Authorization of Emergency Use of an In Vitro Diagnostic for Detection of Middle East Respiratory Syndrome Coronavirus; Availability, 42779-42787 [2013-17103]
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Federal Register / Vol. 78, No. 137 / Wednesday, July 17, 2013 / Notices
an application. The submission
deadline for the application has been
extended to August 1, 2013.
Letter of Intent Submission
Deadline: Interested organizations must
submit a non-binding letter of intent on
or before July 19, 2013, by an online
form at: https://
cmsgov.secure.force.com/cec.
Application Submission Deadline:
Interested organizations must submit an
application on or before August 1, 2013,
as described on the Innovation Center
Web site at: https://innovation.cms.gov/
initiatives/comprehensive-ESRD-care/
apply.html. Interested organizations
should also continue to check the Web
site for updates on this initiative.
DATES:
FOR FURTHER INFORMATION CONTACT:
Melissa Cohen, (410) 786–1829 or
ESRD-CMMI@cms.hhs.gov.
SUPPLEMENTARY INFORMATION:
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I. Background
The Center for Medicare and
Medicaid Innovation (Innovation
Center) is interested in identifying
models designed to improve care for
beneficiaries with end-stage renal
disease (ESRD). To promote seamless
and integrated care for beneficiaries
with ESRD, we are developing a
comprehensive care delivery model to
emphasize coordination of a full-range
of clinical and non-clinical services
across providers, suppliers, and settings.
Through the Comprehensive ESRD Care
Model, we seek to identify ways to
improve the coordination and quality of
care for this population, while lowering
total per-capita expenditures under the
Medicare program. We anticipate that
the Comprehensive ESRD Care Model
would result in improved health
outcomes for beneficiaries with ESRD
regarding the functional status, quality
of life, and overall well-being, as well as
increased beneficiary and caregiver
engagement, and lower costs to
Medicare through improved care
coordination.
On February 6, 2013, we published a
notice in the Federal Register
announcing a request for applications
from organizations to participate in the
testing of the Comprehensive ESRD Care
Model, for a period beginning in 2013
and ending in 2016, with a possible
extension into subsequent years.
In that notice, we stated that
organizations interested in applying to
participate in the testing of the
Comprehensive ESRD Care Model must
submit a non-binding letter of intent by
March 15, 2013, and an application by
May 1, 2013.
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II. Provisions of the Notice
Since the publication of the February
6, 2013 notice, several stakeholders
have requested additional time to
prepare their applications and form
partnerships. Therefore, the Innovation
Center is extending the following
deadlines relating to the Comprehensive
ESRD Care initiative: (1) The letter of
intent submission period has been
reopened. The deadline for submission
of the letter of intent has been extended
to July 19, 2013; and (2) the deadline for
submission of the application has been
extended to August 1, 2013.
In the DATES section of this notice, we
are including the new submissions
deadlines. For additional information
on the Comprehensive ESRD Care
Model and how to apply, we refer
readers to click on the Request for
Applications located on the Innovation
Center Web site at: https://
innovation.cms.gov/initiatives/
comprehensive-ESRD-care.
(No. 93.773 Medicare—Hospital Insurance
Program; and No. 93.774, MedicareSupplementary Medical Insurance Program)
Dated: July 9, 2013.
Marilyn Tavenner,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2013–17131 Filed 7–16–13; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0754]
Authorization of Emergency Use of an
In Vitro Diagnostic for Detection of
Middle East Respiratory Syndrome
Coronavirus; 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 Middle East Respiratory
Syndrome Coronavirus (MERS-CoV),
formerly known as Novel Coronavirus
2012 or NCV–2012. FDA is issuing this
Authorization under the Federal Food,
Drug, and Cosmetic (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
SUMMARY:
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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 MERSCoV. On the basis of such
determination, the Secretary also
declared that circumstances exist
justifying the authorization of
emergency use of in vitro diagnostics for
detection of MERS-CoV 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 June 5, 2013.
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,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 32, Rm.
4118, Silver Spring, MD 20993–0002,
telephone 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
EUAauthority, 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.
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Federal Register / Vol. 78, No. 137 / Wednesday, July 17, 2013 / Notices
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
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 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
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1 As amended by the Pandemic and All-Hazards
Preparedness Reauthorization Act of 2013, 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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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 CDC (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 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 the
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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Secretary of HHS may by regulation
prescribe are satisfied.
