82_FR_10806 82 FR 10776 - Government-Owned Inventions; Availability for Licensing

82 FR 10776 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 82, Issue 30 (February 15, 2017)

Page Range10776-10777
FR Document2017-03015

The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

Federal Register, Volume 82 Issue 30 (Wednesday, February 15, 2017) 
[Federal Register Volume 82, Number 30 (Wednesday, February 15, 2017)]
[Notices]
[Pages 10776-10777]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-03015]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The invention listed below is owned by an agency of the U.S. 
Government and is available for licensing to achieve expeditious 
commercialization of results of federally-funded research and 
development. Foreign patent applications are filed on selected 
inventions to extend market coverage for companies and may also be 
available for licensing.

[[Page 10777]]


FOR FURTHER INFORMATION CONTACT: Licensing information and copies of 
the patent applications listed below may be obtained by communicating 
with the indicated licensing contact at the Technology Transfer and 
Intellectual Property Office, National Institute of Allergy and 
Infectious Diseases, 5601 Fishers Lane, Rockville, MD 20852; tel. 301-
496-2644. A signed Confidential Disclosure Agreement will be required 
to receive copies of unpublished patent applications.

SUPPLEMENTARY INFORMATION: Technology description follows.

Single-Chain Antibodies Directed to Norovirus GI.1 and GII.4 and Their 
Use

    Description of Technology: Vaccines and therapies to prevent and 
treat Norovirus infections are not available, despite the worldwide 
prevalence of Norovirus infections. Outbreaks of human gastroenteritis 
attributable to Norovirus commonly occur in group settings, such as 
hospitals, nursing homes, schools, dormitories, cruise ships and 
military barracks. This application claims isolated VHH monoclonal 
antibodies that specifically bind to a Norovirus polypeptide. Llama-
derived single chain antibody fragments (also called VHH) are small, 
recombinant monoclonal antibodies of 15 kDa (``nanobodies'') with 
several advantages over conventional antibodies. The antibodies that 
were derived from llamas showed strong neutralizing activity against 
Norovirus in in vitro assays. These nanobodies may have application as 
immunoprophylaxis to protect individuals from infections or as a 
possible treatment for infected individuals, or can be used to develop 
a diagnostic for detection of norovirus infections, and may be 
potentially utilized in vaccine research.
    This technology is available for licensing for commercial 
development in accordance with 35 U.S.C. 209 and 37 CFR part 404, as 
well as for further development and evaluation under a research 
collaboration.
    Potential Commercial Applications:

 Therapeutics
 Diagnostics
 Vaccine research

    Competitive Advantages:

 Ease of manufacture
 Potent neutralizing activity
 Potential cross-reactivity
 Low-cost therapeutics/immunoprophylaxis

    Development Stage:

 In vivo data assessment (animal)

    Inventors: Lisbeth Kim Green (NIAID), Karin Bok (NIAID), Stanislav 
Sosnovtsev (NIAID), Marina Bok (EM), Pamela Aguilar (EM), Lorena 
Garaicoechea (EM), and Viviana Parreno (EM).
    Publications: Garaicoechea L. et al., ``Llama nanoantibodies with 
therapeutic potential against human norovirus diarrhea,'' PLoS One. 
2015 Aug 12;10(8):e0133665. doi:10.1371/journal.pone.0133665. 
eCollection 2015. [PMID 26267898].
    Intellectual Property: HHS Reference No. E-136-2013/0--U.S. 
Provisional Application No. 61/821,354, filed May 9, 2013; PCT 
Application No. PCT/US2014/037520, filed May 9, 2014; European 
Application No. 14727696.8, filed May 9, 2014 (pending); U.S. 
Application No. 14/889,774, filed November 6, 2015 (pending); and 
Argentine Application No. 20140101882, filed May 9, 2014 (pending).
    Licensing Contact: Peter Soukas, J.D., 301-594-8730; 
[email protected].
    Collaborative Research Opportunity: The National Institute of 
Allergy and Infectious Diseases is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate or commercialize for development of a therapeutic, 
diagnostic or vaccine for Norovirus infections. For collaboration 
opportunities, please contact Peter Soukas, J.D., 301-594-8730; 
[email protected].

