General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 4476 [2019-02380]
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4476
Federal Register / Vol. 84, No. 32 / Friday, February 15, 2019 / Notices
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–0426]
General and Plastic Surgery Devices
Panel of the Medical Devices Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the General and Plastic
Surgery Devices Panel of the Medical
Devices Advisory Committee. The
general function of the committee is to
provide advice and recommendations to
the Agency on FDA’s regulatory issues.
The meeting will be open to the public.
DATES: The meeting will be held on
March 25 and 26, 2019, 8 a.m. to 6 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.
Information about the FDA’s Meeting
facility on the White Oak Campus can
be found at https://www.fda.gov/
aboutfda/workingatfda/buildingsand
facilities/whiteoakcampusinformation/
ucm241740.htm.
SUMMARY:
khammond on DSKBBV9HB2PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Patricio Garcia, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G610, Silver Spring,
MD 20993–0002, Patricio.Garcia@
fda.hhs.gov, 301–796–6875, 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.
VerDate Sep<11>2014
19:41 Feb 14, 2019
Jkt 247001
Agenda: On March 25 and 26, 2019,
the committee will discuss and make
recommendations regarding the benefits
and risks of breast implants indicated
for breast augmentation and
reconstruction concerning the following
topics: (1) Breast implant associated
anaplastic large cell lymphoma (BIA–
ALCL); (2) systemic symptoms reported
in patients receiving breast implants; (3)
the use of registries for breast implant
surveillance; (4) magnetic resonance
imaging screening for silent rupture of
silicone gel filled breast implants; (5)
the use of surgical mesh in breast
procedures such as breast
reconstruction and mastopexy; (6) the
use of real-world data and patient
perspectives in regulatory decision
making, and (7) best practices for
informed consent discussions between
patients and clinicians.
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: 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 March 4, 2019. Oral
presentations from the public will be
scheduled on March 25, 2019, between
approximately 11 a.m. and 12 noon and
2:30 p.m. to 3:30 p.m. Oral
presentations from the public will be
scheduled on March 26, 2019, between
approximately 10 a.m. and 11 a.m. and
3 p.m. to 4 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and indicate in which session
they would like to present (which day,
morning or afternoon session). The
notification should include 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 27, 2019. Time
allotted for each presentation may be
limited. If the number of registrants
requesting to speak is greater than can
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
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 sessions. The contact
person will notify interested persons
regarding their request to speak by
February 28, 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 AnnMarie
Williams, at annmarie.williams@
fda.hhs.gov or 301–796–5966 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 11, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–02380 Filed 2–14–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–0573]
Blood Products Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Blood Products Advisory
Committee (BPAC). The general
function of the committee is to provide
advice and recommendations to the
Agency on regulatory issues related to
blood and products derived from blood.
Matters considered at the meeting will
include testing of the blood supply for
Zika virus, topics relevant to blood
donation by men who have sex with
men, and an overview of research
programs in the Laboratory of
SUMMARY:
E:\FR\FM\15FEN1.SGM
15FEN1
]]>Agencies
[Federal Register Volume 84, Number 32 (Friday, February 15, 2019)]
[Notices]
[Page 4476]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02380]
[[Page 4476]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-0426]
General and Plastic Surgery Devices Panel of the Medical Devices
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 General and Plastic Surgery
Devices Panel of the Medical Devices Advisory Committee. The general
function of the committee is to provide advice and recommendations to
the Agency on FDA's regulatory issues. The meeting will be open to the
public.
DATES: The meeting will be held on March 25 and 26, 2019, 8 a.m. to 6
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.
Information about the FDA's Meeting facility on the White Oak
Campus can be found at https://www.fda.gov/aboutfda/workingatfda/buildingsandfacilities/whiteoakcampusinformation/ucm241740.htm.
FOR FURTHER INFORMATION CONTACT: Patricio Garcia, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. G610, Silver Spring, MD 20993-0002,
Patricio.Garcia@fda.hhs.gov, 301-796-6875, 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 25 and 26, 2019, the committee will discuss and
make recommendations regarding the benefits and risks of breast
implants indicated for breast augmentation and reconstruction
concerning the following topics: (1) Breast implant associated
anaplastic large cell lymphoma (BIA-ALCL); (2) systemic symptoms
reported in patients receiving breast implants; (3) the use of
registries for breast implant surveillance; (4) magnetic resonance
imaging screening for silent rupture of silicone gel filled breast
implants; (5) the use of surgical mesh in breast procedures such as
breast reconstruction and mastopexy; (6) the use of real-world data and
patient perspectives in regulatory decision making, and (7) best
practices for informed consent discussions between patients and
clinicians.
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: 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
March 4, 2019. Oral presentations from the public will be scheduled on
March 25, 2019, between approximately 11 a.m. and 12 noon and 2:30 p.m.
to 3:30 p.m. Oral presentations from the public will be scheduled on
March 26, 2019, between approximately 10 a.m. and 11 a.m. and 3 p.m. to
4 p.m. Those individuals interested in making formal oral presentations
should notify the contact person and indicate in which session they
would like to present (which day, morning or afternoon session). The
notification should include 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 27, 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 sessions. The contact person will notify interested
persons regarding their request to speak by February 28, 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 AnnMarie Williams, at annmarie.williams@fda.hhs.gov or 301-796-
5966 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 11, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-02380 Filed 2-14-19; 8:45 am]
BILLING CODE 4164-01-P
