[Federal Register Volume 84, Number 30 (Wednesday, February 13, 2019)]
[Notices]
[Pages 3785-3795]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02134]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0126]


Authorization of Emergency Use of an In Vitro Diagnostic Device 
for Detection of Ebola 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 an Emergency Use Authorization (EUA) (the Authorization) 
for an in vitro diagnostic device for detection of Ebola virus (species 
Zaire ebolavirus and hereafter referred to as Ebola virus) in response 
to the Ebola virus outbreak in the Democratic Republic of the Congo. 
FDA issued this Authorization under the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act), as requested by Chembio Diagnostic 
Systems, Inc. The Authorization contains, among other things, 
conditions on the emergency use of the authorized in vitro diagnostic 
device. The Authorization follows the September 22, 2006, determination 
by then-Secretary of the Department of Homeland Security (DHS), Michael 
Chertoff, that the Ebola virus presents a material threat against the 
U.S. population sufficient to affect national security. On the basis of 
such determination, the Secretary of Health and Human Services (HHS) 
declared on August 5, 2014, that circumstances exist justifying the 
authorization of emergency use of in vitro diagnostic devices for 
detection of Ebola virus, 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 9, 2018.

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: Michael Mair, Office of 
Counterterrorism and Emerging Threats,

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Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 1, rm. 
4340, 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, including personnel operating under the 
authority of title 10 or title 50, United States Code, of attack with 
(i) a biological, chemical, radiological, or nuclear agent or agents; 
or (ii) an agent or agents that may cause, or are otherwise associated 
with, an imminently life-threatening and specific risk to U.S. military 
forces\1\; (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.
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    \1\ In the case of a determination by the Secretary of Defense, 
the Secretary of HHS shall determine within 45 calendar days of such 
determination, whether to make a declaration under section 564(b)(1) 
of the FD&C Act, and, if appropriate, shall promptly make such a 
declaration.
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    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), 512 or 515 of the FD&C Act (21 U.S.C. 355, 
360(k), 360b and 360e) or section 351 of the PHS Act (42 U.S.C. 262), 
or conditionally approved under section 571 of the FD&C Act (21 U.S.C. 
360ccc). 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 \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; (4) in the case of a determination described in section 
564(b)(1)(B)(ii), that the request for emergency use is made by the 
Secretary of Defense; and (5) that such other criteria as may be 
prescribed by regulation 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 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 
Ebola Zaire Virus

    On September 22, 2006, then-Secretary of DHS, Michael Chertoff, 
determined that the Ebola virus presents a material threat against the 
U.S. population sufficient to affect national security.\3\ On August 5, 
2014, 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 
devices for detection of Ebola virus, subject to the terms of any 
authorization issued under section 564 of the FD&C Act. Notice of the 
declaration of the Secretary was published in the Federal Register on 
August 12, 2014 (79 FR 47141). On November 5, 2018, Chembio Diagnostic 
Systems, Inc. submitted a complete request for, and on November 9, 
2018, FDA issued, an EUA for the DPP Ebola Antigen System, subject to 
the terms of the Authorization.
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    \3\ Under section 564(b)(1) of the FD&C Act, the HHS Secretary's 
declaration that supports the EUA issuance must be based on one of 
four determinations, including the identification by the DHS 
Secretary of a material threat under section 319F-2 of the PHS Act 
sufficient to affect national security or the health and security of 
U.S. citizens living abroad (section 564(b)(1)(D) of the FD&C Act).

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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 Ebola 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.
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    Dated: February 7, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-02134 Filed 2-12-19; 8:45 am]
 BILLING CODE 4164-01-C