80 FR 55125 - Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Ebola Zaire Virus; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 177 (September 14, 2015)

Page Range		55125-55135
FR Document		2015-23003

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 the Ebola Zaire virus in response to the Ebola virus outbreak in West Africa. FDA issued this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by OraSure Technologies, 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.

Federal Register, Volume 80 Issue 177 (Monday, September 14, 2015)

[Federal Register Volume 80, Number 177 (Monday, September 14, 2015)]
[Notices]
[Pages 55125-55135]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-23003]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1206]


Authorization of Emergency Use of an In Vitro Diagnostic Device 
for Detection of Ebola Zaire 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 the Ebola Zaire 
virus in response to the Ebola virus outbreak in West Africa. FDA 
issued this Authorization under the Federal Food, Drug, and Cosmetic 
Act (the FD&C Act), as requested by OraSure Technologies, 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 July 31, 2015.

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: 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

[[Page 55126]]

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 
(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.
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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.
---------------------------------------------------------------------------

    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.\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 July 20, 2015, OraSure Technologies, Inc. requested, 
and on July 31, 2015, FDA issued, an EUA for the OraQuick[supreg] Ebola 
Rapid Antigen Test, subject to the terms of the Authorization.
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    \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).
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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 http://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 the Ebola Zaire virus (detected in the West Africa 
outbreak in 2014) 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:
BILLING CODE 4164-01-P

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    Dated: September 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-23003 Filed 9-11-15; 8:45 am]
BILLING CODE 4164-01-C

Federal Register / Vol. 80, No. 177 / Monday, September 14, 2015 / Notices 55125

establish any rights for any person and http://www.regulations.gov, but you can DATES: The Authorization is effective as
is not binding on FDA or the public. put your name and/or contact of July 31, 2015.
You can use an alternative approach if information on a separate cover sheet ADDRESSES: Submit written requests for
it satisfies the requirements of the and not in the body of your comments. single copies of the EUA to the Office
applicable statutes and regulations. of Counterterrorism and Emerging
IV. Electronic Access
III. Comments Threats, Food and Drug Administration,
Persons with access to the Internet 10903 New Hampshire Ave., Bldg. 1,
A. General Information About may obtain an electronic version of the Rm. 4338, Silver Spring, MD 20993–
Submitting Comments guidance at either http:// 0002. Send one self-addressed adhesive
www.regulations.gov or http:// label to assist that office in processing
Interested persons may submit either
www.fda.gov/TobaccoProducts/ your request or include a fax number to
electronic comments regarding this
GuidanceComplianceRegulatory which the Authorization may be sent.
document to http://www.regulations.gov
Information/default.htm. See the SUPPLEMENTARY INFORMATION
or written comments to the Division of
Dockets Management (see ADDRESSES). It Dated: September 9, 2015. section for electronic access to the
is only necessary to send one set of Leslie Kux, Authorization.
comments. Identify comments with the Associate Commissioner for Policy. FOR FURTHER INFORMATION CONTACT:
docket number found in brackets in the [FR Doc. 2015–23001 Filed 9–11–15; 8:45 am] Carmen Maher, Acting Assistant
