Prospective Grant of Exclusive Patent Commercialization License: Human Monoclonal Antibodies That Broadly Target Coronaviruses, 72088-72089 [2023-23030]

Download as PDF 72088 Federal Register / Vol. 88, No. 201 / Thursday, October 19, 2023 / Notices In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment. DATES: Comments on the ICR must be received on or before November 20, 2023. ADDRESSES: Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/ PRAMain . Find this particular information collection by selecting ‘‘Currently under 30-day Review—Open for Public Comments’’ or by using the search function. FOR FURTHER INFORMATION CONTACT: Sagal Musa, sagal.musa@hhs.gov or (202) 205–2634. When submitting comments or requesting information, please include the document identifier 4040–0010–30D and project title for reference. SUPPLEMENTARY INFORMATION: Interested persons are invited to send comments SUMMARY: regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency’s functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Title of the Collections: Project/ Performance Site Location(s), Project Abstract, and Key Contacts forms. Type of Collection: Revision. OMB No. 4040–0010. Abstract: The Project/Performance Site Location(s), Project Abstract, and Key Contacts forms provide the Federal grant-making agencies an alternative to the Standard Form 424 data set and form. Agencies may use Project/ Performance Site Location(s), Project Abstract, and Key Contacts forms for grant programs not required to collect all the data that is required on the SF– 424 core data set and form. Type of respondent: Project/ Performance Site Location(s), Project Abstract, and Key Contacts forms are used by organizations to apply for Federal financial assistance in the form of grants. This form is submitted to the Federal grant-making agencies for evaluation and review. Previously, 26 Federal grant-making entities were using this information collection. This information collection will now be utilized by 51 Federal grant-making agencies and additional grant-making entities. To improve the transparency of reading and enhance user-friendliness of the supporting statement A, language modifications were implemented within sections 3 through 16. For section 14, Cost to the Federal Government was adjusted to the 2023 base general schedule.Grants.gov is requesting a revision of this collection to allow for data reporting and publication by agencies requesting to use the common form. The information collection (IC) expires on November 30, 2025. Grants.gov seeks a three-year clearance of these collections. ANNUALIZED BURDEN HOUR TABLE Average burden per response Respondents (if necessary) Number of respondents Project/performance site location(s). Project Abstract ............... Key Contacts ................... Grant Applicants ............. 127,281 ........................... 1 1 127,281 Grant Applicants ............. Grant Applicants ............. 230 .................................. 4,566 ............................... 1 1 1 1 230 4,566 Total .......................... ......................................... 132,077 ........................... 1 1 132,077 Sherrette A. Funn, Paperwork Reduction Act Reports Clearance Officer, Office of the Secretary. [FR Doc. 2023–23074 Filed 10–18–23; 8:45 am] BILLING CODE 4151–AE–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Prospective Grant of Exclusive Patent Commercialization License: Human Monoclonal Antibodies That Broadly Target Coronaviruses AGENCY: Notice. The National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the SUMMARY: VerDate Sep<11>2014 17:48 Oct 18, 2023 Jkt 262001 Only written comments and/or applications for a license which are received by the Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases on or before November 3, 2023 will be considered. Requests for copies of the patent applications, inquiries, and comments relating to the contemplated exclusive patent license should be directed to: Dawn Taylor-Mulneix, Technology Transfer and Patent Specialist, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious ADDRESSES: National Institutes of Health, HHS. ACTION: grant of an exclusive patent license to Leyden Laboratories B.V., located at Emmy Noetherweg 2, 2333 BK Leiden, the Netherlands to practice the inventions embodied in the patent applications listed in the SUPPLEMENTARY INFORMATION section of this notice. DATES: National Institutes of Health lotter on DSK11XQN23PROD with NOTICES1 Number of responses per respondents Forms (if necessary) PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 Total burden hours Diseases, 5601 Fishers Lane, Suite 2G, MSC 9804, Rockville, MD 20852–9804, phone number 301–767–5189, or dawn.taylor-mulneix@nih.gov. The following represents the intellectual property to be licensed under the prospective agreement: U.S. provisional application (63/308,898), filed on February 19, 2022, and the PCT application (PCT/US2023/062324), filed on February 9, 2023, entitled ‘‘Human Monoclonal Antibodies that Broadly Target Coronaviruses’’ (HHS Reference No. E–047–2022). All rights in these inventions have been assigned to the Government of the United States of America. The prospective exclusive patent commercialization license territory may be worldwide, and the field of use may be limited to: Prevention and treatment of coronavirus infection, illness, and transmission through mucosal delivery SUPPLEMENTARY INFORMATION: E:\FR\FM\19OCN1.SGM 19OCN1 lotter on DSK11XQN23PROD with NOTICES1 Federal Register / Vol. 88, No. 201 / Thursday, October 19, 2023 / Notices to the respiratory tract of products, comprised of COV44–62 (fusion peptide), COV44–79 (fusion peptide), COV89–22 (stem helix), and/or COV72– 37 (stem helix), including products that may be obtained from the genetic sequence of the same and derivatives thereof. The prospective exclusive patent commercialization license may include two products (preventative and therapeutic) in the field of use. An abstract for this invention was published in the Federal Register on June 10, 2022. The family of coronaviruses cause