Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Ebola virus; Availability, 3785-3795 [2019-02134]
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Federal Register / Vol. 84, No. 30 / Wednesday, February 13, 2019 / Notices
Prevention and the Agency for Toxic
Substances and Disease Registry.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Sherri Berger,
Chief Operating Officer, Centers for Disease
Control and Prevention.
Centers for Disease Control and
Prevention
Food and Drug Administration
Notice of Closed Meeting
Authorization of Emergency Use of an
In Vitro Diagnostic Device for
Detection of Ebola virus; Availability
[FR Doc. 2019–02165 Filed 2–12–19; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP)—Funding
Opportunity Announcement (FOA),
PAR 16–098, Cooperative Research
Agreements to the World Trade Center
Health Program (U01); Amended
Notice of Meeting
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3785
Notice is hereby given of a change in
the meeting of the Disease, Disability,
and Injury Prevention and Control
Special Emphasis Panel (SEP)—
Funding Opportunity Announcement
(FOA), PAR 16–098, Cooperative
Research Agreements to the World
Trade Center Health Program (U01);
Dates and Times: March 27, 2019, 8:00
a.m.–5:00 p.m., EDT and March 28,
2019, 8:00 a.m.–12:00 p.m., EDT.
Hampton Inn & Suites Atlanta
Buckhead, 3312 Piedmont Road,
Atlanta, Georgia 30305, which was
published in the Federal Register on
January 31, 2019, Volume 84, Number
21, pages 730.
The meeting is being amended to
Atlanta Marriott Buckhead Hotel &
Conference Center, 3405 Lenox Road
NE, Atlanta, GA 30326, Telephone:
(404) 261–9250. The meeting is closed
to the public.
For Further Information Contact: Nina
Turner, Ph.D., Scientific Review Officer,
CDC/NIOSH, 1095 Willowdale Road,
Mailstop L1055, Morgantown, West
Virginia 26505, Telephone: (304) 285–
5975, nxt2@cdc.gov.
The Chief Operating Officer, Centers
for Disease Control and Prevention, has
been delegated the authority to sign
Federal Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended, and Determination of the
Chief Operating Officer, Centers for
Disease Control and Prevention,
pursuant to Public Law 92–463. The
grant applications and the discussions
could disclose confidential trade secrets
or commercial property such as
patentable material, and personal
information concerning individuals
associated with the grant applications,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Disease, Disability,
and Injury Prevention and Control Special
Emphasis Panel (SEP)—SIP19–004, Cancer
Prevention and Control Research Network
Coordinating Center and SIP19–005, Cancer
Prevention and Control Research Network
Collaborating Center.
Dates: April 30, 2019–May 1, 2019.
Times: 10:00 a.m.–6:30 p.m., EDT.
Place: Teleconference.
Agenda: To review and evaluate grant
applications.
For Further Information Contact: Jaya
Raman Ph.D., Scientific Review Officer, CDC,
4770 Buford Highway, Mailstop F80, Atlanta,
Georgia 30341, Telephone: (770) 488–6511,
kva5@cdc.gov.
The Chief Operating Officer, Centers for
Disease Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities, for both
the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Sherri Berger,
Chief Operating Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2019–02172 Filed 2–12–19; 8:45 am]
BILLING CODE 4163–18–P
Sherri Berger,
Chief Operating Officer, Centers for Disease
Control and Prevention.
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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 Ebola virus (species Zaire
ebolavirus and hereafter referred to as
Ebola virus) in response to the Ebola
virus outbreak in the Democratic
Republic of the Congo. FDA issued this
Authorization under the Federal Food,
Drug, and Cosmetic Act (the FD&C Act),
as requested by Chembio Diagnostic
Systems, Inc. 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 diagnostic
devices 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 November 9, 2018.
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.
