81_FR_23787 81 FR 23709 - Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Ebola Zaire Virus; Availability

81 FR 23709 - Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Ebola Zaire Virus; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 78 (April 22, 2016)

Page Range23709-23720
FR Document2016-09369

The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an in vitro diagnostic device for detection of the Ebola Zaire virus in response to the Ebola virus outbreak in West Africa. FDA issued this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by OraSure Technologies, Inc. The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the September 22, 2006, determination by then-Secretary of the Department of Homeland Security (DHS), Michael Chertoff, that the Ebola virus presents a material threat against the U.S. population sufficient to affect national security. On the basis of such determination, the Secretary of Health and Human Services (HHS) declared on August 5, 2014, that circumstances exist justifying the authorization of emergency use of in vitro diagnostic devices for detection of Ebola virus, subject to the terms of any authorization issued under the FD&C Act. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.

Federal Register, Volume 81 Issue 78 (Friday, April 22, 2016) 
[Federal Register Volume 81, Number 78 (Friday, April 22, 2016)]
[Notices]
[Pages 23709-23720]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-09369]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
issuance of an Emergency Use Authorization (EUA) (the Authorization) 
for an in vitro diagnostic device for detection of the Ebola Zaire 
virus in response to the Ebola virus outbreak in West Africa. FDA 
issued this Authorization under the Federal Food, Drug, and Cosmetic 
Act (the FD&C Act), as requested by OraSure Technologies, Inc. The 
Authorization contains, among other things, conditions on the emergency 
use of the authorized in vitro diagnostic device. The Authorization 
follows the September 22, 2006, determination by then-Secretary of the 
Department of Homeland Security (DHS), Michael Chertoff, that the Ebola 
virus presents a material threat against the U.S. population sufficient 
to affect national security. On the basis of such determination, the 
Secretary of Health and Human Services (HHS) declared on August 5, 
2014, that circumstances exist justifying the authorization of 
emergency use of in vitro diagnostic devices for detection of Ebola 
virus, subject to the terms of any authorization issued under the FD&C 
Act. The Authorization, which includes an explanation of the reasons 
for issuance, is reprinted in this document.

DATES: The Authorization is effective as of March 4, 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

[[Page 23710]]

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 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 
August 12, 2014 (79 FR 47141). On February 29, 2016, OraSure 
Technologies, Inc. submitted a complete request for, and on March 4, 
2016, FDA issued, an EUA for the OraQuick[supreg] Ebola Rapid Antigen 
Test, subject to the terms of the Authorization.
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    \2\ Under section 564(b)(1) of the FD&C Act, the HHS Secretary's 
declaration that supports the EUA issuance must be based on one of 
four determinations, including the identification by the DHS 
Secretary of a material threat under section 319F-2 of the PHS Act 
sufficient to affect national security or the health and security of 
U.S. citizens living abroad (section 564(b)(1)(D) of the FD&C Act).
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III. Electronic Access

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

IV. The Authorization

    Having concluded that the criteria for issuance of the 
Authorization under section 564(c) of the FD&C Act are met, FDA has 
authorized the emergency use of an in vitro diagnostic device for 
detection of 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:
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    Dated: April 18, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-09369 Filed 4-21-16; 8:45 am]
 BILLING CODE 4164-01-C

