Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Zika Virus; Availability, 54361-54385 [2017-25010]
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54361
Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices
The following is a summary of the
estimated annual burden hours for
recalling firms (manufacturers,
processors, and distributors) to comply
with the reporting requirements of
FDA’s recall regulations, recognizing
that there may be a vast difference in the
information collection and reporting
time involved in different recalls of
FDA’s regulated products.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
Firm initiated recall (§ 7.46) and recall communications
(§ 7.49) ..............................................................................
Recall status reports (§ 7.53) ...............................................
Termination of a recall (§ 7.55(b)) .......................................
2,853
2,853
2,853
1
13
1
2,853
37,089
2,853
25
10
10
71,325
370,890
28,530
Total ..............................................................................
........................
........................
........................
........................
470,745
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
I. Total Annual Reporting
A. Firm Initiated Recall and Recall
Communications
We request firms that voluntarily
remove or correct foods and drugs
(human or animal), cosmetics, medical
devices, biologics, and tobacco to
immediately notify the appropriate FDA
District Office of such actions. The firm
is to provide complete details of the
recall reason, risk evaluation, quantity
produced, distribution information,
firms’ recall strategy, and a contact
official as well as requires firms to
notify their direct accounts of the recall
and to provide recipients with a ready
means of reporting to the recalling firm.
Under these portions of the collection of
information, the Agency estimates it
will receive 2,853 responses annually
based on the average number of recalls
over the last 3 fiscal years. The number
of responses multiplied by the number
of respondents equals 2,853. The
average burden hours, 25, multiplied by
total number of annual responses equal
71,325.
B. Recall Status Reports
We request that recalling firms
provide periodic status reports so FDA
can ascertain the progress of the recall.
This request only applies to firms with
active recalls, and periodic status
reports are estimated to be reported
every 2 to 4 weeks. This collection of
information will generate approximately
2,853 responses annually, based on the
average number of recalls over the last
3 fiscal years, 8,560. The number of
respondents multiplied by the number
of responses per respondents (13) equals
a total number of annual responses of
37,089. The total number of responses,
37,089, multiplied by an average burden
hours of 10 per response equals a total
of 370,890 total hours.
C. Termination of a Recall
We provide the firms an opportunity
to request in writing that FDA end the
recall. The Agency estimates it will
receive 2,853 responses annually based
on the average number of terminations
over the past 3 fiscal years. The total
annual responses of 2,853 multiplied by
the average burden hours of 10 per
response equals a total number of hours
of 28,530.
II. Total Annual Third-Party Disclosure
Burden
Recall Communications. We request
that firms notify their consignees of the
recall and to provide recipients with a
ready means of reporting to the recalling
firm. Under this portion of the
collection of information, the Agency
estimates firms will provide 4,433,562
notifications annually based on the
number of respondents/consignees
(2,853) multiplied by the number of
disclosures per respondent (1,554). The
total number of hours is 248,279 (based
on 4,433,562 multiplied by 0.056
hours).
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
21 CFR section
Recall communications (§ 7.49) ...........................................
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1 There
Number of
disclosures
per
respondent
2,853
1,554
Total annual
disclosures
4,433,562
Average
burden per
disclosure
Total hours
0.056
248,279
are no capital costs or operating and maintenance costs associated with this information collections.
FDA regulates many different types of
products including, but not limited to,
medical products, food and feed,
cosmetics, and tobacco products. FDA
notes that not all third-party disclosures
provided by firms to their consignees
are similar in nature and may entail
different methods and mediums of
communication. FDA estimates the
burden for third-party disclosure per
recall event to be an average of 25 hours.
This burden estimate factored out to the
average number of consignees per recall
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(1,554) results in a burden per
disclosure estimate of approximate
hours (25 hours per recall/1,554
disclosures/recall = 0.056 hours).
Dated: November 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–24923 Filed 11–16–17; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–6152]
Authorizations of Emergency Use of In
Vitro Diagnostic Devices for Detection
of Zika Virus; Availability
BILLING CODE 4164–01–P
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AGENCY:
Food and Drug Administration,
HHS.
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ACTION:
Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of two Emergency Use
Authorizations (EUAs) (the
Authorizations) for in vitro diagnostic
devices for detection of the Zika virus
in response to the Zika virus outbreak
in the Americas. FDA issued these
Authorizations under the Federal Food,
Drug, and Cosmetic Act (the FD&C Act),
as requested by Siemens Healthcare
Diagnostics, Inc. and Chembio
Diagnostic Systems, Inc. The
Authorizations contain, among other
things, conditions on the emergency use
of the authorized in vitro diagnostic
devices. The Authorizations follow the
February 26, 2016, determination by the
Secretary of Health and Human Services
(HHS) that there is a significant
potential for a public health emergency
that has a significant potential to affect
national security or the health and
security of U.S. citizens living abroad
and that involves Zika virus. On the
basis of such determination, the
Secretary of HHS declared on February
26, 2016, that circumstances exist
justifying the authorization of
emergency use of in vitro diagnostic
tests for detection of Zika virus and/or
diagnosis of Zika virus infection, subject
to the terms of any authorization issued
under the FD&C Act. The
Authorizations, which include an
explanation of the reasons for issuance,
are reprinted in this document.