No other criteria of 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 for Detection of MERS-CoV
On May 29, 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 MERSCoV. Also on May 29, 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 MERSCoV, subject to the terms of any
authorization issued under section 564
of the FD&C Act. On May 31, 2013, CDC
requested, and on June 5, 2013, FDA
issued, an EUA for the CDC Novel
Coronavirus 2012 Real-time RT–PCR
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 MERS-CoV 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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42786
Federal Register / Vol. 78, No. 137 / Wednesday, July 17, 2013 / Notices
Dated: July 11, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and
Planning.
[FR Doc. 2013–17103 Filed 7–16–13; 8:45 am]
BILLING CODE 4160–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0592]
Yuri Izurieta; Conviction Reversal;
Final Order Withdrawing Debarment
Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The U.S. Food and Drug
Administration (FDA) is issuing an
order, under the Federal Food, Drug,
and Cosmetic Act (the FD&C Act),
withdrawing its January 25, 2012, order
debarring Yuri Izurieta from importing
food or offering food for importation
into the United States. FDA is issuing
this order because the U.S. Court of
Appeals for the Eleventh Circuit issued
an order vacating the conviction and
sentence of Yuri Izurieta.
DATES: Effective Date: July 17, 2013.
FOR FURTHER INFORMATION CONTACT:
Kenny Shade, Office of Regulatory
Affairs, Food and Drug Administration,
12420 Parklawn Dr., Rockville, MD
20857, 301–796–4640.
SUPPPLEMENTARY INFORMATION: In a
notice published in the Federal Register
on January 25, 2012 (77 FR 3776), FDA
debarred Yuri Izurieta for a period of 20
years from importing articles of food or
offering such articles for importation
into the United States. FDA issued the
debarment order under section
306(b)(1)(C) of the FD&C Act (21 U.S.C.
335a(b)(1)(C)), which permits FDA to
debar an individual from importing an
article of food or offering such an article
for import into the United States if FDA
finds, as required by section
306(b)(3)(A) of the FD&C Act (21 U.S.C.
335a(b)(3)(A)), that the individual has
been convicted of a felony for conduct
relating to the importation into the
United States of any food. The
debarment was based on FDA’s finding
that Mr. Izurieta was convicted of six
felony counts under Federal law for
conduct relating to the importation into
the United States of an article of food.
Mr. Izurieta was convicted on May 11,
2011, in the U.S. District Court for the
Southern District of Florida and
sentenced on July 29, 2011, for
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SUMMARY:
VerDate Mar<15>2010
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conspiracy to smuggle goods into the
United States and smuggling goods into
the United States. The basis for Mr.
Izurieta’s conviction was his alleged
role in distributing shipments of dairy
products that were adulterated and not
authorized for entry into the United
States. On August 3, 2011, Mr. Izurieta
appealed his conviction and sentence.
On February 22, 2013, the U.S. Court
of Appeals for the Eleventh Circuit
issued an order vacating the conviction
and sentence of Mr. Izurieta. A copy of
the court’s order is available in Docket
No. FDA–2011–N–0592. By this order,
the court vacated Mr. Izurieta’s
conviction. The order was issued as a
mandate on April 23, 2013. Section
306(d)(3)(B)(i) of the FD&C Act (U.S.C.
335a(d)(3)(B)(i)) states that ‘‘If the
conviction which served as the basis for
the debarment of an individual under
subsection . . . (b)(3) is reversed, the
Secretary shall withdraw the order of
debarment.’’:
Accordingly, the Acting Associate
Commissioner for Regulatory Affairs,
Office of Regulatory Affairs, under
section 306(d)(3)(B)(i) of the FD&C Act
and under authority delegated to the
Associate Commissioner (Staff Manual
Guide 1410.21), issues this order
withdrawing the order of debarment of
Yuri Izurieta, thereby allowing him to
import food or offer such articles for
importation into the United States. This
order is effective July 17, 2013.
Dated: July 12, 2013.
Melinda K. Plaisier,
Acting Associate Commissioner for
Regulatory Affairs, Office of Regulatory
Affairs.
[FR Doc. 2013–17122 Filed 7–16–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0589]
Anneri Izurieta; Conviction Reversal;
Final Order Withdrawing Debarment
Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The U.S. Food and Drug
Administration (FDA) is issuing an
order, under the Federal Food, Drug,
and Cosmetic Act (the FD&C Act),
withdrawing its January 13, 2012, order
debarring Anneri Izurieta from
importing food or offering food for
importation into the United States. FDA
is issuing this order because the U.S.
