Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Novel Influenza A (H7N9) Virus; Availability, 21768-21776 [2014-08706]
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21768
Federal Register / Vol. 79, No. 74 / Thursday, April 17, 2014 / Notices
(§§ 1.337 and 1.345). Required records
for transporters include the names of
consignor and consignee, points of
origin and destination, date of
shipment, number of packages,
description of freight, route of
movement and name of each carrier
participating in the transportation, and
transfer points through which shipment
moved (§ 1.352). Existing records may
be used if they contain all of the
required information and are retained
for the required time period.
Section 101 of the FDA Food Safety
Modernization Act (FSMA) (Pub. L.
111–353) amended section 414(a) of the
FD&C Act and expanded our access to
records. Specifically, FSMA expanded
our access to records beyond records
relating to the specific suspect article of
food to records relating to any other
article of food that we reasonably
believe is likely to be affected in a
similar manner. In addition, we can
access records if we believe that there is
a reasonable probability that the use of
or exposure to an article of food, and
any other article of food that we
reasonably believe is likely to be
affected in a similar manner, will cause
serious adverse health consequences or
death to humans or animals. To gain
access to these records, our officer or
employee must present appropriate
credentials and a written notice, at
reasonable times and within reasonable
limits and in a reasonable manner.
On February 23, 2012, we issued an
interim final rule in the Federal
Register (77 FR 10658) (the 2012 IFR)
amending § 1.361 to be consistent with
the current statutory language in section
414(a) of the FD&C Act, as amended by
section 101 of FSMA. In the 2012 IFR,
we concluded that the information
collection provisions of § 1.361 were
exempt from OMB review under 44
U.S.C. 3518(c)(1)(B)(ii) and 5 CFR
1320.4(a)(2) as collections of
information obtained during the
conduct of a civil action to which the
United States or any official or agency
thereof is a party, or during the conduct
of an administrative action,
investigation, or audit involving an
agency against specific individuals or
entities (77 FR at 10661). The
regulations in 5 CFR 1320.3(c) provide
that the exception in 5 CFR 1320.4(a)(2)
applies during the entire course of the
investigation, audit, or action, but only
after a case file or equivalent is opened
with respect to a particular party. Such
a case file would be opened as part of
the request to access records under
§ 1.361. Accordingly, we have not
included an estimate of burden hours
associated with § 1.361 in table 1.
Description of Respondents: Persons
that manufacture, process, pack, hold,
receive, distribute, transport, or import
food in the United States are required to
establish and maintain records,
including persons that engage in both
interstate and intrastate commerce.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR Section
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
1.337, 1.345, and 1.352 (Records maintenance) ................
1.337, 1.345, and 1.352 (Learning for new firms) ...............
379,493
18,975
1
1
379,493
18,975
13.228
4.790
5,020,000
90,890
Total ..............................................................................
........................
........................
........................
........................
5,110,890
TKELLEY on DSK3SPTVN1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
This estimate is based on our estimate
of the number of facilities affected by
the final rule entitled ‘‘Establishment
and Maintenance of Records Under the
Public Health Security and Bioterrorism
Preparedness and Response Act of
2002,’’ published in the Federal
Register of December 9, 2004 (69 FR
71562 at 71650). With regard to records
maintenance, we estimate that
approximately 379,493 facilities will
spend 13.228 hours collecting,
recording, and checking for accuracy of
the limited amount of additional
information required by the regulations,
for a total of 5,020,000 hours annually.
In addition, we estimate that new firms
entering the affected businesses will
incur a burden from learning the
regulatory requirements and
understanding the records required for
compliance. In this regard, the Agency
estimates the number of new firms
entering the affected businesses to be 5
percent of 379,493, or 18,975 firms.
Thus, we estimate that approximately
18,975 facilities will spend 4.790 hours
learning about the recordkeeping and
records access requirements, for a total
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of 90,890 hours annually. We estimate
that approximately the same number of
firms (18,975) will exit the affected
businesses in any given year, resulting
in no growth in the number of total
firms reported on line 1 of table 1.
Therefore, the total annual
recordkeeping burden is estimated to be
5,110,890 hours.
