Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee, Renewal, 850-851 [2016-31847]
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Federal Register / Vol. 82, No. 2 / Wednesday, January 4, 2017 / Notices
Commission informed about the status
of the transfer of the rights and assets to
Elanco and Bayer.
The Commission’s goal in evaluating
possible purchasers of divested rights
and assets is to maintain the
competitive environment that existed
prior to the Proposed Acquisition. If the
Commission determines that either
buyer is not an acceptable acquirer, or
that the manner of the divestiture is not
acceptable, the proposed Order requires
the parties to unwind the sale and then
divest the products to another
Commission-approved acquirer within
six months of the date that the proposed
Order becomes final. The proposed
Order further allows the Commission to
appoint a trustee in the event the parties
fail to divest the products.
The purpose of this analysis is to
facilitate public comment on the
proposed Consent Agreement, and it is
not intended to constitute an official
interpretation of the proposed Order or
to modify its terms in any way.
By direction of the Commission.
April J. Tabor,
Acting Secretary.
[FR Doc. 2016–31848 Filed 1–3–17; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Notice Designating State Title IV–D
Child Support Agencies as ‘‘Public
Bodies’’
Office of Child Support
Enforcement, Administration for
Children and Families, Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
This notice designates state
IV–D child support agencies as public
bodies authorized to perform specific
functions of the Central Authority under
Article 6(3) of the the Hague Convention
of 23 November 2007 on the
International Recovery of Child Support
and Other Forms of Family Maintenance
(Convention).and specifies functions to
be performed by the state agencies in
relation to applications under the
Convention.
mstockstill on DSK3G9T082PROD with NOTICES
SUMMARY:
Interested parties may
submit written comments on this notice
to the United States Central Authority
for International Child Support,
Department of Health and Human
Services, Office of Child Support
Enforcement, 330 C Street SW., 5th
ADDRESSES:
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16:46 Jan 03, 2017
Jkt 241001
Floor, Washington, DC 20201.
Comments received will be available for
public inspection at this address from
9:00 a.m. to 5:00 p.m. EST, Monday
through Friday.
DATES: The Convention will enter into
force for the United States on January 1,
2017.
FOR FURTHER INFORMATION CONTACT: The
Division of Policy and Training, Office
of Child Support Enforcement,
Administration for Children and
Families, 330 C Street SW., 5th Floor,
Washington, DC 20201.
SUPPLEMENTARY INFORMATION: The
President signed the Instrument of
Ratification on August 30, 2016, and the
United States of America deposited its
Instrument of Ratification of the
Convention on September 7, 2016. The
Convention will enter into force for the
United States on January 1, 2017.
Section 459A of the Social Security Act
(42 U.S.C. 659a) and Executive Order
13752, 81 FR 90181 (Dec. 8, 2016)
designate the Department of Health and
Human Services as the Central
Authority of the United States for
purposes of the Convention, and
authorize the Secretary of Health and
Human Services to perform all lawful
acts that may be necessary and proper
in order to execute the functions of the
Central Authority. Article 6(3) of the
Convention authorizes the designation
of public bodies to perform specific
functions under the Convention, subject
to the supervision of the Central
Authority. The Executive Order
specifically authorizes the designation
of the state agencies responsible for
implementing an approved State Plan
under title IV–D of the Social Security
Act, 42 U.S.C. 651 et seq., as public
bodies authorized to perform specific
functions in relation to applications
under the Convention. All states have
enacted the Uniform Interstate Family
Support Act of 2008 (UIFSA 2008) to
enable uniform implementation of the
Convention in the United States.
Under authority delegated by the
Secretary for administration of the title
IV–D program, I hereby designate the
state title IV–D child support agencies
as public bodies authorized to perform
functions related to applications under
the Convention in accordance with
UIFSA 2008, title IV–D and title IV–D
regulations, and guidance and
instructions, subject to the supervision
of the federal Office of Child Support
Enforcement. Such functions shall
include the provision of support
enforcement services to applicants
under the Convention, including:
Transmitting and receiving applications
under the Convention; initiating or
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facilitating the institution of
proceedings with respect to
applications; establishing paternity and
support orders; recognizing, modifying,
and enforcing such orders; collecting
and distributing payments under such
orders; and providing administrative
and legal services without cost to
applicants.
