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          Vaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Announcement - 10/22/2020Advisory Committee Calendar Advisory Committee Meeting
    Event Title
              Vaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Announcement


                  October 22, 2020

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      Meeting Information
                Event MaterialsDate:
            
  


     
           

October 22, 2020   

 
         
                                              Time: 
                                          
10:00 AM
    - 5:00 PM
ET

 


What is an advisory committee?
Advisory committees provide independent expert advice to the FDA on broad scientific topics or on certain products to help the agency make sound decisions based on the available science. Advisory committees make non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so. Please see, "Advisory Committees Give FDA Critical Advice and the Public a Voice," for more information.    


 
UPDATED INFORMATION (as of October 21, 2020)
CBER also plans to make the live webcast available via FDA’s YouTube channel at: https://youtu.be/1XTiL9rUpkg

UPDATED INFORMATION (as of September 30, 2020)
An amended notice was published to announce a new meeting webcast link (see webcast information) and public participation information has been changed to include a docket for written comments.




**Agenda**
The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. On October 22, 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, in general, the development, authorization and/or licensure of vaccines to prevent COVID-19. No specific application will be discussed at this meeting.

**Meeting Materials**
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, 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.

Materials for this meeting will be available at the Vaccines and Related Biological Products Advisory Committee **meetings main page**.

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.

**Public Participation Information**
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

FDA is establishing a docket for public comment on this meeting. The docket number is **FDA-2020-N-1898**. The docket will close on **October 15, 2020**. Submit either electronic or written comments on this public meeting by October 15, 2020. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before October 15, 2020. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of October 15, 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.

Comments received on or before October 15, 2020, 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 cancelled, 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-2020-N-1898** for Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.” Received comments, those filed in a timely manner (see the ADDRESSES section), 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, 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, September18, 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.

On October 22, 2020, **oral presentations** from the public will be scheduled between approximately 2:30 p.m. and 3:30 p.m. EST. 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 October 7, 2020**.

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 October 8, 2020**.

**Webcast Information**
CBER plans to provide a free of charge, live webcast of the Vaccines and Related Biological Products Advisory Committee meeting. If there are instances where the webcast transmission is not successful; staff will work to re-establish the transmission as soon as possible.

The online web conference meeting will be available at: **http://fda.yorkcast.com/webcast/Play/c26e83a0f77a412296949f4f43af4c981d**

CBER also plans to make the live webcast available via FDA’s YouTube channel at: https://youtu.be/1XTiL9rUpkg.

**Recorded Webcast**

**Youtube**
	**Yorkcast****Contact Information**

Prabhakara Atreya, 240-506-4946, e-mail: **Prabhakara.Atreya@fda.hhs.gov**
	or Monique Hill, 301-796-4620, e-mail: **Monique.Hill@fda.hhs.gov**
	FDA Advisory Committee Information Line:
	1-800-741-8138 (301-443-0572 in the Washington, DC area) Please call the Information Line for up-to-date information on this meeting.
	For press inquiries, please contact the Office of Media Affairs at fdaoma@fda.hhs.gov or 301-796-4540.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 **meetings main page** or call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Prabhakara Atreya at least 7 days in advance of the meeting.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site 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).

**FR Notices**

**Official FR Notice**
	**Amended FR Notice**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 or call the committee’s Designated Federal Officer (see Contact Information) to learn about possible modifications before coming to the meeting.
  Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. 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 the committee’s Designated Federal Officer (see Contact Information) at least 7 days in advance of the meeting.
  Answers to commonly asked questions including information regarding special accommodations due to a disability may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings.
  FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee 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).

Event Materials

  Title
            File Type/Size
            Source OrganizationVaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Briefing Document- FDA
              pdf               (462.94 KB)
              FDAVaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Presentation- Speaker
              pdf               (109.73 KB)
              Reagan Udall Foundation for the Food and Drug AdministrationVaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Jeannette Lee- Acknowledgement of Financial Interest
              pdf               (62.20 KB)
              Non-FDAVaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Jeannette Lee- Waiver to Allow Participation
              pdf               (103.99 KB)
              FDAVaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting James Hildreth- Acknowledgement of Financial Interest
              pdf               (64.82 KB)
              Non-FDAVaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting James Hildreth- Waiver to Allow Participation
              pdf               (80.66 KB)
              FDAVaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Draft Agenda
              pdf               (107.88 KB)
              FDAVaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Draft Roster
              pdf               (164.01 KB)
              FDAVaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Discussion Items
              pdf               (44.58 KB)
              FDAVaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Presentation- COVID19 Licensure and EUA Clinical Considerations
              pdf               (258.03 KB)
              FDAVaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Presentation- COVID19 Licensure and EUA CMC Considerations
              pdf               (65.19 KB)
              FDAVaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Presentation- Development, Authorization and Licensure of Vaccines to Prevent COVID-19
              pdf               (221.29 KB)
              FDAVaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Presentation- COVID19 Post-Authorization Post-Licesure Safety Monitoring
              pdf               (1.45 MB)
              Non-FDAVaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Presentation- COVID19 Vaccine Confidence Project
              pdf               (360.67 KB)
              Reagan Udall Foundation for the Food and Drug AdministrationVaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Final Roster
              pdf               (312.68 KB)
              FDAVaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Final Agenda
              pdf               (233.19 KB)
              FDAVaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Presentation- COVID19 CBER Plans for Monitoring Vaccine Safety and Effectiveness
              pdf               (398.02 KB)
              FDAVaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Presentation- Epidemiology, Virology  and Clinical Features of COVID-19
              pdf               (2.87 MB)
              Non-FDAVaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Presentation- COVID19 Vaccine Development- NIH Role
              pdf               (5.76 MB)
              Non-FDAVaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Presentation- COVID19 Vaccine Development- Portfolio
              pdf               (2.60 MB)
              Non-FDAVaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Presentation- COVID19 Vaccine Implementation- Operational aspects of vaccine distribution and tracking
              pdf               (4.38 MB)
              Non-FDAVaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Transcript
              pdf               (3.93 MB)
              FDAVaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Summary Minutes
              pdf               (79.81 KB)
              FDA

                                                                                  Content current as of:
      12/08/2020
         
                   
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