Dated: April 11, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–08707 Filed 4–16–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0306]
Authorization of Emergency Use of an
In Vitro Diagnostic Device for
Detection of Novel Influenza A (H7N9)
Virus; Availability
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
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ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of an Emergency Use
Authorization (EUA) (the Authorization)
for an in vitro diagnostic device for
detection of the novel influenza A
(H7N9) virus (detected in China in
2013). FDA is issuing this Authorization
under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act), as
requested by Quidel Corporation. The
Authorization contains, among other
things, conditions on the emergency use
of the authorized in vitro diagnostic
device. The Authorization follows the
April 19, 2013, 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 the novel influenza A
(H7N9) virus. On the basis of such
determination, the Secretary of HHS
also declared on April 19, 2013, that
circumstances exist justifying the
authorization of emergency use of in
SUMMARY:
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Federal Register / Vol. 79, No. 74 / Thursday, April 17, 2014 / Notices
TKELLEY on DSK3SPTVN1PROD with NOTICES
vitro diagnostics for detection of the
novel influenza A (H7N9) 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 February 14, 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. 32,
Rm. 4121, 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. 32, Rm. 4118,
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
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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; 1 or
(4) the identification of a material threat
by the Secretary of Homeland Security
pursuant to section 319F–2 of the Public
Health Service (PHS) Act (42 U.S.C.
247d-6b) sufficient to affect national
security or the health and security of
U.S. citizens living abroad.
Once the Secretary of HHS has
declared that circumstances exist
justifying an authorization under
section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug,
device, or biological product if the
Agency concludes that the statutory
criteria are satisfied. Under section
564(h)(1) of the FD&C Act, FDA is
required to publish in the Federal
Register a notice of each authorization,
and each termination or revocation of an
authorization, and an explanation of the
reasons for the action. Section 564 of the
FD&C Act permits FDA to authorize the
introduction into interstate commerce of
a drug, device, or biological product
intended for use when the Secretary of
HHS has declared that circumstances
exist justifying the authorization of
emergency use. Products appropriate for
emergency use may include products
and uses that are not approved, cleared,
or licensed under sections 505, 510(k),
or 515 of the FD&C Act (21 U.S.C. 355,
360(k), and 360e) or section 351 of the
PHS Act (42 U.S.C. 262). FDA may issue
an EUA only if, after consultation with
the HHS Assistant Secretary for
Preparedness and Response, the
Director of the National Institutes of
Health, and the Director of the Centers
1 As amended by the Pandemic and All-Hazards
Preparedness Reauthorization Act of 2013 (Pub. L.
113–5), the Secretary of HHS may make a
determination of a public health emergency, or a
significant potential for a public health emergency,
under section 564 of the FD&C Act. The Secretary
is no longer required to make a determination of a
public health emergency under section 319 of the
PHS Act (42 U.S.C. 247d) to support a
determination made under section 564 of the FD&C
Act.
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21769
for Disease Control and Prevention (to
the extent feasible and appropriate
given the applicable circumstances),
FDA 2 concludes: (1) That an agent
referred to in a declaration of emergency
or threat can cause a serious or 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
Novel Influenza A (H7N9) Virus
On April 19, 2013, under section
564(b)(1)(C) of the FD&C Act (21 U.S.C.
360bbb–3(b)(1)(C)), 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 the
novel influenza A (H7N9) virus. Also on
April 19, 2013, 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 the novel influenza A
2 The Secretary of HHS has delegated the
authority to issue an EUA under section 564 of the
FD&C Act to the Commissioner of Food and Drugs.
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Federal Register / Vol. 79, No. 74 / Thursday, April 17, 2014 / Notices
TKELLEY on DSK3SPTVN1PROD with NOTICES
(H7N9) virus, subject to the terms of any
authorization issued under section 564
of the FD&C Act. The Secretary of HHS
also specified that this declaration is a
declaration of an emergency with
respect to in vitro diagnostics as defined
under the Public Readiness and
Emergency Preparedness (PREP) Act
Declaration for Pandemic Influenza
Diagnostics, Personal Respiratory
Protection Devices, and Respiratory
Support Devices signed by then
Secretary Michael Leavitt on December
17, 2008 (73 FR 78362, December 22,
2008). Notice of the determination and
the declaration of the Secretary were
published in the Federal Register on
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April 30, 2013 (78 FR 25273). On
January 28, 2014, Quidel Corporation
requested, and on February 14, 2014,
FDA issued, an EUA for the LyraTM
Influenza A Subtype H7N9 Assay
subject to the terms of this
authorization.
III. Electronic Access
An electronic version of this
document and the full text of the
Authorization are available on the
Internet at https://www.regulations.gov.
IV. The Authorization
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 novel influenza A
(H7N9) virus (detected in China in
2013) subject to the terms of the
Authorization. The Authorization in its
entirety (not including the authorized
versions of the fact sheets and other
written materials) follows and provides
an explanation of the reasons for its
issuance, as required by section
564(h)(1) of the FD&C Act.