SUMMARY:
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42787
Court of Appeals for the Eleventh
Circuit issued an order vacating the
conviction and sentence of Anneri
Izurieta.
DATES: Effective Date: July 17, 2013.
FOR FURTHER INFORMATION CONTACT:
Kenny Shade, Office of Regulatory
Affairs, Food and Drug Administration,
12420 Parklawn Dr., Rockville, MD
20857, 301–796–4640.
SUPPLEMENTARY INFORMATION: In a notice
published in the Federal Register on
January 13, 2012 (77 FR 2070), FDA
debarred Anneri Izurieta for a period of
30 years from importing articles of food
or offering such articles for importation
into the United States. FDA issued the
debarment order under section
306(b)(1)(C) of the FD&C Act (21 U.S.C.
335a(b)(1)(C)), which permits FDA to
debar an individual from importing an
article of food or offering such an article
for importation into the United States if
FDA finds, as required by section
306(b)(3)(A) of the FD&C Act (21 U.S.C.
335a(b)(3)(A)), that the individual has
been convicted of a felony for conduct
relating to the importation into the
United States of any food. The
debarment was based on FDA’s finding
that Ms. Izurieta was convicted of six
felony counts under Federal law for
conduct relating to the importation into
the United States of an article of food.
Ms. Izurieta, the president and director
of Naver Trading, was convicted on May
11, 2011, and sentenced on July 29,
2011, for conspiracy to smuggle goods
into the United States and smuggling
goods into the United States. The basis
for Ms. Izurieta’s conviction was her
alleged role in distributing shipments of
dairy products that were adulterated
and not authorized for entry into the
United States. On August 3, 2011, Ms.
Izurieta appealed her conviction and
sentence.
On February 22, 2013, the U.S. Court
of Appeals for the Eleventh Circuit
issued an order vacating the conviction
and sentence of Ms. Izurieta. A copy of
the court’s order is available in Docket
No. FDA–2011–N–0589. By this order,
the court vacated Ms. Izurieta’s
conviction. The order was issued as a
mandate on April 23, 2013. Section
306(d)(3)(B)(i) of the FD&C Act (U.S.C.
335a(d)(3)(B)(i) states that ‘‘If the
conviction which served as the basis for
the debarment of an individual under
subsection . . . (b)(3) is reversed, the
Secretary shall withdraw the order of
debarment.’’
Accordingly, the Acting Associate
Commissioner for Regulatory Affairs,
Office of Regulatory Affairs, under
section 306(d)(3)(B)(i) of the FD&C Act
and under authority delegated to the
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]]>Agencies
[Federal Register Volume 78, Number 137 (Wednesday, July 17, 2013)]
[Notices]
[Pages 42779-42787]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-17103]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0754]
Authorization of Emergency Use of an In Vitro Diagnostic for
Detection of Middle East Respiratory Syndrome Coronavirus; 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 Middle East
Respiratory Syndrome Coronavirus (MERS-CoV), formerly known as Novel
Coronavirus 2012 or NCV-2012. FDA is issuing this Authorization under
the Federal Food, Drug, and Cosmetic (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
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 MERS-CoV. On
the basis of such determination, the Secretary also declared that
circumstances exist justifying the authorization of emergency use of in
vitro diagnostics for detection of MERS-CoV 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 June 5, 2013.
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, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
32, Rm. 4118, Silver Spring, MD 20993-0002, telephone 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 EUAauthority, 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.
[[Page 42780]]
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 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.
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\1\ As amended by the Pandemic and All-Hazards Preparedness
Reauthorization Act of 2013, 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 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 CDC (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 the Secretary of HHS may
by regulation prescribe 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 of 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 for Detection of MERS-CoV
On May 29, 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 MERS-CoV.
Also on May 29, 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 MERS-CoV, subject to the terms of
any authorization issued under section 564 of the FD&C Act. On May 31,
2013, CDC requested, and on June 5, 2013, FDA issued, an EUA for the
CDC Novel Coronavirus 2012 Real-time RT-PCR 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 MERS-CoV 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:
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Dated: July 11, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2013-17103 Filed 7-16-13; 8:45 am]
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