Authorization of Emergency Use of an In Vitro Diagnostic Device for Diagnosis of Zika Virus Infection; Availability, 17170-17180 [2016-06888]
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17170
Federal Register / Vol. 81, No. 59 / Monday, March 28, 2016 / Notices
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0969]
Authorization of Emergency Use of an
In Vitro Diagnostic Device for
Diagnosis of Zika Virus Infection;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of an Emergency Use
Authorization (EUA) (the Authorization)
for an in vitro diagnostic device for
diagnosis of Zika virus infection in
response to the Zika virus outbreak in
the Americas. FDA issued this
Authorization under the Federal Food,
Drug, and Cosmetic Act (the FD&C Act),
as requested by the U.S. Centers for
Disease Control and Prevention (CDC).
The Authorization contains, among
other things, conditions on the
emergency use of the authorized in vitro
diagnostic device. The Authorization
follows the February 26, 2016,
determination by the Department of
Health and Human Services (HHS)
Secretary 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 U.S. citizens living abroad
and that involves Zika virus. On the
basis of such determination, the HHS
Secretary declared on February 26,
2016, 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 subject to the terms of
any authorization issued under the
FD&C Act. The Authorization, which
includes an explanation of the reasons
for issuance, is reprinted in this
document.
SUMMARY:
The Authorization is effective as
of February 26, 2016.
ADDRESSES: Submit written requests for
single copies of the EUA to the Office
of Counterterrorism and Emerging
Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1,
Rm. 4338, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your request or include a fax number to
which the Authorization may be sent.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the
Authorization.
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DATES:
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Carmen Maher, Office of
Counterterrorism and Emerging Threats,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 1, Rm.
4347, Silver Spring, MD 20993–0002,
301–796–8510.
SUPPLEMENTARY INFORMATION:
I. Background
Section 564 of the FD&C Act (21
U.S.C. 360bbb–3) as amended by the
Project BioShield Act of 2004 (Pub. L.
108–276) and the Pandemic and AllHazards Preparedness Reauthorization
Act of 2013 (Pub. L. 113–5) allows FDA
to strengthen the public health
protections against biological, chemical,
nuclear, and radiological agents. Among
other things, section 564 of the FD&C
Act allows FDA to authorize the use of
an unapproved medical product or an
unapproved use of an approved medical
product in certain situations. With this
EUA authority, FDA can help assure
that medical countermeasures may be
used in emergencies to diagnose, treat,
or prevent serious or life-threatening
diseases or conditions caused by
biological, chemical, nuclear, or
radiological agents; when there are no
adequate, approved, and available
alternatives.
Section 564(b)(1) of the FD&C Act
provides that, before an EUA may be
issued, the Secretary of HHS must
declare that circumstances exist
justifying the authorization based on
one of the following grounds: (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 biological, chemical, radiological,
or nuclear agent or agents; (2) 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 U.S. military forces of
attack with a biological, chemical,
radiological, or nuclear agent or agents;
(3) 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 U.S. citizens living abroad,
and that involves a biological, chemical,
radiological, or nuclear agent or agents,
or a disease or condition that may be
attributable to such agent or agents; or
(4) the identification of a material threat
by the Secretary of Homeland Security
under section 319F–2 of the Public
Health Service (PHS) Act (42 U.S.C.
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247d–6b) sufficient to affect national
security or the health and security of
U.S. citizens living abroad.
Once the Secretary of HHS has
declared that circumstances exist
justifying an authorization under
section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug,
device, or biological product if the
Agency concludes that the statutory
criteria are satisfied. Under section
564(h)(1) of the FD&C Act, FDA is
required to publish in the Federal
Register a notice of each authorization,
and each termination or revocation of an
authorization, and an explanation of the
reasons for the action. Section 564 of the
FD&C Act permits FDA to authorize the
introduction into interstate commerce of
a drug, device, or biological product
intended for use when the Secretary of
HHS has declared that circumstances
exist justifying the authorization of
emergency use. Products appropriate for
emergency use may include products
and uses that are not approved, cleared,
or licensed under sections 505, 510(k),
or 515 of the FD&C Act (21 U.S.C. 355,
360(k), and 360e) or section 351 of the
PHS Act (42 U.S.C. 262). FDA may issue
an EUA only if, after consultation with
the HHS Assistant Secretary for
Preparedness and Response, the
Director of the National Institutes of
Health, and the Director of the CDC (to
the extent feasible and appropriate
given the applicable circumstances),
FDA 1 concludes: (1) That an agent
referred to in a declaration of emergency
or threat can cause a serious or lifethreatening disease or condition; (2)
that, based on the totality of scientific
evidence available to FDA, including
data from adequate and well-controlled
clinical trials, if available, it is
reasonable to believe that: (A) The
product may be effective in diagnosing,
treating, or preventing (i) such disease
or condition; or (ii) a serious or lifethreatening disease or condition caused
by a product authorized under section
564, approved or cleared under the
FD&C Act, or licensed under section 351
of the PHS Act, for diagnosing, treating,
or preventing such a disease or
condition caused by such an agent; and
(B) the known and potential benefits of
the product, when used to diagnose,
prevent, or treat such disease or
condition, outweigh the known and
potential risks of the product, taking
into consideration the material threat
posed by the agent or agents identified
in a declaration under section
564(b)(1)(D) of the FD&C Act, if
1 The Secretary of HHS has delegated the
authority to issue an EUA under section 564 of the
FD&C Act to the Commissioner of Food and Drugs.