BILLING CODE 4160–01–P
Having concluded that the criteria for
issuance of the Authorization under
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Federal Register / Vol. 79, No. 74 / Thursday, April 17, 2014 / Notices
21771
DEPARTMENT OF HEALTH AND HUMAN SERVICES
2014
Clinical and
Affairs
10]65 McKellar Court
San
CA 9212!
Dear Dr. Tamerius:
This letter is in respnl1se tn your
Use Authorization
LI\::I;[\::lcalV
01' nuclear tlgent or agents, or a disease or conditim1
• in this case, novel illfJutmza A
U,S.C. §
»), and Oil the basis
of HHS then declared that circumstances
the
it'll' the detection
authorization ofthe emergcncy usc of ill vitro
intlucllza
to the terms
(If A
issued under 21 U.S.C. §
concluded that thc criteria fbI' issuance of t.his authorizaticm. under section
''''''1711,.1 the emergency use of the
Amendments
"'",f·~t",MP"·· or
laboratmies 011 certain instrllll1tlilts for the
detection of influenza A
virus
in China ill 20
In certain
described in the scope section of this letter
to the terms of this
authorization,
Reoutl:!()riz!ltiml ACI, Pul:!. L No, 113-;, under "cellOll
of a public health emergency,
POlelltial for Public Health t'.m"!·"ef1'~
Pursuant to Sectioll 564 of the
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ullder
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of
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42 U.S.c.
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Declan'llil1I11.ha!
Drug, and C(lsm'!!lC
26:30. to
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Pr",~"rc'd","'~
21772
Federal Register / Vol. 79, No. 74 / Thursday, April 17, 2014 / Notices
I. Criteria f01' Issuance of Authorization
I have concluded Ihat die
the
I. The influenza A
life thl'l~at(mjttg
2.
(md available alternative to the emergency
for
influenza
n.
! luwe
of Authorization
'-'Ul!!';i!l~lvl.!,
pun;umH
virus (dc~tee:ted
infection \"'11110 lulVe "'''''<1',I''
determined to be 'u",_ej,ht,,,,,,j,
influenza
re~;i}iI'atl)ry
S),l'1'l111t0111S
of
"'''P'''''''~''
The Aut.horized Lyra™ Influenza A Subtype H7N9 Assay:
,"""Vlle
H7N9
has tested nA",;t,,,,,,
and has been deteITBincd to be "'Ul'_"" ,nT'"...""",,"
FDA-cleared influenza
with
for all "'", ..,,'''
influcnza A viruscs in the United States
seasonal A/H3 and AlHI nnt'I,11':,t""'"
consists ofl1udclc acid extraction on the FDA-cleared biolvlcrieux
system, followed
rRT-PCR on the FDA-cleared ""'!,w,,,,,,
Fast Ox Rcal-Time peR Instrument
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Sp!~Cllrnen
Federal Register / Vol. 79, No. 74 / Thursday, April 17, 2014 / Notices
21773
The
"
Mastel'Mix
Illflm:nza A <;;nhh'T'lf'
'rhe
"
'"
Process Contl'oJ
Avian IllfluellZI\ A
:svlltllctlc DNA Positive COllt.rnl
The above described
til<: If. n,',,.,,,
tbI'
The above described
IllOuellza A ~"hf~l'"'
the
inforlllatIon .. " ... ""n".,
authorIzed to bc made available to healthcllr<!
is authodzed to bc
Ifact Sheet for llealthcare Providet's:
H7N9
Test Results
Fad Sheet for Patients: jnl:Jlerlstll'lldllI12 Results from the
H7N9
Iluthorization.
~''''t'i1'lM DOJJUli,Ulon.
when used on the S!)t~C!lrlea
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I have COlilclu(led. DUII<iU'Inr
evidence available to
Subhvc H7N9
instruments may be effective in the u""",,,,,,,.,;,,,
ini1uenza A
in China in
infection ill the ""',en""11 ,,,,,,,u,,,,,,,,,,
IJUlfSUam to sootion
ofthe Act The FDA has revie"led the scientific intormatiQn
available
the infomlation
the eonclusions described in Section I
and
concludes that the authorized
Influenza A
H7N9
virus (detected
influenza A
meets the criteria set fortll in seetiol1
effe.ctiveness.
