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Federal Register / Vol. 86, No. 170 / Tuesday, September 7, 2021 / Notices 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
2021N0965 for Vaccines and Related Biological Products; 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., Monday through Friday, 2404027500.
Confidential SubmissionsTo 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 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.

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FOR FURTHER INFORMATION CONTACT:

Prabhakara Atreya or Kathleen Hayes, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6306, Silver Spring, MD 209930002, 2408187798, via email at CBERVRBPAC@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 the Agencys website at https
www.fda.gov/advisory-committees and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before joining the meeting.
SUPPLEMENTARY INFORMATION:
Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. The committee will meet in open session to discuss the Pfizer-BioNTech supplemental Biologics License Application for COMIRNATY for administration of a third dose, or booster dose, of the COVID19
vaccine, in individuals 16 years of age and older.
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, background material will be made publicly available on FDAs website at the time of the advisory committee meeting. Background material and the link to the online teleconference meeting room will be available at https www.fda.gov/
advisory-committees/advisorycommittee-calendar. Scroll down to the appropriate advisory committee meeting link. The meeting will include slide presentations with audio 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 September 13, 2021, will be provided to the committee. Comments received after September 13, 2021, and by September 16, 2021, will be taken into consideration by FDA. Oral
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presentations from the public will be scheduled between approximately 12:30
p.m. Eastern Time and 1:30 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 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 13, 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 14, 2021.
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 meetings and will make every effort to accommodate persons with disabilities.
If you require accommodations due to a disability, please contact Prabhakara Atreya or Kathleen Hayes CBERVRBPAC@fda.hhs.gov 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/about-advisory-committees/
public-conduct-during-fda-advisorycommittee-meetings 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: September 2, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
FR Doc. 202119394 Filed 9221; 4:15 pm BILLING CODE 416401P

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