DATES: The Authorization for Siemens
Healthcare Diagnostics, Inc. is effective
as of September 18, 2017; the
Authorization for Chembio Diagnostic
Systems, Inc. is effective as of
September 27, 2017.
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
section for electronic access to the
Authorizations.
SUMMARY:
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FOR FURTHER INFORMATION CONTACT:
Carmen Maher, Office of
Counterterrorism and Emerging Threats,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 1, Rm.
4347, Silver Spring, MD 20993–0002,
301–796–8510 (this is not a toll free
number).
SUPPLEMENTARY INFORMATION:
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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 ensure
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
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
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Agency concludes that the statutory
criteria are satisfied. Under section
564(h)(1) of the FD&C Act, FDA is
required to publish in the Federal
Register a notice of each authorization,
and each termination or revocation of an
authorization, and an explanation of the
reasons for the action. Section 564 of the
FD&C Act permits FDA to authorize the
introduction into interstate commerce of
a drug, device, or biological product
intended for use when the Secretary of
HHS has declared that circumstances
exist justifying the authorization of
emergency use. Products appropriate for
emergency use may include products
and uses that are not approved, cleared,
or licensed under sections 505, 510(k),
or 515 of the FD&C Act (21 U.S.C. 355,
360(k), and 360e) or section 351 of the
PHS Act (42 U.S.C. 262). FDA may issue
an EUA only if, after consultation with
the HHS Assistant Secretary for
Preparedness and Response, the
Director of the National Institutes of
Health, and the Director of the Centers
for Disease Control and Prevention (to
the extent feasible and appropriate
given the applicable circumstances),
FDA 1 concludes: (1) That an agent
referred to in a declaration of emergency
or threat can cause a serious or 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
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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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.
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II. EUA Requests for In Vitro Diagnostic
Devices for Detection of the Zika Virus
On February 26, 2016, the Secretary of
HHS determined that there is a
significant potential for a public health
emergency that has a significant
potential to affect national security or
the health and security of U.S. citizens
living abroad and that involves Zika
virus. On February 26, 2016, under
section 564(b)(1) of the FD&C Act, and
on the basis of such determination, the
Secretary of HHS declared that
circumstances exist justifying the
authorization of emergency use of in
vitro diagnostic tests for detection of
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Zika virus and/or diagnosis of Zika
virus infection, subject to the terms of
any authorization issued under section
564 of the FD&C Act. Notice of the
determination and declaration of the
Secretary was published in the Federal
Register on March 2, 2016 (81 FR
10878). On September 8, 2017, Siemens
Healthcare Diagnostics, Inc. requested,
and on September 18, 2017, FDA issued,
an EUA for the ADVIA Centaur Zika
test, subject to the terms of the
Authorization. On September 14, 2017,
Chembio Diagnostic Systems, Inc.
requested, and on September 27, 2017,
FDA issued an EUA for the DPP Zika
IgM Assay System, subject to the terms
of the Authorization.
III. Electronic Access
An electronic version of this
document and the full text of the
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54363
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 two in vitro diagnostic devices for
detection of Zika virus subject to the
terms of the Authorizations. The
Authorizations in their entirety (not
including the authorized versions of the
fact sheets and other written materials)
follow and provide an explanation of
the reasons for issuance, as required by
section 564(h)(1) of the FD&C Act:
BILLING CODE 4164–01–P
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Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices
8, 20!7
Matthew Gee, M.Sc.
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Inc.
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Senior M"'n:><Jf'r, ''"'l'.u"w"'
Siemens lleal!heare
511 Benedict Avenue
N'{ 10591-5097
Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices
54365
)),
Zika virus. Pursuant section
the basis of such determination,
'"<'''''"'""' the authorization
concluded that the criteria
issuance of this authorization under section
of the
U.S£. §
are met I am
the emergency
of the ADVI.A
Centaur Zika test (as described in the
of Authorization section of this leuer
CDC Zika virus clinical criteria (e.g., clinical
in individuals
and/or CDC Zika virus cnlde:mJtOI<D!lJ,cal
associated with Zika virus
of residence in or travel
with active Zika transmission at the time
oftravel, or other
criteria
which Zika virus
described in the
of Auth<>ri?~tion section of this letter tc• ••.~·'··deteetion of Zika virus inli>Ptiirm
authorization.
I. Criteria for lssuaru.:e of Authorization
the
""""!"';'"'" meets the
t\et, because I have concluded
I have C(lnduded that the t~mcr~<em:v
nn;~litflti;re detection of Zika
issuance of an authorization
that:
l, The Zika virus can cause Zika virus intection, a serious or
condition to humans infl.~ted with the
7
Based t'l!l the
of scientific evidence available to FDA, it
that the A.DVIA Centaur
reasonable to believe
'"''"rr•v"''' and available a!ternati ve to the emergency use of the
clla:gnos1ngZika virus infection.
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l !3·5. under section
of a sign ill can!
