Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Zika Virus; Availability, 23723-23733 [2016-09370]
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Federal Register / Vol. 81, No. 78 / Friday, April 22, 2016 / Notices
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rubrum and Epidermophyton floccosum
in patients 18 years of age and older.
Subsequent to this approval, the USPTO
received a patent term restoration
application for LUZU (U.S. Patent No.
5,900,488) from Nihon Nohyaku Co.,
Ltd., and the USPTO requested FDA’s
assistance in determining this patent’s
eligibility for patent term restoration. In
a letter dated May 11, 2015, FDA
advised the USPTO that this human
drug product had undergone a
regulatory review period and that the
approval of LUZU represented the first
permitted commercial marketing or use
of the product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
determination regarding whether the
applicant for extension acted with due
diligence during the regulatory review
period. To meet its burden, the petition
must be timely (see DATES) and contain
sufficient facts to merit an FDA
investigation. (See H. Rept. 857, part 1,
98th Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
LUZU is 2,242 days. Of this time, 1,903
days occurred during the testing phase
of the regulatory review period, while
339 days occurred during the approval
phase. These periods of time were
derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 355(i)) became effective:
September 27, 2007. FDA has verified
the Nihon Nohyaku Co., Ltd. claim that
September 27, 2007, is the date the
investigational new drug application
(IND) became effective.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: December 11,
2012. FDA has verified the applicant’s
claim that the new drug application
(NDA) for LUZU (NDA 204153) was
initially submitted on December 11,
2012.
3. The date the application was
approved: November 14, 2013. FDA has
verified the applicant’s claim that NDA
204153 was approved on November 14,
2013.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 1,289 days of patent
term extension.
Dated: April 18, 2016.
Leslie Kux,
Associate Commissioner for Policy.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and ask for a redetermination
(see DATES). Furthermore, any interested
person may petition FDA for a
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[FR Doc. 2016–09374 Filed 4–21–16; 8:45 am]
BILLING CODE 4164–01–P
23723
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.
The Authorization is effective as
of March 17, 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.
DATES:
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
Detection of Zika Virus; 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
detection of Zika virus 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
SUMMARY:
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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 (this is not a toll free
number).
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,
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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,
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360(k), and 360(e)), 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
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.
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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II. EUA Request for an In Vitro
Diagnostic Device for Detection of Zika
Virus
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 March 14, 2016, CDC
requested, and on March 17, 2016, FDA
issued, an EUA for the CDC Trioplex
Real-time RT-PCR Assay (Trioplex rRTPCR), 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
detection of Zika virus 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.
BILLING CODE 4164–01–P
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Centers for Disease Control and Pn;:vention
tor detectton
authorization
I. Criteria for lssulmt·e of Authorizntion
concluded that the emergency use
lilld
or /',ika
infection in thll
issuance
an authorization under section
VlfiJS
M>!Ol:llHCU
virus can caus..:: Zika virus
L The
condition to humans infected with the
or
or scientific evidence availahlll to FDA> it
2.
reasonable to bulicvc
instrument and
when used with the
risk.'! of such
3.
and available altemative to the emergency use
'""'&''""''"& Zika virus infection.
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of Authorization
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u.
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23727
Centers for Disease Control and Pn;:vention
I'RT-PCR
The Authmized
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•
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and P
and
Rand
R a:nd P
•
and
•
•
Posith·e controls for a!!en:t-snocnitc
Inactivated
Inactivated cn:tKlitng:un.ya
lnadivaled Zika virus
•
IU+lase P Primer and Probe Set
sets
pmcess .
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•
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23729
Centers for Disease Control and Pn;:vention
prcg)lilllt women,
•
•
R!!al-
RT-PCR
,.,,,,"'""'"' Real-
•
Time
FDA has reviewed the scientific information available to
infonnation
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when the
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Centers for Disease Control and Pn;:vention
under s.;ction
of thtl i\ct.
rRT-PCR
IV. Conditions of Authorization
Pursuant to section
~Jondit ions
ofth~J
on
this authorization:
Centers for Disease Control and Prevention
CDC will distribute the authorized
rRT-PCR with
may be revised
CDC in consultation with FDA,
to authorized laboratories<
H.
Women, and the authorized
rRT-PCR Fad Sheet for Patients.
