Notice2023-05333
The Use of Published Literature in Support of New Animal Drug Approvals; Guidance for Industry; Availability
Primary source
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Published
March 16, 2023
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 #106 entitled "The Use of Published Literature in Support of New Animal Drug Approvals." This guidance replaces existing guidance #106, "The Use of Published Literature in Support of New Animal Drug Approvals," which FDA published in August 2000. It addressed the use of a single scientific 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 88 Issue 51 (Thursday, March 16, 2023)</title>
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[Federal Register Volume 88, Number 51 (Thursday, March 16, 2023)]
[Notices]
[Pages 16267-16268]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-05333]
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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
Approvals; 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, Agency, or we) is
announcing the availability of a final guidance for industry #106
entitled ``The Use of Published Literature in Support of New Animal
Drug Approvals.'' This guidance replaces existing guidance #106, ``The
Use of Published Literature in Support of New Animal Drug Approvals,''
which FDA published in August 2000. It addressed the use of a single
scientific 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: The announcement of the guidance is published in the Federal
Register on March 16, 2023.
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'').
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.''
[[Page 16268]]
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 Approvals.'' 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: 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#c382aea6baed82a7a2aeb083a5a7a2edababb0eda4acb5"><span class="__cf_email__" data-cfemail="fcbd919985d2bd989d918fbc9a989dd294948fd29b938a">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of April 20, 2022 (87 FR 23523), FDA
published the notice of availability for a draft guidance entitled
``The Use of Published Literature in Support of New Animal Drug
Approvals'' giving interested persons until June 21, 2022, to comment
on the draft guidance. FDA received several comments on the draft
guidance, and those comments were considered as the guidance was
finalized. For example, one comment requested that we further clarify
and discuss the potential utility of published studies conducted
outside of the United States; we added such language to the final
guidance. In addition, other editorial changes were made to improve
clarity. The guidance announced in this notice finalizes the draft
guidance dated April 2022.
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 ``The Use of Published Literature in
Support of New Animal Drug Approvals.'' 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 21 CFR part 514 have been approved under OMB control
number 0910-0032.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
<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: March 10, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-05333 Filed 3-15-23; 8:45 am]
BILLING CODE 4164-01-P
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