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###### Department of Health and Human Services

###### Food and Drug Administration

          - [Docket No. FDA-2016-D-4437]

# 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 self-addressed 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                           ( print page 76086)                        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 in-use 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