[Federal Register Volume 90, Number 224 (Monday, November 24, 2025)]
[Notices]
[Pages 52958-52960]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-20658]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-2976]
Improving Anaphylaxis Outcomes: Approaches for Enhancing Access
to Epinephrine; 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, the Agency, or we) is
announcing the following public workshop entitled ``Improving
Anaphylaxis Outcomes: Approaches for Enhancing Access to Epinephrine.''
The purpose of the public workshop is to initiate a discussion on
expanding epinephrine accessibility and use, including in community
settings, to reduce anaphylaxis-related morbidity and mortality. This
public workshop will be convened and supported by a cooperative
agreement between FDA and the Duke-Margolis Institute for Health
Policy.
DATES: The public workshop will be held virtually and in person on
December 16, 2025, from 9 a.m. to 4:30 p.m. Eastern Time. Either
electronic or written comments on this public workshop must be
submitted by January 16, 2026. See the SUPPLEMENTARY INFORMATION
section for registration date and information.
ADDRESSES: The public workshop will be held virtually using the Zoom
Platform and in person at the Duke in DC Office, 1201 Pennsylvania Ave.
NW, Suite 500, Washington, DC 20004 with limited seat availability.
Parking is available through a number of area garages including one
located at 1201 Pennsylvania Ave. with entrance off of E Street. Names
of in-person attendees will be provided to building security. Upon
entering the building, please walk toward the front desk. The security
staff at the front desk will have a list of all confirmed in-person
attendees and will provide access to the elevators. Upon exiting the
elevator on the 5th floor, turn right and you will find the entrance to
the Duke offices.
You may submit comments as follows: Please note that late, untimely
filed comments will not be considered. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of January 16, 2026. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are received on or before that date.
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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-2025-N-2976 for ``Improving Anaphylaxis Outcomes: Approaches for
Enhancing Access to Epinephrine.'' 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: Phong Pham, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 6122, Silver Spring, MD 20993-0002, 301-837-7656,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Anaphylaxis is a severe and rapidly progressive allergic reaction,
with a lifetime prevalence in the United States of up to 5 percent
(Ref. 1) and resulting in approximately 200 deaths annually (Ref. 2).
This allergic reaction can occur within minutes of exposure to common
allergens, including foods, medications, and insect stings; in some
cases, anaphylaxis occurs with no identifiable trigger. The
physiological cascade of anaphylaxis involves massive histamine release
and vascular permeability changes that can lead to airway obstruction,
cardiovascular collapse, and multi-organ failure within 15 to 30
minutes if left untreated. Unlike milder allergic reactions,
anaphylaxis requires immediate intervention with epinephrine as the
only effective first-line treatment (Refs. 3, 4).
Despite epinephrine's critical role in preventing anaphylactic
deaths, potential barriers limit access to and use of this life-saving
medication (Refs. 5, 6). For example, patients prescribed epinephrine
may not have it available during anaphylaxis; may choose not to use it
due to knowledge gaps, fear, stigma, misperceptions, or discomfort; or
may use it incorrectly, resulting in inadequate dosing (Ref. 7).
Institutional barriers may also present access challenges in community
settings, where anaphylactic emergencies commonly occur. Schools,
workplaces, restaurants, sports facilities, transportation vehicles,
and public venues may lack comprehensive policies for epinephrine
storage, staff training, and emergency administration protocols. State
laws vary significantly regarding Good Samaritan protections for lay
administration of epinephrine, creating liability concerns that
discourage institutions from maintaining emergency supplies. Additional
potential barriers include economic obstacles due to the cost of
epinephrine products that could potentially be administered in
community settings (i.e., ``community-use'' epinephrine products), as
well as geographic disparities, especially in rural communities where
pharmacies may be spread out, emergency medical services can have
longer response times, and healthcare infrastructure is limited. There
are also potential procedural barriers with navigating the healthcare
system such as obtaining healthcare provider authorization and
maintaining a current prescription for epinephrine.
The purpose of the public workshop is to initiate a discussion on
expanding epinephrine accessibility and use, including in community
settings, to reduce anaphylaxis-related morbidity and mortality.
II. Topics for Discussion at the Public Workshop
For more information on the meeting topics, visit https://duke.is/EpiAccess. The Duke-Margolis Institute for Health Policy will publish a
discussion guide outlining background information and current thinking
on the topic areas to this website approximately 1 week before the
meeting date. FDA will also post the agenda and other meeting materials
to this website approximately 3 business days before the meeting.
The format of the public workshop will consist of a series of
presentations, panel discussions, and open discussion.
[[Page 52960]]
III. Participating in the Public Workshop
Registration: To register for the public workshop, please visit the
following website: https://duke.is/EpiAccess. Please provide complete
contact information for each attendee, including name, title,
affiliation, address, email, and telephone number.
Registration is free. Persons interested in attending this public
workshop must register and receive registration confirmation. Early
registration is recommended. Registrants will receive confirmation when
they have been accepted. If you need special accommodations due to a
disability, please contact [email protected] no later than
December 2, 2025, 11:59 p.m. Eastern Time.
