Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Ebola Virus; Availability, 6972-6996 [2015-02467]
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Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices
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Elaine L. Baker,
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Office, Centers for Disease Control and
Prevention.
[FR Doc. 2015–02450 Filed 2–6–15; 8:45 am]
BILLING CODE 4163–18–P
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Title: ORR Requirements for Refugee
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ANNUAL BURDEN ESTIMATES
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Number of
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Average burden
hours per
response
Total burden
hours
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Instrument
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3.88
582
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Consideration will be given to
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comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015–02510 Filed 2–6–15; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0126]
Authorizations of Emergency Use of In
Vitro Diagnostic Devices for Detection
of Ebola Virus; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of three Emergency Use
Authorizations (EUAs) (the
Authorizations), one of which was
amended after initial issuance, for three
in vitro diagnostic devices for detection
of the Ebola virus in response to the
2014 Ebola virus outbreak in West
Africa. FDA is issuing these
Authorizations under the Federal Food,
Drug, and Cosmetic Act (the FD&C Act),
as requested by BioFire Defense, LLC
(BioFire Defense) and altona Diagnostics
GmbH (altona). The Authorizations
contain, among other things, conditions
on the emergency use of the authorized
SUMMARY:
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in vitro diagnostic devices. The
Authorizations follow 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 Authorizations,
which include an explanation of the
reasons for issuance, are reprinted in
this document.
DATES: The Authorizations for the
BioFire FilmArray NGDS BT–E Assay
and BioFire FilmArray Biothreat-E test
are effective as of October 25, 2014. The
Authorization for the altona RealStar®
Ebolavirus RT–PCR Kit 1.0, which was
amended and reissued on November 26,
2014, is effective as of November 10,
2014.
Submit written requests for
single copies of the EUAs 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 Authorizations may be sent.
See the SUPPLEMENTARY INFORMATION
ADDRESSES:
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Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices
section for electronic access to the
Authorizations.
FOR FURTHER INFORMATION CONTACT:
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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 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
the Department 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
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(4) the identification of a material threat
by the Secretary of DHS under section
319F–2 of the Public Health Service
(PHS) Act (42 U.S.C. 247d–6b) sufficient
to affect national security or the health
and security of U.S. citizens living
abroad.
Once the Secretary of HHS has
declared that circumstances exist
justifying an authorization under
section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug,
device, or biological product if the
Agency concludes that the statutory
criteria are satisfied. Under section
564(h)(1) of the FD&C Act, FDA is
required to publish in the Federal
Register a notice of each authorization,
and each termination or revocation of an
authorization, and an explanation of the
reasons for the action. Section 564 of the
FD&C Act permits FDA to authorize the
introduction into interstate commerce of
a drug, device, or biological product
intended for use when the Secretary of
HHS has declared that circumstances
exist justifying the authorization of
emergency use. Products appropriate for
emergency use may include products
and uses that are not approved, cleared,
or licensed under sections 505, 510(k),
or 515 of the FD&C Act (21 U.S.C. 355,
360(k), and 360e) or section 351 of the
PHS Act (42 U.S.C. 262). FDA may issue
an EUA only if, after consultation with
the HHS Assistant Secretary for
Preparedness and Response, the
Director of the National Institutes of
Health, and the Director of the CDC (to
the extent feasible and appropriate
given the applicable circumstances),
FDA 1 concludes: (1) That an agent
referred to in a declaration of emergency
or threat can cause a serious or 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
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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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 Requests for In Vitro Diagnostic
Devices for Detection of the Ebola 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.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
October 22, 2014, BioFire Defense
submitted complete EUA requests for
both the BioFire FilmArray NGDS BT–
E Assay and for the BioFire FilmArray
Biothreat-E test, and on October 25,
2014, FDA issued, an EUA for the
BioFire FilmArray NGDS BT–E Assay
and an EUA for the BioFire FilmArray
Biothreat-E test, subject to the terms of
these authorizations. On October 29,
2014, altona submitted a complete EUA
request for the RealStar® Ebolavirus RT–
PCR Kit 1.0, and on November 10, 2014,
FDA issued, an EUA for the RealStar®
Ebolavirus RT–PCR Kit 1.0, subject to
the terms of this authorization. On
November 26, 2014, in response to a
request from altona on November 18,
2014, FDA amended and reissued in its
entirety the EUA to allow, in addition
to altona, distributors that are
authorized by altona to distribute the
2 Under to section 564(b)(1) of the FD&C Act, 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 under 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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RealStar® Ebolavirus RT–PCR Kit 1.0
with certain conditions applicable to
such authorized distributor(s), and to
allow the use of the assay under the
EUA at certain non-U.S. laboratories,
with certain conditions. The EUA, as
amended and reissued on November 26,
2014, which includes an explanation for
its reissuance, is reprinted in this
document. Because the November 26,
2014, Authorization for altona’s Ebola
assay replaces in its entirety the EUA
issued on November 10, 2014, the
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original Authorization issued on
November 10, 2014, is not reprinted in
this document.