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Federal Register / Vol. 81, No. 59 / Monday, March 28, 2016 / Notices
applicable; (3) that there is no adequate,
approved, and available alternative to
the product for diagnosing, preventing,
or treating such disease or condition;
and (4) that such other criteria as may
be prescribed by regulation are satisfied.
No other criteria for issuance have
been prescribed by regulation under
section 564(c)(4) of the FD&C Act.
Because the statute is self-executing,
regulations or guidance are not required
for FDA to implement the EUA
authority.
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II. EUA Request for an In Vitro
Diagnostic Device for Diagnosis of Zika
Virus Infection
On February 26, 2016, the Secretary of
HHS 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 U.S. citizens
VerDate Sep<11>2014
14:52 Mar 25, 2016
Jkt 238001
living abroad and that involves Zika
virus. On February 26, 2016, under
section 564(b)(1) of the FD&C Act, and
on the basis of such determination, the
Secretary of HHS 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, subject to the terms of
any authorization issued under section
564 of the FD&C Act. Notice of the
determination and declaration of the
Secretary was published in the Federal
Register on March 2, 2016 (81 FR
10878). On February 22, 2016, CDC
requested, and on February 26, 2016,
FDA issued, an EUA for the CDC Zika
Immunoglobulin M (IgM) Antibody
Capture Enzyme-Linked Immunosorbent
Assay (Zika MAC–ELISA), subject to the
terms of the Authorization.
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III. Electronic Access
An electronic version of this
document and the full text of the
Authorization are available on the
Internet at https://www.regulations.gov.
IV. The Authorization
Having concluded that the criteria for
issuance of the Authorization under
section 564(c) of the FD&C Act are met,
FDA has authorized the emergency use
of an in vitro diagnostic device for
diagnosis of Zika virus infection subject
to the terms of the Authorization. The
Authorization in its entirety (not
including the authorized versions of the
fact sheets and other written materials)
follows and provides an explanation of
the reasons for its issuance, as required
by section 564(h)(1) of the FD&C Act:
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I. Criteria for Issuance of Authorization
L
to
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of Authorization
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H.
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The Authorized Zika MAC·ELISA
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Dr. Frieden .
•
ELISA.
The Zika
in
..
..
•
.
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IV. Conditions of Authorization
Centers for Disease Control and Prevention
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B.
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G.
H.
M.
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Authorized Laboratories
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8 Dr.
CDC and Authorized Laboratories
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T.
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Federal Register / Vol. 81, No. 59 / Monday, March 28, 2016 / Notices
Dated: March 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–06888 Filed 3–25–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
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Statement of Organization, Functions
and Delegations of Authority
This notice amends Part R of the
Statement of Organization, Functions
and Delegations of Authority of the
Department of Health and Human
Services (HHS), Health Resources and
Services Administration (HRSA) (60 FR
56605, as amended November 6, 1995;
as last amended at 81 FR 10874–10875
dated March 2, 2016).
This notice reflects organizational
changes in the Health Resources and
Services Administration (HRSA), Office
of Operations (RB), Office of
Information Technology (RB5).
Specifically, this notice: (1) Updates the
functional statement for the Office of the
Director, Office of Information
Technology (RB5); and (2) updates the
functional statement for the Division of
Enterprise Solutions and Applications
Management (RB56) within the Office of
Information Technology (RB5).
Chapter RB5—Office of Information
Technology
Section RQ–20, Function
Delete the functional statement for the
Office of the Director (RB5) and for the
Division of Enterprise Solutions and
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Applications Management (RB56) and
replace in their entirety.
This notice reflects organizational
changes in the Health Resources and
Services Administration (HRSA), Office
of Operations (RB), Office of
Information Technology (RB5).
