[Federal Register Volume 86, Number 191 (Wednesday, October 6, 2021)]
[Notices]
[Pages 55623-55625]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21687]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1400]


Use of Real-World Data and Real-World Evidence To Support 
Effectiveness of New Animal Drugs; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing the availability of a final guidance for industry (GFI) #266 
entitled ``Use of Real-World Data and Real-World Evidence to Support 
Effectiveness of New Animal Drugs.'' The guidance describes FDA's 
current thinking with respect to assisting sponsors in incorporating 
real-world data and real-world evidence (including ongoing surveillance 
activities, observational studies, and registry data) into proposed 
clinical investigation protocols and applications for new animal drugs 
under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

DATES: The announcement of the guidance is published in the Federal 
Register on October 6, 2021.

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

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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-2020-D-1400 for ``Use of Real-World Data and Real-World Evidence to 
Support Effectiveness of New Animal Drugs.'' 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, 7519 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: Susan Storey, Center for Veterinary 
Medicine (HFV-131), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-0578, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    In recent years, the Agency has taken steps to leverage modern, 
rigorous analyses of real-world data to inform our work. The COVID-19 
pandemic has brought an urgency to these efforts and the Agency has 
worked quickly to advance collaborations with public and private 
partners to collect and analyze a variety of real-world data sources. 
We recognize that real-world data sources have the potential to provide 
a wealth of rapid, actionable information to support and advance 
regulatory decision making for both human and animal drugs.
    In the Federal Register of July 15, 2020 (85 FR 42880), FDA 
published the notice of availability for a draft guidance entitled 
``Use of Real-World Data and Real-World Evidence to Support 
Effectiveness of New Animal Drugs,'' giving interested persons until 
October 13, 2020, to comment on the draft guidance. This guidance 
describes how the Center for Veterinary Medicine (CVM) intends to 
evaluate real-world data (RWD) and real-world evidence (RWE) in 
submissions to CVM to demonstrate substantial evidence of effectiveness 
for new animal drug applications or a reasonable expectation of 
effectiveness for applications for conditional approval of a new animal 
drug. It also provides information about how sponsors may obtain 
feedback from CVM on technical issues related to the use of RWD and RWE 
before the submission of an application.
    FDA received comments on the draft guidance and those comments were 
considered as the guidance was finalized. Editorial changes were made 
to this final guidance to improve clarity. For example, we added 
language to provide context to the use of RWD and RWE from 
retrospective studies in addition to RWD and RWE from prospective 
studies. We also revised the language of the guidance to clarify that 
the term ``animals'' can refer to an individual animal or a flock, 
tank, or group depending on the context in which RWD and RWE is 
collected. The guidance announced in this notice finalizes the draft 
guidance dated July 2020.
    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 ``Use of Real-World Data and Real-World 
Evidence to Support Effectiveness of New Animal Drugs.'' 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

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections 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 for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in FDA's guidance entitled ``Use of Real-World Data and 
Real-World Evidence to Support Effectiveness of New Animal Drugs''

[[Page 55625]]

have been approved under OMB control number 0910-0032.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: September 29, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-21687 Filed 10-5-21; 8:45 am]
BILLING CODE 4164-01-P