54366
Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices
3
Mr. Gee. Siemens Healtheare
U.
of Authm·izatiou
authori:r.atlon
Act. that the
•>~""'"';.,"''!laboratories lor the
Centaur Zika test
CDC Zika
antibodies
The Authorized AJlVIA Cenhmr Zika Tt·st
P!l1JertH1naten~:d
serum
CDC Zika virus clinical criteria
CDC Zika virus
with active
Zika virus
Zika transmission at the time
may be '"'''"~t~··1
The ADVIA Centaur Zika test is
of the ADVIA Centaur Zika Ab and ADVIA
Centaur Zika
assays. All AOVIA Centaur Zika Ab reactive
must be tested with
the ADVIA Centaur Zika
assay.
ADVIA Centaur Zika Ab
In the first pass, coated
fromthe
Th.:
anti·Zika antibodies earnm·ed
with aeridinium
fimnaL
antibodies
resl::tsoendled. ln the second
the Solid Phase are detected
addition of NSJ
'-'~"'"'··---H for chemiluminescent detection.
In
from the
antibodies are washt:d and
In the seeond pass, the amhLIKa
Solid Phase is detected the ""'"'"'·""ofNS!
labeled with acridinium ester (Lite
fin chemi!uminescent detection,
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AD VIA Centaur
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The AD VIi\. Centaur Zika test includes use ofthe ADVIA Centaur XP
XPT
and other authorized instruments.
Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices
4
Mr.
..
calibrators;
control
AD VIA Centaur ZHm test
"'
•
"
•
•
54367
ADVIA Centaur ZikaM
ADV!A Centaur ZikaM
ADVIA Centaur ZikaM Cal!i1:ratl)l' ..... ~l>ti!llt'u Value Card ami
ADVIA Centaur ZikaM Master
ADVIA Centaur ZikaM
control
control
as~ng11ed value card and barcode labels
Control
and barcode labels
ADV.IA Centaur Zika test
the
or additional materials and
reagents
com11110111Y used in dlnicallaboratories and that are described in the authori:?.ed AD VIA Centaur
Instructions fhr
The above described i\DVIA Centaur Zika test when labeled
FDA entitled ·'ADVIA Centaur Zika test"
the
information ""'rt"'inirm
healthcare
ADVlA Centaur
• Fact Sheet for Healthcare
• Fact Sheet for Patients: U!'lde:rst~mdin)l
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Siemens Healthcare
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Other Fact Sheets deve!OO<:!'d
with concurrence
the Chief Scientist
Results
54368
Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices
5
described in Section IV below, ~~{~m~~ns
make available additional infimnation
ADVlA Centaur Zika test that
of authorizFltinn.
pursuant to
of the Acl, !hat it reasonable to believe that
the known and
benefits ofthe authorized AD VIA Centaur Zika
when used for
have
pursuant to section
of the Act based on the
ofscicntit1c
evidence available to FDA, that it is reasonable to believe that the authorized ADVIA Centaur
of recent Zika virus
when used
Zika test may be effective in the
of
of this letter
tn section
with the
ofthe Act
has reviewed the scicntille inthmuuion available to FDA. '""'"'''""'
Section I above, and concludes
Centaur Zika test, when used to
Zika virus infection in the
described in the
of
of this letter
set tl:1rth in section
""'II"'" um! the conclusions described
The emergency usc of the authorized ADVIA Centaur Zika test under this
consistent
and may not exceed, the terms ofthis letter,
the
Audt<)rization
and the Conditions of Authori:tlttion
IV).
to the
tenns of this EUA and under the circumstances set forth in the
HHS's detennination
described above and the
ofHHS's
declaration under section
).
to
Zika virus infection in
the AD VIA Centaur Zika test described above is
individuals
CDC Zika
time
the
Waivea· of Certain
the duration of
sradovich on DSK3GMQ082PROD with NOTICES
the
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m.
will cease to be effective when the HHS declaration !hat c!r•cmnstan<:es
of the Act when the
Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices
54369
!l.k Gee, Siemens Healthcare Uu!gnostics Inc.
(2! LLS.C.
on the usc of the device ''"'""''"'"
and any available infom1ation re~:an:iin·g "'""t;·,,."'""'"'"
under 21 CFR
IV. Conditions of Authorization
Pursuant to section 564 ofthe .Act, I am '"''·""''"'"
this authoriz<llkm:
A. Siemens Healthcare
and authorized
to authorized
authorized ADVIA Centaur Zika
laboratories. Siemens Healthcare vti>i':HVM''"~
to the authorized
Siemens Healthcare Dillgnostlcs in
Such requests 'vvi!l be made
consultation with, and
Ct)ncurrence ot: Dlv1D/OIRJCDRH.
[t
Siemens Heahheare
and its authorized
to
authorized laboratories the authorized ADV.!A Centaur Zika tesl Fact Sheet fbr
Hca.lthcare Providers
the authorized ADVIA Centaur Zika
Fact Sheet tbr
Patients, and any additional ADVlA Centaur Zika test Fact Sheets for Healtheare
Prnv.iders and Patients that OCETlOCS/OC and Dl\ltDI'O!R!CDRH
autl1orize.
(' Siemens Healtheare "''.'"'""'"'""'
{)rl their websitcs the nmnm'l7('fl
Providers and the authorized
and any
additional AD VIA Centaur
Sheets
Healthcare Pmviders and Patients
that OCET/OCSIOC and DJvtDfOIR/CDRH may authorize.
