Government-Owned Inventions; Availability for Licensing and Collaboration for Phase 3 Study, 44377-44378 [2023-14761]

Download as PDF lotter on DSK11XQN23PROD with NOTICES1 Federal Register / Vol. 88, No. 132 / Wednesday, July 12, 2023 / Notices for reviewing and editing written materials reflecting the views of the Secretary, Deputy Secretary, and Chief of Staff. Prepares speeches, statements, articles, and related material for the Secretary, Deputy Secretary, and Chief of Staff and other top Departmental officials. Researches and prepares Op Ed pieces, features, articles, and stories for the media. D1. The Office of the Deputy Assistant Secretary for Public Health (APB1). The Office of the Deputy Assistant Secretary for Public Health (APB1)—The Public Health portfolio works with the Centers for Disease Control and Prevention, Agency for Toxic Substances and Disease Registry, U.S. Food and Drug Administration, National Institutes for Health, Office of Global Affairs, Office of the Assistant Secretary for Emergency Preparedness and Response, and Assistant Secretary for Planning and Evaluation/Public Health issues and offices of the Assistant Secretary for Health and the Surgeon General on initiatives and strategies to promote public health, improve health outcomes and national public education communications, prevent disease and outbreak, and accelerate scientific discovery. D2. The Office of the Deputy Assistant Secretary for Health Care (APB2). The Office of the Deputy Assistant Secretary for Health Care (APB2)—The Healthcare portfolio works to advance a healthcare system that delivers high-quality, affordable care to all Americans. The team works with the Agency for Healthcare Research and Quality, Office of the National Coordinator for Health Information Technology, Health Resources and Services Administration, Centers for Medicare & Medicaid Services, and Assistant Secretary for Planning and Evaluation/Health Care issues to improve access, quality, safety, efficiency and effectiveness of the nation’s healthcare and national public education communications. D3. The Office of the Deputy Assistant Secretary for Human Services (APB3). The Office of the Deputy Assistant Secretary for Human Services (APB3)— The Human Services portfolio helps improve and promote national public education communications and Americans of all ages and backgrounds live full, productive lives: kids getting a ‘‘Head Start’’ through early childhood education, families transitioning out of poverty to economic independence, teens and adults recovering from mental illness and addiction, and seniors participating in communities that value their contributions. These and other human service programs are carried out by the Administration for Children and VerDate Sep<11>2014 17:29 Jul 11, 2023 Jkt 259001 Families, Administration for Community Living, Indian Health Service, Office for Civil Rights, Substance Abuse and Mental Health Services Administration, Office of the Chief Technology Officer, Center for Faith-Based and Neighborhood Partnerships, Office of the Chief Information Officer and Assistant Secretary for Planning and Evaluation/ Human Services issues. D4. Broadcast Communications Division (APB4). Broadcast Communications Division—BCD (APB4)—Collaborates with subject matter experts and key stakeholders to create useful and cost effective video products that support Departmental goals. Provides a wide range of video production, A/V, live streaming, and ondemand services. Operates the HHS studio and coordinates activities with other HHS studios as required. Under the direction of the ASPA, supports key initiatives for the Secretary and all HHS Staff and Operating Divisions by developing and implementing media campaigns and special projects. Acts as liaison to broadcast organizations. Supports A/V services in the Studio, Humphrey Auditorium, Great Hall, and any location that require services. D5. Digital Communications Division (APB5). Digital Communications Division—DCD (APB5)—Leads the development and review of HHS Web content, social media, and supporting technologies. Recommends and implements digital (including Web) information policy, standards, guidance, and tools for the Department. Assesses the content and usability of all proposed Department-wide and Office of the Secretary (OS)-level websites to ensure they are consistent with Departmental policies and goals. Manages the daily operations of the main HHS/OS public website (HHS.gov) and associated social media; internal communications, the Department’s priority websites and several cross-federal topic websites, such as FoodSafety.gov, StopBullying.gov, betobaccofree.hhs.gov Secretary-level web pages; and the HHS intranet. Runs the Department’s user experience (UE) program, responsible for Section 508 (accessibility) compliance across all Departmental digital communications platforms, including Web, and national public education communications. Cheryl R. Campbell, Assistant Secretary for Administration. [FR Doc. 2023–14733 Filed 7–11–23; 8:45 am] BILLING CODE 4150–25–P PO 00000 Frm 00128 Fmt 4703 Sfmt 4703 44377 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing and Collaboration for Phase 3 Study AGENCY: National Institutes of Health, HHS. ACTION: Notice. The invention described below will be a first-in-class, reversible, hormonal contraceptive method for males and is co-owned by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health, and The Population Council, Inc., a New York not-for-profit corporation based in New York City (‘‘Population Council’’). The co-owners will complete the Phase 2b clinical stage of development in 2024 and are seeking a licensee and investor/collaborator for the Phase 3 clinical stage, anticipated to begin as