    Dated: February 8, 2017.
Suzanne Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2017-03015 Filed 2-14-17; 8:45 am]
BILLING CODE 4140-01-P

10776 Federal Register / Vol. 82, No. 30 / Wednesday, February 15, 2017 / Notices identifies you in the body of your information about FDA’s posting of industry on BE recommendations for comments, that information will be comments to public dockets, see 80 FR difluprednate emulsion (‘‘Draft posted on http://www.regulations.gov. 56469, September 18, 2015, or access Guidance on Difluprednate’’). • If you want to submit a comment the information at: http://www.gpo.gov/ In September 2016, Alcon with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015- Pharmaceuticals, Ltd. and its affiliated do not wish to be made available to the 23389.pdf. company, Novartis Pharmaceuticals public, submit the comment as a Docket: For access to the docket to Corporation, submitted a citizen written/paper submission and in the read background documents or the petition requesting that FDA take manner detailed (see ‘‘Written/Paper electronic and written/paper comments several actions with respect to ANDAs Submissions’’ and ‘‘Instructions’’). received, go to http:// for difluprednate emulsion, including Written/Paper Submissions www.regulations.gov and insert the regarding the demonstration of BE for docket number, found in brackets in the any ANDA referencing DUREZOL. FDA Submit written/paper submissions as heading of this document, into the has reviewed the issues raised in this follows: ‘‘Search’’ box and follow the prompts citizen petition and is responding to the • Mail/Hand delivery/Courier (for and/or go to the Division of Dockets citizen petition separately in the docket written/paper submissions): Division of Management, 5630 Fishers Lane, Rm. for that citizen petition (Docket No. Dockets Management (HFA–305), Food 1061, Rockville, MD 20852. FDA–2016–P–2781, available at http:// and Drug Administration, 5630 Fishers Submit written requests for single www.regulations.gov). Lane, Rm. 1061, Rockville, MD 20852. copies of the draft guidance to the This draft guidance is being issued • For written/paper comments consistent with FDA’s good guidance Division of Drug Information, Center for submitted to the Division of Dockets Drug Evaluation and Research, Food practices regulation (21 CFR 10.115). Management, FDA will post your and Drug Administration, 10001 New The draft guidance, when finalized, will comment, as well as any attachments, Hampshire Ave., Hillandale Building, represent the current thinking of FDA except for information submitted, 4th Floor, Silver Spring, MD 20993– on the design of BE studies to support marked and identified, as confidential, 0002. Send one self-addressed adhesive ANDAs for difluprednate emulsion. It if submitted as detailed in label to assist that office in processing does not establish any rights for any ‘‘Instructions.’’ Instructions: All submissions received your requests. See the SUPPLEMENTARY person and is not binding on FDA or the must include the Docket No. FDA– INFORMATION section for electronic public. You can use an alternative 2007–D–0369 for ‘‘Draft Guidance on access to the draft guidance document. approach if it satisfies the requirements Difluprednate.’’ Received comments FOR FURTHER INFORMATION CONTACT: of the applicable statutes and will be placed in the docket and, except Xiaoqiu Tang, Center for Drug regulations. for those submitted as ‘‘Confidential Evaluation and Research, Food and II. Electronic Access Submissions,’’ will be publicly viewable Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4730, Persons with access to the Internet at http://www.regulations.gov or at the may obtain the draft guidance at either Division of Dockets Management Silver Spring, MD 20993–0002, 301– 796–5850. http://www.fda.gov/Drugs/Guidance between 9 a.m. and 4 p.m., Monday ComplianceRegulatoryInformation/ through Friday. SUPPLEMENTARY INFORMATION: Guidances/default.htm or http:// • Confidential Submissions—To I. Background www.regulations.gov. submit a comment with confidential information that you do not wish to be In the Federal Register of June 11, Dated: February 9, 2017. made publicly available, submit your 2010 (75 FR 33311), FDA announced the Leslie Kux, comments only as a written/paper availability of a guidance for industry Associate Commissioner for Policy. submission. You should submit two entitled ‘‘Bioequivalence [FR Doc. 2017–02972 Filed 2–14–17; 8:45 am] copies total. One copy will include the Recommendations for Specific BILLING CODE 4164–01–P information you claim to be confidential Products,’’ which explained the process with a heading or cover note that states that would be used to make product- ‘‘THIS DOCUMENT CONTAINS specific BE guidances available to the DEPARTMENT OF HEALTH AND CONFIDENTIAL INFORMATION.’’ The public on FDA’s Web site at http:// HUMAN SERVICES Agency will review this copy, including www.fda.gov/Drugs/Guidance the claimed confidential information, in ComplianceRegulatoryInformation/ National Institutes of Health its consideration of comments. The Guidances/default.htm. second copy, which will have the As described in that guidance, FDA Government-Owned Inventions; claimed confidential information adopted this process to develop and Availability for Licensing redacted/blacked out, will be available disseminate product-specific BE AGENCY: National Institutes of Health, for public viewing and posted on http:// guidances and to provide a meaningful HHS. www.regulations.gov. Submit both opportunity for the public to consider ACTION: Notice. copies to the Division of Dockets and comment on the guidance. This Management. If you do not wish your notice announces the availability of SUMMARY: The invention listed below is name and contact information to be revised draft BE recommendations for owned by an agency of the U.S. made publicly available, you can generic difluprednate emulsion. Government and is available for provide this information on the cover FDA initially approved new drug licensing to achieve expeditious mstockstill on DSK3G9T082PROD with NOTICES sheet and not in the body of your application 022212 for DUREZOL commercialization of results of comments and you must identify this (difluprednate emulsion) in June 2008. federally-funded research and information as ‘‘confidential.’’ Any In January 2016, FDA issued a draft development. Foreign patent information marked as ‘‘confidential’’ guidance for industry on BE applications are filed on selected will not be disclosed except in recommendations for generic inventions to extend market coverage accordance with 21 CFR 10.20 and other difluprednate emulsion. We are now for companies and may also be available applicable disclosure law. For more issuing a revised draft guidance for for licensing. VerDate Sep<11>2014 18:44 Feb 14, 2017 Jkt 241001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\15FEN1.SGM 15FEN1

