Notice2021-27459
Wound Healing Scientific Workshop; Public Workshop; Request for Comments
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 20, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 241 (Monday, December 20, 2021)</title>
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[Federal Register Volume 86, Number 241 (Monday, December 20, 2021)]
[Notices]
[Pages 71897-71898]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, <a href="/cdn-cgi/l/email-protection#d49fb5a4bdb8fa82b1a6b9b594b2b0b5fabcbca7fab3bba2"><span class="__cf_email__" data-cfemail="fab19b8a9396d4ac9f88979bba9c9e9bd4929289d49d958c">[email protected]</span></a>.
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
[[Page 71898]]
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: <a href="https://woundhealingfda2022.eventbrite.com/">https://woundhealingfda2022.eventbrite.com/</a>. 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 <a href="https://fda.zoomgov.com/j/1610233374?pwd=VTU5VDZid3FnaWJKMndOWXRMbmFSUT09">https://fda.zoomgov.com/j/1610233374?pwd=VTU5VDZid3FnaWJKMndOWXRMbmFSUT09</a>. 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
internet at <a href="https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-immunology-and-inflammation-division-dermatology-and-dentistry-ddd">https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-immunology-and-inflammation-division-dermatology-and-dentistry-ddd</a>.
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
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