Office of the Director; Notice of Charter Renewal, 76086-76087 [2020-26167]

Download as PDF 76086 Federal Register / Vol. 85, No. 229 / Friday, November 27, 2020 / Notices finalized. FDA made changes to provide additional clarification, including adding information regarding in-use labeling language that we recommend for multi-dose animal drug products (mostly food animal drugs) for which less than the theoretical maximum number of punctures are used for the inuse stability study; providing examples of adverse trending that may lead us to recommend the use of aged product for in-use stability studies; and clarifying that if changes are made to the storage temperature or expiry period that would impact a current in-use statement on an approved animal drugs, that we recommend sponsors reassess the in-use statement and submit revised labeling for review. This final guidance reflects the Agency’s current thinking on how to formulate in-use statements, as well as how to design and carry out in-use stability studies to support these in-use statements, for multiple-dose injectable drug products intended for use in animals. This current thinking pertains to both generic drug products and pioneer drug products regardless of whether the pioneer RLNAD currently has an in-use statement on the labeling. This level 1 guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ‘‘In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products.’’ It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. jbell on DSKJLSW7X2PROD with NOTICES II. Paperwork Reduction Act of 1995 This guidance contains no collection of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501– 3521) is not required. However, this guidance refers to previously approved FDA collections of information. These collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR part 514 have been approved under OMB control number 0910–0032; the collections of information in 21 CFR part 511 have been approved under OMB control number 0910–0117; and the collections of information in sections 512(b) and 512(n) of the Federal Food, Drug, and Cosmetic Act have been approved under OMB control number 0910–0669. VerDate Sep<11>2014 19:29 Nov 25, 2020 Jkt 253001 III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/animal-veterinary/ guidance-regulations/guidance-industry or https://www.regulations.gov. Dated: November 20, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020–26183 Filed 11–25–20; 8:45 am] BILLING CODE 4164–01–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 inventions listed below are owned by an agency of the U.S. Government and are available for licensing to achieve expeditious commercialization of results of federally-funded research and development. SUMMARY: FOR FURTHER INFORMATION CONTACT: Licensing information may be obtained by communicating with Betty B. Tong, Ph.D., National Institute of Diabetes and Digestive and Kidney Diseases, Technology Advancement Office, 12A South Drive Suite 3011, Bethesda, MD 20892; telephone: 301–451–7836; email: tongb@mail.nih.gov. A signed Confidential Disclosure Agreement may be required to receive any unpublished information. SUPPLEMENTARY INFORMATION: Technology description follows. Potential Commercial Applications Development of P2Y14 receptor antagonist for treatment of disorders, such as: • Inflammation • diabetes • cystic fibrosis • asthma • neurodegeneration Development Stage: • Early stage Inventors: Kenneth A. Jacobson (NIDDK), Jinha Yu (NIDDK), Antonella Ciancetta (NIDDK), Zhiwei Wen (NIDDK), Young-Hwan Jung (NIDDK) Publications: Yu J, Ciancetta A, Dudas S, et al., Structure-guided modification of heterocyclic antagonists of the P2Y14 receptor. J. Med. Chem., 2018, 61: 4860– 4882, Jung YH, Yu J, Wen Z, et al., Exploration of alternative scaffolds for P2Y14 receptor antagonists containing a biaryl core. J. Med. Chem., 2020, 63:9563–9589. Intellectual Property: HHS Reference No. E–028–2018–0/1, US Provisional Patent Application 62/628,699 filed 09 Feb 2018, International Patent Application PCT/US2019/17422, filed 11 Feb 2019. Licensing Contact: Betty B. Tong, Ph.D.; 301–451–7836; tongb@ mail.nih.gov. This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. Dated: November 19, 2020. Bei Tong, Senior Licensing and Patenting Manager, National Institute of Diabetes and Digestive and Kidney Diseases, Technology Advancement Office. [FR Doc. 2020–26168 Filed 11–25–20; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES P2Y14 Receptor Antagonists Containing A Biaryl Core National Institutes of Health The technology discloses composition of compounds that fully antagonize the human P2Y14 receptor, with moderate affinity with insignificant antagonism of other P2Y receptors. Therefore, they are highly selective P2Y14 receptor antagonists. Even though there is no P2Y14 receptor modulators in clinical use currently, selective P2Y14 receptor antagonists are sought as potential therapeutic treatments for asthma, cystic fibrosis, inflammation and possibly diabetes and neurodegeneration. This technology is available for licensing for commercial development in accordance with 35 U.S.C. 209 and 37 CFR part 404. Office of the Director; Notice of Charter Renewal PO 00000 Frm 00083 Fmt 4703 Sfmt 4703 In accordance with Title 41 of the U.S. Code of Federal Regulations, Section 102–3.65(a), notice is hereby given that the Charter for the National Toxicology Program Board of Scientific Counselors was renewed for an additional two-year period on November 14, 2020. It is determined that the National Toxicology Program Board of Scientific Counselors is in the public interest in connection with the performance of duties imposed on the National Institutes of Health by law, and that these duties can best be performed E:\FR\FM\27NON1.SGM 27NON1 Federal