III. Electronic Access
An electronic version of this
document and the full text of the
Authorizations are available on the
Internet at https://www.regulations.gov.
IV. The Authorizations
Having concluded that the criteria for
issuance of the Authorizations under
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section 564(c) of the FD&C Act are met,
FDA has authorized the emergency use
of certain in vitro diagnostic devices.
The Authorization for the BioFire
FilmArray NGDS BT–E Assay issued on
October 25, 2014, 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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October
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2014
Products
BioFlre
LLC
79 W 4500 S, Suite I. 4
Salt Lake
UT 841 07
Dear Dr.
authorization under
the emergency use of the
of Authorization section of this letter 1"'"'-'IJivu
virus infection or
are risk for eXJlosure
Ebola Zaire virus
in the West Africa outbreak in
epi.deJtnH)lo,gicallisk factors (as described in the
of
for tlle
detection ofEbo!a Zaire
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:~n·thnri7ino
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LLC
authorization.
l. Criterilt for lssmmce of Authm·ization
NGDS BT-E
(det,~cted
in the West Africa outbreak in
meets the criteria f11r issuance of an authorization under section
the Act, because f have concluded that
The Ebo!a Zaire virus (detected
vims
this virus;
of
infected with
2.
:u"'"""""
U.
I have
limited
DoD
anlr~m,ve•lL
and available alternative the emergency usc ofthc
'"J>;,nu:>mg Ebola Zaire virus
in the West
of Autboriution
10
to section
the use ofthe authorized
of the
that the sc,)pe of this authorization is
NGDS BT,E
laboratories u"'"ls<"'m.v
West Africa
the
virus (de:tecte•l
cpidc:mh)!o,gicaltisk factors.
NGDS BT-E Assay:
The Author.izcd
real-time reverse tr""Q''rir't'''""'
detection of Ebola Zaire vims de1tec·ted in the
and
symptoms ofEbola vims infection or who are at risk for exposure or may have been
to
the Ebola Zaire virus (detected in the West Afnca outbreak in
in
with
risk factors. The test
consists of nucleic acid extraction follo>ved
The
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instrument.
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the
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BioFire
6977
LLC
and
and Tm parameters could be utlli:cecl
deteetlon results in an
The above described
NGDS BT-E Assay is authorized to be aeC<Impanied
the
follo"'ing information pertaining to the emergency use, which is authorized to be made
available to llealtli care
and PRtier1ts:
•
Fact Slieet for Health Care Providers:
Results for Ebola
"'
h"f""'"""'ti""'
Ntms BT-E Assay
Fact Sbeet for Patients:
Test for Ebola
BioFire Defense is also authorized Ut make availablt1
additional infbrmalion
tn the emergenc;.r use of the authorized
NODS BT-E
that is consistent with, and
not
the terms of this letter of authorization.
I have
known and
pursuant to section
that it is reasonable to believe that the
NGDS BT-E
benefits ofthe authorized
uulllUJ<twJn. when used for
detection ofEbola Zaire virus ,-~W~'W"
AtTica outbreak in
the known and
risks of such a P""""'''""·
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diagmlsis of Ebola Zaire virus
the
A itimt
ofthe Act. The FDA has reviewed
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must be
and
may not
Authorization
and the Conditions of Authorizati<m
to the
ofDHS's detemTination
tem1s of this EUA and under the circumstances set forth in the
described above and the
of HHS's
declaration umler section
NODS BT-E
described above is authorizt-'d to
Ebola Zaire virus
the
the West Afiica outbreak in
infection in individuals with
cease to be effective
is te11ninaled under
ofthe Act.
m.