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D. Siemens Heahhcarc
and its authori?ed
'"''''""'''' will infonn
of this EUA.
health ·mtfmr•'"'
authoriz£d laboratories and relevant
the terms and conditions herein.
54370
Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices
Healthcare Di<lgnostics lnc.
authorized dis:trilJut,or(.s)
AIJVIA Centaur
healthcare nrn,vlcters
lmlhn'''"''d
G. Siemens Healthcare
information on the
report to FDA any
and authorized
will collect
ofthe test Siemens Healthcare
will
occurrence of lalsc
and talse
resulls and
~•gm!Jtc<uudeviations from the established
characteristics ofthe test of
which Siemens Healthcare
becomes aware.
authorized to
of the authorized
ten11s ofthis
H. Siemens Healthcare
make available
ADVV\ Centaur lika
letter of authoriztltion.
L Siemens llealthcare
ADVIA Centaur Zika lest. "'"'"""'"'
authorized
l
Siemens Healthcare
amendments that
materials
K. Siemens He:llthcaw
Centaur Zika test
Zika test
I mmnn'il
ms~h
requests listed in this condition
in consultation
DMD/()IRJCDRlL
~~
'u"'""'u~<•uuuwi!l be made
Siemens Hcaltheare
concurrence of. OCEl:tOCS/OC and
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L, Siemens .He<'llthcare
may request the addition of other instruments l{)r use
\Vith the authorized AD VIA Centaur Zika tesL Such requests will be lllilde
Siemens Heatthcarc
in consultation with, and
concurrence
DMD/OIR/CDRll.
Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices
Siemens
54371
Heailh,~arc
t'hr
with the '"'' ...·""''"·''·"
Siemens Healt!u:at·e
DMD/OIR/CDRIL
with, and
types for
Siemens J!ealthcare
may request the addition of other
use with the authorized i\DVIA Centaur Zika test Such requests will be made
Siemens Healthcare
in consultation
and
concurrence
DJ\.10/0lRlC:DRH.
0. Siemens Healthcare
may request the addition of other
materials
fbr use with the authorized ADVIA Centaur Zika test Such requests >viii he made
in consultation
Siemens liealt.hcare
and
DMDlOIR/CDRH.
P. SieJnens Healtheare m!!.nostH:s may request substitution tbt· or
authorized materials
in the
process of the human 'u"'"'·"'"
Siemens Heallhcare DilU!Il:osl.ics
D!vtD/OIR/CDRH~
Siemens Healthcare
CFR Part 803.
of the ADVJA Centaur
R. Siemens Healtheare
will evaluate the
of characterized clinical
Zika test with any FDA-recommended or established
After D!'viD/OIR/CDRl I's
"'">rim.,·n~ and will subn1it that
data to
review of and concurrence with the data, Sicmen$ Hcalthcare
will
in consultation
and with concurrence ol~ DMD/OIR/CDRR to
reflect the additional
S. Siemens llealthcare
will
test with any FDA-recommended reft~rencc
of the ADVI,.\ Centaur Zika
After submission to FDA and
t~m1currence
to
of the ADVIA Centau.r
18:32 Nov 16, 2017
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Siemens Healthcare
Zika test ami report to
VerDate Sep<11>2014
with the data, Siemens Hca!thcarc
the additional
54372
Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices
Authorized Laboratories
reports of the results
ADVIA Centaur
Hea!theare Providers
authorized Fact
Shee! tor Patients. and
additional
Centaur Zika test
Sheets for
Hea!theare Providers and Patients that OCETlOCS/OC and DMD/OIR/CDRH may
authorize. Linder
other
v.
each collected
alonu~;ide
.,,.,..,.;,,"''"' '""~,,.;..,,,,," or >vith other authorized ~~c·~'M·'-~"
Y. \\lithin the United States and its territories, authorized laboratories
all
Zika Positive results to Siemens Healthcarc ~n'"!.!.'"'~'"""·
Authorized laboratories
the l!nal int,,,..,,,.,,;,nio
Zika Positive,
for
antibodies to Zika
antibodies to Zika virus). described in the Instructions
document, to
healthC<!fC nrrwt,rH•t·~
Authorized laboratories will have
results . addilional
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to
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BR Authorized laboratories will
hcalthcare nwrn.·t.rl•''""
Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices
54373
Authorized laboratories \Vill collect intbrmation on the "''1rfi''""'"'"'"
Centaur Zika test and
DMDIOIR/CDRH {via
and Authorized
Siemens Uealthcare lli:ilglms;tic!>, Its Authorized
l.aboratories
authorized
records associated with this
made available to FDA
notified
request
FF.
All
and
matter
to the use of the
authoriz.ed ADVlA Centaur Zika test shall be consistent ·with the authorized Fact Sheets
the 1em1s set fhrth in this EllA and the
and FDA
GG.
use of the
that
This
aulhori zed
This test has
laboratories:
virus infection
This tesl has been
and r\ot for any other
i'l>t tbe duration of the declaration that
ernergcncy usc of in
m""'" v""'' the authorization
vitro
tests for detection ofZika virus and/or
infection under
of the Act, 21lLS.C
Zika virus
l ),
VerDate Sep<11>2014
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sradovich on DSK3GMQ082PROD with NOTICES
unless the authorization is terminated or revoked sooner.
