Government-Owned Inventions; Availability for Licensing, 27855-27856 [2021-10818]

Download as PDF Federal Register / Vol. 86, No. 98 / Monday, May 24, 2021 / Notices This notice is being published less than 15 days prior to the meeting due to scheduling difficulties. (Catalogue of Federal Domestic Assistance Program Nos. 93.14, Intramural Research Training Award; 93.22, Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds; 93.232, Loan Repayment Program for Research Generally; 93.39, Academic Research Enhancement Award; 93.936, NIH Acquired Immunodeficiency Syndrome Research Loan Repayment Program; 93.187, Undergraduate Scholarship Program for Individuals from Disadvantaged Backgrounds, National Institutes of Health, HHS) Dated: May 19, 2021. David W. Freeman, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–10907 Filed 5–21–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Complementary & Integrative Health; Notice of Closed Meeting khammond on DSKJM1Z7X2PROD with NOTICES 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: National Center for Complementary and Integrative Health Special Emphasis Panel; NCCIH Training and Education Review Panel (CT). Date: June 17th–18th, 2021. Time: 10:00 a.m. to 4:30 p.m. Agenda: To review and evaluate grant applications. Place: NIH/NCCIH Democracy II, 6707 Democracy Blvd., Bethesda, MD 20817 (Virtual Meeting). Contact Person: Patrick Colby Still, Ph.D., Scientific Review Officer, Office of Scientific Review, Division of Extramural Activities, NCCIH/NIH, 6707 Democracy Boulevard, Suite 401, Bethesda, MD 20892–5475, patrick.still@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.213, Research and Training in Complementary and Alternative Medicine, National Institutes of Health, HHS) VerDate Sep<11>2014 17:32 May 21, 2021 Jkt 253001 Dated: May 18, 2021. Tyeshia M. Roberson, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–10870 Filed 5–21–21; 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: Peter Soukas, J.D., 301–496–2644; peter.soukas@nih.gov. 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. SUMMARY: Recombinant Chimeric Bovine/Human Parainfluenza Virus 3 Expressing SARS–CoV–2 Spike Protein and Its Use Description of Technology Vaccines for SARS–CoV–2 are increasingly available under emergency use authorizations; however, indications are currently limited to individuals twelve (12) years or older. They also involve intramuscular immunization, which does not directly stimulate local immunity in the respiratory tract, the primary site of SARS–CoV–2 infection, shedding and spread. While the major burden of COVID–19 disease is in adults, infection and disease also occur in infants and young children, contributing to viral transmission. Therefore, the development of safe and effective pediatric COVID–19 vaccines PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 27855 is important. Ideally, a vaccine should be effective as a single dose, should induce mucosal immunity with the ability to restrict SARS–CoV–2 infection and respiratory shedding, and should easily coordinate with vaccines for other illnesses, such as HPIV3. The live-attenuated vaccine candidates are based on a recombinant chimeric bovine/human parainfluenza virus 3 (rB/HPIV3) vector expressing prefusion-stabilized versions of the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS–CoV–2) Spike (S) protein. The B/HPIV3–SARS CoV–2 vaccine candidates are designed to be administered intranasally by drops or spray to infants and young children. The vaccines are expected to induce durable and broad systemic and respiratory mucosal immunity against SARS–CoV–2 and HPIV3. Immunogenicity and protective efficacy against SARS–CoV–2 challenge was confirmed in experimental animals including non-human primates. Based on experience with this B/HPIV3 platform and other live-attenuated PIV vaccine candidates in previous pediatric clinical studies, the present candidates are anticipated to be well-tolerated in humans, including infants and young children, and are available for clinical evaluation. The National Institute of Allergy and Infectious Diseases has extensive experience and capability in evaluating live-attenuated respiratory virus vaccine candidates in pediatric clinical studies, including PIV vaccine candidates, and opportunity for collaboration exists. This technology is available for nonexclusive 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 • Viral diagnostics • Vaccine research Competitive Advantages • • • • Ease of manufacture B cell and T cell activation Low-cost vaccines Intranasal administration/needle-free delivery Development Stage • In vivo data assessment (animal) Inventors: Ursula Buchholz (NIAID), Shirin Munir (NIAD), Cyril Le Nouen (NIAID), Xueqiao Liu (NIAID), Cindy Luongo (NIAID), Peter Collins (NIAID). Intellectual Property: HHS Reference No. E–239–2020–0—U.S. Provisional E:\FR\FM\24MYN1.SGM 24MYN1 27856 Federal Register / Vol. 86, No. 98 / Monday, May 24, 2021 / Notices Application No. 63/180,534, filed April 27, 2021. Licensing Contact: Peter Soukas, J.D., 301–496–2644; peter.soukas@nih.gov. 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 vaccine for respiratory or other infections. For collaboration opportunities, please contact Peter Soukas, J.D., 301–496–2644; peter.soukas@nih.gov. Dated: May 10, 2021. Surekha Vathyam, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. [FR Doc. 2021–10818 Filed 5–21–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; 60-Day Comment Request: Electronic Individual Development Plan (eIDP) (National Eye Institute) AGENCY: National Institutes of Health, HHS. ACTION: Notice. In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Eye Institute of the National Institutes of Health will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval. DATES: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data collection plans and instruments, submit SUMMARY: development. To enhance their chances of obtaining their ideal career, completing an annual Individual Development Plan (IDP) is an important step in helping a trainee’s career and professional development and is standard practice in graduate and postdoctoral education. An IDP is an effective tool for trainees to think about their career goals and skills needed to achieve them during their time at the NEI. Trainees work together with their research mentor to organize and summarize their research projects, consider career goals, and set training goals and expectations, both for the mentee and mentor. This information collection request is to implement an electronic Individual Development Plan (eIDP). The data collected comes from a detailed questionnaire focused on responses to professional goals and expectations while the they are at the NEI. It is expected that the trainees will complete the eIDP annually and by doing so, it will help enhance the effectiveness of their training by setting clear goals that can be monitored not only by the trainee themselves but also by their mentor, the Training Director, and their Administrative Officer. In addition to this eIDP, the system will also implement an electronic exit survey. The data collected comes from a detailed questionnaire focused on responses to questions focused on trainee mentoring and professional experiences at the NEI as well as their plans after they depart. It is expected that the trainees will complete at the end of their tenure and that by doing so, the NEI Training Program can learn about ways to improve career development opportunities for future trainees as well as learn more about trainee job choices to better advise fellows. Additionally, we can use the survey to help determine mentor effectiveness and help identify problems in mentoring at the NEI. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 450. comments in writing, or request more information on the proposed project, contact: Dr. Cesar E. Perez-Gonzalez, Training Director, Office of the Scientific Director, National Eye Institute, NIH, Building 31, Room 6A22, MSC 0250, Bethesda, Maryland 20892 or call non-toll-free number (301) 451– 6763 or Email your request, including your address to: cesarp@nei.nih.gov. Formal requests for additional plans and instruments must be requested in writing. SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires: Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimizes the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Proposed Collection Title: Electronic Individual Development Plans, 0925– NEW, expiration date XX/XX/XXXX, National Eye Institute (NEI), National Institutes of Health (NIH). Need and Use of Information Collection: The National Eye Institute’s (NEI) Office of the Scientific Director (OSD) goal is to train the next generation of vision researchers and ophthalmologists. Trainees who participate in NEI research come with different levels of education (student, postbaccalaureate, predoctoral including graduate and medical students, postdoctoral fellows) and for different amounts of time (6 months to 5 years). Training at the NEI focuses on scientific and professional skill khammond on DSKJM1Z7X2PROD with NOTICES ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Type of respondent eIDP .................................................. Exit Survey Part 1 ............................. Exit Survey Part 2 ............................. VerDate Sep<11>2014 17:32 May 21, 2021 Individuals ........................................ Individuals ........................................ Individuals ........................................ Jkt 253001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 Number of responses per respondent 150 150 150 E:\FR\FM\24MYN1.SGM 1 1 1 24MYN1 Average time per response (in hours) 2 30/60 30/60 Total annual burden hour 300 75 75

