Determination and Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Middle East Respiratory Syndrome Coronavirus (MERS-CoV), 33842-33843 [2013-13333]
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Federal Register / Vol. 78, No. 108 / Wednesday, June 5, 2013 / Notices
Board, are available for immediate
inspection at the Federal Reserve Bank
indicated. The applications will also be
available for inspection at the offices of
the Board of Governors. Interested
persons may express their views in
writing on the standards enumerated in
the BHC Act (12 U.S.C. 1842(c)). If the
proposal also involves the acquisition of
a nonbanking company, the review also
includes whether the acquisition of the
nonbanking company complies with the
standards in section 4 of the BHC Act
(12 U.S.C. 1843). Unless otherwise
noted, nonbanking activities will be
conducted throughout the United States.
Unless otherwise noted, comments
regarding each of these applications
must be received at the Reserve Bank
indicated or the offices of the Board of
Governors not later than July 1, 2013.
A. Federal Reserve Bank of Boston
(Richard Walker, Community Affairs
Officer) 600 Atlantic Avenue, Boston,
Massachusetts 02210–2204:
1. Hometown Community Bancorp,
MHC, Oxford, Massachusetts; to acquire
100 percent of the voting shares of
Hometown Community Bancorp, Inc.,
Oxford, Massachusetts, which will
acquire Hometown Bank, A Cooperative
Bank, Webster, Massachusetts.
In addition, Hometown Community
Bancorp, Inc., Oxford, Massachusetts,
also has applied to become a bank
holding company, by acquiring
Hometown Bank, A Cooperative Bank,
Webster, Massachusetts.
Board of Governors of the Federal Reserve
System, May 31, 2013.
Margaret McCloskey Shanks,
Deputy Secretary of the Board.
[FR Doc. 2013–13284 Filed 6–4–13; 8:45 am]
BILLING CODE 6210–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Determination and Declaration
Regarding Emergency Use of In Vitro
Diagnostics for Detection of Middle
East Respiratory Syndrome
Coronavirus (MERS-CoV)
Office of the Secretary,
Department of Health and Human
Services.
ACTION: Notice.
mstockstill on DSK4VPTVN1PROD with NOTICES
AGENCY:
SUMMARY: The Secretary of Health and
Human Services (HHS) is issuing this
notice pursuant to section 564 of the
Federal Food, Drug, and Cosmetic
(FD&C) Act, 21 U.S.C. 360bbb–3. On
May 29, 2013, the Secretary determined
that there is a significant potential for a
public health emergency that has a
significant potential to affect national
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security or the health and security of
United States citizens living abroad and
that involves Middle East respiratory
syndrome coronavirus (MERS-CoV).
On the basis of this determination,
she also declared that circumstances
exist justifying the authorization of
emergency use of in vitro diagnostics for
detection of Middle East respiratory
syndrome coronavirus (MERS-CoV)
pursuant to section 564 of the FD&C
Act, subject to the terms of any
authorization issued under that section.
DATES: The determination and
declaration are effective May 29, 2013.
FOR FURTHER INFORMATION CONTACT:
Nicole Lurie, M.D., MSPH, Assistant
Secretary for Preparedness and
Response, Office of the Secretary,
Department of Health and Human
Services, 200 Independence Avenue
SW., Washington, DC 20201, Telephone
(202) 205–2882 (this is not a toll free
number).
SUPPLEMENTARY INFORMATION:
I. Background
Under Section 564 of the FD&C Act,
the Commissioner of the Food and Drug
Administration (FDA), acting under
delegated authority from the Secretary
of HHS, may issue an Emergency Use
Authorization (EUA) authorizing (1) the
emergency use of an unapproved drug,
an unapproved or uncleared device, or
an unlicensed biological product; or (2)
an unapproved use of an approved drug,
approved or cleared device, or licensed
biological product. Before an EUA may
be issued, the Secretary of HHS must
declare that circumstances exist
justifying the authorization based on
one of four determinations: (1) A
determination by the Secretary of
Homeland Security that there is a
domestic emergency, or a significant
potential for a domestic emergency,
involving a heightened risk of attack
with a, chemical, biological,
radiological, or nuclear (‘‘CBRN’’) agent
or agents; (2) the identification of a
material threat by the Secretary of
Homeland Security pursuant to section
319F–2 of the Public Health Service
(PHS) Act 1 sufficient to affect national
security or the health and security of
United States citizens living abroad; (3)
a determination by the Secretary of
Defense that there is a military
emergency, or a significant potential for
a military emergency, involving a
heightened risk to United States military
forces of attack with a CBRN agent or
agents; or (4) a determination by the
Secretary that there is a public health
emergency, or a significant potential for
1 42
PO 00000
U.S.C. 247d–6b
Frm 00045
Fmt 4703
Sfmt 4703
a public health emergency, that affects,
or has a significant potential to affect,
national security or the health and
security of United States citizens living
abroad, and that involves a CBRN agent
or agents, or a disease or condition that
may be attributable to such agent or
agents.2
Based on any of these four
determinations, the Secretary of HHS
may then declare that circumstances
exist that justify the EUA, at which
point the FDA Commissioner may issue
an EUA if the criteria for issuance of an
authorization under section 564 of the
FD&C Act are met.
