Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Zika Virus; Availability, 92822-92832 [2016-30532]
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Federal Register / Vol. 81, No. 244 / Tuesday, December 20, 2016 / Notices
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Drug
Amoxicillin and Clavulanate Potassium Tablets USP, 875 mg/EQ 125 mg base.
Amoxicillin and Clavulanate Potassium Tablets USP, 500 mg/EQ 125 mg base.
Amoxicillin for Oral Suspension USP, 200 mg/5 mL and 400 mg/5 mL.
Cefadroxil for Oral Suspension USP, EQ 125 mg base/5 mL, EQ 250 mg base/5 mL, and EQ 500 mg base/5 mL.
Cefuroxime Axetil Tablets USP, EQ 125 mg base, EQ 250 mg base, and EQ 500 mg base.
Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/EQ 28.5 mg base per 5 mL and 400 mg/EQ
57 mg base per 5 mL.
Amoxicillin and Clavulanate Potassium Tablets USP (Chewable), 200 mg/EQ 28.5 mg base and 400 mg/EQ 57 mg
base.
Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 600 mg/EQ 42.9 mg base per 5 mL.
Cefuroxime Axetil for Oral Suspension USP, EQ 125 mg base/5 mL and EQ 250 mg base/5 mL.
Acyclovir Capsules USP, 200 mg.
Acyclovir Tablets USP, 400 mg and 800 mg.
Ranitidine Tablets USP, EQ 75 mg base.
Ranitidine Tablets USP, EQ 150 mg base and EQ 300 mg base.
Sotret (isotretinoin) Capsules USP, 10 mg, 20 mg, and 40 mg.
Simvastatin Tablets USP, 5 mg, 10 mg, 20 mg, 40 mg, and 80 mg.
Fluconazole for Oral Suspension, 10 mg/mL and 40 mg/mL.
Nefazodone Hydrochloride Tablets USP, 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg.
Sotret (isotretinoin) Capsules USP, 30 mg.
Gabapentin Capsules USP, 100 mg, 300 mg, and 400 mg.
Fosinopril Sodium and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg and 20 mg/12.5 mg.
Therefore, under section 505(e) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(e)) and under authority
delegated to the Director, Center for
Drug Evaluation and Research, by the
Commissioner, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn, effective January
19, 2017.
Dated: December 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–30623 Filed 12–19–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0969]
Authorization of Emergency Use of an
In Vitro Diagnostic Device for
Detection of Zika Virus; Availability
AGENCY:
Food and Drug Administration,
HHS.
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 Zika virus in response
to the Zika virus outbreak in the
Americas. FDA issued this
Authorization under the Federal Food,
Drug, and Cosmetic Act (the FD&C Act),
as requested by Abbott Molecular, Inc.
The Authorization contains, among
other things, conditions on the
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SUMMARY:
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emergency use of the authorized in vitro
diagnostic device. The Authorization
follows 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 Authorization, which
includes an explanation of the reasons
for issuance, is reprinted in this
document.
The Authorization is effective as
of November 21, 2016.
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:
FOR FURTHER INFORMATION CONTACT:
Carmen Maher, Office of
Counterterrorism and Emerging Threats,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 1, Rm.
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
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 AllHazards Preparedness Reauthorization
Act of 2013 (Pub L. 113–5) allows FDA
to strengthen the public health
protections against biological, chemical,
nuclear, and radiological agents. Among
other things, section 564 of the FD&C
Act allows FDA to authorize the use of
an unapproved medical product or an
unapproved use of an approved medical
product in certain situations. With this
EUA authority, FDA can help assure
that medical countermeasures may be
used in emergencies to diagnose, treat,
or prevent serious or life-threatening
diseases or conditions caused by
biological, chemical, nuclear, or
radiological agents when there are no
adequate, approved, and available
alternatives.
Section 564(b)(1) of the FD&C Act
provides that, before an EUA may be
issued, the Secretary of HHS must
declare that circumstances exist
justifying the authorization based on
one of the following grounds: (1) A
determination by the Secretary of
Homeland Security that there is a
domestic emergency, or a significant
potential for a domestic emergency,
involving a heightened risk of attack
with a biological, chemical, radiological,
or nuclear agent or agents; (2) a
determination by the Secretary of
Defense that there is a military
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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
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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
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.
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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92823
II. EUA Request for an In Vitro
Diagnostic Device 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 November 9, 2016, Abbott
Molecular, Inc. requested, and on
November 21, 2016, FDA issued, an
EUA for the Abbott Real Time ZIKA
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 Zika virus 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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Criteria for Issuance of Authorization
of Authorization
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RealTime ZIKA assay
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other
or
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..
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92827
Results
ZIKA
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be
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Abbott RealTime
•
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this
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D.
Abbott Molecular Inc.
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L
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M.
P.
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Authorized Laboratories
Federal Register / Vol. 81, No. 244 / Tuesday, December 20, 2016 / Notices
92831
Y.
Abbott Molecular
and Authorized
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Conditions Related to
92832
Federal Register / Vol. 81, No. 244 / Tuesday, December 20, 2016 / Notices
redetermination by February 21, 2017.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
June 19, 2017. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
ADDRESSES: You may submit comments
as follows:
[FR Doc. 2016–30532 Filed 12–19–16; 8:45 am]
BILLING CODE 4164–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–E–0626]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; COSENTYX
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
COSENTYX and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of an application to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human
biological product.
DATES: Anyone with knowledge that any
of the dates as published (see the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
mstockstill on DSK3G9T082PROD with NOTICES
SUMMARY:
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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
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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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2016–E–0626 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; COSENTYX.’’
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
Division of Dockets Management
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
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Dated: December 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
]]>Agencies
[Federal Register Volume 81, Number 244 (Tuesday, December 20, 2016)]
[Notices]
[Pages 92822-92832]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-30532]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0969]
Authorization of Emergency Use of an In Vitro Diagnostic Device
for Detection of Zika 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 Zika virus in
response to the Zika virus outbreak in the Americas. FDA issued this
Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C
Act), as requested by Abbott Molecular, Inc. The Authorization
contains, among other things, conditions on the emergency use of the
authorized in vitro diagnostic device. The Authorization follows 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 Authorization, which includes an explanation of the
reasons for issuance, is reprinted in this document.
DATES: The Authorization is effective as of November 21, 2016.
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, 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 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
[[Page 92823]]
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.
---------------------------------------------------------------------------
\1\ The Secretary of HHS has delegated the authority to issue an
EUA under section 564 of the FD&C Act to the Commissioner of Food
and Drugs.
---------------------------------------------------------------------------
No other criteria for issuance have been prescribed by regulation
under section 564(c)(4) of the FD&C Act. Because the statute is self-
executing, regulations or guidance are not required for FDA to
implement the EUA authority.
II. EUA Request for an In Vitro Diagnostic Device for Detection of the
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 November 9, 2016, Abbott Molecular,
Inc. requested, and on November 21, 2016, FDA issued, an EUA for the
Abbott Real Time ZIKA 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 Zika virus 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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Dated: December 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-30532 Filed 12-19-16; 8:45 am]
BILLING CODE 4164-01-C