Agencies

[Federal Register Volume 86, Number 98 (Monday, May 24, 2021)]
[Notices]
[Pages 27855-27856]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10818]


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

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: Peter Soukas, J.D., 301-496-2644; 
[email protected]. 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.

Recombinant Chimeric Bovine/Human Parainfluenza Virus 3 Expressing 
SARS-CoV-2 Spike Protein and Its Use

Description of Technology

    Vaccines for SARS-CoV-2 are increasingly available under emergency 
use authorizations; however, indications are currently limited to 
individuals twelve (12) years or older. They also involve intramuscular 
immunization, which does not directly stimulate local immunity in the 
respiratory tract, the primary site of SARS-CoV-2 infection, shedding 
and spread. While the major burden of COVID-19 disease is in adults, 
infection and disease also occur in infants and young children, 
contributing to viral transmission. Therefore, the development of safe 
and effective pediatric COVID-19 vaccines is important. Ideally, a 
vaccine should be effective as a single dose, should induce mucosal 
immunity with the ability to restrict SARS-CoV-2 infection and 
respiratory shedding, and should easily coordinate with vaccines for 
other illnesses, such as HPIV3.
    The live-attenuated vaccine candidates are based on a recombinant 
chimeric bovine/human parainfluenza virus 3 (rB/HPIV3) vector 
expressing prefusion-stabilized versions of the Severe Acute 
Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Spike (S) protein. The 
B/HPIV3-SARS CoV-2 vaccine candidates are designed to be administered 
intranasally by drops or spray to infants and young children. The 
vaccines are expected to induce durable and broad systemic and 
respiratory mucosal immunity against SARS-CoV-2 and HPIV3. 
Immunogenicity and protective efficacy against SARS-CoV-2 challenge was 
confirmed in experimental animals including non-human primates. Based 
on experience with this B/HPIV3 platform and other live-attenuated PIV 
vaccine candidates in previous pediatric clinical studies, the present 
candidates are anticipated to be well-tolerated in humans, including 
infants and young children, and are available for clinical evaluation. 
The National Institute of Allergy and Infectious Diseases has extensive 
experience and capability in evaluating live-attenuated respiratory 
virus vaccine candidates in pediatric clinical studies, including PIV 
vaccine candidates, and opportunity for collaboration exists.
    This technology is available for nonexclusive 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

 Viral diagnostics
 Vaccine research

Competitive Advantages

 Ease of manufacture
 B cell and T cell activation
 Low-cost vaccines
 Intranasal administration/needle-free delivery

Development Stage

 In vivo data assessment (animal)

    Inventors: Ursula Buchholz (NIAID), Shirin Munir (NIAD), Cyril Le 
Nouen (NIAID), Xueqiao Liu (NIAID), Cindy Luongo (NIAID), Peter Collins 
(NIAID).
    Intellectual Property: HHS Reference No. E-239-2020-0--U.S. 
Provisional

[[Page 27856]]

Application No. 63/180,534, filed April 27, 2021.
    Licensing Contact: Peter Soukas, J.D., 301-496-2644; 
[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 vaccine for 
respiratory or other infections. For collaboration opportunities, 
please contact Peter Soukas, J.D., 301-496-2644; [email protected].

    Dated: May 10, 2021.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2021-10818 Filed 5-21-21; 8:45 am]
BILLING CODE 4140-01-P
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