[Federal Register Volume 86, Number 241 (Monday, December 20, 2021)]
[Notices]
[Pages 71897-71898]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27459]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-1212]


Wound Healing Scientific Workshop; Public Workshop; Request for 
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing the following public workshop entitled ``Wound Healing 
Scientific Workshop.'' The purpose of the workshop is to discuss 
nonhealing chronic wounds.

DATES: The public workshop will be held on April 28, 2022 (Day 1), 9 
a.m. to 4 p.m. Eastern Time and April 29, 2022 (Day 2), 9 a.m. to 4 
p.m. Eastern Time. Submit either electronic or written comments on this 
public workshop by June 28, 2022. See the SUPPLEMENTARY INFORMATION 
section for registration date and information.

ADDRESSES: The public workshop will be held in a virtual format.
    You may submit comments as follows. See section III below for 
guidance on structuring comments. Please note that late, untimely filed 
comments will not be considered. Electronic comments must be submitted 
on or before June 28, 2022. The https://www.regulations.gov electronic 
filing system will accept comments until 11:59 p.m. Eastern Time at the 
end of June 28, 2022. Comments received by mail/hand delivery/courier 
(for written/paper submissions) will be considered timely if they are 
postmarked or the delivery service acceptance receipt is on or before 
that date.

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-2021-N-1212 for ``Wound Healing Scientific Workshop.'' Received 
comments, those filed in a timely manner (see ADDRESSES), 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.

FOR FURTHER INFORMATION CONTACT: K. Dev Verma, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 5327, Silver Spring, MD 20993, 240-402-
0282, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In 2020, through a Science Strategies program launched by the 
Office of New Drugs (OND) in the Center for Drug Evaluation and 
Research, the Division of Dermatology and Dentistry collaborated with 
experts from the Center for Biologics Evaluation and Research, Center 
for Devices and Radiological Health, and OND's Division of Clinical 
Outcome Assessments to assess areas of unmet medical need and activity 
in the product development pipeline for wound healing. Because of high 
unmet medical need with relatively limited research and funding, FDA 
identified nonhealing chronic wounds as an area warranting 
prioritization. Root cause analyses indicated that barriers to product 
development for nonhealing chronic wounds involve, but are not limited 
to, deficient biological understanding, challenges in drug delivery, 
challenges in clinical trial execution, and limited commercial 
viability. Specific issues include the lack of current optimal 
preclinical animal models that are capable of properly recapitulating 
human wounds, heterogeneous natural history of different wounds, lack 
of alternative endpoints to complete wound closure, limited 
standardization between clinical trials, high rate of clinical trial 
failures, difficulties with participant enrollment in clinical trials, 
and a complex reimbursement environment.
    FDA recognized the need for a multistakeholder Wound Healing 
Scientific Workshop to enhance

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awareness of these unmet medical needs and barriers, to seek external 
input, to support data sharing, and to communicate current regulatory 
thinking.

II. Topics for Discussion at the Public Workshop

    During the 2-day workshop, FDA and wound-healing experts aim to 
outline the landscape of and review current standards for product 
development in the field of nonhealing chronic wounds, as well as 
identify challenges of implementing and conducting clinical trials, 
discuss potential solutions to overcome these challenges, and explore 
how current research in wound healing can be applied to promote 
innovative product development.
    By building on the science of known physiological processes and 
principles of normal wound healing and recognizing factors that disrupt 
these mechanisms, the workshop anticipates that a better understanding 
of the complexity of chronic wounds will help illustrate the gaps in 
current treatment options.
    Furthermore, hearing from patients and patient representatives 
regarding their understanding of the etiology and pathology of their 
nonhealing chronic wounds, as well as learning what is clinically 
meaningful to them and what their experiences have been with clinical 
trials, will further inform how wound healing measures might be 
improved upon to execute successful clinical trials and drive 
innovation.