The Centers for Disease Control and
Prevention (CDC), HHS, requested that
the FDA, HHS, issue an EUA for in vitro
diagnostics for detection of Middle East
respiratory syndrome coronavirus
(MERS-CoV) to allow the Department to
take preparedness measures based on
information currently available about
the Middle East respiratory syndrome
coronavirus (MERS-CoV). The
determination of a significant potential
for a public health emergency, and the
declaration that circumstances exist
justifying emergency use of in vitro
diagnostics for detection of Middle East
respiratory syndrome coronavirus
(MERS-CoV) by the Secretary of HHS, as
described below, enable the FDA
Commissioner to issue an EUA for
certain in vitro diagnostics for
emergency use under section 564 of the
FD&C Act.
II. Determination by the Secretary of
Health and Human Services
On May 29, 2013, pursuant to section
564 of the FD&C Act, I determined that
there is a significant potential for a
public health emergency that has a
significant potential to affect national
security or the health and security of
United States citizens living abroad and
that involves Middle East respiratory
syndrome coronavirus (MERS-CoV).
III. Declaration of the Secretary of
Health and Human Services
Also on May 29, 2013, on the basis of
my determination of a significant
potential for a public health emergency
that has a significant potential to affect
national security or the health and
security of United States citizens living
2 As amended by the Pandemic and All-Hazards
Preparedness Reauthorization Act, Public Law 113–
5, the Secretary may make determination of a public
health emergency, or a significant potential for a
public health emergency, under section 564 of the
FD&C Act. The Secretary is no longer required to
make a determination of a public health emergency
in accordance with section 319 of the PHS Act, 42
U.S.C. 247d to support a determination or
declaration made under section 564 of the FD&C
Act.
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Federal Register / Vol. 78, No. 108 / Wednesday, June 5, 2013 / Notices
abroad and that involves Middle East
respiratory syndrome coronavirus
(MERS-CoV), I declared that
circumstances exist justifying the
authorization of emergency use of in
vitro diagnostics for detection of Middle
East respiratory syndrome coronavirus
(MERS-CoV) pursuant to section 564 of
the FD&C Act, subject to the terms of
any authorization issued under that
section.
Notice of the EUAs issued by the FDA
Commissioner pursuant to this
determination and declaration will be
provided promptly in the Federal
Register as required under section 564
of the FD&C Act.
Dated May 29, 2013.
Kathleen Sebelius,
Secretary.
[FR Doc. 2013–13333 Filed 6–4–13; 8:45 am]
BILLING CODE 4150–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Request for Comments on Issues
Related to Incidental Findings That
Arise in the Clinical, Research, and
Direct-To-Consumer Contexts
Presidential Commission for
the Study of Bioethical Issues, Office of
the Secretary, Department of Health and
Human Services.
ACTION: Notice.
mstockstill on DSK4VPTVN1PROD with NOTICES
AGENCY:
SUMMARY: The Presidential Commission
for the Study of Bioethical Issues is
requesting public comment on the
ethical, legal, and social issues raised by
incidental findings that arise from
genetic and genomic testing, imaging,
and testing of biological specimens
conducted in the clinical, research, and
direct-to-consumer contexts.
DATES: To ensure consideration,
comments must be received by July 5,
2013. Comments received after this date
will be considered only as time permits.
ADDRESSES: Individuals, groups, and
organizations interested in commenting
on this topic may submit comments by
email to info@bioethics.gov or by mail to
the following address: Public
Commentary, Presidential Commission
for the Study of Bioethical Issues, 1425
New York Ave. NW., Suite C–100,
Washington, DC 20005.
FOR FURTHER INFORMATION CONTACT:
Hillary Wicai Viers, Communications
Director, Presidential Commission for
the Study of Bioethical Issues.
Telephone: 202–233–3960. E-Mail:
hillary.viers@bioethics.gov. Additional
information may be obtained at https://
www.bioethics.gov.
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On
November 24, 2009, the President
established the Presidential Commission
for the Study of Bioethical Issues (the
Bioethics Commission) to advise him on
bioethical issues generated by novel and
emerging research in biomedicine and
related areas of science and technology.
The Bioethics Commission is charged
with identifying and promoting policies
and practices that ensure ethically
responsible conduct of scientific
research and healthcare delivery.
Undertaking these duties, the Bioethics
Commission seeks to identify and
examine specific bioethical, legal, and
social issues related to potential
scientific and technological advances;
examine diverse perspectives and
possibilities for international
collaboration on these issues; and
recommend legal, regulatory, or policy
actions as appropriate.
The Bioethics Commission is
considering the distinct ethical issues
raised by incidental findings in the
contexts of clinical care, research, and
direct-to-consumer testing. Emerging
medical technologies, changing cost
structures, and evolving medical
practice make the likelihood of
discovering incidental findings in the
clinical, research, and direct-toconsumer contexts a growing certainty.
At its meeting on April 30, 2013, the
Bioethics Commission heard from
ethicists, practitioners, and recipients of
incidental findings in each of these
contexts, and began its consideration of
the ethical obligations that clinicians,
researchers, and providers of direct-toconsumer testing owe to patients,
participants, and consumers.
The Bioethics Commission is
interested in receiving views of
individuals, groups, and professional
communities regarding the ethics
surrounding incidental findings
resulting from large-scale genetic
testing, imaging, and testing of
biological specimens in the clinical,
research, and/or direct-to-consumer
contexts. The Bioethics Commission is
particularly interested in receiving
public commentary regarding:
• Information about the likelihood of
incidental findings arising in large-scale
genetic testing, imaging, and testing of
biological specimens in the clinic,
research, and/or direct-to-consumer
contexts and any case studies of such;
• What, if anything, patients,
participants, and/or consumers should
be told about incidental findings
resulting from large-scale genetic
testing, imaging, and testing of
biological specimens before tests are
conducted;
SUPPLEMENTARY INFORMATION:
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33843
• Any duties or ethical obligations
that clinicians, researchers, and directto-consumer companies might have to
actively look for certain incidental
findings;
• Best practices, methods, and
mechanisms for determining when
incidental findings ought to be returned
to patients, participants, and/or
consumers and how the return of these
findings should occur;
• The acceptability of holding back
information—such as establishing ‘‘no
return’’ policies, or stipulations in
advance of clinical intervention,
research, and/or consumer interactions
that no incidental findings will be
returned; and,
• Any best practices or
recommendations regarding incidental
findings that apply no matter the type
of test or context.
To this end, the Commission is
inviting interested parties to provide
input and advice through written
comments.
Comments will be publicly available,
including any personally identifiable or
confidential business information that
they contain. Trade secrets should not
be submitted.
Dated: May 22, 2013.
Lisa M. Lee,
Executive Director, Presidential Commission
for the Study of Bioethical Issues.
[FR Doc. 2013–13329 Filed 6–4–13; 8:45 am]
BILLING CODE 4154–06–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Request for Information: Solicits
Public Input on the Renewal of
‘‘Combating the Silent Epidemic of
Viral Hepatitis, Action Plan for the
Prevention, Care, and Treatment of
Viral Hepatitis’’
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
SUMMARY: The Department of Health and
Human Services (HHS) is seeking broad
public input as it begins efforts to renew
the 2011 Action Plan for the Prevention,
Care, and Treatment of Viral Hepatitis to
include actions which can be
undertaken over the course of the next
three years, 2014–2016.
DATES: To be assured consideration,
comments must be received at one of
the addresses provided below, no later
than 5:00 p.m. EST on July 5, 2013.
ADDRESSES: Electronic responses are
strongly preferred and may be addressed
E:\FR\FM\05JNN1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 108 (Wednesday, June 5, 2013)]
[Notices]
[Pages 33842-33843]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-13333]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Determination and Declaration Regarding Emergency Use of In Vitro
Diagnostics for Detection of Middle East Respiratory Syndrome
Coronavirus (MERS-CoV)
AGENCY: Office of the Secretary, Department of Health and Human
Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Secretary of Health and Human Services (HHS) is issuing
this notice pursuant to section 564 of the Federal Food, Drug, and
Cosmetic (FD&C) Act, 21 U.S.C. 360bbb-3. On May 29, 2013, the Secretary
determined that there is a significant potential for a public health
emergency that has a significant potential to affect national security
or the health and security of United States citizens living abroad and
that involves Middle East respiratory syndrome coronavirus (MERS-CoV).
On the basis of this determination, she also declared that
circumstances exist justifying the authorization of emergency use of in
vitro diagnostics for detection of Middle East respiratory syndrome
coronavirus (MERS-CoV) pursuant to section 564 of the FD&C Act, subject
to the terms of any authorization issued under that section.