Specifically, this notice: (1) Updates the
functional statement for the Office of the
Director (RB5); and (2) updates the
functional statement for the Division of
Enterprise Solutions and Applications
Management (RB56) within the Office of
Information Technology (RB5).
Office of the Director and Chief
Information Officer (RB5)
The Office of Information Technology
is responsible for the organization,
management, and administrative
functions necessary to carry out
responsibilities including: (1)
Architects, deploys, and supports IT
infrastructure; (2) provides IT end user
support; (3) develops enterprise and
custom applications; (4) provides
investment control, budget formulation
and execution, policy development,
strategic and tactical planning, and
performance monitoring; (5) provides
leadership in the development, review,
and implementation of policies and
procedures to promote improved
information technology (IT)
management capabilities and best
practices throughout HRSA; (6)
coordinates IT workforce issues and
works closely with the Office of
Administrative Services on IT
recruitment and training issues; and (7)
oversees HRSA security operations and
management program.
The Office of the Director is also
responsible for the IT business function
including: (1) Provides oversight and
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management of IT budget formulation
and execution; (2) serves as the focal
point to OIT’s contracts; (3) provides
centralized procurement services for the
Office of Information Technology; and
(4) serves as the coordinator for OIT’s
Inter-agency and Service Level
Agreements.
Chief Information Security Officer
The Chief Information Security
Officer, reporting to the Chief
Information Officer, provides leadership
for and collaborates with Agency staff to
oversee the implementation of security
and privacy policy in the management
of their IT systems, and plans all
activities associated with the Federal
Information Security Management Act
or other Agency security and privacy
initiatives including: (1) Implements,
coordinates, and administers security
and privacy programs to protect the
information resources of HRSA in
compliance with legislation, Executive
Orders, directives of the Office of
Management and Budget, or other
mandated requirements; (2) executes the
Agency’s Risk Management Program,
and evaluates and assists with the
implementation of safeguards to protect
major information systems and IT
infrastructure; and (3) manages the
development, implementation, and
evaluation of HRSA’s information
technology security and privacy training
programs to meet requirements
mandated by the Office of Management
and Budget.
Division of Enterprise Solutions and
Applications Management (RB56)
The Division of Enterprise Solutions
and Applications Management
(DESAM) develops the HRSA grants
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BILLING CODE 4164–01–C
Agencies
[Federal Register Volume 81, Number 59 (Monday, March 28, 2016)]
[Notices]
[Pages 17170-17180]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-06888]
[[Page 17170]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0969]
Authorization of Emergency Use of an In Vitro Diagnostic Device
for Diagnosis of Zika Virus Infection; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of an Emergency Use Authorization (EUA) (the Authorization)
for an in vitro diagnostic device for diagnosis of Zika virus infection
in response to the Zika virus outbreak in the Americas. FDA issued this
Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C
Act), as requested by the U.S. Centers for Disease Control and
Prevention (CDC). The Authorization contains, among other things,
conditions on the emergency use of the authorized in vitro diagnostic
device. The Authorization follows the February 26, 2016, determination
by the Department of Health and Human Services (HHS) Secretary 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 U.S. citizens living abroad and that involves Zika virus.
On the basis of such determination, the HHS Secretary declared on
February 26, 2016, 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
subject to the terms of any authorization issued under the FD&C Act.
The Authorization, which includes an explanation of the reasons for
issuance, is reprinted in this document.
DATES: The Authorization is effective as of February 26, 2016.
ADDRESSES: Submit written requests for single copies of the EUA to the
Office of Counterterrorism and Emerging Threats, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a fax number to which
the Authorization may be sent. See the SUPPLEMENTARY INFORMATION
section for electronic access to the Authorization.
FOR FURTHER INFORMATION CONTACT: Carmen Maher, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4347, Silver Spring, MD 20993-
0002, 301-796-8510.
SUPPLEMENTARY INFORMATION:
I. Background
Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the
Project BioShield Act of 2004 (Pub. L. 108-276) and the Pandemic and
All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5)
allows FDA to strengthen the public health protections against
biological, chemical, nuclear, and radiological agents. Among other
things, section 564 of the FD&C Act allows FDA to authorize the use of
an unapproved medical product or an unapproved use of an approved
medical product in certain situations. With this EUA authority, FDA can
help assure that medical countermeasures may be used in emergencies to
diagnose, treat, or prevent serious or life-threatening diseases or
conditions caused by biological, chemical, nuclear, or radiological
agents; when there are no adequate, approved, and available
alternatives.
