Government-Owned Inventions; Availability for Licensing, 65166-65167 [2019-25620]

Download as PDF 65166 Federal Register / Vol. 84, No. 228 / Tuesday, November 26, 2019 / Notices terms of points of view represented and the committee’s function. Every effort is made to ensure that diverse views and perspectives are represented on HHS Federal advisory committees and, therefore, the Department encourages nominations of qualified candidates of all genders, cultural, ethnic, and racial groups, people with disabilities, and individuals who may belong to other underrepresented groups. The Department also seeks geographic diversity in the composition of the Committee. Appointment to this Committee shall be made without discrimination on the basis of age, race, ethnicity, gender, sexual orientation, disability, and cultural, religious, or socioeconomic status. Requests for reasonable accommodation to enable participation on the Committee should be indicated in the nomination submission. requirements met, disability accommodation requests, and an indication of commitment to attend IACC meetings if selected, as well as full contact information and a current resume or curriculum vitae. Up to 2 letters of support are permitted in addition to the nomination, with a page limit of 3 pages per letter. Please do not include other materials unless requested. Nominations are due by Friday January 17, 2020 and may be sent to Dr. Susan Daniels, Director, Office of Autism Research Coordination/NIMH/ NIH, 6001 Executive Boulevard, Room 7220, Bethesda, Maryland 20892 by standard or express mail, or via email to IACCPublicInquiries@mail.nih.gov. Confirmation of receipt will be provided. More information about the IACC is available at iacc.hhs.gov. Member Terms Non-Federal public members of the Committee ‘‘shall serve for a term of 4 years, and may be reappointed for one additional 4-year term. Any member appointed to fill a vacancy for an unexpired term shall be appointed for the remainder of such term. A member [with a valid appointment] may serve after the expiration of the member’s term until a successor has been appointed.’’ Dated: November 20, 2019. Susan A. Daniels, Director, Office of Autism Research Coordination, National Institute of Mental Health, National Institutes of Health. Meetings and Travel ‘‘The Committee shall meet at the call of the chairperson or upon the request of the Secretary. The Committee shall meet not fewer than 2 times each year.’’ In the years 2014–2019, the IACC held an average of 4 meetings, 1 workshop and 2 phone conferences per year, including full committee, subcommittee, working and planning group meetings, and workshops. Travel expenses are provided for non-federal public Committee members to facilitate attendance at in-person meetings. Members are expected to be committed to making every effort to attend all full committee meetings and workshops in person and relevant subcommittee, working and planning group meetings by phone. For those who occasionally cannot travel or for individuals with a disability that prevents travel, remote access options are provided. Submission Instructions and Deadline Nominations should include a cover letter of no longer than 3 pages describing the candidate’s interest in seeking appointment to the IACC, including relevant personal and professional experience with ASD, indication of any membership eligibility VerDate Sep<11>2014 16:47 Nov 25, 2019 Jkt 250001 [FR Doc. 2019–25668 Filed 11–25–19; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, 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: Center for Scientific Review Special Emphasis Panel RFA Panel: Tobacco Regulatory Science C. Date: December 19, 2019. Time: 10:30 a.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Kristen Prentice, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 Health, 6701 Rockledge Drive, Room 3112, MSC 7808, Bethesda, MD 20892, 301–496– 0726, prenticekj@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: November 20, 2019 Sylvia L. Neal, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–25593 Filed 11–25–19; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, HHS. ACTION: Notice. 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. FOR FURTHER INFORMATION CONTACT: Dianca Finch, Ph.D., 240–669–5503; dianca.finch@nih.gov. Licensing information and copies of the U.S. patent application 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: SUMMARY: A High-Yield Perfusion-Based Transient Gene Expression Bioprocess Description of Technology Currently, fed-batch processes are the most commonly used bioprocesses in transient gene expression (TGE) vaccine manufacturing. However, because fedbatch processes keep all the cells and protein product in the vessel throughout the run, some limitations are intrinsic. First, waste products like cell debris or E:\FR\FM\26NON1.SGM 26NON1 Federal Register / Vol. 84, No. 228 / Tuesday, November 26, 2019 / Notices other unwanted small molecules accumulate in the vessel with a potential to disrupt the cell growth, protein production, and the stability of the generated protein of interest. Second, necessary buffer exchange and/ or cell concentration steps must be performed outside of the