54374
Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices
or
ADVIA Centaur Zika test may l'<'l''r"~"'nl
dil~IUIOS!S tlf
virus ini'Cct.ion.
''""'~''"'~rwv
usc of the authori:t:ed ADVIA Centaur Zika
\Vlth !hC <;VJIIUIUUIII:'I
V. DuratiGn of AutbGrization
This
\Vill be efTectivc until the declaration that circumstances
the
authorization of the emergency use
vitro
tests for detection of Zi.ka virus and/or
u"'lS''u"'" of Zika virus infection is terrninated under section
ofthc Act the EUA is
revoked under section
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Enclosures
Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices
54375
3661 Horseblock Road
Medford, NY 11763
Dearfl,k
with active
transmission at the time of travel. or other
Zika virus
laboratories in the United States that are certified under the
to
Amcndzncnts of 1988
~·'''~'''¥"
26, 2016, pursuant to section
the
of Health and Human Services
fi1r a
health emergency that has a
360bbbtbere is a
~X1t.el11lia! to affect
VerDate Sep<11>2014
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sradovich on DSK3GMQ082PROD with NOTICES
comple.~ity
54376
Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices
issued under
concluded that the criteria 1\lr issuance ofthis authorization under section
of the
are met l
the emergency use of the DPP Zika
ofAutl1orization section ofthis letter (Section
(as described in the
m<:etimg CDC Zika virus clinical criteria
a
of clinical
and
Zika virus
criteria
of residence in or travel to a
with active Zika transmis;lion at the
ep:tacmil)!Ogtcat criteria tor which Zika virus
may be mcuclltc•:tJ
for I he rm~sum!Jiti
the terms of
I. Criteria for Issuance of Authorization
concluded thai the emergency use ofthe DPP Zika
detection ofZika virus
meets the criteria for issuance of an authori:ration under section
have concluded that:
'""'~"'"""1
I. fhc Zika vims can cause Zika virus
conditim1 to humans infected with the virus;
1.
3. There is no '"''"'Y'·'"'~'· "'""''"'·'•'··• and available altcmmive to the emergency use of the
DPP Zika
Zika virus infection.
As amended by the Pandcmk and All·Ha?l'!rds Preparedness Reauthnrizatkm Act. Pub.
ofthe Act, the Secretary may
determination of a public health""'"'""''"'"
lbr a public health em~rgem;y.
VerDate Sep<11>2014
18:32 Nov 16, 2017
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Df'itt'rl•iilli11ilm
under sect k111
<lh signifkam
Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices
54377
Inc.
U.
of Allthorization
authorit,ation is
"m""'"'"''t~laboratories for
···~-"Ub CDC
Zika
of residence in or
Del"itlltn1l~d"
nh,nrirlm,~
and/or test results for other
for the
the latest
of Zika ·virus
Tbe Authori.zed JlPP Zika
"'"'"'"'''"m'n"'""' lateral
""•·•tv'tl"'~
nmv assay
in human serum
orEDTA
'"''"''''"''' • s•nec•m,ens and otlu~r
area <md a
area in the test·control wind0\1/ ofthe test device. 'I'he reagent
tbr the
detection of ZIK V
based on
human
that
colored
~.;vlt!~::~.;•~::u and then diluted with
belbre
\llell# l ofthe DPP Zika Test Device. The ;;:ne:cm!lcn
ammcmv~mnmtng
the TEST
colored
antibodies bound to the TEST
colored COJI1jugal.e and detection is nPt·fi"'"""'l
authorized instruments, that uses ass:av·-so;ecu
sradovich on DSK3GMQ082PROD with NOTICES
line and measure color
VerDate Sep<11>2014
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itto
area will capture the
the Chcmhio DPP Micro Reader, or other
the presence of the control
'""'""''"'Q the results
in the TEST
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17NON1
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membrane and is delivered
54378
Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices
Mr.
Inc.
\Vith a
or invalid result
consideration of test
lnnrith'""' for the dHIJ.;Il.()S!S
DPP Zika
materials and instruments. or other
authorized materials and instruments:
control materials
tbe
nrt\\fli'ii>rl
..
DPP Zi.ka
other authorized
with !he test;
Control Padc DPP Zika Reactive Contmt DPP Nonreactive
insert The assay controls are used to
the user's
to
results.
and federal
eo11tml
the use of additional materials and
:n1.~.w:4rv
latiOflitOJ•ies and that arc described in the authorized DPP
The above described DPP Zika
authorized
FDA entitled "DPP Zika
and "DPP Zika
when labeled
with the
" "DPP Micro Reader. "DPP Zika
Rcicrcnce Instructions.
not meet certain
otherwise
Chembin in consultation with, and v.·ith concurrence of, the Division of
Devices
Vitro
and
Health
KaiJHltog!ctu l1eal!h
sradovich on DSK3GMQ082PROD with NOTICES
MI!Ct\JOW,IO~~Y
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lle revised
Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices
5
54379
Mr.
