Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Enterovirus D68; Availability, 37625-37633 [2015-16125]
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37625
Federal Register / Vol. 80, No. 126 / Wednesday, July 1, 2015 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity resulting from Section 510(p) of
the FD&C Act as amended by FDAAA
Number of recordkeepers
Number of records
per recordkeeper
One-time preparation of SOP ................
SOP maintenance ..................................
Total ................................................
1,000
3,295
43,295
1
1
1 There
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–2044]
Authorization of Emergency Use of an
In Vitro Diagnostic Device for
Detection of Enterovirus D68;
Availability
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 in an vitro diagnostic device for
detection of Enterovirus D68 (EV–D68)
strains detected in North America in
2014. FDA issued this Authorization
under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act), as
requested by the Centers for Disease
Control and Prevention (CDC). The
Authorization contains, among other
things, conditions on the emergency use
of the authorized in vitro diagnostic
device. The Authorization follows the
February 6, 2015, determination by the
Department of Health and Human
Services (HHS) Secretary 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 EV–D68.
On the basis of such determination, the
Secretary of HHS also declared on
February 6, 2015, that circumstances
exist justifying the authorization of
emergency use of in vitro diagnostic
devices for detection of EV–D68 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.
SUMMARY:
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3,295
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The Authorization is effective as
of May 12, 2015.
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.
DATES:
[FR Doc. 2015–16129 Filed 6–30–15; 8:45 am]
ACTION:
Average burden
per recordkeeping
40
1
Total hours
40,000
3,295
are no capital costs or operating and maintenance costs associated with the collection of information.
Dated: June 25, 2015.
Leslie Kux,
Associate Commissioner for Policy.
AGENCY:
Total annual
records
FOR FURTHER INFORMATION CONTACT:
Carmen Maher, Acting Assistant
Commissioner for Counterterrorism
Policy and Acting Director, 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.
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
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Fmt 4703
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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).
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Federal Register / Vol. 80, No. 126 / Wednesday, July 1, 2015 / Notices
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
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
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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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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
EV–D68
On February 6, 2015, 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 EV–D68.
Also on February 6, 2015, 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
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Fmt 4703
Sfmt 4703
vitro diagnostics for detection of EV–
D68, 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 February 27, 2015 (80 FR
10685). On April 24, 2015, CDC
requested, and on May 12, 2015, FDA
issued, an EUA for the CDC EV–D68
2014 Real-time RT–PCR Assay, subject
to the terms of the 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 EV–D68 strains detected in
North America 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:
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH
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EN01JY15.005</GPH>
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Prevention
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Federal Register / Vol. 80, No. 126 / Wednesday, July 1, 2015 / Notices
Prevention
I. Criteria for Issuance of Autllorization
a
L
or
2.
3. There is no
D68
4
to the emergency use
II. Scope of Authorization
Real~time RT~PCR
Assay
under section
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of the Act
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EN01JY15.006</GPH>
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Authorized Enterovirus D68 2014
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Prevention
PCR may be effective in the
Act
of
This EUA
cease to be
the EUA is tenninated under section
Act.
to
under
PTTPPTH!t>
III. Waiver of Certain Requirements
lam
rRT-PCR
of
EUA;
"""'~'"r"~"
requirements, including the
TP<mPC"t tO
EV-D68 2014 rRT-PCR.
809.IO(b)(l2).
IV. Conditions of Authorization
CDC and Any Authorized Distributor(s)
the authorized EV-D68 2014 rRTrevised only by CDC in consultation with
u••..:>,tJ<.IHttwu by CDC.
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Htu'""""... ' as may
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CDC
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for Disease Control and Prevention
the addition of other extraction methods
will be made
CDC
rRT-PCR. Such
FDA.
•·urmu~+
the addition of other real-time PCR
rRT-PCR. Such
concurrence
0. CDC
adverse events and
to
21
CDC
P.
S.
CDC
T.
and Promotion
the
ofthe
autno:nzfxt EV-D68 2014 rRT-PCR shall be consistent with the Fact Sheets and
"'"'"'"'"~".'as well a.<> the tenns set forth in this EUA and the ")JIJH'-'"'-'''"
"'"'"'"'"T" set forth in the Act and FDA
and Lit \J'U"IH\J'U<'l fiP<:rri:ntT,!P
EV-D68 2014 rRT-PCR shal1
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This test
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not been FDA cleared or
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•
Dated: June 25, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–16125 Filed 6–30–15; 8:45 am]
BILLING CODE 4164–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
tkelley on DSK3SPTVN1PROD with NOTICES
[Docket No. FDA–2014–D–0967]
Intent to Exempt Certain Unclassified,
Class II, and Class I Reserved Medical
Devices From Premarket Notification
Requirements; Guidance for Industry
and Food and Drug Administration
Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
SUMMARY:
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18:30 Jun 30, 2015
Jkt 235001
availability of the guidance entitled
‘‘Intent to Exempt Certain Unclassified,
Class II, and Class I Reserved Medical
Devices from Premarket Notification
Requirements.’’ This guidance describes
FDA’s intent to exempt certain
unclassified medical devices (that FDA
intends to classify into class I or II),
certain class II medical devices, and
certain class I medical devices from
premarket notification requirements.
