[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]
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