Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Ebola Zaire Virus; Availability, 13854-13862 [2015-06039]
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Federal Register / Vol. 80, No. 51 / Tuesday, March 17, 2015 / Notices
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Aaron Bishop,
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Dated: March 11, 2015.
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Committee Policy.
[FR Doc. 2015–05968 Filed 3–16–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1206]
BILLING CODE 4154–01–P
Authorization of Emergency Use of an
In Vitro Diagnostic Device for
Detection of Ebola Zaire Virus;
Availability
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
[FR Doc. 2015–06085 Filed 3–16–15; 8:45 am]
ACTION:
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; Notice of Closed
Meeting
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Federal Advisory Committee Act, as
amended (5 U.S.C. App.), 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. 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: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel; NINDS Center Core (P30)
and Research Resource (R24) Review.
Date: April 17, 2015.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
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Place: Washington Plaza Hotel, 10 Thomas
Circle NW., Washington, DC 20005.
Contact Person: Natalia Strunnikova,
Ph.D., Scientific Review Officer, Scientific
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(Catalogue of Federal Domestic Assistance
Program Nos. 93.853, Clinical Research
Related to Neurological Disorders; 93.854,
Biological Basis Research in the
Neurosciences, National Institutes of Health,
HHS)
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Food and Drug Administration,
HHS.
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 in
response to the 2014 Ebola virus
outbreak in West Africa. FDA is issuing
this Authorization under the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act), as requested by Roche
Molecular Systems, Inc. (Roche). 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 December 23, 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.
SUMMARY:
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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 AllHazards Preparedness Reauthorization
Act of 2013 (Pub. L. 113–5) allows FDA
to strengthen the public health
protections against biological, chemical,
nuclear, and radiological agents. Among
other things, section 564 of the FD&C
Act allows FDA to authorize the use of
an unapproved medical product or an
unapproved use of an approved medical
product in certain situations. With this
EUA authority, FDA can help assure
that medical countermeasures may be
used in emergencies to diagnose, treat,
or prevent serious or life-threatening
diseases or conditions caused by
biological, chemical, nuclear, or
radiological agents when there are no
adequate, approved, and available
alternatives.
Section 564(b)(1) of the FD&C Act
provides that, before an EUA may be
issued, the Secretary of HHS must
declare that circumstances exist
justifying the authorization based on
one of the following grounds: (1) A
determination by the Secretary of
Homeland Security that there is a
domestic emergency, or a significant
potential for a domestic emergency,
involving a heightened risk of attack
with a biological, chemical, radiological,
or nuclear agent or agents; (2) a
determination by the Secretary of
Defense that there is a military
emergency, or a significant potential for
a military emergency, involving a
heightened risk to U.S. military forces of
attack with a biological, chemical,
radiological, or nuclear agent or agents;
(3) a determination by the Secretary of
HHS that there is a public health
emergency, or a significant potential for
a public health emergency, that affects,
or has a significant potential to affect,
national security or the health and
security of U.S. citizens living abroad,
and that involves a biological, chemical,
radiological, or nuclear agent or agents,
or a disease or condition that may be
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Federal Register / Vol. 80, No. 51 / Tuesday, March 17, 2015 / Notices
attributable to such agent or agents; or
(4) the identification of a material threat
by the Secretary of Homeland Security
under section 319F–2 of the Public
Health Service (PHS) Act (42 U.S.C.
247d–6b) sufficient to affect national
security or the health and security of
U.S. citizens living abroad.
Once the Secretary of HHS has
declared that circumstances exist
justifying an authorization under
section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug,
device, or biological product if the
Agency concludes that the statutory
criteria are satisfied. Under section
564(h)(1) of the FD&C Act, FDA is
required to publish in the Federal
Register a notice of each authorization,
and each termination or revocation of an
authorization, and an explanation of the
reasons for the action. Section 564 of the
FD&C Act permits FDA to authorize the
introduction into interstate commerce of
a drug, device, or biological product
intended for use when the Secretary of
HHS has declared that circumstances
exist justifying the authorization of
emergency use. Products appropriate for
emergency use may include products
and uses that are not approved, cleared,
or licensed under sections 505, 510(k),
or 515 of the FD&C Act (21 U.S.C. 355,
360(k), and 360e) or section 351 of the
PHS Act (42 U.S.C. 262). FDA may issue
an EUA only if, after consultation with
the HHS Assistant Secretary for
Preparedness and Response, the
Director of the National Institutes of
Health, and the Director of the CDC (to
the extent feasible and appropriate
given the applicable circumstances),
FDA 1 concludes: (1) That an agent
referred to in a declaration of emergency
or threat can cause a serious or 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 Homeland Security,
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,
2 Under
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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1 The
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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
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13855
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
December 19, 2014, Roche submitted a
complete request for, and on December
23, 2014, FDA issued, an EUA for the
LightMix® Ebola Zaire rRT–PCR Test,
subject to the terms of this
authorization.
