[Federal Register Volume 90, Number 113 (Friday, June 13, 2025)]
[Notices]
[Pages 25055-25056]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-10749]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-1246]
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 or the Agency) 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.
DATES: The meeting will be held virtually on July 9, 2025, from 10:00
a.m.-3:30 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: https://www.fda.gov/advisory-committees/about-advisory-committees/common-questions-and-answers-about-fda-advisory-committee-meetings.
FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2025-N-1246. The docket will close on July 8,
2025. Submit either electronic or written comments on this public
meeting on or before July 8, 2025. 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 July 8, 2025. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are received on or the delivery service acceptance
receipt is before or on that date.
Comments received on or before July 2, 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:
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-1246 for ``Pediatric Advisory Committee; 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 https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m. ET, 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.'' 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 https://www.regulations.gov. 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: 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: Shivana Srivastava, Office of
Pediatric Therapeutics, Food and Drug Administration, 10903 New
Hampshire
[[Page 25056]]
Ave., Bldg. 32, Rm. 5157, Silver Spring, MD 20993-0002, 301-796-8695,
[email protected], 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 https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link or call the advisory committee
information line to learn about possible modifications about 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 July 9, 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. LIPOSORBER LA-15 SYSTEM (Humanitarian Device Exemption (HDE))
b. MEDTRONIC ACTIVA NEUROSTIMULATOR FOR DYSTONIA TREATMENT (HDE)
c. MINIMALLY INVASIVE DEFORMITY CORRECTION (MID-C) SYSTEM (HDE)
d. REFLECT SCOLIOSIS CORRECTION SYSTEM (HDE)
e. THE TETHER--VERTEBRAL BODY TETHERING SYSTEM (HDE)
2. Center for Biologics Evaluation and Research
a. DENGVAXIA (Dengue Tetravalent Vaccine, Live)
b. EPICEL (cultured epidermal autografts) (HDE)
c. FLUZONE QUADRIVALENT (Influenza Vaccine)
d. GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant)
3. Center for Drug Evaluation and Research
a. AUVI-Q AUTO-INJECTOR (epinephrine)
b. DIOVAN (valsartan)
c. ENTRESTO (sacubitril and valsartan)
d. ERAXIS (anidulafungin)
e. EUCRISA (crisaborole)
f. EXJADE (deferasirox), JADENU (deferasirox), and JADENU SPRINKLE
(deferasirox)
g. FIASP (insulin aspart)
h. JAKAFI (ruxolitinib phosphate) and OPZELURA (ruxolitinib)
i. LATUDA (lurasidone hydrochloride)
j. LILETTA (levonorgestrel-releasing intrauterine system)
k. MYCAMINE (micafungin)
l. NITYR (nitisinone)
m. POTASSIUM PHOSPHATES (potassium phosphate, dibasic injection;
potassium phosphate, monobasic)
n. REPATHA (evolocumab)
o. ROZLYTREK (entrectinib)
p. STELARA (ustekinumab)
q. SUTENT (sunitinib malate)
r. TASIGNA (nilotinib)
s. TOPICORT (desoximetasone)
t. TRIUMEQ (abacavir, dolutegravir, lamivudine) and TRIUMEQ PD
(abacavir, dolutegravir, lamivudine)
u. XYREM (sodium oxybate)
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 at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. 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 submitted to the Docket (see
ADDRESSES) on or before July 2, 2025, will be provided to the
committee. Oral presentations from the public will be scheduled between
approximately 10:30 a.m. to 11:30 a.m. ET on July 9, 2025. Those
individuals interested in making formal oral presentations should
notify the contact person and submit a brief statement of the general
nature of the evidence or 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 June
24, 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 June 25, 2025.
For press inquiries, please contact the HHS Press Room at
www.hhs.gov/press-room/index.html or 202-690-6343.
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 https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm 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. No participant will be prejudiced by
this waiver, and the ends of justice will be served by allowing for
this modification to FDA's advisory committee meeting procedures.
Dated: June 9, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-10749 Filed 6-12-25; 8:45 am]
BILLING CODE 4164-01-P