Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 10447-10448 [2020-03565]
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10447
Federal Register / Vol. 85, No. 36 / Monday, February 24, 2020 / Notices
ANNUAL BURDEN ESTIMATES
Total
number of
respondents
Instrument
Adoption Call to Action: Baseline Survey ............................
Adoption Call to Action: Progress Update ...........................
Estimated Total Annual Burden
Hours: 15.
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: Section 203 of Section II:
Adoption Opportunities of the Child Abuse
Prevention and Treatment Act (42 U.S.C.
5113).
Molly B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2020–03579 Filed 2–21–20; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0008]
Orthopaedic and Rehabilitation
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 Orthopaedic and
Rehabilitation 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
April 23, 2020, from 8 a.m. to 6 p.m.
lotter on DSKBCFDHB2PROD with NOTICES
SUMMARY:
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18:30 Feb 21, 2020
Jkt 250001
Total
number of
responses per
respondent
53
53
1
2
and on April 24, 2020, from 8 a.m. to
1 p.m.
ADDRESSES: FDA White Oak Campus,
10903 New Hampshire Ave., Building
31, Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993–
0002. Entrance for public meeting
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. For security information,
please refer to https://www.fda.gov/
AboutFDA/WorkingatFDA/
BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm. 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:
Patricio Garcia, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5216, 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 April 23, 2020, during
session I, the committee will discuss
and make recommendations regarding
the classification of facet screws
systems, which are currently
unclassified pre-amendment devices to
class II (general and special controls).
During session II, the committee will
PO 00000
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Average
burden hours
per response
.33
.25
Total
burden
hours
Annual
burden
hours
18
27
6
9
discuss and make recommendations
regarding the reclassification of
noninvasive bone growth stimulators,
which are currently post-amendment
devices from class III (general controls
and premarket approval) to class II
(general and special controls).
On April 24, 2020, the committee will
discuss and make recommendations
regarding the classification of three
devices, which are currently
unclassified pre-amendment devices to
class II (general and special controls).
The committee, during session I, will
discuss semiconstrained toe
(metatarsophalangeal) joint prostheses;
during session II, will discuss
intracompartmental pressure monitors;
and during session III, will discuss
intra-abdominal pressure monitoring
devices.
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/
CommitteesMeetingMaterials/
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 April 1, 2020. Oral
presentations from the public will be
scheduled on April 23, 2020, between
approximately 8:15 a.m. and 8:45 a.m.
and between approximately 1 p.m. and
1:30 p.m.; on April 24, 2020, 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 indicate during
which session they would like to
present (see FOR FURTHER INFORMATION
CONTACT). The notification should
include a brief statement of the general
nature of the evidence or arguments
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10448
Federal Register / Vol. 85, No. 36 / Monday, February 24, 2020 / Notices
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 March 24, 2020. 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 March 25,
2020.
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 Artair Mallet
at artair.mallett@fda.hhs.gov or 301–
796–9638 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 19, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–03565 Filed 2–21–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1006]
lotter on DSKBCFDHB2PROD with NOTICES
Providing Regulatory Submissions in
Electronic Format—Certain Human
Pharmaceutical Product Applications
and Related Submissions Using the
eCTD Specifications (Revision 7);
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or the Agency) is
announcing the availability of a final
SUMMARY:
VerDate Sep<11>2014
18:30 Feb 21, 2020
Jkt 250001
guidance for industry entitled
‘‘Providing Regulatory Submissions in
Electronic Format—Certain Human
Pharmaceutical Product Applications
and Related Submissions Using the
eCTD Specifications (Revision 7).’’ FDA
has identified certain submission types
that warrant an exemption (Type III
drug master files (DMFs)) or a long-term
waiver (certain positron emission
tomography (PET) drug products and
certain Type II DMFs supporting PET
drugs or noncommercial submissions or
applications) from the requirement to
submit to the Agency in electronic
common technical document (eCTD)
format. In addition, this guidance
outlines certain circumstances where
FDA may determine that a short-term
waiver from eCTD submission
requirements could be granted. This
guidance finalizes the revised draft
guidance of the same title issued in July
2019 and replaces the final guidance
issued in January 2019 (Revision 6).
DATES: The announcement of the
guidance is published in the Federal
Register on February 24, 2020.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://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
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
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• 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–
2014–N–1006 for ‘‘Providing Regulatory
Submissions in Electronic Format—
Certain Human Pharmaceutical Product
Applications and Related Submissions
Using the eCTD Specifications (Revision
7).’’ Received comments 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.’’ The
Agency 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.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
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
E:\FR\FM\24FEN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 36 (Monday, February 24, 2020)]
[Notices]
[Pages 10447-10448]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03565]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-0008]
Orthopaedic and Rehabilitation 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 Orthopaedic and Rehabilitation
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 April 23, 2020, from 8 a.m. to 6
p.m. and on April 24, 2020, from 8 a.m. to 1 p.m.
ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31,
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Entrance for public meeting participants (non-FDA employees) is
through Building 1 where routine security check procedures will be
performed. For security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. 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: Patricio Garcia, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5216, Silver Spring, MD 20993-0002,
[email protected], 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 April 23, 2020, during session I, the committee will
discuss and make recommendations regarding the classification of facet
screws systems, which are currently unclassified pre-amendment devices
to class II (general and special controls). During session II, the
committee will discuss and make recommendations regarding the
reclassification of noninvasive bone growth stimulators, which are
currently post-amendment devices from class III (general controls and
premarket approval) to class II (general and special controls).
On April 24, 2020, the committee will discuss and make
recommendations regarding the classification of three devices, which
are currently unclassified pre-amendment devices to class II (general
and special controls). The committee, during session I, will discuss
semiconstrained toe (metatarsophalangeal) joint prostheses; during
session II, will discuss intracompartmental pressure monitors; and
during session III, will discuss intra-abdominal pressure monitoring
devices.
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/CommitteesMeetingMaterials/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
April 1, 2020. Oral presentations from the public will be scheduled on
April 23, 2020, between approximately 8:15 a.m. and 8:45 a.m. and
between approximately 1 p.m. and 1:30 p.m.; on April 24, 2020, 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
indicate during which session they would like to present (see FOR
FURTHER INFORMATION CONTACT). The notification should include a brief
statement of the general nature of the evidence or arguments
[[Page 10448]]
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 March 24, 2020. 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 March 25, 2020.
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 Artair Mallet at [email protected] or 301-796-9638 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 19, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-03565 Filed 2-21-20; 8:45 am]
BILLING CODE 4164-01-P
