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  4. Vaccines and Related Biological Products Committee March 9, 2017 Meeting Announcement - 03/09/2017 - 03/09/2017
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Advisory Committee Meeting

Event Title
Vaccines and Related Biological Products Committee March 9, 2017 Meeting Announcement
March 9, 2017

Scheduled

Date:
March 9, 2017
Time:
8:30 AM - 3:00 PM ET
Location:
Event Location
Fishers Lane Conference Center
Fishers Lane Conference Center

5635 Fishers Ln
Rockville, MD 20852
United States



Agenda
On March 9, 2017, the committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2017-2018 influenza season.

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 Web site 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 FDA’s Web site after the meeting.

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

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

  • Written submissions may be made to the contact person on or before February 23, 2017
  • Oral presentations from the public will be scheduled on March 9, 2017 between approximately 12:50 p.m. and 1:50 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 February 14, 2017. 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 February 15, 2017.

For those unable to attend in person, the meeting will also be Web cast. The Web cast will be available at the following link https://videocast.nih.gov/.

Contact Information

  • Prabhakara Atreya or Rosanna Harvey
    10903 New Hampshire Ave., Bldg. 71, rm. 6306, Silver Spring, MD 20993-0002, 240-402-8006 or 240-402-8072
    e-mail: prabhakara.atreya@fda.hhs.gov or email: rosanna.harvey@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.

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 Web site at the Vaccines and Related Biological Products Advisory Committee meetings main page and call the appropriate advisory committee hot line/phone line 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. Seating for this meeting may be limited, so the public is encouraged to watch the free webcast if you are unable to attend. Webcast will be available at 8:30 a.m. on March 9, 2017 by using the following link https://videocast.nih.gov/. 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 Rosanna Harvey 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). Official FR Notice

Recorded Webcast


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 Organization
Vaccines and Related Biological Products Committee March 9, 2017 Meeting Summary Minutes pdf (196.89 KB) FDA
Vaccines and Related Biological Products Committee March 9, 2017 Meeting Transcript pdf (510.63 KB) FDA
Vaccines and Related Biological Products Committee March 9, 2017 Meeting Final Roster pdf (113.14 KB) FDA
Vaccines and Related Biological Products Committee March 9, 2017 Meeting Final Agenda pdf (65.80 KB) FDA
Vaccines and Related Biological Products Committee March 9, 2017 Meeting Voting Questions for the Committee pdf (35.11 KB) FDA
Vaccines and Related Biological Products Committee March 9, 2017 Meeting WHO Web Links pdf (145.94 KB) Non-FDA
Vaccines and Related Biological Products Committee March 9, 2017 Meeting Presentation- Influenza Vaccine Manufacturing: Industry Perspective for 2017-18 Northern Hemisphere Influenza Vaccine Supply pdf (354.67 KB) Non-FDA
Vaccines and Related Biological Products Committee March 9, 2017 Meeting Presentation- DoD Influenza Surveillance and Mid-Season Vaccine Effectiveness pdf (2.22 MB) Non-FDA
Vaccines and Related Biological Products Committee March 9, 2017 Meeting WHO Web Links for Briefing Materials pdf (14.44 KB) Non-FDA
Vaccines and Related Biological Products Committee March 9, 2017 Meeting Presentation- Global Surveillance and Virus Characterization pdf (17.81 MB) Non-FDA
Vaccines and Related Biological Products Committee March 9, 2017 Meeting Presentation- U.S. Influenza Surveillance and Vaccine Effectiveness Update pdf (943.35 KB) Non-FDA
Vaccines and Related Biological Products Committee March 9, 2017 Meeting Presentation- Candidate Vaccine Strains and Potency Reagents for 2017-18 Influenza Season pdf (188.92 KB) FDA
Vaccines and Related Biological Products Committee March 9, 2017 Meeting Presentation- Influenza Virus Vaccine 2017-2018 Strain Selection pdf (273.92 KB) FDA
Vaccines and Related Biological Products Committee March 9, 2017 Meeting Draft Roster pdf (42.07 KB) FDA
Vaccines and Related Biological Products Committee March 9, 2017 Meeting Draft Agenda pdf (47.68 KB) FDA
Vaccines and Related Biological Products Committee March 9, 2017 Meeting Waiver for Conflicts of Interest pdf (21.05 KB) FDA

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