80_FR_32248 80 FR 32140 - Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Ebola Virus; Availability

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)

Page Range32140-32157
FR Document2015-13699

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 Issue 108 (Friday, June 5, 2015) 
[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]


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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 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.
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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 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.
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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

    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

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    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:

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    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

32140 Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Notices TABLE 3—ESTIMATED ONE-TIME REPORTING BURDEN 1 Average Number of Number of Total one-time burden per Guidance document provision responses per Total hours respondents responses response respondent (in hours) Initial VQIP application ......................................................... 100 1 100 80 8,000 Initial VQIP application with re-submissions ........................ 100 1 100 100 10,000 Total One-Time Reporting Burden ............................... ........................ ........................ ........................ ........................ 18,000 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 4—ESTIMATED ANNUAL REPORTING BURDEN 1 Average Number of Number of Total annual burden per Guidance document provision responses per Total hours responses responses response respondent (in hours) Renewal of VQIP application ............................................... 200 1 200 20 4,000 Total Annual Reporting Burden .................................... ........................ ........................ ........................ ........................ 4,000 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The draft guidance document allows 200 importers is estimated at 4,000 find the most current version of the for food importers to apply for VQIP. hours (200 applications × 20 hours/ guidance. We estimate that up to 200 qualified application) (see table 4). For the VI. References importers will be accepted in the first purposes of the PRA analysis of the year of VQIP. We estimate that it will draft guidance document, we have 1. U.S. Food and Drug Administration. take 80 person-hours to compile all the estimated costs assuming that, during Proposed Analysis of Economic relevant information and complete the the annual application process, affected Impacts—Current Good Manufacturing application for the VQIP program. For Practice and Hazard Analysis and Risk- importers will do their paperwork Based Preventive Controls for Human the purpose of this analysis, we assume properly and completely the first time. Food, available under Docket No. FDA– that 50 percent of all applications Because we assume that importers will 2011–N–0920. received will require additional have learned about supporting 2. U.S. Food and Drug Administration. information and it would take an documentation they need to submit Focused Mitigation Strategies to Protect additional 20 person-hours by the during the initial application process, Food Against Intentional Adulteration importer to provide that information. we have not estimated an additional (78 FR 78014, December 24, 2013). Therefore, we estimate that 100 burden for less than complete annual Dated: May 29, 2015. importers will spend 8,000 hours (80 applications. If we assumed a less Leslie Kux, hours/importer × 100 importers) and consistent outcome, the annual burden Associate Commissioner for Policy. 100 importers will spend 10,000 hours might be slightly higher. [FR Doc. 2015–13706 Filed 6–4–15; 8:45 am] (100 hours/importer × 100 importers) to submit their initial VQIP applications IV. Comments BILLING CODE 4164–01–P for a total one-time reporting burden of Interested persons may submit either 18,000 hours (see table 3). DEPARTMENT OF HEALTH AND electronic comments regarding this draft The draft guidance document states guidance to http://www.regulations.gov HUMAN SERVICES that each VQIP participant will submit to FDA a notice of intent to maintain its or written comments to the Division of Dockets Management (see ADDRESSES). It Food and Drug Administration participation in VQIP and update information on its original application is only necessary to send one set of [Docket No. FDA–2015–N–0126] on an annual basis. We expect that each comments. Identify comments with the docket number found in brackets in the Authorizations of Emergency Use of In of the expected 200 importers in VQIP heading of this document. Received Vitro Diagnostic Devices for Detection would apply to renew their intent to comments may be seen in the Division of Ebola Virus; Availability maintain their participation in VQIP. We expect that annual applications to of Dockets Management between 9 a.m. AGENCY: Food and Drug Administration, renew participation in VQIP will take and 4 p.m., Monday through Friday, and HHS. significantly less time to prepare than will be posted to the docket at http:// www.regulations.gov. ACTION: Notice. initial applications. We use 25 percent of the amount of effort to prepare and SUMMARY: The Food and Drug asabaliauskas on DSK5VPTVN1PROD with NOTICES V. Electronic Access submit the initial application for Administration (FDA) is announcing the acceptance in VQIP. Therefore, it is Persons with access to the Internet issuance of two Emergency Use expected that, on average, each VQIP may obtain this draft guidance at either Authorizations (EUAs) (the importer will spend 20 hours every year http://www.fda.gov/Food/ Authorizations), one of which was to complete and submit an application GuidanceRegulation/FSMA/ amended after initial issuance, for in for renewal of its VQIP status. The ucm253380.htm or http:// vitro diagnostic devices for detection of annual burden of completing the www.regulations.gov. Use the FDA Web the Ebola virus in response to the Ebola renewal application for VQIP status by site listed in the previous sentence to virus outbreak in West Africa. FDA VerDate Sep<11>2014 18:31 Jun 04, 2015 Jkt 235001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\05JNN1.SGM 05JNN1

Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Notices 32141 issued these Authorizations under the other things, section 564 of the FD&C intended for use when the Secretary of Federal Food, Drug, and Cosmetic Act Act allows FDA to authorize the use of HHS has declared that circumstances (the FD&C Act), as requested by an unapproved medical product or an exist justifying the authorization of Corgenix, Inc. (Corgenix), and Cepheid. unapproved use of an approved medical emergency use. Products appropriate for The Authorizations contain, among product in certain situations. With this emergency use may include products other things, conditions on the EUA authority, FDA can help assure and uses that are not approved, cleared, emergency use of the authorized in vitro that medical countermeasures may be or licensed under sections 505, 510(k), diagnostic devices. The Authorizations used in emergencies to diagnose, treat, or 515 of the FD&C Act (21 U.S.C. 355, follow the September 22, 2006, or prevent serious or life-threatening 360(k), and 360e) or section 351 of the determination by then-Secretary of the diseases or conditions caused by PHS Act (42 U.S.C. 262). FDA may issue Department of Homeland Security biological, chemical, nuclear, or an EUA only if, after consultation with (DHS), Michael Chertoff, that the Ebola radiological agents when there are no the HHS Assistant Secretary for virus presents a material threat against adequate, approved, and available Preparedness and Response, the the U.S. population sufficient to affect alternatives. Director of the National Institutes of national security. On the basis of such Section 564(b)(1) of the FD&C Act Health, and the Director of the Centers determination, the Secretary of Health provides that, before an EUA may be for Disease Control and Prevention (to and Human Services (HHS) declared on issued, the Secretary of HHS must the extent feasible and appropriate August 5, 2014, that circumstances exist declare that circumstances exist given the applicable circumstances), justifying the authorization of justifying the authorization based on FDA 1 concludes: (1) That an agent emergency use of in vitro diagnostics for one of the following grounds: (1) A referred to in a declaration of emergency detection of Ebola virus subject to the determination by the Secretary of or threat can cause a serious or life- terms of any authorization issued under Homeland Security that there is a threatening disease or condition; (2) the FD&C Act. The Authorizations, domestic emergency, or a significant that, based on the totality of scientific which include an explanation of the potential for a domestic emergency, evidence available to FDA, including reasons for issuance, are reprinted in involving a heightened risk of attack data from adequate and well-controlled this document. with a biological, chemical, radiological, clinical trials, if available, it is DATES: The Authorization for the or nuclear agent or agents; (2) a reasonable to believe that: (A) The Corgenix ReEBOVTM Antigen Rapid Test determination by the Secretary of product may be effective in diagnosing, is effective as of February 24, 2015, and Defense that there is a military treating, or preventing (i) such disease was amended and reissued on March emergency, or a significant potential for or condition; or (ii) a serious or life- 16, 2015. The Authorization for the a military emergency, involving a threatening disease or condition caused Cepheid Xpert® Ebola Assay is effective heightened risk to U.S. military forces of by a product authorized under section as of March 23, 2015. attack with a biological, chemical, 564, approved or cleared under the ADDRESSES: Submit written requests for radiological, or nuclear agent or agents; FD&C Act, or licensed under section 351 single copies of the EUAs to the Office (3) a determination by the Secretary of of the PHS Act, for diagnosing, treating, of Counterterrorism and Emerging HHS that there is a public health or preventing such a disease or Threats, Food and Drug Administration, emergency, or a significant potential for condition caused by such an agent; and 10903 New Hampshire Ave., Bldg. 1, a public health emergency, that affects, (B) the known and potential benefits of Rm. 4338, Silver Spring, MD 20993– or has a significant potential to affect, the product, when used to diagnose, 0002. Send one self-addressed adhesive national security or the health and prevent, or treat such disease or label to assist that office in processing security of U.S. citizens living abroad, condition, outweigh the known and your request or include a fax number to and that involves a biological, chemical, potential risks of the product, taking which the Authorizations may be sent. radiological, or nuclear agent or agents, into consideration the material threat See the SUPPLEMENTARY INFORMATION or a disease or condition that may be posed by the agent or agents identified section for electronic access to the attributable to such agent or agents; or in a declaration under section Authorizations. (4) the identification of a material threat 564(b)(1)(D) of the FD&C Act, if by the Secretary of Homeland Security FOR FURTHER INFORMATION CONTACT: applicable; (3) that there is no adequate, under section 319F–2 of the Public Carmen Maher, Acting Assistant approved, and available alternative to Health Service Act (PHS Act) (42 U.S.C. Commissioner for Counterterrorism the product for diagnosing, preventing, 247d–6b) sufficient to affect national Policy and Acting Director, Office of or treating such disease or condition; security or the health and security of Counterterrorism and Emerging Threats, and (4) that such other criteria as may U.S. citizens living abroad. Food and Drug Administration, 10903 Once the Secretary of HHS has be prescribed by regulation are satisfied. New Hampshire Ave., Bldg. 1, Rm. No other criteria for issuance have declared that circumstances exist 4347, Silver Spring, MD 20993–0002, been prescribed by regulation under justifying an authorization under 301–796–8510 (this is not a toll free section 564(c)(4) of the FD&C Act. section 564 of the FD&C Act, FDA may number). Because the statute is self-executing, authorize the emergency use of a drug, device, or biological product if the regulations or guidance are not required SUPPLEMENTARY INFORMATION: Agency concludes that the statutory for FDA to implement the EUA I. Background criteria are satisfied. Under section authority. Section 564 of the FD&C Act (21 564(h)(1) of the FD&C Act, FDA is asabaliauskas on DSK5VPTVN1PROD with NOTICES II. EUA Requests for In Vitro Diagnostic U.S.C. 360bbb–3) as amended by the required to publish in the Federal Devices for Detection of the Ebola Virus Project BioShield Act of 2004 (Pub. L. Register a notice of each authorization, On September 22, 2006, then- 108–276) and the Pandemic and All- and each termination or revocation of an Secretary of Homeland Security, Hazards Preparedness Reauthorization authorization, and an explanation of the Michael Chertoff, determined that the Act of 2013 (Pub L. 113–5) allows FDA reasons for the action. Section 564 of the to strengthen the public health FD&C Act permits FDA to authorize the 1 The Secretary of HHS has delegated the protections against biological, chemical, introduction into interstate commerce of authority to issue an EUA under section 564 of the nuclear, and radiological agents. Among a drug, device, or biological product FD&C Act to the Commissioner of Food and Drugs. VerDate Sep<11>2014 18:31 Jun 04, 2015 Jkt 235001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\05JNN1.SGM 05JNN1

32142 Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Notices Ebola virus presents a material threat ReEBOVTM Antigen Rapid Test, subject III. Electronic Access against the U.S. population sufficient to to the terms of the Authorization. On affect national security.2 On August 5, March 16, 2015, in response to a request Electronic versions of these 2014, under section 564(b)(1) of the from Corgenix on March 10, 2015, FDA documents and the full text of the FD&C Act, and on the basis of such amended and reissued in its entirety the Authorizations are available on the determination, the Secretary of HHS EUA to allow, in addition to Corgenix, Internet at http://www.regulations.gov. declared that circumstances exist distributors that are authorized by IV. The Authorizations justifying the authorization of Corgenix to distribute the ReEBOVTM emergency use of in vitro diagnostics for Antigen Rapid Test, with certain Having concluded that the criteria for detection of Ebola virus, subject to the conditions applicable to such issuance of the Authorizations under terms of any authorization issued under authorized distributor(s), subject to the section 564(c) of the FD&C Act are met, section 564 of the FD&C Act. Notice of terms of this Authorization. This EUA, FDA has authorized the emergency use the declaration of the Secretary was as amended and reissued on March 16, of in vitro diagnostic devices for published in the Federal Register on 2015, which includes an explanation for detection of the Ebola virus subject to August 12, 2014 (79 FR 47141). On its reissuance, is reprinted in this the terms of the Authorizations. The February 22, 2015, Corgenix submitted document. Because the March 16, 2015, a complete request for, and on February Authorization for the Corgenix Authorization for Corgenix’s assay 24, 2015, FDA issued, an EUA for the ReEBOVTM Antigen Rapid Test issued replaces in its entirety the EUA issued on March 16, 2015, in its entirety (not on February 24, 2015, the original 2 Under section 564(b)(1) of the FD&C Act, the including the authorized versions of the Authorization issued on February 24, HHS Secretary’s declaration that supports EUA 2015, is not reprinted in this document. fact sheets and other written materials) issuance must be based on one of four follows and provides an explanation of determinations, including the identification by the On February 26, 2015, Cepheid DHS Secretary of a material threat under section submitted a complete request for, and the reasons for its issuance, as required 319F–2 of the PHS Act sufficient to affect national on March 23, 2015, FDA issued, an EUA by section 564(h)(1) of the FD&C Act: security or the health and security of U.S. citizens living abroad (section 564(b)(1)(D) of the FD&C for the Xpert® Ebola Assay, subject to BILLING CODE 4164–01–P Act). the terms of this Authorization. asabaliauskas on DSK5VPTVN1PROD with NOTICES VerDate Sep<11>2014 18:31 Jun 04, 2015 Jkt 235001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 E:\FR\FM\05JNN1.SGM 05JNN1

ww60 6 & ‘ —é DEPARTMENT OF HEALTH & HUMAN SERVICES yh ht ~1 ty measo Food and Drug Administration Silver Spring, MD 20993 March 16, 2015 Daniel F. Simpson, RAC (U.S., CAN), ASQ CBA Sr., Director of Quality and Regulatory Affairs Corgenix Inc. 11575 Main Street, Suite 400 Broomfield, CO 80020 Dear Mr. Simpson: On February 24, 2015, based on a request by Corgenix Inc., the Food and Drug Administration {(FDA) issued a letter authorizing the emergency use of the ReEBOYV‘TY Antigen Rapid Test for the presumptive detection of Ebola viruses‘ in individuals with signs and symptoms of Ebola virus Infection in conjunction with epidemiclogical risk factors (including geographic locations with high prevalence of Ebola infection), pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 360bbb—3). Theauthorized ReEBOY*Y Antigen Rapid Test is intended for circumstances when use of a rapid Ebola virus test is determined to be more appropriate than use of an authorized Ebola virus nucletc acid test, which has been demonstrated to be more sensitive in detécting the Ebola Zaire virus. The authorized ReFBOVTY Antigen Rapid Test is not intended for use for general Ebola virus infection screening, such as airport screening or contact tracing. The ReEBOYV*Y Antigen Rapid Test is authorized for use in laboratories or facilities adequately equipped, trained, and capable of such testing (including treatment centers and public health clinics}. On March 10, 2015, FDA received a request from Corgenix Inc. for an amendment to the Emergency Use Authorization (EUA). In response to that request, and having concluded that revising the February 24, 2015, EUA is appropriate to protect the public health or safety under section 564(g)(2)(C) of the Act (21 U.S.C. § 360bbb— 3(g)(2)(C)), the February 24, 2015, letter authorizing the emergency use of the ReEBOVTYM Antigen Rapid Test is being reissued in its entirety with the amendments incorporated." On September 22, 2006, then—Secretary of the Department of Homeland Security (DHS), Michael Chertoff, determined, pursuant to section 319F—2 of the Public Health Service (PHS) Act (42 U.S.C. § 2474—6b), that the Ebola virus presents a material threat against the United States population sufficient to affect national security." Pursuant to section 564(b)(1) of the Act * This assay is intended for the qualitative detection of antigen from Zaire Ebola virus [detected in the West Africa cutbreak in 2014), Sudan Ebola virus, and Bundibugyo Ebola virus; however, it does not distinguish between these different Ebola virus straing. * The amendments to the February 24, 2015, letter allow, in addition to Corgenix Inc., distributors that are authorized by Corgenix Inc. to distribute the ReEBOV*Y Antigen Rapid Test with certain conditions applicable to such authorized distributor(s).. The Instructions for Use have also been updated to incorporate these amendments. * Pursuant to section 564(b)(1) of the Act (21 U.S.C. § 360bbb—3(b)(1}), the HHS Secretary‘s dectaration that supports EUA issuance must be based on one of four determinations, including the identification by the DHS Secretary of a material threat pursuant to section 319FP—2 of the PHS Act sufficient to affect national security or the health and security of United States citizens living abroad (section 564(b)(1 (D) of the Act),

