Notice2021-21687
Use of Real-World Data and Real-World Evidence To Support Effectiveness of New Animal Drugs; Guidance for Industry; Availability
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Published
October 6, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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).
Full Text
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<title>Federal Register, Volume 86 Issue 191 (Wednesday, October 6, 2021)</title>
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[Federal Register Volume 86, Number 191 (Wednesday, October 6, 2021)]
[Notices]
[Pages 55623-55625]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are
[[Page 55624]]
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, <a href="/cdn-cgi/l/email-protection#1a696f697b7434696e75687f635a7c7e7b34727269347d756c"><span class="__cf_email__" data-cfemail="3744424456591944435845524e77515356195f5f4419505841">[email protected]</span></a>.
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''
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have been approved under OMB control number 0910-0032.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
either <a href="https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry">https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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
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