Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Ebola Zaire Virus; Availability, 44616-44626 [2016-16176]

Download as PDF 44616 Federal Register / Vol. 81, No. 131 / Friday, July 8, 2016 / Notices V. Other Issues for Consideration it satisfies the requirements of the applicable statutes and regulations. III. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the Internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm, and for Center for Biologics Evaluation and Research guidance documents is available at https://www.fda.gov/ BiologicsBloodVaccines/ GuidanceCompliance RegulatoryInformation/Guidances/ default.htm. Guidance documents are also available at https:// www.regulations.gov. Persons unable to download an electronic copy of ‘‘Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases’’ may send an email request to CDRHGuidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 16009 to identify the guidance you are requesting. asabaliauskas on DSK3SPTVN1PROD with NOTICES IV. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in 21 CFR part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910–0120; the collections of information in 21 CFR part 801 and 21 CFR 809.10, regarding labeling, have been approved under OMB control number 0910–0485; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910–0231; the collections of information in 21 CFR part 820, regarding the quality system regulation, have been approved under OMB control number 0910–0073; and the collections of information in the guidance document ‘‘Requests for Feedback on Medical Device Submissions: The PreSubmission Program and Meetings with Food and Drug Administration Staff’’ have been approved under OMB control number 0910–0756. VerDate Sep<11>2014 17:00 Jul 07, 2016 Jkt 238001 The Agency invites comments on the draft guidance document entitled ‘‘Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases,’’ in general, and on the following questions, in particular: 1. Does the draft guidance content adequately address the analytical performance of targeted and whole exome human DNA sequencing (WES) NGS-based tests intended to aid in the diagnosis of individuals with suspected germline diseases or other conditions (referred to as ‘‘NGS-based tests for germline diseases’’ or ‘‘NGS-based tests’’ in the guidance)? For example, do the recommendations outlined in the draft guidance adequately address the analytical performance of NGS-based tests used as an aid in diagnosis of patients with signs and symptoms of developmental delay or intellectual disability, undiagnosed diseases, or hereditary cancer syndromes? If not, what additional test design, development, or validation activities are necessary for analytical validation of such tests? Are there specific indications within this broad intended use that require different or additional test design, development, or validation activities from those described in the draft guidance? 2. Do the recommendations in the draft guidance adequately address the analytical validation of NGS-based tests that use targeted panels or WES? Targeted sequencing panels? Are there differences between the use of targeted panels and WES that were not adequately distinguished in the recommendations described in the draft guidance? 3. The recommendations in this document focus on WES and targeted NGS-based tests for germline diseases. Are the recommendations outlined in the guidance sufficient to address analytical validation for whole genome sequencing (WGS) NGS-based tests for germline diseases? If not, what additional test design, development, and validation activities are needed to address the analytical validation of such tests? 4. Accuracy is generally described using an agreement, typically positive and negative percent agreement (PPA and NPA), between a new test and an accepted reference method. For NGSbased tests, positive predictive value (PPV) may be a more meaningful metric than NPA when calculating the likelihood that a variant call detected by the test is a true positive. If PPV is PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 calculated using only analytical results without taking into account prevalence in a population, it is sometimes called ‘‘technical’’ PPV (TPPV) to distinguish it from prevalence-based PPV. What are the benefits and weaknesses to assessing NGS-based test accuracy using TPPV in addition to PPA and NPA, or instead of NPA? 5. Are the minimum performance thresholds presented in this draft guidance appropriate, or are alternative thresholds more appropriate? Are there ‘‘best ways’’ to determine acceptable thresholds for each metric? Are there performance metrics that do not require minimum thresholds? Are there test scenarios where minimum thresholds are not useful or relevant? 6. How can bias and over-fitting be minimized or accounted for if known ‘‘reference’’ samples are used as comparators in accuracy studies? Dated: July 5, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–16201 Filed 7–7–16; 8:45 am] BILLING CODE 4164–01–P 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. 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 Biocartis NV. 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 SUMMARY: E:\FR\FM\08JYN1.SGM 08JYN1 Federal Register / Vol. 81, No. 131 / Friday, July 8, 2016 / Notices asabaliauskas on DSK3SPTVN1PROD with NOTICES 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 May 26, 2016. 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, 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 AllHazards 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 VerDate Sep<11>2014 17:00 Jul 07, 2016 Jkt 238001 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 (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 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. PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 44617 referred to in a declaration of emergency or threat can cause a serious or lifethreatening 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 lifethreatening 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. 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, thenSecretary 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 diagnostic devices for detection of Ebola virus, subject to the terms of any authorization issued under section 564 of the FD&C Act. Notice of the declaration of the Secretary was published in the Federal Register on 2 Under section 564(b)(1) of the FD&C Act, the HHS Secretary’s declaration that supports the EUA issuance must be based on one of four determinations, including the identification by the DHS Secretary of a material threat under section 319F–2 of the PHS Act sufficient to affect national security or the health and security of U.S. citizens living abroad (section 564(b)(1)(D) of the FD&C Act. E:\FR\FM\08JYN1.SGM 08JYN1 44618 Federal Register / Vol. 81, No. 131 / Friday, July 8, 2016 / Notices August 12, 2014 (79 FR 47141). On May 2, 2016, Biocartis NV submitted a complete request for, and on May 26, 2016, FDA issued, an EUA for the IdyllaTM Ebola Virus Triage Test, subject to the terms of the Authorization. III. Electronic Access asabaliauskas on DSK3SPTVN1PROD with NOTICES An electronic version of this document and the full text of the VerDate Sep<11>2014 17:00 Jul 07, 2016 Jkt 238001 Authorization are available on the Internet at https://www.regulations.gov. IV. The Authorization Having concluded that the criteria for issuance of the Authorization under section 564(c) of the FD&C Act are met, FDA has authorized the emergency use of an in vitro diagnostic device for detection of Ebola Zaire virus (detected PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 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 E:\FR\FM\08JYN1.SGM 08JYN1 Federal Register / Vol. 81, No. 131 / Friday, July 8, 2016 / Notices 44619 VerDate Sep<11>2014 17:00 Jul 07, 2016 Jkt 238001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4725 E:\FR\FM\08JYN1.SGM 08JYN1 EN08JY16.000</GPH> asabaliauskas on DSK3SPTVN1PROD with NOTICES Dear Dr. 44620 Federal Register / Vol. 81, No. 131 / Friday, July 8, 2016 / Notices I. Criteria for Issuance of Authorization VerDate Sep<11>2014 of Authorization 17:00 Jul 07, 2016 Jkt 238001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4725 E:\FR\FM\08JYN1.SGM 08JYN1 EN08JY16.001</GPH> asabaliauskas on DSK3SPTVN1PROD with NOTICES II. Federal Register / Vol. 81, No. 131 / Friday, July 8, 2016 / Notices 44621 Test VerDate Sep<11>2014 17:00 Jul 07, 2016 Jkt 238001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4725 E:\FR\FM\08JYN1.SGM 08JYN1 EN08JY16.002</GPH> asabaliauskas on DSK3SPTVN1PROD with NOTICES .. 44622 Federal Register / Vol. 81, No. 131 / Friday, July 8, 2016 / Notices VerDate Sep<11>2014 17:00 Jul 07, 2016 Jkt 238001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4725 E:\FR\FM\08JYN1.SGM 08JYN1 EN08JY16.003</GPH> asabaliauskas on DSK3SPTVN1PROD with NOTICES "' Federal Register / Vol. 81, No. 131 / Friday, July 8, 2016 / Notices 44623 III. WaiYcr of Certain lam the the IV. Conditions of Authorization Biocartis NV and A. VerDate Sep<11>2014 17:00 Jul 07, 2016 Jkt 238001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4725 E:\FR\FM\08JYN1.SGM 08JYN1 EN08JY16.004</GPH> asabaliauskas on DSK3SPTVN1PROD with NOTICES B. 44624 Federal Register / Vol. 81, No. 131 / Friday, July 8, 2016 / Notices H. Biocartis VerDate Sep<11>2014 17:00 Jul 07, 2016 Jkt 238001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4725 E:\FR\FM\08JYN1.SGM 08JYN1 EN08JY16.005</GPH> asabaliauskas on DSK3SPTVN1PROD with NOTICES I. Federal Register / Vol. 81, No. 131 / Friday, July 8, 2016 / Notices 44625 Authorized Laboratories P. VerDate Sep<11>2014 17:00 Jul 07, 2016 Jkt 238001 Authorized Distributors and Authorized Laboratories PO 00000 Frm 00046 Fmt 4703 Sfmt 4725 E:\FR\FM\08JYN1.SGM 08JYN1 EN08JY16.006</GPH> asabaliauskas on DSK3SPTVN1PROD with NOTICES Biocartis 44626 Federal Register / Vol. 81, No. 131 / Friday, July 8, 2016 / Notices • • " and • V. Uuration of Authorization Dated: July 1, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–16176 Filed 7–7–16; 8:45 am] BILLING CODE 4164–01–C VerDate Sep<11>2014 17:00 Jul 07, 2016 Jkt 238001 PO 00000 Frm 00047 Fmt 4703 Sfmt 9990 E:\FR\FM\08JYN1.SGM 08JYN1 EN08JY16.007</GPH> asabaliauskas on DSK3SPTVN1PROD with NOTICES authorization