upper respiratory tract disease in humans and have caused three major disease outbreaks in recent history: the 2003 SARS outbreak, the 2012 MERS outbreak, and the current SARS–CoV–2 pandemic. There is an urgent need for strategies that broadly target coronaviruses, both to deal with new SARS–CoV–2 variants and future coronavirus outbreaks. Scientists at NIAID have developed several novel human monoclonal antibodies that bind to conserved parts of the SARS–CoV–2 spike protein. These antibodies can neutralize SARS– CoV–2 variants of concern including Omicron BA.1 and BA.2, as well as neutralize at least one other betacoronavirus. Further, these antibodies limit disease in animal models. Broadly reactive antibodies against coronaviruses are useful tools to identify conserved sites on the coronavirus spike protein, which could be investigated for the development of broad coronavirus vaccines that aim to prevent future pandemics. Potent neutralizers that target these sites could also be useful for prevention of disease caused by diverse coronaviruses, including those that may emerge in the future. This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive patent commercialization license will be royalty bearing, and may be granted unless within fifteen (15) days from the date of this published notice, the National Institute of Allergy and Infectious Diseases 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. Complete applications for a license in the prospective field of use that are timely filed in response to this notice will be treated as objections to the grant of the contemplated exclusive patent commercialization 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 VerDate Sep<11>2014 18:21 Oct 18, 2023 Jkt 262001 under the Freedom of Information Act, 5 U.S.C. 522. Surekha Vathyam, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. [FR Doc. 2023–23030 Filed 10–18–23; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG–2023–0823] National Maritime Security Advisory Committee; December 2023 Virtual Meeting U.S. Coast Guard, Department of Homeland Security. ACTION: Notice of Federal advisory committee virtual meeting. AGENCY: The National Maritime Security Advisory Committee (Committee) will conduct a virtual meeting to discuss the Committee’s final recommendations concerning ways to enhance cyber security information sharing between the U. S. Coast Guard and Marine Transportation System (MTS) stakeholders. The virtual meeting will be open to the public. DATES: Meeting: The Committee will meet virtually on Tuesday, December 5, 2023, from 1 p.m. until 3 p.m. Eastern Standard Time (EST). Please note this virtual meeting may close early if the Committee has completed its business. Comments and supporting documentation: To ensure your comments are received by Committee members before the virtual meeting, submit your written comments no later than December 1, 2023. ADDRESSES: To join the virtual meeting or to request special accommodations, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section no later than 1 p.m. EST on December 4, 2023, to obtain the needed information. The number of virtual lines are limited and will be available on a first-come, first-served basis. Pre-registration information: Preregistration is required for attending the virtual meeting. You must request attendance by contacting the individual listed in the FOR FURTHER INFORMATION CONTACT section below. You will receive a response with attendance instructions. The National Maritime Security Advisory Committee is committed to ensuring all participants have equal access regardless of disability status. If you require reasonable accommodations SUMMARY: PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 72089 due to a disability to fully participate, please email Mr. Ryan Owens at ryan.f.owens.uscg.mil or call (202) 302– 6565 as soon as possible. Instructions: You are free to submit comments at any time, including orally at the meeting as time permits, But, if you want Committee members to review your comment before the meeting, please submit your comments no later than December 1, 2023. We are particularly interested in comments regarding the topics in the ‘‘Agenda’’ section below. We encourage you to submit comments through the Federal Decision Making Portal at https:// www.regulations.gov. To do so, go to https://www.regulations.gov, type USCG–2023–0823 in the search box and click ‘‘Search’’. Next, look for this document in the Search Results column, and click on it. Then click on the Comment option. If your material cannot be submitted using https:// www.regulations.gov, contact the individual in the FOR FURTHER INFORMATION CONTACT section for alternate instructions. You must include the docket number USCG–2023–0823. Comments received will be posted without alteration at https:// www.regulations.gov including any personal information provided. You may wish to review the Privacy and Security Notice found via a link on the homepage https://www.regulations.gov. For more about the privacy and submissions in response to this document, see DHS’s eRulemaking System of Records notice (85 FR 14226, March 11, 2020). If you encounter technical difficulties with comment submission, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this notice. Docket Search: Documents mentioned in this notice as being available in the docket, and all public comments, will be in our online docket at https:// www.regulations.gov, and can be viewed by following that website’s instructions. Additionally, if you go to the online docket and sign-up for email alerts, you will be notified when comments are posted. FOR FURTHER INFORMATION CONTACT: Mr. Ryan Owens, Alternate Designated Federal Officer of the National Maritime Security Advisory Committee, 2703 Martin Luther King Jr. Avenue SE, Washington, DC 20593, Stop 7581, Washington, DC 20593–7581; telephone 202–302–6565 or via email at ryan.f.owens@uscg.mil. SUPPLEMENTARY INFORMATION: Notice of this meeting is in compliance with the Federal Advisory Committee Act, (Pub. L. 117–286, 5 U.S.C., ch. 10). The E:\FR\FM\19OCN1.SGM 19OCN1

