Federal Register / Vol. 85, No. 229 / Friday, November 27, 2020 / Notices 76085 

Dated: November 23, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–26226 Filed 11–25–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–D–4437] 

In-Use Stability Studies and 

Associated Labeling Statements for 

Multiple-Dose Injectable Animal Drug 

Products; Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance for industry (GFI) #242 

entitled ‘‘In-Use Stability Studies and 

Associated Labeling Statements for 

Multiple-Dose Injectable Animal Drug 

Products.’’ The purpose of in-use 

stability testing is to establish a period 

of time during which a multiple-dose 

drug product may be used while 

retaining acceptable quality 

specifications once the container is 

opened (e.g., after a container has been 

needle-punctured). This 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 reference listed 

new animal drug (RLNAD) currently has 

an in-use statement on the labeling. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on November 27, 2020. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2016–D–4437 for ‘‘In-Use Stability 

Studies and Associated Labeling 

Statements for Multiple-Dose Injectable 

Animal Drug Products.’’ Received 

comments will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the guidance to the Policy and 

Regulations Staff (HFV–6), Center for 

Veterinary Medicine, Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Kevin Rice, Center for Veterinary 

Medicine (HFV–140), Food and Drug 

Administration, 7500 Standish Place, 

Rockville, MD 20855, 240–402–0680, 

kevin.rice@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of January 4, 

2017 (82 FR 851), FDA published the 

notice of availability for a draft GFI #242 

entitled ‘‘In-Use Stability Studies and 

Associated Labeling Statements for 

Multiple-Dose Injectable Animal Drug 

Products.’’ The purpose of in-use 

stability testing is to establish a period 

of time during which a multiple-dose 

drug product may be used while 

retaining acceptable quality 

specifications once the container is 

opened (e.g., after a container has been 

needle-punctured). 

FDA received two comments on the 

draft guidance and those comments 

were considered as the guidance was 


jbell on DSKJLSW7X2PROD with NOTICES
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