rmu"m''"'
entcrJ~~:ertcv
information
aulht1rized to be ac<:ornp<mu~d
use. which is authorized
available to healthcam
Otht~r Fact Sheets
Chembio in em1sultation with. and with concurrence
the
Office of Counterterrorism and
Threats
of the Chief Scientist
of the Commissioner
and DMD!OIR/CDRII may be authorized to
ac<x1mpany the above described DPP Zika
Assay
and 10 be made available to
healthcare
and "'"""''"'·
described in Section IV below. Chembio is also authorized to make available additional
to the emergency
authorized DPP Zika
that
consistent ;vith, and does no!
the 1em1s of this letter
inihnmttion
detection
of this letter '~"•V"'~"
the known
I have concluded, pursuant to section
of the Act based on the
ofsdentific
evidence available to
that it is reasonable to believe that the authorized DPI' Zika
of recent Zika vims infection. when used
may be e!Tcctive in the
of Authorization ofthis letter
pursuant to section
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sradovich on DSK3GMQ082PROD with NOTICES
"'"'?'"'"~'"'" ust~ of the authorized DPP Zika
consistent '"''ilh. and may no! exceed, the terms ofthis letter.
ami the Conditions of Authorization
t() the
Authorization
tenns of this EUA and under the circumstances set t(ll1h in the
of HHS's determination
described above and the
of HHS's
declaration under section
).
the DPP Zika
Zika virus infection
in individuals
a
of clinical
and
'""""''""'" associated with Zika virus
and/or CDC Zika virus
criteria
of residence in ot travel
transmission at the
time oftmveL or other
be
54380
Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices
EUA will cease to be et!ectivc when the IHIS declaration that circumstances exist to
the EUA is tcm1inated under st.-ction
of the Act when the
is revoked
of the Act
under section
m.
Waiver of Certain
I am
the
duration of this EUA:
ir.-m .. nt<
the DPP Zika
the
under 21 CrR Part 820 with respect to the
storage, and distribution of the DPP Zika
..
and any available intormatit1n """'"""d''""
under2l CFR
ne1rli\:rrn::lrl<'<'
IV. Conditions of Authorization
Pursuant to section 564 of the Act, f am '""'""''"'"m~" the
this authorization:
conditions on
will distribute the authorized DPI' Zika
to authorized laboratories. Chcmbio
be made
Such
DMD/OIR/CDRH.
'""ill
It Chembio and its aulhmizcd
to authorized la!:lOratories the
authorized DPP Zika
tbr Hcalthcare Providers and the
authorized DPP Zika
Fact Sheet fhr Patients. and
additional
DPP Zika
fact Sheets !or Heal!hcare Providers and Patients that
OCET/OCS/OC and DMD/OJR/CDRH may authorize"
VerDate Sep<11>2014
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17NON1
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sradovich on DSK3GMQ082PROD with NOTICES
C Chembio and i!s authorized
will make available on their \vcbsites the
authorized DPP Zika
Fact Sheet tor Hcalthcare Providers and the
authorized DPP Zika
Fact Sheet fbr Patients, and any additional
DPP Zika
Sheets l'br Healtheare Providers and Patients that
OCET/OCS/OC and D!VlO/OIR/CDRH may authorize.
Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices
54381
7 ?v1r.
D.
will inform authorized labmatories and
the
Ct'lndi t ions
Chembio and its authorized
authorized DPP Zika
resulls to healthcare ·~··"·"'"'"'""
a process
will
controL Chemblo and its authorized
maintain records of device usage.
G. Chembio and its authorized
will collect information on the""'''''{'',""''"'
ofthe assay. Chembio will report to FDA any
occurrence of false
and false
results and
deviations from the established '"''rtr'r"'""'''"'
characteristics of the
Chembio and its authorized
infonnation
that
"'"''""''"'arc authorized to 1nake
of the authorized DPP
the terms
auth~lrization.
L Chembio and its authorized
Control Pack control material or other authorized comml materials for
same time the DPP Zika
at the
Cbembio
authorized
K. Chembio will
be
Chembio may request
the authorized DPP Zika
Sheet for Hea.lthcare
and the authorized DPP Zlka
Sheet for Patients. Chembio may also
Sheets for Healtheare Providers and Patients, !IPI'ropri~ne, and ma}' request
such Fact Sheets. All such requests listed in
condition <}f authorization will be
OCET/OCSlOC
made
Chembio in consultation with, <md
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18:32 Nov 16, 2017
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sradovich on DSK3GMQ082PROD with NOTICES
and DrviD/OlR/CDRII.
54382
Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices
~L
request the addition of other instruments ft•r use with the authorized
Such requests \Viii be made Chembio in eonsultaliQn
com::urrence of, D!VfD/()!R/CDIUL
Chembi"
DPP Zika
and
Chembio
request the addition of oiher
reagents fin
with the
authorized
Zika
Such requests will be made Chembio in
consultation with. and
concurrence ot: D!'v1D/OIR/CDRI!.