32144 Federal Register/Vol. 80, No. 108 /Friday, June 5, 2015 /Notices Page 2 — Mr. Simpson, Corgenix Inc. (21 U.S.C. § 360bbb—3(b)(1)), and on the basis of such determination, the Secretary of the Department of Health and Human Services (HHS) declared on August 5, 2014, that circumstances exist justifying the authorization of emergency use of is vitro diagnostics for detection of Ebola virus, subject to the terms of any authorization issued under 21 U.S.C. $ 360bbb—3(a)." Having concluded that the criteria for issuance of this authorization under section 564(c) ofthe Act (21 U.S.C, §360bbb—3{c)) are met, 1 am authorizing the emergency use of the ReEBOVTYY Antigen Rapid Testias described in the Scope of Authorization section of this letter (section I1)) in individuals with signs and symptoms of Ebola virus infection in confunction with epidemiological risk factors (including geographic locations with high prevalence of Ebola infection) (as described in the Scope of Authorization section of this letter (section II)) for the presumptive detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014). L Criteria for Issuance of Authorization I have concluded that the emergency use ofthe ReEBOVTY Antigen Rapid Test for the presumptive detection of Ebola viruses (detected in the West Africa outbreak in 2014) in the specified population meets the criteria for issuance of an authorization under section 564(c) of the Act, because I have concluded that: 1. The Ebola Zaire virus (detected in the West Africa outbreak in 2014) can cause Ebola virus disease, a serious or life—threatening disease or condition to humans infected with this virus; 2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that the ReEBOV*Y Antigen Rapid Test may be effective in diagnosing Ebola Zaire virus {detected in the West Africa outbreak in 2014) infection, and that the known and potential benefits of the ReEBOVTY Antigen Rapid Test for diagnosing Ebola Zaire virus {detected in the West Africa outbreak in 2014) infection, outweigh the known and potential risks of such product; and 3. There is no adequate, approved, and available alternative to the emergency use ofthe ReEBOV!Y Antigen Rapid Test for diagnosing Ebola Zaire virus {detected in the West Africa outbreak in 2014) infection." ILScope of Authorization I have concluded, pursuant to section §64(d)(1) of the Act, that the scope of this authorization is limited to the use of the authorized ReEBOV*Y Antigen Rapid Test for the presumptive detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) in individuals with signs and symptoms of Ebola virus infection in confunction with epidemiological risk factors *1J.8. Department of Health and Human Services. Declaration Regarding Emergency Use ofIn Vitro Diagnosties for Detection ofEbolg Yirus, 79 Fed, Reg, 47141 (Augast 12, 2014), * ho other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act.

Federal Register/Vol. 80, No. 108 /Friday, June 5, 2015 /Notices 32145 Page 3 — Mr. Simpson, Corgenix Inc. {including geographic locations with high prevalence of Ebola infection}. The authorized ReEBOV*Y Antigen Rapid Test is intended for circumstances when use of a rapid Ebola virus test is determined to be more appropriate than use of an authorized Ebola virus nucleic acid test, which has been demonstrated to be more sensitive in detecting the Ebola Zaire virus. The authorized ReEBOV*Y Antigen Rapid Test is not intended for use for general Ebola infection screening, such as airport screening or contact tracing. The ReEBOYV*Y Antigen Rapid Test is authorized for use in laboratories or facilities adequately equipped, trained, and capable of such testing {including treatment centers and public health clinics). The Authorized ReEBOV‘** Antigen Rapid Test The ReEBOVTY Antigen Rapid Test is a chromatographic dipstick—format lateral flow immunoassay for the in vitro qualitative detection of VP40 protein from the Ebola Zaire virus {detected in the West Africa outbreak in 2014) in fingerstick (capillary) whole blood, venous whole blood, plasma, and other authorized specimen types from individuals with signs and symptoms of Ebola virus infection in conjfunction with epidemiological risk factors (including geographic locations with high prevalence of Ebola infection). The test procedure consists of a dipstick—format lateral flow immunoassay that is initiated by applying the clinical specimen to the dipstick sample pad followed by insertion of the dipstick into a test fube containing sample buffer which initiates flow within the dipstick device. The testis then incubsted for 15—25 minutes before being visually interpreted. The ReEBOVTY Antigen Rapid Test is a point—of—care test. The ReEBOV*Y Antigen Rapid Test consists of a self—contained, disposable dipstick—format lateral flow test that includes an internal process Control Line. Following application of the clinical specimen and insertion into the test tube containing sample buffer, the specimen flows through the reagent pads causing the Ebola Zaire virus antigen, VP40 protein, present in the specimen, to bind nanoparticles labeled with antigen specific antibodies. As the specimen and nanoparticles flow across the device membrane, immobilized Ebola Zaire virus antigen—specific antibody absorbs the nanoparticle immune—complexes at the Test Line. Antigen dependent deposition of the nanoparticle at the Test Line generates a chromogenic signal relative to the antigen titer. The test is incubated for 15—25 minutes to allow full development of the signal. The test result is determined by visual interpretation of the signal in the Test and Control Lines, with a positive sample resulting in development of a faint pink to dark red signal on the Test Line. Oncea clinical specimen is collected and the test is initiated, it takes 15—25 minutes to produce results. The ReEBOVTY Antigen Rapid Test includes the following internal process Control Line: * The Process Control Line, located following the Test Line on the dipstick, is comprised of Ebola Zaire virus antigen and binds excess or unreacted nanoparticles resulting in a visual pink to red line. A visual signal on the Control Line indicates that the test was performed correctly and that the conted nanoparticles are reactive to the Ebola Zaire virus antigen. The above described ReEBOVTY Antigen Rapid Test, when labeled consistently with the labeling authorized by FDA entitled "ReEBOVTY Antigen Rapid Test Instructions for Use"

32146 Federal Register/Vol. 80, No. 108 /Friday, June 5, 2015 /Notices Page 4 — Mr. Simpson, Corgenix Inc. {available at http://wo. fda. gov/MedicalDevices/Safety/EmergencySituations/uem |161496.htm), which may be revised by Corgenix Inc. in consultation with FDA, is authorized to be distributed to laboratories and facilities adequately equipped, trained, and capable of testing for Ebola infection, despite the fact that it does not meet certain requirements otherwise required by federal law. The above described ReEBOVYY Antigen Rapid Test is authorized to be accompanied by the following information pertaining to the emergency use, which is quthorized to be made available to health care professionals and patients: + Fact Sheet for Health Care Providers: Interpreting ReEBOV*Y Antigen Rapid Test Results «+ Fact Sheet for Patients: Understanding Results from the ReEBOYVT* Antigen Rapid Test As described in section IV below, Corgentx Inc. and its authorized distributor(s) are also authorized to make available additional information relating to the emergency use of the authorized ReEBOVTY Antigen Rapid Test that is consistent with, and does not exceed, the terms of this letter of authorization. I have concluded, pursuant to section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of the authorized ReEROVTY Antigen Rapid Test in the specified population, when used for presumptive detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014), outweigh the known and potential risks of such a product. T have concluded, pursuant to section 564(d)(3) of the Act, based on the totality of stientific evidence available to FDA, that it is reasonable to believe that the authorized ReEBOY*Y Antigen Rapid Test may be effective in the diagnosis of Ebola Zaire virus (detected in the West Africa outbreak in 2014) infection pursuant to section 564(c)(2)(A) of the Act. FDA has reviewed the scientific information available to FDA including the information supporting the conclusions described in section I above, and concludes that the authorized ReEBOYVTY Antigen Rapid Test, when used to diagnose Ebola Zaire virus (detected in the West Africa outbreak in 2014) infection in the specified population, meets the criteria set forth in section 564(c) of the Act concerning safety and potential effectiveness. The emergency use of the authorized ReEBOVYY Antigen Rapid Test under this EUA must be consistent with, and may not exceed, the terms of this letter; including the Scope of Authorization (section II) and the Conditions of Authorization (section TV). Subject to the terms of this EUA and under the circumstances set forth in the Secretary of DHS‘s determination described above and the Secretary of HHS‘s corresponding declaration under section 564(b)(1), the ReEBOV!*Y Antigen Rapid Test described above is authorized to diagnose Ebola Zaire virus {detected in the West Africa outbreak in 2014) infection in individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiclogical risk factors {including geographic locations with high prevalence of Ebola infection).