heading of this document. BILLING CODE 4164–01–P
Commissioner for Counterterrorism
Policy and Acting Director, Office of
B. Public Availability of Comments Counterterrorism and Emerging Threats,
Received comments may be seen in DEPARTMENT OF HEALTH AND Food and Drug Administration, 10903
the Division of Dockets Management HUMAN SERVICES New Hampshire Ave., Bldg. 1, Rm.
between 9 a.m. and 4 p.m., Monday 4347, Silver Spring, MD 20993–0002,
through Friday, and will be posted to Food and Drug Administration 301–796–8510 (this is not a toll free
the docket at http:// number).
[Docket No. FDA–2014–N–1206]
www.regulations.gov. As a matter of SUPPLEMENTARY INFORMATION:
Agency practice, FDA generally does Authorization of Emergency Use of an
not post comments submitted by I. Background
In Vitro Diagnostic Device for
individuals in their individual capacity Detection of Ebola Zaire Virus; Section 564 of the FD&C Act (21
on http://www.regulations.gov. This is Availability U.S.C. 360bbb–3) as amended by the
determined by information indicating Project BioShield Act of 2004 (Pub. L.
that the submission is written by an AGENCY: Food and Drug Administration, 108–276) and the Pandemic and All-
individual, for example, the comment is HHS. Hazards Preparedness Reauthorization
identified with the category ‘‘Individual ACTION: Notice. Act of 2013 (Pub. L. 113–5) allows FDA
Consumer’’ under the field titled to strengthen the public health
‘‘Category (Required),’’ on the ‘‘Your SUMMARY: The Food and Drug protections against biological, chemical,
Information’’ page on Administration (FDA) is announcing the nuclear, and radiological agents. Among
www.regulations.gov. For this docket, issuance of an Emergency Use other things, section 564 of the FD&C
however, FDA will not be following this Authorization (EUA) (the Authorization) Act allows FDA to authorize the use of
general practice. Instead, FDA will post for an in vitro diagnostic device for an unapproved medical product or an
on http://www.regulations.gov detection of the Ebola Zaire virus in unapproved use of an approved medical
comments to this docket that have been response to the Ebola virus outbreak in product in certain situations. With this
submitted by individuals in their West Africa. FDA issued this EUA authority, FDA can help assure
individual capacity. If you wish to Authorization under the Federal Food, that medical countermeasures may be
submit any information under a claim of Drug, and Cosmetic Act (the FD&C Act), used in emergencies to diagnose, treat,
confidentiality, please refer to 21 CFR as requested by OraSure Technologies, or prevent serious or life-threatening
10.20. Inc. The Authorization contains, among diseases or conditions caused by
other things, conditions on the biological, chemical, nuclear, or
C. Information Identifying the Person emergency use of the authorized in vitro radiological agents when there are no
Submitting the Comment diagnostic device. The Authorization adequate, approved, and available
Please note that your name, contact follows the September 22, 2006, alternatives.
information, and other information determination by then-Secretary of the Section 564(b)(1) of the FD&C Act
identifying you will be posted on Department of Homeland Security provides that, before an EUA may be
http://www.regulations.gov if you (DHS), Michael Chertoff, that the Ebola issued, the Secretary of HHS must
include that information in the body of virus presents a material threat against declare that circumstances exist
your comments. For electronic the U.S. population sufficient to affect justifying the authorization based on
comments submitted to http:// national security. On the basis of such one of the following grounds: (1) A
www.regulations.gov, FDA will post the determination, the Secretary of Health determination by the Secretary of
body of your comment on http:// and Human Services (HHS) declared on Homeland Security that there is a
www.regulations.gov along with your August 5, 2014, that circumstances exist domestic emergency, or a significant
State/province and country (if justifying the authorization of potential for a domestic emergency,
tkelley on DSK3SPTVN1PROD with NOTICES

