Request for Nominations for Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee, 45249 [2018-19355]
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Federal Register / Vol. 83, No. 173 / Thursday, September 6, 2018 / Notices
Evaluation, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G610, Silver Spring,
MD 20993–0002, 301–796–6875, email:
Patricio.Garcia@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
requesting nominations for voting
members on TEPRSSC that include
three general public representatives.
part 822 have been approved under
OMB control number 0910–0449.
Dated: August 30, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–19249 Filed 9–5–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
I. General Description of the
Committee’s Duties
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 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 November 5, 2018 will be given
first consideration for membership on
TEPRSSC. Nominations received after
November 5, 2018 will be considered for
nomination to the committee as later
vacancies occur.
ADDRESSES: All nominations for
membership should be sent
electronically by accessing 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, Office of Device
daltland on DSKBBV9HB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:56 Sep 05, 2018
Jkt 244001
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: August 31, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–19355 Filed 9–5–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
The committee provides advice and
consultation to the Commissioner of
Food and Drugs (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.
[Docket Nos. FDA–1999–D–0081, FDA–
2008–D–0205, FDA–2018–D–2173, FDA–
2018–D–2236, FDA–2018–D–2238, and FDA–
2018–D–2258]
Draft Guidances Relating to the
Development of Human Gene Therapy
Products; Availability; Extension of
Comment Period
AGENCY:
II. Criteria for Voting Members
HHS.
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.
ACTION:
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
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
45249
Food and Drug Administration,
Notification; extension of
comment period.
The Food and Drug
Administration (FDA or the Agency) is
extending the comment period for the
notices of availability for six draft
guidance documents relating to the
development of human gene therapy
products that appeared in the Federal
Register of July 12, 2018. The Agency is
taking this action in response to
requests for an extension to allow
interested persons additional time to
submit comments and any new
information.
SUMMARY:
FDA is extending the comment
period on the six documents that
published on July 12, 2018 (see
SUPPLEMENTARY INFORMATION). Submit
either electronic or written comments
by December 10, 2018, to ensure that the
Agency considers your comment on
these draft guidances before it begins
work on the final version of the
guidances.
DATES:
You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before December 10,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of December 10, 2018.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
ADDRESSES:
E:\FR\FM\06SEN1.SGM
06SEN1
Agencies
[Federal Register Volume 83, Number 173 (Thursday, September 6, 2018)]
[Notices]
[Page 45249]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19355]
-----------------------------------------------------------------------
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 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 November 5, 2018 will be given
first consideration for membership on TEPRSSC. Nominations received
after November 5, 2018 will be considered for nomination to the
committee as later vacancies occur.
ADDRESSES: All nominations for membership should be sent electronically
by accessing 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, Office of Device
Evaluation, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G610, Silver
Spring, MD 20993-0002, 301-796-6875, email:
[email protected].
SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
members on TEPRSSC that include three general public representatives.
I. General Description of the Committee's Duties
The committee provides advice and consultation to the Commissioner
of Food and Drugs (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: August 31, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19355 Filed 9-5-18; 8:45 am]
BILLING CODE 4164-01-P