Register / Vol. 85, No. 229 / Friday, November 27, 2020 / Notices through the advice and counsel of this group. Inquiries may be directed to Claire Harris, Director, Office of Federal Advisory Committee Policy, Office of the Director, National Institutes of Health, 6701 Democracy Boulevard, Suite 1000, Bethesda, Maryland 20892 (Mail Stop Code 4875), Telephone (301) 496–2123, or harriscl@mail.nih.gov. Dated: November 20, 2020. Tyeshia M. Roberson, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2020–26167 Filed 11–25–20; 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 jbell on DSKJLSW7X2PROD with NOTICES Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Vaccine Research Center Board of Scientific Counselors, NIAID. The meeting will be closed to the public as indicated below in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual grant applications conducted by the NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Vaccine Research Center Board of Scientific Counselors, NIAID. Date: December 15–16, 2020. Time: 8:00 a.m. to 5:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institute of Allergy and Infectious Diseases, National Institutes of Health, 40 Convent Drive, Bethesda, MD 20892, (Virtual Meeting). Contact Person: John R. Mascola, MD, Director, Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 40 Convent Drive, Bethesda, MD 20892, (301) 496–1852, jmascola@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) VerDate Sep<11>2014 19:29 Nov 25, 2020 Jkt 253001 76087 Dated: November 20, 2020. Tyeshia M. Roberson, Program Analyst, Office of Federal Advisory Committee Policy. Dated: November 24, 2020. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2020–26150 Filed 11–25–20; 8:45 am] [FR Doc. 2020–26369 Filed 11–25–20; 8:45 am] BILLING CODE 4140–01–P BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institutes of Health National Institute on Aging; Notice of Closed Meetings Government-Owned Inventions; Availability for Licensing Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings 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 on Aging Initial Review Group; Behavior and Social Science of Aging Review Committee NIA–S. Date: February 4–5, 2021. Time: 11:00 a.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Carmen Moten, Ph.D., MPH, Scientific Review Officer, Scientific Review Branch, National Institute on Aging, National Institutes of Health, Gateway Bldg., 2C212, 7201 Wisconsin Avenue, Bethesda, MD 20814, (301) 402–7703, cmoten@ mail.nih.gov. Name of Committee: National Institute on Aging Initial Review Group; Biological Aging Review Committee NIA–B. Date: February 11–12, 2021. Time: 10:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Bita Nakhai, Ph.D., Scientific Review Officer, Scientific Review Branch, National Institute on Aging, National Institutes of Health, Gateway Bldg., 2C212, 7201 Wisconsin Avenue, Bethesda, MD 20892, (301) 402–7701, nakhaib@nia.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS) PO 00000 Frm 00084 Fmt 4703 Sfmt 4703 AGENCY: National Institutes of Health, HHS. ACTION: Notice. The inventions listed below are owned by an agency of the U.S. Government and are available for licensing to achieve expeditious commercialization of results of federally-funded research and development. SUMMARY: FOR FURTHER INFORMATION CONTACT: Licensing information may be obtained by communicating with Betty B. Tong, Ph.D., National Institute of Diabetes and Digestive and Kidney Diseases, Technology Advancement Office, 12A South Drive Suite 3011, Bethesda, MD 20892; telephone: 301–451–7836; email: tongb@mail.nih.gov. A signed Confidential Disclosure Agreement may be required to receive any unpublished information. SUPPLEMENTARY INFORMATION: Technology description follows. Triazole Derivatives as P2Y14 Receptor Antagonists The technology describes the composition of small molecule compounds that are antagonists of the P2Y14 receptor. Also provided are methods of using the compounds, including a method of treating a disorder, such as inflammation, diabetes, insulin resistance, hyperglycemia, a lipid disorder, obesity, a condition associated with metabolic syndrome, and asthma, and a method of antagonizing P2Y14 receptor activity in a cell. 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: Development of P2Y14 receptor antagonist for treatment of disorders, such as: • Inflammation • diabetes • obesity • asthma E:\FR\FM\27NON1.SGM 27NON1

Agencies

[Federal Register Volume 85, Number 229 (Friday, November 27, 2020)]
[Notices]
[Pages 76086-76087]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26167]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Office of the Director; Notice of Charter Renewal

    In accordance with Title 41 of the U.S. Code of Federal 
Regulations, Section 102-3.65(a), notice is hereby given that the 
Charter for the National Toxicology Program Board of Scientific 
Counselors was renewed for an additional two-year period on November 
14, 2020.
    It is determined that the National Toxicology Program Board of 
Scientific Counselors is in the public interest in connection with the 
performance of duties imposed on the National Institutes of Health by 
law, and that these duties can best be performed

[[Page 76087]]

through the advice and counsel of this group.
    Inquiries may be directed to Claire Harris, Director, Office of 
Federal Advisory Committee Policy, Office of the Director, National 
Institutes of Health, 6701 Democracy Boulevard, Suite 1000, Bethesda, 
Maryland 20892 (Mail Stop Code 4875), Telephone (301) 496-2123, or 
[email protected].

    Dated: November 20, 2020.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2020-26167 Filed 11-25-20; 8:45 am]
BILLING CODE 4140-01-P

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