HHS declaration
A.ct or when the EUA
Waiver of Certain
.lam
the
duration ofthis EUA:
!he
NODS BT-E
IV. Conditions of Atlfhorfzation
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Pursuant to section 564 oftl1e Act, I am establishing the ro!!ovvmg conditions on this
authorization:
Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices
6979
LLC
.Bio.Fire Defense
with
authorized
!O lHboratorics
·'~·~'";n,,n,,,,J
R BioFire Defense
NGDS BT~E
NGDS BT-E
DoD the authorized
Care Providers
authorized
Fact Sheet for Patients.
C BloFire Defense will make available on ils website the authorized
Assay Fact Sheet for Health Care Providers and the aut!mrized
Sheet for Patients.
NGDS BTNGDS BT-E
DoD and rc!.cvant
BioFirc Defense vv.iU !rack
G.
health
to FDA under21 CFR Part 803.
a process
BioFire Defense will maintain ret:ords ofdeviee
usage.
H. BioFire Defense will collect intonmnion on the "'~'""~'"'"Q'"'"'
FDA
occurrence
to
or ll1lse ""·'"'.;""
Defense becomes avvare.
L BioFire Defense is authorized
8
~'A'''"~'"'" use of the
not exceed, the
available additional infom1ation
NGDS BT-E
that
BioFire Defense may
to the authorized
Fact She.et for Health Care Providers the authorized >•llnH~rr:ul
Shet~t for Patients. Such ro•m••ct<· will be made
BioFire Defense in consultation
with FDA.
Laboratories
by DoD
DoD 'NiH include with
of the results ofthe
the authorizt,-d Fact Sheet fin Health Care Providers and the
for Patients. Under
these Fact Sheets may be
the
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DoD
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NGDS
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on
09FEN1
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K Laboratories
NGDSBT-E
authorized Fact
methods for
media.
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results to
infonnation
smst,c:cte:d occurrence
DoD
Defense and laborat(Wics A,,.,.;m'''''"';
associated \Vilh this
made available to FDi~
will be
~u~
•
laboratories
fbr the deteetim1 ofEbola Zaire
and
fbr any other
,.
This test is
authorized lx1r the duuttkm of the declaration
the authorization of the t':l:nergency use of in
ofEbola Zaire virus under section
!) ofthe
unless tl1e authorization is terminated or revoked sooner.
matter
to !he use ofthe authorized
may represent or suggest that this test is safe or effective tiJr the
West Africa outbreak in
emergency use of the authorized
NGDS BT-E
must
the ctmdilions and all other tenns
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V. Duration of Authorization
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including the authorized versions of the
fact sheets and other written materials)
follows and provides an explanation of
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the reasons for its issuance, as required
by section 564(h)(1) of the FD&C Act:
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The Authorization for the BioFire
FilmArray Biothreat-E test issued
October 25, 2014, in its entirety (not
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OF IU:ALTH ANU HOMAN SERVICES
October
BloFire
79 W 4500 S, Suite 14
Salt Lake
84 I 07
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Dear Dr.
Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices
6983
the lenns of
I. Critet·ia for Issuance <)f Authorization
IA'fl"""'""' meets the criteria fbr issuance
I have concluded that
I_ The Ebola Zaire virus \u.;tc<.:lcu
virus
can cause Ebola
"'''-""'"''"+""'"'" diseaSl~ or condition to humans infedcd with
virus:
when used \vith the
the
Atl·lca outbreak in
and
'H'"'"u'''" alternative
dl1tj!;l:los1ng Ebola Zaire virus
U.
the emerge.ney use of the
in
West Afiica
of Authorization
l have
pursuant section
limited to the use of the authorized
Ctlm-ple:xl1'Y Laboratories for
Afi-ica outbreak in
with ••n•d•-··•ni"
The Autborb:ed
oftbe Act, that the scope of ti1is authorization is
Biotlm:at-E lest
Moderate and
detection ofEbola Zaire virus {dcrtected
and symptoms of Eoola
Biotbreat·E test:
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Biothreat-E test
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LLC
Once a clinical
The
takes about 5 minutes to
l hour.
the automated test, which
assay control:
Biolhreat-E test includes !he
RNA Process Control is a
process to demonstrate !hal
successfuL The
BioFire Defense in consultation with FDA, is authorized to
CLIA Moderate and
Laboratories under th1s
it does not meet certain
federal law.