Section 564(b)(1) of the FD&C Act provides that, before an EUA may
be issued, the Secretary of HHS must declare that circumstances exist
justifying the authorization based on one of the following grounds: (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 biological,
chemical, radiological, or nuclear agent or agents; (2) 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 U.S. military forces of attack with a biological, chemical,
radiological, or nuclear agent or agents; (3) 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 U.S. citizens living abroad, and that involves a
biological, chemical, radiological, or nuclear agent or agents, or a
disease or condition that may be attributable to such agent or agents;
or (4) the identification of a material threat by the Secretary of
Homeland Security under section 319F-2 of the Public Health Service
(PHS) Act (42 U.S.C. 247d-6b) sufficient to affect national security or
the health and security of U.S. citizens living abroad.
Once the Secretary of HHS has declared that circumstances exist
justifying an authorization under section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug, device, or biological product if
the Agency concludes that the statutory criteria are satisfied. Under
section 564(h)(1) of the FD&C Act, FDA is required to publish in the
Federal Register a notice of each authorization, and each termination
or revocation of an authorization, and an explanation of the reasons
for the action. Section 564 of the FD&C Act permits FDA to authorize
the introduction into interstate commerce of a drug, device, or
biological product intended for use when the Secretary of HHS has
declared that circumstances exist justifying the authorization of
emergency use. Products appropriate for emergency use may include
products and uses that are not approved, cleared, or licensed under
sections 505, 510(k), or 515 of the FD&C Act (21 U.S.C. 355, 360(k),
and 360e) or section 351 of the PHS Act (42 U.S.C. 262). FDA may issue
an EUA only if, after consultation with the HHS Assistant Secretary for
Preparedness and Response, the Director of the National Institutes of
Health, and the Director of the CDC (to the extent feasible and
appropriate given the applicable circumstances), FDA \1\ concludes: (1)
That an agent referred to in a declaration of emergency or threat can
cause a serious or life-threatening disease or condition; (2) that,
based on the totality of scientific evidence available to FDA,
including data from adequate and well-controlled clinical trials, if
available, it is reasonable to believe that: (A) The product may be
effective in diagnosing, treating, or preventing (i) such disease or
condition; or (ii) a serious or life-threatening disease or condition
caused by a product authorized under section 564, approved or cleared
under the FD&C Act, or licensed under section 351 of the PHS Act, for
diagnosing, treating, or preventing such a disease or condition caused
by such an agent; and (B) the known and potential benefits of the
product, when used to diagnose, prevent, or treat such disease or
condition, outweigh the known and potential risks of the product,
taking into consideration the material threat posed by the agent or
agents identified in a declaration under section 564(b)(1)(D) of the
FD&C Act, if
[[Page 17171]]
applicable; (3) that there is no adequate, approved, and available
alternative to the product for diagnosing, preventing, or treating such
disease or condition; and (4) that such other criteria as may be
prescribed by regulation are satisfied.
---------------------------------------------------------------------------
\1\ The Secretary of HHS has delegated the authority to issue an
EUA under section 564 of the FD&C Act to the Commissioner of Food
and Drugs.
---------------------------------------------------------------------------
No other criteria for issuance have been prescribed by regulation
under section 564(c)(4) of the FD&C Act. Because the statute is self-
executing, regulations or guidance are not required for FDA to
implement the EUA authority.
II. EUA Request for an In Vitro Diagnostic Device for Diagnosis of Zika
Virus Infection
On February 26, 2016, the Secretary of HHS 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 U.S. citizens living abroad and that involves Zika virus.
On February 26, 2016, under section 564(b)(1) of the FD&C Act, and on
the basis of such determination, the Secretary of HHS 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, subject to the terms of any authorization issued
under section 564 of the FD&C Act. Notice of the determination and
declaration of the Secretary was published in the Federal Register on
March 2, 2016 (81 FR 10878). On February 22, 2016, CDC requested, and
on February 26, 2016, FDA issued, an EUA for the CDC Zika
Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent
Assay (Zika MAC-ELISA), subject to the terms of the Authorization.
III. Electronic Access
An electronic version of this document and the full text of the
Authorization are available on the Internet at https://www.regulations.gov.
IV. The Authorization
Having concluded that the criteria for issuance of the
Authorization under section 564(c) of the FD&C Act are met, FDA has
authorized the emergency use of an in vitro diagnostic device for
diagnosis of Zika virus infection subject to the terms of the
Authorization. The Authorization in its entirety (not including the
authorized versions of the fact sheets and other written materials)
follows and provides an explanation of the reasons for its issuance, as
required by section 564(h)(1) of the FD&C Act:
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BILLING CODE 4164-01-C
Dated: March 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-06888 Filed 3-25-16; 8:45 am]
BILLING CODE 4164-01-P