[Federal Register Volume 84, Number 121 (Monday, June 24, 2019)]
[Notices]
[Pages 29524-29525]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13354]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-2836]
Allergenic 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 Allergenic Products Advisory
Committee. The general function of the committee is to provide advice
and recommendations to the Agency on FDA's regulatory issues.
DATES: The meeting will be held on September 13, 2019, from 8:30 a.m.
to 4:30 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/apac091319/.
FOR FURTHER INFORMATION CONTACT: CAPT Serina Hunter-Thomas or Ms.
[[Page 29525]]
Monique Hill, 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 301-796-4620, [email protected]
respectively, 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. For those unable to attend
in person, the meeting will also be available via Webcast. The Webcast
will be available at the following link: https://collaboration.fda.gov/apac091319/.
SUPPLEMENTARY INFORMATION:
Agenda: On September 13, 2019, the Center for Biologics Evaluation
and Research's (CBER) Vaccines and Related Biological Products Advisory
Committee (VRBPAC) will meet in open session to discuss and make
recommendations on the safety and efficacy of Peanut [Arachis hypogaea]
Allergen Powder manufactured by Aimmune Therapeutics, Inc, indicated
for treatment to reduce the risk of anaphylaxis after accidental
exposure to peanut in patients aged 4 to 17 years with a confirmed
diagnosis of peanut allergy.
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 September 13, 2019, from 8:30 a.m. to 4:30 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 September 6, 2019. On September 13, 2019, oral presentations
from the public will be scheduled between approximately 1 p.m. to 2
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
August 29, 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 August 30, 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 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: June 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-13354 Filed 6-21-19; 8:45 am]
BILLING CODE 4164-01-P