The ab!we described FilmArray Biothreat-E test is authorized to be aeco:mpanied
the
tolllm.viiU! information
to the emergency use, V1lhicll is authorized to be made
available tn health care professionals and patients:
•
Fact Sheet. for Health Care Providers: Jnterpreting
Results for Ebola
"
Biothreat~E
Fact Sheet for Patiellts:
Test for Ebola
'""""'"....'" infonnation
consistent
Test
BioFire Defense is also authorized
to the emergency use ofthe authorized
BiodJreat-E
and docs no!
the temu; of this letter of authmization.
of the Act, that it is reasonable to believe that the
Biothreat-E test in the ~..,,.~ .... vu
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have concluded, pursuant to section
of the Act, based on the
reasonable to believe that the authorized
evidence available to FDA. that
Biothreat-E test may be ell'eetive .i11
ofEbola Zaire vims (de:tected
Africa outbreak in
infection pursuant
of the
rHv"'"""n the scientific information av<mame
Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices
BioFirc
6985
LLC
to the
tenus oft!1is EUA and under the circumstances set t'i.Jt1h in the <.!,.,.,.,,,,..,
described above and the
ofHHS's
declaration under section
Blothreat-E test described above is authorized to
Ebolu Zaire virus
and S}1nptoms
will cease to be etfcetivc
the EllA is tem1inatcd under section
ofthe Act.
HHS dcch1ration that circumstance~; exi:st
of the Aet or v.rhen the EllA revoked under
Biothrcat-E
the duration
under 21 CFR Part 820 with respect io the
Biothreat-E test.
storage, and distribution ofthe
~t'\'"'"''"'"''·'h' limitations on the use of the
available
.,.,.,.m;,•.,rr,,,.,t., under 21 CFR
IV, Conditions of Authorization
conditions on this
BioFire Defense
A. BioFire Defense wfll distribute the authorized
Biothreat-E test with the
BioFlre Defense in consultation with FDA,
rnnw.l••>•iht laboratories.
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B. BioFire Defense will
CLIA Moderate and
Laboratories the
authorized
Biothreat-E test Fact Sheet tor Health Care Providers and tl1e
authorized
Fact Sheet fbr Patients.
6986
Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices
BinFire Defense,
BioFire Defense
Sheet f{1r Health
Patients.
D.
Laboratories m1d
herein.
E. Bk)Fire Defense will ensure that CUA Moderate and
the authorized
BioFire Defense vvill track
events and report to FDA
Detl~nse
CFR Part 803.
will maintain records of device
usage.
H.
and report to
of•vhich BioFire
BioFire Defense is authtlrized to make available additional
Biothrcat-E
emergency use of the authorized
does not exceed, the tenus of this letter of authorization.
l
BioFire Detensemay
Sheet for Health Care """""'"'""
BioFire Defense in consultation with FDA.
<m~tw;;"rn
Lahotatt>ries wlll include wlth
the authorized Fact Sheet
tbt· Patients.
these Fact Sheets may he
other
mass media.
CUA Moderate and
Biotluent-E test on
~on1Pl,exi't'v
Laboratories will
the
instrument.
Comp1exitv Laboratories will have a process in
fQr
M. CUA Moderate and
''"""'-tmo test results to health care
and relevant
health authorities, as
Laboratories will collect infimnation on the
and re.port 10 Bit>Fil·e Dt~fense any
occurrence
false n"''""''"p
of which
become
CL!A M<>derate and
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""'rt"'""~'""" ofthc
Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices
6987
Biof.'iri' Defi'USi' and CLIA !VIoderate and
--···r···-···-,, Laboratories
ensure that
FDA. Such
any records associated with this EllA are '""""'·""'"'u
records will be made available to FDA for m~;pe,C!1(m
Conditions Related to
"
This rest has been authmized
the West Al1ica (m!brcak in
"
f11r the detection of Ebola Zaire virus , •.,.. __., __ in
and no! fi.1r any other viruses
This test is
authorized
the authorization
Ebola Zaire virus
unlcs$ the authorization
matter
the
that this test is safe
for the
Aft'ica outbreak in
Biothreat-E test described in this letter of
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with the conditions and all other terms of this authmization,
Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
The Authorization for the RealStar®
Ebolavirus RT–PCR Kit 1.0, originally
issued on November 10, 2014, as
amended and reissued in its entirety on
VerDate Sep<11>2014
17:39 Feb 06, 2015
Jkt 235001
November 26, 2014, (not including the
authorized versions of the fact sheets
and other written materials) follows and
provides an explanation of the reasons
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for its issuance, as required by section
564(h)(1) of the FD&C Act, and its
amendment:
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6988
Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices
6989
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DEPARTJI.lENT OF HEALTH & HllMAN SERVICES
6990
Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices
2
Dr. Sven Cramer, altona
Diag;ao~;ti{:s
GmbH
concluded that the criteria fhr issua11ee
I U.S.C.