III. Request for Specific Public Comments

    FDA is also soliciting public comment on experiences with 
nonhealing chronic wounds. When submitting a comment, FDA requests that 
commenters identify whether they are a patient, caregiver, medical 
provider, product developer, or other stakeholder. FDA also requests 
that commenters answer the following questions based on their 
identifications:
    1. If you are a patient or a caregiver of an individual who has 
experience living with a nonhealing chronic wound:
    a. Meaningful outcomes: What results of treatment would you 
consider meaningful to you (e.g., complete healing of the wound, 
partial healing of the wound, decreased pain, easier wound care/
dressing changes)?
    b. Clinical trial experience: If you have been involved in a 
clinical trial to treat a nonhealing chronic wound, please describe 
your experience. If you have not been able to participate (e.g., not 
eligible), or if you have chosen not to participate in a clinical 
trial, please tell us why.
    c. Impact on quality of life: What aspects of the nonhealing 
wound(s) have the most significant impact on your quality of life 
(e.g., odor, pain, discharge, decreased mobility, burdensome wound 
care, etc.)? Please provide a specific example, if possible.
    2. If you are a caregiver or loved one, in addition to the above 
questions:
    a. Challenges: Which aspect(s) of providing care have been the most 
challenging (e.g., logistics of coordinating appointments, burdensome 
wound care, affordability of products/supplies, access to treatment, 
emotional stress)?
    b. Education/Training: Were you trained on how to care for your 
loved one and the individual's nonhealing chronic wound? If so, did the 
training and education that you were provided allow you to feel 
confident in your ability to perform dressing changes and other 
necessary care? Please explain.
    3. If you are a healthcare provider:
    a. Wound types: What subtypes of nonhealing chronic wounds do you 
treat in your practice (e.g., diabetic foot ulcers, pressure wounds, 
arterial wounds, venous wounds)?
    b. Challenges: What have been your challenges to providing care to 
patients with nonhealing chronic wounds?
    c. Standard of Care: Do you utilize a standard of care protocol for 
your nonhealing chronic wound patients? If so, describe what standard 
of care protocol you utilize (specified by wound etiology).
    d. Products: What new products (e.g., drugs, devices, biologics, 
combination products) would you find helpful in treating nonhealing 
chronic wounds?
    e. Reimbursement: How does reimbursement affect your ability to 
provide care?
    4. If you are a product developer/researcher:
    a. Challenges: What are strategic, operational, and tactical 
challenges (and possible solutions) to implementation of successful 
clinical trials for chronic, nonhealing wounds?
    b. Innovation: What are barriers (and possible solutions) to wound 
care research in the development of innovative wound care products?
    5. If you are involved in the reimbursement landscape (e.g., 
Centers for Medicare and Medicaid Services, insurance payors, billers):
    a. Acceptable evidence: What is the current acceptable evidence for 
coverage decisions related to wound care products (devices, drugs, 
biologics, combination products)?
    b. Challenges: What are challenges (and possible solutions) 
encountered in reimbursement-related decisions for wound care 
treatment?

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please visit the 
following website: https://woundhealingfda2022.eventbrite.com/. Please 
provide complete contact information for each attendee, including name, 
title, affiliation, address, email, and telephone.
    Registration is free and based on space availability, with priority 
given to early registrants. Persons interested in attending this public 
workshop must register by April 3, 2022, by 11:59 p.m. Eastern Time. 
Registrants will receive confirmation when they have been accepted. 
Early registration is recommended because space is limited; therefore, 
FDA may limit the number of participants from each organization.
    Streaming Webcast of the public workshop: This public workshop will 
be webcast at https://fda.zoomgov.com/j/1610233374?pwd=VTU5VDZid3FnaWJKMndOWXRMbmFSUT09. The link above should 
allow you to enter the webinar directly. If Zoom asks for a passcode, 
please use the case-sensitive passcode below.

Case-Sensitive Passcode for Zoom Webinar: eEG.p5

    FDA has verified the website addresses in this document, as of the 
date this document publishes in the Federal Register, but websites are 
subject to change over time.
    Transcripts: Please be advised that as soon as a transcript of the 
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff 
(see ADDRESSES). A link to the transcript will also be available on the 
internet at https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-immunology-and-inflammation-division-dermatology-and-dentistry-ddd.

    Dated: December 15, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-27459 Filed 12-17-21; 8:45 am]
BILLING CODE 4164-01-P