0. Chembio may request the addition of other
types for use with the authori7:ed
DPP Zika
Such requests will be made Chembio in consultation
with. and
DMD/OlRlCDRH.
the addition of other control materials fbr u~"e with the
Such
will be made Chcmbio in
P.
consultation
Chembio may
substitution for enrnu'"'~ to the authorized materials used in
the dctcctil.m process of the human anti·Zika
in the
Such requests will
be made
Chcmbio in consultation \Vi!h,
R. Chembio ;viii track adverse events and report to FDA undcr2l CFR Part 803.
S. Chembio will evaluate the
Assay
with any
of characterized clinical
and
FDA-recommended or established
will submit that
data to FDA After DMD/OIRlCDRH's revie\V of and
Chcmbio will
its
in commltalion with, and
'""ith concurrence
to reflect the additional
T. Chcmbio \lv'i!l
with any FDArecommended l"cfet·encc
to FDA and
DMD/OIR/CDRH's review ofand concurrence with the data, Chembio will
its
to reJ:1eet the additional
of the DPP Zika
Chembio will track the
D!'v1D/OIR/CDRH 011 a semi-annual
and report to
V Authorized laboratories will include with reports of the results of the DPP Zika
the authorized Fact Sheet f<Jr Healtheare Providers and the authorized
Fact
for
and any additional DPP Zika
Fact Sheets
tor Hcalthearc Providers and Patients ahat OCETIOCS/OC and DMDlOIR/CDRH may
authorize. Under
other
methods
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sradovich on DSK3GMQ082PROD with NOTICES
mlllerial.
Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices
these Fact Sheets may be
54383
may include mass media.
X. !fnon-senm1 ~'""'"""''"'"
laboratories
Authorized laboratories must read the results ofthe DPP Zika
authorized instruments.
DPP Micro Reader or on
inrm·"'""' the results
DPP Zika
terl'itories. authorized la!1,or!ttm!les
Zika
to Chembio.
l.
to ensure
report all
1~)r
reactive results
described in !he Instructions
BB. Authorized laboratories \\~ll have
hcalthcare
ami re.lcvant
to
CC Authorized laboratories will collect information on the J~c~·tmmance
and
DMD/OIR/CDRH (via email .:. ·'"·'·"'·'·····'
and
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sradovich on DSK3GMQ082PROD with NOTICES
in accordance with
the assay must also be trained in
of the DPP Zika
54384
Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices
and Authorized Laboratories
Chembio. its authorized
records associated with this
will be made available to FDA
and authorized laboratories will ensure that. an.Y
maintained until notified FDA. Such records
inspel:Ll(m upon request
matter
the use of the
Assay
shall be consistent with the authorized Fact
'"""'"""'· as well as the terms set torth in this
and the
FF.
in the Act and FDA re~::cuwmons.
00. All
and ""'''",.,''""''"'r
authorized DPP Zika
state that:
for
This test has been authorized
"
This test has been authorized
and not tor <my other viruses or patMJ;en.s;
authorized
virus intection
the authorization oft he emergency usc of in
tests t(Jr detection of Zika virus and/or
of Zika virus
).
l) of!hc Act, 21 U.S. C.
infection under section
unless the authorization is tem1ina1cd or revoked sooner.
vitro
matter
to the use
safe
authorized
eflective for the
of the authorized DPP Zika
as described this letter
must
with the conditions and all olher tenns ofthis authorization,
•"m<'r<J't".lu'v use
•H""'i'mh."'"
V. Duration of Authorization
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sradovich on DSK3GMQ082PROD with NOTICES
the
This EUA will be efl:cctive until the declaration that cireurnstanecs
authorization ofthe ''"'~'r''"""'" usc
vilro
tests for detection of Zika virus and/or
<mtgnos11s of Zika virus
is terminated under section
ofthe Act or the EU A is
revoked under section
of the
Dated: November 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–25010 Filed 11–16–17; 8:45 am]
BILLING CODE 4164–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–6159]
Expedited Programs for Regenerative
Medicine Therapies for Serious
Conditions; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
document entitled ‘‘Expedited Programs
for Regenerative Medicine Therapies for
Serious Conditions; Draft Guidance for
Industry.’’ The draft guidance, when
finalized, will provide stakeholders
engaged in the development of
regenerative medicine therapies with
FDA’s current thinking on the expedited
development and review of these
products. The draft guidance describes
the expedited programs available to
sponsors of regenerative medicine
therapies for serious or life-threatening
diseases or conditions (referred to in the
draft guidance as serious conditions),
including those products designated as
regenerative advanced therapies (which
FDA refers to as ‘‘regenerative medicine
advanced therapy’’ (RMAT)
designation); describes how the Center
for Biologics Evaluation and Research
(CBER) will work with sponsors and
encourage flexibility in clinical trial
design to facilitate the development of
data to demonstrate the safety and
effectiveness of regenerative medicine
therapies being developed to address
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:32 Nov 16, 2017
Jkt 244001
unmet medical needs in patients with
serious or life-threatening diseases or
conditions; and describes the
opportunities for sponsors of
regenerative medicine therapies to
interact with CBER review staff.
DATES: Submit either electronic or
written comments on the draft guidance
by February 15, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
PO 00000
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54385
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2017–D–6159 for ‘‘Expedited Programs
for Regenerative Medicine Therapies for
Serious Conditions; Draft Guidance for
Industry.’’ Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
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E:\FR\FM\17NON1.SGM
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Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices
]]>Agencies
[Federal Register Volume 82, Number 221 (Friday, November 17, 2017)]
[Notices]
[Pages 54361-54385]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25010]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-6152]
Authorizations of Emergency Use of In Vitro Diagnostic Devices
for Detection of Zika Virus; Availability
AGENCY: Food and Drug Administration, HHS.
