid and economical detection of sublethal concentrations of prions by using recombinant, normal, prion protein (rPrP-sen) as a marker or indicator of infectious prions in a sample. Specifically, prions (contained in a sample) seed the polymerization of rPrP-sen, and polymerized rPrP-sen is detected as an amplified indicator of prions in the sample. This assay differs from the protein-misfolding cyclic amplification assay (PMCA) because it enables the effective use of rPrP-sen and does not require multiple amplification cycles unless a higher degree of sensitivity is required. It is anticipated that this technology can be combined with additional prion-detection technologies to further improve the sensitivity of the assay. In its current embodiment, this assay has been used to detect prions in brain tissue or cerebral spinal fluid (CSF) from humans (variant CJD), sheep (scrapie), and hamsters (scrapie). The proposed field of exclusivity may be limited to diagnostics requiring premarket approval by a U.S. or a foreign regulatory agency. Properly filed competing applications for a license filed in response to this notice will be treated as objections to the contemplated license. Comments and objections submitted in response 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: September 27, 2013. Richard U. Rodriguez, Director, Division of Technology Development & Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2013–24141 Filed 10–2–13; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\03OCN1.SGM 03OCN1

Agencies

[Federal Register Volume 78, Number 192 (Thursday, October 3, 2013)]
[Notices]
[Page 61375]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-24141]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Use of Quaking-Induced 
Conversion (QUIC) for Detection of Prions

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 
part 404, that the National Institutes of Health (NIH), Department of 
Health and Human Services, is contemplating the grant of an exclusive 
license to practice the inventions embodied in U.S. provisional 
Application 60/961,364 filed July 20, 2007 [E-109-2007/0-US-01], PCT/
US2008/070656, filed July 21, 2008; [E-109-2007/1-PCT-01], EPC 
application No 08796382.3 filed July 21, 2008 [E-109-2007/1-EP-03], US 
Application No. 12/177,012, filed July 21, 2008 and issued as US patent 
8,216,788 on July 10, 2012 [E-109-2007/1-US-02], and US Application No. 
13/489,321, filed June 5, 2012 [E-109-2007/1-US-04]; Each entitled 
``Detection of Infectious Prion Protein by Seeded Conversion of 
Recombinant Prion Protein'' By Byron Caughey et al. to Prionics AG 
having a place of business at Wagistrasse 27a CH-8952 Schlieren-Zurich, 
Switzerland. The patent rights in this invention have been assigned to 
the United States of America.

DATES: Only written comments and/or application for a license that are 
received by the NIH Office of Technology Transfer on or before November 
4, 2013 will be considered.

ADDRESSES: Requests for a copy of the patent application, inquiries, 
comments and other materials relating to the contemplated license 
should be directed to: Tedd Fenn, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, MD 20852-3804; Email: Tedd.Fenn@mail.nih.gov; Telephone: 
301-435-5031; Facsimile: 301-402-0220.

SUPPLEMENTARY INFORMATION: 
    The prospective worldwide exclusive license will be royalty bearing 
and will comply with the terms and conditions of 35 U.S.C. 209 and 37 
CFR part 404. The prospective exclusive license may be granted unless, 
within thirty (30) days from the date of this published Notice, NIH 
receives written evidence and argument that establishes that the grant 
of the license would not be consistent with the requirements of 35 
U.S.C. 209 and 37 CFR part 404.
    The invention relates to methods and compositions for the detection 
of infectious proteins or prions and diagnosis of prion related 
diseases. Prion diseases are neurodegenerative diseases of great public 
concern because humans may be infected from hoofed animals used as 
food, food products such as milk, or blood products. Currently 
available tests for disease-causing prions are either incapable of 
detecting low concentrations of prions and must be used post-mortem or 
are incapable of detecting low concentrations of prions economically or 
accurately. This technology enables rapid and economical detection of 
sub-lethal concentrations of prions by using recombinant, normal, prion 
protein (rPrP-sen) as a marker or indicator of infectious prions in a 
sample. Specifically, prions (contained in a sample) seed the 
polymerization of rPrP-sen, and polymerized rPrP-sen is detected as an 
amplified indicator of prions in the sample. This assay differs from 
the protein-misfolding cyclic amplification assay (PMCA) because it 
enables the effective use of rPrP-sen and does not require multiple 
amplification cycles unless a higher degree of sensitivity is required. 
It is anticipated that this technology can be combined with additional 
prion-detection technologies to further improve the sensitivity of the 
assay. In its current embodiment, this assay has been used to detect 
prions in brain tissue or cerebral spinal fluid (CSF) from humans 
(variant CJD), sheep (scrapie), and hamsters (scrapie).
    The proposed field of exclusivity may be limited to diagnostics 
requiring premarket approval by a U.S. or a foreign regulatory agency.
    Properly filed competing applications for a license filed in 
response to this notice will be treated as objections to the 
contemplated license. Comments and objections submitted in response 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: September 27, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development & Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-24141 Filed 10-2-13; 8:45 am]
BILLING CODE 4140-01-P
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