FDA believes the devices identified in
this guidance document are sufficiently
well understood and do not require
premarket notification to assure their
safety and effectiveness.
DATES: Submit either electronic or
written comments on this guidance at
any time. General comments on Agency
guidance documents are welcome at any
time.
ADDRESSES: An electronic copy of the
guidance document is available for
download from the Internet. See the
SUPPLEMENTARY INFORMATION section for
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37633
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the guidance
document entitled ‘‘Intent to Exempt
Certain Unclassified, Class II, and Class
I Reserved Medical Devices from
Premarket Notification Requirements’’
to the Office of the Center Director,
Guidance and Policy Development,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
Rm. 5431, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your request.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. Identify comments with the
docket number found in brackets in the
heading of this document.
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Federal Register / Vol. 80, No. 126 / Wednesday, July 1, 2015 / Notices
]]>Agencies
[Federal Register Volume 80, Number 126 (Wednesday, July 1, 2015)]
[Notices]
[Pages 37625-37633]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16125]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-2044]
Authorization of Emergency Use of an In Vitro Diagnostic Device
for Detection of Enterovirus D68; 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 in an vitro diagnostic device for detection of Enterovirus D68 (EV-
D68) strains detected in North America in 2014. FDA issued this
Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C
Act), as requested by the Centers for Disease Control and Prevention
(CDC). The Authorization contains, among other things, conditions on
the emergency use of the authorized in vitro diagnostic device. The
Authorization follows the February 6, 2015, determination by the
Department of Health and Human Services (HHS) Secretary 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 EV-D68. On
the basis of such determination, the Secretary of HHS also declared on
February 6, 2015, that circumstances exist justifying the authorization
of emergency use of in vitro diagnostic devices for detection of EV-D68
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 May 12, 2015.
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: Carmen Maher, Acting Assistant
Commissioner for Counterterrorism Policy and Acting Director, 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.
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;
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).
[[Page 37626]]
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 CDC (to the extent
feasible and appropriate given the applicable circumstances), FDA \1\
concludes: (1) That an agent referred to in a declaration of emergency
or threat can cause a serious or life-threatening disease or condition;
(2) that, based on the totality of scientific evidence available to
FDA, including data from adequate and well-controlled clinical trials,
if available, it is reasonable to believe that: (A) The product may be
effective in diagnosing, treating, or preventing (i) such disease or
condition; or (ii) a serious or life-threatening disease or condition
caused by a product authorized under section 564, approved or cleared
under the FD&C Act, or licensed under section 351 of the PHS Act, for
diagnosing, treating, or preventing such a disease or condition caused
by such an agent; and (B) the known and potential benefits of the
product, when used to diagnose, prevent, or treat such disease or
condition, outweigh the known and potential risks of the product,
taking into consideration the material threat posed by the agent or
agents identified in a declaration under section 564(b)(1)(D) of the
FD&C Act, if applicable; (3) that there is no adequate, approved, and
available alternative to the product for diagnosing, preventing, or
treating such disease or condition; and (4) that such other criteria as
may be prescribed by regulation are satisfied.
---------------------------------------------------------------------------
\1\ The Secretary of HHS has delegated the authority to issue an
EUA under section 564 of the FD&C Act to the Commissioner of Food
and Drugs.
---------------------------------------------------------------------------
No other criteria for issuance have been prescribed by regulation
under section 564(c)(4) of the FD&C Act. Because the statute is self-
executing, regulations or guidance are not required for FDA to
implement the EUA authority.
II. EUA Request for an In Vitro Diagnostic Device for Detection of EV-
D68
On February 6, 2015, 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 EV-D68. Also
on February 6, 2015, 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 EV-D68, 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 February 27, 2015 (80 FR 10685). On April 24, 2015,
CDC requested, and on May 12, 2015, FDA issued, an EUA for the CDC EV-
D68 2014 Real-time RT-PCR Assay, subject to the terms of the
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 EV-D68 strains detected in North America 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:
BILLING CODE 4164-01-P
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[GRAPHIC] [TIFF OMITTED] TN01JY15.011
Dated: June 25, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-16125 Filed 6-30-15; 8:45 am]
BILLING CODE 4164-01-C