SUMMARY:
Michael Mair, Office of
Counterterrorism and Emerging Threats,
BILLING CODE 4163–18–P
17:22 Feb 12, 2019
AGENCY:
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2019–02164 Filed 2–12–19; 8:45 am]
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Federal Register / Vol. 84, No. 30 / Wednesday, February 13, 2019 / Notices
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:
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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
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,
including personnel operating under the
authority of title 10 or title 50, United
States Code, of attack with (i) a
biological, chemical, radiological, or
nuclear agent or agents; or (ii) an agent
or agents that may cause, or are
otherwise associated with, an
imminently life-threatening and specific
risk to U.S. military forces1; (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
1 In the case of a determination by the Secretary
of Defense, the Secretary of HHS shall determine
within 45 calendar days of such determination,
whether to make a declaration under section
564(b)(1) of the FD&C Act, and, if appropriate, shall
promptly make such a declaration.
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17:22 Feb 12, 2019
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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),
512 or 515 of the FD&C Act (21 U.S.C.
355, 360(k), 360b and 360e) or section
351 of the PHS Act (42 U.S.C. 262), or
conditionally approved under section
571 of the FD&C Act (21 U.S.C. 360ccc).
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 2 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
2 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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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; (4)
in the case of a determination described
in section 564(b)(1)(B)(ii), that the
request for emergency use is made by
the Secretary of Defense; and (5) 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.
population sufficient to affect national
security.3 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 diagnostic devices 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
November 5, 2018, Chembio Diagnostic
Systems, Inc. submitted a complete
request for, and on November 9, 2018,
FDA issued, an EUA for the DPP Ebola
Antigen System, subject to the terms of
the Authorization.
3 Under section 564(b)(1) of the FD&C Act, the
HHS Secretary’s declaration that supports the EUA
issuance must be based on one of four
determinations, including the identification by the
DHS Secretary of a material threat under 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. 84, No. 30 / Wednesday, February 13, 2019 / Notices
III. Electronic Access
IV. The Authorization
An electronic version of this
document and the full text of the
Authorization are available on the
internet at https://www.regulations.gov.
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 Ebola virus subject to the
3787
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
November 9, 2018
Thomas D.
Vice President, Clinical and
Chembio Dia;gnc,stic
3661
Road
Ml!(:!tord. NY 11763
Ke!~Ui<atOJ·y
Affairs
Dear .Mr.
respoJr~se
to your request that the Food and
Administration
for
use of Chembio Ul<tg:nostlc ".Y:.t,;;m:~,
for the
detection ofEbola virus
Sej)telnbc~r22,
2006,
ofthe
of Homeland St>r:nrt1tv
Chertoff, detennined, pursuant to section 31 9F-2 ofthe Public Health
U.S.C. §
that the Ebola virus presents a material threat
4
popullatlon sufficient to affect national
Pursuant to section
not cross-react
other Eb<:>ICJ1c•in,rs
of reference, this lener will refer to "l.ilmr"t"rie~
of such testing
treatment centers and
Pursuant to section
of the Act {2 I
supports EllA issuance must based on one
Secretary of a materia! threat pursuant to section 3 I 9F-2 of the PHS Act
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security or the
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it
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Inc.
U.S.C §
and on the basis of such determination, the Set~retRrv
declared on
5,
vitro Otagnc>Sti•cs
n""'"rtm.,.nt of Health and Human Services
circumstances
detection ofEbola
the Act (21 U.S.C. § ->vvuvv·->
of
concluded that the criteria for issuance of this authorization under section
of the
U.S. C. §
are met, f am
the emergency use of the DPP Ebola
II)) in
(as described in the
section ofthis letter
individuals with
and
with
risk factors
described in
for the pre:surnptive
detection of Ebola virus.
I. Criteria for Issuance of Autboriz~tion
I have concluded that the emergenc:y
detection ofEbola
an authorization under section
l. The Ebola virus can cause EVD, a serious or
humans infected with this virus;
2.
it is reasonable to believe
otagmJsu!g EVD, and that the
EVD,
for
3. There is no ad1:quate, an,nm.ve,rl and available alternative to the emergency use of the
DPP Ebo!a
for
EVD.
Il.
of Authorization
I have concluded,
of this authorization is
limited to the use
laboratories and
detection of Ebola virus in individuals with
facilities for the
and symptoms of
EVD in
risk factors. The DPP Ebola
is
intended for circumstances when use
Ebola virus test is determined to be more
than use of an Ebola virus nucleic acid test, which has been demonstrated to be
the Ebola virus. The DPP Ebola
is not intended for
more sensitive in
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health and security of United States citbroens living abroad {section
'U.S.
of Health and Human Services. Declaration Reg:ara'ingErmtrg~:ncy
Virus. 79 Fed. Reg. 47141
!2,
have been
regulation under section564(c)(4) of !he Act.
