Pediatric Advisory Committee; 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.

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 the 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 September 18, 2024, from 10 a.m. to 4 p.m. Eastern Time.

ADDRESSES:

All meeting participants will be joining this advisory committee meeting via an online platform and heard, viewed, captioned, and recorded via an online and/or video conferencing platform. Answers to commonly asked questions about FDA advisory committee meetings may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2024-N-3294. The docket will close on September 17, 2024. Submit either electronic or written comments on this public meeting by September 17, 2024. 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 September 17, 2024. 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 September 9, 2024, 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 canceled, 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-2024-N-3294 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. EST, 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 Ave., Bldg. 32, Rm. 5152, Silver Spring, MD 20993-0002, 301-796-8695, shivana.srivastava@fda.hhs.gov, 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 the Agency'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 before coming to the meeting.

SUPPLEMENTARY INFORMATION:

Agenda: On September 18, 2024, the PAC will meet to discuss post-marketing pediatric-focused safety reviews of the following products:

1. Center for Biologics Evaluation and Research

a. AGRIFLU (influenza virus vaccine)

b. CUTAQUIG (immune globulin subcutaneous (human)-hipp, 16.5%)

c. XYNTHA (antihemophilic factor (recombinant), plasma/albumin Free)

2. Center for Drug Evaluation and Research

a. AZSTARYS (serdexmethylphenidate/dexmethylphenidate)

b. CAFCIT (caffeine citrate)

c. CHANTIX (varenicline)

d. CIMDUO, TEMIXYS (lamivudine/tenofovir disoproxil fumarate)

e. CLEOCIN HYDROCHLORIDE (clindamycin hydrochloride), CLEOCIN PHOSPHATE (clindamycin phosphate), CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER (clindamycin phosphate), CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE (clindamycin phosphate)

f. DYANAVEL XR (amphetamine)

g. EVEKEO ODT (amphetamine sulfate)

h. GATTEX (teduglutide)

i. GILENYA (fingolimod) and TASCENSO ODT (fingolimod)

j. JANUVIA (sitagliptin) and JANUMET (sitagliptin/metformin HCl), JANUMET XR (sitagliptin/metformin hydrochloride extended release)

k. KAPSPARGO SPRINKLE (metoprolol succinate extended release)

l. LITHIUM (lithium carbonate), (lithium oral solution)

m. LOTEMAX (loteprednol etabonate)

n. LUMASON (sulfur hexafluoride lipid-type A microspheres)

o. MAVYRET (glecaprevir/pibrentasvir)

p. MIRCERA (methoxy polyethylene glycol-epoetin beta)

q. MULTRYS (trace elements), TRALEMENT (trace elements), ZINC SULFATE, SELENIOUS ACID

r. MYDAYIS (mixed salts of a single-entity amphetamine)

s. NATROBA (spinosad)

t. PRADAXA (dabigatran etexilate)

u. QELBREE (viloxazine extended-release)

v. RIOMET ER (metformin hydrochloride extended-release)

w. TEFLARO (ceftaroline fosamil)

x. TIROSINT-SOL (levothyroxine sodium)

y. TYBOST (cobicistat)

z. ULTRAVATE (halobetasol propionate), LEXETTE (halobetasol propionate)

aa. VEKLURY (remdesivir)

bb. VYVANSE (lisdexamfetamine dimesylate)

cc. XACIATO (clindamycin phosphate)

dd. XEGLYZE (abametapir)

ee. XELSTRYM (dextroamphetamine)

ff. YERVOY (ipilimumab)

3. Center for Devices and Radiological Health

a. CONTEGRA PULMONARY VALVED CONDUIT (Humanitarian Device Exemption (HDE))

b. ENTERRA THERAPY SYSTEM (HDE)

c. FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA DEVICE (HDE)

d. PLEXIMMUNE IN-VITRO DIAGNOSTIC TEST (HDE)

e. PULSERIDER ANEURYSM NECK RECONSTRUCTION DEVICE (HDE)

f. SONALLEVE MR-HIFU (HDE)

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 after the meeting. Background material and the link to the online 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 to the Docket (see ADDRESSES ) on or before September 9, 2024, will be provided to the committee. Written submissions may be made to the contact person on or before September 11, 2024. Oral presentations from the public will be scheduled between approximately 11 a.m. to 12 p.m. Eastern Standard Time on September 18, 2024. 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 September 9, 2024. 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 September 10, 2024.

For press inquiries, please contact the Office of Media Affairs at fdaoma@fda.hhs.gov or 301-796-4540.

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.