[Federal Register Volume 85, Number 229 (Friday, November 27, 2020)]
[Notices]
[Pages 76085-76086]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26183]


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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.

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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

[[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


