[Federal Register Volume 87, Number 76 (Wednesday, April 20, 2022)]
[Notices]
[Pages 23523-23525]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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Applications; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry #106 entitled ``The 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 This draft guidance, when finalized, will replace the 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DATES: Submit either electronic or written comments on the draft 
guidance by June 21, 2022 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:
     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 solely responsible for ensuring that your comment 
does not include any confidential information that you or a

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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-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 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, 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, [email protected].

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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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: 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