Federal Register/Vol. 80, No. 108 /Friday, June 5, 2015 /Notices 32147 Page 5 —Mr. Simpson, Corgenix Inc. This EUA will cease to be effective when the HHS declaration that circumstances exist to justify the EUA is terminated under section 564(b)(2) of the Act or when the EUA is revoked under section 564(g) of the Act. HL Waiver of Certain Requirements I am waiving the following requirements for the ReEBOVTY Antigen Rapid Test during the duration of this EUA: «_ Current good manufacturing practice requirements, including the quality system requirements under 21 CFR Part 820, with respect to the design, manufacture, packaging, labeling, storage, and distribution of the ReEBOV*Y Antigen Rapid Test. a Labeling requirements for cleared, approved, or investigational devices, including labeling requirements under 21 CFR 809.10 and 21 CFR $09.30, except for the intended use statement (21 CFR 809.10(a)(2), (b)(2)), adequate directions for use (21 U.S.C. 352(f)), (21 CFR 809.10(b)(5), (7), and (8)), any appropriate limitations on the use of the device including information required under 21 CFR 809.10(a)(4), and any available information regarding performance of the device, including requirements under 71 CFR 809.10(b)(12). IV. Conditions of Authorization Pursuant to section 564 of the Act, I am establishing the following conditions on this authorization: Corgenix Inc. and its Authorized Distributor(s) A. Corgenix Inc. and its authorized distributor(s) will distribute the authorized ReEROYVTN Antigen Rapid Test with the authorized labeling, as may be revised only by Corgenix Inc. in consultation with FDA, to laboratories and facilities adequately equipped, trained, and capable of testing for Ebola infection (including treatment centers and public health clinics). B. Corgenix Inc. and its authorized distributor(s) will provide to laboratories and facilities (including treatment centers and public health clinies) adequately equipped, trained, and capable of testing for Ebola infection the authorized ReFEBOVTY! Antigen Rapid Test Fact Sheet for Health Care Providers and the authorized ReEBBOVTY Antigen Rapid Test Fact Sheet for Patients. C. Corgenix Inc. and its authorized distributor(s) will make available on their websites the ReEBOV*Y Antigen Rapid Test Fact Sheet for Health Care Providers and the authorized ReEBOVYY Antigen Rapid Test Fact Sheet for Patients. D. Corgenix Inc. and its avthorized distributor(s) will inform laboratories, facilities adequately equipped, trained, and capable of testing for Ebola infection (including

32148 Federal Register/Vol. 80, No. 108 /Friday, June 5, 2015 /Notices Page 6 —Mr. Simpson, Corgenix Inc. treatment centers and public health clinics), and relevant public health authority(ies) of this EUA, including the terms and conditions herein. Corgenix Inc. and its authorized distributor(s) will ensure that laboratortes and facilities adequately equipped, trained, and capable of testing for Ebola infection (including treatment centers and public health clinics) using the authorized ReEBOV!Y Antigen Rapid Test have a process in place for reporting test results to health care professionals and relevant public health authorities, as appropriate. Through a process of inventory control, Corgenix Inc. and its authorized distributor(s} will maintain records of device usage. . Corgenix Inc. and its authorized distributor(s) will collect information on the performance of the assay, and report to FDA any suspected occurrence offalse positive or false negative results of which Corgenix Inc. and its authorized distributor(s} becomes aware. . Corgenix Inc. and its authorized distributor(s) are authorized to make available additional information relating to the emergency use ofthe authorized ReEBOV‘Y Antigen Rapid Test that is consistent with, and does not exceed, the terms of this letter of authorization. Corgenix Inc. L. Corgenix Inc will notify FDA of any authorized distributor(s) of the ReEROV!YM Antigen Rapid Test, including the name, address, and phone number of any authorized distributor(s). Corgenix Inc. will provide its authorized distributor(s) with a copy of this EUA, and communicate to its authorized distributor(s) any subsequent amendments that might be made to this EUA and its authorized accompanying materials (e.g., fact sheets, instructions for use). . Corgenix Inc. only may request changes to the authorized ReEBOV*Y Antigen Rapid Test Fact Sheet for Health Care Providers or the authorized ReEBOVTY Antigen Rapid Test Fact Sheet for Patients. Such requests will be made only by Corgenix Inc. in consultation with FDA. Corgenix Inc. may request the addition of other specimen types for use with the authorized ReEBOVTY Antigen Rapid Test, Such requests will be made by Corgenix Inc. in consultation with, and require concurrence of, FDA. M. Corgentx Inc. will track adverse events and report to FDA under 21 CFR Part 803. Laboratories and Facilities Adequately Equipped, Trained, and Capable of Testing for Ebola Infection