Agencies

[Federal Register Volume 88, Number 201 (Thursday, October 19, 2023)]
[Notices]
[Pages 72088-72089]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-23030]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent Commercialization License: 
Human Monoclonal Antibodies That Broadly Target Coronaviruses

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: The National Institute of Allergy and Infectious Diseases, an 
institute of the National Institutes of Health, Department of Health 
and Human Services, is contemplating the grant of an exclusive patent 
license to Leyden Laboratories B.V., located at Emmy Noetherweg 2, 2333 
BK Leiden, the Netherlands to practice the inventions embodied in the 
patent applications listed in the SUPPLEMENTARY INFORMATION section of 
this notice.

DATES: Only written comments and/or applications for a license which 
are received by the Technology Transfer and Intellectual Property 
Office, National Institute of Allergy and Infectious Diseases on or 
before November 3, 2023 will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
and comments relating to the contemplated exclusive patent license 
should be directed to: Dawn Taylor-Mulneix, Technology Transfer and 
Patent Specialist, Technology Transfer and Intellectual Property 
Office, National Institute of Allergy and Infectious Diseases, 5601 
Fishers Lane, Suite 2G, MSC 9804, Rockville, MD 20852-9804, phone 
number 301-767-5189, or [email protected].

SUPPLEMENTARY INFORMATION: The following represents the intellectual 
property to be licensed under the prospective agreement: U.S. 
provisional application (63/308,898), filed on February 19, 2022, and 
the PCT application (PCT/US2023/062324), filed on February 9, 2023, 
entitled ``Human Monoclonal Antibodies that Broadly Target 
Coronaviruses'' (HHS Reference No. E-047-2022). All rights in these 
inventions have been assigned to the Government of the United States of 
America.
    The prospective exclusive patent commercialization license 
territory may be worldwide, and the field of use may be limited to: 
Prevention and treatment of coronavirus infection, illness, and 
transmission through mucosal delivery

[[Page 72089]]

to the respiratory tract of products, comprised of COV44-62 (fusion 
peptide), COV44-79 (fusion peptide), COV89-22 (stem helix), and/or 
COV72-37 (stem helix), including products that may be obtained from the 
genetic sequence of the same and derivatives thereof. The prospective 
exclusive patent commercialization license may include two products 
(preventative and therapeutic) in the field of use.
    An abstract for this invention was published in the Federal 
Register on June 10, 2022. The family of coronaviruses cause upper 
respiratory tract disease in humans and have caused three major disease 
outbreaks in recent history: the 2003 SARS outbreak, the 2012 MERS 
outbreak, and the current SARS-CoV-2 pandemic. There is an urgent need 
for strategies that broadly target coronaviruses, both to deal with new 
SARS-CoV-2 variants and future coronavirus outbreaks.
    Scientists at NIAID have developed several novel human monoclonal 
antibodies that bind to conserved parts of the SARS-CoV-2 spike 
protein. These antibodies can neutralize SARS- CoV-2 variants of 
concern including Omicron BA.1 and BA.2, as well as neutralize at least 
one other betacoronavirus. Further, these antibodies limit disease in 
animal models. Broadly reactive antibodies against coronaviruses are 
useful tools to identify conserved sites on the coronavirus spike 
protein, which could be investigated for the development of broad 
coronavirus vaccines that aim to prevent future pandemics. Potent 
neutralizers that target these sites could also be useful for 
prevention of disease caused by diverse coronaviruses, including those 
that may emerge in the future.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive patent commercialization license 
will be royalty bearing, and may be granted unless within fifteen (15) 
days from the date of this published notice, the National Institute of 
Allergy and Infectious Diseases 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.
    Complete applications for a license in the prospective field of use 
that are timely filed in response to this notice will be treated as 
objections to the grant of the contemplated exclusive patent 
commercialization 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. 522.

Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2023-23030 Filed 10-18-23; 8:45 am]
BILLING CODE 4140-01-P

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