[Federal Register Volume 84, Number 190 (Tuesday, October 1, 2019)]
[Notices]
[Pages 52111-52113]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21248]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-3767]
Immunology Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting; Establishment of a Public Docket; Request
for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; establishment of a public docket; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Immunology Devices Panel of
the Medical Devices Advisory Committee. The general function of the
committee is to provide advice and recommendations to FDA on scientific
issues. The meeting will be open to the public. FDA is establishing a
docket for public comment on this document.
DATES: The meeting will be held on November 13 and 14, 2019, from 8
a.m. to 6 p.m.
ADDRESSES: Doubletree by Hilton DC North/Gaithersburg, Grand Ballroom,
620 Perry Pkwy., Gaithersburg, MD 20877. The hotel's telephone number
is 301-977-8900. The hotel's website is at: https://doubletree3.hilton.com/en/hotels/maryland/doubletree-by-hilton-washington-dc-north-gaithersburg-GAIGWDT/index.html. 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.
FDA is establishing a docket for public comments on this meeting.
The docket number is FDA-2019-N-3767. The docket will close on December
16, 2019. Submit either electronic or written comments on this public
meeting to the docket by December 16, 2019. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before December 16, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 16, 2019. Comments
received by mail/hand delivery/courier (for written/paper submission)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Comments received on or before October 28, 2019, will be provided
to the Committee. Comments received after that date will be taken into
consideration by FDA. You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submission'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2019-N-3767 for ``Immunology Devices Panel of the Medical Devices
Advisory Committee; Notice of Meeting; Establishment of a Public
Docket; Request for Comments.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' FDA will review
this copy, including the claimed confidential information, in its
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information to be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
[[Page 52112]]
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Aden Asefa, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G642, Silver Spring, MD 20993-0002, 301-796-0400,
[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 FDA'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 November 13 and 14, 2019, the committee will discuss the
topic of immunological responses to metal-containing products regulated
as medical devices. The discussion will focus on metal-containing
implants as well as dental amalgam. Implants are medical devices that
are placed into a surgically or naturally formed opening of the human
body and are intended to remain there after the procedure for an
extended period of time (typically, greater than 30 days). For decades,
metal-containing implants have been used in a large number of medical
specialties including cardiology, orthopedics, dentistry,
gastroenterology, and neurology or neurosurgery. Recent postmarket
issues with some metal-on-metal orthopedic implants and gynecological
metal-containing implants have raised questions about the potential for
some patients to develop unexpected or heightened biological responses
to the implant. These may include local (peri-implant) adverse events
and potentially systemic manifestations, which may impact a patient's
quality of life and necessitate medical or surgical intervention. While
not considered an implant, dental amalgam is included in this
discussion because of its potential for patient and user exposure to
mercury compounds and some purported similarities in the adverse
biological responses and clinical manifestations elicited by some
dental amalgams to that of traditional metal implants.
FDA is convening this committee to promote an open public
discussion of, and seek expert opinion on, currently available
scientific and clinical data pertaining to the biological responses to
metal implants and dental amalgam and the potential associated clinical
sequelae. The committee will be asked to discuss and provide
recommendations regarding:
The extent immunological responses to certain metals may
cause or contribute to device-related local and systemic adverse
effects as well as the potential underlying mechanism(s) involved and
corresponding clinical manifestations.
Patient characteristics, metal types, and/or anatomical
considerations that may put an individual at higher risk for a
heightened immunological response to a metal-containing implant, and
methods that may assist in their identification.
Mitigations that may reduce the risk for unintended
immunological responses, including changes to device composition and
design.
The evidentiary gaps in biomedical research and clinical/
diagnostic management associated with immunological responses to metal
implants.
The adequacy, conclusions, and evidence gaps identified by
a systemic literature review aimed to assess the recent epidemiologic
and clinical evidence on adverse health effects reported in relation to
occupational or non-occupational exposure to dental amalgam.
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.
FDA plans to provide a live webcast of the November 13 and 14,
2019, meeting of the Immunology Devices Panel. While the Center for
Devices and Radiological Health is working to make webcasts available
to the public, there may be instances where the webcast transmission is
not successful; staff will work to reestablish the transmission as soon
as possible. The link for the webcast is available at: https://collaboration.fda.gov. Further information regarding the webcast,
including the web address for the webcast, will be made available at
least 2 days in advance of the meeting at the following website:
November 13, 2019: http://fda.yorkcast.com/webcast/Play/390aea8fa1db4d42ba59e514b24e8f301d.
November 14, 2019: http://fda.yorkcast.com/webcast/Play/d4174e54b00e4f7ab8ffb3ec8c99d3f51d.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
All written and electronic submissions made to the docket on or before
October 28, 2019, will be provided to the panel. Oral presentations
from the public will be scheduled on November 13, 2019, between
approximately 2:15 p.m. and 3:15 p.m., and on November 14, 2019,
between approximately 8:15 a.m. and 9:15 a.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 October 16, 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 October 17, 2019.
Persons attending FDA's advisory committee meetings are advised
that FDA is not responsible for providing access to electrical outlets.
For press inquiries, please contact the Office of Media Affairs at
[email protected] or 301-796-4540.
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
[[Page 52113]]
disability, please contact AnnMarie Williams, at
[email protected] 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: September 25, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-21248 Filed 9-30-19; 8:45 am]
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