provided), the name of your emergency use of in vitro diagnostic involving a heightened risk of attack
representative (if any), and the category devices for detection of Ebola virus with a biological, chemical, radiological,
identifying you (e.g., individual, subject to the terms of any authorization or nuclear agent or agents; (2) a
consumer, academic, industry). For issued under the FD&C Act. The determination by the Secretary of
written submissions submitted to the Authorization, which includes an Defense that there is a military
Division of Dockets Management, FDA explanation of the reasons for issuance, emergency, or a significant potential for
will post the body of your comments on is reprinted in this document. a military emergency, involving a

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55126 Federal Register / Vol. 80, No. 177 / Monday, September 14, 2015 / Notices

heightened risk to U.S. military forces of for Disease Control and Prevention (to determined that the Ebola virus presents
attack with a biological, chemical, the extent feasible and appropriate a material threat against the U.S.
radiological, or nuclear agent or agents; given the applicable circumstances), population sufficient to affect national
(3) a determination by the Secretary of FDA 1 concludes: (1) That an agent security.2 On August 5, 2014, under
HHS that there is a public health referred to in a declaration of emergency section 564(b)(1) of the FD&C Act, and
emergency, or a significant potential for or threat can cause a serious or life- on the basis of such determination, the
a public health emergency, that affects, threatening disease or condition; (2) Secretary of HHS declared that
or has a significant potential to affect, that, based on the totality of scientific circumstances exist justifying the
national security or the health and evidence available to FDA, including authorization of emergency use of in
security of U.S. citizens living abroad, data from adequate and well-controlled vitro diagnostics for detection of Ebola
and that involves a biological, chemical, clinical trials, if available, it is virus, subject to the terms of any
radiological, or nuclear agent or agents, reasonable to believe that: (A) The authorization issued under section 564
or a disease or condition that may be product may be effective in diagnosing, of the FD&C Act. Notice of the
attributable to such agent or agents; or treating, or preventing (i) such disease declaration of the Secretary was
(4) the identification of a material threat or condition; or (ii) a serious or life- published in the Federal Register on
by the Secretary of Homeland Security threatening disease or condition caused August 12, 2014 (79 FR 47141). On July
under section 319F–2 of the Public by a product authorized under section 20, 2015, OraSure Technologies, Inc.
Health Service (PHS) Act (42 U.S.C. 564, approved or cleared under the requested, and on July 31, 2015, FDA
247d–6b) sufficient to affect national FD&C Act, or licensed under section 351 issued, an EUA for the OraQuick® Ebola
security or the health and security of of the PHS Act, for diagnosing, treating, Rapid Antigen Test, subject to the terms
U.S. citizens living abroad. or preventing such a disease or of the Authorization.
Once the Secretary of HHS has condition caused by such an agent; and
(B) the known and potential benefits of III. Electronic Access
declared that circumstances exist
justifying an authorization under the product, when used to diagnose, An electronic version of this
section 564 of the FD&C Act, FDA may prevent, or treat such disease or document and the full text of the
authorize the emergency use of a drug, condition, outweigh the known and Authorization are available on the
device, or biological product if the potential risks of the product, taking Internet at http://www.regulations.gov.
Agency concludes that the statutory into consideration the material threat
posed by the agent or agents identified IV. The Authorization
criteria are satisfied. Under section
564(h)(1) of the FD&C Act, FDA is in a declaration under section Having concluded that the criteria for
required to publish in the Federal 564(b)(1)(D) of the FD&C Act, if issuance of the Authorization under
Register a notice of each authorization, applicable; (3) that there is no adequate, section 564(c) of the FD&C Act are met,
and each termination or revocation of an approved, and available alternative to FDA has authorized the emergency use
authorization, and an explanation of the the product for diagnosing, preventing, of an in vitro diagnostic device for
reasons for the action. Section 564 of the or treating such disease or condition; detection of the Ebola Zaire virus
FD&C Act permits FDA to authorize the and (4) that such other criteria as may (detected in the West Africa outbreak in
introduction into interstate commerce of be prescribed by regulation are satisfied. 2014) subject to the terms of the
a drug, device, or biological product No other criteria for issuance have Authorization. The Authorization in its
intended for use when the Secretary of been prescribed by regulation under entirety (not including the authorized
HHS has declared that circumstances section 564(c)(4) of the FD&C Act. versions of the fact sheets and other
exist justifying the authorization of Because the statute is self-executing, written materials) follows and provides
emergency use. Products appropriate for regulations or guidance are not required an explanation of the reasons for its
emergency use may include products for FDA to implement the EUA issuance, as required by section
and uses that are not approved, cleared, authority. 564(h)(1) of the FD&C Act:
or licensed under sections 505, 510(k), BILLING CODE 4164–01–P
II. EUA Request for an In Vitro
or 515 of the FD&C Act (21 U.S.C. 355, Diagnostic Device for Detection of the 2 Under section 564(b)(1) of the FD&C Act, the
360(k), and 360e) or section 351 of the Ebola Zaire Virus HHS Secretary’s declaration that supports EUA
PHS Act (42 U.S.C. 262). FDA may issue issuance must be based on one of four
On September 22, 2006, then-
an EUA only if, after consultation with determinations, including the identification by the
Secretary of DHS, Michael Chertoff, DHS Secretary of a material threat under section
the HHS Assistant Secretary for
319F–2 of the PHS Act sufficient to affect national
Preparedness and Response, the 1 The Secretary of HHS has delegated the security or the health and security of U.S. citizens
Director of the National Institutes of authority to issue an EUA under section 564 of the living abroad (section 564(b)(1)(D) of the FD&C
Health, and the Director of the Centers FD&C Act to the Commissioner of Food and Drugs. Act).
tkelley on DSK3SPTVN1PROD with NOTICES

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Document Created: 2018-02-26 10:15:09
Document Modified: 2018-02-26 10:15:09

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		The Authorization is effective as of July 31, 2015.
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).
FR Citation		80 FR 55125

80 FR 55125 - Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Ebola Zaire Virus; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 177 (September 14, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration