Notice2022-08452
The Use of Published Literature in Support of New Animal Drug Applications; Draft Guidance for Industry; Availability
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Published
April 20, 2022
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry #106 entitled "The Use of Published Literature in Support of New Animal Drug Applications." This draft guidance, when finalized, will replace the existing final guidance #106, "The Use of Published Literature in Support of New Animal Drug Approval," which FDA published in August 2000 and which specifically addressed the use of a single article to support drug approval. This revision of the guidance document considers multiple uses of the scientific literature, including narrative reviews, systematic reviews, and meta-analyses to support approval of a new animal drug.
Full Text
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<title>Federal Register, Volume 87 Issue 76 (Wednesday, April 20, 2022)</title>
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[Federal Register Volume 87, Number 76 (Wednesday, April 20, 2022)]
[Notices]
[Pages 23523-23525]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-08452]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-D-1155]
The Use of Published Literature in Support of New Animal Drug
Applications; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry #106 entitled ``The
Use of Published Literature in Support of New Animal Drug
Applications.'' This draft guidance, when finalized, will replace the
existing final guidance #106, ``The Use of Published Literature in
Support of New Animal Drug Approval,'' which FDA published in August
2000 and which specifically addressed the use of a single article to
support drug approval. This revision of the guidance document considers
multiple uses of the scientific literature, including narrative
reviews, systematic reviews, and meta-analyses to support approval of a
new animal drug.
DATES: Submit either electronic or written comments on the draft
guidance by June 21, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance 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
[[Page 23524]]
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-2021-D-1155 for ``The Use of Published Literature in Support of New
Animal Drug Applications.'' 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 draft guidance document.
FOR FURTHER INFORMATION CONTACT: Amey Adams, Center for Veterinary
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-402-0816, <a href="/cdn-cgi/l/email-protection#551438302c7b1431343826153331347b3d3d267b323a23"><span class="__cf_email__" data-cfemail="6e2f030b17402f0a0f031d2e080a0f4006061d40090118">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
#106 entitled ``The Use of Published Literature in Support of New
Animal Drug Applications.'' The purpose of this document is to provide
guidance to animal drug sponsors on specific areas of the approval
process where the available scientific literature may be useful to
support the approval of a new animal drug application, an abbreviated
new animal drug application, or a conditionally approved new animal
drug application, as well as methodologies to ensure the validity of
conclusions drawn by animal drug sponsors from the scientific
literature to support an approval.
The original guidance #106, ``The Use of Published Literature in
Support of New Animal Drug Approval,'' was published in 2000 and
specifically addressed the use of a single article to support drug
approval. Since its publication, animal drug sponsors have used
literature to support various aspects of animal drug development and
approval, including early stages of drug development, dosage
characterization, microbial food safety, design of the target animal
safety evaluation, prediction of potential adverse effects, and
substantial evidence of effectiveness.
Animal drug sponsors have expressed interest in further leveraging
information published in the scientific literature to support new
animal drug approvals. Use of published scientific literature is of
interest because it makes use of existing knowledge and may reduce the
number of animals needed for studies to support approval and, in some
cases, may provide greater inferential value compared to individual
studies conducted for the purpose of supporting an approval. Scientific
literature may also be used to respond to specific regulatory
questions, identify data gaps, and inform protocol design. This draft
guidance expands upon the original guidance #106 by considering
multiple uses of the scientific literature, including narrative
reviews, systematic reviews, and meta-analyses to support approval of a
new animal drug.
This level 1 draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent the current thinking of FDA on ``The Use
of Published Literature in Support of New Animal Drug Applications.''
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 ``The Use of Published
Literature in Support of New Animal Drug Applications'' have been
approved under OMB control number 0910-0032.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at either
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<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: April 15, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-08452 Filed 4-19-22; 8:45 am]
BILLING CODE 4164-01-P
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