21774
Federal Register / Vol. 79, No. 74 / Thursday, April 17, 2014 / Notices
III. 'Waiver of Certain
lip,flniirpllllplflt~
"',,"V,,,,, Ihe
the
Influenza
the lise of the device
and
avail~lble infom.ation
reqUIr!~m\;l1ts under 21 CFR
IV. Coudilious of Authorization
Pursuant to section 564 ofthe
authorization:
.I am
<;;:>lillHJ:>illHg
l11e
'V"VVVUj.,",
conditions on this
Quidel Corporation
A.
as may be reviseti with written
Laboratories or
laboratories.
Comp,leXJtv Laboratories the
Fact Sheet for Healthcare Providers
H7N9
and tJ1e authorized
'r.""',,,eM"{\TI
Fact Sheet for Patients.
wm make avail<lblc on its website t11t: authorized
Influenza A
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Fact Sheet for Healthcare Providers and the aufuorizcd
SUllh'Tll' H7N9
Fact Sheet for P<ltiellts.
21775
Federal Register / Vol. 79, No. 74 / Thursday, April 17, 2014 / Notices
5
Dr.
·",·,,,,,",,tli"'"
\vil! infbt111 stcltc and/or local
the terms and conditions herein.
D,
oftl1is
to the usc oCthe
matter
shall
F All
It
This test has not been FDA ele"l1'ed or ,ITI,\r,'VP,'"
It
This test has been authurized fbr use
"
This test has been authorized
Ii>
This lest has been amhorlzed
in Chintl in 201
Ii>
This test is
this
Laboratories or
FDA. under an
vil1.ls
and Ilot
that
unless the authorization is revoked sootler.
to the use of the
may rt~prescnt or suggest that this
of influenza A
virus
G.
lltl th0l1 zed
test results to healthcare ",,'.vU!I,>r'"
''''''''''''"h"." will track adverse events and
H.
health
to FDA as
under 2L
CFR Part 803..
L
will collect .information on the ,,,,/>,'1<',,,,,,,,,,
lIstlected occurrence of false
or false
heeomes aware,
K
of the assay, lind rc,port
results of which
is authorized to make available additional infbnnation
to the
emergency usc of the authorized
Influenza A
H7N9
that is
consLsten!
and does not
the terms of this letter of authorization.
Illay request
to the ~Iuthorized
Influenza A
Fact Sheet for Healtheare Providers or the authorized
H7N9
Fuet Sheet for Patients, Such
will be made
FDA review and ""rn·m,.."
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Cnmn,n.tinn
21776
Federal Register / Vol. 79, No. 74 / Thursday, April 17, 2014 / Notices
[FR Doc. 2014–08706 Filed 4–16–14; 8:45 am]
TKELLEY on DSK3SPTVN1PROD with NOTICES
BILLING CODE 4160–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–0331]
Live Case Presentations During
Investigational Device Exemption
Clinical Trials; Draft Guidance for
Institutional Review Boards, Industry,
Investigators, and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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Notice.
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The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘Live Case Presentations During
Investigational Device Exemption (IDE)
Clinical Trials: Draft Guidance for
Institutional Review Boards, Industry,
Investigators, and Food and Drug
Administration Staff.’’ This guidance is
intended, in part, to improve the quality
of information submitted by sponsors in
an IDE application or supplement to an
IDE application and to ensure
consistency in the review of those
submissions. This draft guidance is
intended to clarify FDA’s regulations
and policies regarding live case
SUMMARY:
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Dated: April 11, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
]]>Agencies
[Federal Register Volume 79, Number 74 (Thursday, April 17, 2014)]
[Notices]
[Pages 21768-21776]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-08706]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0306]
Authorization of Emergency Use of an In Vitro Diagnostic Device
for Detection of Novel Influenza A (H7N9) Virus; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of an Emergency Use Authorization (EUA) (the Authorization)
for an in vitro diagnostic device for detection of the novel influenza
A (H7N9) virus (detected in China in 2013). FDA is issuing this
Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C
Act), as requested by Quidel Corporation. The Authorization contains,
among other things, conditions on the emergency use of the authorized
in vitro diagnostic device. The Authorization follows the April 19,
2013, 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
the novel influenza A (H7N9) virus. On the basis of such determination,
the Secretary of HHS also declared on April 19, 2013, that
circumstances exist justifying the authorization of emergency use of in
[[Page 21769]]
vitro diagnostics for detection of the novel influenza A (H7N9) 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 February 14, 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. 32, Rm. 4121, 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. 32, Rm. 4118, 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 attributable to such agent or agents;
\1\ or (4) the identification of a material threat by the Secretary of
Homeland Security pursuant to section 319F-2 of the Public Health
Service (PHS) Act (42 U.S.C. 247d-6b) sufficient to affect national
security or the health and security of U.S. citizens living abroad.
