Request for Nominations for Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee, 86571-86572 [2020-28833]
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Federal Register / Vol. 85, No. 250 / Wednesday, December 30, 2020 / Notices
when LPMs are used. Parasitic myomas
and disseminated peritoneal
leiomyomatosis, while benign, have
been associated with the need for
additional surgery due to symptoms
such as abdominal pain and distension.
Finally, FDA considered additional
available mitigations for the spread of
uterine tissue. Since 2014, FDA has
provided marketing authorization for
LPM containment systems intended to
isolate and contain tissue that is
considered benign. These products have
been shown, through bench testing and
simulated use testing, to contain such
tissue during morcellation.
For these reasons, FDA is updating its
recommendations, as originally
described in the 2014 guidance
document, concerning the content and
format of certain labeling information
for LPMs. Specifically, FDA is
recommending that manufacturers
incorporate into the labeling for these
devices information providing greater
specificity regarding the risks of use as
it relates to age, information regarding
the risk of spreading benign uterine
tissue, and information regarding the
use of LPM containment systems.
A notice of availability of the draft
guidance appeared in the Federal
Register of February 26, 2020 (85 FR
11093). FDA considered comments
received and revised the guidance as
appropriate in response to the
comments, including revisions to
further discuss shared decision making
that should occur between a physician
and patient prior to undergoing the
procedure, to elaborate on the benefits
and risks of LPM containment systems,
and to refine one of the sample warning
statements.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on product labeling for
laparoscopic power morcellators. It does
not establish any rights for any person
and is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Electronic Access
Persons interested in obtaining a copy
of the guidance may do so by
downloading an electronic copy from
the internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/medical-devices/
device-advice-comprehensive-
regulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This
guidance document is also available at
https://www.regulations.gov and at
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments. Persons unable to download
an electronic copy of ‘‘Product Labeling
for Laparoscopic Power Morcellators’’
may send an email request to CDRHGuidance@fda.hhs.gov to receive an
electronic copy of the document. Please
use the document number 1400052 and
complete title to identify the guidance
you are requesting.
III. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in the following FDA
regulations have been approved by OMB
as listed in the following table:
OMB control
No.
21 CFR part
Topic
807, subpart E ...............
800, 801, and 809 ..........
803 .................................
Premarket notification .............................................................................................................................
Medical Device Labeling Regulations .....................................................................................................
Medical Devices; Medical Device Reporting; Manufacturer reporting, importer reporting, user facility
reporting, distributor reporting.
Dated: December 22, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–28816 Filed 12–29–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3233]
Request for Nominations for Voting
Members on a Public Advisory
Committee; Technical Electronic
Product Radiation Safety Standards
Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting
nominations for voting members to
SUMMARY:
VerDate Sep<11>2014
17:47 Dec 29, 2020
Jkt 253001
serve on the Technical Electronic
Product Radiation Safety Standards
Committee (TEPRSSC) in the Center for
Devices and Radiological Health.
Nominations will be accepted for
current and upcoming vacancies
effective with this notice. FDA seeks to
include the views of women and men,
members of all racial and ethnic groups,
and individuals with and without
disabilities on its advisory committees
and, therefore, encourages nominations
of appropriately qualified candidates
from these groups.
DATES: Nominations received on or
before March 1, 2021, will be given first
consideration for membership on
TEPRSSC. Nominations received after
March 1, 2021, will be considered for
nomination to the committee as later
vacancies occur.
ADDRESSES: All nominations for
membership should be sent
electronically by logging into FDA’s
Advisory Committee Membership
Nomination Portal at https://
PO 00000
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86571
0910–0120
0910–0485
0910–0437
www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm or by
mail to Advisory Committee Oversight
and Management Staff, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5103, Silver Spring,
MD 20993–0002. Information about
becoming a member on an FDA advisory
committee can also be obtained by
visiting FDA’s website at https://
www.fda.gov/AdvisoryCommittees/
default.htm.
FOR FURTHER INFORMATION CONTACT:
Patricio G. Garcia, Division of
Management Services, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5216,
Silver Spring, MD 20993–0002, 301–
796–6875, Patricio.Garcia@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
requesting nominations for voting
members to serve on TEPRSSC that
include five general public
representatives and five government
representatives.
E:\FR\FM\30DEN1.SGM
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86572
Federal Register / Vol. 85, No. 250 / Wednesday, December 30, 2020 / Notices
I. General Description of the
Committee’s Duties
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
The committee provides advice and
consultation to the Commissioner of
Food and Drugs (the Commissioner) on
the technical feasibility, reasonableness,
and practicability of performance
standards for electronic products to
control the emission of radiation from
such products, and may recommend
electronic product radiation safety
standards to the Commissioner for
consideration.
National Institutes of Health
National Institutes of Health
National Center for Advancing
Translational Sciences; Notice of
Closed Meeting
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
II. Criteria for Voting Members
The committee consists of a core of 15
voting members including the Chair.
Members and the Chair are selected by
the Commissioner or designee from
among authorities knowledgeable in the
fields of science or engineering,
applicable to electronic product
radiation safety. Members will be
invited to serve for overlapping terms of
up to 4 years. Terms of more than 2
years are contingent upon the renewal
of the committee by appropriate action
prior to its expiration.
III. Nomination Procedures
Any interested person may nominate
one or more qualified individuals for
membership on the committee. Selfnominations are also accepted.
