Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee; Renewal, 12616 [2019-06360]
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12616
Federal Register / Vol. 84, No. 63 / Tuesday, April 2, 2019 / Notices
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Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–06312 Filed 4–1–19; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–0803]
Advisory Committee; Technical
Electronic Product Radiation Safety
Standards Committee; Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of advisory
committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Technical Electronic
Product Radiation Safety Standards
Committee (Committee) by the
Commissioner of Food and Drugs (the
Commissioner). The Commissioner has
determined that it is in the public
interest to renew the Committee for an
additional 2 years beyond the charter
expiration date. The new charter will be
in effect until December 24, 2020.
DATES: Authority for the Technical
Electronic Product Radiation Safety
Standards Committee would have
expired on December 24, 2018, unless
the Commissioner formally determined
that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT:
Patricio Garcia, 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,
Patricio.Garcia@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services pursuant to 45 CFR part 11 and
by the General Services Administration,
FDA is announcing the renewal of the
Committee. The Committee is a nondiscretionary Federal advisory
SUMMARY:
amozie on DSK9F9SC42PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
Type of respondents
VerDate Sep<11>2014
18:45 Apr 01, 2019
Jkt 247001
committee established to provide advice
and consultation to the Commissioner.
The Commissioner of Food and Drugs is
charged with the administration of the
Radiation Control for Health and Safety
Act of 1968. This act creates the
Committee and requires the
Commissioner to consult with the
Committee before prescribing standards
for radiation emissions from electronic
products. This Committee provides
advice and consultation to the
Commissioner of Food and Drugs 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.
The Committee shall consist 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. The core of
voting members will include five
members selected from governmental
agencies, including State and Federal
Governments, five members from the
affected industries, and five members
from the general public, of which at
least one shall be a representative of
organized labor. A quorum shall consist
of 10 members, of which at least 3 shall
be from the general public, 3 from the
government agencies, and 3 from the
affected industries.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/RadiationEmittingProducts/TechnicalElectronic
ProductRadiationSafetyStandards
Committee/default.htm or by contacting
the Designated Federal Officer (see FOR
FURTHER INFORMATION CONTACT). In light
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
of the fact that no change has been made
to the committee name or description of
duties, no amendment will be made to
21 CFR 14.100.
This document is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please visit us at https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: March 27, 2019.
Lowell J. Schiller,
Commissioner of Food and Drugs.
[FR Doc. 2019–06360 Filed 4–1–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–P–2754]
Determination That ONFI (Clobazam)
Tablets, 5 Milligrams, Was Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that ONFI (clobazam)
tablets, 5 milligrams (mg), was not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) that refer to the
drug product, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
Darren Eicken, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave. Bldg. 51, Rm. 6206,
Silver Spring, MD 20993–0002, 240–
402–0978.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
SUMMARY:
E:\FR\FM\02APN1.SGM
02APN1
]]>Agencies
[Federal Register Volume 84, Number 63 (Tuesday, April 2, 2019)]
[Notices]
[Page 12616]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06360]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-0803]
Advisory Committee; Technical Electronic Product Radiation Safety
Standards Committee; Renewal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; renewal of advisory committee.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of the Technical Electronic Product Radiation Safety Standards
Committee (Committee) by the Commissioner of Food and Drugs (the
Commissioner). The Commissioner has determined that it is in the public
interest to renew the Committee for an additional 2 years beyond the
charter expiration date. The new charter will be in effect until
December 24, 2020.
DATES: Authority for the Technical Electronic Product Radiation Safety
Standards Committee would have expired on December 24, 2018, unless the
Commissioner formally determined that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT: Patricio Garcia, 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 protected].
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services pursuant to 45 CFR part 11
and by the General Services Administration, FDA is announcing the
renewal of the Committee. The Committee is a non-discretionary Federal
advisory committee established to provide advice and consultation to
the Commissioner. The Commissioner of Food and Drugs is charged with
the administration of the Radiation Control for Health and Safety Act
of 1968. This act creates the Committee and requires the Commissioner
to consult with the Committee before prescribing standards for
radiation emissions from electronic products. This Committee provides
advice and consultation to the Commissioner of Food and Drugs 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.
The Committee shall consist 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. The core of voting members will include five members
selected from governmental agencies, including State and Federal
Governments, five members from the affected industries, and five
members from the general public, of which at least one shall be a
representative of organized labor. A quorum shall consist of 10
members, of which at least 3 shall be from the general public, 3 from
the government agencies, and 3 from the affected industries.
Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Radiation-EmittingProducts/TechnicalElectronicProductRadiationSafetyStandardsCommittee/default.htm
or by contacting the Designated Federal Officer (see FOR FURTHER
INFORMATION CONTACT). In light of the fact that no change has been made
to the committee name or description of duties, no amendment will be
made to 21 CFR 14.100.
This document is issued under the Federal Advisory Committee Act (5
U.S.C. app.). For general information related to FDA advisory
committees, please visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.
Dated: March 27, 2019.
Lowell J. Schiller,
Commissioner of Food and Drugs.
[FR Doc. 2019-06360 Filed 4-1-19; 8:45 am]
BILLING CODE 4164-01-P