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\1\ As amended by the Pandemic and All-Hazards Preparedness
Reauthorization Act of 2013 (Pub. L. 113-5), the Secretary of HHS
may make a determination of a public health emergency, or a
significant potential for a public health emergency, under section
564 of the FD&C Act. The Secretary is no longer required to make a
determination of a public health emergency under section 319 of the
PHS Act (42 U.S.C. 247d) to support a determination made under
section 564 of the FD&C Act.
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Once the Secretary of HHS has declared that circumstances exist
justifying an authorization under section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug, device, or biological product if
the Agency concludes that the statutory criteria are satisfied. Under
section 564(h)(1) of the FD&C Act, FDA is required to publish in the
Federal Register a notice of each authorization, and each termination
or revocation of an authorization, and an explanation of the reasons
for the action. Section 564 of the FD&C Act permits FDA to authorize
the introduction into interstate commerce of a drug, device, or
biological product intended for use when the Secretary of HHS has
declared that circumstances exist justifying the authorization of
emergency use. Products appropriate for emergency use may include
products and uses that are not approved, cleared, or licensed under
sections 505, 510(k), 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 \2\ concludes: (1) That an agent referred to in a
declaration of emergency or threat can cause a serious or life-
threatening disease or condition; (2) that, based on the totality of
scientific evidence available to FDA, including data from adequate and
well-controlled clinical trials, if available, it is reasonable to
believe that: (A) The product may be effective in diagnosing, treating,
or preventing (i) such disease or condition; or (ii) a serious or life-
threatening disease or condition caused by a product authorized under
section 564, approved or cleared under the FD&C Act, or licensed under
section 351 of the PHS Act, for diagnosing, treating, or preventing
such a disease or condition caused by such an agent; and (B) the known
and potential benefits of the product, when used to diagnose, prevent,
or treat such disease or condition, outweigh the known and potential
risks of the product, taking into consideration the material threat
posed by the agent or agents identified in a declaration under section
564(b)(1)(D) of the FD&C Act, if applicable; (3) that there is no
adequate, approved, and available alternative to the product for
diagnosing, preventing, or treating such disease or condition; and (4)
that such other criteria as may be prescribed by regulation are
satisfied.
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\2\ The Secretary of HHS has delegated the authority to issue an
EUA under section 564 of the FD&C Act to the Commissioner of Food
and Drugs.
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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
Novel Influenza A (H7N9) Virus
On April 19, 2013, under section 564(b)(1)(C) of the FD&C Act (21
U.S.C. 360bbb-3(b)(1)(C)), 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 the novel
influenza A (H7N9) virus. Also on April 19, 2013, 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
the novel influenza A
[[Page 21770]]
(H7N9) virus, subject to the terms of any authorization issued under
section 564 of the FD&C Act. The Secretary of HHS also specified that
this declaration is a declaration of an emergency with respect to in
vitro diagnostics as defined under the Public Readiness and Emergency
Preparedness (PREP) Act Declaration for Pandemic Influenza Diagnostics,
Personal Respiratory Protection Devices, and Respiratory Support
Devices signed by then Secretary Michael Leavitt on December 17, 2008
(73 FR 78362, December 22, 2008). Notice of the determination and the
declaration of the Secretary were published in the Federal Register on
April 30, 2013 (78 FR 25273). On January 28, 2014, Quidel Corporation
requested, and on February 14, 2014, FDA issued, an EUA for the
LyraTM Influenza A Subtype H7N9 Assay subject to the terms
of this authorization.
III. Electronic Access
An electronic version of this document and the full text of the
Authorization are available on the Internet at https://www.regulations.gov.
IV. The Authorization
Having concluded that the criteria for issuance of the
Authorization under section 564(c) of the FD&C Act are met, FDA has
authorized the emergency use of an in vitro diagnostic device for
detection of the novel influenza A (H7N9) virus (detected in China in
2013) subject to the terms of the Authorization. The Authorization in
its entirety (not including the authorized versions of the fact sheets
and other written materials) follows and provides an explanation of the
reasons for its issuance, as required by section 564(h)(1) of the FD&C
Act.
BILLING CODE 4160-01-P
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Dated: April 11, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-08706 Filed 4-16-14; 8:45 am]
BILLING CODE 4160-01-C