Agencies

[Federal Register Volume 81, Number 131 (Friday, July 8, 2016)]
[Notices]
[Pages 44616-44626]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-16176]


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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.

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

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 Biocartis NV. 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

[[Page 44617]]

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 May 26, 2016.

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, 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 
(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.
---------------------------------------------------------------------------

    \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 
diagnostic devices for detection of Ebola virus, subject to the terms 
of any authorization issued under section 564 of the FD&C Act. Notice 
of the declaration of the Secretary was published in the Federal 
Register on

[[Page 44618]]

August 12, 2014 (79 FR 47141). On May 2, 2016, Biocartis NV submitted a 
complete request for, and on May 26, 2016, FDA issued, an EUA for the 
Idylla^TM Ebola Virus Triage Test, subject to the terms of 
the Authorization.
---------------------------------------------------------------------------

    \2\ Under section 564(b)(1) of the FD&C Act, the HHS Secretary's 
declaration that supports the EUA issuance must be based on one of 
four determinations, including the identification by the DHS 
Secretary of a material threat under section 319F-2 of the PHS Act 
sufficient to affect national security or the health and security of 
U.S. citizens living abroad (section 564(b)(1)(D) of the FD&C Act.
---------------------------------------------------------------------------

III. Electronic Access

    An electronic version of this document and the full text of the 
Authorization are available on the Internet at https://www.regulations.gov.

IV. The Authorization

    Having concluded that the criteria for issuance of the 
Authorization under section 564(c) of the FD&C Act are met, FDA has 
authorized the emergency use of an in vitro diagnostic device for 
detection of Ebola 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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[GRAPHIC] [TIFF OMITTED] TN08JY16.007


    Dated: July 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-16176 Filed 7-7-16; 8:45 am]
 BILLING CODE 4164-01-C

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