
[Federal Register Volume 81, Number 209 (Friday, October 28, 2016)]
[Notices]
[Pages 75092-75130]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-26066]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-3330]


Authorizations of Emergency Use of In Vitro Diagnostic Devices 
for Detection and/or Diagnosis 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 four Emergency Use Authorizations (EUAs) (the 
Authorizations) for four in vitro diagnostic devices for detection and/
or diagnosis 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 Siemens 
Healthcare Diagnostics, Inc., Luminex Corporation, InBios 
International, Inc., and Roche Molecular Systems, Inc. The 
Authorizations contain, 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 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 Authorizations, which include an explanation of 
the reasons for issuance, are reprinted in this document.

DATES: The Authorization for Siemens Healthcare Diagnostics, Inc., is 
effective as of July 29, 2016; the Authorization for Luminex 
Corporation is effective as of August 4, 2016; the Authorization for 
InBios International, Inc., is effective as of August 17, 2016; and the 
Authorization for Roche Molecular Systems, Inc., is effective as of 
August 26, 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: Michael Mair, Office of 
Counterterrorism and Emerging Threats, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 1, Rm. 4336, Silver Spring, MD 20993-
0002, 301-796-8510 (this is not a toll-free number).

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the 
Project BioShield Act of 2004 (Pub L. 108-276) and the Pandemic and 
All-Hazards Preparedness Reauthorization Act of 2013 (Pub L. 113-5) 
allows FDA to strengthen the public health protections against 
biological, chemical, nuclear, and radiological agents. Among other 
things, section 564 of the FD&C Act allows FDA to authorize the use of 
an unapproved medical product or an unapproved use of an approved 
medical product in certain situations. With this EUA authority, FDA can 
help assure that medical countermeasures may be used in emergencies to 
diagnose, treat, or prevent serious or life-threatening diseases or 
conditions caused by biological, chemical, nuclear, or radiological 
agents when there are no adequate, approved, and available 
alternatives.
    Section 564(b)(1) of the FD&C Act provides that, before an EUA may 
be issued, the Secretary of HHS must declare that circumstances exist 
justifying the authorization based on one of the following grounds: (1) 
A determination by the Secretary of Homeland Security that there is a 
domestic emergency, or a significant potential for a domestic 
emergency, involving a heightened risk of attack with a biological, 
chemical, radiological, or nuclear agent or agents; (2) a determination 
by the Secretary of Defense that there is a military emergency, or a 
significant potential for a military emergency, involving a heightened 
risk to U.S. military forces of attack with a biological, chemical, 
radiological, or nuclear agent or agents; (3) a determination by the 
Secretary of HHS that there is a public health emergency, or a 
significant potential for a public health emergency, that affects, or 
has a significant potential to affect, national security or the health 
and security of U.S. citizens living abroad, and that involves a 
biological, chemical, radiological, or nuclear agent or agents, or a 
disease or condition that may be attributable to such agent or agents; 
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,

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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 and/or 
Diagnosis 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 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 July 21, 2016, Siemens Healthcare 
Diagnostics, Inc., requested, and on July 29, 2016, FDA issued, an EUA 
for the VERSANT[supreg] Zika RNA 1.0 Assay (kPCR) Kit, subject to the 
terms of the Authorization. On August 1, 2016, Luminex Corporation 
requested, and on August 4, 2016, FDA issued, an EUA for the 
xMAP[supreg] MultiFLEXTM Zika RNA Assay, subject to the 
terms of the Authorization. On July 21, 2016, InBios International, 
Inc., requested, and on August 17, 2016, FDA issued, an EUA for the 
ZIKV DetectTM IgM Capture ELISA, subject to the terms of the 
Authorization. On August 18, 2016, Roche Molecular Systems, Inc., 
requested, and on August 26, 2016, FDA issued, an EUA for the 
LightMix[supreg] Zika rRT-PCR Test, 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 four in vitro diagnostic devices for 
detection and/or diagnosis 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 an explanation of the reasons for their issuance, as 
required by section 564(h)(1) of the FD&C Act:
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    Dated: October 24, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-26066 Filed 10-27-16; 8:45 am]
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