<>nilhnri"·'"" the emergency
of the '"''mcaru
Eholavirus RT-PCR Kit 1.0
of Authorization section of this letter
in individuals with
and symptoms of Ehola virus infection in
with
''"""'''""' risk factors (as described
nf Authorization section ofthis letter
the
detection of RNA from Ebolaviruses
"""lii'i~r~ non~U.S.
to
terms of this
authorization.
t Criteria for Issuance of Authorization
Ebolaviruses can cause
serious or llt•e-tilm::al<lni.ngdisease or
condition to humans infected \Vith this
2.
of scientific evidence <lvailable to FDA, it is reasonable to believe
that the
Ebolav!rus RT-PCR Kit 1 when used with the"'"'";;''""
may be effective in u•v'"'"~~'"'·"'
henel1ts of the '"""'':""''
instruments thr uu'l5"""'"'l5
and available altemative to
Kit
for
Ebolavirus int;,.,.,ti:nn
VerDate Sep<11>2014
17:39 Feb 06, 2015
of Authorizat.ion
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U.
Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices
-Dr, Sven
6991
GmbH
The Authorized
E:twhwirus RT-PCR Kit Ul:
the CFX9()TM
includes
"n''"'"'~~
RT-PCR inhib.itkln and
Ebolavirus RT-PC:R Kit
The internal Control contains a defined copy number of an
molecule
with no
any other kno\vn sctJUcnccs. lt has to be added to the nucleic acid
and reverse
and detected in
to the
RNA. The fimction oftlu: internal C:<)ntml is
real-time RT-.PCR results
The PCR
water is to usec.i
fimction is to indicate contamination
""''"M"'" control for the RT-PCR reaction. its
RT-PCR reagents.
The "Positive Control
target sequence usc{j
Ebolavirus
RNA.
cont1'0I for
PCR detection system,
Kit 1.0, when labeled ,.,~,,,~;,,.,..,.
Ebolavirus RT-PCR Kit l
wl1ich nu1y be revised
to be distributed tn and
under this
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federal law.
6992
Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices
4 -- Dr. Sven Cramer,
I<:boJavi.ru:s RT~PCR Kit 1.0 is auUwdzed to be
Tl1e above desedbed
the
information
aut.l:u:n·ized to be ntlldc a:vailable to health care
..
Fact Sheet for Health Care Providers:
Kit Ul Results
•
to the entcrgeney use, which is
and """i"nt~
Fact Sbeet for Patients:
Ebolavirus RT-PCR
PCR Kit 1.0
As described in Section lV
altona
GmbH and its authorized
available additional information
to the ''''"'"'"'""''"'"v
Ebolavims RT-PCR Kit 1.0 that is consistent
the terms of this letter
co.nd.uded. pursuant to section
of the
based on the
that is reasonable to believe that the authorized ._<::m.:nm
the
ofinfcction
pursuant to section
The FDA has reviewed the scientific intt1nnalion
availuhle to FDA
the int(Jrmation ~"T"'""'""' the conclusions described in Section I
and concludes that the authorized
Ebnlavinas RT~PCR Kit
w!1en used to
dmll:m:1se inteetinn with Ebolaviruses in the
meets the criteria set forth in
of the Aot
efrectivencss.
declaration under
,;,,c,..~.;r.F'''
ab<rve is authorized to d!~tgnose
and symptoms of Ebola
This EUA \Viii cease to be effective when the HHS declaration that circumstances exist
oftlle Acl or when the ElJA is revoked under
the EUA is terminated under section
seetion
ofthe Act.
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Ebolavirus RT-PCR Kit LO
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EN09FE15.017</GPH>
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the
Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices
6993
tV. Conditions of Authorization
Pursuant to section 564 of the
lam
the
conditions
this
will
toCL!A
non-U.S. laboratories the authorized
Fact Sheet for Health Care Providers and the
Ebolavirus RT-PCR Kit 1.0 Fact Sheet forPatients.
