83 FR 6194 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 30 (February 13, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 30 (February 13, 2018)
| Page Range | 6194-6194 | |
| FR Document | 2018-02853 |
[Federal Register Volume 83, Number 30 (Tuesday, February 13, 2018)] [Notices] [Page 6194] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-02853] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-0536] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: 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. At least one portion of the meeting will be closed to the public. DATES: The meeting will be held on March 1, 2018, from 8 a.m. to 5 p.m. ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993- 0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. For those unable to attend in person, the meeting will also be webcast and will be available at the following link: https://collaboration.fda.gov/vrbpac030118. FOR FURTHER INFORMATION CONTACT: Serina Hunter-Thomas or Rosanna Harvey, 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 and 240-402-8072, rosanna.harvey@fda.hhs.gov, or 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. SUPPLEMENTARY INFORMATION: Agenda: On March 1, 2018, under Topic I, the Center for Biologics Evaluation and Research's (CBER) VRBPAC will meet in open session to hear an overview of the research program in the Laboratory of Mucosal Pathogens and Cellular Immunology (LMPCI), Division of Bacterial, Parasitic and Allergenic Products (DBPAP), Office of Vaccines Research and Review (OVRR), CBER, FDA. Also on March 1, 2018, under Topic II, 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 2018-2019 influenza season. 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, 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 website after the meeting. Background material is available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: On March 1, 2018, from 8 a.m. to 9:15 a.m., and 9:45 a.m. to 5 p.m., the meeting is open to the public. 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 22, 2018. Oral presentations from the public will be scheduled between approximately 9 a.m. to 9:15 a.m. for the overview portion of the LMPCI Site Visit portion of the meeting, and 2:10 p.m. to 2:55 p.m. for the flu strain selection portion of the meeting. 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 21, 2018. 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 22, 2018. Closed Committee Deliberations: On March 1, 2018, from 9:15 a.m. to 9:45 a.m., the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). The recommendations of the advisory committee regarding the progress of the investigator's research will, along with other information, be used in making decisions regarding pay adjustments of service fellows or promotion and permanent staff regarding individual scientists. We believe that public discussion of these recommendations on individual scientists would constitute an unwarranted invasion of personal privacy. 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 Serina Hunter-Thomas at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm 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). Dated: February 7, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-02853 Filed 2-12-18; 8:45 am] BILLING CODE 4164-01-P
![6194 Federal Register / Vol. 83, No. 30 / Tuesday, February 13, 2018 / Notices
Submit petitions electronically to Committee Information Line, 1–800– statement of the general nature of the
https://www.regulations.gov at Docket 741–8138 (301–443–0572 in the evidence or arguments they wish to
No. FDA–2013–S–0610. Submit written Washington, DC area). A notice in the present, the names and addresses of
petitions (two copies are required) to the Federal Register about last minute proposed participants, and an
Dockets Management Staff (HFA–305), modifications that impact a previously indication of the approximate time
Food and Drug Administration, 5630 announced advisory committee meeting requested to make their presentation on
Fishers Lane, Rm. 1061, Rockville, MD cannot always be published quickly or before February 21, 2018. Time
20852. enough to provide timely notice. allotted for each presentation may be
Dated: February 5, 2018. Therefore, you should always check the limited. If the number of registrants
Leslie Kux, Agency’s website at https:// requesting to speak is greater than can
Associate Commissioner for Policy.
www.fda.gov/AdvisoryCommittees/ be reasonably accommodated during the
default.htm and scroll down to the scheduled open public hearing session,
[FR Doc. 2018–02851 Filed 2–12–18; 8:45 am]
appropriate advisory committee meeting FDA may conduct a lottery to determine
BILLING CODE 4164–01–P
link, or call the advisory committee the speakers for the scheduled open
information line to learn about possible public hearing session. The contact
DEPARTMENT OF HEALTH AND modifications before coming to the person will notify interested persons
HUMAN SERVICES meeting. regarding their request to speak by
SUPPLEMENTARY INFORMATION: February 22, 2018.
Food and Drug Administration Agenda: On March 1, 2018, under Closed Committee Deliberations: On
[Docket No. FDA–2018–N–0536] Topic I, the Center for Biologics March 1, 2018, from 9:15 a.m. to 9:45
Evaluation and Research’s (CBER) a.m., the meeting will be closed to
Vaccines and Related Biological VRBPAC will meet in open session to permit discussion where disclosure
Products Advisory Committee; Notice hear an overview of the research would constitute a clearly unwarranted
of Meeting program in the Laboratory of Mucosal invasion of personal privacy (5 U.S.C.