Nominations must include a current,
complete re´sume´ or curriculum vitae for
each nominee, including current
business address and/or home address,
telephone number, and email address if
available and a signed copy of the
Acknowledgement and Consent form
available at the FDA Advisory
Nomination Portal (see ADDRESSES).
Nominations must also specify the
advisory committee for which the
nominee is recommended. Nominations
must also acknowledge that the
nominee is aware of the nomination
unless self-nominated. FDA will ask
potential candidates to provide detailed
information concerning such matters
related to financial holdings,
employment, and research grants and/or
contracts to permit evaluation of
possible sources of conflicts of interest.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: December 22, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
Name of Committee: National Center for
Advancing Translational Sciences Special
Emphasis Panel; SBIR Contract Review Topic
20.
Date: January 12, 2021.
Time: 12:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Center for Advancing
Translational Sciences, National Institutes of
Health, 6701 Democracy Boulevard, Room
1078, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Rahat (Rani) Khan, Ph.D.
Scientific Review Officer, Office of Scientific
Review, National Center for Advancing
Translational Sciences, National Institutes of
Health, 6701 Democracy Boulevard, Room
1078 Bethesda, MD 20892, 301–594–7319
khanr2@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.350, B—Cooperative
Agreements; 93.859, Biomedical Research
and Research Training, National Institutes of
Health, HHS)
Dated: December 22, 2020.
David W. Freeman,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–28842 Filed 12–29–20; 8:45 am]
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[FR Doc. 2020–28841 Filed 12–29–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
BILLING CODE 4164–01–P
17:47 Dec 29, 2020
Dated: December 23, 2020.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory
Committee Policy.
BILLING CODE 4140–01–P
[FR Doc. 2020–28833 Filed 12–29–20; 8:45 am]
VerDate Sep<11>2014
Name of Committee: National Institute of
Child Health and Human Development Initial
Review Group; Health, Behavior, and Context
Subcommittee.
Date: February 22, 2021.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: NICHD/NIH, 6710B Rockledge
Drive, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Kimberly L. Houston,
M.D., Scientific Review Officer, Eunice
Kennedy Shriver National Institute of Child
Health and Human Development, 6701B
Rockledge Drive, Room 2137C, Bethesda, MD
20892, 301–827–4902, kimberly.houston@
nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
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Agencies
[Federal Register Volume 85, Number 250 (Wednesday, December 30, 2020)]
[Notices]
[Pages 86571-86572]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28833]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3233]
Request for Nominations for Voting Members on a Public Advisory
Committee; Technical Electronic Product Radiation Safety Standards
Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is requesting
nominations for voting members to serve on the Technical Electronic
Product Radiation Safety Standards Committee (TEPRSSC) in the Center
for Devices and Radiological Health. Nominations will be accepted for
current and upcoming vacancies effective with this notice. FDA seeks to
include the views of women and men, members of all racial and ethnic
groups, and individuals with and without disabilities on its advisory
committees and, therefore, encourages nominations of appropriately
qualified candidates from these groups.
DATES: Nominations received on or before March 1, 2021, will be given
first consideration for membership on TEPRSSC. Nominations received
after March 1, 2021, will be considered for nomination to the committee
as later vacancies occur.
ADDRESSES: All nominations for membership should be sent electronically
by logging into FDA's Advisory Committee Membership Nomination Portal
at https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm
or by mail to Advisory Committee Oversight and Management Staff, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103,
Silver Spring, MD 20993-0002. Information about becoming a member on an
FDA advisory committee can also be obtained by visiting FDA's website
at https://www.fda.gov/AdvisoryCommittees/default.htm.
FOR FURTHER INFORMATION CONTACT: Patricio G. Garcia, Division of
Management Services, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5216,
Silver Spring, MD 20993-0002, 301-796-6875,
[email protected].
SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
members to serve on TEPRSSC that include five general public
representatives and five government representatives.
[[Page 86572]]
I. General Description of the Committee's Duties
The committee provides advice and consultation to the Commissioner
of Food and Drugs (the Commissioner) on the technical feasibility,
reasonableness, and practicability of performance standards for
electronic products to control the emission of radiation from such
products, and may recommend electronic product radiation safety
standards to the Commissioner for consideration.
II. Criteria for Voting Members
The committee consists of a core of 15 voting members including the
Chair. Members and the Chair are selected by the Commissioner or
designee from among authorities knowledgeable in the fields of science
or engineering, applicable to electronic product radiation safety.
Members will be invited to serve for overlapping terms of up to 4
years. Terms of more than 2 years are contingent upon the renewal of
the committee by appropriate action prior to its expiration.
III. Nomination Procedures
Any interested person may nominate one or more qualified
individuals for membership on the committee. Self-nominations are also
accepted. Nominations must include a current, complete
r[eacute]sum[eacute] or curriculum vitae for each nominee, including
current business address and/or home address, telephone number, and
email address if available and a signed copy of the Acknowledgement and
Consent form available at the FDA Advisory Nomination Portal (see
ADDRESSES). Nominations must also specify the advisory committee for
which the nominee is recommended. Nominations must also acknowledge
that the nominee is aware of the nomination unless self-nominated. FDA
will ask potential candidates to provide detailed information
concerning such matters related to financial holdings, employment, and
research grants and/or contracts to permit evaluation of possible
sources of conflicts of interest.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.
Dated: December 22, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-28833 Filed 12-29-20; 8:45 am]
BILLING CODE 4164-01-P