Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Ebola Zaire Virus; Availability, 55804-55812 [2014-22086]
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55804
Federal Register / Vol. 79, No. 180 / Wednesday, September 17, 2014 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
21 CFR Section;
[FDA Form No.]
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
314.50(a), (b), (c), (d), (e), (f), (g), (i), (j), (k) and (l)
[356h] ..........................................................................
314.52 ............................................................................
314.95 ............................................................................
314.60 ............................................................................
314.65 ............................................................................
314.70 and 314.71 .........................................................
314.72 ............................................................................
314.81(b)(1) [3331] ........................................................
314.81(b)(2) [2252] ........................................................
314.81(b)(3)(i) [2253] .....................................................
314.94(a) and (d) ...........................................................
314.96 ............................................................................
314.97 ............................................................................
314.99(a) ........................................................................
314.101(a) ......................................................................
314.420 ..........................................................................
314.550 ..........................................................................
106
7
209
277
18
374
66
260
930
520
251
434
306
219
1
524
20
1.42
3
3
8.73
1.16
7.63
2.20
16.31
11.28
87.43
4.73
24.60
18.34
3.01
1
1.98
7
151
21
627
2,419
21
2,854
145
4,241
10,495
45,461
1,186
10,675
5,611
659
1
1,038
140
1,921
16
16
80
2
150
2
8
40
2
480
80
80
2
* .50
61
120
290,071
336
10,032
193,520
42
428,100
290
33,928
419,800
90,922
569,280
854,000
448,880
1,318
.50
63,318
16,800
Total ........................................................................
........................
..........................
........................
..........................
3,420,637.50
There are no capital costs or operating and maintenance costs associated with this collection of information.
* 30 minutes.
Dated: September 11, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–22088 Filed 9–16–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1206]
Authorization of Emergency Use of an
In Vitro Diagnostic Device for
Detection of Ebola Zaire 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 the Ebola Zaire virus
(detected in the West Africa outbreak in
2014). FDA is issuing this Authorization
under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act), as
requested by the U.S. Department of
Defense (DoD). The Authorization
contains, among other things,
conditions on the emergency use of the
authorized in vitro diagnostic device.
The Authorization follows the
September 22, 2006, determination by
then-Secretary of the Department of
Homeland Security (DHS), Michael
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SUMMARY:
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Chertoff, that the Ebola virus presents a
material threat against the U.S.
population sufficient to affect national
security. On the basis of such
determination, the Secretary of Health
and Human Services (HHS) declared on
August 5, 2014, that circumstances exist
justifying the authorization of
emergency use of in vitro diagnostics for
detection of Ebola virus 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 August 5, 2014.
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:
Luciana Borio, Assistant Commissioner
for Counterterrorism Policy, Office of
Counterterrorism and Emerging Threats,
and Acting Deputy Chief Scientist, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 1, Rm. 4340,
Silver Spring, MD 20993–0002, 301–
796–8510 (this is not a toll free number).
SUPPLEMENTARY INFORMATION:
PO 00000
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Fmt 4703
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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 DHS
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
DoD that there is a military emergency,
or a significant potential for a military
emergency, involving a heightened risk
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Federal Register / Vol. 79, No. 180 / Wednesday, September 17, 2014 / Notices
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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 DHS pursuant to
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 Centers
for Disease Control and Prevention (to
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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.
II. EUA Request for an In Vitro
Diagnostic Device for Detection of the
Ebola Zaire Virus
On September 22, 2006, thenSecretary of DHS, Michael Chertoff,
determined that the Ebola virus presents
a material threat against the U.S.
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.
PO 00000
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Sfmt 4703
55805
population sufficient to affect national
security.2 On August 5, 2014, 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 diagnostics for detection of Ebola
virus, subject to the terms of any
authorization issued under section 564
of the FD&C Act. Notice of the
declaration of the Secretary was
published in the Federal Register on
August 12, 2014 (79 FR 47141). On
August 4, 2014, DoD submitted a
complete request for, and on August 5,
2014, FDA issued an EUA for the Ebola
Zaire (Target 1) Real-Time PCR
(TaqMan®) (EZ1 rRT–PCR) Assay,
subject to the terms of this
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 the Ebola Zaire virus
(detected in the West Africa outbreak in
2014) 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
2 Pursuant to section 564(b)(1) of the FD&C Act
(21 U.S.C. 360bbb–3(b)(1)), the HHS Secretary’s
declaration that supports EUA issuance must be
based on one of four determinations, including the
identification by the Secretary of DHS of a material
threat pursuant to section 319F–2 of the PHS Act
sufficient to affect national security or the health
and security of U.S. citizens living abroad (section
564(b)(1)(D) of the FD&C Act).