Federal Register / Vol. 82, No. 30 / Wednesday, February 15, 2017 / Notices 10777 FOR FURTHER INFORMATION CONTACT: Sosnovtsev (NIAID), Marina Bok (EM), FOR FURTHER INFORMATION CONTACT: Glen Licensing information and copies of the Pamela Aguilar (EM), Lorena Nuckolls, Ph.D., by email to nuckollg@ patent applications listed below may be Garaicoechea (EM), and Viviana Parreno ninds.nih.gov. obtained by communicating with the (EM). SUPPLEMENTARY INFORMATION: The indicated licensing contact at the Publications: Garaicoechea L. et al., Muscular Dystrophy Coordinating Technology Transfer and Intellectual ‘‘Llama nanoantibodies with therapeutic Committee (MDCC) is a federal advisory Property Office, National Institute of potential against human norovirus committee established in accordance Allergy and Infectious Diseases, 5601 diarrhea,’’ PLoS One. 2015 Aug with the Muscular Dystrophy Fishers Lane, Rockville, MD 20852; tel. 12;10(8):e0133665. doi:10.1371/ Community Assistance, Research, and 301–496–2644. A signed Confidential journal.pone.0133665. eCollection 2015. Education Amendments of 2001 (MD– Disclosure Agreement will be required [PMID 26267898]. CARE Act; Pub. L. 107–84). The MD– to receive copies of unpublished patent Intellectual Property: HHS Reference CARE Act was reauthorized in 2008 by applications. No. E–136–2013/0—U.S. Provisional Pub. L. 110–361, and again in 2014 by SUPPLEMENTARY INFORMATION: Application No. 61/821,354, filed May Pub. L. 113–166. The MD–CARE Act Technology description follows. 9, 2013; PCT Application No. PCT/ specifies that the committee US2014/037520, filed May 9, 2014; Single-Chain Antibodies Directed to membership be composed of 2/3 European Application No. 14727696.8, Norovirus GI.1 and GII.4 and Their Use governmental agency representatives filed May 9, 2014 (pending); U.S. and 1/3 public members. We are seeking Description of Technology: Vaccines Application No. 14/889,774, filed nominations for four non-federal, public and therapies to prevent and treat November 6, 2015 (pending); and members at this time, due to turnover of Norovirus infections are not available, Argentine Application No. 20140101882, filed May 9, 2014 committee membership. Nominations despite the worldwide prevalence of will be accepted between February 17 Norovirus infections. Outbreaks of (pending). Licensing Contact: Peter Soukas, J.D., and March 17, 2017. human gastroenteritis attributable to Who is Eligible: Nominations are Norovirus commonly occur in group 301–594–8730; peter.soukas@nih.gov. Collaborative Research Opportunity: encouraged for new or reappointment of settings, such as hospitals, nursing non-federal public members who can homes, schools, dormitories, cruise The National Institute of Allergy and Infectious Diseases is seeking statements provide the public and/or patient ships and military barracks. This perspectives to discussions of issues application claims isolated VHH of capability or interest from parties interested in collaborative research to considered by the Committee. Self- monoclonal antibodies that specifically nominations and nominations of other bind to a Norovirus polypeptide. Llama- further develop, evaluate or commercialize for development of a individuals are both permitted. Only derived single chain antibody fragments one nomination per individual is (also called VHH) are small, therapeutic, diagnostic or vaccine for Norovirus infections. For collaboration required. Multiple nominations for the recombinant monoclonal antibodies of same individual will not increase 15 kDa (‘‘nanobodies’’) with several opportunities, please contact Peter Soukas, J.D., 301–594–8730; likelihood of selection. Non-federal, advantages over conventional