83_FR_45422 83 FR 45249 - Request for Nominations for Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee

83 FR 45249 - Request for Nominations for Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 173 (September 6, 2018)

Page Range45249-45249
FR Document2018-19355

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.

Federal Register, Volume 83 Issue 173 (Thursday, September 6, 2018)
[Federal Register Volume 83, Number 173 (Thursday, September 6, 2018)]
[Notices]
[Page 45249]
From the Federal Register Online  [www.thefederalregister.org]
[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



                                                                         Federal Register / Vol. 83, No. 173 / Thursday, September 6, 2018 / Notices                                                 45249

                                               part 822 have been approved under                       Evaluation, Center for Devices and                    U.S.C. app. 2) and 21 CFR part 14,
                                               OMB control number 0910–0449.                           Radiological Health, Food and Drug                    relating to advisory committees.
                                                 Dated: August 30, 2018.                               Administration, 10903 New Hampshire                     Dated: August 31, 2018.
                                               Leslie Kux,                                             Ave., Bldg. 66, Rm. G610, Silver Spring,              Leslie Kux,
                                               Associate Commissioner for Policy.
                                                                                                       MD 20993–0002, 301–796–6875, email:
                                                                                                                                                             Associate Commissioner for Policy.
                                                                                                       Patricio.Garcia@fda.hhs.gov.
                                               [FR Doc. 2018–19249 Filed 9–5–18; 8:45 am]                                                                    [FR Doc. 2018–19355 Filed 9–5–18; 8:45 am]
                                               BILLING CODE 4164–01–P
                                                                                                       SUPPLEMENTARY INFORMATION: FDA is
                                                                                                                                                             BILLING CODE 4164–01–P
                                                                                                       requesting nominations for voting
                                                                                                       members on TEPRSSC that include
                                               DEPARTMENT OF HEALTH AND                                three general public representatives.                 DEPARTMENT OF HEALTH AND
                                               HUMAN SERVICES                                          I. General Description of the                         HUMAN SERVICES
                                                                                                       Committee’s Duties
                                               Food and Drug Administration                                                                                  Food and Drug Administration
                                               [Docket No. FDA–2018–N–3233]
                                                                                                         The committee provides advice and
                                                                                                       consultation to the Commissioner of                   [Docket Nos. FDA–1999–D–0081, FDA–
                                               Request for Nominations for Voting                      Food and Drugs (Commissioner) on the                  2008–D–0205, FDA–2018–D–2173, FDA–
                                               Members on a Public Advisory                            technical feasibility, reasonableness,                2018–D–2236, FDA–2018–D–2238, and FDA–
                                               Committee; Technical Electronic                         and practicability of performance                     2018–D–2258]
                                               Product Radiation Safety Standards                      standards for electronic products to
                                               Committee                                               control the emission of radiation from                Draft Guidances Relating to the
                                                                                                       such products, and may recommend                      Development of Human Gene Therapy
                                               AGENCY:    Food and Drug Administration,                electronic product radiation safety                   Products; Availability; Extension of
                                               HHS.                                                    standards to the Commissioner for                     Comment Period
                                               ACTION:   Notice.                                       consideration.
                                                                                                                                                             AGENCY:    Food and Drug Administration,
                                               SUMMARY:   The Food and Drug                            II. Criteria for Voting Members                       HHS.
                                               Administration (FDA) is requesting
                                                                                                          The committee consists of a core of 15                   Notification; extension of
                                                                                                                                                             ACTION:
                                               nominations for members to serve on
                                                                                                       voting members including the Chair.                   comment period.
                                               the Technical Electronic Product
                                                                                                       Members and the Chair are selected by
                                               Radiation Safety Standards Committee                                                                          SUMMARY:   The Food and Drug
                                                                                                       the Commissioner or designee from
                                               (TEPRSSC) in the Center for Devices                                                                           Administration (FDA or the Agency) is
                                                                                                       among authorities knowledgeable in the
                                               and Radiological Health. Nominations                                                                          extending the comment period for the
                                                                                                       fields of science or engineering,
                                               will be accepted for current and                                                                              notices of availability for six draft
                                                                                                       applicable to electronic product
                                               upcoming vacancies effective with this                                                                        guidance documents relating to the
                                                                                                       radiation safety. Members will be
                                               notice.                                                                                                       development of human gene therapy
                                                                                                       invited to serve for overlapping terms of
