80 FR 32140 - Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Ebola Virus; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 108 (June 5, 2015)

The Food and Drug Administration (FDA) is announcing the issuance of two Emergency Use Authorizations (EUAs) (the Authorizations), one of which was amended after initial issuance, for in vitro diagnostic devices for detection of the Ebola virus in response to the Ebola virus outbreak in West Africa. FDA issued these Authorizations under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Corgenix, Inc. (Corgenix), and Cepheid. The Authorizations contain, among other things, conditions on the emergency use of the authorized in vitro diagnostic devices. The Authorizations follow 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 diagnostics for detection of Ebola virus 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.

[Federal Register Volume 80, Number 108 (Friday, June 5, 2015)]
[Notices]
[Pages 32140-32157]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-13699]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Authorizations of Emergency Use of In Vitro Diagnostic Devices 
for Detection of Ebola 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), one of which was amended after initial issuance, for 
in vitro diagnostic devices for detection of the Ebola virus in 
response to the Ebola virus outbreak in West Africa. FDA

[[Page 32141]]

issued these Authorizations under the Federal Food, Drug, and Cosmetic 
Act (the FD&C Act), as requested by Corgenix, Inc. (Corgenix), and 
Cepheid. The Authorizations contain, among other things, conditions on 
the emergency use of the authorized in vitro diagnostic devices. The 
Authorizations follow 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 diagnostics for detection of 
Ebola virus 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 the Corgenix ReEBOVTM Antigen 
Rapid Test is effective as of February 24, 2015, and was amended and 
reissued on March 16, 2015. The Authorization for the Cepheid 
Xpert[supreg] Ebola Assay is effective as of March 23, 2015.

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, Acting Assistant 
Commissioner for Counterterrorism Policy and Acting Director, 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 (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 Act 
(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 the 
Ebola Virus

    On September 22, 2006, then-Secretary of Homeland Security, Michael 
Chertoff, determined that the

[[Page 32142]]

Ebola virus presents a material threat against the U.S. population 
sufficient to affect national security.\2\ 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 diagnostics 
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 February 22, 2015, Corgenix submitted a complete 
request for, and on February 24, 2015, FDA issued, an EUA for the 
ReEBOVTM Antigen Rapid Test, subject to the terms of the 
Authorization. On March 16, 2015, in response to a request from 
Corgenix on March 10, 2015, FDA amended and reissued in its entirety 
the EUA to allow, in addition to Corgenix, distributors that are 
authorized by Corgenix to distribute the ReEBOVTM Antigen 
Rapid Test, with certain conditions applicable to such authorized 
distributor(s), subject to the terms of this Authorization. This EUA, 
as amended and reissued on March 16, 2015, which includes an 
explanation for its reissuance, is reprinted in this document. Because 
the March 16, 2015, Authorization for Corgenix's assay replaces in its 
entirety the EUA issued on February 24, 2015, the original 
Authorization issued on February 24, 2015, is not reprinted in this 
document. On February 26, 2015, Cepheid submitted a complete request 
for, and on March 23, 2015, FDA issued, an EUA for the Xpert[supreg] 
Ebola Assay, subject to the terms of this Authorization.
---------------------------------------------------------------------------

    \2\ Under section 564(b)(1) of the FD&C Act, the HHS Secretary's 
declaration that supports 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).
---------------------------------------------------------------------------

III. Electronic Access

    Electronic versions of these documents 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 in vitro diagnostic devices for 
detection of the Ebola virus subject to the terms of the 
Authorizations. The Authorization for the Corgenix ReEBOVTM 
Antigen Rapid Test issued on March 16, 2015, 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 4164-01-P

[[Page 32143]]

[GRAPHIC] [TIFF OMITTED] TN05JN15.000


[[Page 32144]]


[GRAPHIC] [TIFF OMITTED] TN05JN15.001


[[Page 32145]]


[GRAPHIC] [TIFF OMITTED] TN05JN15.002


[[Page 32146]]


[GRAPHIC] [TIFF OMITTED] TN05JN15.003


[[Page 32147]]


[GRAPHIC] [TIFF OMITTED] TN05JN15.004


[[Page 32148]]


[GRAPHIC] [TIFF OMITTED] TN05JN15.005


[[Page 32149]]


[GRAPHIC] [TIFF OMITTED] TN05JN15.006


[[Page 32150]]


[GRAPHIC] [TIFF OMITTED] TN05JN15.007

    The Authorization for the Cepheid Xpert[supreg] Ebola Assay issued 
on March 23, 2015, 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:

[[Page 32151]]

[GRAPHIC] [TIFF OMITTED] TN05JN15.008


[[Page 32152]]


[GRAPHIC] [TIFF OMITTED] TN05JN15.009


[[Page 32153]]


[GRAPHIC] [TIFF OMITTED] TN05JN15.010


[[Page 32154]]


[GRAPHIC] [TIFF OMITTED] TN05JN15.011


[[Page 32155]]


[GRAPHIC] [TIFF OMITTED] TN05JN15.012


[[Page 32156]]


[GRAPHIC] [TIFF OMITTED] TN05JN15.013


[[Page 32157]]


[GRAPHIC] [TIFF OMITTED] TN05JN15.014


    Dated: May 29, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-13699 Filed 6-4-15; 8:45 am]
 BILLING CODE 4164-01-C