Determination and Declaration Regarding Emergency Use of in Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection, 10878-10879 [2016-04624]
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10878
Federal Register / Vol. 81, No. 41 / Wednesday, March 2, 2016 / Notices
September 18, 2014, authority was given
to the Secretary of Health and Human
Services to establish the Presidential
Advisory Council on Combating
Antibiotic-Resistant Bacteria (Advisory
Council), in consultation with the
Secretaries of Defense (DoD) and
Agriculture (USDA). Activities of the
Advisory Council are governed by the
provisions of Public Law 92–463, as
amended (5 U.S.C. App.), which sets
forth standards for the formation and
use of federal advisory committees.
The Advisory Council will provide
advice, information, and
recommendations to the Secretary of
HHS regarding programs and policies
intended to support and evaluate the
implementation of Executive Order
13676, including the National Strategy
for Combating Antibiotic-Resistant
Bacteria (Strategy) and the National
Action Plan for Combating AntibioticResistant Bacteria (Action Plan). The
Advisory Council shall function solely
for advisory purposes.
In carrying out its mission, the
Advisory Council will provide advice,
information, and recommendations to
the Secretary regarding programs and
policies intended to preserve the
effectiveness of antibiotics by
optimizing their use; advance research
to develop improved methods for
combating antibiotic resistance and
conducting antibiotic stewardship;
strengthen surveillance of antibioticresistant bacterial infections; prevent
the transmission of antibiotic-resistant
bacterial infections; advance the
development of rapid point-of-care and
agricultural diagnostics; further research
on new treatments for bacterial
infections; develop alternatives to
antibiotics for agricultural purposes;
maximize the dissemination of up-todate information on the appropriate and
proper use of antibiotics to the general
public and human and animal
healthcare providers; and improve
international coordination of efforts to
combat antibiotic resistance.
The March public meeting will be
dedicated to presentations by the five
currently active working groups of the
Advisory Council, which are: Antibiotic
Stewardship; One Health Surveillance;
Diagnostic Innovations; Treatment,
Prevention and Control Research and
Development; and International
Collaboration on Combating AntibioticResistant Bacteria (CARB). The
Advisory Council will deliberate and
vote on the working groups’ findings
and recommendations. In addition, the
Advisory Council will be presented
with a new task(s) from the Secretary of
HHS, in consultation with USDA and
DoD. The meeting agenda will be posted
VerDate Sep<11>2014
19:10 Mar 01, 2016
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on the Advisory Council Web site at
https://www.hhs.gov/ash/carb when it
has been finalized.
Public attendance at the meeting is
limited to the available space.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Advisory Council at the
address/telephone number listed above
at least one week prior to the meeting.
For those unable to attend in person, a
live webcast will be available. More
information on registration and
accessing the webcast can be found at
https://www.hhs.gov/ash/carb/.
Members of the public will have the
opportunity to provide comments prior
to the Advisory Council meeting by
emailing CARB@hhs.gov. Public
comments should be sent in by
midnight March 21, 2016, and should be
limited to no more than one page. All
public comments received prior to
March 21, 2016, will be provided to
Advisory Council members and read
during the public comment period
designated on the agenda; comments are
limited to two minutes per speaker.
Dated: February 25, 2016.
Bruce Gellin,
Designated Federal Officer, Presidential
Advisory Council on Combating AntibioticResistant Bacteria, Deputy Assistant Secretary
for Health.
[FR Doc. 2016–04473 Filed 3–1–16; 8:45 am]
BILLING CODE 4150–44–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Determination and Declaration
Regarding Emergency Use of in Vitro
Diagnostic Tests for Detection of Zika
Virus and/or Diagnosis of Zika Virus
Infection
Office of the Secretary,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
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
February 26, 2016, 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 Zika virus.
On the basis of this determination,
she also declared that circumstances
exist justifying the authorization of
SUMMARY:
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emergency use of in vitro diagnostic
tests for detection of Zika virus and/or
diagnosis of Zika virus infection
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 February 26,
2016.
