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. 

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. 

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. 

SUMMARY: 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. 

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. 

P2Y14 Receptor Antagonists Containing 

A Biaryl Core 

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. 

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 

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 


jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 85, No. 229 / Friday, November 27, 2020 / Notices 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 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 

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) 

Dated: November 20, 2020. 

Tyeshia M. Roberson, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2020–26150 Filed 11–25–20; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Aging; Notice of 

Closed Meetings 

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) 

Dated: November 24, 2020. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2020–26369 Filed 11–25–20; 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. 

SUMMARY: 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. 

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 


jbell on DSKJLSW7X2PROD with NOTICES