Document ID: FDA-2020-D-1402-0014
Agency: fda
Document Type: Notice
Title: Biomarkers and Surrogate Endpoints
in Clinical Studies To Support
Effectiveness of New Animal Drugs;
Guidance for Industry; Availability
Posted Date: 2021-10-06T04:00Z

[Federal Register Volume 86, Number 191 (Wednesday, October 6, 2021)]
[Notices]
[Pages 55619-55620]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21688]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1402]

Biomarkers and Surrogate Endpoints in Clinical 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, Agency, or we) is 
announcing the availability of a final guidance for industry (GFI) #267 
entitled ``Biomarkers and Surrogate Endpoints in Clinical Studies to 
Support Effectiveness of New Animal Drugs.'' The guidance describes 
FDA's current thinking with respect to incorporating biomarkers and 
surrogate endpoints into proposed clinical investigational 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:
     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 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-2020-D-1402 for ``Biomarkers and Surrogate Endpoints in Clinical 
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 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

[[Page 55620]]

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 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, susan.storey@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of July 15, 2020 (85 FR 42879), FDA 
published the notice of availability for a draft guidance entitled 
``Biomarkers and Surrogate Endpoints in Clinical 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 how the Center for Veterinary Medicine (CVM) intends to 
evaluate biomarkers, including surrogate endpoints, when they are 
incorporated into clinical investigations submitted 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 
describes how sponsors may obtain feedback from CVM on technical issues 
related to the use of biomarkers before the submission of an 
application.
    FDA received comments on the draft guidance and those comments were 
considered as the guidance was finalized. For example, we received a 
comment suggesting that we remove from the guidance discussion of 
biomarkers and a new animal drug's mechanism of action (MOA) with the 
thought that the MOA is not a primary endpoint and is, therefore, out 
of the scope of the guidance. We revised this section of the final 
guidance by adding examples of when consideration of a new animal 
drug's MOA may be relevant for purposes of evaluating the use of 
biomarkers. We also made other editorial changes to this final guidance 
to improve clarity. 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 ``Biomarkers and Surrogate Endpoints in 
Clinical 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 ``Biomarkers and Surrogate 
Endpoints in Clinical 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 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: September 29, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-21688 Filed 10-5-21; 8:45 am]
BILLING CODE 4164-01-P