C. CDC will make available on its website the authorized
rRT-PCR Fact Sheet
for Health Care
the authorized
Fa!,lt Sheet for •-r"""''"''
and the authorized
rRT-PCR Fact Sheet for Patients.
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to
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under
health
Part
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D. CDC will infonn authorized laboratories and relevant
fbis
Federal Register / Vol. 81, No. 78 / Friday, April 22, 2016 / Notices
23731
Centers for Disease Control and Pn;:vention
control, CDC
G.
maintain records of devic.:
II.
authorized make avaih<ble additional '"'·"~'"''~<"·"
of the authorized
rRT-PCR tlmt is''"'"'"""·''"'
the tem1s ofthis letter (if authorization.
CDC
J.
and the authorized
made
CDC
request the addition
PCR instruments
rRT-PCR.
requests will be made
concun·encc of, FDA.
L.
the addition
rRT-PCR. Such requests will be made
concurrence of,
M. CDC may request the addition of other Rn•>"i'"'""
u1vv:'"'" rRT-PCR. Such requests
be made
concun·ence
and
FDA.
CDC will
reference standard when the
material ne•:on11es av.ruu•u''"·
FDA and
of and concurrence with
to reflect the additional
Authorized Laboratories
0. Authorized laboratories will include
the authorized Fact Sheet for Health Care I'Nlvmers
Prr•onqnt Women, and the authorized Fact Sheet for Patients. Under
"'"'"'"'""''"'"'"'' other
methods for
include mass media.
P. Authorized laboratories will
be
these
the
7500
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material.
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Centers for Disease Control and Pn;:vention
health
CDC and authorized
IU!llll114UilCU Until
the use ofthe
'Ihis lest ha<: been authorized
This
FDA under an
for
authorized
for the detection and ditlerentiation
from
other
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tenninated or revoked sooner.
Federal Register / Vol. 81, No. 78 / Friday, April 22, 2016 / Notices
produce grown in fields or other
growing areas amended with untreated
biological soil amendments of animal
origin (including raw manure). We are
taking this action for an extension to
allow interested persons additional time
to submit comments.
[FR Doc. 2016–09370 Filed 4–21–16; 8:45 am]
BILLING CODE 4164–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DATES:
Food and Drug Administration
ADDRESSES:
Submit either electronic or
written comments by July 5, 2016.
[Docket No. FDA–2016–N–0321]
Risk Assessment of Foodborne Illness
Associated With Pathogens From
Produce Grown in Fields Amended
With Untreated Biological Soil
Amendments of Animal Origin;
Request for Scientific Data,
Information, and Comments; Extension
of Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Notice; request for comments
and for scientific data and information;
extension of comment period.
ACTION:
The Food and Drug
Administration (FDA or we) is
extending the comment period for the
notice entitled ‘‘Risk Assessment of
Foodborne Illness Associated With
Pathogens From Produce Grown in
Fields Amended With Untreated
Biological Soil Amendments of Animal
Origin; Request for Scientific Data,
Information, and Comments’’ that
appeared in the Federal Register of
March 4, 2016. The notice requested
scientific data, information, and
comments that would assist in the
development of a risk assessment for
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SUMMARY:
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You may submit comments
as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• 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
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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–N–0321 for ‘‘Risk Assessment of
Foodborne Illness Associated With
Pathogens From Produce Grown in
Fields Amended With Untreated
Biological Soil Amendments of Animal
Origin; Request for Scientific Data,
Information, and Comments.’’ 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
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Dated: April 18, 2016.
Leslie Kux,
Associate Commissioner for Policy.
23733
]]>Agencies
[Federal Register Volume 81, Number 78 (Friday, April 22, 2016)]
[Notices]
[Pages 23723-23733]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09370]
-----------------------------------------------------------------------
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 Detection of Zika Virus; 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 detection of Zika virus 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 March 17, 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 (this is not a toll free number).
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,
[[Page 23724]]
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 360(e)), 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 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.
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\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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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 Detection of Zika
Virus
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 March 14, 2016, CDC requested, and on
March 17, 2016, FDA issued, an EUA for the CDC Trioplex Real-time RT-
PCR Assay (Trioplex rRT-PCR), 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
detection of Zika virus 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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Dated: April 18, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-09370 Filed 4-21-16; 8:45 am]
BILLING CODE 4164-01-C