Federal Register / Vol. 84, No. 30 / Wednesday, February 13, 2019 / Notices
3789
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use for
without
of individuals
The Authorized DPP Eboia
area functionalized
the Chembio DPP Micro Reader, or other authorized mstruments,
of the CONTROL
area and
the
area vo:sulon;
and reports a reactive, nm1re:actiive.
value for the TEST
area.
The DPP Ebola
other authorized materials:
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The DPP Ebola
authorized control materials and m~m•1m""'"
used in
with the DPP Ebola
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"'
"'
The DPP Ebola
Test Control Pack: contains the DPP Ebola Reactive
Ebola Non-Reactive Control and
insert. The assay controls are used to
and assess the assay
the user's
to
the test
the results.
and to
The DPP Micro Reader: contains the Chembio DPP Micro Reader with Ebola RF!D
3
type CR2032
coin cell
custom
DPP
Holder, microfiber
and DPP
rcg,wauuJ.I:>
reaui11~m(:nts should be followed in conformance with
state, and federal
or accreditation reouir1•me,nts and the user
standard
control
the use of additional materials and"""'""'"
also
cornmonllv used clinical laboratories and that are described in the i!11fhn•ri,.,.,.l
Instructions for Use.
The above described DPP Ehola
follov.·irur information "",.;,;,,;,"
available to healthcare """'vld!,.ro
"
•
is authorized to be
the
emergency use, which is authorized to be made
Fact Sheet for Healthcare Providers: DPP Ebola
Fact Sheet for Patients: DPP Ebola
As described in Section IV
Chembio is also authorized to make available additional
information
to the emergency use of the authorized DPP Ebola
that
is consistent
and does not exceed, the terms of this letter
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I have concluded, pursuant to section
of the Act, that it is reasonable to believe that
the known and
benefits of the ""1·hn•ri7•>rl DPP Ebola
in the spe:cified
notml~ttlon. when used for ore~urmn1vt:
detection ofVP40
of Authorization of this letter
virus and used "'v"'~'~'''"
the known and ,..,.,,.,.,,,;,! risks of such a
Federal Register / Vol. 84, No. 30 / Wednesday, February 13, 2019 / Notices
5-Mr.
3791
lnc.
ofthe Act, based on the
of scientific
I have concluded, pursuant to section
evidence available to FDA, that it is reasonable to believe that the authorized DPP Ebola
be effective in the
when used
with the
Autho,riz:ati<m of this letter
of the Act.
the information
the authorized
"~''"""'""" OO!Jut<atKm (as
criteria set forth
The emergency use of the authorized DPP Ebola
consistent
and may not
the terms of this !ett'Cr, ...............15
Authorization
!I) and the Conditions of Authorization
to the
of OHS's determination
terms of this EUA and under the circumstances set forth in the
described above and the
ofl-[HS's
declaration under section
to
EVO in individuals
the OPP Ebola
described above is
with
and symptoms ofEVO in
with
risk factors.
This EUA will cease to be effective when the HHS declaration that circumstances exist to
the EUA is terminated under section
of the Act or when the EUA is revoked
under section
of the Act.
I am
the tollo~rim:•
of this EUA:
r<'Afmncnu""'
for the DPP Ebola
the duration
..
IV. Conditions of Authorization
Pursuant to section 564 of the Act, I am
authorization:
the
conditions on this
A.
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>Viii distribute the authori.zed DPP Ebola
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B. Chembio and its authorized
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C. Chembio and its authorized di~,tril)ntorf~1
facilities the authorized DPP Ebola
Providers and the authorized DPP Ebola
to authorized laboratories and
Fact Sheet tor Healthcare
Fact Sheet for Patients.
D. Chembio and its authorized di<tril)utorf~l will make available on their websites the
authorized DPP Ebola
Fact Sheet for Healthcare Providers and the
authorized DPP Ebola
Fact Sheet for Patients.
