Notice2021-21686
Use of Data From Foreign Investigational Studies To Support Effectiveness of New Animal Drugs; Guidance for Industry; Availability
Primary source
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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 or Agency) is announcing the availability of a final guidance for industry #265 entitled "Use of Data from Foreign Investigational Studies to Support Effectiveness of New Animal Drugs." The guidance describes FDA's current thinking with respect to assisting sponsors in incorporating data from foreign countries into proposed clinical investigational protocols and applications for new animal drugs under the Federal Food, Drug, and Cosmetic 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 55616-55617]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-21686]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-D-1396]
Use of Data From Foreign Investigational Studies 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 or Agency) is announcing
the availability of a final guidance for industry #265 entitled ``Use
of Data from Foreign Investigational Studies to Support Effectiveness
of New Animal Drugs.'' The guidance describes FDA's current thinking
with respect to assisting sponsors in incorporating data from foreign
countries into proposed clinical investigational protocols and
applications for new animal drugs under the Federal Food, Drug, and
Cosmetic 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 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'').
[[Page 55617]]
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-1396 for ``Use of Data from Foreign Investigational Studies
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, 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: 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#491a3c3a2827671a3d263b2c30092f2d286721213a672e263f"><span class="__cf_email__" data-cfemail="51022422303f7f02253e233428113735307f3939227f363e27">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of July 15, 2020 (85 FR 42867), FDA
published the notice of availability for a draft guidance entitled
``Use of Data from Foreign Investigational Studies to Support
Effectiveness of New Animal Drugs,'' giving interested persons until
October 13, 2020, to comment on the draft guidance. This final guidance
describes principles for designing, conducting, and reporting the
results for investigations or studies, including data from foreign
countries, in submissions to FDA of investigational new animal drug
files, new animal drug applications (NADAs), and applications for
conditional approval of a new animal drug (CNADAs) to demonstrate
substantial evidence of effectiveness for NADAs or a reasonable
expectation of effectiveness for CNADAs. It also describes how sponsors
may obtain feedback from the Center for Veterinary Medicine regarding
the incorporation of data from foreign countries into investigations
and study protocols 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 revised the
language of the draft guidance to provide greater clarity regarding the
level of evidence that may be required under certain circumstances to
support effectiveness in clinical investigation protocols and
applications. 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 Data from Foreign
Investigational Studies 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 Data from Foreign
Investigational Studies to Support Effectiveness of New Animal Drugs''
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. 2021-21686 Filed 10-5-21; 8:45 am]
BILLING CODE 4164-01-P
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