Statutory Authority: Section 459(a) of the
Social Security Act (42 U.S.C. 659(a)
Dated: December 29, 2016.
Mark H. Greenberg,
Acting Assistant Secretary for Children and
Families.
[FR Doc. 2016–31895 Filed 1–3–17; 8:45 am]
BILLING CODE 4184–42–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
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 by the Commissioner of
Food and Drugs (the Commissioner).
The Commissioner has determined that
it is in the public interest to renew the
Technical Electronic Product Radiation
Safety Standards Committee for an
additional 2 years beyond the charter
expiration date. The new charter will be
in effect until December 24, 2018.
DATES: Authority for the Technical
Electronic Product Radiation Safety
Standards Committee will expire on
December 24, 2016, unless the
Commissioner formally determines that
renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT:
Shanika Craig, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1613, Silver Spring,
MD, 20993–0002, 301–796–6639,
Shanika.Craig@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
Technical Electronic Product Radiation
Safety Standards Committee. The
SUMMARY:
E:\FR\FM\04JAN1.SGM
04JAN1
mstockstill on DSK3G9T082PROD with NOTICES
Federal Register / Vol. 82, No. 2 / Wednesday, January 4, 2017 / Notices
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 Technical Electronic
Product Radiation Safety Standards
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 two
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/
TechnicalElectronicProductRadiation
SafetyStandardsCommittee/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,
VerDate Sep<11>2014
16:46 Jan 03, 2017
Jkt 241001
please visit us at https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: December 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–31847 Filed 1–3–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–4437]
In-Use Stability Studies and
Associated Labeling Statements for
Multiple-Dose Injectable Animal Drug
Products; Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry (GIF) #242
entitled ‘‘In-Use Stability Studies and
Associated Labeling Statements for
Multiple-Dose Injectable Animal Drug
Products.’’ The purpose of in-use
stability testing is to establish a period
of time during which a multiple-dose
drug product may be used while
retaining acceptable quality
specifications once the container is
opened (e.g., after a container has been
needle-punctured). This draft guidance
reflects the Agency’s current thinking
on how to formulate in-use statements,
as well as how to design and carry out
in-use stability studies to support these
in-use statements, for multiple-dose
injectable drug products intended for
use in animals. This current thinking
pertains to both generic drug products
and pioneer drug products regardless of
whether or not the pioneer reference
listed new animal drug (RLNAD)
currently has an in-use statement on the
labeling.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by March 6, 2017.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
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851
• 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:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2016–D–4437 for ‘‘In-Use Stability
Studies and Associated Labeling
Statements for Multiple-Dose Injectable
Animal Drug Products.’’ 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 Division of Dockets
Management 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
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Agencies
[Federal Register Volume 82, Number 2 (Wednesday, January 4, 2017)]
[Notices]
[Pages 850-851]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31847]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
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 by the Commissioner of Food and Drugs (the Commissioner). The
Commissioner has determined that it is in the public interest to renew
the Technical Electronic Product Radiation Safety Standards Committee
for an additional 2 years beyond the charter expiration date. The new
charter will be in effect until December 24, 2018.
DATES: Authority for the Technical Electronic Product Radiation Safety
Standards Committee will expire on December 24, 2016, unless the
Commissioner formally determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT: Shanika Craig, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1613, Silver Spring, MD, 20993-0002, 301-796-6639,
Shanika.Craig@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 Technical Electronic Product Radiation Safety Standards
Committee. The
[[Page 851]]
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 Technical Electronic Product Radiation Safety Standards
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 two 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: December 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31847 Filed 1-3-17; 8:45 am]
BILLING CODE 4164-01-P