Federal Register/Vol. 80, No. 108 /Friday, June 5, 2015 /Notices 32149 Page 7 =—Mr. Simpson, Corgenix Inc. N. Laboratories and facilities adequately equipped, trained, and capable of testing for Ebola infection (including treatment centers and public health clinics) will include with reports of the results of the ReEBOVTY Antigen Rapid Test the authorized Fact Sheet for Health Care Providers and the authorized Fact Sheet for Patients, Under exigent cireumstances, other appropriate methods for disseminating these Fact Sheets may be used, which may include mass media. ©. Laboratories and facilities adequately equipped, trained, and capable of testing for Ebola infection (including treatment centers and public health clinics) will have a process in place for reporting test results to health care professionals and relevant public health avuthorities, as appropriate. P. Laboratories and facilities adequately equipped, trained, and capable of testing for Ebola infection {including treatment centers and public health clinics) will collect information on the performance of the assay, and report to Corgentx Inc..and its authorized distributor(s) any suspected occurrence of false positive or false negative results of which they become aware. (}. All laboratory personnel and personnel from facilities adequately equipped, trained, and capable oftesting for Ebola infection (including treatment centers and public health clinics) using the assay will be appropriately trained on the ReEBOYVYY Antigen Rapid Test and use appropriate laboratory and personal protective equipment when handling this kit. Corgenix Inc., its Authorized Distributors(s), and Laboratories and Facilities Adequately Equipped, Trained, and Capable of Testing for Ebola Infection R. Corgenix Inc., its authorized distributor(s}, and laboratories and facilities adequately equipped, trained, and capable of testing for Ebola infection (including treatment centers and public health clinics) will ensure that any records associated with this EUA are maintained until notified by FDA. Such records will be made available to FDA for inspection upon request. Conditions Related to Advertising and Promotion 8. All advertising and promotional descriptive printed maiter relating to the use of the authorized ReEBOVTY Antigen Rapid Test shall be consistent with the Fact Sheets and authorized labeling, as well as the terms set forth in this EUA and the applicable requirements set forth in the Act and FDA regulations. T. All advertising and promotional deseriptive printed matter relating to the use of the authorized ReEBOVTY Antigen Rapid Test shall clearly and conspicuously state that: « This test has not been FDA cleared or approved;

32150 Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Notices The Authorization for the Cepheid authorized versions of the fact sheets for its issuance, as required by section Xpert® Ebola Assay issued on March 23, and other written materials) follows and 564(h)(1) of the FD&C Act: 2015, in its entirety (not including the provides an explanation of the reasons asabaliauskas on DSK5VPTVN1PROD with NOTICES EN05JN15.007</GPH> VerDate Sep<11>2014 18:31 Jun 04, 2015 Jkt 235001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 E:\FR\FM\05JNN1.SGM 05JNN1

Federal Register/Vol. 80, No. 108 /Friday, June 5, 2015 /Notices 32151 L609 e %, & —(!fi DEPARTMENT OF HEALTH & HUMAN SERVICES 4 80%, *n Shae Food and Drug Administration March 23, 2015 Silver Spring, MD 20993 James F. Kelly, Ph.D. Executive Director, Regulatory Affairs Cepheid 904 Caribbean Drive Sunnyvale, CA 94089 Dear Dr. Kelly: This letter is in response to your request that the Food and Drug Admzms&ratmn (FDA) issue an Emergency Use Authorization (EUA) for emergency use of the Xpert® Ebola Assay for the presumptive detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) on the CGeneXpert Instrument Systems in EDTA venous whole blood specimens from individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiclogical risk factors, by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderam complexity tests and by Iaboratories certified under CLIA to perform high complexxty tests," or in similarlyy qualified non—U.S. labommnee,by clinical laboratory personnel who have received specific training on the use of the Xput Ebola Assay on GeneXpert Instrument Systems, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.KC. §360bbb—3). On September 22, 2006, then—Secretary of the Department of Homeland Security (DHS), Michael Chertoff, determined, pursuant to section 319F—2 of the Public Health Service (PHS) Act(42 U.S.C. § 2470—6b), that the Ebola virus presents a material threat against the United States population sufficient to affect national security.* Pursuant to section 564(b)(1) of the Act (21 USXC,. § 360bbb—3(b)(1)), and on the basis of such determination, the Secretary of the Department of Health and Human Services (HHS) declared on August 5, 2014, that circumstances existjustifying the authorization of emergency use of in vitro diagnosties for detection of ]jboia virus, subject to the terms of any authorization issued under 21 U.S.C. $ 360bbb—3(a)." Having concluded that the criteria for issuance ofthis authorization under section 564(c)of the Act (21 U.S.C. § 360bbb—3(c)) are met, I am authorizing the emergency use of the }{pert Ebola Assay (as described in the Scope of Authorization section ofthis lefter (section f)) in individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiofogical risk ‘ For ease of reference, this letter will refer to these two types of Iaboratories together as "CLIA Moderate and High Complexity Laboratories," * Pursuant to section 564(b)(1) of the Act (21 U.S.C. § 360bbb—3(b)(1Y), the HHS Secretary‘s dectaration that supports EUA issuance must be based on one of four determinations, including the identification by the DHS Secretary of a material threat pursuant to section 3 19F—2 of the PHS Act sufficient to affect national security or the health and security of United States citizens living abroad (section 564(b)(1)(D) of the Act). * 1J.8. Department of Health and Human Services. Declaration Regarding Emergency Use ofIn Vitro Dlagnosties Jor Detection ofEbola Virus, 79 Fed, Reg, 47141 (August 12, 2014)