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 of HHS
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
1 42
U.S.C. 247d–6b.
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02MRN1
Federal Register / Vol. 81, No. 41 / Wednesday, March 2, 2016 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
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)
requested that the FDA issue an EUA for
in vitro diagnostic tests for detection of
Zika virus and/or diagnosis of Zika
virus infection to allow the Department
to take preparedness measures based on
information currently available about
the active transmission of Zika virus, as
of February 24, 2016, in the
Commonwealth of Puerto Rico, the U.S.
Virgin Islands, American Samoa, 31
countries in the Americas, Pacific
Islands, and Africa. On February 1,
2016, the World Health Organization
declared a Public Health Emergency of
International Concern because of
clusters of microcephaly and other
neurological disorders in some areas
affected by Zika virus. On January 22,
2016, CDC activated its Incident
Management System and, working
through the Emergency Operations
Center, centralized its response to the
outbreaks of Zika occurring in the
Americas and increased reports of birth
´
defects and Guillain-Barre syndrome in
areas affected by Zika virus. On
February 8, 2016, CDC elevated its
response efforts to a Level 1 activation,
the highest response level. The
Secretary’s Operations Center, which is
operated by the Office of the Assistant
Secretary of Preparedness and
Response, is also activated. The
determination of a significant potential
for a public health emergency, and the
declaration that circumstances exist
justifying the authorization of
emergency use of in vitro diagnostic
tests for detection of Zika virus and/or
diagnosis of Zika virus infection by the
Secretary of HHS, as described below,
enable the FDA Commissioner to issue
an EUA for certain diagnostic tests for
emergency use under section 564 of the
FD&C Act.
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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19:10 Mar 01, 2016
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II. Determination by the Secretary of
Health and Human Services
On February 26, 2016, pursuant to
section 564 of the FD&C Act, I
determined that a 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 Zika virus.
III. Declaration of the Secretary of
Health and Human Services
Also on February 26, 2016, 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 abroad and that involves
Zika virus, I declared that circumstances
exist justifying the authorization of
emergency use of in vitro diagnostic
tests for detection of Zika virus and/or
diagnosis of Zika virus infection
pursuant to section 564 of the FD&C
Act, subject to the terms of any
authorization issued under that section.
Notice of any 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: February 26, 2016.
Sylvia M. Burwell,
Secretary.
[FR Doc. 2016–04624 Filed 3–1–16; 8:45 am]
BILLING CODE 4150–37–P
DEPARTMENT OF HOMELAND
SECURITY
[Docket No. DHS–DHS–2016–0019]
Agency Information Collection
Activities: Submission for Review;
Information Collection Request for the
Department of Homeland Security
Science & Technology Technology
Acceptance and Evaluation Survey
Science and Technology
Directorate, DHS.
ACTION: 60-Day notice and request for
comment.
AGENCY:
The Department of Homeland
Security (DHS) invites the general
public to comment on the data
collection form for the DHS Science &
Technology Directorate (S&T)
Technology Acceptance and Evaluation
(TAE) Survey. The TAE web based tool
proposes to collect information from
1,200 members of an online Internet
panel. All information collected will be
on a voluntary basis. DHS will not
SUMMARY:
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10879
receive any personally identifying
information. As part of its core mission,
DHS is tasked with preventing terrorism
and enhancing security, securing and
managing our borders, and ensuring
resilience to disasters. In order to assist
in those key mission spaces, the S&T
managed work to create a Rapid DNA
Technology that allows field testing of
DNA that is inexpensive and quick
while performing with high accuracy in
a non-laboratory setting. To ensure the
effective implementation and diffusion
of this new technology, DHS S&T seeks
to better understand public perceptions
of Rapid DNA, its use cases, and its
collection through the TAE Survey. This
notice and request for comments is
required by the Paperwork Reduction
Act of 1995 (Pub. L. 104–13, 44 U.S.C.
chapter 35).
