[Federal Register Volume 80, Number 26 (Monday, February 9, 2015)]
[Notices]
[Pages 6972-6996]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-02467]


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

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 three Emergency Use Authorizations (EUAs) (the 
Authorizations), one of which was amended after initial issuance, for 
three in vitro diagnostic devices for detection of the Ebola virus in 
response to the 2014 Ebola virus outbreak in West Africa. FDA is 
issuing these Authorizations under the Federal Food, Drug, and Cosmetic 
Act (the FD&C Act), as requested by BioFire Defense, LLC (BioFire 
Defense) and altona Diagnostics GmbH (altona). 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 Authorizations for the BioFire FilmArray NGDS BT-E Assay and 
BioFire FilmArray Biothreat-E test are effective as of October 25, 
2014. The Authorization for the altona RealStar[supreg] Ebolavirus RT-
PCR Kit 1.0, which was amended and reissued on November 26, 2014, is 
effective as of November 10, 2014.

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

[[Page 6973]]

section for electronic access to the Authorizations.

FOR FURTHER INFORMATION CONTACT: Luciana Borio, Assistant Commissioner 
for Counterterrorism Policy, Office of Counterterrorism and Emerging 
Threats, and Acting Deputy Chief Scientist, 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 DHS 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 the Department 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 DHS 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 CDC (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 DHS, Michael Chertoff, 
determined that the 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 October 22, 2014, BioFire Defense submitted complete 
EUA requests for both the BioFire FilmArray NGDS BT-E Assay and for the 
BioFire FilmArray Biothreat-E test, and on October 25, 2014, FDA 
issued, an EUA for the BioFire FilmArray NGDS BT-E Assay and an EUA for 
the BioFire FilmArray Biothreat-E test, subject to the terms of these 
authorizations. On October 29, 2014, altona submitted a complete EUA 
request for the RealStar[supreg] Ebolavirus RT-PCR Kit 1.0, and on 
November 10, 2014, FDA issued, an EUA for the RealStar[supreg] 
Ebolavirus RT-PCR Kit 1.0, subject to the terms of this authorization. 
On November 26, 2014, in response to a request from altona on November 
18, 2014, FDA amended and reissued in its entirety the EUA to allow, in 
addition to altona, distributors that are authorized by altona to 
distribute the

[[Page 6974]]

RealStar[supreg] Ebolavirus RT-PCR Kit 1.0 with certain conditions 
applicable to such authorized distributor(s), and to allow the use of 
the assay under the EUA at certain non-U.S. laboratories, with certain 
conditions. The EUA, as amended and reissued on November 26, 2014, 
which includes an explanation for its reissuance, is reprinted in this 
document. Because the November 26, 2014, Authorization for altona's 
Ebola assay replaces in its entirety the EUA issued on November 10, 
2014, the original Authorization issued on November 10, 2014, is not 
reprinted in this document.
---------------------------------------------------------------------------

    \2\ Under to 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 
Secretary of DHS of a material threat under to 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

    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 certain in vitro diagnostic devices. 
The Authorization for the BioFire FilmArray NGDS BT-E Assay issued on 
October 25, 2014, 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 6975]]

[GRAPHIC] [TIFF OMITTED] TN09FE15.000


[[Page 6976]]


[GRAPHIC] [TIFF OMITTED] TN09FE15.001


[[Page 6977]]


[GRAPHIC] [TIFF OMITTED] TN09FE15.002


[[Page 6978]]


[GRAPHIC] [TIFF OMITTED] TN09FE15.003


[[Page 6979]]


[GRAPHIC] [TIFF OMITTED] TN09FE15.004


[[Page 6980]]


[GRAPHIC] [TIFF OMITTED] TN09FE15.005


[[Page 6981]]


[GRAPHIC] [TIFF OMITTED] TN09FE15.006

    The Authorization for the BioFire FilmArray Biothreat-E test issued 
October 25, 2014, 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 6982]]

[GRAPHIC] [TIFF OMITTED] TN09FE15.007


[[Page 6983]]


[GRAPHIC] [TIFF OMITTED] TN09FE15.008


[[Page 6984]]


[GRAPHIC] [TIFF OMITTED] TN09FE15.009


[[Page 6985]]


[GRAPHIC] [TIFF OMITTED] TN09FE15.010


[[Page 6986]]


[GRAPHIC] [TIFF OMITTED] TN09FE15.011


[[Page 6987]]


[GRAPHIC] [TIFF OMITTED] TN09FE15.012


[[Page 6988]]


[GRAPHIC] [TIFF OMITTED] TN09FE15.013

    The Authorization for the RealStar[supreg] Ebolavirus RT-PCR Kit 
1.0, originally issued on November 10, 2014, as amended and reissued in 
its entirety on November 26, 2014, (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, and its amendment:

[[Page 6989]]

[GRAPHIC] [TIFF OMITTED] TN09FE15.014


[[Page 6990]]


[GRAPHIC] [TIFF OMITTED] TN09FE15.015


[[Page 6991]]


[GRAPHIC] [TIFF OMITTED] TN09FE15.016


[[Page 6992]]


[GRAPHIC] [TIFF OMITTED] TN09FE15.017


[[Page 6993]]


[GRAPHIC] [TIFF OMITTED] TN09FE15.018


[[Page 6994]]


[GRAPHIC] [TIFF OMITTED] TN09FE15.019


[[Page 6995]]


[GRAPHIC] [TIFF OMITTED] TN09FE15.020


[[Page 6996]]


[GRAPHIC] [TIFF OMITTED] TN09FE15.021


    Dated: February 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-02467 Filed 2-6-15; 8:45 am]
BILLING CODE 4164-01-C