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Federal Register / Vol. 86, No. 151 / Tuesday, August 10, 2021 / Notices 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 FDAs 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-201509-18/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, 2404027500.
FOR FURTHER INFORMATION CONTACT:
Marieann Brill, Office of Pediatric Therapeutics, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5154, Silver Spring, MD 209930002, 2404023838, Marieann.Brill@fda.hhs.gov, or FDA
Advisory Committee Information Line, 18007418138 3014430572 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 FDAs 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:
The meeting presentations will be heard, viewed, captioned, and recorded
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through an online teleconferencing platform. On September 17, 2021, the Pediatric Advisory Committee PAC
will discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act Pub.
L. 107109 and the Pediatric Research Equity Act of 2003 Pub. L. 108155.
The PAC will meet to discuss the following product: Center for Devices and Radiological Health FLOURISHTM
Pediatric Esophageal Atresia Device humanitarian device exemption.
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 at the location of the advisory committee meeting, and the background material will be posted on FDAs website after the meeting. Background material is available at https www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the appropriate advisory committee meeting link.
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 September 10. 2021, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 11:30 a.m. and 12:30
p.m. 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 2, 2021. 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 2, 2021.
Persons attending FDAs advisory committee meetings are advised that FDA is not responsible for providing access to electrical outlets.
For press inquiries, please contact the Office of Media Affairs at fdaoma@
fda.hhs.gov or 3017964540.
FDA welcomes the attendance of the public at its advisory committee
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meetings and will make every effort to accommodate persons with disabilities.
If you require accommodations due to a disability, please contact Marieann Brill 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. app. 2.
Dated: August 4, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
FR Doc. 202116984 Filed 8921; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2021N0834

Post-Marketing Pediatric-Focused Product Safety Reviews;
Establishment of a Public Docket;
Request for Comments AGENCY:

Food and Drug Administration,
HHS.
Notice; establishment of a public docket; request for comments.

ACTION:

The Food and Drug Administration FDA is establishing a public docket to collect comments related to the post-marketing pediatricfocused safety reviews of products posted between September 2, 2020, and September 2, 2021, on FDAs website but not presented at the September 17, 2021, Pediatric Advisory Committee PAC meeting. These reviews are intended to be available for review and comment by members of the PAC, interested parties such as academic researchers, regulated industries, consortia, and patient groups, and the general public.
DATES: Submit either electronic or written comments by September 24, 2021.
SUMMARY:

FDA is establishing a docket for public comment on this document.
The docket number is FDA2021N
0834. The docket will close on September 24, 2021. Submit either electronic or written comments by that
ADDRESSES:

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