DATES: Comments are encouraged and
will be accepted until May 2, 2016.
ADDRESSES: Interested persons are
invited to submit comments, identified
by docket number DHS–2016–0019, by
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Please follow the
instructions for submitting comments.
• Email:
Kathleen.Deloughery@hq.dhs.gov.
Please include docket number DHS–
DHS–2016–0019 in the subject line of
the message.
• Fax: (202) 254–6911. (Not a toll-free
number).
• Mail: Science and Technology
Directorate, ATTN: Kathleen
Deloughery 6–055, 245 Murray Lane,
Mail Stop 0210, Washington, DC 20528–
0210.
FOR FURTHER INFORMATION CONTACT: DHS
FRCoP Contact Kathleen Deloughery
(202) 254–6189 (Not a toll free number).
SUPPLEMENTARY INFORMATION: The
Department is committed to improving
its information collection and urges all
interested parties to suggest how these
materials can further reduce burden
while seeking necessary information
under the Act.
DHS is particularly interested in
comments that:
(1) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
(2) Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(3) Suggest ways to enhance the
quality, utility, and clarity of the
information to be collected; and
E:\FR\FM\02MRN1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 41 (Wednesday, March 2, 2016)]
[Notices]
[Pages 10878-10879]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04624]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Determination and Declaration Regarding Emergency Use of in Vitro
Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika
Virus Infection
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 February 26, 2016, 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 Zika virus.
On the basis of this determination, she also declared that
circumstances exist justifying the authorization of emergency use of in
vitro diagnostic tests for detection of Zika virus and/or diagnosis of
Zika virus infection 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 February 26,
2016.
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 of HHS 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
[[Page 10879]]
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) requested that the
FDA issue an EUA for in vitro diagnostic tests for detection of Zika
virus and/or diagnosis of Zika virus infection to allow the Department
to take preparedness measures based on information currently available
about the active transmission of Zika virus, as of February 24, 2016,
in the Commonwealth of Puerto Rico, the U.S. Virgin Islands, American
Samoa, 31 countries in the Americas, Pacific Islands, and Africa. On
February 1, 2016, the World Health Organization declared a Public
Health Emergency of International Concern because of clusters of
microcephaly and other neurological disorders in some areas affected by
Zika virus. On January 22, 2016, CDC activated its Incident Management
System and, working through the Emergency Operations Center,
centralized its response to the outbreaks of Zika occurring in the
Americas and increased reports of birth defects and Guillain-
Barr[eacute] syndrome in areas affected by Zika virus. On February 8,
2016, CDC elevated its response efforts to a Level 1 activation, the
highest response level. The Secretary's Operations Center, which is
operated by the Office of the Assistant Secretary of Preparedness and
Response, is also activated. The determination of a significant
potential for a public health emergency, and the declaration that
circumstances exist justifying the authorization of emergency use of in
vitro diagnostic tests for detection of Zika virus and/or diagnosis of
Zika virus infection by the Secretary of HHS, as described below,
enable the FDA Commissioner to issue an EUA for certain diagnostic
tests for emergency use under section 564 of the FD&C Act.
II. Determination by the Secretary of Health and Human Services
On February 26, 2016, pursuant to section 564 of the FD&C Act, I
determined that a 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 Zika virus.
III. Declaration of the Secretary of Health and Human Services
Also on February 26, 2016, 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 abroad and that involves Zika
virus, I declared that circumstances exist justifying the authorization
of emergency use of in vitro diagnostic tests for detection of Zika
virus and/or diagnosis of Zika virus infection pursuant to section 564
of the FD&C Act, subject to the terms of any authorization issued under
that section.
Notice of any 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: February 26, 2016.
Sylvia M. Burwell,
Secretary.
[FR Doc. 2016-04624 Filed 3-1-16; 8:45 am]
BILLING CODE 4150-37-P
