Notice2025-19281
Pediatric Advisory Committee (PAC); Notice of Meeting; Establishment of a Public Docket; Request for Comments
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Published
October 2, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pediatric Advisory Committee (PAC). The general function of the Committee is to provide advice and recommendations to FDA on pediatric regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Full Text
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<title>Federal Register, Volume 90 Issue 189 (Thursday, October 2, 2025)</title>
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[Federal Register Volume 90, Number 189 (Thursday, October 2, 2025)]
[Notices]
[Pages 47776-47778]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-19281]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No: FDA-2025-N-3774]
Pediatric Advisory Committee (PAC); Notice of Meeting;
Establishment of a Public Docket; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; establishment of a public docket; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Pediatric Advisory Committee
(PAC). The general function of the Committee is to provide advice and
recommendations to FDA on pediatric regulatory issues. The meeting will
be open to the public. FDA is establishing a docket for public comment
on this document.
[[Page 47777]]
DATES: The meeting will be held on virtually on November 13, 2025, from
10:00 a.m. to 4:00 p.m. Eastern Time (ET).
ADDRESSES: All meeting participants will be heard, viewed, captioned,
and recorded for this advisory committee meeting via an online
teleconferencing and/or video conferencing platform. Answers to
commonly asked questions about FDA advisory committee meetings, may be
accessed at <a href="https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm">https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm</a>.
FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2025-N-1246. The docket will close on November
12, 2025. Submit either electronic or written comments on this public
meeting on or before November 12, 2025. Please note that late, untimely
filed comments will not be considered. 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 November 12, 2025. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are received on or before that date.
Comments received on or before November 5, 2025, will be provided
to the Committee. Comments received after that date will be taken into
consideration by FDA. In the event that the meeting is cancelled, FDA
will continue to evaluate any relevant applications or information, and
consider any comments submitted to the docket, as appropriate.
You may submit comments as follows:
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-2025-N-3774 for ``Pediatric Advisory Committee meeting; Notice of
Meeting; Establishment of a Public Docket; Request for Comments.''
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.'' FDA 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 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 the 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: Shivana Srivastava, Office of
Pediatric Therapeutics, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 5157, Silver Spring, MD 20993-0002, 301-
796-8695, <a href="/cdn-cgi/l/email-protection#f182999887909f90df82839887908285908790b1979590df999982df969e87"><span class="__cf_email__" data-cfemail="f3809b9a85929d92dd80819a85928087928592b3959792dd9b9b80dd949c85">[email protected]</span></a>, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area. A notice in the Federal Register about last-minute modifications
that impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice. Therefore,
you should always check FDA's website at <a href="https://www.fda.gov/AdvisoryCommittees/default.htm">https://www.fda.gov/AdvisoryCommittees/default.htm</a> and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before the
meeting.
SUPPLEMENTARY INFORMATION: The meeting presentations will be heard,
viewed, captioned, and recorded through an online teleconferencing and/
or video conferencing platform.