Requests for Oral Presentations: During online registration you may
indicate if you wish to present during a public comment session. All
requests to make oral presentations must be received by November 21,
2025, 11:59 p.m. Eastern Time. We will do our best to accommodate
requests to make public comments. Individuals and organizations with
common interests are urged to consolidate or coordinate their
presentations, and request time for a joint presentation, or submit
requests for designated representatives to participate in the focused
sessions. Following the close of registration, we will determine the
amount of time allotted to each presenter and the approximate time each
oral presentation is to begin and will select and notify participants
by December 1, 2025, 11:59 p.m. Eastern Time. All requests to make oral
presentations must be received by November 21, 2025, 11:59 p.m. Eastern
Time. If selected for presentation, any presentation materials must be
emailed to Brian Canter at [email protected] no later than December
11, 2025, 11:59 p.m. Eastern Time. No commercial or promotional
material will be permitted to be presented or distributed at the public
workshop.
Streaming Webcast of the Public Workshop: This public workshop will
also be webcast via Zoom and the archived video footage will be
available at the event website. The link for registration is the same
as above: https://duke.is/EpiAccess. Registered webcast participants
will be sent technical system requirements in advance of the event. It
is recommended that you review these technical system requirements
before joining the streaming webcast of the public workshop.
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://duke.is/EpiAccess.
Notice of this meeting is given pursuant to 21 CFR 10.65.
IV. References
The following references are on display at the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; these are not
available electronically at https://www.regulations.gov as these
references are copyright protected. Some may be available at the
website address, if listed. Although FDA verified the website addresses
in this document, please note that websites are subject to change over
time.
1. Wood, RA, CA Camargo Jr., P Lieberman, HA Sampson, LB Schwartz, M
Zitt, C Collins, M Tringale, M Wilkinson, J Boyle, and FER Simons,
2014, Anaphylaxis in America: The Prevalence and Characteristics of
Anaphylaxis in the United States, J Allergy Clin Immunol,
133(2):461-467. Available at https://doi.org/10.1016/j.jaci.2013.08.016.
2. Ma, L, TM Danoff, and L Borish, 2014, Case Fatality and
Population Mortality Associated With Anaphylaxis in the United
States, J Allergy Clin Immunol, 133(4):1075-1083. Available at
https://doi.org/10.1016/j.jaci.2013.10.029.
3. Golden, DBK, J Wang, S Waserman, C Akin, RL Campbell, AK Ellis, M
Greenhawt, DM Lang, DK Ledford, J Lieberman, J Oppenheimer, MS
Shaker, DV Wallace, EM Abrams, JA Bernstein, DK Chu, CC Horner, MA
Rank, DR Stukus; Collaborators: AG Burrows, H Cruickshank; Workgroup
Contributors: DBK Golden, J Wang, C Akin, RL Campbell, AK Ellis, M
Greenhawt, DM Lang, DK Ledford, J Lieberman, J Oppenheimer, MS
Shaker, DV Wallace, S Waserman; Joint Task Force on Practice
Parameters Reviewers: EM Abrams, JA Bernstein, DK Chu, AK Ellis, DBK
Golden, M Greenhawt, CC Horner, DK Ledford, J Lieberman, MA Rank, MS
Shaker, DR Stukus, and J Wang, 2024, Anaphylaxis: A 2023 Practice
Parameter Update, Ann Allergy Asthma Immunol, 132(2):124-176.
Available at https://doi.org/10.1016/j.anai.2023.09.015.
4. Dribin, TE, S Waserman, and PJ Turner, 2023, Who Needs
Epinephrine? Anaphylaxis, Autoinjectors, and Parachutes, J Allergy
Clin Immunol Pract, 11(4):1036-1046. Available at https://doi.org/10.1016/j.jaip.2023.02.002.
5. Prince, BT, I Mikhail, and DR Stukus, 2018, Underuse of
Epinephrine for the Treatment of Anaphylaxis: Missed Opportunities,
J Asthma Allergy, 11:143-151. Available at https://doi.org/10.2147/JAA.S159400.
6. Lieberman, JA and J Wang, 2020, Epinephrine in Anaphylaxis: Too
Little, Too Late, Curr Opin Allergy Clin Immunol, 20(5):452-458.
Available at https://doi.org/10.1097/ACI.0000000000000680.
7. Ridolo, E, M Montagni, L Bonzano, E Savi, S Peveri, MT
Costantino, M Crivellaro, G Manzotti, C Lombardi, M Caminati, C
Incorvaia, and G Senna, 2015, How Far From Correct Is the Use of
Adrenaline Auto-Injectors? A Survey in Italian Patients, Intern
Emerg Med, 10(8):937-941. Available at https://doi.org/10.1007/s11739-015-1255-z.
Lowell M. Zeta,
Acting, Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2025-20658 Filed 11-21-25; 8:45 am]
BILLING CODE 4164-01-P