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Federal Register / Vol. 86, No. 27 / Thursday, February 11, 2021 / Notices
Notice; establishment of a public docket; request for comments.

ACTION:

The Food and Drug Administration FDA or Agency announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee the committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Consistent with FDAs regulations, this notice is being published with less than 15 days prior to the date of the meeting based on a determination that convening a meeting of the Vaccines and Related Biological Products Advisory Committee as soon as possible is warranted. This Federal Register notice could not be published 15 days prior to the date of the meeting due to a recent submission by Janssen Biotech Inc. of a request for emergency use authorization EUA for an investigational vaccine to prevent Coronavirus Disease 2019 COVID19
and the need for prompt discussion of such submission, given the COVID19
pandemic.

SUMMARY:

The meeting will be held on February 26, 2021, from 9 a.m. Eastern Time to 5:30 p.m. Eastern Time.
ADDRESSES: Please note that due to the impact of this COVID19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform.
Answers to commonly asked questions including information regarding special accommodations due to a disability may be accessed at: https www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm. The online web conference meeting will be available at the following link on the day of the meeting: https youtu.be/Qd7mlCDrEA.
FDA is establishing a docket for public comment on this meeting. The docket number is FDA2021N0173.
The docket will close on February 25, 2021. Submit either electronic or written comments on this public meeting by February 25, 2021. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before February 25, 2021. The https
www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of February 25, 2021. Comments received by mail/hand delivery/courier for
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DATES:

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written/paper submissions will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.
Comments received on or before February 18, 2021, will be provided to the committee. Comments received after February 18, 2021, and by February 25, 2021, will be taken into consideration by FDA. In the event that the meeting is cancelled, FDA will continue to evaluate any relevant applications, submissions, 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 elses 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 HFA305, 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
2021N0173 for Vaccines and Related
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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.
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, CBERVRBPAC@
fda.hhs.gov; or FDA Advisory Committee Information Line, 1800

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