Vaccines and Related Biological Products Advisory Committee; Notice of Meeting, 44900 [2019-18410]

Download as PDF 44900 Federal Register / Vol. 84, No. 166 / Tuesday, August 27, 2019 / Notices be accessed at: https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm408555.htm. Reallotment Grantee name amount FOR FURTHER INFORMATION CONTACT: Alaska ..................................... $1,579,924 Capt. Serina Hunter-Thomas, Center for Biologics Evaluation and Research, Five Sandoval Indian Pueblos, INC ...................................... 16,089 Food and Drug Administration, 10903 Hoh Indian Tribe ..................... 4,378 New Hampshire Ave., Bldg. 71, Rm. Little River Band of Ottawa In6338, Silver Spring, MD 20993–0002, dians .................................... 47,440 240–402–5771, serina.hunter-thomas@ Northern Cheyenne Tribe ....... 45,607 fda.hhs.gov, or FDA Advisory Three Affiliated Tribes ............ 140,582 Committee Information Line, 1–800– Turtle Mountain Band of Chip741–8138 (301–443–0572 in the pewa Indians ....................... 5,108 Washington, DC area). A notice in the Total .................................... $1,839,128 Federal Register about last minute modifications that impact a previously announced advisory committee meeting Statutory Authority: 42 U.S.C. 8626. cannot always be published quickly enough to provide timely notice. Elizabeth Leo, Therefore, you should always check the Senior Grants Policy Specialist, Division of Agency’s website at https:// Grants Policy, Office of Administration. www.fda.gov/AdvisoryCommittees/ [FR Doc. 2019–18374 Filed 8–26–19; 8:45 am] default.htm and scroll down to the BILLING CODE 4184–80–P appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible DEPARTMENT OF HEALTH AND modifications before coming to the HUMAN SERVICES meeting. Food and Drug Administration SUPPLEMENTARY INFORMATION: Agenda: On October 9, 2019, under [Docket No. FDA–2019–N–3612] topic I, the Center for Biologics Vaccines and Related Biological Evaluation and Research’s (CBER) Products Advisory Committee; Notice VRBPAC will meet in open session to of Meeting hear an overview of the research programs in the Laboratory of Hepatitis AGENCY: Food and Drug Administration, Viruses (LIR) and the Laboratory of HHS. Vector-Borne Viral Diseases (LVVD), ACTION: Notice. Division of Viral Products, Office of Vaccines Research and Review, CBER, SUMMARY: The Food and Drug FDA. Also, on October 9, 2019, under Administration (FDA or the Agency) topic II, the committee will meet in announces a forthcoming public open session to discuss and make advisory committee meeting of the recommendations on the selection of Vaccines and Related Biological strains to be included in an influenza Products Advisory Committee virus vaccine for the 2020 southern (VRBPAC). The general function of the hemisphere influenza season. committee is to provide advice and FDA intends to make background recommendations to the Agency on material available to the public no later FDA’s regulatory issues. At least one than 2 business days before the meeting. portion of the meeting will be closed to If FDA is unable to post the background the public. Members will participate via material on its website prior to the teleconference. meeting, the background material will DATES: The meeting will be held on be made publicly available at the October 9, 2019, from 8:30 a.m. to 3:30 location of the advisory committee p.m. meeting, and the background material ADDRESSES: FDA White Oak Campus, will be posted on FDA’s website after 10903 New Hampshire Avenue, Bldg. 31 the meeting. Background material is Conference Center, the Great Room (Rm. available at https://www.fda.gov/ 1503), Silver Spring, MD 20993–0002. AdvisoryCommittees/Calendar/ For those unable to attend in person, the default.htm. Scroll down to the meeting will also be webcast and will be appropriate advisory committee meeting available at the following link: https:// link. collaboration.fda.gov/vrbpac100919/. Procedure: On October 9, 2019, from Answers to commonly asked questions 8:30 a.m. to approximately 10 a.m. and including information regarding special from 11 a.m. to 3:30 p.m., the meeting accommodations due to a disability, is open to the public. Interested persons visitor parking, and transportation may may present data, information, or views, jspears on DSK3GMQ082PROD with NOTICES ESTIMATED REALLOTMENT AMOUNTS OF FY 2018 LIHEAP FUNDS VerDate Sep<11>2014 19:12 Aug 26, 2019 Jkt 247001 PO 00000 Frm 00059 Fmt 4703 Sfmt 9990 orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before October 2, 2019. Oral presentations from the public will be scheduled between approximately 9:45 a.m. and 10 a.m. for the overview portion of the LHV/LVVD Site Visit (topic I), and from 1:30 p.m. to 2:15 p.m. for the influenza strain selection portion of the meeting (topic II). 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 September 24, 2019. 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 September 25, 2019. 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 Capt. 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: August 16, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–18410 Filed 8–26–19; 8:45 am] BILLING CODE 4164–01–P E:\FR\FM\27AUN1.SGM 27AUN1

Agencies

[Federal Register Volume 84, Number 166 (Tuesday, August 27, 2019)]
[Notices]
[Page 44900]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18410]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3612]


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 or the Agency) 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. Members will participate via 
teleconference.

DATES: The meeting will be held on October 9, 2019, from 8:30 a.m. to 
3:30 p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Avenue, Bldg. 31 
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. 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/vrbpac100919/. 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 FURTHER INFORMATION CONTACT: Capt. 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, [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.

SUPPLEMENTARY INFORMATION: 
    Agenda: On October 9, 2019, 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 programs in the Laboratory of 
Hepatitis Viruses (LIR) and the Laboratory of Vector-Borne Viral 
Diseases (LVVD), Division of Viral Products, Office of Vaccines 
Research and Review, CBER, FDA. Also, on October 9, 2019, under topic 
II, the committee will meet in open session to discuss and make 
recommendations on the selection of strains to be included in an 
influenza virus vaccine for the 2020 southern hemisphere 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 October 9, 2019, from 8:30 a.m. to approximately 10 
a.m. and from 11 a.m. to 3:30 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 October 2, 2019. Oral 
presentations from the public will be scheduled between approximately 
9:45 a.m. and 10 a.m. for the overview portion of the LHV/LVVD Site 
Visit (topic I), and from 1:30 p.m. to 2:15 p.m. for the influenza 
strain selection portion of the meeting (topic II). 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 September 24, 2019. 
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 September 25, 2019.
    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 Capt. 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: August 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-18410 Filed 8-26-19; 8:45 am]
 BILLING CODE 4164-01-P

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