D.
will ensure that CLIA
a process
altona
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will maintain records of device usage.
6994
Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices
H. altona
GmbH and
available additional mton111ation
Ebo!avi.r11s RT·PCR Kit LO
tenns of this letter of authorization.
make
emergency use ofthe. authorized
is consistent
and
tl1e
altona Diagnostics GmbH
GmbH
and communicate to
with C<)py
amendments that
ac<:on1pBIIlYing materials
:su,.,::;~:::uuem
be made to this
instructions for
!o
the authorized
Providers
the " 111 ""''""""'
Ebolavirus RT-PCR Kit l Fact Sheet for Patients. Sueh rt'<Jtlt,sts will be
'-'""15....,.,,,,..., GmbH in consultation with FDA.
K altona
803.
adverse <rvents and report
FDA under 21 CFR Part
CUA High Complexity Laboratories and Sintilady Qualified Non-U.S. Labon1.tories
laboratories wilJ
include with reports
results of the
Ebolavirus RT -PCR Kil .0 the
authorized Fact Sheet ibr Health Care Providers and the authorized Fact Sheet for
Patients. Under
other
methods
Fact Sheets may be
real-time system.
Laboratories and
non-U$. laboratories will
and re.!evant
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17:39 Feb 06, 2015
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''"'""'"'"'" test results to health care
Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices
Dr. Sven
6995
GmbH
CLIA
Non-U.S. Laboratories
CLIA
and
m.m-U.S. laboratories will ensure that any records
FDA Such records
be
associated with tl1is EUA are maintained until notit1cd
made available to FDA for
upon request.
'"·ill
Conditions Related to
R.
"
Laboratories and
f(Jr the detection of RNA
fh.Jl11
Ebolaviruses (such
lincludi.rm the Zaire cbolavirus strain
Reston
.,
Africa
and
Tai Forest ebolavirus,
other viruses or
This test
aut11orizcd for the duration of the declaration that circumstances exist
the authorization ofthe emergeuey use of in
for detection
of the
),
virus Utlder section
unless the authorization terminated m revoked sooner.
or
matter
to the use of the authmizerl
Ebolavin1s RT-PCR Kit l may represent nr suggest that this test is saie or effective
'""!;;'"''"" of infection with Ebolavirus.
VerDate Sep<11>2014
17:39 Feb 06, 2015
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Ebolavirus RT-PCR Kit l described in this
the conditions and all other terms of this authmization.
Fmt 4703
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EN09FE15.020</GPH>
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The emergency use of the authorized
letter ofauthorizalion must
6996
Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices
[FR Doc. 2015–02467 Filed 2–6–15; 8:45 am]
BILLING CODE 4164–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0354]
Guidance for Industry: Questions and
Answers Regarding the Effect of
Section 4205 of the Patient Protection
and Affordable Care Act of 2010 on
State and Local Menu and Vending
Machine Labeling Laws; Withdrawal of
Guidance
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; withdrawal.
The Food and Drug
Administration (FDA or we) is
announcing the withdrawal of a
guidance entitled ‘‘Guidance for
Industry: Questions and Answers
Regarding the Effect of Section 4205 of
the Patient Protection and Affordable
Care Act of 2010 on State and Local
Menu and Vending Machine Labeling
Laws,’’ dated August 2010. We are
taking this action because the policies
stated in the guidance have been
superseded by our issuance of final
rules on menu and vending machine
labeling.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
5100 Paint Branch Pkwy., College Park,
MD 20740, 240–402–2371.
SUPPLEMENTARY INFORMATION: In a notice
published in the Federal Register of
August 25, 2010 (75 FR 52427), we
announced the availability of a guidance
entitled ‘‘Guidance for Industry:
Questions and Answers Regarding the
Effect of Section 4205 of the Patient
Protection and Affordable Care Act of
2010 on State and Local Menu and
Vending Machine Labeling Laws.’’ The
guidance stated that we were issuing the
guidance to: (1) Ensure that industry
and State and local governments
understand the immediate effects of the
law, and (2) clarify the effect of section
4205 of the Patient Protection and
Affordable Care Act of 2010 on State
and local menu and vending machine
labeling laws.
