[Federal Register Volume 81, Number 117 (Friday, June 17, 2016)]
[Notices]
[Pages 39653-39672]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-14380]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-1486]
Authorizations of Emergency Use of In Vitro Diagnostic Devices
for Detection of Zika Virus; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of two Emergency Use Authorizations (EUAs) (the
Authorizations) for two in vitro diagnostic devices for detection of
Zika virus in response to the Zika virus outbreak in the Americas. FDA
issued these Authorizations under the Federal Food, Drug, and Cosmetic
Act (the FD&C Act), as requested by Focus Diagnostics, Inc., and altona
Diagnostics GmbH. The Authorizations contain,
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among other things, conditions on the emergency use of the authorized
in vitro diagnostic devices. The Authorizations follow the February 26,
2016, determination by the 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 Zika virus. On the basis of such determination, the HHS
Secretary declared on February 26, 2016, that circumstances exist
justifying the authorization of emergency use of in vitro diagnostic
tests for detection of Zika virus and/or diagnosis of Zika virus
infection subject to the terms of any authorization issued under the
FD&C Act. The Authorizations, which include explanations of the reasons
for issuance, are reprinted in this document.
DATES: The Authorization for Focus Diagnostics, Inc., is effective as
of April 28, 2016, and the Authorization for altona Diagnostics GmbH is
effective as of May 13, 2016.
ADDRESSES: Submit written requests for single copies of the EUAs to the
Office of Counterterrorism and Emerging Threats, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a fax number to which
the Authorizations may be sent. See the SUPPLEMENTARY INFORMATION
section for electronic access to the Authorizations.
FOR FURTHER INFORMATION CONTACT: Carmen Maher, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4347, Silver Spring, MD 20993-
0002, 301-796-8510.
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). FDA may issue
an EUA only if, after consultation with the HHS Assistant Secretary for
Preparedness and Response, the Director of the National Institutes of
Health, and the Director of the Centers for Disease Control and
Prevention (to the extent feasible and appropriate given the applicable
circumstances), FDA \1\ concludes: (1) That an agent referred to in a
declaration of emergency or threat can cause a serious or life-
threatening disease or condition; (2) that, based on the totality of
scientific evidence available to FDA, including data from adequate and
well-controlled clinical trials, if available, it is reasonable to
believe that: (A) The product may be effective in diagnosing, treating,
or preventing (i) such disease or condition; or (ii) a serious or life-
threatening disease or condition caused by a product authorized under
section 564, approved or cleared under the FD&C Act, or licensed under
section 351 of the PHS Act, for diagnosing, treating, or preventing
such a disease or condition caused by such an agent; and (B) the known
and potential benefits of the product, when used to diagnose, prevent,
or treat such disease or condition, outweigh the known and potential
risks of the product, taking into consideration the material threat
posed by the agent or agents identified in a declaration under section
564(b)(1)(D) of the FD&C Act, if applicable; (3) that there is no
adequate, approved, and available alternative to the product for
diagnosing, preventing, or treating such disease or condition; and (4)
that such other criteria as may be prescribed by regulation are
satisfied.
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\1\ The Secretary of HHS has delegated the authority to issue an
EUA under section 564 of the FD&C Act to the Commissioner of Food
and Drugs.
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No other criteria for issuance have been prescribed by regulation
under section 564(c)(4) of the FD&C Act. Because the statute is self-
executing, regulations or guidance are not required for FDA to
implement the EUA authority.
II. EUA Requests for In Vitro Diagnostic Devices for Detection of 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
[[Page 39655]]
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 April 26, 2016, Focus Diagnostics, Inc., requested, and on
April 28, 2016, FDA issued, an EUA for the Zika Virus RNA Qualitative
Real-Time RT-PCR test, subject to the terms of the Authorization. On
May 11, 2016, altona Diagnostics GmbH requested, and on May 13, 2016,
FDA issued, an EUA for the RealStar[supreg] Zika Virus RT-PCR Kit U.S.,
subject to the terms of the Authorization.
III. Electronic Access
An electronic version of this document and the full text of the
Authorizations are available on the Internet at http://www.regulations.gov.
IV. The Authorizations
Having concluded that the criteria for issuance of the
Authorizations under section 564(c) of the FD&C Act are met, FDA has
authorized the emergency use of two in vitro diagnostic devices for
detection of Zika virus subject to the terms of the Authorizations. The
Authorizations in their entirety (not including the authorized versions
of the fact sheets and other written materials) follow and provide
explanations of the reasons for their issuance, as required by section
564(h)(1) of the FD&C Act.
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Dated: June 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-14380 Filed 6-16-16; 8:45 am]
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