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 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.
Dated: March 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
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. 80, No. 51 / Tuesday, March 17, 2015 / Notices
DEPARTJ\1ENT OF HEAl:TH & HU1\1AN SERVICES
December
Roche Molecular
4300 Hacienda
2014
Inc.
CA 94588
Dear Dr. Chen:
that the Food and
for emergency use of the Lil>!htMix®
from Ebola Zaire virus
in the West Africa
~~.-~:<r~&.-1 iustruments in EDTA whole blood or whole blood inactivated with
and symptoms ofEbola virus infection in
with
l'"''"tnri"c certified under the Clinical La
to
then-S:em·eta.rv ofthc
of Homeland :se!:un:tv
deten1nined, ~'""~"~"• to section 3l9F·2 ofthe Public Health Service
nresenls a material threat
tbe United States pOJJUilltio•n
Pursm.:mt to section
of the Act
uc•:cu.mnttut•u, the
ofHHS declared on
that circumstances
the authorization
usc of in vitro
for
detection ofEbola virus,
authorization issued under21 U.S.C. § 360bbb4
Having concluded that the criteria for issuance of this authorization under section
(21 U.S.C. §
are met, I am
the
use of the Lutl'lt~vtlx®
Zaire rRT-PCR Test
' Roche
section of this letter {S!~cti:on
described in the
in
is the exclusive distributor oftlle "''ll•"'"'""'"'
Conditions of Authorization {Section
Molecular
Inc. as the
parties
or
MOLBIOL.
For ease of reference,
letter will
to this
!ah,~ratorv
Pursuant to section .
ofthe Act (21
EU A issuance must be
on one of four determinations.
!he idemlficadon the DHS
material threat pursuant to sectiM 3l9F-2 of !he PHS Act sufficient to affect national security or the health
States citizens
abroad (section
of tile Act),
De•oarlment of Health
Human Services.
Diagllastlcs far
Virus. 79 fed, Reg. 47141 {August !2, 2014),
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3
Federal Register / Vol. 80, No. 51 / Tuesday, March 17, 2015 / Notices
Page 2- Dr. Jintao Chen, Roche Molecular
13857
Inc.
individuals with
and symptoms ofEbola virus iniection in
with '-!J'"'"·u"Jiu;.;'"·"'
risk factors (as described in the
of Authorization section ofthis letter (Section II)) for the
presumptive detection of RNA from Ebola Zaire vims (detected in the West Africa outbreak of
2014) CLIA High Complexity
or similarly qualified non-U.S. l::.n•cw::.1Tu'"""
to the terms of this authorization.
I. Criteria for Issuance of Authorization
I have concluded that the emergency use of the
Ebola Zaire rRT -PCR Test for the
detection of RNA from Ebola Zaire virus (detected in the West Africa outbreak of
the specified population meets the criteria for issuance of an authorization under section
of the
because I have concluded that:
I. Ebola Zaire virus
in the West Africa outbreak
can cause Ebola virus
te-1tlm:ate:ninlg disease or condition to humans infected with this
2.
of scientmc evidence available to
it is reasonable to believe that
when used with the
may
,.,,.,,.,...,,,., in the West Africa outbreak
benefits ofthe
Ebola Zaire rRT-PCR
spE:el!tea ""'''u""''"'"' for
Ebola virus
in the
the known and
risks of such
3.
and available alternative to the emergency use of the
Zaire rRT-PCR
for
Ebola virus
in the West
outbreak of 20 14) infection.
II. Scope of Authorization
of the
that the scope of this authorization is
Ebola Zaire rRT·PCR Test CUA
w'""'"'"J 1.-!U·dWCI<::V non-U.S.
for the Ul<O:>O.UIIHJLI
of RNA from Ebola Zaire vims
in the West Africa outbreak of 201
and
ofEbola virus infection in
with
The Authorized
Ebola Zaire rRT-PCR Test:
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The '"'"'uu••u.-.·., EbolaZaire rRT-PCR Test is a real-time reverse traJnseriptiOl nnrvm,"""''" chain
in the West
intended fbr the
detection ofEbola Zaire virus
Africa outbreak in
from whole blood
or whole blood
on nucleic acid extracted either
inactivated ·with TriPure. The assay is
Pure 96 DNA and Viral Nucleic
the automated
Pure 96
13858
Federal Register / Vol. 80, No. 51 / Tuesday, March 17, 2015 / Notices
3 - Dr. Jintao Chen, Roche Molecular Systems, Inc.
