United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2019_register executive 2019-03-14 article Notices D09002ee1c7d91e6c D09002ee1c7d91f3e United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. Consistent with FDA's regulations, notice is being published with less than 15 days prior to the date of the meeting based on a determination that an immediate meeting of the Vaccines and Related Biological Products Advisory Committee is needed. This Federal Register notice could not be published 15 days prior to the date of the meeting due to a delay by the World Health Organization (WHO) in recommending H3N2 strain for inclusion in the 2019-2020 seasonal influenza vaccines. 84 FR 9344 https://www.govinfo.gov/app/details/FR-2019-03-14/2019-04708 2019-04708 fr14mr19-68 4164-01-P Docket No. FDA-2019-N-1045 https://www.govinfo.gov/app/details/FR-2019-03-14/2019-04708 https://www.govinfo.gov/content/pkg/FR-2019-03-14/html/2019-04708.htm https://www.govinfo.gov/content/pkg/FR-2019-03-14/pdf/2019-04708.pdf 2 p. 9344 9345 84 FR 9344 Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Federal Register Vol. 84, Issue NOTICE 2019-04708 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2019-03-22 Docket No. FDA-2019-N-1045 4164-01-P 2019-04708 Notice.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. Consistent with FDA's regulations, notice is being published with less than 15 days prior to the date of the meeting based on a determination that an immediate meeting of the Vaccines and Related Biological Products Advisory Committee is needed. This Federal Register notice could not be published 15 days prior to the date of the meeting due to a delay by the World Health Organization (WHO) in recommending H3N2 strain for inclusion in the 2019-2020 seasonal influenza vaccines.

The meeting will be held on March 22, 2019, from 8:30 a.m. to 2:30 p.m. Serina Hunter-Thomas, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6338, Silver Spring, MD 20993-0002, 240-402-5771, serina.hunter-thomas@fda.hhs.gov; or Monique Hill, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6307C, Silver Spring, MD 20993- 0002, 301-796-4620, monique.hill@fda.hhs.gov; or the FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 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 Agency's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. Meetings: Vaccines and Related Biological Products Advisory Committee , monique.hill@fda.hhs.gov serina.hunter-thomas@fda.hhs.gov https://collaboration.fda.gov/vrbpac032019 https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm https://www.fda.gov/AdvisoryCommittees/default.htm Vol. 84, no. 50 Office of the Federal Register, National Archives and Records Administration 2019-03-14 continuing daily deposited born digital 239 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2019-03-14 P0b002ee19fedfa8e 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr14mr19 https://www.govinfo.gov/app/details/FR-2019-03-14 https://www.govinfo.gov/content/pkg/FR-2019-03-14/pdf/FR-2019-03-14.pdf https://www.govinfo.gov/content/pkg/FR-2019-03-14/xml/FR-2019-03-14.xml fdlp 9221 9449 DGPO 2019-03-14 2024-05-31 FR-2019-03-14 machine generated eng FR FR-2019-03-14 84 50