Agenda: On November 13, 2025, the PAC will meet to discuss post-
marketing pediatric-focused safety reviews of the following products:
1. Center for Devices and Radiological Health
a. ENTERRA THERAPY SYSTEM (Humanitarian Device Exemption (HDE))
b. CONTEGRA PULMONARY VALVED CONDUIT (HDE)
c. PLEXIMMUNE (HDE)
d. SONALLEVE MR-HIFU (HDE)
2. Center for Biologics Evaluation and Research
a. QUELIMMUNE (HDE)
b. SEVENFACT (coagulation factor VIIa (recombinant)-jncw)
c. VAXCHORA (Cholera Vaccine, Live, Oral)
3. Center for Drug Evaluation and Research
[[Page 47778]]
a. ABRAXANE (paclitaxel)
b. ARMONAIR RESPICLICK (fluticasone propionate), ARMONAIR DIGIHALER
(fluticasone propionate), AIRDUO RESPICLICK (fluticasone propionate and
salmeterol xinafoate), AIRDUO DIGIHALER (fluticasone propionate and
salmeterol xinafoate)
c. AUBAGIO (teriflunomide)
d. AUSTEDO (deutetrabenazine)
e. BREXAFEMME (ibrexafungerp)
f. BYDUREON (exenatide), BYDUREON BCISE (exenatide), BYETTA
(exenatide)
g. CIBINQO (abrocitinib)
h. COSENTYX (secukinumab)
i. DESCOVY (emtricitabine and tenofovir alafenamide)
j. DUPIXENT (dupilumab)
k. EDURANT (rilpivirine), EDURANT PED (rilpivirine)
l. ENBREL (etanercept)
m. EVOTAZ (atazanavir and cobicistat)
n. LIALDA (mesalamine)
o. LINZESS (linaclotide)
p. LITFULO (ritlecitinib)
q. MYRBETRIQ EXTENDED-RELEASE TABLETS (mirabegron), MYRBETRIQ
GRANULES (mirabegron)
r. NUCYNTA (tapentadol), NUCYNTA ER (tapentadol)
s. OPANA (oxymorphone hydrochloride)
t. PIFELTRO (doravirine), DELSTRIGO (doravirine, lamivudine, and
tenofovir disoproxil fumarate)
u. RAPIVAB (peramivir)
v. REXULTI (brexpiprazole)
w. RYALTRIS (olopatadine hydrochloride and mometasone furoate)
x. SELZENTRY (maraviroc)
y. SIMPONI ARIA (golimumab)
z. SMOFLIPID (lipid injectable emulsion)
aa. SOLOSEC (secnidazole)
bb. TAYTULLA (norethindrone acetate/ethinyl estradiol capsules and
ferrous fumarate capsules)
cc. TEZSPIRE (tezepelumab-ekko)
dd. TRINTELLIX (vortioxetine)
ee. VIIBRYD (vilazodone hydrochloride)
ff. XOFLUZA (baloxavir marboxil)
gg. YCANTH (cantharidin)
hh. ZEGALOGUE (dasiglucagon)
ii. ZEPATIER (elbasvir and grazoprevir)
jj. ZERBAXA (ceftolozane and tazobactam)
kk. ZOSYN (piperacillin and tazobactam)
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available on FDA's website at
the time of the advisory committee meeting. Background material and the
link to the online teleconference and/or video conference meeting will
be available <a href="https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm">https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm</a>.
Scroll down to the appropriate advisory committee meeting link.
The meeting will include slide presentations with audio and video
components to allow the presentation of materials in a manner that most
closely resembles an in-person advisory committee meeting.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the Committee.
All electronic and written submissions to the Docket (see ADDRESSES) on
or before November 5, 2025, will be provided to the Committee. Oral
presentations from the public will be scheduled between approximately
1:15 p.m. to 2:15 p.m. Eastern Time. Those individuals interested in
making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the arguments they
wish to present, the names and addresses of proposed participants, and
an indication of the approximate time requested to make their
presentation on or before October 28, 2025. Time allotted for each
presentation may be limited. If the number of registrants requesting to
speak is greater than can be reasonably accommodated during the
scheduled open public hearing session, FDA may conduct a lottery to
determine the speakers for the scheduled open public hearing session.
The contact person will notify interested persons regarding their
request to speak by October 29, 2025.
For press inquiries, please contact the FDA Newsroom at
<a href="http://www.fda.gov/news-events/fda-newsroom">www.fda.gov/news-events/fda-newsroom</a>.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Shivana Srivastava (see FOR FURTHER INFORMATION CONTACT) at
least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at <a href="https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm">https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm</a> for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. 1001 et seq.). This meeting notice also serves
as notice that, pursuant to 21 CFR 10.19, the requirements in 21 CFR
14.22(b), (f), and (g) relating to the location of advisory committee
meetings are hereby waived to allow for this meeting to take place
using an online meeting platform. This waiver is in the interest of
allowing greater transparency and opportunities for public
participation, in addition to convenience for advisory committee
members, speakers, and guest speakers. The conditions for issuance of a
waiver under 21 CFR 10.19 are met.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-19281 Filed 10-1-25; 8:45 am]
BILLING CODE 4164-01-P
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