We are withdrawing this guidance
because we recently issued two final
rules entitled ‘‘Food Labeling; Nutrition
Labeling of Standard Menu Items in
Restaurants and Similar Retail Food
Establishments’’ and ‘‘Food Labeling;
Calorie Labeling of Articles of Food in
Vending Machines’’ (see 79 FR 71156
(December 1, 2014) and 79 FR 71259
(December 1, 2014), respectively). The
preambles for these final rules discuss
issues relating to Federalism and to
federal preemption of State and local
laws and reflect our latest thinking on
those issues. Consequently, the
guidance no longer reflects our current
thinking insofar as the law’s effect on
State and local menu and vending
machine labeling laws is concerned.
FOR FURTHER INFORMATION CONTACT:
Felicia B. Billingslea, Center for Food
Safety and Applied Nutrition (HFS–
820), Food and Drug Administration,
Dated: February 3, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–02526 Filed 2–6–15; 8:45 am]
DATES:
February 9, 2015.
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17:39 Feb 06, 2015
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–0798]
Medical Device Data Systems, Medical
Image Storage Devices, and Medical
Image Communication Devices; Mobile
Medical Applications: Guidances for
Industry and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of two guidance documents.
FDA is issuing ‘‘Medical Device Data
Systems, Medical Image Storage
Devices, and Medical Image
Communication Devices’’ to inform
manufacturers, distributors, and other
entities that the Agency does not intend
to enforce compliance with regulatory
requirements for Medical Device Data
Systems (MDDS) and two similar
radiology device types due to the low
risk they pose to patients and the
importance they play in advancing
digital health. FDA is also issuing an
updated version of the guidance
document ‘‘Mobile Medical
Applications,’’ originally issued on
September 25, 2013, that has been
edited to be consistent with the MDDS
guidance document.
DATES: Submit either electronic or
written comments on this guidance at
any time. General comments on Agency
guidance documents are welcome at any
time.
ADDRESSES: An electronic copy of the
guidance document is available for
SUMMARY:
E:\FR\FM\09FEN1.SGM
09FEN1
EN09FE15.021</GPH>
Dated: February 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
]]>Agencies
[Federal Register Volume 80, Number 26 (Monday, February 9, 2015)]
[Notices]
[Pages 6972-6996]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-02467]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0126]
Authorizations of Emergency Use of In Vitro Diagnostic Devices
for Detection of Ebola Virus; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of three Emergency Use Authorizations (EUAs) (the
Authorizations), one of which was amended after initial issuance, for
three in vitro diagnostic devices for detection of the Ebola virus in
response to the 2014 Ebola virus outbreak in West Africa. FDA is
issuing these Authorizations under the Federal Food, Drug, and Cosmetic
Act (the FD&C Act), as requested by BioFire Defense, LLC (BioFire
Defense) and altona Diagnostics GmbH (altona). The Authorizations
contain, among other things, conditions on the emergency use of the
authorized in vitro diagnostic devices. The Authorizations follow 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 Authorizations, which include an explanation of the reasons for
issuance, are reprinted in this document.
DATES: The Authorizations for the BioFire FilmArray NGDS BT-E Assay and
BioFire FilmArray Biothreat-E test are effective as of October 25,
2014. The Authorization for the altona RealStar[supreg] Ebolavirus RT-
PCR Kit 1.0, which was amended and reissued on November 26, 2014, is
effective as of November 10, 2014.
ADDRESSES: Submit written requests for single copies of the EUAs 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 Authorizations may be sent. See the SUPPLEMENTARY INFORMATION
[[Page 6973]]
section for electronic access to the Authorizations.
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 the Department 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 DHS under section 319F-2 of the Public Health Service
(PHS) Act (42 U.S.C. 247d-6b) sufficient to affect national security or
the health and security of U.S. citizens living abroad.