early as 2024. ADDRESSES: Inquiries relating to this licensing and collaboration opportunity should be directed to: Heather Gunas, JD, MPH, Senior Technology Transfer Manager, National Cancer Institute (NCI) Technology Transfer Center, 9609 Medical Center Drive, Room 1E446, Rockville, MD 20850 (for overnight mail) or Bethesda, MD 20892 (for regular mail), Telephone: (240) 276– 5530; Facsimile: (240) 276–5504; Email: gunash@mail.nih.gov. A Confidential Disclosure Agreement will be required to receive copies of unpublished information regarding this invention. SUPPLEMENTARY INFORMATION: The following and all continuing U.S. and foreign patents/patent applications thereof are available for licensing: PCT Application No. PCT/US23/21154, filed May 5, 2023, and entitled ‘‘Progestin/ Testosterone Transdermal Gel’’. Government rights to this invention are consolidated to Population Council under an active InterinstitutionalAgreement Institution Lead. The invention pertains to a combination of progestin and testosterone in a transdermal composition for use as male contraception. The transdermal gel is applied daily to the shoulders and upper arms, has had a low incidence of adverse events in early clinical trials, and its sperm suppression is reversible. There is currently no available highly effective reversible method of male contraception; the methods of condom and withdrawal are not highly effective, and vasectomy is not always reversible. SUMMARY: E:\FR\FM\12JYN1.SGM 12JYN1 44378 Federal Register / Vol. 88, No. 132 / Wednesday, July 12, 2023 / Notices NICHD’s Contraceptive Clinical Trials Network is currently conducting the Phase 2b clinical study, which will complete in 2024. The Phase 2b study had favorable interim results and high acceptability with subjects; some subjects requested to re-enroll or participate in a later phase trial. The coowners are planning the Phase 3 stage and will finalize the protocol design in conjunction with a licensee and after Food and Drug Administration (FDA) feedback. A licensee and commercial collaborator for Phase 3 is desired—the license will be established with Population Council as the technology lead, and if the NICHD Contraceptive Clinical Trials Network conducts the Phase 3 clinical program or a portion of it, the licensee would collaborate with NICHD under a Cooperative Research and Development Agreement (CRADA) to facilitate funding and conduct of the study. The licensee needs the capacity to file and maintain an NDA (New Drug Application) with the US FDA and take responsibility for sales, marketing, and distribution of the approved product in the U.S. and other territories to be determined. Achieving expeditious commercialization of federally funded research and development is consistent with the goals of the Bayh-Dole Act, codified as 35 U.S.C. 200–212. Potential Commercial Application: male contraceptive. Development Stage: Phase 2b study completes in 2024; Phase 3 study starts in 2024+. Dated: July 7, 2023. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health lotter on DSK11XQN23PROD with NOTICES1 National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting Pursuant to section 1009 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 17:29 Jul 11, 2023 Jkt 259001 Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; Detection of HIV for SelfTesting (R61/R33 Clinical Trial Not Allowed). Date: August 3, 2023. Time: 10:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute of Allergy and Infectious Diseases, National Institutes of Health, 5601 Fishers Lane, Room 3G11A, Rockville, MD 20892 (Virtual Meeting). Contact Person: J. Bruce Sundstrom, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 5601 Fishers Lane, Room 3G11A, Rockville, MD 20852, 240–669–5045, sundstromj@ niaid.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) Dated: July 6, 2023. Tyeshia M. Roberson-Curtis, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2023–14711 Filed 7–11–23; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Mental Health; Notice of Closed Meeting [FR Doc. 2023–14761 Filed 7–11–23; 8:45 am] VerDate Sep<11>2014 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. Pursuant to section 1009 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 Institute of Mental Health Special Emphasis Panel; Mental Health Research. Date: July 31, 2023. Time: 12:00 p.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. PO 00000 Frm 00129 Fmt 4703 Sfmt 4703 Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Virtual Meeting). Contact Person: Nicholas Gaiano, Ph.D., Review Branch Chief, Division of Extramural Activities, National Institute of Mental Health, National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Bethesda, MD 20892–9606, 301– 443–2742 nick.gaiano@nih.gov. (Catalogue of Federal Domestic Assistance Program No. 93.242, Mental Health Research Grants, National Institutes of Health, HHS) Dated: July 6, 2023. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2023–14675 Filed 7–11–23; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting Pursuant to section 1009 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 Institute of Allergy and Infectious Diseases Special Emphasis Panel; Maintaining Immunity after Immunization (U01 Clinical Trial Not Allowed). Date: August 7–8, 2023. Time: 9:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute of Allergy and Infectious Diseases, National Institutes of Health, 5601 Fishers Lane, Room 3G31B, Rockville, MD 20892 (Virtual Meeting). Contact Person: James T. Snyder, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 5601 Fishers Lane, Room 3G31B, Rockville, MD 20852, (240) 669–5060, james.snyder@ nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, E:\FR\FM\12JYN1.SGM 12JYN1

