4164-01-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-4067]
Diabetic Foot Infections: Developing Drugs for Treatment; 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 final guidance for industry entitled “Diabetic Foot Infections: Developing Drugs
for Treatment.” The purpose of this guidance is to assist sponsors in the clinical development of
drugs for the treatment of diabetic foot infections (DFI) without concomitant bone and joint
involvement. This guidance finalizes and replaces the draft guidance of the same title issued on
October 17, 2023.
DATES: The announcement of the guidance is published in the Federal Register on [INSERT
DATE OF PUBLICATION IN THE FEDERAL REGISTER].
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-2023-D-4067

for “Diabetic Foot Infections: Developing Drugs for Treatment.” 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 this guidance to the Division of Drug
Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001
New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. 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: Mayurika Ghosh, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22,
Rm. 6219, Silver Spring, MD 20993; 301-796-4776.
SUPPLEMENTARY INFORMATION:
I. Background

FDA is announcing the availability of a guidance for industry entitled “Diabetic Foot
Infections: Developing Drugs for Treatment.” The purpose of this guidance is to assist sponsors
in the clinical development of drugs for the treatment of DFI without concomitant bone and joint
involvement. Specifically, this guidance addresses FDA’s current thinking regarding the overall
development program and clinical trial designs for the development of drugs to support an
indication for treatment of DFI.
This guidance finalizes the draft guidance entitled “Diabetic Foot Infections: Developing
Drugs for Treatment” issued on October 17, 2023 (88 FR 71578). FDA reviewed public
comments on the published draft guidance and determined, after careful consideration, that no
revisions were needed to finalize the guidance.
This 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 “Diabetic Foot
Infections: Developing Drugs for Treatment.” 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. The previously approved collections of information
are subject to review by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information in 21 CFR
part 312 pertaining to the submission of investigational new drug applications have been
approved under OMB control number 0910-0014. The collections of information in 21 CFR part
314 pertaining to the submission of new drug applications have been approved under OMB
control number 0910-0001. The collections of information in 21 CFR 201.56 and 201.57
relating to prescription product labeling requirements have been approved under OMB control
number 0910-0572.

III. Electronic Access
Persons with access to the internet may obtain the guidance at
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs,
https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or
https://www.regulations.gov.
Dated: June 11, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-13237 Filed: 6/14/2024 8:45 am; Publication Date: 6/17/2024]