32152 Federal Register/Vol. 80, No. 108 /Friday, June 5, 2015 /Notices Page 2— Dr. James F. Kelly, Cepheid factors (as described in the Scope of Authorization section of this letter {section (1)) for the presumptive detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014), 1. Criteria for Issuance of Authorization T have concluded that the emergency use of the Xpert® Ebola Assay for the presumptive detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) in the specified population meets the criteria for issuance of an authorization under section 564(c) of the Act, because I have concluded that: 1. ‘The Ebola Zaire virus (detected in the West Affica outbreak in 2014) can cause Ebola virus disease, a serious or life—threatening disease or condition to humans infected with this virus; 2. Based on the totamy of scientific evidence available to FDA, it is reasonable to believe that the Xpert® Ebola Assay may be effective in diagnosing Ebola Zaire virus (detected in the West Africa outbreak in 2014) infection, and that the known and potential benefits of the Xpert® Ebola Assay for diagnosing Ebola Zaire virus (detected in the West Africa outbreak in 2014) infection, outweigh the known and potential risks of such product; and 3. Thereis no adequate, approved, and available alternative to the emergency use of the Xpert® Ebola Assay for d;afi,nnsmg Ebola Zaire virus (detected in the West Africa outbreak in 2014) infection.* IL Scope of Authorization 1 have concluded, pursuant to section 564((1)(1) of the Act, that the seope ofthis authorization is limited to the use of the authorized Xpert® Ebola Assay in CLIA Moderate and High Complexity Laboratories or in similarly qualified non—U.S. laboratories for the presumptive detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) in individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors. The Authorized Xpert® Ebola Assay The Xpert® Ebola Assay is an automated test intended for the in vitro qualitative detection of Ebola Zaire virus RNA from EDTA venous whole blood specimens. The assay is performed on the Cepheid GeneXpert Instrument Systems. GeneXpert Instrument Systems automate and integrate sample preparation, nucleic acid extraction, amplification, and detection of the target sequence in simple or complex samples using real—time reverse transcriptase PCR {rRT-PCR} The systems consist of an instrument, personal computer, and preloaded software for running tests and viewing the results. The test is run in single—use disposable GeneXpert cartridges that hold the sample extraction and rRT—PCR reagents and run the sample preparation and rRT—PCR processes. Because the cartridges are self—contained, cross—contamination between samples is minimized. End users collect the sample, transferit to a sample transport tube containing a *No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act.

Federal Register/Vol. 80, No. 108 /Friday, June 5, 2015 /Notices 32153 Page 3 — Dr. James F. Kelly, Cepheid buffer that inactivates virus, and transfer the inactivated virus sample to the cartridge. All subsequent steps of sample extraction, amplification, and detection are fully automated. Each Xpert® Ebola Assay includes a Sample Adequacy Control (SAC), Sample Processing Control (SPC), and Probe Check Control (PCC)Y: « Sample Adequacy Control (SAC): Ensures that the sample was correctly added to the cartridge. The SAC verifies that the correct volume of sample has been added in the sample chamber. The SAC passes ifit meets the validated acceptance criteria. e Sample Processing Lontml {(SPC): Ensures the sample was correctly processed. The SPC is an Armored RNA® in the form ofa dry bead that is included in each cartridge to verify adequate processing of the sample virus. The SPC verifies that lysis of Ebola has occurred if the organism is present and verifies that the specimen processing is adequate, Additionally this control detects specimen—associated inhibition of the RT—PCR reaction. The SPC should be positive in a negative sample and can be negative or positive in a positive sample. The SPC passes if it meets the validated acceptance criteria. The SPC is also referred to as the Cepheid Internal Control {CIC). * Probe Check Control (PCC): Refore the start of the PCR reaction, the GeneXpert Instrument System measures the fluorescence signal from the probes to monitor bead rehydration, reaction tube filling, probe integrity, and dye stability. There are two probe check controls. The first PCC occurs after sample processing but before the start of the RT—PCR reaction and the second PCC occurs before the PCR reaction starts. The PCCs pass if they meet the validated acceptance criteria. The above described Xpert® Ebola Assay, when labeled consistently with the labeling authorized by FDA entitled "Xpert® Ebola Assay Instructions for Use" (available at hittp://ww.fda.gov/MedicalDevices/Safety/EmergencySituations/uem 161496.htm), which may be revised by Cepheid in consultation with FDA, is authorized to be distributed to and used by CLIA Moderate and High Complexity Laboratories and similarly qualified non—U.S. laboratories, despite the fact that it does not meet certain requirements otherwise required by federal law. The above described Xpert® Ebola Assay is authorized to be accompanied by the following information pertaining to the emergency use, which is authorized to be made available to health care professionals and patients: * Fact Sheet for Health Care Providers: Interpreting Xpert® Ebola Assay Results » Fact Sheet for Patients: Understanding Results from the Cepheid" Xpert® Ebola Assay As described in section IV below, Cepheld and any authorized distributor(s) are also smthcmzed to make available additional information relating to the energency use of the authorized Xpert Ebola Assay that is consistent with, and does not exceed, the terms of this letter of authorization,

32154 Federal Register/Vol. 80, No. 108 /Friday, June 5, 2015 /Notices Page 4 —Dr. James F. Kelly, Cepheid 1 have concluded, pursuant to section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of the authorized Xpert® Ebola Assay in the specified population, when used for presumptive detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014), outweigh the known and potential risks of such a product. I have concluded, pursuant to section 564{(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that the authorized Xpert® Ebola Assay may be effective in the diagnosis of Ebola Zaire virus (detected in the West Africa outbreak in 2014) infection pursuant to section 564(c)(2)}(A) of the Act, FDA has reviewed the scientific information available to FDA including the information su;gartmg the conclusions described in section I above, and concludes that the authorized Xpert® Ebola Assay, when used to diagnose Ebola Zaire virus {detected in the West Africa outbreak in 2014) infection in the specified population, meets the criteria set forth in section 564(c) of the Act concerning safety and potential effectiveness. The emergency use of the authorized Xpert® Ebola Assay under this EUA must be consistent with, and may not exceed, the terms of this letter, including the Scope of Authorization (section IF) and the Conditions of Authorization (section IV), Subject to the terms ofthis EUA and under the circurnstances set forth in the Secretary of DHS‘s determination described above and the Secretary of HHS‘s corresponding declaration under section 564(b)(1), the Xpert® Ebola Assay described above is authorized to diagnose Ebola Zaire virus (detected in the West Africa outbreak in 2014) infection in individuals with signs and symptoms of Ebola virus infection in confjfunction with epidemiological risk factors. This EUA will cease to be effective when the HHS declaration that cireumstances exist to justify the EUA is terminated under section 564(b)(2) of the Act or when the EUA is revoked under section 564(g) of the Act. I{L Waiver of Certain Requirements I am waiving the following requirements for the Xpert® Ebola Assay during the duration ofthis EUA: s Current good manufacturing practice requirements, including the quality system requirements under 21 CFR part 820 with respect to the design, manufacture, packaging, labeling, storage, and distribution of the Xpert® Ebola Assay. » Labeling requirements for cleared, approved, or investigational devices, including labeling requirements under 21 CFR 809.10 and 21 CFR 809.30, except for the intended use statement (21 CFR 809.10(a)(2), (b)(2)), adequate directions for use (21 U.S.C. 352(f)), (21 CFR §09.10(b)(5), (7), and (8)), any appropriate limitations on the use of the device including information required under 21 CFR 809.10(a)}(4), and any available information regarding performance of the device, including requirements under 21 CFR 809.10(b)(12). IV, Conditions of Authorization