[[Page 54362]]
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of two Emergency Use Authorizations (EUAs) (the
Authorizations) for in vitro diagnostic devices for detection of the
Zika virus in response to the Zika virus outbreak in the Americas. FDA
issued these Authorizations under the Federal Food, Drug, and Cosmetic
Act (the FD&C Act), as requested by Siemens Healthcare Diagnostics,
Inc. and Chembio Diagnostic Systems, Inc. The Authorizations contain,
among other things, conditions on the emergency use of the authorized
in vitro diagnostic devices. The Authorizations follow the February 26,
2016, determination by the Secretary of Health and Human Services (HHS)
that there is a significant potential for a public health emergency
that has a significant potential to affect national security or the
health and security of U.S. citizens living abroad and that involves
Zika virus. On the basis of such determination, the Secretary of HHS
declared on February 26, 2016, that circumstances exist justifying the
authorization of emergency use of in vitro diagnostic tests for
detection of Zika virus and/or diagnosis of Zika virus infection,
subject to the terms of any authorization issued under the FD&C Act.
The Authorizations, which include an explanation of the reasons for
issuance, are reprinted in this document.
DATES: The Authorization for Siemens Healthcare Diagnostics, Inc. is
effective as of September 18, 2017; the Authorization for Chembio
Diagnostic Systems, Inc. is effective as of September 27, 2017.
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
section for electronic access to the Authorizations.
FOR FURTHER INFORMATION CONTACT: Carmen Maher, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4347, Silver Spring, MD 20993-
0002, 301-796-8510 (this is not a toll free number).
SUPPLEMENTARY INFORMATION:
I. Background
Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the
Project BioShield Act of 2004 (Pub L. 108-276) and the Pandemic and
All-Hazards Preparedness Reauthorization Act of 2013 (Pub L. 113-5)
allows FDA to strengthen the public health protections against
biological, chemical, nuclear, and radiological agents. Among other
things, section 564 of the FD&C Act allows FDA to authorize the use of
an unapproved medical product or an unapproved use of an approved
medical product in certain situations. With this EUA authority, FDA can
help ensure 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 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 Centers for Disease Control and
Prevention (to the extent feasible and appropriate given the applicable
circumstances), FDA \1\ concludes: (1) That an agent referred to in a
declaration of emergency or threat can cause a serious or life-
threatening disease or condition; (2) that, based on the totality of
scientific evidence available to FDA, including data from adequate and
well-controlled clinical trials, if available, it is reasonable to
believe that: (A) the product may be effective in diagnosing, treating,
or preventing (i) such disease or condition; or (ii) a serious or life-
threatening disease or condition caused by a product authorized under
section 564, approved or cleared under the FD&C Act, or licensed under
section 351 of the PHS Act, for diagnosing, treating, or preventing
such a disease or condition caused by such an agent; and (B) the known
and potential benefits of the product, when used to diagnose, prevent,
or treat such disease or condition, outweigh the known and potential
risks of the product, taking into consideration the material threat
posed by the agent or agents identified in a declaration under section
564(b)(1)(D) of the FD&C Act, if applicable; (3) that there is no
adequate, approved, and available alternative to the product for
diagnosing, preventing, or treating such disease or condition; and (4)
that such other criteria as may be prescribed by regulation are
satisfied.
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\1\ The Secretary of HHS has delegated the authority to issue an
EUA under section 564 of the FD&C Act to the Commissioner of Food
and Drugs.
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No other criteria for issuance have been prescribed by regulation
under
[[Page 54363]]
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
Zika Virus
On February 26, 2016, the Secretary of HHS determined that there is
a significant potential for a public health emergency that has a
significant potential to affect national security or the health and
security of U.S. citizens living abroad and that involves Zika virus.
On February 26, 2016, under section 564(b)(1) of the FD&C Act, and on
the basis of such determination, the Secretary of HHS declared that
circumstances exist justifying the authorization of emergency use of in
vitro diagnostic tests for detection of Zika virus and/or diagnosis of
Zika virus infection, subject to the terms of any authorization issued
under section 564 of the FD&C Act. Notice of the determination and
declaration of the Secretary was published in the Federal Register on
March 2, 2016 (81 FR 10878). On September 8, 2017, Siemens Healthcare
Diagnostics, Inc. requested, and on September 18, 2017, FDA issued, an
EUA for the ADVIA Centaur Zika test, subject to the terms of the
Authorization. On September 14, 2017, Chembio Diagnostic Systems, Inc.
requested, and on September 27, 2017, FDA issued an EUA for the DPP
Zika IgM Assay System, subject to the terms of the 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 two in vitro diagnostic devices for
detection of Zika virus subject to the terms of the Authorizations. The
Authorizations in their entirety (not including the authorized versions
of the fact sheets and other written materials) follow and provide an
explanation of the reasons for issuance, as required by section
564(h)(1) of the FD&C Act:
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Dated: November 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-25010 Filed 11-16-17; 8:45 am]
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