![]() ![]() Instructions:All submissions received must include the Docket No. 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.”.Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.Submit written/paper submissions as follows: 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”).Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to 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. Submit electronic comments in the following way: Comments received after December 4, 2020, and by December 9, 2020, 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. Eastern Time at the end of December 9, 2020. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.Ĭomments received on or before Decemwill be provided to the committee. The electronic filing system will accept comments until 11:59 p.m. Electronic comments must be submitted on or before December 9, 2020. Please note that late, untimely filed comments will not be considered. ![]() Submit either electronic or written comments on this public meeting by December 9, 2020. The docket will close on December 9, 2020. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.įDA is establishing a docket for public comment on this meeting. The docket number is FDA-2020-N-1898. 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. Materials for this meeting will be available at the Vaccines and Related Biological Products Advisory Committee meetings main page. If FDA is unable to post the background material on its website prior to the meeting, any background material will be made publicly available at the time of the advisory committee meeting, and additional materials will be posted on FDA's website after the meeting. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. On December 10, 2020, the Center for Biologics Evaluation and Research’s (CBER), Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in open session to discuss Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 in individuals 16 years of age and older.įDA intends to make background material available to the public no later than 2 business days before the meeting.
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