E. Chembio and its authorized
facilities and relevant
health
conditions herein.
will inform authorized laboratories and
of this EUA,
the terms and
mllm,.·nv•
will ensure that authorized laboratories and
F. Chembio and its authorized
facilities
the authorized DPP Ebola
have a
for
..,...,.,,,..;.,,.test results to healthcare
as
G.
a process
maintain records of device usage.
H. Chembio and its authorized
will collect information on the perrormance
of the assay. Chembio will report to FDA any suspec:ted
results and
deviations
the established ,..,,form~,.,.,"
and false
chara.cteris;tics of the assay of which Chembio becomes aware.
L Chembio and its authorized
are authorized to make available additional
to the emergency use of the authorized DPP Ebola
COJi1si:steJttt with, and does not exceed, the terms of this letter of
J. Chembio and its authorized
will make available the DPP Ebola
Test Control Pack or other authorized control materials for
as the DPP Ebola
Chembio
authorized
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Chembiowill
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communicate to its authorized
made to this EUA and its authorized ac<:on1P2UiVin
be
M. Chembio may request
to the authorized DPP Ebola
Sheet for Healthcare Providers and the authorized DPP Ebola
Fact
Chembio in consultation with, and
Sheet for Patients. Such requests will be made
concurrence of. DMD/OIR!CDRH.
N. Chembio may request the addition of other instruments for use with the authorized
Such requests will be made Chembio in consultation
DPP Ebo.!a
and
DMD/OIR!CDRH.
0. Chembio may request the addition of other'""""''"·' reagents for use with the
authorized DPP Ebo!a
Such
will be made by Chembio in
consultation
and
P. Chembio may request the addition of other
types for use with the authorized
DPP Ebola
will be made Chembio in consultation
and
consultation
R. Chembio may request substitution tor or
to the authorized materials used in
the detection process ofEbola virus in the
Such requests will be made
Chembio in consultation with, and
concurrence of, DMD/OIRJCDRH.
S. Chembio will track adverse events and report to FDA under 21 CFR Part 803.
T. Chembio W'i!l assess
of the DPP Ebola
with any FDArecommended reference
After submission to FDA and
Chembio will
its
DMD/OlR/CDRH's review of and concurrence with the
to reflect the additional
Such
will be made
consultation
and
U. Chembio will finalize the additional
upon
7, 2018) crcfss-reacti,vitv
studies within 3 months of the date ofEUA issuance.
and DMD/OIR!CDRH's review of and concurrence \Vith the
to reflect the
Such
will be made in
V. Chembio will track the
of the DPP Ebola
DMD/OIRICDRH on a semi-annual basis.
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1
and report to
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Inc.
Authorized Laboratories and Facilities
W. Authorized laboratories and facilities will include with
Ebola
the authorized Fact Sheet for t·r"'"'m'""''""'
for Patients. Under
,.u.,e.,.,e.;n<>t;,,, these Fact Sheets may be used, which may include mass
X. Authorized laboratories and facilities will
as
Instructions for Use.
the
outlined in the DPP Ebo!a
authorized
the authorized
authorized clinical
types, authorized control materials, authorized
"'"'"'"''"Y reagents and
the DPP Ebola
authorized materials
to
are not
Y. Authorized laboratories and facilities must read the results of the DPP Ebola
on the DPP Micro Reader or on other authorized instruments. Alrthr:rri:~ed
laboratories and facilities must not attempt to
the results of the DPP Ebola
Z. Authorized laboratories and facilities will have a process in
results to healthcare
and relevant
health autllor!ttes,
AA, Authorized laboratories and facilities will collect information on the netfmmance
DPP Ebola
and report to DMD/OIRICDRH
I~£PJ,l!lill:g:g;J~!cflllt:?:,l!,.\t~J and Chembio any sus.pec:ted
results and
deviations
characteristics of which
a\vare.
BB.
!abOr<ltOJ:y
"'"''"'"'"!:; this
use the test in accordance with
the assay must also be trained in and be
DPP Ebola
mn.l'l>1r<\f1,~t.n<n•!>r'lihif' U:O'-'IIIItYUCl>, USe lll'lf)r<)l'!ri:ate
and Authorized Laboratories and Facilities
CC.
its authorized
and authorized laboratories and facilities will
ensure that any records associated with this EUA are maintained until notified by FDA.