Pathogens and Cellular Immunology 552b(c)(6)). The recommendations of the
AGENCY: Food and Drug Administration, (LMPCI), Division of Bacterial, Parasitic
HHS. advisory committee regarding the
and Allergenic Products (DBPAP), progress of the investigator’s research
ACTION: Notice. Office of Vaccines Research and Review will, along with other information, be
(OVRR), CBER, FDA. Also on March 1, used in making decisions regarding pay
SUMMARY: The Food and Drug
2018, under Topic II, the committee will adjustments of service fellows or
Administration (FDA) announces a
meet in open session to discuss and promotion and permanent staff
forthcoming public advisory committee
make recommendations on the selection regarding individual scientists.
meeting of the Vaccines and Related
of strains to be included in the influenza
Biological Products Advisory We believe that public discussion of
virus vaccines for the 2018–2019
Committee (VRBPAC). The general these recommendations on individual
influenza season. FDA intends to make
function of the committee is to provide scientists would constitute an
background material available to the
advice and recommendations to the unwarranted invasion of personal
public no later than 2 business days
Agency on FDA’s regulatory issues. At privacy.
before the meeting. If FDA is unable to
least one portion of the meeting will be
post the background material on its Persons attending FDA’s advisory
closed to the public.
website prior to the meeting, the committee meetings are advised that the
DATES: The meeting will be held on Agency is not responsible for providing
background material will be made
March 1, 2018, from 8 a.m. to 5 p.m. publicly available at the location of the access to electrical outlets.
ADDRESSES: FDA White Oak Campus, advisory committee meeting, and the
10903 New Hampshire Ave., Bldg. 31 FDA welcomes the attendance of the
background material will be posted on public at its advisory committee
Conference Center, the Great Room (Rm. FDA’s website after the meeting.
1503), Silver Spring, MD 20993–0002. meetings and will make every effort to
Background material is available at accommodate persons with disabilities.
Answers to commonly asked questions https://www.fda.gov/Advisory
including information regarding special If you require accommodations due to a
Committees/Calendar/default.htm. disability, please contact Serina Hunter-
accommodations due to a disability, Scroll down to the appropriate advisory
visitor parking, and transportation may Thomas at least 7 days in advance of the
committee meeting link. meeting.
be accessed at: https://www.fda.gov/ Procedure: On March 1, 2018, from 8
AdvisoryCommittees/AboutAdvisory a.m. to 9:15 a.m., and 9:45 a.m. to 5 FDA is committed to the orderly
Committees/ucm408555.htm. p.m., the meeting is open to the public. conduct of its advisory committee
For those unable to attend in person, Interested persons may present data, meetings. Please visit our website at:
the meeting will also be webcast and information, or views, orally or in https://www.fda.gov/Advisory
will be available at the following link: writing, on issues pending before the Committees/AboutAdvisoryCommittees/
https://collaboration.fda.gov/ committee. Written submissions may be ucm111462.htm for procedures on
vrbpac030118. made to the contact person on or before public conduct during advisory
FOR FURTHER INFORMATION CONTACT: February 22, 2018. Oral presentations committee meetings.
Serina Hunter-Thomas or Rosanna from the public will be scheduled Notice of this meeting is given under
Harvey, Center for Biologics Evaluation between approximately 9 a.m. to 9:15 the Federal Advisory Committee Act (5
sradovich on DSK3GMQ082PROD with NOTICES
and Research, Food and Drug a.m. for the overview portion of the U.S.C. app. 2).
Administration, 10903 New Hampshire LMPCI Site Visit portion of the meeting, Dated: February 7, 2018.
Ave., Bldg. 71, Rm. 6338, Silver Spring, and 2:10 p.m. to 2:55 p.m. for the flu
Leslie Kux,
MD 20993–0002, 240–402–5771, strain selection portion of the meeting.
serina.hunter-thomas@fda.hhs.gov and Those individuals interested in making Associate Commissioner for Policy.
240–402–8072, rosanna.harvey@ formal oral presentations should notify [FR Doc. 2018–02853 Filed 2–12–18; 8:45 am]
fda.hhs.gov, or FDA Advisory the contact person and submit a brief BILLING CODE 4164–01–P
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Document Created: 2018-02-13 02:32:24
Document Modified: 2018-02-13 02:32:24
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | The meeting will be held on March 1, 2018, from 8 a.m. to 5 p.m. | |
| Contact | Serina Hunter-Thomas or Rosanna Harvey, 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, [email protected] and 240-402-8072, [email protected], or 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. | |
| FR Citation | 83 FR 6194 |
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