Agencies

[Federal Register Volume 88, Number 132 (Wednesday, July 12, 2023)]
[Notices]
[Pages 44377-44378]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-14761]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing and 
Collaboration for Phase 3 Study

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: The invention described below will be a first-in-class, 
reversible, hormonal contraceptive method for males and is co-owned by 
the Eunice Kennedy Shriver National Institute of Child Health and Human 
Development (NICHD), National Institutes of Health, and The Population 
Council, Inc., a New York not-for-profit corporation based in New York 
City (``Population Council''). The co-owners will complete the Phase 2b 
clinical stage of development in 2024 and are seeking a licensee and 
investor/collaborator for the Phase 3 clinical stage, anticipated to 
begin as early as 2024.

ADDRESSES: Inquiries relating to this licensing and collaboration 
opportunity should be directed to: Heather Gunas, JD, MPH, Senior 
Technology Transfer Manager, National Cancer Institute (NCI) Technology 
Transfer Center, 9609 Medical Center Drive, Room 1E446, Rockville, MD 
20850 (for overnight mail) or Bethesda, MD 20892 (for regular mail), 
Telephone: (240) 276-5530; Facsimile: (240) 276-5504; Email: 
[email protected]. A Confidential Disclosure Agreement will be 
required to receive copies of unpublished information regarding this 
invention.

SUPPLEMENTARY INFORMATION: The following and all continuing U.S. and 
foreign patents/patent applications thereof are available for 
licensing: PCT Application No. PCT/US23/21154, filed May 5, 2023, and 
entitled ``Progestin/Testosterone Transdermal Gel''. Government rights 
to this invention are consolidated to Population Council under an 
active Interinstitutional-Agreement Institution Lead. The invention 
pertains to a combination of progestin and testosterone in a 
transdermal composition for use as male contraception. The transdermal 
gel is applied daily to the shoulders and upper arms, has had a low 
incidence of adverse events in early clinical trials, and its sperm 
suppression is reversible. There is currently no available highly 
effective reversible method of male contraception; the methods of 
condom and withdrawal are not highly effective, and vasectomy is not 
always reversible.

[[Page 44378]]

    NICHD's Contraceptive Clinical Trials Network is currently 
conducting the Phase 2b clinical study, which will complete in 2024. 
The Phase 2b study had favorable interim results and high acceptability 
with subjects; some subjects requested to re-enroll or participate in a 
later phase trial. The co-owners are planning the Phase 3 stage and 
will finalize the protocol design in conjunction with a licensee and 
after Food and Drug Administration (FDA) feedback. A licensee and 
commercial collaborator for Phase 3 is desired--the license will be 
established with Population Council as the technology lead, and if the 
NICHD Contraceptive Clinical Trials Network conducts the Phase 3 
clinical program or a portion of it, the licensee would collaborate 
with NICHD under a Cooperative Research and Development Agreement 
(CRADA) to facilitate funding and conduct of the study.
    The licensee needs the capacity to file and maintain an NDA (New 
Drug Application) with the US FDA and take responsibility for sales, 
marketing, and distribution of the approved product in the U.S. and 
other territories to be determined.
    Achieving expeditious commercialization of federally funded 
research and development is consistent with the goals of the Bayh-Dole 
Act, codified as 35 U.S.C. 200-212.
    Potential Commercial Application: male contraceptive.
    Development Stage: Phase 2b study completes in 2024; Phase 3 study 
starts in 2024+.

    Dated: July 7, 2023.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2023-14761 Filed 7-11-23; 8:45 am]
BILLING CODE 4140-01-P

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