public members may be selected from antibodies. The antibodies that were peter.soukas@nih.gov. the pool of submitted nominations or derived from llamas showed strong Dated: February 8, 2017. other sources as needed to meet neutralizing activity against Norovirus Suzanne Frisbie, statutory requirements and to form a in in vitro assays. These nanobodies Deputy Director, Technology Transfer and balanced committee that represents the may have application as Intellectual Property Office, National Institute diversity within the muscular dystrophy immunoprophylaxis to protect of Allergy and Infectious Diseases. communities. Nominations are individuals from infections or as a [FR Doc. 2017–03015 Filed 2–14–17; 8:45 am] especially encouraged from leaders or possible treatment for infected BILLING CODE 4140–01–P representatives of muscular dystrophy individuals, or can be used to develop research, advocacy, or service a diagnostic for detection of norovirus organizations, individuals with infections, and may be potentially DEPARTMENT OF HEALTH AND muscular dystrophy or their parents or utilized in vaccine research. HUMAN SERVICES guardians. In accordance with White This technology is available for House Office of Management and licensing for commercial development National Institutes of Health Budget guidelines (FR Doc. 2014– in accordance with 35 U.S.C. 209 and 37 19140), federally-registered lobbyists are National Institute of Neurological CFR part 404, as well as for further not eligible. Disorders and Stroke, Muscular development and evaluation under a Committee Composition: The Dystrophy Coordinating Committee research collaboration. Department strives to ensure that the Potential Commercial Applications: Call for Committee Membership Nominations membership of HHS Federal advisory • Therapeutics committees is fairly balanced in terms of • Diagnostics SUMMARY: The Office of the Secretary of • Vaccine research points of view represented and the the Department of Health and Human committee’s function. Every effort is Competitive Advantages: Services (HHS) is seeking nominations made to ensure that the views of all • Ease of manufacture for an individual to serve as a genders, all ethnic and racial groups, • Potent neutralizing activity nonfederal public member on the and people with disabilities are mstockstill on DSK3G9T082PROD with NOTICES • Potential cross-reactivity Muscular Dystrophy Coordinating • Low-cost therapeutics/ represented on HHS Federal advisory Committee. committees and, therefore, the immunoprophylaxis DATES: Nominations are due by 5 p.m. Department encourages nominations of Development Stage: EST on March 17, 2017. qualified candidates from these groups. • In vivo data assessment (animal) ADDRESSES: Nominations must be sent The Department also encourages Inventors: Lisbeth Kim Green (NIAID), to Glen Nuckolls, Ph.D., by email to geographic diversity in the composition Karin Bok (NIAID), Stanislav nuckollg@ninds.nih.gov. of the Committee. Appointment to this VerDate Sep<11>2014 18:44 Feb 14, 2017 Jkt 241001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\15FEN1.SGM 15FEN1


Document Created: 2017-02-15 00:55:01
Document Modified: 2017-02-15 00:55:01
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactLicensing information and copies of the patent applications listed below may be obtained by communicating with the indicated licensing contact at the Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases, 5601 Fishers Lane, Rockville, MD 20852; tel. 301- 496-2644. A signed Confidential Disclosure Agreement will be required to receive copies of unpublished patent applications.
FR Citation82 FR 10776 
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