Such records will be made available to FDA for
upon request
matter
to the use of the
be consistent with the authorized Fact
VerDate Sep<11>2014
17:22 Feb 12, 2019
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khammond on DSKBBV9HB2PROD with NOTICES
According to CDC, EVD is a nationally notifiable condition
Federal Register / Vol. 84, No. 30 / Wednesday, February 13, 2019 / Notices
[FR Doc. 2019–02134 Filed 2–12–19; 8:45 am]
Food and Drug Administration
[Docket No. FDA–2019–N–0361]
BILLING CODE 4164–01–C
khammond on DSKBBV9HB2PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Takeda Pharmaceuticals U.S.A., Inc.;
Withdrawal of Approval of a New Drug
Application for OMONTYS
(peginesatide) Injection
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
VerDate Sep<11>2014
17:22 Feb 12, 2019
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PO 00000
Approval is withdrawn as of
February 13, 2019.
DATES:
Notice.
Frm 00049
Fmt 4703
The Food and Drug
Administration (FDA) is withdrawing
approval of new drug application (NDA)
202799 for OMONTYS (peginesatide)
Injection, held by Takeda
Pharmaceuticals U.S.A., Inc. (Takeda
USA). Takeda Development Center
America, Inc., on behalf of Takeda USA,
requested withdrawal of approval of this
application under relevant FDA
regulations and, in so doing, has waived
its opportunity for a hearing.
SUMMARY:
Sfmt 4703
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13FEN1
EN13FE19.010</GPH>
Dated: February 7, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
3795
]]>Agencies
[Federal Register Volume 84, Number 30 (Wednesday, February 13, 2019)]
[Notices]
[Pages 3785-3795]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02134]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0126]
Authorization of Emergency Use of an In Vitro Diagnostic Device
for Detection of Ebola virus; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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 Ebola virus (species
Zaire ebolavirus and hereafter referred to as Ebola virus) in response
to the Ebola virus outbreak in the Democratic Republic of the Congo.
FDA issued this Authorization under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act), as requested by Chembio Diagnostic
Systems, Inc. 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 diagnostic devices 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 November 9, 2018.
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: Michael Mair, Office of
Counterterrorism and Emerging Threats,
[[Page 3786]]
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 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, including personnel operating under the
authority of title 10 or title 50, United States Code, of attack with
(i) a biological, chemical, radiological, or nuclear agent or agents;
or (ii) an agent or agents that may cause, or are otherwise associated
with, an imminently life-threatening and specific risk to U.S. military
forces\1\; (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.
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\1\ In the case of a determination by the Secretary of Defense,
the Secretary of HHS shall determine within 45 calendar days of such
determination, whether to make a declaration under section 564(b)(1)
of the FD&C Act, and, if appropriate, shall promptly make such a
declaration.
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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), 512 or 515 of the FD&C Act (21 U.S.C. 355,
360(k), 360b and 360e) or section 351 of the PHS Act (42 U.S.C. 262),
or conditionally approved under section 571 of the FD&C Act (21 U.S.C.
360ccc). 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 \2\ 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; (4) in the case of a determination described in section
564(b)(1)(B)(ii), that the request for emergency use is made by the
Secretary of Defense; and (5) that such other criteria as may be
prescribed by regulation are satisfied.
---------------------------------------------------------------------------
\2\ 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 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.\3\ 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 diagnostic
devices 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 November 5, 2018, Chembio Diagnostic
Systems, Inc. submitted a complete request for, and on November 9,
2018, FDA issued, an EUA for the DPP Ebola Antigen System, subject to
the terms of the Authorization.
---------------------------------------------------------------------------
\3\ Under section 564(b)(1) of the FD&C Act, the HHS Secretary's
declaration that supports the EUA issuance must be based on one of
four determinations, including the identification by the DHS
Secretary of a material threat under 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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[[Page 3787]]
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 Ebola 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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[GRAPHIC] [TIFF OMITTED] TN13FE19.010
Dated: February 7, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-02134 Filed 2-12-19; 8:45 am]
BILLING CODE 4164-01-C