Federal Register/Vol. 80, No. 108 /Friday, June 5, 2015 /Notices 32155 Page 5 —Dr. James F. Kelly, Cepheid Pursuant to section 564 of the Act, I am establishing the following conditions on this authorization: Cepheid and Any Authorized Distributor(s) A. Cepheid and any authorized distributor(s) will distribute the authorized Xpert® Ebola Assay with the authorized labeling, as may be—revised only by Cepheid in consultation with FDA, to CLIA Moderate and High Complexity Laboratories or similarly qualified non—U.S. laboratories. B. Cepheid and any authorized distributor(s) will provide to CLIA Moderate and High Complexity Laboratories or similarly qualified non—U.S. laboratories the authorized Xpert® Ebola Assay Fact Sheet for Health Care Providers and the authorized Xpert® Ebola Assay Fact Sheet for Patients, C. Cepheid and any authorized distributor(s} will make available on their websites the Xpert® Ebola Assay Fact Sheet for Health Care Providers and the authorized Xpert® Ebola Assay Fact Sheet for Patients. D. Cepheid and any authorized distributor(s) will inform CLIA Moderate and High Complexity Laboratories or similarly qualified non—U.S. laboratories and relevant public health authority(ies) of this EUA, including the terms and conditions herein. E. Cepheid and any authorized distributor(s) will ensure that CLIA Moderate and High Complexity Laboratories or similarly qualified non—U.S. laboratories using the authorized Xpert® Ebola Assay have a process in place for reporting test results to health care professionals and relevant public health authorities, as appropriate. F. Through a process of inventory control, Cepheid and any authorized distributor(s} will maintain records of device usage. G. Cepheid and any authorized distributor(§) will collect information on the performance of the assay, and report to FDA any suspected occurrence of false positive or false negative results of which Cepheid and any authorized distributor(s} become aware, H. Cepheid and any authorized distributor(s) are authorized to make available additional information relating to the emergency use of the authorized Xpert® Ebola Assay that is consistent with, and does not exceed, the terms of this letter of authorization. Cepheid L Cepheld will notify FDA of any authorized distributor(s) of the Xpert® Rbola Assay, including the name, address, and phone number of any authorized distributor(s). J. Cepheid will provide any authorized distributor(s) with a copy of this EUA, and communicate to any authorized distributor(s) any subsequent amendments that might be made to this EUA and its authorized accompanying materials (e.g., fact sheets, instructions for use).

32156 Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Notices 6 Dr. James F. K. request Care or the authorized Such requests will be made L. the addition of other spe:cmum Such will be made FDA and report FDA under21 CFR CLIA Moderate and Laboratories CLIA Moderate and laboratories will authorized Patients. Under these Fact Sheets may be 0. P. CLIA Moderate and laboratories will collect inf:r.rn-,,.t;,,, or apJ>rOJlriately trained on the use of the Sv<ztPcnM and use apJ>fOJ>riate la1botato.ry hartdli11g this kit. Jli:qtriihutor·s. and CLIA Moderate and .... ,.... t .....; .... or,., .. ,.. .,,,.,. Ou:alillied Non-U.S. Laboratories R. and CLIA Moderate and Laboratories or non-U.S.laboratories will ensure any records associated with this EUA are maintained until notified FDA. Such records made available to FDA for upon request. asabaliauskas on DSK5VPTVN1PROD with NOTICES EN05JN15.013</GPH> VerDate Sep<11>2014 18:31 Jun 04, 2015 Jkt 235001 PO 00000 Frm 00075 Fmt 4703 Sfmt 4725 E:\FR\FM\05JNN1.SGM 05JNN1

Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Notices 32157 Dated: May 29, 2015. DEPARTMENT OF HEALTH AND information has been submitted to the Leslie Kux, HUMAN SERVICES Office of Management and Budget Associate Commissioner for Policy. (OMB) for review and clearance under Food and Drug Administration the Paperwork Reduction Act of 1995 [FR Doc. 2015–13699 Filed 6–4–15; 8:45 am] BILLING CODE 4164–01–C [Docket No. FDA–2013–D–0286] (the PRA). DATES: Fax written comments on the Agency Information Collection collection of information by July 6, Activities; Submission for Office of 2015. Management and Budget Review; Comment Request; Guidance for ADDRESSES: To ensure that comments on Industry on Formal Meetings Between the information collection are received, the Food and Drug Administration and OMB recommends that written Biosimilar Biological Product comments be faxed to the Office of asabaliauskas on DSK5VPTVN1PROD with NOTICES Sponsors or Applicants Information and Regulatory Affairs, AGENCY: Food and Drug Administration, OMB, Attn: FDA Desk Officer, FAX: HHS. 202–395–7285, or emailed to oira_ ACTION: Notice. submission@omb.eop.gov. All comments should be identified with the SUMMARY: The Food and Drug title. Also include the FDA docket Administration (FDA) is announcing number found in brackets in the that a proposed collection of heading of this document. EN05JN15.014</GPH> VerDate Sep<11>2014 18:31 Jun 04, 2015 Jkt 235001 PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 E:\FR\FM\05JNN1.SGM 05JNN1


Document Created: 2015-12-15 15:20:34
Document Modified: 2015-12-15 15:20:34
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesThe Authorization for the Corgenix ReEBOV<SUP>TM</SUP> 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.
ContactCarmen 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 Citation80 FR 32140 
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