culturing vessel. These steps are more involved and increase the risk of contamination. Lastly, even with the addition of daily supplementation in the fed-batch process, there are limitations in length of time that the transfected cells remain viable and productive. Researchers at the Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases (NIAID) developed a new transient gene expression (TGE) bioprocess using a perfusion system that resolves the current fed-batch limitations for influenza vaccine production. The major components of this technology are two-fold: the optimization of conditions for polyethylenimine (PEI)-mediated gene transfection in the bioreactor without the interference of microbubbles; and the implementation of a perfusion-based alternating tangential flow (ATF) system for singlesystem, prolonged cell culture, combining the steps of cell concentration, waste clearance, culturing/media replenishment, and protein expression within a single vessel. The development of the TGE bioprocess included optimization of conditions for HEK293 cell growth in the bioreactor, optimized transfection mediated by PEI, and protein expression for an extended period to achieve reproducibility and high protein yield. Due to high improvement in cell growth and protein production without external handling, this bioprocess could lead to substantial cost saving and other benefits in vaccine and drug manufacturing of clinical grade materials. This technology is available for licensing for commercial development in accordance with 35 U.S.C. 209 and 37 CFR part 404. Potential Commercial Applications • Bioprocess—A single-use protein production platform for transient gene expression (TGE) with potential applications in rapid protein expression as well as vaccine and drug manufacturing. Competitive Advantages The new transient gene expression (TGE) bioprocess for vaccine manufacturing has the following VerDate Sep<11>2014 16:47 Nov 25, 2019 Jkt 250001 features compared to commonly used related processes such as fed-batch: • Robust, prolonged cell growth. • High levels of protein production and reproducibility. • Cost efficiency. • Reduction in contamination risk. Development Stage: Final Product. Inventors: Jinsung Hong, Ph.D. (NIAID); Jacob Demirji, Ph.D. (NIAID); Daniel Blackstock, Ph.D. (NIAID); and Joe Horwitz, Ph.D. (NIAID). Intellectual Property: HHS Reference Number E–187–2018 includes U.S. Provisional Patent Application Number 62/751,204 filed 10/26/2018. Licensing Contact: To license this technology, please contact Dianca Finch, Ph.D., 240–669–5503; dianca.finch@nih.gov. Dated: October 10, 2019. Wade W. Green, Acting Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. [FR Doc. 2019–25620 Filed 11–25–19; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Eye Institute; Notice of Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Advisory Eye Council. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the 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 Advisory Eye Council. Date: January 17, 2020. Open: 8:30 a.m. to 12:00 p.m. Agenda: Following opening remarks by the Acting Director, NEI, there will be PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 65167 presentations by the staff of the Institute and discussions concerning Institute programs. Place: National Eye Institute, 6700B Rockledge Drive, 1st Floor Conference Room, Bethesda, MD 20817. Closed: 1:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Eye Institute, 6700B Rockledge Drive, 1st Floor Conference Room, Bethesda, MD 20817. Contact Person: Anne E. Schaffner, Ph.D., Chief, Scientific Review Branch, Division of Extramural Research, National Eye Institute, National Institutes of Health, 6700 B Rockledge Dr. Ste 3400, Bethesda, MD 20892–9300, (301) 451–2020, aes@nei.nih.gov. Information is also available on the Institute’s/Center’s home page: www.nei.nih.gov, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.867, Vision Research, National Institutes of Health, HHS) Dated: November 21, 2019. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–25687 Filed 11–25–19; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Interagency Coordinating Committee on the Validation of Alternative Methods Communities of Practice Webinar on Use of Animal-Free Affinity Reagents; Notice of Public Webinar; Registration Information AGENCY: National Institutes of Health, HHS. ACTION: Notice. The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) announces a public webinar ‘‘Use of Animal-free Affinity Reagents.’’ The webinar is organized on behalf of ICCVAM by the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM). Interested persons may participate via WebEx. Time will be allotted for questions from the audience. Information about the webinar and registration are available at https://ntp.niehs.nih.gov/go/commprac2020. SUMMARY: DATES: Webinar: January 21, 2020, 11:00 a.m. to approximately 12:30 p.m. EST. E:\FR\FM\26NON1.SGM 26NON1

Agencies

[Federal Register Volume 84, Number 228 (Tuesday, November 26, 2019)]
[Notices]
[Pages 65166-65167]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25620]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

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.