System or with the manual High Pure Viral Nucleic Acid Kit using the
480
Instrument or eobas z 480
with
Multiplex RNA Virus Master reagents for
atn1Pllttca1jon and detection.
•
•
and FAM-Iabeled
and 2) lYOI)hill:zed
R6G-labeled probe sequences that specifically detect an en<iog;en<)US human
house-keeping gene, RNase P, used as an internal
control with each clinical
specimen to indicate that
isolation
acid resulted from the clinical
sp~~u111en and PCR has worked
from the extracted nucleic acid.
l Vial Ebola Positive Control
to react with the
aes1gm~<t
""'~·"'"'"'"'"" Ebola Zaire rRT-PCR
when labeled
with the
·~·~'"L"'"""'"'' Ebola Zaire rRT-PCR Test Instructions for Use"
The above described LightMb:® Ebola Zaire rRT-PCR Test is authorized to be accontpanied
by the following information pertaining to the emergency usc, ·which is authorized to be ntade
available to health care professionals and patients:
•
Fact Sheet for Health Care Providers: Interpreting L1J~IltMix® Ehola Zaire rRT-PCR
Test Results
•
Fact Sheet for Patients: Understanding Results from the Li!~htMix®Ebola Zaire
PCRTest
rRT~
As described in Seetion IV
Roche Dil:tgn:osties and Roche Molecular
Inc. are also
authorized to make available additional information
to the emergency use of the authorized
Ebola Zaire rRT-PCR Test that is consistent
and does not
the terms of this
letter of authorization.
cortcllrdel:l, p1.1rsttant to section
that it is reasonable to believe that the
pot~entia! benefits of the autl1orizc<t Li!.l:l1t!lllix1 Ebola Zaire rRT-PCR Test in the
®
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detection of RNA from Ebola Z..<t.ire virus {Ge:tectea
the known and
rlsks of such a
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sp<!dtied j.JV~Juuu•uu, when used for
outbreak
13859
Federal Register / Vol. 80, No. 51 / Tuesday, March 17, 2015 / Notices
4 - Dr. Jintao
of the
based on the
I have
pursuant to section
evidence available to
that it is reasonable to believe that the authorized
Ebola
ofinfection with Ebola Zaire virus (detected
Zaire rRT-PCR Test may he effective in the
in the West Africa outbreak
pursuant to section
of the Act FDA has
reviewed the scientific infonnation available to FDA
the
conclusions described in Section I
and concludes that
authorized
Zaire
rRT·PCR
infection with Ebola Zaire virus
in the West Africa
of the
outbreak
meets the criteria set forth in section
Act concen1tng
The cm<~rge'ncy
be consistent
·'"''!!''"''''"""" Ebola Zaire rRT-PCR Test under this EllA must
inciudillg the
AuthoriZlitic•n
of
to the tenus of
de1:em11in:aticm described
the
This EUA will cease to be effective when the HHS declaration that
exist
the EUA is tenninated under section
of the Act or when the EUA is revoked under section
ofthe Act.
Ill. Waiver of Certain
I am
the •'"
duration of this EUA:
11
'""''""
requinem<~nts for the Lie:htl\tl:Lx®
rRT-PCR Test
the
system
req\ureJnents under 21 CFR Part 820
'""""'"!;;'storage, and distribution offue 'J'I!;'""'""''""
IV. Conditions of Authorization
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Roche Diagnostics or Roche Molecular Systems, Inc.
13860
Federal Register / Vol. 80, No. 51 / Tuesday, March 17, 2015 / Notices
5- Dr. Jinta.o
A. Roche Diagnostics will distribute the authorized
Ebola Zaire rRT-PCR Test with
the authorized
as may be revised only by Roche Molecular Systems, Inc. in
consultation with FDA,
to CLIA High Complexity Laboratories or similarly au:alltiea
non-U.S. laboratories.
B. Roche
will
to CLIA High Complexity Laboratories or
qualified non-U.S. laboratories the authorized
Ebola Zaire rRT-PCR Test Fact
Sheet for Health Care Providers and the authorized
Ebola Zaire rRT-PCR Test
Fact Sheet for Patients.
C. Roche
will make available on its website the LU!,flH\'llX'"" Ebula Zaire rRT-PCR
Test Fact Sheet for Health Care Providers and the authorized
Ebola Zaire rRTPCR Test Fact Sheet for Patients.
D. Roche
wiU inform CLIA
non-U.S. laboratories and relevant
tenns and conditions herein.
E.
JJtiUm:ostics will ensure that CLIA
Laboratories or ~•m1wuty
the authorized Li~!ht11.1lx\E Ebola Zaire rRT-PCR Test
prc~fessioJilals and relevant
F.
usage.
Di2u:mosties will collect information on the .,,..-tr,.,.,.,.,""
sus:pe(;ted occurrence of false
or
(;1""'t"".'" Inc. becomes aware.
H. Roche
is authorized to make available additional information
to the
emergency use ofthe authorized
Ebula Zaire rRT-PCR Test that is consistent
and does not
the tcrn1s of this letter of authorization.
I. Roche Molecular
Inc. will
TIB MOLBIOL with a
ofthis
and
communicate to TIB MOLBIOL
sul,se~~uent amendments that
be made to this
EUA and its authorized acc:omoatrYitll!
Fact
Instructions For
J. Roche Molecular
Inc.
to the authorized Lig;htlllfix'®
Ebola Zaire rRT-PCR Test Fact Sheet
Care Providers or the autho1rizerd
Ltgllt.i\1l!X1 Ebola Zaire rRT-PCR Test Fact Sheet for Patients. Such requests will be made
®
Roche Molecular
Inc. in consultation 'With FDA.
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K. Roche
...~~"'"''"']<; the medical device rep,orting res1oonsibiiliti~~s ofthe
manufacturer of the
Ebola Zaire
to FDA as
in 21 CFR Part 803.
Federal Register / Vol. 80, No. 51 / Tuesday, March 17, 2015 / Notices
13861
6 - Dr. Jintao
L Roche Molecular
Inc. will comply with the ap~mciw<c
so<~cified in the Waiver of Certain Requirements
M. Roche Molecular Systems, Inc. wiU
exclusive distributor ofthe Lig~htfl,1ix(g;
authorization of additional distributors.
CLIA High Complexity l,aboratories and Similarly Qualified Non~U.S. Laboratories
N. CLIA
Comttlel!:itv Laboratories and
aualifi1ed non-U.S. laboratories will
of the results ofthe L1~:llt~l11x® Ebola Zaire rRT·PCR Test the
for Health Care
and the authorized Fact Sheet for Patients.
cinmn1stacnec~s, other
methods for
these Fact Sheets
which may include mass
CoJmollexi.tv Laboratories and
non-U.S. laboratories will
Lif.!:ht11.1ix® Ebola Zaire rRT-PCR Test on only the
480
co bas z 480
P.
non~ U.S. laboratories will have
or<)fe1>Sicmals and relevant
~.oJrnpJieluw
Laboratories and
non-U.S. laboratories will
ner·fc)rmlln~"" of the assay, and report to Roche
any
or false
results of which
aware.
"IJ<'""'""' instruments and use llnr>rnr•rit~M laibor:ato:rv <md
nan1ttllr1g this kit
Roche Di.agnostics, Roche Molecular
Similarly Qualified Non-U.S. Laboratories
S.
Inc., CLIA High Co'mJJIICJtitJ.•
Roche Molecular
CLIA
and
non-U.S. laboratories will ensure that
this EUA are maintained until notified FDA. Such records
FDA for
upon request
Conditions Related to Advertising and Promotion
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matter
to the use of the
Li2htl\ilix.® Ebola Zaire
shall be consistent \Vith the Fact Sheets
1aot~ung, as well as the terms set forth in tllis EUA and the ap~!lie<lble
the Act and FDA '"~oe.un•uu••"·
13862
Federal Register / Vol. 80, No. 51 / Tuesday, March 17, 2015 / Notices
U. All adverti:lint:~
authorized Lig:htll!lix®
•
This test has been authorized by FDA under an Erru::r~(en•cv Use Authorization for use by
CUA
Laboratories and
non-U.S. laboraJories;
•
This test has been authorized only fur the detection of Ri~A from Ebo!a Zaire virus
(detected in the West Africa outbreak of2014) and not for any other viruses or
patlmg1~ns;
•
and
This test is
authorized for the duration of the declaration that circumstances exist
justifying the authorization of the
use of in vitro
for detection of
virus under section
Act, 21 U.S.C.
unless
the authorization is terminated or
to the use of the authorized
matter
Li1P1tJMi:x:® L:.O'OI<Ii L~ure rRT-PCR Test may represent or suggest that this test is safe or effective for
dia1gn1Jsis ofinfectJon with Ebola virus.
The emergenc~y use of the authorized
Ebola Zaire rRT-PCR Test described in this letter
ofauthoJtiZ1<tio'n must
with the conditions and all other terms of this authorization.
V. Duration of Authorization
This EUA will be effective until the declaration that circumstances exist justifying the authorization
of the
use of in vitro
for detection of Ebola virus
under section
Act or the EUA is revoked under section
ofthe Act.
[FR Doc. 2015–06039 Filed 3–16–15; 8:45 am]
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Enclosures
]]>Agencies
[Federal Register Volume 80, Number 51 (Tuesday, March 17, 2015)]
[Notices]
[Pages 13854-13862]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-06039]
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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.
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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 the Ebola Zaire
virus in response to the 2014 Ebola virus outbreak in West Africa. FDA
is issuing this Authorization under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act), as requested by Roche Molecular Systems,
Inc. (Roche). 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 December 23, 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 Homeland Security that there is a
domestic emergency, or a significant potential for a domestic
emergency, involving a heightened risk of attack with a biological,
chemical, radiological, or nuclear agent or agents; (2) a determination
by the Secretary of Defense that there is a military emergency, or a
significant potential for a military emergency, involving a heightened
risk to U.S. military forces of attack with a biological, chemical,
radiological, or nuclear agent or agents; (3) a determination by the
Secretary of HHS that there is a public health emergency, or a
significant potential for a public health emergency, that affects, or
has a significant potential to affect, national security or the health
and security of U.S. citizens living abroad, and that involves a
biological, chemical, radiological, or nuclear agent or agents, or a
disease or condition that may be
[[Page 13855]]
attributable to such agent or agents; or (4) the identification of a
material threat by the Secretary of Homeland Security under section
319F-2 of the Public Health Service (PHS) Act (42 U.S.C. 247d-6b)
sufficient to affect national security or the health and security of
U.S. citizens living abroad.
Once the Secretary of HHS has declared that circumstances exist
justifying an authorization under section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug, device, or biological product if
the Agency concludes that the statutory criteria are satisfied. Under
section 564(h)(1) of the FD&C Act, FDA is required to publish in the
Federal Register a notice of each authorization, and each termination
or revocation of an authorization, and an explanation of the reasons
for the action. Section 564 of the FD&C Act permits FDA to authorize
the introduction into interstate commerce of a drug, device, or
biological product intended for use when the Secretary of HHS has
declared that circumstances exist justifying the authorization of
emergency use. Products appropriate for emergency use may include
products and uses that are not approved, cleared, or licensed under
sections 505, 510(k), or 515 of the FD&C Act (21 U.S.C. 355, 360(k),
and 360e) or section 351 of the PHS Act (42 U.S.C. 262). FDA may issue
an EUA only if, after consultation with the HHS Assistant Secretary for
Preparedness and Response, the Director of the National Institutes of
Health, and the Director of the CDC (to the extent feasible and
appropriate given the applicable circumstances), FDA \1\ concludes: (1)
That an agent referred to in a declaration of emergency or threat can
cause a serious or life-threatening disease or condition; (2) that,
based on the totality of scientific evidence available to FDA,
including data from adequate and well-controlled clinical trials, if
available, it is reasonable to believe that: (A) The product may be
effective in diagnosing, treating, or preventing (i) such disease or
condition; or (ii) a serious or life-threatening disease or condition
caused by a product authorized under section 564, approved or cleared
under the FD&C Act, or licensed under section 351 of the PHS Act, for
diagnosing, treating, or preventing such a disease or condition caused
by such an agent; and (B) the known and potential benefits of the
product, when used to diagnose, prevent, or treat such disease or
condition, outweigh the known and potential risks of the product,
taking into consideration the material threat posed by the agent or
agents identified in a declaration under section 564(b)(1)(D) of the
FD&C Act, if 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.
---------------------------------------------------------------------------
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 Homeland Security, 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 December 19, 2014, Roche submitted
a complete request for, and on December 23, 2014, FDA issued, an EUA
for the LightMix[supreg] Ebola Zaire rRT-PCR Test, subject to the terms
of this authorization.
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\2\ Under 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 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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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 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.
Dated: March 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
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[FR Doc. 2015-06039 Filed 3-16-15; 8:45 am]
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