Once the Secretary of HHS has declared that circumstances exist
justifying an authorization under section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug, device, or biological product if
the Agency concludes that the statutory criteria are satisfied. Under
section 564(h)(1) of the FD&C Act, FDA is required to publish in the
Federal Register a notice of each authorization, and each termination
or revocation of an authorization, and an explanation of the reasons
for the action. Section 564 of the FD&C Act permits FDA to authorize
the introduction into interstate commerce of a drug, device, or
biological product intended for use when the Secretary of HHS has
declared that circumstances exist justifying the authorization of
emergency use. Products appropriate for emergency use may include
products and uses that are not approved, cleared, or licensed under
sections 505, 510(k), or 515 of the FD&C Act (21 U.S.C. 355, 360(k),
and 360e) or section 351 of the PHS Act (42 U.S.C. 262). FDA may issue
an EUA only if, after consultation with the HHS Assistant Secretary for
Preparedness and Response, the Director of the National Institutes of
Health, and the Director of the CDC (to the extent feasible and
appropriate given the applicable circumstances), FDA \1\ concludes: (1)
That an agent referred to in a declaration of emergency or threat can
cause a serious or life-threatening disease or condition; (2) that,
based on the totality of scientific evidence available to FDA,
including data from adequate and well-controlled clinical trials, if
available, it is reasonable to believe that: (A) The product may be
effective in diagnosing, treating, or preventing (i) such disease or
condition; or (ii) a serious or life-threatening disease or condition
caused by a product authorized under section 564, approved or cleared
under the FD&C Act, or licensed under section 351 of the PHS Act, for
diagnosing, treating, or preventing such a disease or condition caused
by such an agent; and (B) the known and potential benefits of the
product, when used to diagnose, prevent, or treat such disease or
condition, outweigh the known and potential risks of the product,
taking into consideration the material threat posed by the agent or
agents identified in a declaration under section 564(b)(1)(D) of the
FD&C Act, if applicable; (3) that there is no adequate, approved, and
available alternative to the product for diagnosing, preventing, or
treating such disease or condition; and (4) that such other criteria as
may be prescribed by regulation are satisfied.
---------------------------------------------------------------------------
\1\ The Secretary of HHS has delegated the authority to issue an
EUA under section 564 of the FD&C Act to the Commissioner of Food
and Drugs.
---------------------------------------------------------------------------
No other criteria for issuance have been prescribed by regulation
under section 564(c)(4) of the FD&C Act. Because the statute is self-
executing, regulations or guidance are not required for FDA to
implement the EUA authority.
II. EUA Requests for In Vitro Diagnostic Devices for Detection of the
Ebola 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 October 22, 2014, BioFire Defense submitted complete
EUA requests for both the BioFire FilmArray NGDS BT-E Assay and for the
BioFire FilmArray Biothreat-E test, and on October 25, 2014, FDA
issued, an EUA for the BioFire FilmArray NGDS BT-E Assay and an EUA for
the BioFire FilmArray Biothreat-E test, subject to the terms of these
authorizations. On October 29, 2014, altona submitted a complete EUA
request for the RealStar[supreg] Ebolavirus RT-PCR Kit 1.0, and on
November 10, 2014, FDA issued, an EUA for the RealStar[supreg]
Ebolavirus RT-PCR Kit 1.0, subject to the terms of this authorization.
On November 26, 2014, in response to a request from altona on November
18, 2014, FDA amended and reissued in its entirety the EUA to allow, in
addition to altona, distributors that are authorized by altona to
distribute the
[[Page 6974]]
RealStar[supreg] Ebolavirus RT-PCR Kit 1.0 with certain conditions
applicable to such authorized distributor(s), and to allow the use of
the assay under the EUA at certain non-U.S. laboratories, with certain
conditions. The EUA, as amended and reissued on November 26, 2014,
which includes an explanation for its reissuance, is reprinted in this
document. Because the November 26, 2014, Authorization for altona's
Ebola assay replaces in its entirety the EUA issued on November 10,
2014, the original Authorization issued on November 10, 2014, is not
reprinted in this document.
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\2\ Under to section 564(b)(1) of the FD&C Act, 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 under 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
Authorizations are available on the Internet at https://www.regulations.gov.
IV. The Authorizations
Having concluded that the criteria for issuance of the
Authorizations under section 564(c) of the FD&C Act are met, FDA has
authorized the emergency use of certain in vitro diagnostic devices.
The Authorization for the BioFire FilmArray NGDS BT-E Assay issued on
October 25, 2014, 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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The Authorization for the BioFire FilmArray Biothreat-E test issued
October 25, 2014, 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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The Authorization for the RealStar[supreg] Ebolavirus RT-PCR Kit
1.0, originally issued on November 10, 2014, as amended and reissued in
its entirety on November 26, 2014, (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, and its amendment:
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Dated: February 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-02467 Filed 2-6-15; 8:45 am]
BILLING CODE 4164-01-C