FOR FURTHER INFORMATION CONTACT: Dianca Finch, Ph.D., 240-669-5503; 
[email protected]. Licensing information and copies of the U.S. 
patent application 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:

A High-Yield Perfusion-Based Transient Gene Expression Bioprocess

Description of Technology

    Currently, fed-batch processes are the most commonly used 
bioprocesses in transient gene expression (TGE) vaccine manufacturing. 
However, because fed-batch processes keep all the cells and protein 
product in the vessel throughout the run, some limitations are 
intrinsic. First, waste products like cell debris or

[[Page 65167]]

other unwanted small molecules accumulate in the vessel with a 
potential to disrupt the cell growth, protein production, and the 
stability of the generated protein of interest. Second, necessary 
buffer exchange and/or cell concentration steps must be performed 
outside of the culturing vessel. These steps are more involved and 
increase the risk of contamination. Lastly, even with the addition of 
daily supplementation in the fed-batch process, there are limitations 
in length of time that the transfected cells remain viable and 
productive.
    Researchers at the Vaccine Research Center (VRC) of the National 
Institute of Allergy and Infectious Diseases (NIAID) developed a new 
transient gene expression (TGE) bioprocess using a perfusion system 
that resolves the current fed-batch limitations for influenza vaccine 
production. The major components of this technology are two-fold: the 
optimization of conditions for polyethylenimine (PEI)-mediated gene 
transfection in the bioreactor without the interference of 
microbubbles; and the implementation of a perfusion-based alternating 
tangential flow (ATF) system for single-system, prolonged cell culture, 
combining the steps of cell concentration, waste clearance, culturing/
media replenishment, and protein expression within a single vessel.
    The development of the TGE bioprocess included optimization of 
conditions for HEK293 cell growth in the bioreactor, optimized 
transfection mediated by PEI, and protein expression for an extended 
period to achieve reproducibility and high protein yield.
    Due to high improvement in cell growth and protein production 
without external handling, this bioprocess could lead to substantial 
cost saving and other benefits in vaccine and drug manufacturing of 
clinical grade materials.
    This technology is available for licensing for commercial 
development in accordance with 35 U.S.C. 209 and 37 CFR part 404.

Potential Commercial Applications

     Bioprocess--A single-use protein production platform for 
transient gene expression (TGE) with potential applications in rapid 
protein expression as well as vaccine and drug manufacturing.

Competitive Advantages

    The new transient gene expression (TGE) bioprocess for vaccine 
manufacturing has the following features compared to commonly used 
related processes such as fed-batch:
     Robust, prolonged cell growth.
     High levels of protein production and reproducibility.
     Cost efficiency.
     Reduction in contamination risk.
    Development Stage: Final Product.
    Inventors: Jinsung Hong, Ph.D. (NIAID); Jacob Demirji, Ph.D. 
(NIAID); Daniel Blackstock, Ph.D. (NIAID); and Joe Horwitz, Ph.D. 
(NIAID).
    Intellectual Property: HHS Reference Number E-187-2018 includes 
U.S. Provisional Patent Application Number 62/751,204 filed 10/26/2018.
    Licensing Contact: To license this technology, please contact 
Dianca Finch, Ph.D., 240-669-5503; [email protected].

    Dated: October 10, 2019.
Wade W. Green,
Acting Deputy Director, Technology Transfer and Intellectual Property 
Office, National Institute of Allergy and Infectious Diseases.
[FR Doc. 2019-25620 Filed 11-25-19; 8:45 am]
 BILLING CODE 4140-01-P

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