                                                  FDA seeks to include the views of                                                                          products that appeared in the Federal
                                                                                                       up to 4 years. Terms of more than 2
                                               women and men, members of all racial                                                                          Register of July 12, 2018. The Agency is
                                                                                                       years are contingent upon the renewal
                                               and ethnic groups, and individuals with                                                                       taking this action in response to
                                                                                                       of the committee by appropriate action
                                               and without disabilities on its advisory                                                                      requests for an extension to allow
                                                                                                       prior to its expiration.
                                               committees and, therefore, encourages                                                                         interested persons additional time to
                                               nominations of appropriately qualified                  III. Nomination Procedures                            submit comments and any new
                                               candidates from these groups.                                                                                 information.
                                                                                                          Any interested person may nominate
                                               DATES: Nominations received on or
                                                                                                       one or more qualified individuals for
                                               before November 5, 2018 will be given                                                                         DATES:  FDA is extending the comment
                                                                                                       membership on the committee. Self-
                                               first consideration for membership on                                                                         period on the six documents that
                                                                                                       nominations are also accepted.
                                               TEPRSSC. Nominations received after                                                                           published on July 12, 2018 (see
                                                                                                       Nominations must include a current,
                                               November 5, 2018 will be considered for                                                                       SUPPLEMENTARY INFORMATION). Submit
                                                                                                       complete résumé or curriculum vitae for
                                               nomination to the committee as later                                                                          either electronic or written comments
                                                                                                       each nominee, including current
                                               vacancies occur.                                                                                              by December 10, 2018, to ensure that the
                                                                                                       business address and/or home address,
                                               ADDRESSES: All nominations for                                                                                Agency considers your comment on
                                                                                                       telephone number, and email address if
                                               membership should be sent                                                                                     these draft guidances before it begins
                                                                                                       available, and a signed copy of the
                                               electronically by accessing FDA’s                                                                             work on the final version of the
                                                                                                       Acknowledgement and Consent form
                                               Advisory Committee Membership                                                                                 guidances.
                                                                                                       available at the FDA Advisory
                                               Nomination Portal at https://                           Nomination Portal (see ADDRESSES).                    ADDRESSES:   You may submit comments
                                               www.accessdata.fda.gov/scripts/                         Nominations must also specify the                     as follows. Please note that late,
                                               FACTRSPortal/FACTRS/index.cfm or by                     advisory committee for which the                      untimely filed comments will not be
                                               mail to Advisory Committee Oversight                    nominee is recommended. Nominations                   considered. Electronic comments must
                                               and Management Staff, Food and Drug                     must also acknowledge that the                        be submitted on or before December 10,
                                               Administration, 10903 New Hampshire                     nominee is aware of the nomination                    2018. The https://www.regulations.gov
                                               Ave., Bldg. 32, Rm. 5103, Silver Spring,                unless self-nominated. FDA will ask                   electronic filing system will accept
                                               MD 20993–0002. Information about                        potential candidates to provide detailed              comments until midnight Eastern Time
daltland on DSKBBV9HB2PROD with NOTICES




                                               becoming a member on an FDA advisory                    information concerning such matters                   at the end of December 10, 2018.
                                               committee can also be obtained by                       related to financial holdings,                        Comments received by mail/hand
                                               visiting FDA’s website at https://                      employment, and research grants and/or                delivery/courier (for written/paper
                                               www.fda.gov/AdvisoryCommittees/                         contracts to permit evaluation of                     submissions) will be considered timely
                                               default.htm.                                            possible sources of conflicts of interest.            if they are postmarked or the delivery
                                               FOR FURTHER INFORMATION CONTACT:                           This notice is issued under the                    service acceptance receipt is on or
                                               Patricio G. Garcia, Office of Device                    Federal Advisory Committee Act (5                     before that date.


                                          VerDate Sep<11>2014   16:56 Sep 05, 2018   Jkt 244001   PO 00000   Frm 00044   Fmt 4703   Sfmt 4703   E:\FR\FM\06SEN1.SGM   06SEN1



Document Created: 2018-09-05 23:56:35
Document Modified: 2018-09-05 23:56:35
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesNominations 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.
ContactPatricio 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]
FR Citation83 FR 45249 

2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR