2020-15240. Biomarkers and Surrogate Endpoints in Clinical Studies To Support Effectiveness of New Animal Drugs; Draft Guidance for Industry; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of availability.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #267 entitled “Biomarkers and Surrogate Endpoints in Clinical Studies Support Effectiveness of New Animal Drugs.” The draft guidance, if finalized, will describe FDA's current thinking with respect to assisting sponsors in incorporating biomarkers and surrogate endpoints into proposed clinical investigation protocols and applications for new animal drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

DATES:

Submit either electronic or written comments on the draft guidance by October 13, 2020 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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 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 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:

Susan Storey, Center for Veterinary Medicine (HFV-131), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0578, [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of draft GFI #267 entitled “Biomarkers and Surrogate Endpoints in Clinical Studies to Support Effectiveness of New Animal Drugs.” Section 305 of the Animal Drug and Animal Generic Drug User Fee Amendments of 2018 (Pub. L. 115-234), among other things, directed FDA to hold a public meeting for interested parties to discuss innovative animal drug investigation designs and to issue guidance addressing the incorporation of the use of such elements of investigations as complex adaptive and other novel investigation designs, data from foreign countries, real-world evidence (including ongoing surveillance activities, observational studies, and registry data), biomarkers, and surrogate endpoints into proposed clinical investigation protocols and applications for new animal drugs.

In the Federal Register of July 9, 2019 (84 FR 32749), FDA's Center for Veterinary Medicine (CVM) published a notice of a public meeting entitled “Incorporating Alternative Approaches in Clinical Investigations for New Animal Drugs” giving interested persons until August 17, 2019, to comment on the topics discussed at the public meeting and the questions published in the meeting notice (84 FR 32749 at 32750 to 32751).^[1] On August 13, 2019, we published a notice announcing the extension of the comment period to September 16, 2019 (84 FR 40071). CVM received numerous comments on the topics discussed at the public meeting and the questions published in the meeting notice and those comments were considered as the draft GFI #267 was developed.

This draft guidance describes how 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 provides information about how sponsors may obtain feedback from CVM on technical issues related to the use of biomarkers before the submission of an application.

This level 1 draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, if finalized, will represent the current thinking of FDA regarding the use of biomarkers, including surrogate endpoints, to support the 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

FDA tentatively concludes that this draft guidance contains no collection 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.

However, this draft guidance refers to previously approved FDA collections of information found in FDA regulations for new animal drug applications submitted under sections 512(b) (21 U.S.C. 360b(b)) and 571 of the FD&C Act. These collections of information are subject to review by the OMB under the PRA. The collections of information in 21 part 514 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 https://www.fda.gov/​animal-veterinary/​guidance-regulations/​guidance-industry or https://www.regulations.gov.

Dated: July 9, 2020.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.

Footnotes

1.  https://www.fda.gov/​animal-veterinary/​workshops-conferences-meetings/​public-meeting-incorporating-alternative-approaches-clinical-investigations-new-animal-drugs.