Federal Register / Vol. 81, No. 78 / Friday, April 22, 2016 / Notices 23709 documents relating to the regulation of diagnostic device. The Authorization Section 564(b)(1) of the FD&C Act HCT/Ps. FDA will provide a summary of follows the September 22, 2006, provides that, before an EUA may be the workshop at the part 15 public determination by then-Secretary of the issued, the Secretary of HHS must hearing. Department of Homeland Security declare that circumstances exist Registration: Persons (including FDA (DHS), Michael Chertoff, that the Ebola justifying the authorization based on employees) seeking to view the public virus presents a material threat against one of the following grounds: (1) A workshop via Adobe Connect or who the U.S. population sufficient to affect determination by the Secretary of wish to attend in person must register national security. On the basis of such Homeland Security that there is a at http://www.eventbrite.com/o/food- determination, the Secretary of Health domestic emergency, or a significant amp-drug-administration-fda- and Human Services (HHS) declared on potential for a domestic emergency, 6730245227 on or before August 1, August 5, 2014, that circumstances exist involving a heightened risk of attack 2016, and provide complete contact justifying the authorization of with a biological, chemical, radiological, information, including name, title, emergency use of in vitro diagnostic or nuclear agent or agents; (2) a affiliation, email, and phone number. devices for detection of Ebola virus, determination by the Secretary of There is no registration fee for the subject to the terms of any authorization Defense that there is a military public workshop. Early registration is issued under the FD&C Act. The emergency, or a significant potential for recommended because seating is limited Authorization, which includes an a military emergency, involving a and is on a first-come, first-served basis. explanation of the reasons for issuance, heightened risk to U.S. military forces of There will be no onsite registration. is reprinted in this document. attack with a biological, chemical, If you need special accommodations DATES: The Authorization is effective as radiological, or nuclear agent or agents; due to a disability and/or have of March 4, 2016. (3) a determination by the Secretary of registration questions, please contact ADDRESSES: Submit written requests for HHS that there is a public health Tasha Johnson or Pauline Cottrell at single copies of the EUA to the Office emergency, or a significant potential for CBERPublicEvents@fda.hhs.gov (Subject of Counterterrorism and Emerging a public health emergency, that affects, line: FDA SEDHC workshop). Threats, Food and Drug Administration, or has a significant potential to affect, Transcripts: Please be advised that as 10903 New Hampshire Ave., Bldg. 1, national security or the health and soon as possible after a transcript of the Rm. 4338, Silver Spring, MD 20993– security of U.S. citizens living abroad, public workshop is available, it will be 0002. Send one self-addressed adhesive and that involves a biological, chemical, accessible at: http://www.fda.gov/ label to assist that office in processing radiological, or nuclear agent or agents, BiologicsBloodVaccines/NewsEvents/ your request or include a fax number to or a disease or condition that may be WorkshopsMeetingsConferences/ which the Authorization may be sent. attributable to such agent or agents; or ucm492499.htm. See the SUPPLEMENTARY INFORMATION (4) the identification of a material threat Dated: April 19, 2016. section for electronic access to the by the Secretary of Homeland Security Authorization. under section 319F–2 of the Public Leslie Kux, FOR FURTHER INFORMATION CONTACT: Health Service (PHS) Act (42 U.S.C. Associate Commissioner for Policy. Carmen Maher, Office of 247d–6b) sufficient to affect national [FR Doc. 2016–09373 Filed 4–21–16; 8:45 am] Counterterrorism and Emerging Threats, security or the health and security of BILLING CODE 4164–01–P U.S. citizens living abroad. Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. Once the Secretary of HHS has DEPARTMENT OF HEALTH AND 4347, Silver Spring, MD 20993–0002, declared that circumstances exist HUMAN SERVICES 301–796–8510 (this is not a toll free justifying an authorization under number). section 564 of the FD&C Act, FDA may Food and Drug Administration SUPPLEMENTARY INFORMATION: authorize the emergency use of a drug, device, or biological product if the [Docket No. FDA–2014–N–1206] I. Background Agency concludes that the statutory Section 564 of the FD&C Act (21 criteria are satisfied. Under section Authorization of Emergency Use of an U.S.C. 360bbb–3), as amended by the 564(h)(1) of the FD&C Act, FDA is In Vitro Diagnostic Device for Project BioShield Act of 2004 (Pub. L. required to publish in the Federal Detection of Ebola Zaire Virus; 108–276) and the Pandemic and All- Register a notice of each authorization, Availability Hazards Preparedness Reauthorization and each termination or revocation of an AGENCY: Food and Drug Administration, Act of 2013 (Pub. L. 113–5), allows FDA authorization, and an explanation of the HHS. to strengthen the public health reasons for the action. Section 564 of the ACTION: Notice. protections against biological, chemical, FD&C Act permits FDA to authorize the nuclear, and radiological agents. Among introduction into interstate commerce of SUMMARY: The Food and Drug other things, section 564 of the FD&C a drug, device, or biological product Administration (FDA) is announcing the Act allows FDA to authorize the use of intended for use when the Secretary of issuance of an Emergency Use an unapproved medical product or an HHS has declared that circumstances Authorization (EUA) (the Authorization) unapproved use of an approved medical exist justifying the authorization of for an in vitro diagnostic device for product in certain situations. With this emergency use. Products appropriate for detection of the Ebola Zaire virus in EUA authority, FDA can help assure emergency use may include products mstockstill on DSK4VPTVN1PROD with NOTICES response to the Ebola virus outbreak in that medical countermeasures may be and uses that are not approved, cleared, West Africa. FDA issued this used in emergencies to diagnose, treat, or licensed under sections 505, 510(k), Authorization under the Federal Food, or prevent serious or life-threatening or 515 of the FD&C Act (21 U.S.C. 355, Drug, and Cosmetic Act (the FD&C Act), diseases or conditions caused by 360(k), and 360e) or section 351 of the as requested by OraSure Technologies, biological, chemical, nuclear, or PHS Act (42 U.S.C. 262). FDA may issue Inc. The Authorization contains, among radiological agents when there are no an EUA only if, after consultation with other things, conditions on the adequate, approved, and available the HHS Assistant Secretary for emergency use of the authorized in vitro alternatives. Preparedness and Response, the VerDate Sep<11>2014 19:18 Apr 21, 2016 Jkt 238001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\22APN1.SGM 22APN1

23710 Federal Register / Vol. 81, No. 78 / Friday, April 22, 2016 / Notices Director of the National Institutes of applicable; (3) that there is no adequate, Ebola virus, subject to the terms of any Health, and the Director of the Centers approved, and available alternative to authorization issued under section 564 for Disease Control and Prevention (to the product for diagnosing, preventing, of the FD&C Act. Notice of the the extent feasible and appropriate or treating such disease or condition; declaration of the Secretary was given the applicable circumstances), and (4) that such other criteria as may published in the Federal Register on FDA 1 concludes: (1) That an agent be prescribed by regulation are satisfied. August 12, 2014 (79 FR 47141). On referred to in a declaration of emergency No other criteria for issuance have February 29, 2016, OraSure or threat can cause a serious or life- been prescribed by regulation under Technologies, Inc. submitted a complete threatening disease or condition; (2) section 564(c)(4) of the FD&C Act. request for, and on March 4, 2016, FDA that, based on the totality of scientific Because the statute is self-executing, issued, an EUA for the OraQuick® Ebola evidence available to FDA, including regulations or guidance are not required Rapid Antigen Test, subject to the terms data from adequate and well-controlled for FDA to implement the EUA of the Authorization. clinical trials, if available, it is authority. III. Electronic Access reasonable to believe that: (A) The II. EUA Request for an In Vitro product may be effective in diagnosing, Diagnostic Device for Detection of the An electronic version of this treating, or preventing (i) such disease Ebola Zaire Virus document and the full text of the or condition; or (ii) a serious or life- Authorization are available on the threatening disease or condition caused On September 22, 2006, then- Secretary of DHS, Michael Chertoff, Internet at http://www.regulations.gov. by a product authorized under section 564, approved or cleared under the determined that the Ebola virus presents IV. The Authorization FD&C Act, or licensed under section 351 a material threat against the U.S. population sufficient to affect national Having concluded that the criteria for of the PHS Act, for diagnosing, treating, issuance of the Authorization under security.2 On August 5, 2014, under or preventing such a disease or section 564(c) of the FD&C Act are met, section 564(b)(1) of the FD&C Act and condition caused by such an agent; and FDA has authorized the emergency use on the basis of such determination, the (B) the known and potential benefits of of an in vitro diagnostic device for Secretary of HHS declared that the product, when used to diagnose, detection of Ebola Zaire virus (detected circumstances exist justifying the prevent, or treat such disease or in the West Africa outbreak in 2014) authorization of emergency use of in condition, outweigh the known and subject to the terms of the vitro diagnostic devices for detection of potential risks of the product, taking Authorization. The Authorization in its into consideration the material threat 2 Under section 564(b)(1) of the FD&C Act, the entirety (not including the authorized posed by the agent or agents identified HHS Secretary’s declaration that supports the EUA versions of the fact sheets and other in a declaration under section issuance must be based on one of four written materials) follows and provides 564(b)(1)(D) of the FD&C Act, if determinations, including the identification by the DHS Secretary of a material threat under section an explanation of the reasons for its 319F–2 of the PHS Act sufficient to affect national issuance, as required by section 1 The Secretary of HHS has delegated the security or the health and security of U.S. citizens authority to issue an EUA under section 564 of the living abroad (section 564(b)(1)(D) of the FD&C 564(h)(1) of the FD&C Act: FD&C Act to the Commissioner of Food and Drugs. Act). BILLING CODE 4164–01–P mstockstill on DSK4VPTVN1PROD with NOTICES VerDate Sep<11>2014 19:18 Apr 21, 2016 Jkt 238001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\22APN1.SGM 22APN1

Federal Register/Vol. 81, No. 78/Friday, April 22, 2016 /Notices 23711 i "{C DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration Silver Spring, MD 20893 March 4, 2016 Tiffany Miller, RAC Director, Regulatory Affairs OraSure Technologies, Inc. 220 East First Street Bethichem, PA 18015 Dear Ms. Miller: This letter is in responseto your request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for emergencyuse of the OraQuick® Ebola Rapid Antigen Test for the detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014)" in cadaveric oral fluid swab specimens from individuals with epidemctogical risk factors for Ebola virus infection and suspected to have died of Ebola. The test is intended to aid in diagnosing Ebola Zaire virus infection as the cause of death in order to inform decistons on safe and dignified burial procedures to prevent transmission of Ebota virus in the community. The test is to be used by personnel who are adequately equipped, trained, and capable oftesting for Ebota infection, in laboratories, facilities, and in field surveillance and response teams acting under the direction of public health authorities ("covered personnel"), pursuant to section 564 of the Federal Food, Drug. and Cosmeftic Aet (the Act) (21 L.S.C. § 360bbb—3). The OraQuick® Ebola Rapid Antigen Test for use with cadaveric orat fluidis not intended for use with oral fluid specimens from living individuals. On September 22, 2006, then—Secretary ofthe Department of Homeland Secuarity (DHS). Michael Chertoff, determined, pursuant to section 319F—2 ofthe 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 Acet (21 U.S.C. §360bbb—3(b)(1)), and onthe basis of such determination, the Secretary ofthe ‘ For purposes ofthis authorization, the term "OraQuick" Ebola Rapid Antigen Test" includes, in addifion to the OraQuick® Ebola Rapid Antigen Test Kit, the OraQuick® Ebola Rapid Antigen Test Kit Controls {quality control reagents interded for use only with the OraQuick® Ebola Rupid Antigen Test] and the OraQuick® Ebola Visual Reference Panel {intended to assist new operators in becoming proficient at reading specimens with attigen levels near the limit of detection ofthe device]. While the OraQuick" Ebols Rapid Antigen Test Kit Controls and OraQuick* Ebota Visual Reference Panel are both sold separately, under this authorization they must be used in conjunction with the OraQuick®Ebala Rapid Antigen Test Kit. * This assayis intended for the qualitative detection ofantigens from Ebola virus (specics Zaire cholavirus, detected in the West Africa outbreak in 2014), but may also detect antigens from Sudarrebotavirus and Bundibugye ebolavirus, however, it does not distinguish between these different Ebola virus species. ‘ Pursuant to section 564(b)(1) ofthe Act (21 ULS.C, § 360bbb—3(b)(1)); the HHS Secrctary‘s declaration that supports EUA issuance must be based on one offour determinations. including the identification by the DHS Secretary of a material threat pursuant to section 319F—2 ofthe PHS Act sufficient to affect national security or the health and security of United States citizens living abroad {section S64(M(TND) ofthe Act).

23712 Federal Register / Vol. 81, No. 78 / Friday, April 22, 2016 / Notices I. Criteria for Issuance of Authorization mstockstill on DSK4VPTVN1PROD with NOTICES EN22AP16.039</GPH> VerDate Sep<11>2014 19:18 Apr 21, 2016 Jkt 238001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4725 E:\FR\FM\22APN1.SGM 22APN1

Federal Register/Vol. 81, No. 78/Friday, April 22, 2016 /Notices 23713 Page 3 —Ms. Miller, OraSure Technologies, Inc. virus (detected in the West Africa outbreak in 2014) infection, outweigh the known and potential risks ofsuch product; and 3. There is no adequate, approved, and available alternative to the emergency use of the OraQuick® Ebola Rapid Antigen Test for use with cadaveric oral fluid as an aid in diagnosing Ebola Zaire virus (detected in the West Africa outbreak in 2014) infection as the cause of death to inform decisions on safe and dignified burial procedures to prevent transmission of Ebola virus in the community." 11. Scope of Authorization 1 have concluded, pursuant to section 564(d)(1) ofthe Act, that the scope of this authorization is limited to the use of the authorized OraQuick® Ebola Rapid Antigen Test by covered personnel for the detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) in cadaveric oral fluid swab specimens from individuals with epidermological risk factors for Ebola virus infection and suspected to have died of Ebola. The test is intended to aid in diagnosing Ebola Zaire virus infection as the cause ofdeath in order to inform decisions on safe and dignified burial procedures to prevent transmission of Ebola virus in the community. The authorized OraQuick® Ebola Rapid Antigen Test for use with cadaveric oral fluid is not intended for use with oral fluid specimens from living individuals. The Authorized OraQuick® Ebola Rapid Antigen Test The OraQuick® Ebola Rapid Antigen Test is a rapid single—use chromatographic lateral flow immunoassay contained within a rigid plastic device housing that is intended for the in vitro qualitative detection ofantigens from the Ebola Zaire virus (detected in the West Africa outbreak in 2014) in authorized specimen types. The OraQuick" Ebola Rapid Antigen Test utilizes a sandwich capture lateral flow immunoassay method to detect Ebola virus antigens. This lateral flow test is composed ofan assay strip with several components; the flat pad, the blocker pad, the conjugate pad, the nitrocellulose membrané {with a Test Line ("T") and a Control ("C") line}, and the absorbent pad. The clinical specimen is applied to the device followed by insertion ofthe device into the developer solution. The execution ofthe assay occurs as reagents are hydrated and Hiquid is transported along with the specimen across the strip towards the test zone. If Ebola viral antigens are present in the specimen, then they will be bound by biotinylated anti— Ebola polyclonal antibodies etuting from the blocker pad. These.complexed Ebola antigens will then form immunological sandwiches with signal generating colloidal gold labeled Ebola antibodies that are eluting from the conjugate pad. The immunclogical sandwich complex is subsequently captured through reaction of the biotinylated anti—Ebota antibody with the biotin binding protein streptavidin that is immobilized at the Test Line ("T") ofthe test strip. * Noother criteria of ssuance have been prescribed by regulation under section 564(c)(4) of the Act.

Page 4 — Ms. Miller, OraSure Technologies, Inc. The OraQuick® Ebola Rapid Antigen Test Kit is comprised of an OraQuick" Ebola Rapid Antigen Test device, a filled, capped and labeled Developer Vial, a device stand {used to hold the device during the running ofthetest following specimen collection), micropipettes, one quick reference guide for cadaveric oral fluid testing, and one package insert for cadaveric oral fluid testing. The OraQuick® Ebola Rapid Antigen Test Kit may also include one quick reference guide and one packageinsert for other currently authorized use(s). The OraQuick® Ebola Rapid Antigen Test device, the developer solution and the micropipettes to be used with the device are identical for both authorized test methods (ie., use with whole blood from a fiving individual, and for cadaveric oral fluid); however, the instructions for use are different. The test kit has a built—in procedural control that demonstrates assay validity. A purple line in the Control ("C")Y area of the Result Windowindicates that the fluid migrated appropriately through the Test Device. The Control line will appear on all valid tests, whether or not the sample is positive (Le., reactive) or negative (i.e., non—reactive). The cadaveric oral fluid specimens to be tested with the above described OraQuick®" Ebola Rapid Antigen Test are collected by swabbm,g,x the gum ofthe deceased individual. Swabbing can be performed directly with the Oraquick® Ebols Rapid Antigen Test device or with a validated and authorized swab that is z.uh%equem}y stored in a validated and authorized viral transport media. Please referto the Oraquick* Ebola Rapid Antigen Test — Instructions for Use — Cadaveric Oral Fluid for information on validated swabs and viral transport media. The OraQuick® Ebola Rapid Antigen Test Kit Controls must be used with the OraQuick® Ebola Rapid Antigen Test. The OraQuick® Ebola Rapid Antigen Test Kit Controls contain two vials, one Ebola positive control vial (Grange capped) and one Ebola negative control vial (white capped). The OraQuick® Ebola Visual Reference Panel is intended to assist new operators in becoming proficient at reading specimens with antigen levels—near the limit of detection ofthe device. It consists ofthree devices that have been specifically formulated and manufactured to represent positive results near the limit of detection, low positive, and utgatw; test results. New operators must be able to correctly mtf:rprct all devices of the OraQuick" Ebola Visual Reference Panel prior to using the OraQuick®" Ebola Rapid Antigen Test device. The above described OraQuick® Ebola Rapid Atmg,n;n Test, when labeled consistently with the labeling authorized by FDA entitled "OraQuick" Ebola Rapid Antigen Test Instructions for Use —Cadaveric Oral Fluid" (available at hitp w filk goy MedicalDevieces SafehEmerponcySittuations/uem161496 fitm}, which may be revised by OraSure Technologies, Inc. in consultation with FDA, is authorized to be distributed to laboratories, facilities, and public health authorities oversecing personnel adequately equipped, trained. and capable oftesting for Ebola virus, and stakeholders working with such public health authorities, despite the fact that it does not meet certain requirements otherwise required by federal law. The above described OraQuick"Ebola Rapid Antigen Test is authorized to be accompanied by the following information pertaining to the emergency use with cadaveric oral fluid, which is

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23716 Federal Register / Vol. 81, No. 78 / Friday, April 22, 2016 / Notices Miller, OraSure IV. Conditions of Authorization to section B. mstockstill on DSK4VPTVN1PROD with NOTICES EN22AP16.043</GPH> VerDate Sep<11>2014 19:18 Apr 21, 2016 Jkt 238001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4725 E:\FR\FM\22APN1.SGM 22APN1

Federal Register / Vol. 81, No. 78 / Friday, April 22, 2016 / Notices 23717 EUA. E. OraSure J. K. FDA. mstockstill on DSK4VPTVN1PROD with NOTICES EN22AP16.044</GPH> VerDate Sep<11>2014 19:18 Apr 21, 2016 Jkt 238001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4725 E:\FR\FM\22APN1.SGM 22APN1

23718 Federal Register/Vol. 81, No. 78/Friday, April 22, 2016 /Notices Page 8 — Ms. Miller, OraSure Technologies, Inc. M. OraSiure Technologies, Inc. may request the addition of other specimen types for use with the authorized OraQuick®Ebola Rapid Antigen Test, Such requests will be made by COraSure Technologies, Inc. in consultation with, and require concurrence of, FDA. OraSure Technologies, Inc. may request the addition ofother cadaveric oral fluid collection methods, mcludmgx other swab and/or viral transport media, for use with the authorized OraQuick® Ebola Rapid Antigen Test for use with cadaveric oral fluid. Such requests will be made by OraSure Technologies, Inc. in consultation with, and require concurrence of, FDA. OraSure Technologies, Inc. will track adverse events and report to FDA under 21 CFR Part 803. OraSure Technologies, Inc. will contact health care providers, public health authorities, and stakeholders working with such public health authorities in the event of any significant new findings that negatively impact the performance Uf the test and that are observed during the course ofthe emergency use of the OraQuick"® Ebola Rapid Antigen Test when used with cadaveric oral flnd. OraSure Technologies, Inc. will submit additional data (1e., an LOD study with cadaveric oral fluid swab specimens, a cross reactivity study for potential cross reacting organisms relevant to oral fluid and an interference study with potentially interfering substances relevant to oral fluid) to FDA no later than 6 months after authorization [September 4, 2016]. Laboratories, Facilities, and Public Health Authorities Oversceing Personnel Adcquately Equipped, Trained, and Capable of Testing for Ebola Infection, and Stakeholders Working with Such Public Health Authorities R. Laboratories, facilities, and public health authorities oversecing personnel adequately equipped, trained, and capable of testing for Ebola infection, and stakeholders working with such public health authorities, will provide the authorized Fact Sheet for Response Teams to personnel performing the cadaveric oral fluid testing, and will include with reports of the OraQuick® Ebola Rapid Antigen Test results the authorized Fact Sheet for Relatives and Caregivers. Under exigent cireumstances, other appropriate methods for disseminating these Fact Sheets may be used, which may include mass media. Laboratories, facilities, and public health authorities oversecing personnel adequately equipped, trained, and capable of testing for Ebola infection, and stakeholders working with such public health authorities, will have a process in place for the personnel performing the test to report test results back to the overseeing entity and to health care professionals, as appropriate. Laboratories, facilities, and public health authorities overseeing personnel adequately equipped, trained, and capable oftesting for Ebola infection, and stakeholders working with such public health authorities, will collect information on the performance ofthe

Federal Register/Vol. 81, No. 78/Friday, April 22, 2016 /Notices 23719 Page 9 —Ms. Miller, OraSure Technologies, Inc. assay, and report to OraSure Technologies, Inc. and any authorized distributor(s) any suspected occurrence of false positive or false negative results of which they become aware. U. All covered personnel will be appropriately trained on the OraQuick" Eboala Rapid Antigen Test and use appropriate laboratory and/or personal protective equipment when handling this kit, OraSure Technologies, Inc., Any Authorized Distributor(s), and Laboratories, Facilitics, and Public Health Authorities Oversceing Personnel Adequately Equipped, Trained, and Capable of Testing for Ebola Infection, and Stakeholders Working with Such Public Health Authorities V. OraSure Technologies, Inc., any authorized distributor(s), and laboratories, facilities, and public health authorities oversecing personnel adequately equipped, trained, and capable oftesting for Ebola infection, and stakeholders working with such public health authorities, will ensure that any records associated with this EUA are maintaimed until notified by FDA. Such records will be made available to FDA for inspection upon request. Conditions Related to Advertising and Promotion W . All advertising and promotional descriptive printed matter relating to the use ofthe authorized OraQuick® Ebola Rapid Antigen Test shall be conststent 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. X. Alladvertising and promotional descriptive printed matter relating to the use of the authorized OraQuick® Ebola Rapid Antigen Test shall clearly and conspicuously state that: e This test has not been FDA cleared or approved; * This test has been authorized by FDA under an EUA for use by personnel who are adequately equipped, trained, and capable of testing for Ebola infection, in laboratories, facifities, and in freld surveiflance and response teams acting under the direction of public health authorities; a This test has been authorized only for the detection of Ebola Zaire virus {detected in the West Africa outbreak in 2014); and * This test has not been authorized for use with oral fluid from Eving individuals e This test is authorized only for the duration of the declaration that cireumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection

23720 Federal Register / Vol. 81, No. 78 / Friday, April 22, 2016 / Notices Dated: April 18, 2016. intend to export certain unapproved written/paper submission and in the Leslie Kux, medical devices. manner detailed (see ‘‘Written/Paper Associate Commissioner for Policy. DATES: Submit either electronic or Submissions’’ and ‘‘Instructions’’). [FR Doc. 2016–09369 Filed 4–21–16; 8:45 am] written comments on the collection of Written/Paper Submissions BILLING CODE 4164–01–C information by June 21, 2016. Submit written/paper submissions as ADDRESSES: You may submit comments follows: as follows: • Mail/Hand delivery/Courier (for DEPARTMENT OF HEALTH AND HUMAN SERVICES Electronic Submissions written/paper submissions): Division of Dockets Management (HFA–305), Food Submit electronic comments in the and Drug Administration, 5630 Fishers Food and Drug Administration following way: Lane, Rm. 1061, Rockville, MD 20852. [Docket No. FDA–2013–N–0370] • Federal eRulemaking Portal: http:// • For written/paper comments www.regulations.gov. Follow the submitted to the Division of Dockets Agency Information Collection instructions for submitting comments. Management, FDA will post your Activities; Proposed Collection; Comments submitted electronically, comment, as well as any attachments, Comment Request; Export of Medical including attachments, to http:// except for information submitted, Devices; Foreign Letters of Approval www.regulations.gov will be posted to marked and identified, as confidential, AGENCY: Food and Drug Administration, the docket unchanged. Because your if submitted as detailed in HHS. comment will be made public, you are ‘‘Instructions.’’ ACTION: Notice. solely responsible for ensuring that your Instructions: All submissions received comment does not include any must include the Docket No. FDA– SUMMARY: The Food and Drug confidential information that you or a 2013–N–0370 for ‘‘Agency Information Administration (FDA) is announcing an third party may not wish to be posted, Collection Activities; Proposed opportunity for public comment on the such as medical information, your or Collection; Comment Request; Export of proposed collection of certain anyone else’s Social Security number, or Medical Devices; Foreign Letters of information by the Agency. Under the confidential business information, such Approval.’’ Received comments will be Paperwork Reduction Act of 1995 (the as a manufacturing process. Please note placed in the docket and, except for PRA), Federal Agencies are required to that if you include your name, contact those submitted as ‘‘Confidential mstockstill on DSK4VPTVN1PROD with NOTICES publish notice in the Federal Register information, or other information that Submissions,’’ publicly viewable at concerning each proposed collection of identifies you in the body of your http://www.regulations.gov or at the information, including each proposed comments, that information will be Division of Dockets Management extension of an existing collection of posted on http://www.regulations.gov. between 9 a.m. and 4 p.m., Monday information, and to allow 60 days for • If you want to submit a comment through Friday. public comment in response to the with confidential information that you • Confidential Submissions—To notice. This notice solicits comments on do not wish to be made available to the submit a comment with confidential EN22AP16.047</GPH> reporting requirements for firms that public, submit the comment as a information that you do not wish to be VerDate Sep<11>2014 19:18 Apr 21, 2016 Jkt 238001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\22APN1.SGM 22APN1


Document Created: 2017-08-22 23:37:25
Document Modified: 2017-08-22 23:37:25
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 is effective as of March 4, 2016.
ContactCarmen 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).
FR Citation81 FR 23709 
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