[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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,

[[Page 39654]]

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.
---------------------------------------------------------------------------

    \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 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.
BILLING CODE 4164-01-P

[[Page 39656]]

[GRAPHIC] [TIFF OMITTED] TN17JN16.007


[[Page 39657]]


[GRAPHIC] [TIFF OMITTED] TN17JN16.008


[[Page 39658]]


[GRAPHIC] [TIFF OMITTED] TN17JN16.009


[[Page 39659]]


[GRAPHIC] [TIFF OMITTED] TN17JN16.010


[[Page 39660]]


[GRAPHIC] [TIFF OMITTED] TN17JN16.011


[[Page 39661]]


[GRAPHIC] [TIFF OMITTED] TN17JN16.012


[[Page 39662]]


[GRAPHIC] [TIFF OMITTED] TN17JN16.013


[[Page 39663]]


[GRAPHIC] [TIFF OMITTED] TN17JN16.014


[[Page 39664]]


[GRAPHIC] [TIFF OMITTED] TN17JN16.015


[[Page 39665]]


[GRAPHIC] [TIFF OMITTED] TN17JN16.016


[[Page 39666]]


[GRAPHIC] [TIFF OMITTED] TN17JN16.017


[[Page 39667]]


[GRAPHIC] [TIFF OMITTED] TN17JN16.018


[[Page 39668]]


[GRAPHIC] [TIFF OMITTED] TN17JN16.019


[[Page 39669]]


[GRAPHIC] [TIFF OMITTED] TN17JN16.020


[[Page 39670]]


[GRAPHIC] [TIFF OMITTED] TN17JN16.021


[[Page 39671]]


[GRAPHIC] [TIFF OMITTED] TN17JN16.022


[[Page 39672]]


[GRAPHIC] [TIFF OMITTED] TN17JN16.023


    Dated: June 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-14380 Filed 6-16-16; 8:45 am]
 BILLING CODE 4164-01-C