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Federal Register / Vol. 79, No. 180 / Wednesday, September 17, 2014 / Notices
DEPART111ENT OF HEALTH & HUMAN SERVICES
Drug Administration
MD20993
5, 2014
Dear Dr. Miller:
of the
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the Ebola virus
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of Homeland ""···nri'"'
319.F-2 of the Public Health
a material threat
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tilen-~iecret1arv
'"""~.,.'"'"""''''""ir""" pursuant to section
Federal Register / Vol. 79, No. 180 / Wednesday, September 17, 2014 / Notices
55807
Dr.
virus
in the \Vest Africa outbreak in
to the terms ofthis aut'bo.riZldicm
I. Criteria forlssuauce of Autllorizatiou
emergency use of the EZl rRT·PCR
West Africa
in
for issuance of an authorization under section
because l have concluded that
L
disease
Ebola
c(mdition to humans infected
believe
when used with the
may be effective
diatgnosing Eboia Zaire virus
in the West Africa outbreak in
and !hat
t)OtelltJ,al ba1efi1s of the EZI rRT-PCR
SJ>I~Citied m~;rrumc:nrs for
Ebola Zaire virus
infiection, ""''"'"'"'" the known and
and
and available altemative to the emergency use ofthe
in
West Africa
un1guos.J;ug Ebola Zaire virus
outbreak in
U.
of Authorization
The Authorized .EZI rRT-PCR
1 "~'t"'''"'" in
Trizol-inactivated whole blood or Trizol-inactivnted
from individuals in
and
of Ebola virus infection or who are at risk: for exposure
the
Zaire virus
in the West Africa outbreak
epideJrni<llO;gical risk factors. The test
of nucleic
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regulation under section
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JNo
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Federal Register / Vol. 79, No. 180 / Wednesday, September 17, 2014 / Notices
the ABT 7500 FAST DX instrument, the JBAJDS
instramenl.
instrument,
the
and RNase f'
assay controls:
The EZl rRT-PCR
•
"
RNTC
is a ner~ative control used in the am.nlific:aticm
step demonstrate no reagent contamination,
SNTC '"'"'"'"'~ NlPcn>>ti'··'"' ~v"'""'
step
..
..
extraction
is authorized to be distributed to and used
the fact that it does
the
The above described EZJ rRT~PCR
"""-t"i"l"'"' to the emergency use, which is authorized to
made
pt·c•fe~;sionalls and patients:
Care Providers: Interpreting Ebcla Zaire
l) Real-Time
Results
VerDate Sep<11>2014
Fact Sheet for Patients: Understanding Results from the Ebcla Zaire
Time PCR
Test
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1)
Real~
17SEN1
EN17SE14.004</GPH>
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•
Federal Register / Vol. 79, No. 180 / Wednesday, September 17, 2014 / Notices
information
55809
DoD is also authorized to make available additional
clnergenc:y use of the authorized EZl rRT-PCR
of this letter rot" lmtlu\rii?l>li'm
the
pursuant to section
of the Act, that it is reasonable to believe that the
of the authorized EZl rRT-PCR
the spe,eifi<:d DllUU1am:1n.
pot,ential
presu~:nptivedeteetlon of Ebola Zaire virus (<letecte<t
and
risks of such
cmlcRme•:~,
''"'"""'"''to section
of the Act, based on the
of scientific
reasonable to believe that the authorized EZ l
dtagn<)SlS of Ebola Zaire virus
in the
Attica
intectionnmr~u,.ntto seclion
ofthe Act The FDA has reviewed
to FDA
the inf(lmlaticm sttptxntirlg
and conclude.<~ that the authorized EZ1 rRT-PCR
ofEbola Zaire virus
in the We.<>l Africa outbreak in
,,,,.,,,,, ..rt pOJpulatJ•on, meets the criteria set forth in section
ofthe Act """'""r""
"'"'"'"""' effectiveness.
The emergency use ofthe authQrized EZ! rRT -PCR
under this EUA must be consistent
and may not
the terms ofthis
the
of Authorization
and under
and the Conditions of Authorization
the :se(:retaryofDHS's detennination deseribe<l
and the
the EZl rRT-PCR
(df:tected in the West Africa
and
Ebola
virus infection or who are at risk for eXJX)Sure or may have been
u~::":;;;tt;u in the West Afiica outbreak in 2014) in OOIIJUJnctJion
EUA
to be etlective when the HHS declaration that cm:urr1stana:s
the EUA is terminated under section
ofthe Act or when the EUA
section
ofthe Act
the duration of this
lam
EUA:
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mstockstill on DSK4VPTVN1PROD with NOTICES
""''"'''')';'''"!"''"devices, mc!udmg
except for the intended
ade,qua!e directions
U.S.C.
apJJropriate limitations on the use ofthe
55810
Federal Register / Vol. 79, No. 180 / Wednesday, September 17, 2014 / Notices
5
of Defense
Dr.
IV. Conditions of Authorization
of the
Pursuant
authorization:
am
A.
with
to laboratories ~~,.. 6 •• ~ ...~.
DoD.
R DoD
laboratories
DoD the authorized EZI rRT-PCR
Fact Sheet
Fact Sheet for Health Care Providers and the authorized EZ1 rRT-PCR
for
C DoD will make available on its website the <mthorized EZl rRT-PCR
for Health Care Providers and the autl1orized EZ1 rRT-PCR
Patients.
Fact Sheet
Fact Sheet for
D. DoD will inform laboratories
DoD and relevant
of this
the terms and conditions herein.
DoD
F. DoD
the authorized EZi rRT-PCR
pr<}te:>si<ma.ls and
track adverse events and report to FDA under 21 CFR Part 803.
G.
DoD will maintain records of device
of the assay, and report FDA any
of which DoD becomes
H.
"'"'~"'t1'v'" results
aware.
DoD may request
to the authorized EZl rRT-PCR
Fact
Health Care Providers or the authorized EZl rRT-PCR
Such
will be made DoD in consultation with FDA.
18:24 Sep 16, 2014
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Patients.
17SEN1
EN17SE14.006</GPH>
VerDate Sep<11>2014
DoD is authorized to make available additional information
of the authorized EZl rRT -PCR
that is consistent
terms of this letter of authorization.
l
mstockstill on DSK4VPTVN1PROD with NOTICES
l.
Federal Register / Vol. 79, No. 180 / Wednesday, September 17, 2014 / Notices
55811
DoD
K.
ABI
DoD will have
FAST
to
DoD will collect information 011 the pcrrorma1occ
suspec:ted occun·enee of talse
or false ne:gatxve
DoD
P. DoD and laboratmies u~::~agt~<:nt:u
EUA
DoD will ensure that
associated with this
FDA. Such records will be made available FDA
for lllSI>CCI!On
to the use ot'the
..
VerDate Sep<11>2014
18:24 Sep 16, 2014
This test has been. authorized
outbreak in
the West
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for the detection ofEbola Zaire virus {de:tec:ted in
and not for any other viruses or
and
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"
55812
Federal Register / Vol. 79, No. 180 / Wednesday, September 17, 2014 / Notices
Dr.
7
Depar'tment of Defense
..
rRT-PCR Assay
author'izatio11 must comply \~lith the conditimts and all other
V. Duration of Authorization
etli:::ctive until the declaration !hat circumstances exist"justifjrin;g tlr1e
dilllgnos1jcs fbr detection
EUA is revoked under
Dated: September 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–22086 Filed 9–16–14; 8:45 am]
BILLING CODE 4164–01–C
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Enclosures
]]>Agencies
[Federal Register Volume 79, Number 180 (Wednesday, September 17, 2014)]
[Notices]
[Pages 55804-55812]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22086]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1206]
Authorization of Emergency Use of an In Vitro Diagnostic Device
for Detection of Ebola Zaire 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 the Ebola Zaire
virus (detected in the West Africa outbreak in 2014). FDA is issuing
this Authorization under the Federal Food, Drug, and Cosmetic Act (the
FD&C Act), as requested by the U.S. Department of Defense (DoD). The
Authorization contains, among other things, conditions on the emergency
use of the authorized in vitro diagnostic device. The Authorization
follows the September 22, 2006, determination by then-Secretary of the
Department of Homeland Security (DHS), Michael Chertoff, that the Ebola
virus presents a material threat against the U.S. population sufficient
to affect national security. On the basis of such determination, the
Secretary of Health and Human Services (HHS) declared on August 5,
2014, that circumstances exist justifying the authorization of
emergency use of in vitro diagnostics for detection of Ebola virus
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 August 5, 2014.
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: Luciana Borio, Assistant Commissioner
for Counterterrorism Policy, Office of Counterterrorism and Emerging
Threats, and Acting Deputy Chief Scientist, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4340, 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 DHS 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 DoD that there is a military emergency, or a significant
potential for a military emergency, involving a heightened risk
[[Page 55805]]
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 DHS
pursuant to 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 Centers for Disease Control and
Prevention (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 the
Ebola Zaire Virus
On September 22, 2006, then-Secretary of DHS, Michael Chertoff,
determined that the Ebola virus presents a material threat against the
U.S. population sufficient to affect national security.\2\ On August 5,
2014, 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 diagnostics
for detection of Ebola virus, subject to the terms of any authorization
issued under section 564 of the FD&C Act. Notice of the declaration of
the Secretary was published in the Federal Register on August 12, 2014
(79 FR 47141). On August 4, 2014, DoD submitted a complete request for,
and on August 5, 2014, FDA issued an EUA for the Ebola Zaire (Target 1)
Real-Time PCR (TaqMan[supreg]) (EZ1 rRT-PCR) Assay, subject to the
terms of this authorization.
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\2\ Pursuant to section 564(b)(1) of the FD&C Act (21 U.S.C.
360bbb-3(b)(1)), the HHS Secretary's declaration that supports EUA
issuance must be based on one of four determinations, including the
identification by the Secretary of DHS of a material threat pursuant
to section 319F-2 of the PHS Act sufficient to affect national
security or the health and security of U.S. citizens living abroad
(section 564(b)(1)(D) of the FD&C Act).
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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
detection of the Ebola Zaire virus (detected in the West Africa
outbreak in 2014) 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: September 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22086 Filed 9-16-14; 8:45 am]
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