DATES: The determination and declaration are effective May 29, 2013.
FOR FURTHER INFORMATION CONTACT: Nicole Lurie, M.D., MSPH, Assistant
Secretary for Preparedness and Response, Office of the Secretary,
Department of Health and Human Services, 200 Independence Avenue SW.,
Washington, DC 20201, Telephone (202) 205-2882 (this is not a toll free
number).
SUPPLEMENTARY INFORMATION:
I. Background
Under Section 564 of the FD&C Act, the Commissioner of the Food and
Drug Administration (FDA), acting under delegated authority from the
Secretary of HHS, may issue an Emergency Use Authorization (EUA)
authorizing (1) the emergency use of an unapproved drug, an unapproved
or uncleared device, or an unlicensed biological product; or (2) an
unapproved use of an approved drug, approved or cleared device, or
licensed biological product. Before an EUA may be issued, the Secretary
of HHS must declare that circumstances exist justifying the
authorization based on one of four determinations: (1) A determination
by the Secretary of Homeland Security that there is a domestic
emergency, or a significant potential for a domestic emergency,
involving a heightened risk of attack with a, chemical, biological,
radiological, or nuclear (``CBRN'') agent or agents; (2) the
identification of a material threat by the Secretary of Homeland
Security pursuant to section 319F-2 of the Public Health Service (PHS)
Act \1\ sufficient to affect national security or the health and
security of United States citizens living abroad; (3) a determination
by the Secretary of Defense that there is a military emergency, or a
significant potential for a military emergency, involving a heightened
risk to United States military forces of attack with a CBRN agent or
agents; or (4) a determination by the Secretary that there is a public
health emergency, or a significant potential for a public health
emergency, that affects, or has a significant potential to affect,
national security or the health and security of United States citizens
living abroad, and that involves a CBRN agent or agents, or a disease
or condition that may be attributable to such agent or agents.\2\
---------------------------------------------------------------------------
\1\ 42 U.S.C. 247d-6b
\2\ As amended by the Pandemic and All-Hazards Preparedness
Reauthorization Act, Public Law 113-5, the Secretary may make
determination of a public health emergency, or a significant
potential for a public health emergency, under section 564 of the
FD&C Act. The Secretary is no longer required to make a
determination of a public health emergency in accordance with
section 319 of the PHS Act, 42 U.S.C. 247d to support a
determination or declaration made under section 564 of the FD&C Act.
---------------------------------------------------------------------------
Based on any of these four determinations, the Secretary of HHS may
then declare that circumstances exist that justify the EUA, at which
point the FDA Commissioner may issue an EUA if the criteria for
issuance of an authorization under section 564 of the FD&C Act are met.
The Centers for Disease Control and Prevention (CDC), HHS,
requested that the FDA, HHS, issue an EUA for in vitro diagnostics for
detection of Middle East respiratory syndrome coronavirus (MERS-CoV) to
allow the Department to take preparedness measures based on information
currently available about the Middle East respiratory syndrome
coronavirus (MERS-CoV). The determination of a significant potential
for a public health emergency, and the declaration that circumstances
exist justifying emergency use of in vitro diagnostics for detection of
Middle East respiratory syndrome coronavirus (MERS-CoV) by the
Secretary of HHS, as described below, enable the FDA Commissioner to
issue an EUA for certain in vitro diagnostics for emergency use under
section 564 of the FD&C Act.
II. Determination by the Secretary of Health and Human Services
On May 29, 2013, pursuant to section 564 of the FD&C Act, I
determined that there is a significant potential for a public health
emergency that has a significant potential to affect national security
or the health and security of United States citizens living abroad and
that involves Middle East respiratory syndrome coronavirus (MERS-CoV).
III. Declaration of the Secretary of Health and Human Services
Also on May 29, 2013, on the basis of my determination of a
significant potential for a public health emergency that has a
significant potential to affect national security or the health and
security of United States citizens living
[[Page 33843]]
abroad and that involves Middle East respiratory syndrome coronavirus
(MERS-CoV), I declared that circumstances exist justifying the
authorization of emergency use of in vitro diagnostics for detection of
Middle East respiratory syndrome coronavirus (MERS-CoV) pursuant to
section 564 of the FD&C Act, subject to the terms of any authorization
issued under that section.
Notice of the EUAs issued by the FDA Commissioner pursuant to this
determination and declaration will be provided promptly in the Federal
Register as required under section 564 of the FD&C Act.
Dated May 29, 2013.
Kathleen Sebelius,
Secretary.
[FR Doc. 2013-13333 Filed 6-4-13; 8:45 am]
BILLING CODE 4150-37-P
