[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]
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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.
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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.
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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 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.
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\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).
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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:
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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:
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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:
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Dated: February 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-02467 Filed 2-6-15; 8:45 am]
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